OF RECORD

The following policy, published by the Vice Provost for Research For Comment on April 11, 1995, has been adopted and is effective October 1, 1995

Financial Disclosure Policy for Sponsored Projects

Background

The National Science Foundation (NSF), and the U.S. Public Health Service including the National Institutes of Health (NIH) have issued, new regulations which require disclosure of personal financial interests by Principal Investigators (PIs) and others engaged in a project being proposed to those agencies, when such interests would reasonably appear to be affected by the research or other activity being proposed. These regulations require that the University have in place a policy on conflicts of interest which:

1) requires such financial disclosure by PIs and others (including interests of their spouses and dependent children) responsible for the design, implementation and reporting of the proposed research;

2) designates an individual(s) to review disclosures, determine if a conflict of interest exists, and resolve problems related to conflicts;

3) provides enforcement mechanisms and sanctions for individuals who fail to comply;

4) provides for notification to the responsible agency; and

5) assures the maintenance of records for at least three years after a project has been completed.

In addition, each proposal submitted to the NSF and NIH will require certification by the institutional official who signs the proposal, that the individuals have made appropriate disclosures, and that, if there are any real or apparent conflicts of interest, the institution will have eliminated, reduced or managed such conflicts before expenditure of any funds under the award.

The Financial Disclosure Policy described below will apply to proposals and applications submitted to NSF and NIH on or after October 1, 1995. The Policy will be supplementary to the University's current Conflict of Interest Policy for Faculty (see Handbook for Faculty and Academic Administrators, Section II.E.1). A list of University policies related to the proposed Financial Disclosure Policy may be found in Appendix 1.

Policy

Definitions

Administrator means cognizant Dean, or his/her designee, for Investigators who are faculty or staff of a School. When there is no cognizant Dean, as in the case of the staff of some Centers and Institutes, the Center or Institute Director will be the Administrator.

Investigator means a Principal Investigator, Co-Principal Investigator, or others (e.g., individuals with supervisory or oversight function in the context of a large grant) responsible for the design, implementation and reporting of the proposed research.

Significant financial interest means anything of monetary value, including, but 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); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include:

-- salary, royalties or other remuneration from the University;

-- income from service on advisory committees or review panels for public or non-profit entities;

-- income from seminars, lectures, or teaching engagements

sponsored by public or nonprofit entities; or

--an equity interest that when aggregated for the Investigator and the Investigators spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value; and does not represent more than five percent (5%) ownership interest in any single entity; or

-- salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children, are not expected to exceed $10,000 during the next twelve-month period.

Procedures

Disclosure. Prior to submission of a grant proposal an investigator may seek advice from the Conflict of Interest Committee as to whether any real or apparent conflict of interest exists with respect to a sponsored program for which an application is being prepared. Investigators must at the time a proposal is submitted to ORA for approval, certify on the ORA Transmittal/Approval Form whether or not they, or their spouses and dependent children, have any significant financial interests that would reasonably appear to be affected by the activities proposed to be funded, thus creating a potential conflict of interest. When an Investigator indicates that there may be a potential conflict of interest, he/she must complete a Statement of Potential Conflict of Interest form (see Appendix 2) and submit it to ORA with (or in advance of) the proposal. ORA will not submit a proposal until the Investigator(s) have certified whether a conflict or potential conflict exists, and, if necessary, submitted a Statement of Potential Conflict of Interest. Investigators must update financial disclosures during the period of an award when new reportable significant financial interests are acquired. Where pertinent, addition of new investigators to an ongoing award activity will require an updated financial disclosure.

Review. Prior to expenditure of any funds under an award, the Conflict of Interest Committee (see Appendix 3) will review the Statement(s) of Potential Conflict of Interest, determine if, in its judgment, any actual or potential conflicts of interest are present, and if so, recommend to the Vice Provost for Research how such conflicts should be eliminated, reduced or managed. Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate actual or potential conflicts of interest include:

-- public disclosure of significant financial interests;

-- monitoring of research by independent reviewers;

-- modification of the research plan;

-- disqualification from participation in the portion of the funded research that would be affected by the significant financial interests;

-- divestiture of significant financial interests; or

-- severance of relationships that create actual or potential conflicts.

If the Committee determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the Committee may recommend that the research go forward without imposing such conditions or restrictions.

Implementation. The Vice Provost, on recommendation of the Conflict of Interest Committee and in consultation with the responsible Administrator(s) , will decide how the real or potential conflict is to be managed, reduced, or eliminated. An award will not be accepted until this decision is made and agreed to by the Investigator(s).

The decision will be conveyed by letter to the responsible Administrator(s), who will be responsible for assuring that the decision of the Vice Provost is implemented. Copies of the letter will be sent to the Chairman of the Conflict of Interest Committee and to the involved Investigator(s). The Investigator will reply by letter (Appendix 4) indicating either acceptance of the decision, or an inability to carry out the decision, or a disagreement with the decision. Every effort should be made by the Vice Provost to reach accord with the Investigator(s). In the event agreement is not reached, appeals to decision(s) of the Vice Provost may be made by the Investigator(s) and/or responsible Administrator to the Provost. The decision of the Provost shall be final.

Administrators will submit an annual report to the Vice Provost for Research, describing their implementation of the Vice Provost's decisions with respect to Investigators for whom they are responsible.

Enforcement and sanctions. A complaint alleging that an Investigator has violated this policy or failed to comply with a decision of the Vice Provost for Research for the management, reduction, or elimination of a conflict should be brought to the attention of the Vice Provost for Research. While the procedure for handling a complaint will depend upon the particulars of the complaint, normally the Vice Provost will interview the person bringing the complaint and the Investigator who is alleged to have violated the policy or failed to comply with a decision. If the complaint is not resolved or the violation or failure to comply remedied informally by the Vice Provost, the Vice Provost shall conduct an investigation, with the assistance of the cognizant Administrator and/or other appropriate University offices. If, as a result of the investigation, the Vice Provost believes that sanctions are warranted, he/she shall consult with the Provost and the cognizant Administrator to aid in determining an appropriate sanction, including whether there is substantial reason to believe that just cause exists for imposition of a major sanction, including suspension or termination of a faculty appointment.

When an Investigator is a faculty member and the Provost or the cognizant Dean determines that action should be taken for imposition of a major sanction, including suspension or termination of a faculty appointment, the Dean shall refer the matter to the Committee on Academic Freedom and Responsibility of the School for proceedings in accordance with the procedures set out in Section II.E.10 of the Handbook for Faculty and Academic Administrators.

Notification of sponsor. NIH requires that the University report to the Awarding Component the existence but not the substance of a conflicting interest, and assure that it has been managed, reduced, or eliminated.The University will inform the sponsor if it finds that it is unable to satisfactorily manage an actual or potential conflict of interest. It will be the responsibility of the Investigator(s) and responsible Administrator(s) to notify the Vice Provost for Research if at any time the recommendations of the Committee and the Vice Provost cannot be fulfilled. The Vice Provost or his/her designee will be responsible for notifying the sponsor.

Confidentiality. The confidentiality of all transactions pertaining to financial disclosure forms must be strictly maintained by all those involved in the process.

Record retention. Records of all financial disclosures and of all actions taken to resolve actual or potential conflicts of interest shall be maintained for at least three years after the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

Appendix 1

University policies related to the Financial Disclosure Policy:

1. University of Pennsylvania: Conflict of Interest Policy for Faculty Members, Almanac March 8, 1993; and Handbook for Faculty and Academic Administrators, Section II.E.1.

2. University of Pennsylvania: Policy Information for Potential Commercial Sponsors of Research at the University of Pennsylvania, Almanac May 17, 1983.

3. University of Pennsylvania: Guidelines for Student Protection in Sponsored Research Projects and Student Access to Information Regarding Sources of Financial Support, Almanac October 21, 1986.

4. University of Pennsylvania: Use of Consultants, Office of Research Administration, Research Investigators Handbook, pp 58-59, 1990.

5. University of Pennsylvania: Guidelines for Extramural Activities, Associations, and Interest for Staff, Human Resources Policy Manual, February 1, 1990.

6. University of Pennsylvania: Patent and Tangible Research Property Policies and Procedures of the University of Pennsylvania, Almanac March 15, 1994.

Appendix 2

University of Pennsylvania
Statement of Potential Conflict of Interest

Name:________________________Title:___________________________

Department:____________School:__________Date Submitted: ________

Requirement for Financial Disclosure

The University requires that an Investigator, at the time a proposal for funding is submitted, disclose significant financial interests (i) that would reasonably appear to be directly and significantly affected by the research or educational activities to be funded by the agency; or (ii) in entities whose financial interests would reasonably appear to be directly and significantly affected by such activities.

Definition of Significant Financial Interest

Significant financial interest means anything of monetary value, including, but 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); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include

(i) salary, royalties or other remuneration from the University;

(ii) income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

(iii) income from service on advisory committees or review panels for public or nonprofit entities; or

(iv) an equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, if it meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not constitute more than five percent ownership interest in any single entity; or

(v) salary, royalties of other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000.

Note: Be sure to categorize appropriately the significant financial interests referred to above. However, please note that individuals should not report holdings in mutual funds, or pension accounts, and are not expected to list individual dollar amounts for any entity disclosed.

Based upon the above definition:

1. Please identify below any significant financial interests as defined above which might constitute a conflict of interest in the conduct or reporting of the research or other activities proposed herein. (Use additional sheets if necessary.)

2. Please identify below anything in your opinion that would not compromise your objectivity, but might have the appearance of so doing. (Use additional sheets if necessary.)

Certification

I certify that the above information is complete and true to the best of my knowledge and that I have read the University's policies related to conflict of interest as described in the Handbook for Faculty and Academic Administrators Section II.E.1., Conflict of Interest Policy for Faculty and the supplementary Financial Disclosure Policy for Sponsored Projects. This information is provided with the understanding that its review shall be conducted in confidence by appropriate University officials. The information may only be released by the University 1) in statistical or aggregate form that fully protects my privacy, or 2) to comply with the requirements of the sponsors of this research, or 3) as may be required to comply with University policies and procedures or any applicable legal requirements, or 4) with my written permission.

(Signature__________________________)

Appendix 3

Conflict of Interest Standing Committee (CISC)

Procecures

The Conflict of Interest Standing Committee (CISC) reviews and makes recommendations on the resolution of cases of potential or real conflict of interest which arise from technology transfer activities or from sponsored projects of the University or its faculty. The recommendations of the CISC are transmitted to the Vice Provost as advice on the disposition of cases involving potential conflicts of interest, including a determination whether a real or potential conflict exists, and proposals on how such conflicts should be eliminated, reduced, or managed. The Vice Provost may accept the recommendations or may return them to the CISC for further consideration, revision, or clarification. The proceedings of the CISC are confidential, including all documents, drafts, and discussions.

Cases involving potential conflict of interest may be referred to the CISC by the Center for Technology Transfer (CTT), by the Office of Research Administration (ORA), by University or School administrators, Department Chairs, or individual faculty. The staff of the Center for Technology Transfer (CTT) is responsible for referring to the CISC cases which arise from applications under consideration by the CTT. The ORA staff is responsible for referring to the CISC cases which arise from applications for sponsored research support. Cases from other sources. Deans, Department Chairs, or individual faculty may refer cases of potential conflict of interest to the Chair or staff of the CISC, who will review them, determine whether they are appropriate for consideration, and present them for review by the committee.

Membership

The CISC consists of approximately 10 members of the standing faculty appointed by the Vice Provost for Research. Faculty members are expected to serve as members of the University and not as advocates for specific schools or constituencies. There are three ex-officio members, the Executive Director, Sponsored Programs, the Managing Director, Center for Technology Transfer, and an attorney from the Office of the General Counsel. In addition, invitations to meetings are extended to professional staff of the Center for Technology Transfer and to selected professional staff from the Schools. The CISC is chaired by a faculty member appointed by the Vice Provost. Staff support for the CISC is provided by the Office of Research Administration and/or the Center for Technology Transfer, which will designate an individual to serve as Secretary of the Committee.

All faculty members, plus the Director, Office of Research Administration, and the Director, Center for Technology Transfer have voting rights. Other attendees participate in discussion but do not vote.

Meetings

Attendance. Meetings are limited to CISC members, invited staff, and other invitees, and are not open to the public.

Quorum. A quorum consists of over half of all voting members. In general, an attempt will be made to insure that there is a quorum present at all meetings. The CISC Chair, at her/his discretion, may require that certain decisions be approved by a majority of all voting members not just a majority of those attending a specific meeting. Final versions of recommendations will usually be approved by mail/FAX in order to insure that all voting members have an opportunity to register their opinions.

Conflicts for Committee Members

A CISC member is recused from discussion of a particular case under the following conditions:

(1) The case involves a member of the same department.

(2) The CISC member has a personal interest because of inter-departmental relationships, such as collaboration with the faculty member whose case is under consideration.

(3) The CISC member has a fiscal interest in the case under discussion.

Special exceptions to these guidelines may be made but only with the prior approval of a majority of the voting members.

Appendix 4

University of Pennsylvania Memorandum of Understanding for the Management of Potential Conflict of Interest

Name___________________________Title______________________

Department__________________ School_________________________

Date of Original Statement of Potential Conflict of Interest___________

I have read the decision of the Vice Provost for Research on how the potential conflict of interest disclosed in my Statement of Potential Conflict of Interest referenced above and (check one of the following):

A. I agree with the decision and will abide by it.

B. I do not agree with the decision. However, I believe the potential

conflict of interest can be resolved as follows:

[. . .]

C. I do not agree with the decision and request that it be reviewed

by the Provost.

(Signature____________________________)