Special Consideration: Research Involving Human Participants
Research projects involving human participants are reviewed before they can
be started by the Institutional Review BoardInstitutional Review Board (IRB)
The committee established by the institution to review and approve research protocols involving the use of human participants., (IRB). The federal agency with primary responsibility for human participant research is the Office for Human Research Protections (OHRP). In 2001, OHRP published interim guidance on the conflict of interest issues that need to be considered when reviewing research protocolsProtocols
The written plan describing the methodology and research design of projects involving animals or human participants.. That interim guidance was replaced with final guidance on May 5, 2004.
Conflicts of interest are a special concern in human participant research since researchers are responsible for protecting the rights and welfare of human participants. Furthermore, due to the very nature of the research, the results may have a significant effect on the health of the general public. Situations in which researchers have significant financial interests in companies either sponsoring or potentially benefiting from the research can easily raise questions about the objectivity of the researcher in conducting the project. IRBs must ensure that human participants have adequate information on the risks related to the financial interests of the researchers so they can make an informed decision on whether or not to participate. IRBs are generally not well-equipped to evaluate this set of issues, so many institutions have worked out procedures by which the IRB works closely with the Conflict of Interest Committee.
Frequently, the application requesting review and approval of a protocol by the IRB contains questions concerning potential conflicts of interest. If a researcher indicates through his or her answers that a conflict either exists or may exist, the IRB informs the office having cognizance over conflicts of interest. If the situation appears to present no actual or potential conflict, the matter is referred back to the IRB. If a real or potential conflict exists, the matter is referred to the Conflict of Interest Committee which then acts to manage the conflict. The Conflict of Interest Committee then informs the IRB how the matter is to be resolved, and the IRB documents this in its protocol file.