Every investigator, employee and other representative performing work for GHSU shall disclose any significant institutional financial or other conflict of interest which arises during the course of his or her work to the appropriate Responsible Representative.
Reason for Policy
Consistent with its system for the disclosure and management or elimination of individual conflicts of interest, and to further protect the integrity of our institution, GHSU has adopted this policy on institutional conflicts of interest. Institutional financial reward, business relationships and commercial activities are appropriate only to the extent that they further GHSU’s mission: to improve health and reduce the burden of illness in society by discovering, disseminating, and applying knowledge of human health and disease.
Entities Affected by this Policy
Every investigator, employee and other representative performing work for GHSU, concerning any significant institutional financial or other conflict of interest which arises during the course of his or her work.
Who Should Read this Policy
Every GHSU employee, including faculty and staff, and every representative performing work on behalf of GHSU.
|Office of Legal Affairs||(706) 721-4018||http://www.georgiahealth.edu/Services/Legal/|
GHSU Ethics Policy – http://policy.georgiahealth.edu/2010/03/29/ethics/
Board of Regents Ethics Policy – http://www.usg.edu/compliance/ethics/
Individual Conflicts of Interest Policy – http://policy.georgiahealth.edu/2010/09/23/individual-conflicts-of-interest-policy/
Georgia Health Sciences University Industry Policy – (MCG Dean’s Office)
1. “Institutional conflict of interest” means any situation in which Georgia Health Sciences University, any of its senior management, a department, college, or other sub-unit, or affiliated foundation or organization, has an external relationship with or financial interest in an individual or company that has a) a financial interest in a faculty research project and/or b) other significant commercial dealings with GHSU or its affiliates. The existence or appearance of such conflicts of interest can lead to real or apparent bias in the review or conduct of research or other work on behalf of GHSU.
Major types of institutional conflicts of interests:
a. Equity interests are those that may create actual or apparent bias in decisions about research or other institutional work where GHSU holds relevant equity positions or has royalty arrangements, and the equity or royalties are derived from GHSU or its affiliates’ inventions, start-ups, or other institutional technology transfer. An example of potential institutional conflicts of equity interests: Institution transfers technology to a faculty member’s small, private start-up company, retaining an equity position in the company where the stock is not yet traded on the open market. The faculty member may have an individual conflict of interest, and GHSU may have an institutional conflict of interest. Both conflicts of interest should be disclosed and managed or eliminated according to policy.
b. Interests of officials are those concerning individuals in positions to make decisions with institution-wide implications. These individuals include the President, other senior officers, deans, research center leaders, and members of governing boards. Their duty to report individual conflicts are addressed in GHSU’s Individual Conflicts of Interest Policy (see Related Documents, above). Additionally, their external work and activities such as board service, for example, creates potential for institutional conflicts of interest as the officials make decisions that affect GHSU and also the external board(s) or entities that they serve.
2. “Responsible Representative” of the institution means:
a. Department Chair for faculty and other departmental personnel meeting the definition of investigator;
b. Dean for Department Chair;
c. Provost for Deans (other than Dean, Medical College of Georgia) and other Vice-Presidents;
d. President for Provost and Dean, Georgia Health Sciences University;
e. University System of Georgia Chancellor for President;
f. Chair, supervisor or other officer in leadership chain of command for members of GHSU-affiliated service boards and cooperative entities; and
g. Institutional official for designee.
3. “Significant institutional financial interest” means anything of monetary value, including, but not limited to payments, equity interests (such as stocks, stock options or other ownership interest); and intellectual property rights (such as patents, trademarks, copyrights and royalties from such rights) that, during the next twelve-month period, meets either of these criteria: (i) meets or exceeds one hundred thousand dollars ($100,000.00) value as determined through reference to public prices or other reasonable measures of fair market value; or (ii) represents 10% or more ownership in any single entity.
The Georgia Health Sciences University has in place a system for the disclosure and management or elimination of individual conflicts of interest. Institutional financial reward, business relationships and commercial activities are appropriate only to the extent that they further GHSU’s mission.
DISCLOSURE OF INSTITUTIONAL CONFLICTS OF INTEREST
Every investigator, employee and other representative performing work for GHSU shall disclose any significant institutional financial or other conflict of interest which arises during the course of his or her work to the appropriate Responsible Representative. This disclosure shall be on GHSU’s “Conflict of Interest Disclosure Form,” a copy of which is attached. The Conflict of Interest Disclosure Form shall be signed by the person who completes it. A separate disclosure form is required for each institutional conflict of interest. The disclosure shall be updated by the individual who determines that a conflict of interest may exist immediately as new reportable significant institutional financial or other conflicts of interest are acquired or discovered (in no event less than 30 days after the interest is acquired or the conflict is discovered). If no conflict of interest existed at the time of an initial proposal, project or action but such a conflict arises during the course of the proposal, project or action, the individual who determines that a conflict of interest may exist shall file a Conflict of Interest Disclosure Form as soon as facts creating the conflict become known to him or her.
RESOLUTION OF INSTITUTIONAL CONFLICTS OF INTEREST
The Responsible Representative to whom a disclosure of potential institutional conflict of interest is made shall forward the disclosure form to the Conflicts of Interest Panel (Membership as per GHSU Individual Conflicts of Interest Policy). Upon referral of an institutional conflict of interest from a Responsible Representative of GHSU, the Conflicts of Interest Panel shall meet and determine whether a conflict exists and provide guidance and recommendations to manage, reduce or eliminate the conflict. The cooperation of the Responsible Representative and/or the individual who reported the conflict of interest may be solicited by the Panel. The Panel may designate a member to approve administratively any interim conflict management plan submitted by the Responsible Representative. Some examples of possible recommendations, without limitation, are as follows:
1. public disclosure of significant financial interest;
2. 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 (consider monitoring of research by independent reviewers);
3. modification or cessation of the research or project (e.g., not conducting proposed research at GHSU or halting it if it has commenced);
4. disqualification from participation in that portion of the research that would be affected by the institution’s significant financial or other interest;
5. reducing or otherwise modifying the financial (equity or royalty) stake involved; or
6. increasing the segregation between the decision-making regarding the financial and the research activities;
7. obtaining recommendation(s) to manage or eliminate the conflict of interest from an advisor or group that is not affiliated with GHSU.
In addition to the examples listed above, the Conflicts of Interest Panel may recommend any other conditions or restrictions which in its judgment would manage, reduce or eliminate the actual or potential conflict of interest, consistent with applicable policies, regulations, and laws.
In its deliberations to manage, reduce or eliminate conflicts of interest, the Panel shall consider the following guidelines:
- GHSU will not ordinarily participate in any clinical trial of a drug, device or product if either GHSU or the GHSU Research Institute, Inc., has a significant financial interest in a company sponsoring the trial. However, if GHSU, its investigator, GHSURI, or any of them, hold significant financial interest in a sponsoring company, and GHSU is the preferred or only feasible site for a clinical trial, then the Conflict of Interest Panel may recommend that the trial be allowed to proceed at GHSU.
As to GHSU faculty startup companies in which faculty involvement is limited to equity holdings or rights to equity, GHSU may invest in such companies as follows:
- GHSU will not act as a lead investor or syndicating agent. All investments, if appropriate, will be as a “passive investor.”
- GHSU will not acquire an equity holding greater than 10% of the ownership of a company.
- No GHSU officer is to be a member of the board or an officer of the faculty start-up company, or have a personal equity position in the company at the time of GHSU’s investment in any of the equity rounds before the company goes public.
- Institutional investments in faculty start-up companies in which GHSU faculty have equity interests are subject to case-by-case consideration and approval of the Provost, based upon recommendations of the Conflict of Interest Panel. If the involved faculty member(s) subsequently create GHSU-owned intellectual property for which the start-up company seeks a license for commercial use or development, the licensing request will be subject to the review and approval of the appropriate department chair or dean, in consultation with the Vice President for Legal Affairs and Vice President for Research.
All recommendations made by the Conflicts of Interest Panel shall be in writing and shall state the reasons therefore. The recommendations of the Conflicts of Interest Panel shall be delivered to the Provost, who will decide whether or not to adopt or modify them.
The written recommendations together with the Interest Disclosure Form shall be maintained for at least three years after the later of:
a. the termination or completion of the award, project, action or transaction to which they relate; or
b. the resolution of any government action involving those records.
In addition to providing recommendations to resolve conflicts of interest, the Conflicts of Interest Panel shall provide recommendations as it deems appropriate for the improvement of this policy.
Except where an institutional conflict of interest concerns his or her actions, the President of Georgia Health Sciences University, either directly or through his/her designee, reserves the right to review all decisions regarding management and resolution of institutional conflicts of interest. In the event the President determines that the decision concerning a conflict of interest is incorrect, inappropriate, or inconsistent with applicable law, the President reserves the right to rescind, modify, or reverse such decision.
The Conflicts of Interest Panel and the Provost shall notify the Responsible Representative, the individual reporting the conflict of interest, and other appropriate department, such as Division of Sponsored Program Administration, Office of Human Research Protection, Purchasing, etc., of their recommendations and decisions concerning the management or elimination of the reported conflict. Where applicable, the Division of Sponsored Program Administration shall be responsible for notifying the sponsor of the conflict of interest and GHSU’s determination as to the management or elimination of the conflict within 60 days after the conflict is reported.
None beyond the guidelines described in “Overview,” above.
The responsibilities each party has in connection with the Institutional Conflict of Interest Policy, are:
|Vice President for Legal Affairs||Responsible for management and oversight of Institutional Conflicts of Interest Policy|
|Responsible Representative||See number 2 in “Definitions,” above|
|All Georgia Health Sciences University faculty, employees, and students||Responsible for adhering to the Administrative Policies of the Georgia Health Sciences University.|