The federal government requires every institution that receives federal research funding to maintain an Institutional Review Board (IRB) for the protection of human subjects. Failing to maintain federal standards governing this protection--whether from researchers pursuing research without proper approval or from the IRB granting improper approval--can result in the loss of all federal research funding at the school. The federal regulations that inform the work of the IRB can be found in Title 45, Part 46 of the Code of Federal Regulations (45 CRF 46).
For the full text of 45 CFR 46, see https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html.
For information about what 45 CFR 46 is, see https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html.
Why does the federal government take this research so seriously? Obviously, medical experiments on subjects whose consent is ill-informed or coerced can have disastrous consequences. Perhaps the federal government learned this from its own mistakes, such as the Tuskegee Syphilis Study1. In 1932, in order to study the long-term effects of syphilis on the human body, the U.S. Public Health Service enrolled 400 men in the study after diagnosing them with syphilis. The Health Service did not obtain informed consent, disclose the diagnosis to the patients, or offer them treatment (penicillin, for example) which was an available and effective cure beginning in 1947. During the 40 years in which the study continued, many of the men unwittingly infected their wives, who then passed the infection on to their children. The IRB is a safeguard against this type of suffering, as IRB approval requires that subjects know the risks to them of participation and available treatments.
There are other examples of research, including social behavioral studies (e.g., Stanford Prison Project, Milgram’s obedience to authority study), that have violated human rights. The bottom line is that all researchers must protect human subject participants; there is no study that is without risk to the subjects. The risk may be small and the consequences light, such as the risk of wasting an hour of your life, or the risk of adding an annoyance to an already trying day, but any intervention in someone's life carries risk. Submitting research applications to the IRB requires the researcher to identify, assess, and take steps to manage this risk. That's why the Belmont IRB is here to support you.
The current U.S. system of the protection of human subjects is heavily influenced by the Belmont Report. The Report was named after the Belmont Conference Center at the Smithsonian Institution where the discussions began which resulted in this report. As such, the title of this report is not connected to Belmont University.
The primary purpose of the Belmont Report is to protect subjects and participants in clinical trials or research studies, and it identifies three principles essential to the ethical conduct of research with humans:
- 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.
These three basic principles serve as the foundation of the current HHS regulations and guidelines for the ethical conduct of human subjects research supported by HHS.
The full report and additional information can be found at https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html.
For more information on the history and background of the U.S. system of protection for human research subjects see: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
End Notes:
Alex Chadwick, "Remembering Tuskegee", National Public Radio, 2002, http://www.npr.org/programs/morning/features/2002/jul/tuskegee/
Russell Bernard,Social research methods: Qualitative and quantitative approaches, Sage Publications, 200, ISBN 0-7619-1403-X, pp. 70-73, found athttp://books.google.com/