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What is an IRB and it's purpose?

An Institutional Review Board (IRB) is charged with protecting the rights and welfare of people involved in research.  The IRB reviews plans for research involving human subjects.  Institutions that accept research funding from the federal government must have an IRB to review all research involving human subjects (even if a given research project does not involve federal funds).  The Food and Drug Administration and the Office for Human Research Protections (OHRP) (part of the National Institutes of Health) set the guidelines and regulations governing human subjects research and IRBs.

The definition of research involving human subjects is broad.  The IRB must review research that involves the following areas, among others:

  • Medical and administrative record data.
  • Research that uses leftover tissues.
  • Health services research.
  • Survey research.
  • Behavioral research.
  • Biomedical and other clinical research.

Purpose of the Instituional Review Board

The New Hanover Regional Medical Center (NHRMC) Institutional Review Board (IRB) is stablished under the authority of the Food and Drug Administration for the purpose of protecting the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of NHRMC. The IRB is intended to protect the rights and welfare of subjects by reviewing clinical investigations regulated by the FDA under sections 505, 507, and 520 of the Federal Food, Drug and Cosmetic Act. In addition, the IRB will review all clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use and electronic products.

Why Does an IRB Review and Approve Research?

Review of research involving human subjects is required by federal law.  Federal laws and regulations regarding research on human subjects have specific requirements for IRB and study administration.

The federal requirement for review of research by human subjects committee stems directly from previously conducted unethical research experiences like the Tuskegee Study.  The Tuskegee Study was a federally funded study.  In it, a large number of poor African-American men with syphilis were studied for several decades to determine the natural history of untreated syphilis.  The diagnosis of syphilis was made before treatments for syphilis were available.  But the men were not offered treatment with penicillin even after it became available.  Worse, the men were not told they were subjects in a research study.  Many men in the study died of the complications of syphilis.

When this breach of ethics became publicly known in the middle of the 1970s, the federal government decided to put in place legal requirements for an external process for review and approval of research done using federal funds.  The federal government also decided to require that all institutions accepting federal research funds review all research done in that institution by the same procedures.

Responsibilities Of The Institutional Review Board

The NHRMC IRB operates under the principles of The Belmont Report. The Belmont Report exists because of the unfortunate history of unethical research conducted on human subjects. It clearly explains the three principals that are the main tools that all IRB members should use to evaluate the ethics of specific research proposals. Respect for Persons is the first principle which mandates that subjects voluntarily consent to participate in research, that they are adequately and thoroughly informed about the research and what is required, and that their privacy and confidentiality are protected. Beneficence is the second principle which mandates the risks of research are justified by potential benefits to the individual or society and that those risks are minimized. Justice is the third and final principle which mandates the equitable distribution of risks and benefits among those who may benefit from the research, meaning that one subset of a population should not take on all the burden of risk and reap all of the rewards; risks and rewards should be applicable and available to all subsets of a community.

To read additional information about the Belmont Report please click here.

 

 
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