Conflicts of Interest Disclosure Form

This form should be submitted annually and updated within 30 days of any material change.

I certify that the above information is complete and true to the best of my knowledge and that I have read the New York Structural Biology Center’s (the “Center”) Policy on Conflict of Interest. This information is provided with the understanding that review of it will be conducted in confidence under Center procedures. The information may be released by the Center only 1) in statistical or aggregate form that protects my privacy, or 2) to comply with the requirements of the sponsors of my research, or 3) as may be required to comply with Center policies and procedures or any applicable legal requirements, or 4) with my written permission.

Contents of COI Policy

NEW YORK STRUCTURAL BIOLOGY CENTER -- CONFLICT OF INTEREST POLICY – RESEARCH -- Active January 2002.

I. Introduction

The objective of this policy is to facilitate professional opportunity and sponsorship of research while minimizing conflict and managing that conflict that remains.

The Conflicts of Interest Policy applies to each employee of the New York Structural Biology Center (the “Center”), or independent contractor conducting research on behalf of and/or under agreement with the Center, who is responsible for the design, conduct, or reporting of research (collectively, an “Investigator”). The Center shall require every such individual to complete, on an annual basis and updated within thirty days of any material changes, a disclosure statement (the “Conflicts of Interest Disclosure Form”). The Conflicts of Interest Disclosure Form is attached as Attachment A. The financial interests and fiduciary positions that must be disclosed are those that relate to an Investigator’s research. If an Investigator’s Conflicts of Interest Disclosure Form reflects conflict, assistance will be provided to reduce the conflict and to manage that which persists.

An individual conducting research at the Center, but not on behalf of the Center, and who is not an employee of the Center, shall be governed by the conflicts of interest policy of the institution with which such individual is affiliated for purposes of such research and not by the Center’s Conflict of Interest Policy.

Disclosure of conflict will not impose a bar to science; it will merely occasion the need for appropriate management.

II. Summary of Policy

An Investigator has a conflict of interest where his or her significant financial interest (defined, infra), or fiduciary position, in an entity could directly and significantly affect the design, conduct, analysis or reporting of research.

To determine whether there is such a conflict, an Investigator will report to the Center all those financial interests and fiduciary positions that are relevant to the Investigator’s research (e.g., the Investigator is an inventor whose research is sponsored by the company holding the license on the Investigator’s invention; or the Investigator holds equity in a company whose product is being clinically tested by the Investigator, or the Investigator is an officer of a company whose current or future valuation or profits could be affected by the Investigator’s research.).

In each such case, the investigator’s financial holdings or fiduciary positions are relevant to the Investigator’s work though they may not be “significant financial interests” or may not have the potential directly and significantly to affect the research. All relevant interests and positions must be disclosed so that a finding may be made as to whether there is a conflict. If a conflict exists, it must be eliminated, reduced or managed so that the Investigator’s research may go forward.

Conflicts shall be overseen and managed by the Center’s Conflicts Review Committee, headed by the President of the Center.

III. Federal Laws and Regulations on Conflict of Interest

A. Federal Definition of Conflict of Interest

The Center’s policy on conflict of interest is predicated on federal legal requirements found in two documents: regulations of the Public Health Service (PHS) governing PHS-supported research[1] and regulations of the Food and Drug Administration (FDA) governing clinical studies submitted in marketing applications for new human drugs, biologics and certain medical devices.[2]

PHS and FDA do not have identical rules. Where the agencies’ policies conflict, generally, we satisfy the stricter rule. Where one agency’s mandates are additional to (not in conflict with) those of the other, both sets of rules apply.

The key definition is “conflict of interest.” Each agency’s approach is set out below.

PHS Definition. A conflict of interest exists when a significant financial interest could directly and significantly affect the design, conduct or reporting of research.

FDA Definition. The central FDA notion is the concept of “Compensation affected by the outcome of clinical studies.” In FDA’s regulation, that term “…means compensation that could be higher for a favorable outcome than for an unfavorable outcome such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.”

Importantly, neither approach requires consideration of an investigator’s motive in doing her or his work or any finding that bias has actually crept into the scientific enterprise.

The regulations then both turn to the financial interests or compensation arrangements that give rise to potential conflicts of interest. Again, each agency has its own approach.

B. Federal Definition of Financial Entanglements

• salary or other payments for services (e.g., consulting fees or honoraria),
• intellectual property rights (e.g., patents, copyrights and royalties from such rights), or
• equity interests (e.g., stocks, stock options or other ownership interests of the Investigator and her or his spouse and dependent children that exceed $10,000 in public price or by another reasonable measure of fair market value and that represent more than a 5% ownership in any entity.)

Per the PHS, Significant Financial Interest does not include

• salary, royalties or other remuneration from the Center to its employees,
• income from seminars, lectures or teaching sponsored by public or non-profit entities,
• income from service on advisory committees or review panels for public or non-profit entities, or
• salary, royalties or other payments that when aggregated for the Investigator and her or his spouse and dependent children over the next 12 months are not expected to exceed $10,000.

2. FDA Compensation Affected by the Outcome of Clinical Studies. Per the FDA, such compensation includes:

• significant equity interests (ownership, stock options or other financial interest) in a non-publicly traded entity,
• equity in excess of $50,000 in a publicly traded entity during the time of a clinical trial or for 1 year thereafter,
• a proprietary or other financial interest including but not limited to patent or licensing agreements, and
• significant payments of other sorts that have monetary value of over $25,000 (not including the costs of the clinical studies) such as research grants, equipment and on-going consultation or honoraria during the clinical study and for 12 months thereafter.

As is reflected below, the Center’s policy incorporates elements of both the PHS and FDA requirements regarding relevant financial entanglements. The Center’s Policy also addresses fiduciary positions

IV. The Center’s Policy on Conflict of Interest Generally

The following is the definition in the Center’s policy of conflict of interest.

A conflict of interest exists when an Investigator, defined as an employee of the Center, or an independent contractor conducting research on behalf of and/or under an agreement with the Center, has a significant financial interest in an entity, or position as a fiduciary of an entity, which interest or position could directly and significantly affect the design, conduct, analysis or reporting of research.

The standard requires (i) a significant financial interest (defined elsewhere in our policy, see infra) or a fiduciary position (e.g. a senior manager, officer or director), (ii) the possibility of an effect on research, and (iii) the requirement that such potential effect be direct and significant. Importantly, full disclosure of any potential conflict is required. Only thereafter can a decision be made whether the potential conflict is actual, requiring reduction, elimination or management.

V. The Center’s Policy on Significant Financial Interest and Fiduciary Position

A. Significant Financial Interest and Fiduciary Position

1. The Center’s definition of a significant financial interest is consistent with federal regulations.

Significant Financial Interest under the Center’s Policy is anything of monetary value acquired or held by the Investigator and her or his immediate family (spouse and dependent children) including but not limited to salary or other payments for intellectual property rights or services; equity interests in a privately-held entity and in a publicly traded entity with the exception of:

1. Salary, royalties, or other remuneration from the Center or

2. An equity interest in business enterprises or entities that when aggregated is both not more than $10,000 and is not more than 5% ownership interest; or

3. Salary, royalties or other payment obligations or expectations that when aggregated during the research and for the twelve months following its termination, are not expected to exceed $10,000.

2. The Center has chosen to include within its conflict of interest, “fiduciary positions.” The Center’s definition of a “fiduciary position” is as follows:

Fiduciary Interest includes a position as an officer, director, senior manager, or its equivalent thereof, held by an Investigator or his or her immediate family.

Note that an Investigator need disclose only financial interests and fiduciary positions relevant to his or her research.

Note that though FDA set the permissible public company equity holdings at $50,000, the Center is bound by the stricter PHS $10,000 rule. And because FDA looks at payments made or expectations held both during the research and for twelve months thereafter, we conform to that as the more restrictive dictate.

VI. Procedures for Disclosure and Managing Conflict

A. Review of Disclosures

A completed Conflicts of Interest Disclosure Form shall be provided annually by each Investigator and returned to the Executive Officer. These forms must be updated within thirty days of any material changes. Those forms that include disclosure of a financial interest or a fiduciary position shall be delivered to the Center’s Counsel for review. Counsel shall make a determination whether, in his or her opinion a conflict of interest exists, that is, if he or she believes that such significant financial interest or that such fiduciary position disclosed could affect the design, conduct or reporting of the research or educational activities, which are the subject of a grant application.

If Counsel concludes that a conflict exists, he or she shall so inform the President of the Center, who shall in turn inform the Conflicts Review Committee. The Conflicts Review Committee shall be established by the Center’s Board (or, until the Conflicts Review Committee is formally constituted, the Conflicts Review Committee shall be comprised of the President and two other designees appointed by the Executive Committee of the Board). Counsel shall also inform such Investigator. The Conflicts Review Committee shall oversee the management and resolution of actual or potential problems revealed. In the case of a conflict that involves a member of the Conflicts Review Committee, the Executive Committee of the Board shall appoint a substitute for such member for oversight and resolution of the conflict in question.

B. Management and Resolution of Conflicts

Those charged with oversight will manage and resolve conflicts by any or all of the following means:

• public disclosure of significant financial interest or fiduciary position;
• monitoring of research by independent reviewers;
• modification of the research plan;
• disqualification from participation in the portion of the research funded by the applicable agency;
• divestiture of significant financial interest; or
• severance of relationships that create actual or potential conflicts;
• such other or further conditions, limitations, disclosure, reviews or actions as the Conflicts Review Committee deems appropriate.

C. Enforcement

It is the policy of the Center to require full compliance with the management and resolution of the conflicting interests as recommended by the Conflicts Review Committee. The conditions and restrictions proposed must be instituted before submission of the subject grant application. Violations of this Policy will be referred to the Conflicts Review Committee for appropriate enforcement action for failure to comply. If the failure to comply with this Policy has biased the design, conduct or reporting of the funded research, the Center will promptly notify the appropriate funding agency that the corrective action it has or will take.

D. Maintenance of Records

The Conflicts Review Committee shall maintain records, identifiable to each award, of all financial disclosures, including, but not limited to, the Conflicts of Interest Disclosure Form and of all actions taken to resolve actual or potential conflicts of interest until at least three (3) years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

E. Obligation to Disclose to Agency or Department of Health and Human Services

The Center may have an obligation, prior to the expenditure of any funds under an award, to advise the applicable governmental granting agency or the Department of Health and Human Services (“HHS”) of any conflicting interest (but not the nature of the interest or other details) found by the institution and assure such agency or HHS that the interest has been managed, reduced, or eliminated to protect the research from bias in accordance with all applicable law and regulations; and for any interest that the Center identifies as conflicting subsequent to the Center’s initial report under the award, the report will be made and the conflicting interest managed, reduced or eliminated, at least on an interim basis, within sixty days of such identification. The Center also has the responsibility to keep the applicable granting agency fully informed if the Center finds that it is unable to satisfactorily manage an actual or potential conflict of interest.

The Center shall make information available, upon request, to HHS regarding all conflicting interests identified by the Center and how those interests have been managed, reduced or eliminated to protect research from bias.

[1] 42 C.F.R. Part 50 Subpart F and Part 94.

[2] 21 C.F.R. Part 54. The regulation regarding National Science Foundation research awards with respect to conflicts of interest are very close in content to the PHS rules. Should the Center contemplate applying for an NSF research award, however, the Policy should be reviewed to confirm compliance with NSF rules.

-- DhireshVyas - 30 May 2006

Conflicts of Interest Disclosure Form

This form should be submitted annually and updated within 30 days of any material change.

Contents of COI Policy

NEW YORK STRUCTURAL BIOLOGY CENTER -- CONFLICT OF INTEREST POLICY – RESEARCH -- Active January 2002.

I. Introduction

The objective of this policy is to facilitate professional opportunity and sponsorship of research while minimizing conflict and managing that conflict that remains.

The Conflicts of Interest Policy applies to each employee of the New York Structural Biology Center (the “Center”), or independent contractor conducting research on behalf of and/or under agreement with the Center, who is responsible for the design, conduct, or reporting of research (collectively, an “Investigator”). The Center shall require every such individual to complete, on an annual basis and updated within thirty days of any material changes, a disclosure statement (the “Conflicts of Interest Disclosure Form”). The Conflicts of Interest Disclosure Form is attached as Attachment A. The financial interests and fiduciary positions that must be disclosed are those that relate to an Investigator’s research. If an Investigator’s Conflicts of Interest Disclosure Form reflects conflict, assistance will be provided to reduce the conflict and to manage that which persists.

An individual conducting research at the Center, but not on behalf of the Center, and who is not an employee of the Center, shall be governed by the conflicts of interest policy of the institution with which such individual is affiliated for purposes of such research and not by the Center’s Conflict of Interest Policy.

Disclosure of conflict will not impose a bar to science; it will merely occasion the need for appropriate management.

II. Summary of Policy

An Investigator has a conflict of interest where his or her significant financial interest (defined, infra), or fiduciary position, in an entity could directly and significantly affect the design, conduct, analysis or reporting of research.

To determine whether there is such a conflict, an Investigator will report to the Center all those financial interests and fiduciary positions that are relevant to the Investigator’s research (e.g., the Investigator is an inventor whose research is sponsored by the company holding the license on the Investigator’s invention; or the Investigator holds equity in a company whose product is being clinically tested by the Investigator, or the Investigator is an officer of a company whose current or future valuation or profits could be affected by the Investigator’s research.).

In each such case, the investigator’s financial holdings or fiduciary positions are relevant to the Investigator’s work though they may not be “significant financial interests” or may not have the potential directly and significantly to affect the research. All relevant interests and positions must be disclosed so that a finding may be made as to whether there is a conflict. If a conflict exists, it must be eliminated, reduced or managed so that the Investigator’s research may go forward.

Conflicts shall be overseen and managed by the Center’s Conflicts Review Committee, headed by the President of the Center.

III. Federal Laws and Regulations on Conflict of Interest

A. Federal Definition of Conflict of Interest

The Center’s policy on conflict of interest is predicated on federal legal requirements found in two documents: regulations of the Public Health Service (PHS) governing PHS-supported research[1] and regulations of the Food and Drug Administration (FDA) governing clinical studies submitted in marketing applications for new human drugs, biologics and certain medical devices.[2]

PHS and FDA do not have identical rules. Where the agencies’ policies conflict, generally, we satisfy the stricter rule. Where one agency’s mandates are additional to (not in conflict with) those of the other, both sets of rules apply.

The key definition is “conflict of interest.” Each agency’s approach is set out below.

PHS Definition. A conflict of interest exists when a significant financial interest could directly and significantly affect the design, conduct or reporting of research.

FDA Definition. The central FDA notion is the concept of “Compensation affected by the outcome of clinical studies.” In FDA’s regulation, that term “…means compensation that could be higher for a favorable outcome than for an unfavorable outcome such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.”

Importantly, neither approach requires consideration of an investigator’s motive in doing her or his work or any finding that bias has actually crept into the scientific enterprise.

The regulations then both turn to the financial interests or compensation arrangements that give rise to potential conflicts of interest. Again, each agency has its own approach.

B. Federal Definition of Financial Entanglements

• salary or other payments for services (e.g., consulting fees or honoraria),
• intellectual property rights (e.g., patents, copyrights and royalties from such rights), or
• equity interests (e.g., stocks, stock options or other ownership interests of the Investigator and her or his spouse and dependent children that exceed $10,000 in public price or by another reasonable measure of fair market value and that represent more than a 5% ownership in any entity.)

Per the PHS, Significant Financial Interest does not include

• salary, royalties or other remuneration from the Center to its employees,
• income from seminars, lectures or teaching sponsored by public or non-profit entities,
• income from service on advisory committees or review panels for public or non-profit entities, or
• salary, royalties or other payments that when aggregated for the Investigator and her or his spouse and dependent children over the next 12 months are not expected to exceed $10,000.

2. FDA Compensation Affected by the Outcome of Clinical Studies. Per the FDA, such compensation includes:

• significant equity interests (ownership, stock options or other financial interest) in a non-publicly traded entity,
• equity in excess of $50,000 in a publicly traded entity during the time of a clinical trial or for 1 year thereafter,
• a proprietary or other financial interest including but not limited to patent or licensing agreements, and
• significant payments of other sorts that have monetary value of over $25,000 (not including the costs of the clinical studies) such as research grants, equipment and on-going consultation or honoraria during the clinical study and for 12 months thereafter.

As is reflected below, the Center’s policy incorporates elements of both the PHS and FDA requirements regarding relevant financial entanglements. The Center’s Policy also addresses fiduciary positions

IV. The Center’s Policy on Conflict of Interest Generally

The following is the definition in the Center’s policy of conflict of interest.

A conflict of interest exists when an Investigator, defined as an employee of the Center, or an independent contractor conducting research on behalf of and/or under an agreement with the Center, has a significant financial interest in an entity, or position as a fiduciary of an entity, which interest or position could directly and significantly affect the design, conduct, analysis or reporting of research.

The standard requires (i) a significant financial interest (defined elsewhere in our policy, see infra) or a fiduciary position (e.g. a senior manager, officer or director), (ii) the possibility of an effect on research, and (iii) the requirement that such potential effect be direct and significant. Importantly, full disclosure of any potential conflict is required. Only thereafter can a decision be made whether the potential conflict is actual, requiring reduction, elimination or management.

V. The Center’s Policy on Significant Financial Interest and Fiduciary Position

A. Significant Financial Interest and Fiduciary Position

1. The Center’s definition of a significant financial interest is consistent with federal regulations.

Significant Financial Interest under the Center’s Policy is anything of monetary value acquired or held by the Investigator and her or his immediate family (spouse and dependent children) including but not limited to salary or other payments for intellectual property rights or services; equity interests in a privately-held entity and in a publicly traded entity with the exception of:

1. Salary, royalties, or other remuneration from the Center or

2. An equity interest in business enterprises or entities that when aggregated is both not more than $10,000 and is not more than 5% ownership interest; or

3. Salary, royalties or other payment obligations or expectations that when aggregated during the research and for the twelve months following its termination, are not expected to exceed $10,000.

2. The Center has chosen to include within its conflict of interest, “fiduciary positions.” The Center’s definition of a “fiduciary position” is as follows:

Fiduciary Interest includes a position as an officer, director, senior manager, or its equivalent thereof, held by an Investigator or his or her immediate family.

Note that an Investigator need disclose only financial interests and fiduciary positions relevant to his or her research.

Note that though FDA set the permissible public company equity holdings at $50,000, the Center is bound by the stricter PHS $10,000 rule. And because FDA looks at payments made or expectations held both during the research and for twelve months thereafter, we conform to that as the more restrictive dictate.

VI. Procedures for Disclosure and Managing Conflict

A. Review of Disclosures

A completed Conflicts of Interest Disclosure Form shall be provided annually by each Investigator and returned to the Executive Officer. These forms must be updated within thirty days of any material changes. Those forms that include disclosure of a financial interest or a fiduciary position shall be delivered to the Center’s Counsel for review. Counsel shall make a determination whether, in his or her opinion a conflict of interest exists, that is, if he or she believes that such significant financial interest or that such fiduciary position disclosed could affect the design, conduct or reporting of the research or educational activities, which are the subject of a grant application.

If Counsel concludes that a conflict exists, he or she shall so inform the President of the Center, who shall in turn inform the Conflicts Review Committee. The Conflicts Review Committee shall be established by the Center’s Board (or, until the Conflicts Review Committee is formally constituted, the Conflicts Review Committee shall be comprised of the President and two other designees appointed by the Executive Committee of the Board). Counsel shall also inform such Investigator. The Conflicts Review Committee shall oversee the management and resolution of actual or potential problems revealed. In the case of a conflict that involves a member of the Conflicts Review Committee, the Executive Committee of the Board shall appoint a substitute for such member for oversight and resolution of the conflict in question.

B. Management and Resolution of Conflicts

Those charged with oversight will manage and resolve conflicts by any or all of the following means:

• public disclosure of significant financial interest or fiduciary position;
• monitoring of research by independent reviewers;
• modification of the research plan;
• disqualification from participation in the portion of the research funded by the applicable agency;
• divestiture of significant financial interest; or
• severance of relationships that create actual or potential conflicts;
• such other or further conditions, limitations, disclosure, reviews or actions as the Conflicts Review Committee deems appropriate.

C. Enforcement

It is the policy of the Center to require full compliance with the management and resolution of the conflicting interests as recommended by the Conflicts Review Committee. The conditions and restrictions proposed must be instituted before submission of the subject grant application. Violations of this Policy will be referred to the Conflicts Review Committee for appropriate enforcement action for failure to comply. If the failure to comply with this Policy has biased the design, conduct or reporting of the funded research, the Center will promptly notify the appropriate funding agency that the corrective action it has or will take.

D. Maintenance of Records

The Conflicts Review Committee shall maintain records, identifiable to each award, of all financial disclosures, including, but not limited to, the Conflicts of Interest Disclosure Form and of all actions taken to resolve actual or potential conflicts of interest until at least three (3) years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

E. Obligation to Disclose to Agency or Department of Health and Human Services

The Center may have an obligation, prior to the expenditure of any funds under an award, to advise the applicable governmental granting agency or the Department of Health and Human Services (“HHS”) of any conflicting interest (but not the nature of the interest or other details) found by the institution and assure such agency or HHS that the interest has been managed, reduced, or eliminated to protect the research from bias in accordance with all applicable law and regulations; and for any interest that the Center identifies as conflicting subsequent to the Center’s initial report under the award, the report will be made and the conflicting interest managed, reduced or eliminated, at least on an interim basis, within sixty days of such identification. The Center also has the responsibility to keep the applicable granting agency fully informed if the Center finds that it is unable to satisfactorily manage an actual or potential conflict of interest.

The Center shall make information available, upon request, to HHS regarding all conflicting interests identified by the Center and how those interests have been managed, reduced or eliminated to protect research from bias.

[1] 42 C.F.R. Part 50 Subpart F and Part 94.

[2] 21 C.F.R. Part 54. The regulation regarding National Science Foundation research awards with respect to conflicts of interest are very close in content to the PHS rules. Should the Center contemplate applying for an NSF research award, however, the Policy should be reviewed to confirm compliance with NSF rules.

-- DhireshVyas - 30 May 2006

Conflicts of Interest Disclosure Form

This form should be submitted annually and updated within 30 days of any material change.

I certify that the above information is complete and true to the best of my knowledge and that I have read the New York Structural Biology Center’s (the “Center”) Policy on Conflict of Interest. This information is provided with the understanding that review of it will be conducted in confidence under Center procedures. The information may be released by the Center only 1) in statistical or aggregate form that protects my privacy, or 2) to comply with the requirements of the sponsors of my research, or 3) as may be required to comply with Center policies and procedures or any applicable legal requirements, or 4) with my written permission.

I acknowledge my obligation to submit an updated disclosure statement annually or when there is any change in my activities or financial interests otherwise reportable on this form.

Contents of COI Policy

NEW YORK STRUCTURAL BIOLOGY CENTER -- CONFLICT OF INTEREST POLICY – RESEARCH -- Active January 2002.

I. Introduction

The objective of this policy is to facilitate professional opportunity and sponsorship of research while minimizing conflict and managing that conflict that remains.

The Conflicts of Interest Policy applies to each employee of the New York Structural Biology Center (the “Center”), or independent contractor conducting research on behalf of and/or under agreement with the Center, who is responsible for the design, conduct, or reporting of research (collectively, an “Investigator”). The Center shall require every such individual to complete, on an annual basis and updated within thirty days of any material changes, a disclosure statement (the “Conflicts of Interest Disclosure Form”). The Conflicts of Interest Disclosure Form is attached as Attachment A. The financial interests and fiduciary positions that must be disclosed are those that relate to an Investigator’s research. If an Investigator’s Conflicts of Interest Disclosure Form reflects conflict, assistance will be provided to reduce the conflict and to manage that which persists.

An individual conducting research at the Center, but not on behalf of the Center, and who is not an employee of the Center, shall be governed by the conflicts of interest policy of the institution with which such individual is affiliated for purposes of such research and not by the Center’s Conflict of Interest Policy.

Disclosure of conflict will not impose a bar to science; it will merely occasion the need for appropriate management.

II. Summary of Policy

An Investigator has a conflict of interest where his or her significant financial interest (defined, infra), or fiduciary position, in an entity could directly and significantly affect the design, conduct, analysis or reporting of research.

To determine whether there is such a conflict, an Investigator will report to the Center all those financial interests and fiduciary positions that are relevant to the Investigator’s research (e.g., the Investigator is an inventor whose research is sponsored by the company holding the license on the Investigator’s invention; or the Investigator holds equity in a company whose product is being clinically tested by the Investigator, or the Investigator is an officer of a company whose current or future valuation or profits could be affected by the Investigator’s research.).

In each such case, the investigator’s financial holdings or fiduciary positions are relevant to the Investigator’s work though they may not be “significant financial interests” or may not have the potential directly and significantly to affect the research. All relevant interests and positions must be disclosed so that a finding may be made as to whether there is a conflict. If a conflict exists, it must be eliminated, reduced or managed so that the Investigator’s research may go forward.

Conflicts shall be overseen and managed by the Center’s Conflicts Review Committee, headed by the President of the Center.

III. Federal Laws and Regulations on Conflict of Interest

A. Federal Definition of Conflict of Interest

The Center’s policy on conflict of interest is predicated on federal legal requirements found in two documents: regulations of the Public Health Service (PHS) governing PHS-supported research[1] and regulations of the Food and Drug Administration (FDA) governing clinical studies submitted in marketing applications for new human drugs, biologics and certain medical devices.[2]

PHS and FDA do not have identical rules. Where the agencies’ policies conflict, generally, we satisfy the stricter rule. Where one agency’s mandates are additional to (not in conflict with) those of the other, both sets of rules apply.

The key definition is “conflict of interest.” Each agency’s approach is set out below.

PHS Definition. A conflict of interest exists when a significant financial interest could directly and significantly affect the design, conduct or reporting of research.

FDA Definition. The central FDA notion is the concept of “Compensation affected by the outcome of clinical studies.” In FDA’s regulation, that term “…means compensation that could be higher for a favorable outcome than for an unfavorable outcome such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.”

Importantly, neither approach requires consideration of an investigator’s motive in doing her or his work or any finding that bias has actually crept into the scientific enterprise.

The regulations then both turn to the financial interests or compensation arrangements that give rise to potential conflicts of interest. Again, each agency has its own approach.

B. Federal Definition of Financial Entanglements

• salary or other payments for services (e.g., consulting fees or honoraria),
• intellectual property rights (e.g., patents, copyrights and royalties from such rights), or
• equity interests (e.g., stocks, stock options or other ownership interests of the Investigator and her or his spouse and dependent children that exceed $10,000 in public price or by another reasonable measure of fair market value and that represent more than a 5% ownership in any entity.)

Per the PHS, Significant Financial Interest does not include

• salary, royalties or other remuneration from the Center to its employees,
• income from seminars, lectures or teaching sponsored by public or non-profit entities,
• income from service on advisory committees or review panels for public or non-profit entities, or
• salary, royalties or other payments that when aggregated for the Investigator and her or his spouse and dependent children over the next 12 months are not expected to exceed $10,000.

2. FDA Compensation Affected by the Outcome of Clinical Studies. Per the FDA, such compensation includes:

• significant equity interests (ownership, stock options or other financial interest) in a non-publicly traded entity,
• equity in excess of $50,000 in a publicly traded entity during the time of a clinical trial or for 1 year thereafter,
• a proprietary or other financial interest including but not limited to patent or licensing agreements, and
• significant payments of other sorts that have monetary value of over $25,000 (not including the costs of the clinical studies) such as research grants, equipment and on-going consultation or honoraria during the clinical study and for 12 months thereafter.

As is reflected below, the Center’s policy incorporates elements of both the PHS and FDA requirements regarding relevant financial entanglements. The Center’s Policy also addresses fiduciary positions

IV. The Center’s Policy on Conflict of Interest Generally

The following is the definition in the Center’s policy of conflict of interest.

A conflict of interest exists when an Investigator, defined as an employee of the Center, or an independent contractor conducting research on behalf of and/or under an agreement with the Center, has a significant financial interest in an entity, or position as a fiduciary of an entity, which interest or position could directly and significantly affect the design, conduct, analysis or reporting of research.

The standard requires (i) a significant financial interest (defined elsewhere in our policy, see infra) or a fiduciary position (e.g. a senior manager, officer or director), (ii) the possibility of an effect on research, and (iii) the requirement that such potential effect be direct and significant. Importantly, full disclosure of any potential conflict is required. Only thereafter can a decision be made whether the potential conflict is actual, requiring reduction, elimination or management.

V. The Center’s Policy on Significant Financial Interest and Fiduciary Position

A. Significant Financial Interest and Fiduciary Position

1. The Center’s definition of a significant financial interest is consistent with federal regulations.

Significant Financial Interest under the Center’s Policy is anything of monetary value acquired or held by the Investigator and her or his immediate family (spouse and dependent children) including but not limited to salary or other payments for intellectual property rights or services; equity interests in a privately-held entity and in a publicly traded entity with the exception of:

1. Salary, royalties, or other remuneration from the Center or

2. An equity interest in business enterprises or entities that when aggregated is both not more than $10,000 and is not more than 5% ownership interest; or

3. Salary, royalties or other payment obligations or expectations that when aggregated during the research and for the twelve months following its termination, are not expected to exceed $10,000.

2. The Center has chosen to include within its conflict of interest, “fiduciary positions.” The Center’s definition of a “fiduciary position” is as follows:

Fiduciary Interest includes a position as an officer, director, senior manager, or its equivalent thereof, held by an Investigator or his or her immediate family.

Note that an Investigator need disclose only financial interests and fiduciary positions relevant to his or her research.

Note that though FDA set the permissible public company equity holdings at $50,000, the Center is bound by the stricter PHS $10,000 rule. And because FDA looks at payments made or expectations held both during the research and for twelve months thereafter, we conform to that as the more restrictive dictate.

VI. Procedures for Disclosure and Managing Conflict

A. Review of Disclosures

A completed Conflicts of Interest Disclosure Form shall be provided annually by each Investigator and returned to the Executive Officer. These forms must be updated within thirty days of any material changes. Those forms that include disclosure of a financial interest or a fiduciary position shall be delivered to the Center’s Counsel for review. Counsel shall make a determination whether, in his or her opinion a conflict of interest exists, that is, if he or she believes that such significant financial interest or that such fiduciary position disclosed could affect the design, conduct or reporting of the research or educational activities, which are the subject of a grant application.

If Counsel concludes that a conflict exists, he or she shall so inform the President of the Center, who shall in turn inform the Conflicts Review Committee. The Conflicts Review Committee shall be established by the Center’s Board (or, until the Conflicts Review Committee is formally constituted, the Conflicts Review Committee shall be comprised of the President and two other designees appointed by the Executive Committee of the Board). Counsel shall also inform such Investigator. The Conflicts Review Committee shall oversee the management and resolution of actual or potential problems revealed. In the case of a conflict that involves a member of the Conflicts Review Committee, the Executive Committee of the Board shall appoint a substitute for such member for oversight and resolution of the conflict in question.

B. Management and Resolution of Conflicts

Those charged with oversight will manage and resolve conflicts by any or all of the following means:

• public disclosure of significant financial interest or fiduciary position;
• monitoring of research by independent reviewers;
• modification of the research plan;
• disqualification from participation in the portion of the research funded by the applicable agency;
• divestiture of significant financial interest; or
• severance of relationships that create actual or potential conflicts;
• such other or further conditions, limitations, disclosure, reviews or actions as the Conflicts Review Committee deems appropriate.

C. Enforcement

It is the policy of the Center to require full compliance with the management and resolution of the conflicting interests as recommended by the Conflicts Review Committee. The conditions and restrictions proposed must be instituted before submission of the subject grant application. Violations of this Policy will be referred to the Conflicts Review Committee for appropriate enforcement action for failure to comply. If the failure to comply with this Policy has biased the design, conduct or reporting of the funded research, the Center will promptly notify the appropriate funding agency that the corrective action it has or will take.

D. Maintenance of Records

The Conflicts Review Committee shall maintain records, identifiable to each award, of all financial disclosures, including, but not limited to, the Conflicts of Interest Disclosure Form and of all actions taken to resolve actual or potential conflicts of interest until at least three (3) years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

E. Obligation to Disclose to Agency or Department of Health and Human Services

The Center may have an obligation, prior to the expenditure of any funds under an award, to advise the applicable governmental granting agency or the Department of Health and Human Services (“HHS”) of any conflicting interest (but not the nature of the interest or other details) found by the institution and assure such agency or HHS that the interest has been managed, reduced, or eliminated to protect the research from bias in accordance with all applicable law and regulations; and for any interest that the Center identifies as conflicting subsequent to the Center’s initial report under the award, the report will be made and the conflicting interest managed, reduced or eliminated, at least on an interim basis, within sixty days of such identification. The Center also has the responsibility to keep the applicable granting agency fully informed if the Center finds that it is unable to satisfactorily manage an actual or potential conflict of interest.

The Center shall make information available, upon request, to HHS regarding all conflicting interests identified by the Center and how those interests have been managed, reduced or eliminated to protect research from bias.

[1] 42 C.F.R. Part 50 Subpart F and Part 94.

[2] 21 C.F.R. Part 54. The regulation regarding National Science Foundation research awards with respect to conflicts of interest are very close in content to the PHS rules. Should the Center contemplate applying for an NSF research award, however, the Policy should be reviewed to confirm compliance with NSF rules.

-- DhireshVyas - 30 May 2006

Conflicts of Interest Disclosure Form

This form should be submitted annually and updated within 30 days of any material change.

I certify that the above information is complete and true to the best of my knowledge and that I have read the New York Structural Biology Center’s (the “Center”) Policy on Conflict of Interest. This information is provided with the understanding that review of it will be conducted in confidence under Center procedures. The information may be released by the Center only 1) in statistical or aggregate form that protects my privacy, or 2) to comply with the requirements of the sponsors of my research, or 3) as may be required to comply with Center policies and procedures or any applicable legal requirements, or 4) with my written permission.

I acknowledge my obligation to submit an updated disclosure statement annually or when there is any change in my activities or financial interests otherwise reportable on this form.

Contents of COI Policy

NEW YORK STRUCTURAL BIOLOGY CENTER -- CONFLICT OF INTEREST POLICY – RESEARCH -- Active January 2002.

I. Introduction

The objective of this policy is to facilitate professional opportunity and sponsorship of research while minimizing conflict and managing that conflict that remains.

The Conflicts of Interest Policy applies to each employee of the New York Structural Biology Center (the “Center”), or independent contractor conducting research on behalf of and/or under agreement with the Center, who is responsible for the design, conduct, or reporting of research (collectively, an “Investigator”). The Center shall require every such individual to complete, on an annual basis and updated within thirty days of any material changes, a disclosure statement (the “Conflicts of Interest Disclosure Form”). The Conflicts of Interest Disclosure Form is attached as Attachment A. The financial interests and fiduciary positions that must be disclosed are those that relate to an Investigator’s research. If an Investigator’s Conflicts of Interest Disclosure Form reflects conflict, assistance will be provided to reduce the conflict and to manage that which persists.

An individual conducting research at the Center, but not on behalf of the Center, and who is not an employee of the Center, shall be governed by the conflicts of interest policy of the institution with which such individual is affiliated for purposes of such research and not by the Center’s Conflict of Interest Policy.

Disclosure of conflict will not impose a bar to science; it will merely occasion the need for appropriate management.

II. Summary of Policy

An Investigator has a conflict of interest where his or her significant financial interest (defined, infra), or fiduciary position, in an entity could directly and significantly affect the design, conduct, analysis or reporting of research.

To determine whether there is such a conflict, an Investigator will report to the Center all those financial interests and fiduciary positions that are relevant to the Investigator’s research (e.g., the Investigator is an inventor whose research is sponsored by the company holding the license on the Investigator’s invention; or the Investigator holds equity in a company whose product is being clinically tested by the Investigator, or the Investigator is an officer of a company whose current or future valuation or profits could be affected by the Investigator’s research.).

In each such case, the investigator’s financial holdings or fiduciary positions are relevant to the Investigator’s work though they may not be “significant financial interests” or may not have the potential directly and significantly to affect the research. All relevant interests and positions must be disclosed so that a finding may be made as to whether there is a conflict. If a conflict exists, it must be eliminated, reduced or managed so that the Investigator’s research may go forward.

Conflicts shall be overseen and managed by the Center’s Conflicts Review Committee, headed by the President of the Center.

III. Federal Laws and Regulations on Conflict of Interest

A. Federal Definition of Conflict of Interest

The Center’s policy on conflict of interest is predicated on federal legal requirements found in two documents: regulations of the Public Health Service (PHS) governing PHS-supported research[1] and regulations of the Food and Drug Administration (FDA) governing clinical studies submitted in marketing applications for new human drugs, biologics and certain medical devices.[2]

PHS and FDA do not have identical rules. Where the agencies’ policies conflict, generally, we satisfy the stricter rule. Where one agency’s mandates are additional to (not in conflict with) those of the other, both sets of rules apply.

The key definition is “conflict of interest.” Each agency’s approach is set out below.

PHS Definition. A conflict of interest exists when a significant financial interest could directly and significantly affect the design, conduct or reporting of research.

FDA Definition. The central FDA notion is the concept of “Compensation affected by the outcome of clinical studies.” In FDA’s regulation, that term “…means compensation that could be higher for a favorable outcome than for an unfavorable outcome such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.”

Importantly, neither approach requires consideration of an investigator’s motive in doing her or his work or any finding that bias has actually crept into the scientific enterprise.

The regulations then both turn to the financial interests or compensation arrangements that give rise to potential conflicts of interest. Again, each agency has its own approach.

B. Federal Definition of Financial Entanglements

• salary or other payments for services (e.g., consulting fees or honoraria),
• intellectual property rights (e.g., patents, copyrights and royalties from such rights), or
• equity interests (e.g., stocks, stock options or other ownership interests of the Investigator and her or his spouse and dependent children that exceed $10,000 in public price or by another reasonable measure of fair market value and that represent more than a 5% ownership in any entity.)

Per the PHS, Significant Financial Interest does not include

• salary, royalties or other remuneration from the Center to its employees,
• income from seminars, lectures or teaching sponsored by public or non-profit entities,
• income from service on advisory committees or review panels for public or non-profit entities, or
• salary, royalties or other payments that when aggregated for the Investigator and her or his spouse and dependent children over the next 12 months are not expected to exceed $10,000.

2. FDA Compensation Affected by the Outcome of Clinical Studies. Per the FDA, such compensation includes:

• significant equity interests (ownership, stock options or other financial interest) in a non-publicly traded entity,
• equity in excess of $50,000 in a publicly traded entity during the time of a clinical trial or for 1 year thereafter,
• a proprietary or other financial interest including but not limited to patent or licensing agreements, and
• significant payments of other sorts that have monetary value of over $25,000 (not including the costs of the clinical studies) such as research grants, equipment and on-going consultation or honoraria during the clinical study and for 12 months thereafter.

As is reflected below, the Center’s policy incorporates elements of both the PHS and FDA requirements regarding relevant financial entanglements. The Center’s Policy also addresses fiduciary positions

IV. The Center’s Policy on Conflict of Interest Generally

The following is the definition in the Center’s policy of conflict of interest.

A conflict of interest exists when an Investigator, defined as an employee of the Center, or an independent contractor conducting research on behalf of and/or under an agreement with the Center, has a significant financial interest in an entity, or position as a fiduciary of an entity, which interest or position could directly and significantly affect the design, conduct, analysis or reporting of research.

The standard requires (i) a significant financial interest (defined elsewhere in our policy, see infra) or a fiduciary position (e.g. a senior manager, officer or director), (ii) the possibility of an effect on research, and (iii) the requirement that such potential effect be direct and significant. Importantly, full disclosure of any potential conflict is required. Only thereafter can a decision be made whether the potential conflict is actual, requiring reduction, elimination or management.

V. The Center’s Policy on Significant Financial Interest and Fiduciary Position

A. Significant Financial Interest and Fiduciary Position

1. The Center’s definition of a significant financial interest is consistent with federal regulations.

Significant Financial Interest under the Center’s Policy is anything of monetary value acquired or held by the Investigator and her or his immediate family (spouse and dependent children) including but not limited to salary or other payments for intellectual property rights or services; equity interests in a privately-held entity and in a publicly traded entity with the exception of:

1. Salary, royalties, or other remuneration from the Center or

2. An equity interest in business enterprises or entities that when aggregated is both not more than $10,000 and is not more than 5% ownership interest; or

3. Salary, royalties or other payment obligations or expectations that when aggregated during the research and for the twelve months following its termination, are not expected to exceed $10,000.

2. The Center has chosen to include within its conflict of interest, “fiduciary positions.” The Center’s definition of a “fiduciary position” is as follows:

Fiduciary Interest includes a position as an officer, director, senior manager, or its equivalent thereof, held by an Investigator or his or her immediate family.

Note that an Investigator need disclose only financial interests and fiduciary positions relevant to his or her research.

Note that though FDA set the permissible public company equity holdings at $50,000, the Center is bound by the stricter PHS $10,000 rule. And because FDA looks at payments made or expectations held both during the research and for twelve months thereafter, we conform to that as the more restrictive dictate.

VI. Procedures for Disclosure and Managing Conflict

A. Review of Disclosures

A completed Conflicts of Interest Disclosure Form shall be provided annually by each Investigator and returned to the Executive Officer. These forms must be updated within thirty days of any material changes. Those forms that include disclosure of a financial interest or a fiduciary position shall be delivered to the Center’s Counsel for review. Counsel shall make a determination whether, in his or her opinion a conflict of interest exists, that is, if he or she believes that such significant financial interest or that such fiduciary position disclosed could affect the design, conduct or reporting of the research or educational activities, which are the subject of a grant application.

If Counsel concludes that a conflict exists, he or she shall so inform the President of the Center, who shall in turn inform the Conflicts Review Committee. The Conflicts Review Committee shall be established by the Center’s Board (or, until the Conflicts Review Committee is formally constituted, the Conflicts Review Committee shall be comprised of the President and two other designees appointed by the Executive Committee of the Board). Counsel shall also inform such Investigator. The Conflicts Review Committee shall oversee the management and resolution of actual or potential problems revealed. In the case of a conflict that involves a member of the Conflicts Review Committee, the Executive Committee of the Board shall appoint a substitute for such member for oversight and resolution of the conflict in question.

B. Management and Resolution of Conflicts

Those charged with oversight will manage and resolve conflicts by any or all of the following means:

• public disclosure of significant financial interest or fiduciary position;
• monitoring of research by independent reviewers;
• modification of the research plan;
• disqualification from participation in the portion of the research funded by the applicable agency;
• divestiture of significant financial interest; or
• severance of relationships that create actual or potential conflicts;
• such other or further conditions, limitations, disclosure, reviews or actions as the Conflicts Review Committee deems appropriate.

C. Enforcement

It is the policy of the Center to require full compliance with the management and resolution of the conflicting interests as recommended by the Conflicts Review Committee. The conditions and restrictions proposed must be instituted before submission of the subject grant application. Violations of this Policy will be referred to the Conflicts Review Committee for appropriate enforcement action for failure to comply. If the failure to comply with this Policy has biased the design, conduct or reporting of the funded research, the Center will promptly notify the appropriate funding agency that the corrective action it has or will take.

D. Maintenance of Records

The Conflicts Review Committee shall maintain records, identifiable to each award, of all financial disclosures, including, but not limited to, the Conflicts of Interest Disclosure Form and of all actions taken to resolve actual or potential conflicts of interest until at least three (3) years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

E. Obligation to Disclose to Agency or Department of Health and Human Services

The Center may have an obligation, prior to the expenditure of any funds under an award, to advise the applicable governmental granting agency or the Department of Health and Human Services (“HHS”) of any conflicting interest (but not the nature of the interest or other details) found by the institution and assure such agency or HHS that the interest has been managed, reduced, or eliminated to protect the research from bias in accordance with all applicable law and regulations; and for any interest that the Center identifies as conflicting subsequent to the Center’s initial report under the award, the report will be made and the conflicting interest managed, reduced or eliminated, at least on an interim basis, within sixty days of such identification. The Center also has the responsibility to keep the applicable granting agency fully informed if the Center finds that it is unable to satisfactorily manage an actual or potential conflict of interest.

The Center shall make information available, upon request, to HHS regarding all conflicting interests identified by the Center and how those interests have been managed, reduced or eliminated to protect research from bias.

[1] 42 C.F.R. Part 50 Subpart F and Part 94.

[2] 21 C.F.R. Part 54. The regulation regarding National Science Foundation research awards with respect to conflicts of interest are very close in content to the PHS rules. Should the Center contemplate applying for an NSF research award, however, the Policy should be reviewed to confirm compliance with NSF rules.

-- DhireshVyas - 30 May 2006

Conflicts of Interest Disclosure Form

This form should be submitted annually and updated within 30 days of any material change.

I certify that the above information is complete and true to the best of my knowledge and that I have read the New York Structural Biology Center’s (the “Center”) Policy on Conflict of Interest. This information is provided with the understanding that review of it will be conducted in confidence under Center procedures. The information may be released by the Center only 1) in statistical or aggregate form that protects my privacy, or 2) to comply with the requirements of the sponsors of my research, or 3) as may be required to comply with Center policies and procedures or any applicable legal requirements, or 4) with my written permission.

I acknowledge my obligation to submit an updated disclosure statement annually or when there is any change in my activities or financial interests otherwise reportable on this form.

Contents of COI Policy

NEW YORK STRUCTURAL BIOLOGY CENTER -- CONFLICT OF INTEREST POLICY – RESEARCH -- Active January 2002.

I. Introduction

The objective of this policy is to facilitate professional opportunity and sponsorship of research while minimizing conflict and managing that conflict that remains.

The Conflicts of Interest Policy applies to each employee of the New York Structural Biology Center (the “Center”), or independent contractor conducting research on behalf of and/or under agreement with the Center, who is responsible for the design, conduct, or reporting of research (collectively, an “Investigator”). The Center shall require every such individual to complete, on an annual basis and updated within thirty days of any material changes, a disclosure statement (the “Conflicts of Interest Disclosure Form”). The Conflicts of Interest Disclosure Form is attached as Attachment A. The financial interests and fiduciary positions that must be disclosed are those that relate to an Investigator’s research. If an Investigator’s Conflicts of Interest Disclosure Form reflects conflict, assistance will be provided to reduce the conflict and to manage that which persists.

An individual conducting research at the Center, but not on behalf of the Center, and who is not an employee of the Center, shall be governed by the conflicts of interest policy of the institution with which such individual is affiliated for purposes of such research and not by the Center’s Conflict of Interest Policy.

Disclosure of conflict will not impose a bar to science; it will merely occasion the need for appropriate management.

II. Summary of Policy

An Investigator has a conflict of interest where his or her significant financial interest (defined, infra), or fiduciary position, in an entity could directly and significantly affect the design, conduct, analysis or reporting of research.

To determine whether there is such a conflict, an Investigator will report to the Center all those financial interests and fiduciary positions that are relevant to the Investigator’s research (e.g., the Investigator is an inventor whose research is sponsored by the company holding the license on the Investigator’s invention; or the Investigator holds equity in a company whose product is being clinically tested by the Investigator, or the Investigator is an officer of a company whose current or future valuation or profits could be affected by the Investigator’s research.).

In each such case, the investigator’s financial holdings or fiduciary positions are relevant to the Investigator’s work though they may not be “significant financial interests” or may not have the potential directly and significantly to affect the research. All relevant interests and positions must be disclosed so that a finding may be made as to whether there is a conflict. If a conflict exists, it must be eliminated, reduced or managed so that the Investigator’s research may go forward.

Conflicts shall be overseen and managed by the Center’s Conflicts Review Committee, headed by the President of the Center.

III. Federal Laws and Regulations on Conflict of Interest

A. Federal Definition of Conflict of Interest

The Center’s policy on conflict of interest is predicated on federal legal requirements found in two documents: regulations of the Public Health Service (PHS) governing PHS-supported research[1] and regulations of the Food and Drug Administration (FDA) governing clinical studies submitted in marketing applications for new human drugs, biologics and certain medical devices.[2]

PHS and FDA do not have identical rules. Where the agencies’ policies conflict, generally, we satisfy the stricter rule. Where one agency’s mandates are additional to (not in conflict with) those of the other, both sets of rules apply.

The key definition is “conflict of interest.” Each agency’s approach is set out below.

PHS Definition. A conflict of interest exists when a significant financial interest could directly and significantly affect the design, conduct or reporting of research.

FDA Definition. The central FDA notion is the concept of “Compensation affected by the outcome of clinical studies.” In FDA’s regulation, that term “…means compensation that could be higher for a favorable outcome than for an unfavorable outcome such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.”

Importantly, neither approach requires consideration of an investigator’s motive in doing her or his work or any finding that bias has actually crept into the scientific enterprise.

The regulations then both turn to the financial interests or compensation arrangements that give rise to potential conflicts of interest. Again, each agency has its own approach.

B. Federal Definition of Financial Entanglements

• salary or other payments for services (e.g., consulting fees or honoraria),
• intellectual property rights (e.g., patents, copyrights and royalties from such rights), or
• equity interests (e.g., stocks, stock options or other ownership interests of the Investigator and her or his spouse and dependent children that exceed $10,000 in public price or by another reasonable measure of fair market value and that represent more than a 5% ownership in any entity.)

Per the PHS, Significant Financial Interest does not include

• salary, royalties or other remuneration from the Center to its employees,
• income from seminars, lectures or teaching sponsored by public or non-profit entities,
• income from service on advisory committees or review panels for public or non-profit entities, or
• salary, royalties or other payments that when aggregated for the Investigator and her or his spouse and dependent children over the next 12 months are not expected to exceed $10,000.

2. FDA Compensation Affected by the Outcome of Clinical Studies. Per the FDA, such compensation includes:

• significant equity interests (ownership, stock options or other financial interest) in a non-publicly traded entity,
• equity in excess of $50,000 in a publicly traded entity during the time of a clinical trial or for 1 year thereafter,
• a proprietary or other financial interest including but not limited to patent or licensing agreements, and
• significant payments of other sorts that have monetary value of over $25,000 (not including the costs of the clinical studies) such as research grants, equipment and on-going consultation or honoraria during the clinical study and for 12 months thereafter.

As is reflected below, the Center’s policy incorporates elements of both the PHS and FDA requirements regarding relevant financial entanglements. The Center’s Policy also addresses fiduciary positions

IV. The Center’s Policy on Conflict of Interest Generally

The following is the definition in the Center’s policy of conflict of interest.

A conflict of interest exists when an Investigator, defined as an employee of the Center, or an independent contractor conducting research on behalf of and/or under an agreement with the Center, has a significant financial interest in an entity, or position as a fiduciary of an entity, which interest or position could directly and significantly affect the design, conduct, analysis or reporting of research.

The standard requires (i) a significant financial interest (defined elsewhere in our policy, see infra) or a fiduciary position (e.g. a senior manager, officer or director), (ii) the possibility of an effect on research, and (iii) the requirement that such potential effect be direct and significant. Importantly, full disclosure of any potential conflict is required. Only thereafter can a decision be made whether the potential conflict is actual, requiring reduction, elimination or management.

V. The Center’s Policy on Significant Financial Interest and Fiduciary Position

A. Significant Financial Interest and Fiduciary Position

1. The Center’s definition of a significant financial interest is consistent with federal regulations.

Significant Financial Interest under the Center’s Policy is anything of monetary value acquired or held by the Investigator and her or his immediate family (spouse and dependent children) including but not limited to salary or other payments for intellectual property rights or services; equity interests in a privately-held entity and in a publicly traded entity with the exception of:

1. Salary, royalties, or other remuneration from the Center or

2. An equity interest in business enterprises or entities that when aggregated is both not more than $10,000 and is not more than 5% ownership interest; or

3. Salary, royalties or other payment obligations or expectations that when aggregated during the research and for the twelve months following its termination, are not expected to exceed $10,000.

2. The Center has chosen to include within its conflict of interest, “fiduciary positions.” The Center’s definition of a “fiduciary position” is as follows:

Fiduciary Interest includes a position as an officer, director, senior manager, or its equivalent thereof, held by an Investigator or his or her immediate family.

Note that an Investigator need disclose only financial interests and fiduciary positions relevant to his or her research.

Note that though FDA set the permissible public company equity holdings at $50,000, the Center is bound by the stricter PHS $10,000 rule. And because FDA looks at payments made or expectations held both during the research and for twelve months thereafter, we conform to that as the more restrictive dictate.

VI. Procedures for Disclosure and Managing Conflict

A. Review of Disclosures

A completed Conflicts of Interest Disclosure Form shall be provided annually by each Investigator and returned to the Executive Officer. These forms must be updated within thirty days of any material changes. Those forms that include disclosure of a financial interest or a fiduciary position shall be delivered to the Center’s Counsel for review. Counsel shall make a determination whether, in his or her opinion a conflict of interest exists, that is, if he or she believes that such significant financial interest or that such fiduciary position disclosed could affect the design, conduct or reporting of the research or educational activities, which are the subject of a grant application.

If Counsel concludes that a conflict exists, he or she shall so inform the President of the Center, who shall in turn inform the Conflicts Review Committee. The Conflicts Review Committee shall be established by the Center’s Board (or, until the Conflicts Review Committee is formally constituted, the Conflicts Review Committee shall be comprised of the President and two other designees appointed by the Executive Committee of the Board). Counsel shall also inform such Investigator. The Conflicts Review Committee shall oversee the management and resolution of actual or potential problems revealed. In the case of a conflict that involves a member of the Conflicts Review Committee, the Executive Committee of the Board shall appoint a substitute for such member for oversight and resolution of the conflict in question.

B. Management and Resolution of Conflicts

Those charged with oversight will manage and resolve conflicts by any or all of the following means:

• public disclosure of significant financial interest or fiduciary position;
• monitoring of research by independent reviewers;
• modification of the research plan;
• disqualification from participation in the portion of the research funded by the applicable agency;
• divestiture of significant financial interest; or
• severance of relationships that create actual or potential conflicts;
• such other or further conditions, limitations, disclosure, reviews or actions as the Conflicts Review Committee deems appropriate.

C. Enforcement

It is the policy of the Center to require full compliance with the management and resolution of the conflicting interests as recommended by the Conflicts Review Committee. The conditions and restrictions proposed must be instituted before submission of the subject grant application. Violations of this Policy will be referred to the Conflicts Review Committee for appropriate enforcement action for failure to comply. If the failure to comply with this Policy has biased the design, conduct or reporting of the funded research, the Center will promptly notify the appropriate funding agency that the corrective action it has or will take.

D. Maintenance of Records

The Conflicts Review Committee shall maintain records, identifiable to each award, of all financial disclosures, including, but not limited to, the Conflicts of Interest Disclosure Form and of all actions taken to resolve actual or potential conflicts of interest until at least three (3) years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

E. Obligation to Disclose to Agency or Department of Health and Human Services

The Center may have an obligation, prior to the expenditure of any funds under an award, to advise the applicable governmental granting agency or the Department of Health and Human Services (“HHS”) of any conflicting interest (but not the nature of the interest or other details) found by the institution and assure such agency or HHS that the interest has been managed, reduced, or eliminated to protect the research from bias in accordance with all applicable law and regulations; and for any interest that the Center identifies as conflicting subsequent to the Center’s initial report under the award, the report will be made and the conflicting interest managed, reduced or eliminated, at least on an interim basis, within sixty days of such identification. The Center also has the responsibility to keep the applicable granting agency fully informed if the Center finds that it is unable to satisfactorily manage an actual or potential conflict of interest.

The Center shall make information available, upon request, to HHS regarding all conflicting interests identified by the Center and how those interests have been managed, reduced or eliminated to protect research from bias.

[1] 42 C.F.R. Part 50 Subpart F and Part 94.

[2] 21 C.F.R. Part 54. The regulation regarding National Science Foundation research awards with respect to conflicts of interest are very close in content to the PHS rules. Should the Center contemplate applying for an NSF research award, however, the Policy should be reviewed to confirm compliance with NSF rules.

-- DhireshVyas - 30 May 2006

Conflicts of Interest Disclosure Form

This form should be submitted annually and updated within 30 days of any material change.

I certify that the above information is complete and true to the best of my knowledge and that I have read the New York Structural Biology Center’s (the “Center”) Policy on Conflict of Interest. This information is provided with the understanding that review of it will be conducted in confidence under Center procedures. The information may be released by the Center only 1) in statistical or aggregate form that protects my privacy, or 2) to comply with the requirements of the sponsors of my research, or 3) as may be required to comply with Center policies and procedures or any applicable legal requirements, or 4) with my written permission.

I acknowledge my obligation to submit an updated disclosure statement annually or when there is any change in my activities or financial interests otherwise reportable on this form.

Contents of COI Policy

NEW YORK STRUCTURAL BIOLOGY CENTER -- CONFLICT OF INTEREST POLICY – RESEARCH -- Active January 2002.

I. Introduction

The objective of this policy is to facilitate professional opportunity and sponsorship of research while minimizing conflict and managing that conflict that remains.

The Conflicts of Interest Policy applies to each employee of the New York Structural Biology Center (the “Center”), or independent contractor conducting research on behalf of and/or under agreement with the Center, who is responsible for the design, conduct, or reporting of research (collectively, an “Investigator”). The Center shall require every such individual to complete, on an annual basis and updated within thirty days of any material changes, a disclosure statement (the “Conflicts of Interest Disclosure Form”). The Conflicts of Interest Disclosure Form is attached as Attachment A. The financial interests and fiduciary positions that must be disclosed are those that relate to an Investigator’s research. If an Investigator’s Conflicts of Interest Disclosure Form reflects conflict, assistance will be provided to reduce the conflict and to manage that which persists.

An individual conducting research at the Center, but not on behalf of the Center, and who is not an employee of the Center, shall be governed by the conflicts of interest policy of the institution with which such individual is affiliated for purposes of such research and not by the Center’s Conflict of Interest Policy.

Disclosure of conflict will not impose a bar to science; it will merely occasion the need for appropriate management.

II. Summary of Policy

An Investigator has a conflict of interest where his or her significant financial interest (defined, infra), or fiduciary position, in an entity could directly and significantly affect the design, conduct, analysis or reporting of research.

To determine whether there is such a conflict, an Investigator will report to the Center all those financial interests and fiduciary positions that are relevant to the Investigator’s research (e.g., the Investigator is an inventor whose research is sponsored by the company holding the license on the Investigator’s invention; or the Investigator holds equity in a company whose product is being clinically tested by the Investigator, or the Investigator is an officer of a company whose current or future valuation or profits could be affected by the Investigator’s research.).

In each such case, the investigator’s financial holdings or fiduciary positions are relevant to the Investigator’s work though they may not be “significant financial interests” or may not have the potential directly and significantly to affect the research. All relevant interests and positions must be disclosed so that a finding may be made as to whether there is a conflict. If a conflict exists, it must be eliminated, reduced or managed so that the Investigator’s research may go forward.

Conflicts shall be overseen and managed by the Center’s Conflicts Review Committee, headed by the President of the Center.

III. Federal Laws and Regulations on Conflict of Interest

A. Federal Definition of Conflict of Interest

The Center’s policy on conflict of interest is predicated on federal legal requirements found in two documents: regulations of the Public Health Service (PHS) governing PHS-supported research[1] and regulations of the Food and Drug Administration (FDA) governing clinical studies submitted in marketing applications for new human drugs, biologics and certain medical devices.[2]

PHS and FDA do not have identical rules. Where the agencies’ policies conflict, generally, we satisfy the stricter rule. Where one agency’s mandates are additional to (not in conflict with) those of the other, both sets of rules apply.

The key definition is “conflict of interest.” Each agency’s approach is set out below.

PHS Definition. A conflict of interest exists when a significant financial interest could directly and significantly affect the design, conduct or reporting of research.

FDA Definition. The central FDA notion is the concept of “Compensation affected by the outcome of clinical studies.” In FDA’s regulation, that term “…means compensation that could be higher for a favorable outcome than for an unfavorable outcome such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.”

Importantly, neither approach requires consideration of an investigator’s motive in doing her or his work or any finding that bias has actually crept into the scientific enterprise.

The regulations then both turn to the financial interests or compensation arrangements that give rise to potential conflicts of interest. Again, each agency has its own approach.

B. Federal Definition of Financial Entanglements

• salary or other payments for services (e.g., consulting fees or honoraria),
• intellectual property rights (e.g., patents, copyrights and royalties from such rights), or
• equity interests (e.g., stocks, stock options or other ownership interests of the Investigator and her or his spouse and dependent children that exceed $10,000 in public price or by another reasonable measure of fair market value and that represent more than a 5% ownership in any entity.)

Per the PHS, Significant Financial Interest does not include

• salary, royalties or other remuneration from the Center to its employees,
• income from seminars, lectures or teaching sponsored by public or non-profit entities,
• income from service on advisory committees or review panels for public or non-profit entities, or
• salary, royalties or other payments that when aggregated for the Investigator and her or his spouse and dependent children over the next 12 months are not expected to exceed $10,000.

2. FDA Compensation Affected by the Outcome of Clinical Studies. Per the FDA, such compensation includes:

• significant equity interests (ownership, stock options or other financial interest) in a non-publicly traded entity,
• equity in excess of $50,000 in a publicly traded entity during the time of a clinical trial or for 1 year thereafter,
• a proprietary or other financial interest including but not limited to patent or licensing agreements, and
• significant payments of other sorts that have monetary value of over $25,000 (not including the costs of the clinical studies) such as research grants, equipment and on-going consultation or honoraria during the clinical study and for 12 months thereafter.

As is reflected below, the Center’s policy incorporates elements of both the PHS and FDA requirements regarding relevant financial entanglements. The Center’s Policy also addresses fiduciary positions

IV. The Center’s Policy on Conflict of Interest Generally

The following is the definition in the Center’s policy of conflict of interest.

A conflict of interest exists when an Investigator, defined as an employee of the Center, or an independent contractor conducting research on behalf of and/or under an agreement with the Center, has a significant financial interest in an entity, or position as a fiduciary of an entity, which interest or position could directly and significantly affect the design, conduct, analysis or reporting of research.

The standard requires (i) a significant financial interest (defined elsewhere in our policy, see infra) or a fiduciary position (e.g. a senior manager, officer or director), (ii) the possibility of an effect on research, and (iii) the requirement that such potential effect be direct and significant. Importantly, full disclosure of any potential conflict is required. Only thereafter can a decision be made whether the potential conflict is actual, requiring reduction, elimination or management.

V. The Center’s Policy on Significant Financial Interest and Fiduciary Position

A. Significant Financial Interest and Fiduciary Position

1. The Center’s definition of a significant financial interest is consistent with federal regulations.

Significant Financial Interest under the Center’s Policy is anything of monetary value acquired or held by the Investigator and her or his immediate family (spouse and dependent children) including but not limited to salary or other payments for intellectual property rights or services; equity interests in a privately-held entity and in a publicly traded entity with the exception of:

1. Salary, royalties, or other remuneration from the Center or

2. An equity interest in business enterprises or entities that when aggregated is both not more than $10,000 and is not more than 5% ownership interest; or

3. Salary, royalties or other payment obligations or expectations that when aggregated during the research and for the twelve months following its termination, are not expected to exceed $10,000.

2. The Center has chosen to include within its conflict of interest, “fiduciary positions.” The Center’s definition of a “fiduciary position” is as follows:

Fiduciary Interest includes a position as an officer, director, senior manager, or its equivalent thereof, held by an Investigator or his or her immediate family.

Note that an Investigator need disclose only financial interests and fiduciary positions relevant to his or her research.

Note that though FDA set the permissible public company equity holdings at $50,000, the Center is bound by the stricter PHS $10,000 rule. And because FDA looks at payments made or expectations held both during the research and for twelve months thereafter, we conform to that as the more restrictive dictate.

VI. Procedures for Disclosure and Managing Conflict

A. Review of Disclosures

A completed Conflicts of Interest Disclosure Form shall be provided annually by each Investigator and returned to the Executive Officer. These forms must be updated within thirty days of any material changes. Those forms that include disclosure of a financial interest or a fiduciary position shall be delivered to the Center’s Counsel for review. Counsel shall make a determination whether, in his or her opinion a conflict of interest exists, that is, if he or she believes that such significant financial interest or that such fiduciary position disclosed could affect the design, conduct or reporting of the research or educational activities, which are the subject of a grant application.

If Counsel concludes that a conflict exists, he or she shall so inform the President of the Center, who shall in turn inform the Conflicts Review Committee. The Conflicts Review Committee shall be established by the Center’s Board (or, until the Conflicts Review Committee is formally constituted, the Conflicts Review Committee shall be comprised of the President and two other designees appointed by the Executive Committee of the Board). Counsel shall also inform such Investigator. The Conflicts Review Committee shall oversee the management and resolution of actual or potential problems revealed. In the case of a conflict that involves a member of the Conflicts Review Committee, the Executive Committee of the Board shall appoint a substitute for such member for oversight and resolution of the conflict in question.

B. Management and Resolution of Conflicts

Those charged with oversight will manage and resolve conflicts by any or all of the following means:

• public disclosure of significant financial interest or fiduciary position;
• monitoring of research by independent reviewers;
• modification of the research plan;
• disqualification from participation in the portion of the research funded by the applicable agency;
• divestiture of significant financial interest; or
• severance of relationships that create actual or potential conflicts;
• such other or further conditions, limitations, disclosure, reviews or actions as the Conflicts Review Committee deems appropriate.

C. Enforcement

It is the policy of the Center to require full compliance with the management and resolution of the conflicting interests as recommended by the Conflicts Review Committee. The conditions and restrictions proposed must be instituted before submission of the subject grant application. Violations of this Policy will be referred to the Conflicts Review Committee for appropriate enforcement action for failure to comply. If the failure to comply with this Policy has biased the design, conduct or reporting of the funded research, the Center will promptly notify the appropriate funding agency that the corrective action it has or will take.

D. Maintenance of Records

The Conflicts Review Committee shall maintain records, identifiable to each award, of all financial disclosures, including, but not limited to, the Conflicts of Interest Disclosure Form and of all actions taken to resolve actual or potential conflicts of interest until at least three (3) years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

E. Obligation to Disclose to Agency or Department of Health and Human Services

The Center may have an obligation, prior to the expenditure of any funds under an award, to advise the applicable governmental granting agency or the Department of Health and Human Services (“HHS”) of any conflicting interest (but not the nature of the interest or other details) found by the institution and assure such agency or HHS that the interest has been managed, reduced, or eliminated to protect the research from bias in accordance with all applicable law and regulations; and for any interest that the Center identifies as conflicting subsequent to the Center’s initial report under the award, the report will be made and the conflicting interest managed, reduced or eliminated, at least on an interim basis, within sixty days of such identification. The Center also has the responsibility to keep the applicable granting agency fully informed if the Center finds that it is unable to satisfactorily manage an actual or potential conflict of interest.

The Center shall make information available, upon request, to HHS regarding all conflicting interests identified by the Center and how those interests have been managed, reduced or eliminated to protect research from bias.

[1] 42 C.F.R. Part 50 Subpart F and Part 94.

[2] 21 C.F.R. Part 54. The regulation regarding National Science Foundation research awards with respect to conflicts of interest are very close in content to the PHS rules. Should the Center contemplate applying for an NSF research award, however, the Policy should be reviewed to confirm compliance with NSF rules.

-- DhireshVyas - 30 May 2006

Conflicts of Interest Disclosure Form

This form should be submitted annually and updated within 30 days of any material change.

I certify that the above information is complete and true to the best of my knowledge and that I have read the New York Structural Biology Center’s (the “Center”) Policy on Conflict of Interest. This information is provided with the understanding that review of it will be conducted in confidence under Center procedures. The information may be released by the Center only 1) in statistical or aggregate form that protects my privacy, or 2) to comply with the requirements of the sponsors of my research, or 3) as may be required to comply with Center policies and procedures or any applicable legal requirements, or 4) with my written permission.

I acknowledge my obligation to submit an updated disclosure statement annually or when there is any change in my activities or financial interests otherwise reportable on this form.

Contents of COI Policy

NEW YORK STRUCTURAL BIOLOGY CENTER -- CONFLICT OF INTEREST POLICY – RESEARCH -- Active January 2002.

I. Introduction

The objective of this policy is to facilitate professional opportunity and sponsorship of research while minimizing conflict and managing that conflict that remains.

The Conflicts of Interest Policy applies to each employee of the New York Structural Biology Center (the “Center”), or independent contractor conducting research on behalf of and/or under agreement with the Center, who is responsible for the design, conduct, or reporting of research (collectively, an “Investigator”). The Center shall require every such individual to complete, on an annual basis and updated within thirty days of any material changes, a disclosure statement (the “Conflicts of Interest Disclosure Form”). The Conflicts of Interest Disclosure Form is attached as Attachment A. The financial interests and fiduciary positions that must be disclosed are those that relate to an Investigator’s research. If an Investigator’s Conflicts of Interest Disclosure Form reflects conflict, assistance will be provided to reduce the conflict and to manage that which persists.

An individual conducting research at the Center, but not on behalf of the Center, and who is not an employee of the Center, shall be governed by the conflicts of interest policy of the institution with which such individual is affiliated for purposes of such research and not by the Center’s Conflict of Interest Policy.

Disclosure of conflict will not impose a bar to science; it will merely occasion the need for appropriate management.

II. Summary of Policy

An Investigator has a conflict of interest where his or her significant financial interest (defined, infra), or fiduciary position, in an entity could directly and significantly affect the design, conduct, analysis or reporting of research.

To determine whether there is such a conflict, an Investigator will report to the Center all those financial interests and fiduciary positions that are relevant to the Investigator’s research (e.g., the Investigator is an inventor whose research is sponsored by the company holding the license on the Investigator’s invention; or the Investigator holds equity in a company whose product is being clinically tested by the Investigator, or the Investigator is an officer of a company whose current or future valuation or profits could be affected by the Investigator’s research.).

In each such case, the investigator’s financial holdings or fiduciary positions are relevant to the Investigator’s work though they may not be “significant financial interests” or may not have the potential directly and significantly to affect the research. All relevant interests and positions must be disclosed so that a finding may be made as to whether there is a conflict. If a conflict exists, it must be eliminated, reduced or managed so that the Investigator’s research may go forward.

Conflicts shall be overseen and managed by the Center’s Conflicts Review Committee, headed by the President of the Center.

III. Federal Laws and Regulations on Conflict of Interest

A. Federal Definition of Conflict of Interest

The Center’s policy on conflict of interest is predicated on federal legal requirements found in two documents: regulations of the Public Health Service (PHS) governing PHS-supported research[1] and regulations of the Food and Drug Administration (FDA) governing clinical studies submitted in marketing applications for new human drugs, biologics and certain medical devices.[2]

PHS and FDA do not have identical rules. Where the agencies’ policies conflict, generally, we satisfy the stricter rule. Where one agency’s mandates are additional to (not in conflict with) those of the other, both sets of rules apply.

The key definition is “conflict of interest.” Each agency’s approach is set out below.

PHS Definition. A conflict of interest exists when a significant financial interest could directly and significantly affect the design, conduct or reporting of research.

FDA Definition. The central FDA notion is the concept of “Compensation affected by the outcome of clinical studies.” In FDA’s regulation, that term “…means compensation that could be higher for a favorable outcome than for an unfavorable outcome such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.”

Importantly, neither approach requires consideration of an investigator’s motive in doing her or his work or any finding that bias has actually crept into the scientific enterprise.

The regulations then both turn to the financial interests or compensation arrangements that give rise to potential conflicts of interest. Again, each agency has its own approach.

B. Federal Definition of Financial Entanglements

• salary or other payments for services (e.g., consulting fees or honoraria),
• intellectual property rights (e.g., patents, copyrights and royalties from such rights), or
• equity interests (e.g., stocks, stock options or other ownership interests of the Investigator and her or his spouse and dependent children that exceed $10,000 in public price or by another reasonable measure of fair market value and that represent more than a 5% ownership in any entity.)

Per the PHS, Significant Financial Interest does not include

• salary, royalties or other remuneration from the Center to its employees,
• income from seminars, lectures or teaching sponsored by public or non-profit entities,
• income from service on advisory committees or review panels for public or non-profit entities, or
• salary, royalties or other payments that when aggregated for the Investigator and her or his spouse and dependent children over the next 12 months are not expected to exceed $10,000.

2. FDA Compensation Affected by the Outcome of Clinical Studies. Per the FDA, such compensation includes:

• significant equity interests (ownership, stock options or other financial interest) in a non-publicly traded entity,
• equity in excess of $50,000 in a publicly traded entity during the time of a clinical trial or for 1 year thereafter,
• a proprietary or other financial interest including but not limited to patent or licensing agreements, and
• significant payments of other sorts that have monetary value of over $25,000 (not including the costs of the clinical studies) such as research grants, equipment and on-going consultation or honoraria during the clinical study and for 12 months thereafter.

As is reflected below, the Center’s policy incorporates elements of both the PHS and FDA requirements regarding relevant financial entanglements. The Center’s Policy also addresses fiduciary positions

IV. The Center’s Policy on Conflict of Interest Generally

The following is the definition in the Center’s policy of conflict of interest.

A conflict of interest exists when an Investigator, defined as an employee of the Center, or an independent contractor conducting research on behalf of and/or under an agreement with the Center, has a significant financial interest in an entity, or position as a fiduciary of an entity, which interest or position could directly and significantly affect the design, conduct, analysis or reporting of research.

The standard requires (i) a significant financial interest (defined elsewhere in our policy, see infra) or a fiduciary position (e.g. a senior manager, officer or director), (ii) the possibility of an effect on research, and (iii) the requirement that such potential effect be direct and significant. Importantly, full disclosure of any potential conflict is required. Only thereafter can a decision be made whether the potential conflict is actual, requiring reduction, elimination or management.

V. The Center’s Policy on Significant Financial Interest and Fiduciary Position

A. Significant Financial Interest and Fiduciary Position

1. The Center’s definition of a significant financial interest is consistent with federal regulations.

Significant Financial Interest under the Center’s Policy is anything of monetary value acquired or held by the Investigator and her or his immediate family (spouse and dependent children) including but not limited to salary or other payments for intellectual property rights or services; equity interests in a privately-held entity and in a publicly traded entity with the exception of:

1. Salary, royalties, or other remuneration from the Center or

2. An equity interest in business enterprises or entities that when aggregated is both not more than $10,000 and is not more than 5% ownership interest; or

3. Salary, royalties or other payment obligations or expectations that when aggregated during the research and for the twelve months following its termination, are not expected to exceed $10,000.

2. The Center has chosen to include within its conflict of interest, “fiduciary positions.” The Center’s definition of a “fiduciary position” is as follows:

Fiduciary Interest includes a position as an officer, director, senior manager, or its equivalent thereof, held by an Investigator or his or her immediate family.

Note that an Investigator need disclose only financial interests and fiduciary positions relevant to his or her research.

Note that though FDA set the permissible public company equity holdings at $50,000, the Center is bound by the stricter PHS $10,000 rule. And because FDA looks at payments made or expectations held both during the research and for twelve months thereafter, we conform to that as the more restrictive dictate.

VI. Procedures for Disclosure and Managing Conflict

A. Review of Disclosures

A completed Conflicts of Interest Disclosure Form shall be provided annually by each Investigator and returned to the Executive Officer. These forms must be updated within thirty days of any material changes. Those forms that include disclosure of a financial interest or a fiduciary position shall be delivered to the Center’s Counsel for review. Counsel shall make a determination whether, in his or her opinion a conflict of interest exists, that is, if he or she believes that such significant financial interest or that such fiduciary position disclosed could affect the design, conduct or reporting of the research or educational activities, which are the subject of a grant application.

If Counsel concludes that a conflict exists, he or she shall so inform the President of the Center, who shall in turn inform the Conflicts Review Committee. The Conflicts Review Committee shall be established by the Center’s Board (or, until the Conflicts Review Committee is formally constituted, the Conflicts Review Committee shall be comprised of the President and two other designees appointed by the Executive Committee of the Board). Counsel shall also inform such Investigator. The Conflicts Review Committee shall oversee the management and resolution of actual or potential problems revealed. In the case of a conflict that involves a member of the Conflicts Review Committee, the Executive Committee of the Board shall appoint a substitute for such member for oversight and resolution of the conflict in question.

B. Management and Resolution of Conflicts

Those charged with oversight will manage and resolve conflicts by any or all of the following means:

• public disclosure of significant financial interest or fiduciary position;
• monitoring of research by independent reviewers;
• modification of the research plan;
• disqualification from participation in the portion of the research funded by the applicable agency;
• divestiture of significant financial interest; or
• severance of relationships that create actual or potential conflicts;
• such other or further conditions, limitations, disclosure, reviews or actions as the Conflicts Review Committee deems appropriate.

C. Enforcement

It is the policy of the Center to require full compliance with the management and resolution of the conflicting interests as recommended by the Conflicts Review Committee. The conditions and restrictions proposed must be instituted before submission of the subject grant application. Violations of this Policy will be referred to the Conflicts Review Committee for appropriate enforcement action for failure to comply. If the failure to comply with this Policy has biased the design, conduct or reporting of the funded research, the Center will promptly notify the appropriate funding agency that the corrective action it has or will take.

D. Maintenance of Records

The Conflicts Review Committee shall maintain records, identifiable to each award, of all financial disclosures, including, but not limited to, the Conflicts of Interest Disclosure Form and of all actions taken to resolve actual or potential conflicts of interest until at least three (3) years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

E. Obligation to Disclose to Agency or Department of Health and Human Services

The Center may have an obligation, prior to the expenditure of any funds under an award, to advise the applicable governmental granting agency or the Department of Health and Human Services (“HHS”) of any conflicting interest (but not the nature of the interest or other details) found by the institution and assure such agency or HHS that the interest has been managed, reduced, or eliminated to protect the research from bias in accordance with all applicable law and regulations; and for any interest that the Center identifies as conflicting subsequent to the Center’s initial report under the award, the report will be made and the conflicting interest managed, reduced or eliminated, at least on an interim basis, within sixty days of such identification. The Center also has the responsibility to keep the applicable granting agency fully informed if the Center finds that it is unable to satisfactorily manage an actual or potential conflict of interest.

The Center shall make information available, upon request, to HHS regarding all conflicting interests identified by the Center and how those interests have been managed, reduced or eliminated to protect research from bias.

[1] 42 C.F.R. Part 50 Subpart F and Part 94.

[2] 21 C.F.R. Part 54. The regulation regarding National Science Foundation research awards with respect to conflicts of interest are very close in content to the PHS rules. Should the Center contemplate applying for an NSF research award, however, the Policy should be reviewed to confirm compliance with NSF rules.

-- DhireshVyas - 30 May 2006

Conflicts of Interest Disclosure Form

This form should be submitted annually and updated within 30 days of any material change.

I certify that the above information is complete and true to the best of my knowledge and that I have read the New York Structural Biology Center’s (the “Center”) Policy on Conflict of Interest. This information is provided with the understanding that review of it will be conducted in confidence under Center procedures. The information may be released by the Center only 1) in statistical or aggregate form that protects my privacy, or 2) to comply with the requirements of the sponsors of my research, or 3) as may be required to comply with Center policies and procedures or any applicable legal requirements, or 4) with my written permission.

I acknowledge my obligation to submit an updated disclosure statement annually or when there is any change in my activities or financial interests otherwise reportable on this form.

Contents of COI Policy

NEW YORK STRUCTURAL BIOLOGY CENTER -- CONFLICT OF INTEREST POLICY – RESEARCH -- Active January 2002.

I. Introduction

The objective of this policy is to facilitate professional opportunity and sponsorship of research while minimizing conflict and managing that conflict that remains.

The Conflicts of Interest Policy applies to each employee of the New York Structural Biology Center (the “Center”), or independent contractor conducting research on behalf of and/or under agreement with the Center, who is responsible for the design, conduct, or reporting of research (collectively, an “Investigator”). The Center shall require every such individual to complete, on an annual basis and updated within thirty days of any material changes, a disclosure statement (the “Conflicts of Interest Disclosure Form”). The Conflicts of Interest Disclosure Form is attached as Attachment A. The financial interests and fiduciary positions that must be disclosed are those that relate to an Investigator’s research. If an Investigator’s Conflicts of Interest Disclosure Form reflects conflict, assistance will be provided to reduce the conflict and to manage that which persists.

An individual conducting research at the Center, but not on behalf of the Center, and who is not an employee of the Center, shall be governed by the conflicts of interest policy of the institution with which such individual is affiliated for purposes of such research and not by the Center’s Conflict of Interest Policy.

Disclosure of conflict will not impose a bar to science; it will merely occasion the need for appropriate management.

II. Summary of Policy

An Investigator has a conflict of interest where his or her significant financial interest (defined, infra), or fiduciary position, in an entity could directly and significantly affect the design, conduct, analysis or reporting of research.

To determine whether there is such a conflict, an Investigator will report to the Center all those financial interests and fiduciary positions that are relevant to the Investigator’s research (e.g., the Investigator is an inventor whose research is sponsored by the company holding the license on the Investigator’s invention; or the Investigator holds equity in a company whose product is being clinically tested by the Investigator, or the Investigator is an officer of a company whose current or future valuation or profits could be affected by the Investigator’s research.).

In each such case, the investigator’s financial holdings or fiduciary positions are relevant to the Investigator’s work though they may not be “significant financial interests” or may not have the potential directly and significantly to affect the research. All relevant interests and positions must be disclosed so that a finding may be made as to whether there is a conflict. If a conflict exists, it must be eliminated, reduced or managed so that the Investigator’s research may go forward.

Conflicts shall be overseen and managed by the Center’s Conflicts Review Committee, headed by the President of the Center.

III. Federal Laws and Regulations on Conflict of Interest

A. Federal Definition of Conflict of Interest

The Center’s policy on conflict of interest is predicated on federal legal requirements found in two documents: regulations of the Public Health Service (PHS) governing PHS-supported research[1] and regulations of the Food and Drug Administration (FDA) governing clinical studies submitted in marketing applications for new human drugs, biologics and certain medical devices.[2]

PHS and FDA do not have identical rules. Where the agencies’ policies conflict, generally, we satisfy the stricter rule. Where one agency’s mandates are additional to (not in conflict with) those of the other, both sets of rules apply.

The key definition is “conflict of interest.” Each agency’s approach is set out below.

PHS Definition. A conflict of interest exists when a significant financial interest could directly and significantly affect the design, conduct or reporting of research.

FDA Definition. The central FDA notion is the concept of “Compensation affected by the outcome of clinical studies.” In FDA’s regulation, that term “…means compensation that could be higher for a favorable outcome than for an unfavorable outcome such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.”

Importantly, neither approach requires consideration of an investigator’s motive in doing her or his work or any finding that bias has actually crept into the scientific enterprise.

The regulations then both turn to the financial interests or compensation arrangements that give rise to potential conflicts of interest. Again, each agency has its own approach.

B. Federal Definition of Financial Entanglements

• salary or other payments for services (e.g., consulting fees or honoraria),
• intellectual property rights (e.g., patents, copyrights and royalties from such rights), or
• equity interests (e.g., stocks, stock options or other ownership interests of the Investigator and her or his spouse and dependent children that exceed $10,000 in public price or by another reasonable measure of fair market value and that represent more than a 5% ownership in any entity.)

Per the PHS, Significant Financial Interest does not include

• salary, royalties or other remuneration from the Center to its employees,
• income from seminars, lectures or teaching sponsored by public or non-profit entities,
• income from service on advisory committees or review panels for public or non-profit entities, or
• salary, royalties or other payments that when aggregated for the Investigator and her or his spouse and dependent children over the next 12 months are not expected to exceed $10,000.

2. FDA Compensation Affected by the Outcome of Clinical Studies. Per the FDA, such compensation includes:

• significant equity interests (ownership, stock options or other financial interest) in a non-publicly traded entity,
• equity in excess of $50,000 in a publicly traded entity during the time of a clinical trial or for 1 year thereafter,
• a proprietary or other financial interest including but not limited to patent or licensing agreements, and
• significant payments of other sorts that have monetary value of over $25,000 (not including the costs of the clinical studies) such as research grants, equipment and on-going consultation or honoraria during the clinical study and for 12 months thereafter.

As is reflected below, the Center’s policy incorporates elements of both the PHS and FDA requirements regarding relevant financial entanglements. The Center’s Policy also addresses fiduciary positions

IV. The Center’s Policy on Conflict of Interest Generally

The following is the definition in the Center’s policy of conflict of interest.

A conflict of interest exists when an Investigator, defined as an employee of the Center, or an independent contractor conducting research on behalf of and/or under an agreement with the Center, has a significant financial interest in an entity, or position as a fiduciary of an entity, which interest or position could directly and significantly affect the design, conduct, analysis or reporting of research.

The standard requires (i) a significant financial interest (defined elsewhere in our policy, see infra) or a fiduciary position (e.g. a senior manager, officer or director), (ii) the possibility of an effect on research, and (iii) the requirement that such potential effect be direct and significant. Importantly, full disclosure of any potential conflict is required. Only thereafter can a decision be made whether the potential conflict is actual, requiring reduction, elimination or management.

V. The Center’s Policy on Significant Financial Interest and Fiduciary Position

A. Significant Financial Interest and Fiduciary Position

1. The Center’s definition of a significant financial interest is consistent with federal regulations.

Significant Financial Interest under the Center’s Policy is anything of monetary value acquired or held by the Investigator and her or his immediate family (spouse and dependent children) including but not limited to salary or other payments for intellectual property rights or services; equity interests in a privately-held entity and in a publicly traded entity with the exception of:

1. Salary, royalties, or other remuneration from the Center or

2. An equity interest in business enterprises or entities that when aggregated is both not more than $10,000 and is not more than 5% ownership interest; or

3. Salary, royalties or other payment obligations or expectations that when aggregated during the research and for the twelve months following its termination, are not expected to exceed $10,000.

2. The Center has chosen to include within its conflict of interest, “fiduciary positions.” The Center’s definition of a “fiduciary position” is as follows:

Fiduciary Interest includes a position as an officer, director, senior manager, or its equivalent thereof, held by an Investigator or his or her immediate family.

Note that an Investigator need disclose only financial interests and fiduciary positions relevant to his or her research.

Note that though FDA set the permissible public company equity holdings at $50,000, the Center is bound by the stricter PHS $10,000 rule. And because FDA looks at payments made or expectations held both during the research and for twelve months thereafter, we conform to that as the more restrictive dictate.

VI. Procedures for Disclosure and Managing Conflict

A. Review of Disclosures

A completed Conflicts of Interest Disclosure Form shall be provided annually by each Investigator and returned to the Executive Officer. These forms must be updated within thirty days of any material changes. Those forms that include disclosure of a financial interest or a fiduciary position shall be delivered to the Center’s Counsel for review. Counsel shall make a determination whether, in his or her opinion a conflict of interest exists, that is, if he or she believes that such significant financial interest or that such fiduciary position disclosed could affect the design, conduct or reporting of the research or educational activities, which are the subject of a grant application.

If Counsel concludes that a conflict exists, he or she shall so inform the President of the Center, who shall in turn inform the Conflicts Review Committee. The Conflicts Review Committee shall be established by the Center’s Board (or, until the Conflicts Review Committee is formally constituted, the Conflicts Review Committee shall be comprised of the President and two other designees appointed by the Executive Committee of the Board). Counsel shall also inform such Investigator. The Conflicts Review Committee shall oversee the management and resolution of actual or potential problems revealed. In the case of a conflict that involves a member of the Conflicts Review Committee, the Executive Committee of the Board shall appoint a substitute for such member for oversight and resolution of the conflict in question.

B. Management and Resolution of Conflicts

Those charged with oversight will manage and resolve conflicts by any or all of the following means:

• public disclosure of significant financial interest or fiduciary position;
• monitoring of research by independent reviewers;
• modification of the research plan;
• disqualification from participation in the portion of the research funded by the applicable agency;
• divestiture of significant financial interest; or
• severance of relationships that create actual or potential conflicts;
• such other or further conditions, limitations, disclosure, reviews or actions as the Conflicts Review Committee deems appropriate.

C. Enforcement

It is the policy of the Center to require full compliance with the management and resolution of the conflicting interests as recommended by the Conflicts Review Committee. The conditions and restrictions proposed must be instituted before submission of the subject grant application. Violations of this Policy will be referred to the Conflicts Review Committee for appropriate enforcement action for failure to comply. If the failure to comply with this Policy has biased the design, conduct or reporting of the funded research, the Center will promptly notify the appropriate funding agency that the corrective action it has or will take.

D. Maintenance of Records

The Conflicts Review Committee shall maintain records, identifiable to each award, of all financial disclosures, including, but not limited to, the Conflicts of Interest Disclosure Form and of all actions taken to resolve actual or potential conflicts of interest until at least three (3) years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

E. Obligation to Disclose to Agency or Department of Health and Human Services

The Center may have an obligation, prior to the expenditure of any funds under an award, to advise the applicable governmental granting agency or the Department of Health and Human Services (“HHS”) of any conflicting interest (but not the nature of the interest or other details) found by the institution and assure such agency or HHS that the interest has been managed, reduced, or eliminated to protect the research from bias in accordance with all applicable law and regulations; and for any interest that the Center identifies as conflicting subsequent to the Center’s initial report under the award, the report will be made and the conflicting interest managed, reduced or eliminated, at least on an interim basis, within sixty days of such identification. The Center also has the responsibility to keep the applicable granting agency fully informed if the Center finds that it is unable to satisfactorily manage an actual or potential conflict of interest.

The Center shall make information available, upon request, to HHS regarding all conflicting interests identified by the Center and how those interests have been managed, reduced or eliminated to protect research from bias.

[1] 42 C.F.R. Part 50 Subpart F and Part 94.

[2] 21 C.F.R. Part 54. The regulation regarding National Science Foundation research awards with respect to conflicts of interest are very close in content to the PHS rules. Should the Center contemplate applying for an NSF research award, however, the Policy should be reviewed to confirm compliance with NSF rules.

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