Guidance - Human Subjects Research

All members of the Health Science Center research community should be sensitive to the potential impacts of financial interests and/or non-financial relationships with commercial sponsors or other external entities on the conduct of research and the participation and protection of human research subjects. In compliance with Federal regulations and guidance, and Health Science Center policy, the Institutional Review Boards (IRBs) must consider such relationships and determine, in conjunction with the the Health Science Center Conflict of Interest Official or designee whether they might influence or appear to influence the outcome of a research project involving human subjects, the objectivity of the Researcher during the performance of such a project, or the Researcher’s interactions with research subjects who participate in the project. Accordingly, the IRBs solicit and review relevant information regarding possible conflict of interests of all Researchers including investigators and key study personnel participating in a protocol involving human research subjects prior to approving or re-approving that protocol.

 

Role of the IRB

The IRB is the primary authority at the Health Science Center responsible for ensuring that human research participants are protected in accordance with federal regulations, University policies and ethical principles. One of the primary responsibilities of the IRB is to ensure that human research participants receive all information needed to provide informed consent. The IRB's consideration of the Researcher’s financial interests is intended to ensure:

1. that the informed consent process provides the subjects with the facts necessary to make a knowledgeable and sound decision as to whether they wish to participate in the study, and
2. that no conflict exists that would otherwise compromise the protection of human subjects.

 

The IRB's consideration of a Researcher’s financial interests as they relate to human subject research complements, but does not supplant, the established Health Science Center process for reviewing and disposition of the financial disclosures of all Researchers in accordance with the Health Science Center’s policy on Conflict of Interest.

 

The IRB has the final authority to decide whether the conflicting interest and its management plan, if any, allow the research to be approved.

 

Role of Researchers, including Faculty

For all protocols submitted to the IRB, including new protocols and those submitted for re-approval at continuing review, each researcher must complete Form X, Human Use Research Protocol Related Conflict of Interest Supplemental Form whenever an interest exists with an external entity associated with the study, regardless of funding or regulatory oversight. Researchers are reminded of the separate obligation to complete the annual disclosure form required by the Health Science Center’s policy on conflict of interest and commitment.

 

Process

Prior to the IRB meeting at which a protocol is scheduled for consideration, the IRB staff will review the IRB documents and, if a disclosure is made, submit it to the Vice President for Research, through the Assistant Vice President for Research and Sponsored Programs, for review, comment, and, if necessary, further disposition.

 

As part of its deliberations, the IRB will review any potential conflicts disclosed along with the recommendations of the Health Science Center administrative officials (including a management plan, if applicable) to determine:

1. the effect of the interests on the protection of participants;
2. whether the conflict is permissible in the context of the protocol; and, if so,
3. whether the conflict warrants disclosure to potential subjects as part of the informed consent process.

 

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