Makeup and Role of the IRB

Human Subjects Protection - IRB Review


 

The IRB should include

  • 1. at least five people
  • 2. varying backgrounds
  • 3. diversity in race, gender, cultural backgrounds
  • 4. sufficient qualifications and expertise to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects
  • 5. knowledge in areas of institutional commitments and regulations, applicable law, and standards of professional conduct and practice regarding human subjects protection
  • 6. knowledge about and experience in working with "vulnerable" subjects (children, prisoners, pregnant women, etc.) if they are involved in research
  • 7. at least one economist and at least one non-economist
  • 8. at least one member who is not affiliated with NBER and who is not part of the immediate family of a person who is affiliated with NBER.

The IRB should not consist of

  • 1. all men or all women
  • 2. all members of one profession

The IRB may exclude or include particular members in the review of particular projects:

  • 1. any member who has a conflicting interest with a project should not participate in reviewing that project
  • 2. individuals with competence in special areas may be invited to assist in the review of issues that require expertise beyond or in addition to that available on the IRB.

The IRB ensures that researchers inform human subjects of basic elements involved in the research. Those most applicable to economic research are itemized here:

  • 1. Purpose and duration of research
  • 2. Expected benefits to the subject or others
  • 3. Extent of confidentiality to be maintained
  • 4. Contacts for answers to questions about the research and subjects' rights
  • 5. Terms of participation

The IRB reviews, prospectively approves and provides continuing oversight for research that is non-exempt from human subjects protection.

The IRB votes on research protocols with the authority to:

  • 1. approve
  • 2. require modification
  • 3. disapprove all research activities, including proposed changes in previously approved research
  • 4. suspend or terminate previously approved research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.