IRB Chair Job Description

An Institutional Review Board (IRB) is a committee that is required by the federal government to be in place at any health care or research facility that does clinical research on human subjects and is supported by the federal government. Hospitals, universities and research institutes may have one or more IRBs. The board is charged with protecting the rights and welfare of human subjects taking part in clinical research conducted at that facility and has the responsibility to review, approve, disapprove, require modifications to and provide ongoing monitoring of research proposals and methodologies involving humans in conjunction with federal and state regulations.

Background of the IRB

• The concept of formal protections of human subjects was first codified in response to human rights abuses conducted by Nazi Germany. The current regulations establishing Institutional Review Boards are found in the Code of Federal Regulations as Title 45 CFR Part 46 “Protection of Human Subjects” and were enacted in 1974 (See References1). These rules cover, with few exceptions, the regulation of all scientific research conducted both within and outside the United States involving human subjects and supported in any way by the federal government. In 1978, The Belmont Report provided further guidelines.

Chair Selection and Requirements

• The Chair of the IRB is selected by the institution’s authorized institution official (an institution employee who provides oversight of research and IRB functions) or by the full IRB or an administrative committee of the IRB.

  As members of the board, IRB Chairs must comply with the overall requirements of board membership and, thus, may have varying backgrounds both scientific and nonscientific and may be selected from the Institution or the community at large, although some IRBs require the Chair to be a member or retired member of the institution staff.

  There are no specific educational requirements for the IRB Chair, unless imposed by the rules of the specific IRB, but he must possess sufficient knowledge and understanding of medical research to be able to effectively read, interpret and judge the research proposals under consideration.

  In addition, the effective IRB Chair should have extensive knowledge and understanding of federal, state and institutional regulations and policies and any ethical issues involved in all scientific research performed by the institution that falls under the jurisdiction of the IRB.

  The Chair must be screened for conflict of interest and may be an employee or volunteer, depending on the structure and bylaws of the specific IRB.

Additional Qualifications

• The Chair should be a respected member of the community, both within and outside the institution, who is able to act fairly and impartially in managing the IRB and the activities in which it engages. The Chair must be immune to possible pressures that could be brought to bear by those engaged in research the IRB is reviewing.

  He must be able to use good interpersonal skills to build trust and to work effectively with the IRB, leading meetings, focusing discussions and directing decision making in a timely but thorough manner. The Chair should also be effective at interfacing with the institutional officer and staff assigned to support the IRB. Good written and verbal communication skills and highly respected ethical and moral values are essential traits for the qualified IRB Chair.

  He should be comfortable working in stressful and time-pressured conditions and be able to balance and explain the need for rapid and thorough deliberation and decision making. The Chair should be comfortable discussing research directly with researchers, avoid undue influence and be committed to the ethical principles respecting scientific research laid out by the Belmont Report:
  • “Respect for persons involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy.
  • Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.
  • Justice requires that the benefits and burdens of research be distributed fairly.”

Role of the Chair

• The depth of the role of the IRB Chairperson may vary somewhat according to the specific model used by the institution. Some IRB Chairs are required to be on staff at the institution; some may take a more hands-on role; others may serve part time on a volunteer basis and depend heavily on institution staff for support. For the purposes of this article, it is assumed that the IRB Chair described will take an active role in all workings of the IRB.

  Responsibilities include the following:
  Chair full IRB meetings, directing discussions, leading review and voting on research proposals.
  Take an active role in establishing and reviewing IRB policies and procedures.
  Chair sub-committees of the IRB, if applicable.
  Read research proposals, identify issues needing discussion and direct discussion and decision making.
  Vote as a member of the IRB.
  Conduct expedited reviews with a subset of the full IRB.
  Monitor and report any attempts to influence or coerce IRB members.
  Resolve any issues arising during the work of the board or refer unresolved issues to the institution.

Working with IRB Staff

• The IRB Chair will work with the institution official and IRB staff support to
  • ensure accurate records of membership, meetings, decision and research protocols are kept
  GO
  • ensure IRB members are appropriately selected, ensuring that a diverse mix of institutional and community representatives are present and that members have been screened for conflict of interest
  GO
  • prepare members for meetings and deliberations and provide any necessary training
  GO
  • represent the IRB in communicating with other constituencies within and without the institution, including researchers and government regulators;
  • ensure assessments and audits are conducted as required by the institution and IRB policies; and
  • ensure the membership and proceedings of the IRB comply with state and federal regulations as well as institutional and IRB bylaws.