The Harvard University Area IRB aims to promote a culture of compliance and to establish across the University the highest expectations for performance and oversight of research involving human subjects. The Harvard University Area IRB is also committed to education of the Harvard research community and outreach to collaborating institutions.
The mission of the IRB is to assure that all participants are protected from any unnecessary risk when enrolled in a research study; that they can make an informed decision to participate, and when possible, that participant and/or society at large benefits from the knowledge gained from the research study. The goal of the IRB is to assist Investigators in developing appropriate research protocols in accordance with federal, and University policies, and within accepted ethical guidelines.
All Human Subjects Research conducted by Harvard University investigators, regardless of source of funding or location of the research, is guided by the ethical principles of respect for persons, beneficence, and justice, as set forth in the April 18, 1979 report of The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research, also known as “The Belmont Report.”
The IRB is made up of members in the disciplines of research typically reviewed. In accordance with 45 CFR § 46.107, each IRB is comprised of at least five members, with at least one member who is not affiliated with Harvard University (either directly or through an immediate family member); at least one member whose “primary concern” is in a scientific area, and at least one member whose “primary concerns” are in a non-scientific area and who must be present at each meeting.
Convened meetings of the IRB occurs the third Thursday of each month. The IRB may hold interim review sessions, called by the Chair at the request of any IRB member or Institutional Official, to consider matters regarding the rights and welfare of any participant, or participant population.
Expectations of IRB Members
IRB members attend the monthly IRB meeting and prepare for these meetings by reading the materials sent to them a week in advance. IRB members must be knowledgeable about federal human research regulations and familiar with standards of professional conduct and practice. IRB members participate in study discussions, voicing any concerns they may have with the study under review, vote on protocols, and recuse themselves in the event that they have a conflict of interest (either financial, personal or professional) with the research under review.
IRB members are expected to maintain confidentiality about IRB deliberations and discussions, with the IRB chair and staff acting as the conduits of information to Investigators. IRB should disclose the content of deliberations or discussions only to University and school officials who have responsibility for IRB activities or related compliance obligations, or otherwise as required by law. The purpose of confidentiality in IRB deliberations and discussions is to encourage IRB members to offer their frank opinions to one another.
IRB Member Conflict of Interest
At the beginning of each IRB meeting, the Chair asks the IRB if any members have a conflict of interest (professional, financial, or personal) with the particular research study under review that might influence his/her evaluation and thus might jeopardize the rights and welfare of the research participants or the credibility of the IRB. IRB members and consultants also have a conflicting interest when their spouse, partner, or relative has a professional or financial conflict of interest. All IRB members with a potential conflict identify themselves and the nature of the conflict. IRB members with conflicts may provide additional information about the project; however, they may not be present for the vote. Consultants and ad hoc members must disclose any potential conflicts. Any conflict revealed at the meeting is documented in the minutes and the IRB members who recuse themselves are not counted towards the quorum for that particular vote.
IRB Member Indemnification
IRB staff and members are agents of the University. Thus, they ordinarily will be indemnified by the University in the event of lawsuits against them based on their involvement with the IRB actions as IRB members, provided of course that they were acting within the scope of their duties and in good faith. Indemnification means that the University will defend a lawsuit (incurring all legal fees and other expenses) and pay any judgment or settlement.