About This Series
Publication Date: January 2010
Contents
Who Approves Affected Activities?
Forms and Written Statements
Appendixes
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About This GuideResources

Who Approves Affected Activities?

What is an Institutional Review Board and
how does it work?

If you determine that your research activities involve human subjects who need to be protected, you may have to seek approval of these activities from a reviewing board known as an Institutional Review Board (IRB). An IRB is an administrative body established pursuant to federal regulations to review research activities involving human subjects. An IRB consists of at least five members with diverse backgrounds, expertise, and experience. It has the authority to approve, require modifications to, or disapprove research activities involving human subjects that fall within its jurisdiction.

The role of an IRB is to ensure that—

  • Risks to subjects are minimized.
  • Risks to subjects are reasonable in relation to anticipated benefits and the importance of knowledge.
  • There is proper informed consent and documentation of informed consent.
  • The research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.
  • When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  • Additional safeguards have been included in the study to protect the rights and welfare of any subjects likely to be vulnerable to coercion or undue influence.

This section reviews—