(SOP) for Managing Conflict of Interest

Standard Operating Procedures for Managing Conflicts of Interest

VA Long Beach Healthcare System

Research Healthcare Group

Version: 08/07/14 replaces 08/20/10

STANDARD OPERATING PROCEDURES

FOR

MANAGING CONFLICTS OF INTEREST

VA Long Beach Healthcare System

Research Healthcare Group

1. PURPOSE:

The VA’s general policy on conflict of interest is that none of its faculty, staff, managers, or officials shall engage in any activities that place them in a conflict of interest between their official activities and any other interest or obligation, financial or otherwise. The policy related to research activities extends to the investigator's spouse and dependent children, while other VA policies related to purchasing decision-making extend to siblings, parents and in laws.

The purpose of this Standard Operating Procedure is to establish uniform procedures for consideration of potential conflicts of interest in human research. This document covers procedures for dealing with the following areas of potential conflicts of interest:

A. The review of research protocols by members of the Research & Development Committee or any of its subcommittees (Institutional Review Board, Institutional Animal Care and Use Committee, Subcommittee for Biosafety, Space Subcommittee, Budget Subcommittee, ACOS for R&D, and other individuals and committees that may be involved in review of research or decisions about funding or resource allocation within the Research Healthcare Group.

B. Investigator’s responsibilities to disclose financial conflict of interest involving research protocols, or other matters involving research.

2. SCOPE:

This policy applies to all research conducted under the authority of the VALBHS. This policy applies to investigators, IRB members and staff, R&D members and staff, and institutional officials.

3. BACKGROUND:

A. Members of the Research & Development Committee and any of its subcommittees may find themselves in any of the following personal conflicts of interest when reviewing research:

1) When the Chair or member of the R&D Committee or subcommittees is listed as an investigator on the research.

2) When any Investigator must report to or is under the supervision of the Chair or member of the R&D Committee or subcommittees, or vice versa.

3) When the Chair or member of the R&D Committee or subcommittees competes for research grants or contracts in the same or similar field as an investigator whose research is scheduled for review.

A potential conflict of interest may also be present when there is close professional, personal, or financial relationship between a member and an investigator.

B. Investigators may have the potential for conflict of interest when approached to conduct research sponsored by organizations with which they have a financial interest.

C. Institutional Review Boards or IACUCs may not have the expertise to address financial conflicts of interest and should have a resource for an independent review.

3.DEFINITIONS:

CONFLICT OF INTEREST: A convergence of an individual’s private interests with his or her research interests, such that an independent observer might reasonably question whether their professional actions or decisions are improperly influenced by considerations of personal gain, financial or otherwise.

DISCLOSURE: Disclosure is the formal written process of documenting all aspects relating to the development of potential intellectual property for the purpose of determining and assigning ownership.

EQUITY: The money value of a property or of an interest in a property in excess of claims or liens against it. FINANCIAL CONFLICT OF INTEREST: A Financial Conflict of Interest exists in research when an individual, group, or Institution may benefit financially from either the performance of, or the outcome of, or reporting of a research project. The appearance of a conflict of interest from the point of view of a disinterested party is also a potential conflict of interest. Potential conflicts of interest extend to individuals, spouses, and dependent children. Financial interest does not include:

1) Salary, royalties, or other remuneration from VALBHS or a VA-non profit institution;

2) Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; or

3) Income from service on advisory committees or review panels for public or nonprofit entities.

4) Investment in mutual funds.

FINANCIAL AND EMPLOYMENT RELATIONSHIPS: Financial and employment relationships include but are not limited to salary or other payments for services (e.g. consulting fees or honoraria), equity interests (e.g. stocks, stock options or other ownership interests), appointed position in the sponsoring agency including positions on a Board of Directors, consultant ship, or advisory group, and intellectual property rights (e.g. patents, copyrights, and royalties from such rights).

INSTITUTIONAL CONFLICT OF INTEREST: An institutional conflict of interest may occur when the institution, or any of its senior management or an affiliate foundation or organization, has an external relationship or financial interest in a company or organization that itself has a financial interest in a VA investigator’s research project.

INSTITUTIONAL OFFICIALS: Individuals in a position to make decisions with institution-wide implications. These include the Medical Center Director, Chief of Staff, Associate Chief of Staff for Research & Development, and other senior officers.

INTELLECTUAL PROPERTY (INVENTION): Intellectual property is any art, machine, manufacture, design, or composition of matter, or any variety of plant, which is or may be patentable under the patent laws of the United States.

INVENTOR: The inventor is the individual responsible for the conception or reduction to practice of a device or process.

PATENT: A patent is an official written document securing to an inventor for a term of years the exclusive right to make, use, or sell an invention.

PERSONAL CONFLICT OF INTEREST: A Personal Conflict of Interest exists when personal obligations compromise or appear to compromise an individual’s or group’s professional judgment in conducting, reviewing, or reporting research. This may occur when the investigator serves dual roles, such as investigator and health care provider. It may also involve issues of nepotism. Other interests such as publications, promotion or tenure can also become conflicts of interest that may affect an investigator’s judgment.

RECUSAL: When a member or R&D Committee, one of its subcommittees, or other member of the Research Healthcare Group declines to participate in a matter because of a potential conflict of interest under the Code of Ethics. As distinguished from abstention, the official recusing him/herself will not be present during or participate in deliberations or voting on the matter where there are potential conflicts of interest.

RE-DISCLOSURE: Re-disclosure is the formal written process of documenting all aspects relating to any improvement of a previously disclosed invention for the purpose of issuing a new determination on the improved invention.

ROYALTY: A royalty is compensation for an invention.

SIGNIFICANT FINANCIAL INTEREST: Any financial interest that exceeds the thresholds stated on the Disclosure of Relationships and Financial Interests Form.

4. POLICY:

The policy of the VA is to ensure that the welfare of human subjects and the integrity of research will not be compromised, or appear to be compromised, by competing institutional

interests or obligations. Although the Department of Veterans Affairs (VA) has separated technology transfer functions (see VHA Handbook 1200.18) from research administration, circumstances may exist in which separation of function is not sufficient to avoid the appearance of institutional conflict of interest.

A. Financial Disclosure and Conflict of Interest for R&D and Subcommittee Members:

Chairs and members of the Research & Development Committee and subcommittees who have a conflict of interest are prohibited from participating in the initial or continuing review of research protocols. The Chair or member(s) with a conflict of interest will verbally disclose the nature and extent of the conflict of interest to the Research & Development Committee or subcommittee at the time of review and will recuse himself/herself from any discussion and voting on such research except when asked to answer questions directed by the Research & Development Committee or subcommittee. The recusal will be noted in the minutes of the Research & Development Committee or subcommittee.

Each regular or alternate member must complete a conflict of interest statement annually, or at any time within 30 days of a significant change in the member's relationship to or financial interest in a sponsoring entity. Each member must also disclose any patents they have been awarded during the year, which may affect their conflict of interest in a particular company, their product(s), data, or method(s). The Research Office will hold Conflict of Interest Statements on file.

Other individuals have conflicts of interest inherent in their positions, and may not serve on the R&D Committee or its subcommittees as voting members. This includes, but is not limited to, officers of the Southern California Research and Education Foundation, other grants contracts or fiscal officers affiliated with the institution.

B. Financial Disclosure and Conflict of Interest for Investigators:

The Principal Investigator and all Co-Principal Investigators, Co-Investigators, Sub-Investigators, key participants and all personnel responsible for the design, conduct or reporting of the study must report all significant financial interests and any conflicts of interest using the conflict of interest section of the Research Prospectus form at the time of initial review. Disclosures must also be made at the time of continuing review or if there are changes in financial circumstances. The policy pertains to interests in business, non-profit and public entities in an area related to the research, where the entity could reasonably appear to affect or be affected by the design, conduct, or reporting of the sponsored project.

C. The R&D Committee will be responsible for evaluating potential institutional conflict of interest and will take actions as required to avoid, or to appropriately manage, apparent institutional COI. These actions may involve referral to appropriate advisors outside the facility or obtaining advisement from the Office of Regional Council. If used, outside advisors will be individuals, who have sufficient seniority,

expertise, and independence to evaluate the competing interests at stake and to make credible and effective recommendations. All outside advisors will be independent of the management of oversight for the Human Research Protection Program (HRPP) within the institution. The utilization of outside advisors will increase the transparency of the deliberations and enhance the credibility of determinations. After reviewing a significant financial interest in research, the R&D Committee will communicate its conclusions, along with any management arrangements to be imposed, to the IRB and/or IACUC (as relevant). For studies that involve human subjects, all relevant conflicts will be disclosed to research participants in a form to be determined by the IRB. The R&D Committee also will communicate conclusions and COI management strategies to the Institutional Official and the Principal Investigator.

D. A Conflict of Interest Committee will be convened on an as needed basis to review any perceived conflicts and make recommendations to the R&D Committee and its subcommittees, or if circumstances warrant, to the Medical Center Director regarding any conflicts that could adversely affect the design, conduct, or reporting of a research project conducted at VALBHS. Final determination of the presence of a member’s conflict of interest and a plan for its management will reside with the Conflict of Interest Committee. Committee members should be individuals who have sufficient seniority, expertise, and independence to evaluate the competing interests at stake and make credible and effective recommendations. All members of the COI committee should be independent of the direct line of authority for HRPP oversight within the institution. One or more external (public) members are strongly urged as the inclusion of public members will increase the transparency of the committee’s deliberations and enhance the credibility of its determinations.

E. Financial Disclosure Thresholds

Thresholds for disclosure of financial conflicts of interest in all cases will conform at least to the federal guidelines for PHS grants. Default thresholds for the disclosure of financial interests are described on the VALBHS Disclosure of Relationships and Financial Interests Form. However, disclosure standards of other agencies (e.g. commercial sponsor, or University of California) must also be met in some cases, if they have authority over a project.)

F. To the extent permitted by law, the R&D Committee, its subcommittees and the Research Healthcare Group will maintain the confidentiality of all records of financial interests.

5. PROCEDURES:

A. Assessment of Potential Conflict of Interest (COI)

1. The Principal Investigator will act on behalf of all Investigators and key personnel on the project by completing Section 7 of the Prospectus of Research Study entitled “Financial Conflict of Interest” (Attachment A) and include it in the submission package for all new studies. This will be a part of the information forwarded to subcommittees for their review of studies and to the R&D. The PI will also be responsible for bringing to the ACOS/R&D attention any potential conflict of interest that occurs throughout the conduct of the study.

a) Invention/Intellectual Property Disclosure

In the case of an invention (to include a new use or improvement of an invention) or believed invention, the inventor must complete a VA outline for reporting and certification forms. These documents are available at the Technology Transfer Program (TTP) website at http://www1.va.gov/resdev/programs/tech_transfer/default.cfm

The inventor’s supervisor must review the outline for reporting of inventions and certification forms. The file is then submitted to the Director, Technology Transfer Program, via the Research and Development (R&D) Office, for review and approval. The Technology Transfer Program recommends one of three outcomes. The Office of General Counsel issues the final agency decision. The possible outcomes are as follows: The government maintains right, title, and interest in, and to, any invention of a Government employee; the government is entitled to a royalty free license with ownership remaining with the inventor; or The government claims no interest or license; i.e., all rights remain with the inventor.

b.) Cooperative Technology Administration Agreements (CTAA)

Since many VA’s researchers hold appointments with both VALBHS and the University of California, Irvine (UCI), VA recognizes that UCI may also have an interest in an invention made at a VA facility, resulting in joint ownership. In response to this situation, TTP developed a Cooperative Technology Administration Agreement (CTAA). This legal agreement outlines relevant definitions, terms, and conditions for handling jointly owned intellectual property (IP) between both organizations.

c.) Cooperative Research and Development Agreement (CRADA)

A CRADA is an agreement between the VA facility and one or more non-Federal parties (such as an academic affiliate) under which VA medical center Directors may accept, retain, and use funds, personnel, services, facilities, equipment, or other resources from collaborating parties in order to conduct

R&D in a particular project. This may include the further development of a VA-owned invention and may be entered into in cooperation with a license

agreement. CRADAs are negotiated by the VA medical center and regional counsel attorneys. Following review and approval by the Office of General Counsel (OGC), they are returned to the medical center for execution.

d.) Royalties

Royalty income to the VA will be accepted, monitored, and distributed by the Technology Transfer Program (TTP). All royalties go to VA Central Office. Centralized compilation of royalty income data is required for evaluating and reporting on the program's effectiveness and to ensure compliance with applicable laws; e.g., current Federal royalty income cap of $150,000 per year. Note: Royalties paid to employees from non-Federal sources such as universities are not subject to this ceiling.

B. Review

1. Conflicts of interest are initially evaluated by a Primary Review Committee. The primary review of projects that involve human subjects is the IRB; the primary review of projects that involve animals is the IACUC or SAS. The primary review committee for all other projects is the R&D committee.

2. The Primary Review Committee will review protocols to assure that, when applicable, the above arrangements are in place in situations where a VA researcher has an intellectual property interest. The R&D Committee and its subcommittees will review the investigator’s statement of disclosure as part of their initial review of a study. When one of these committees or subcommittees perceive a financial conflict of interest that might adversely affect study design, conduct or reporting, that cannot be resolved by the subcommittee, they may refer their concerns to the ACOS/R&D and request that an independent Conflict of Interest Review Committee be convened to review the issue and report to the R&D Committee and referring subcommittee. The subcommittees (e.g. IRB and IACUC) can proceed with their review and even grant approval contingent upon a resolution of the conflict that has the endorsement of the R&D Committee.

3. The Primary Review Committee also has a responsibility to review the potential for institutional conflict of interest, including intellectual property agreements, and to evaluate whether the potential conflict is managed adequately for the protection of human participants. Committee members are annually required to disclose institutional affiliations on the Disclosure of Relationships and Financial Interests Form. Required disclosures include:

· Interests in SCIRE or the VALBHS Research Healthcare group

· Academic appointments

· Managerial positions with any interested entity.

The Primary Review Committee review of possible Institutional conflicts of Interest may include input from a variety of other sources that include, but are not limited to:

· Input from affiliated institutions, e.g. the Deans’ Committee member on the R&D committee

· Input from VALBHS management, e.g. Conflicts with patient care duties

· Input from the Sponsor

· Input from the Non-Profit research Foundation

· Input from the VALBHS Privacy Officer

The Primary Review Committee will consider such input in determining if there is the potential for an institutional conflict of interest such as:

· A conflict in responsibilities between VALBHS and an affiliate with regard to procedures that are performed on subjects at both institutions.

· A conflict in the allocation of space or resources for projects that involve more than one institution

· A conflict in the distribution of royalties, intellectual property rights, inventions between the VALBHS and an affiliate or sponsor

· A conflict with regard to differences in institutional policies with regard to information sharing, storage, and disposal

· A conflict with regard to investigator time allocation and duties at VALBHS and affiliated institutions, or uncompensated time to perform work for a sponsor or affiliate

· A conflict with regard to institutional differences with regard to restriction on the dissemination of research information

Committee members are required to declare and recuse themselves from votes concerning the approval of projects that might present an institutional conflict of interest. This may be the case if:

· The members affiliated entity may benefit may benefit from the outcome of the study; or

· The members affiliated entity is conducting a study, or is likely to conduct a study that may compete for funding, or other resources, with the study that is under review

4. If the Primary Review Committee is unable to manage the conflict of interest for any reason then the matter will be referred to the R&D committee for resolution. This may be the case if the Primary Review Committee lacks sufficient expertise to make a determination. The R&D committee will convene a conflict of interest committee to review the matter.

C. Management of Conflict in Interest

1. Assumption of conflict of interest

If the VA facility retains a significant financial interest, or if an institutional official with direct responsibility for the HRPP holds a significant financial

interest in the invention, then the R&D Committee must assess the potential conflict of interest and weigh the magnitude of any risk to human participants. When reviewing potential institutional conflict of interest, the R&D Committee

will assume an inclination against the conduct of human participants research at, or under the auspices, of the institution where a COI appear to exist. However, the assumption may be overturned by the Committee when the circumstances are compelling and the Committee has approved an effective conflict management plan.

2. The ACOS/R&D, upon receipt of a request from a subcommittee for a conflict of interest review will convene a Conflict of Interest Review Committee, chaired by a non research service, management designated individual, and composed of one member from the referring committee, two senior investigators and the Research Compliance Officer (RCO) for the VALBHS. Committee members should be individuals who have sufficient seniority, expertise, and independence to evaluate the competing interests at stake and make credible and effective recommendations. All members of the COI committee should be independent of the direct line of authority for HRPP oversight within the institution. One or more external (public) members are strongly urged as the inclusion of public members will increase the transparency of the committee’s deliberations and enhance the credibility of its determinations. This Committee is free to interact with the investigator in an effort to find an acceptable resolution to any conflicts. The Investigator may also petition the Committee to make a presentation. Any of the R&D subcommittees can also refer a situation in which one of its members has a Conflict of Interest to this committee if it cannot resolve the issue itself.

3. The Conflict of Interest Review Committee members will keep their deliberations and proceedings of their meetings and findings in the strictest of confidence both during the time they serve as active members of the Committee and thereafter. All copies of handouts, agendas, and meetings minutes will be retained by the RCO and secured in a locked file cabinet. Key to the secured files will be the responsibility of the RCO.

4. Decision making

a.) A key aspect in decision-making is to analyze when it would be appropriate and in the public interest to accept and manage a COI, rather than require than require that the COI be eliminated. In some cases, the benefits of conducting a proposed research activity at the institution will be potentially high, and the risks will be low. In other cases, the scientific advantages of conducting the research may be speculative and the risks may be great, in these latter instances, the conflict should be avoided by disapproving the research application.

b.) The Committee will review disclosures to determine whether any related financial interest is one that would reasonably appear to be directly and significantly affected by the proposed project. A direct impact occurs when the project results would be directly relevant to the development, manufacturing, or improvement of the products or services of an organization in which the Investigator has a financial interest, or when the organization is a proposed subcontractor or participant in the project, or when there exists a relationship between the Sponsor of a project and the Investigator outside of the Sponsored Project agreement that has the potential to effect the performance of the project.

c.) Evaluation of risk

Each case should be evaluated based upon the following:

· the nature of the science;

· the nature of the interest;

· how closely the interest is related to the research;

· the degree of risk that the research poses to human participants; and

· the degree to which the interest may be affect by the research.

The R&D committee will consider whether the institution is uniquely qualified, by virtue of its attributes (e.g., special facilities or equipment, unique patient population) and the experience and expertise of its investigators, to conduct the research and safeguard the welfare of the human subjects involved.

D. Potential Actions

1) Based on information provided in the Disclosure, the Conflict of Interest Review Committee may determine that there is no reasonable basis on which to conclude that a project could directly and significantly affect the financial interest and that the financial interest is not likely to affect the design, conduct, or reporting of the project. In this case, a record will be made of the Committee’s action and the referring subcommittee and R&D Committee will be so notified.

2) Should the Committee conclude that a project might have a direct and significant impact on financial interest and that the financial arrangements could affect the design, conduct or reporting of the project, the Conflict of Interest Review Committee may make recommendations as to how to manage the potential conflict of interest. Examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to:

· Public disclosure of financial interests to potential subjects

· Not conducting proposed research at the institution, or halting it if it has commenced

· Disclosure of financial interests to research subjects, journal editors and in presentations

· Monitoring of research by independent reviewers

· Modification of the research plan

· Reducing or otherwise modifying the financial (equity or royalty) stake involved

· Increasing the segregation between the decision-making regarding the financial and the research activities

· Requiring an independent data safety monitoring committee or similar monitoring body

· Modifying the role(s) of particular research staff or changes in location for certain research activities; e.g., a change of the person who seeks consent, or a change in investigator

· Establishing a research monitoring process, so that the research can be closely scrutinized to ensure that potential conflicts do not undermine the integrity of the work and the VA

· Education of research personnel

· Disqualification from participation in all or a portion of the research funded

· Divestiture of significant financial interest

· Severance of relationships that create actual or potential conflicts

3). The Conflict of Interest Review Committee may recommend whether the project should be approved and whether conditions or restrictions should be placed on the project. A plan for the management of any conflict will be devised, agreed to by the PI and the Conflict of Interest Review Committee and forwarded to the Institutional Official (Medical Center Director) for concurrence.

4). Review by a conflict of Interest Review Committee does not provide assurance of the absence of a financial conflict of interest. Other factors, which may not be known to the Conflict of Interest Review Committee, could result in real conflicts, or facts could change over time such that a conflict may arise in the future.

6. REFERENCES:

VHA Handbook 1200.5 paragraph 7.A(9)

VHA Handbook 1200.18

42 CFR 50.601-607 [PHS Policy]

21 CFR 54.4-6 [FDA Disclosure Policy]

45 CFR 94.4-6 [Policy for PHS contractors]

OHRP Final Guidance Document. Financial relationships and interests in research involving human subjects: Guidance for human subject protection. May 5, 2004.

Association of American Medical Colleges. Protecting subjects, preserving trust, promoting progress II: Principles and recommendations for oversight of an institution’s financial interests in human subjects research. October 2002.

FDA Guidance: HHS, Part 54 “Financial Disclosure by Clinical Investigators.” www.fda.gov/oc/guidance/financialdis.html

FDA Forms 3454 and 3455 Certification: Financial Interests and Arrangements of Clinical Investigators. http://forms.psc.gov/forms/FDA/fda3454.pdf, http://forms.psc.gov/forms/FDA/fda3455.pdf

HHS August 2000 conference on Conflict of Interest. http://ohrp.osophs.dhhs.gov/coi/index.htm.

7. RESCISSION: Standard Operating Procedures for Managing Conflicts of Interest (12/14/07).

8. REVIEW DATE: Review as needed and reissue every three years.

9. ATTACHMENTS:

Attachment A - Investigator Financial Interest Disclosure, Section B of the Prospectus of Research Study

Attachment B – Research healthcare Group Financial Interest Disclosure Form

Attachment C – Flowchart for Evaluations of Conflicts of Interest

______________________________________________

Jeffrey Webster Ph.D.Date

Chair, Research and Development Committee

Attachment A

INVESTIGATOR CONFLICT OF INTEREST PEPORTING

“PROSPECTUS OF RESEARCH STUDY” FORM

7. FINANCIAL CONFLICT OF INTEREST

4. With respect to the sponsor (source of funding or in-kind support) or other entity external to the Veterans Administration or SCIRE whose business interests are related to the data or results of this study, do/(did) the Principal Investigator, any Co-investigator or their spouse or dependent child(ren) have:

· Outside income exceeding $10,000 (including salary, consultant payments, honoraria, royalty payments, dividends, loan, or any other payments or consideration with value over the prior twelve months or anticipated during the forthcoming twelve months? |_| No |_| Yes If yes, identify person(s) with interest:      

· Equity in the form of stock, stock options, real estate, loan to, or any other investment or ownership interest exceeding $10,000 (current market value); or a 5% or greater ownership interest?|_| No |_| Yes If yes, identify person(s) with interest:      

· A management position (e.g., director, officer, partner or trustee) at the sponsor company/interested entity? |_| No |_| Yes, If yes, identify person(s) with interest:      

· An intellectual property interest on an actual or planned patent, patent application, or a copyright of software for the product under study that is assigned or will be assigned to a party other than the US Government or the University of California? |_| No |_| Yes

If yes, identify person(s) with interest:      

B. Has the Principal Investigator for the award reported a potential conflict of interest to the sponsoring agency? |_| No |_| Yes |_| N/A (no external funds)

C. If you have answered “yes” to questions #1 or #2 above, you must provide additional information regarding the specific financial interest(s).

Please attach:

· A completed copy of the sponsors financial disclosure form, OR

· A completed copy of FDA form FD 3455, OR

· A completed copy of the VALBHS Disclosure or Relationships & Financial Interests Form

Note: If a financial interest is present, the informed consent document in human studies should include a statement that one or more investigators have a personal financial interest in the Sponsor company or other entity, and the nature of the interest. A statement may also be included to the effect that there is no financial interest, if none exists.

Attachment B

VALBHCS RESEARCH HEALTHCARE GROUP

DISCLOSURE OF RELATIONSHIPS AND FINANCIAL INTERESTS

Member Name:     

Position in Research HCG:      

Contact information:

Phone:      

Mail code:      

Email:      

Department:      

Health Care Group:      

Date:      

4. Instructions (please read carefully):

This form requests information on all financial interests and other interests which you have that may be related to your duties as a member of the R&D Committee, one of its Subcommittees, or other staff position in the Research Healthcare Group. This request applies to your current activities within the last 12 months and any activities anticipated during the next 12 months. It applies to you, your spouse, and any dependent children. Please complete all sections. If there is no interest, please check “No”. This information is required for determination of potential conflicts of interest. Any Significant Financial Interest that could reasonably appear to significantly affect the member’s activities within the Research Healthcare Group should be disclosed. The Research Office will maintain this information confidentially. It will only be accessed by those responsible for determining conflict of interest in research and will not be disclosed to other individuals or agencies. An updated form must be submitted annually, or within 30 days of a change in the information to be disclosed.

4. Definitions:

Financial Interest means anything of monetary value held by you, your spouse, or your dependent children now, in the past 12 months, or anticipated in the next 12 months. This includes but is not limited to salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g. stocks, stock options or other ownership interests), intellectual property rights (e.g., patents, copyrights and royalties from such rights), conduct of clinical trials, interest in commercial firms that sponsor clinical trials reviewed by the VALBHCS Research Healthcare Group, financial or other relationships with facilities or personnel of the VALBHCS or SCIRE, outside professional and commercial activities, or other involvement or financial interest that might be perceived to conflict with your VA responsibilities. The term does NOT include salary, royalties, or other remuneration from the VALBHCS, income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities, or investment in mutual funds.

Significant Financial Interests are financial interests with respect to any entity whose business interests are related to the data or results of a study or studies which may be reviewed by the Research Healthcare Group, which meet the following thresholds. Such interests must be reported.

4. Outside income exceeding $10,000 (including salary, consultant payments, honoraria, royalty payments, dividends, loan, or any other payments or consideration with value over the prior twelve months or anticipated during the forthcoming twelve months;

2) Equity in the form of stock, stock options, real estate, loan to, or any other investment or ownership interest exceeding $10,000 (current market value) or a 5% or greater ownership interest;

3) A management position (e.g., director, officer, partner or trustee) with the sponsor/interested entity;

4) An intellectual property interest on an actual or planned patent, patent application, or a copyright of software for the product under study which is assigned or will be assigned to a party other than the US Government or the University of California.

Sponsored means research, training and instructional projects involving funds, materials, or other compensation including gifts from outside sources.

Investigator means the principal investigator and any other person at the Institution who is responsible for the design, conduct or reporting of research; for purposes of information relating to disclosure of financial interests, “Investigator” includes the person completing the form and his/her spouse and dependent children.

Executive Position refers to any salaried position that includes responsibilities for a material segment of the operation or management of a Business.

DESCRIPTION OF FINANCIAL INTERESTS

For each entity in which you have a significant financial interest (defined on page 1), complete the following sections describing the financial interest in detail. Use additional pages if necessary.

Describe:

4. The nature and extent of interest you, any member of your Family or an Associated Entity has or receives in or from the Business or activity in question (e.g., the percentage and value of any ownership interest in the Business or activity in question (e.g., the percentage and value of any ownership interest in the Business and/or the type and value of any payment received from the Business),

(2) Your role or that of any member of your Family or Associated Entity in the Business,

(3) The nature of the Business and its relationship to your VA activities

4. Interest in Commercial Firm

Do you consult or have a significant financial interest with any commercial funding source that also sponsors clinical trials conducted by the VALBHCS in which you simultaneously are responsible for the design, conduct or reporting of the project? No |_| Yes |_|

Financial interests to be reported, if significant, include: 1) conduct of clinical trials, 2) interest in entities manufacturing commercializing any drug, vaccine, device, procedure or any other product that is associated with or that will predictably result from the project, 2) ownership, equity, management, consultant, contractor positions or similar relationships with the entity, 3) financial interests that could be directly and significantly affected by the design conduct or reporting of the research activity under review, 4) honoraria,

Name of Entity

Role in Entity

Interest in Entity

(% or approx. $ amt))

Nature of Interest

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

Additional description:

Further describe the nature of your consulting duties or relationship of monetary value. List the financial or other material consideration that you have, or expect to receive, for these services.

     

2. Facilities or Personnel

4. Do you have financial or other relationships with facilities or personnel of VALBHCS or SCIRE that might be perceived to conflict with your responsibilities within the VALBHCS Research Healthcare Group?

No |_| Yes |_|

b. Do you have personal, financial, or professional relationships with individuals of VALBHCS or SCIRE that might be perceived to conflict with your responsibilities within the VALBHCS Research Healthcare Group (eg: close collaboration with colleagues, department chair)? No |_| Yes |_|

Facilities or personnel involved

Your involvementNature of Relationship

     

     

     

     

     

     

     

     

     

     

     

     

3. Outside Professional and Commercial Activity Disclosures

a. Do you have any external professional or commercial activities, including outside staff or academic appointments that might be perceived to conflict with your responsibilities within the VALBHCS Research Healthcare Group? No |_| Yes |_|

b. Do you participate in research, including any clinical trial, on a Technology owned or contractually obligated to a Business in which you, any member of your Family, or an Associated Entity has a Significant Financial Interest, other than royalties and/or licensing fees under institutional agreements? No |_| Yes |_|

Activity

Your involvement

Nature of involvement

     

     

     

     

     

     

     

     

     

     

     

     

How are you keeping your interest in or outside obligations to the Entity separate from your Research Healthcare Group commitment?      

4. Patents and Intellectual Property

Do you have patent or licensing agreement with any commercial entity, or the possibility for patentable inventions being developed? No |_| Yes |_|

Nature of Intellectual Property

Your involvement

Nature of involvement

     

     

     

     

     

     

Describe:      

5. Other Conflict of Interest Involvement

a. Do you have any involvement or financial interest that is, or could be perceived to be in conflict with the proper discharge of your duties at the VALBHCS? Apply a standard of what a “reasonable” person confronted with the financial relationship would consider to be a conflict. No |_| Yes |_|

b. Have you taken any administrative action within the University or VALBHCS that might conflict with your duties as part of the VALBHCS Research Healthcare Group in a particular case? No |_| Yes |_|

c. Do you serve on the Board of Directors or Scientific Advisory Board of any Business? No |_| Yes |_|

d. Do you have any other conflict of interest or commitment that might conflict with your duties as part of the VALBHCS Research Healthcare Group? No |_| Yes |_|

Describe any “yes” answers below. Use extra pages if necessary:

     

6. Additional Explanation

Describe below any additional relevant information.      

4. ASSURANCE STATEMENT

I certify under penalty of perjury that this is a complete disclosure of all significant financial interests related to the specified project, I have used all reasonable diligence in preparing this Conflict of Interest Disclosure, and to the best of my knowledge it is true and complete. I understand that I must update this disclosure whenever changes occur.

_______________________________________ _____________________

SignatureDate

Attachment C

12mcoi10/27/00

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