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OF RECORD


The Faculty Senate Committee on Administration reviewed the proposed policy, Financial Disclosure and Presumptively Prohibited Conflicts for Faculty Participating in Clinical Trials, developed in consultation with the School of Medicine administration and faculty. An earlier version of this policy has been used as an interim policy for the past two years by the Conflict of Interest Standing Committee. The Senate Executive Committee approved the following version at its meeting on April 2, 2003. This policy becomes effective immediately.

-- Robert Barchi, Provost
-- Neal Nathanson, Vice Provost for Research

Financial Disclosure and Presumptively Prohibited Conflicts for Faculty Participating in Clinical Trials

Preamble

Clinical trials represent a special area of research, which is distinguished by the involvement of human subjects who are often particularly vulnerable because they suffer from serious illness, may be searching desperately for treatments, and are being asked to participate in research that carries unknown risks and indeterminate benefits. Under these circumstances, it is particularly important that clinical research be insulated from potential conflicts of interest that might be perceived to influence its conduct or outcome. Therefore, for investigators involved in clinical trials, the University has implemented an additional set of requirements involving disclosure and prohibition of financial interests, which supplement the standard conflict of interest policies.

These guidelines are consistent with the provisions of the AAMC white paper issued in December, 2001, "Protecting Subjects, Preserving Trust, Promoting Progress--Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research."

Investigators are expected to comply with all other relevant Conflict of Interest and Disclosure policies of the University (see Appendix).

In order to be eligible to conduct clinical trials, investigators are required to complete a patient oriented research certification program and to sign a document indicating that they agree to comply with the University policies regarding human subject research. In addition, in connection with each clinical trial in which an investigator intends to participate, the investigator must submit a Financial Disclosure Form that discloses relationships the investigator has with the sponsor of the trial and interests the investigator has in the product or procedure being evaluated in the trial.

I. Presumptive Prohibitions and Significant Financial Interests

Presumptive prohibitions refer to prohibited participation in clinical trials on the part of researchers who have Significant Financial Interests (defined below) that constitute potential conflicts of interest. Significant Financial Interests require review by the University Conflict of Interest Standing Committee (CISC), which will consider the circumstances in each instance and will determine whether the participation of the investigator should be prohibited, or whether there are compelling circumstances that left an exception to the presumptive prohibition. If the CISC determines that an exception is justified, they will recommend a management plan. This Process is described below in more detail.

Significant Financial Interests include:

1. Service by the investigator or any member of his or her immediate family on the Board of Directors or as an officer (see Definitions) of any company or entity that sponsors or supports the investigator's clinical trial.

2. Ownership by the investigator, any member of his or her immediate family or any related entity, of a significant equity interest (see Definitions) in a company or entity that sponsors or supports the clinical trial, or receipt by the investigator, any member of his or her immediate family or any related entity, of significant payments (see Definitions) from a company or entity that sponsors or supports the clinical trial.

3. Ownership of a proprietary interest in the tested product by the investigator, any member of his or her immediate family or any related entity.

II. Definitions of Terms:

a. Significant equity interest in the sponsor of a clinical trial study means any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices (generally, interests in a non-publicly traded corporation), or any equity interest in a publicly traded corporation that exceeds $10,000 (or exceeds 5% ownership) during the time the clinical investigator is carrying out the study and for 1 year following the completion of the study. Interest in any publicly traded mutual fund is excluded.

b. Significant payments means payments (e.g., retainers for ongoing consultation, honoraria, or gifts) made by or on behalf of the sponsor of a clinical trial study that have a monetary value of more than $10,000 per year, exclusive of the costs of conducting the clinical study or other clinical studies, during the time the clinical investigator is carrying out the study and for 1 year following the completion of the study. Excluded are payments to a department or school from the sponsor of a covered study.

c. Proprietary interest in the tested product means property or other financial interest in the product including, but not limited to, a patent, trademark, copyright or licensing agreement, or right to receive income in connection with the development or sale of the tested product.

d. Officers of a company or entity are those individuals with fiduciary responsibility as defined by the operating rules of the company or entity.

e. Participation in a trial includes the recruitment of patients, patient selection, the informed consent process, conduct of the trial, patient visits, procedures, and the analysis and interpretation of data.

f. Compelling circumstances are facts that convince the CISC that an investigator should be permitted to participate in a specific trial in spite of a Significant Financial Interest. Relevant information to be considered by the CISC includes the nature of the research; the magnitude of the financial interest; the extent to which the financial interest could be influenced by the research; the degree of risk to human subjects; and whether the interest is amenable to management.

g. Clinical trial means any research involving human subjects that is designed to test the safety and/or efficacy of an intervention to diagnose, treat, or prevent disease, and that exposes research subjects to procedures or treatments which they would not have received from their own health care providers as part of their clinical care. For the purposes of this policy, this usually excludes investigations involving the consented use of human tissue or participant information used for analysis of disease mechanisms or for outcome evaluations.

h. Disclosure is described below.

i. Research staff includes professional and support staff who have a significant role in the conduct of a specific trial, as determined by the Principal Investigator.

j. Member of the immediate family includes the spouse, children, and parents of the investigator.

k. Related entity means any corporation, foundation, trust or other entity controlled or directed by the investigator or his or her spouse.

III. Process

1. In connection with the submission to ORS (Office of Research Services) of an application for grants and contracts for a clinical trial, or for IRB (Institutional Review Board) approval of a clinical trial, investigators must submit a completed Financial Disclosure Form.

2. The Financial Disclosure Form and other available information will be reviewed by staff of the IRB or ORS, and if it appears that the investigator has a Significant Financial Interest the matter will be referred to the Conflict of Interest Standing Committee (CISC). The CISC will determine whether the investigator has a Significant Financial Interest. If so, the investigator may not participate in the clinical trial unless the CISC determines that there are compelling circumstances that left the investigator's participation in the trial. If the CISC determines that there are compelling circumstances, it will develop a plan for managing the conflict.

3. The CISC will report its findings to the Vice Provost for Research, with a recommendation for appropriate action, including a management plan when appropriate. The Vice Provost for Research may accept or reject the CISC's findings or resubmit the matter to the CISC for additional consideration or clarification. The Vice Provost for Research shall decide whether the investigator will be permitted to participate in the clinical trial and, if so, shall also decide the terms of an appropriate management plan. The Vice Provost for Research shall communicate his or her decision and the terms of any required management plan to the investigator, the CISC and other parties as appropriate.

4. An investigator may request that the Vice Provost for Research reconsider his or her decision. If the investigator is not satisfied with the decision of the Vice Provost for Research after such reconsideration, the investigator may appeal to the Provost, whose determination is final.

5. Every attempt will be made to make this process as expeditious as possible.

IV. Implementation of Conflict of Interest Management Plans

1. The Vice Provost for Research is responsible for the implementation of the approved management plan, in conjunction with the appropriate Deans and other administrative officials of the University.

2. Implementation begins with a signed agreement by the investigator to accept the required management plan, with copies to the CISC, IRB, ORS, Dean and department chair. In instances where there is a conflict of interest issue, final IRB approval is contingent upon signed agreement by the Principal Investigator of the COI management plan.

3. The Office of the Vice Provost for Research will obtain written assurance from the investigator and others as appropriate of continued compliance with the management plan, at least once a year. Such records will be maintained on file for reference by the VPR and CISC, in accordance with institutional record retention policy.

In the instance of complex management plans, such as those involving a committee charged to oversee the management plan, more detailed reports at intervals no less than once a year, may be required.

The Office of the Vice Provost for Research is responsible for maintaining an up to date file that documents the monitoring of all COI management plans. Any lapses in documentation must be reported to the Vice Provost for Research and the appropriate Dean.

4. Investigators shall also notify the CISC and IRB of any changes in their financial interests or relationships, so that it can be determined if further management or recommendations are appropriate.

V. Disclosure

1. Any investigator who has a Significant Financial Interest who is permitted to participate in a clinical trial under this policy must disclose the existence of the Significant Financial Interest: to subjects participating in a clinical trial; on all presentations and publications of the data emanating from the trial; and to the research staff engaged in the trial. More detailed guidelines for disclosure are set forth in the existing University of Pennsylvania policy Financial Disclosure Policy for Research and Sponsored Projects, available at www.upenn.edu/research/rcr/conflict.htm.

2. An investigator's Significant Financial Interest must be disclosed to trial participants in the informed consent documents in the manner and format approved by the IRB. It is the responsibility of the Principal Investigator to be sure that the IRB is aware of the Significant Financial Interest and explicitly approves its presentation within the informed consent from.

3. An investigator's Significant Financial Interest must be clearly disclosed in any published paper emanating from the clinical trial, consistent with the editorial practices and format of the specific journal, and it is the responsibility of the authors to insure that this takes place.

4. The investigator shall inform her or his research staff both of the existence of his or her Significant Financial Interest and of the essential elements, as determined by the Vice Provost for Research, of the approved management plan, with a written record of the information transmitted. Likewise, a written disclosure must be made to participating investigators in a multi-site trial.

VI. Sanctions

1. If it is suspected that an investigator has deliberately violated this policy by, for example, failing to disclose a Significant Financial Interest or failing to comply with an accepted management plan, the Vice Provost for Research, in conjunction with the appropriate Deans and other administrative officials of the University, will investigate the circumstances and take appropriate action. Depending on the circumstances, such action may include initiation of proceedings under other University policies, including the Procedures Regarding Misconduct in Research and the Procedure Governing Sanctions Against Members of the Faculty.

Appendix

Other University policies relevant to conflict of interest may be accessed on the University web site at www.upenn.edu/research/rcr/conflict.htm. Existing conflict of interest policies include: (1) Layman's Guide to Conflict of Interest; (2) Financial Disclosure Policy for Research and Sponsored Projects; and (3) UPHS Guidelines for Extramural Activities of Faculty. The AAMC white paper is available at www.aamc.org/members/coitf/start.htm.


  Almanac, Vol. 49, No. 32, May 6, 2003

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