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Are You Part of a Research Project?

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Institutional Review Board (IRB) Is Here to Protect You
By Francois Pouliot, M.D,  PhD., assistant professor, Department of Anesthesiology and Critical Care, MD Anderson

lab1.jpgIf you are a patient at MD Anderson Cancer Center, you might have been invited to be part of a research project. By research we mean a systematic investigation designed to develop or contribute to generalizable knowledge.

As a participant you may be asked to take a new drug, be part of a cognitive intervention to change your behavior, or simply authorize the analysis of blood specimens and medical information.

Research is different from prevention and care, but is an integral part of our mission of Making Cancer History®.

To make sure that participants are well protected, the U.S. Congress established in 1974 the Institutional Review Board (IRB) for federally funded research with human subjects. At MD Anderson we have five IRBs. Each IRB has a minimum of five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.

Among the specifications:

  • No IRB may consist entirely of men or entirely of women, or entirely of members of one profession.
  • Each IRB shall include at least one member not otherwise affiliated with the institution or part of the immediate family of a person who is affiliated with the institution.

After reviewing the research project, the IRB can approve, require modifications or disapprove the project in accordance with the U.S. Food and Drug Administration and the Office of Human Research Protections regulations.

Decisions are made according to a list of criteria. Among the most important ones we have are:

  • Risks to participants are minimized.
  • Risks are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be reasonably expected to result.
  • Selection of subjects is equitable.
  • Informed consent is sought from each prospective subject.
  • Informed consent is appropriately documented.
  • There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

For further reflection: Emanuel E et al. What makes clinical research ethical? JAMA 2000; 283:2701-11

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