Cal Poly Pomona IRB

Conflict of Interest, Confidentiality, and Non-DisclosureGuidelines for IRB Members

Version: March28, 2011, Reviewed by IRB on: June 5, 2016

Overview – Conflict of Interest, Confidentiality, and Non-Disclosure

The Cal Poly Pomona Institutional Review Board (IRB or “Board”)is the human subjects protection committee for the university. During their IRB service, members encounter privileged information. Although unlikely, it is possible that a member’s judgmentregarding their use of the confidential information that they encounter could be biased in some way, e.g., they might have prior knowledge of the information that might create a conflict of interest. Hence, there is the potential for compromising the objectivity and credibility of the research review process. This guideline highlightsthe issues associated with conflict of interest situations and the use and non-disclosure of confidential data during the protocol review process.

Conflict of Interest (COI)

Federal regulations do not permit an IRB member to participate in the review of research in which s/he has a conflicting interest, except to provide information as requested by the IRB. This restriction helps to ensure that personal interests do not compromise the rights and welfare of both the investigator and the subjects when a member performs mandated duties for the IRB. COIs may be of either a financial (i.e., having monetary value) or non-financial nature (e.g., having influence over another, loyalty to colleagues).

Definition of “Conflict of Interest”. The definition of COI from Nelson in Institutional Review Board – Management and Function (Bankert and Amdur, 2005, 2nd edition, p. 167) is “a set of conditions in which an investigator’s judgment concerning a primary interest (e.g., subject welfare, integrity of research) could be biased by a secondary interest (e.g., personal or financial gain).” For purposes of this guideline, the word investigator is replaced by member.

Definition of “Member” and “Immediate Family”. All IRB members are subject to this Guideline, which applies to all business that comes before the Board, and to individual protocols submitted for IRB review and approval. For the purposes of this guideline, a “member” is defined as the Chair, both regular and alternate members, unaffiliated members, any consultants serving the IRB, the IRB administrator (Compliance Associate), the IRBInstitutional Official (IO), and all others who may – with the understanding of the Chair – conduct business with or on behalf of the IRB. While similarities exist, the conflict of interest faced bya principal investigator (PI)is not the focus of theseguidelines.

A conflict may involve IRB members, administrators, or individuals directly involved in the research as well as members of their immediate family, including spouses, parents, children, domestic partner, siblings, and household members.

Types of Conflict. There are many types of situations in which actual conflict, or the potential for a conflict of interest, exists. The following list highlights the more obvious situations:

1.The Member has a personal relationship with the researcher(s), either as a member of their immediate family (as defined above) or another personal relationship with the PI(s) or Co-PIs, e.g., intimate friendship.

2.Involvement in the Research Under IRB Review, for example, the Member:

  • Serves as the Chair or as a committee member for a student’s thesis or project;
  • Serves as a principal investigator (PI) or co-PI of the research;
  • Provides guidance on a research project and could serve as an author in future publications.

3.The PI or co-PI of the research under review supervises a Member in some official capacity, e.g., chair of the Member’s department.

4.The Member has some financial interest in the research under IRB review, for example, the Member:

  • has entered into a financial arrangement with the sponsor or agent of the sponsor, whereby the outcome of the study could influence the value of some economic interest (e.g., ownership of stock in the non-governmental entity sponsoring the research).

5.The Member has a competitive relationship with the researchers, e.g., the Member is directly competing with the researchers for the same kind of funding.

6.The Member has some other relationship with the sponsor of the research, e.g., serving on a Board of Directors or on an Advisory Board or in some other capacity as an office or director of the sponsor or agent of the sponsor.

7.The Member holds personal biaseswhich may interfere with his or her impartial judgment.

8.For any other reason, the Member identifies him- or herself as having an actual or perceived conflict.

Disclosure of a Conflict of Interest. IRB members are asked to disclose a known or potential conflicting interest to the IRB Chair (or acting Chair) or to the IRB Administrator (Compliance Associate)and to recuse themselves before the review or any other business begins. The IRB Chair or a designee will then determine whether the member should abstain from further deliberation on the issue.

If the potential conflict involves the IRB Chair (or acting Chair) or the IRB Administrator (Compliance Associate), then the Institutional Official will determine whether a COI exists. If an actual or potential conflict involves the IO, then the Provost will make the determination.

A PI, who submits a protocol andbelieves that an IRB member has a potential conflict of interest, may request the exclusion of the member from the review process. The Chair will present the declared conflict and may request the assistance of the Board in determining whether an actual conflict exists. The Chair has the final authority to determine when there is a conflict. Conversely, the Chair may decide that no “significant” COI exists. This determination may be informed by a vote of the IRB members. If a COI has been determined to exist, then the member’s presence does not count towards quorum for voting. An abstention or recusing oneself does not count as a “nay” vote.

Response to a Conflict of Interest. IRB members with an actual, anticipated, or self-identified COI will not review the IRB protocol in any way. If a conflict is identified after the assignment to a reviewer, the IRB Administrator, in concert with the IRB Chair, will assign the protocol to another IRB member. The conflict is presented to the IRB as is noted in the minutes. In addition, the Member is not counted as a member of a quorum if a vote occurs.

If a conflict exists for the IRB Chair, the Administrator, in concert with the IO, assigns the protocol to a member for review. If a conflict exists for the IRB Administrator and not for the IRB Chair, the IRB Chair assumes all duties with relation to the review of the protocol, including all communication with the PI(s).

Regulatory References:

21 CFR 56.107(e)

38 CFR 16.107(e)

45 CFR 46.107(e)

The following are general guidelines for IRB members relating to ethics in general and conflict of interest in particular:

Act not as an advocate or representative of a department or as the delegate of any organization or private interest without declaring same;

Act independently in the review of both scientific and ethical aspects of research protocols involving human subjects and make a determination and the best possible objective recommendations, based on the merits of the submissions under review;

Earn and merit the trust and confidence of the various communities represented in the protection of the rights and well-being of human subjects;

Meet the same high standards of ethical behavior to carry out the mandate of the Cal Poly Pomona IRB;

Adhere to relevant national, local regulations, institutional policies and guidelines about human subject protections and the ethical issues associated with them;

Confidentiality

Definition of Confidentiality. Dictionary.com defines “confidentiality" as: “1) spoken, written, acted on, etc., in strict privacy or secrecy; secret: a confidential remark;2) indicating confidence or intimacy; imparting private matters: a confidential tone of voice; and 3) having another's trust or confidence; entrusted with secrets or private affairs: a confidential secretary.” ( July 19, 2010).

The following are general guidelines for IRB members relating to the confidentiality of IRB proceedings, discussions and documents:

Avoid any discussion, disclosure, or reproductionof any confidential IRB information, except as necessary to carry out IRB membership responsibilities or as required by law;

Maintain the confidentiality of IRB-related information;

Recognize the confidential or proprietary nature of the information and not disclose (expose or reveal)it;

Written (e.g., meeting agendas) and electronic (e.g., emails and e-protocols) confidential information provided for review shall not be copied or retained. All confidential information (and any copies and notes thereof) shall remain the sole property of the IRB and shall be destroyed when no longer needed for the conduct of IRB duties (e.g., when a protocol review has been completed); and

Appreciate that the type of information that can be included under the umbrella of "confidential information" is virtually unlimited and remains so forever.

Training and Notification

Periodically, but at least once per calendar year, the Chair will remind the IRB through discussion, inclusion on the meeting agenda, and/or continuing education or training about the contents of this Guideline.