The review system we use today in conducting research involving human subjects is the direct outcome of the 1976 Belmont Report which identified three basic principles
- Respect for persons
- Beneficence; and
- Justice
as foundational to the ethical conduct of research involving people as subjects. Making these judgments, the Committee determined that the conduct of studies using human subjects must therefore address certain requirements:
- informed consent – the human subject must be competent to consent and informed concerning what will happen to them so that they can, if they choose to, (voluntary) consent;
- systematic assessment of risks and benefits; and
- equitable selection of subjects both socially and individually.
A good example of the importance of our review system is provided by a now classic study designed by Dr. Wendell Johnson, a well known and highly regarded speech pathologist ((2001). Boston Globe. June 12, p. A20. "Secret Experiment Created Stutterers.") In the late 1930’s Dr. Johnson, ironically himself a chronic stutterer, hypothesized that stuttering arose not from genetic predisposition but from environmental conditioning. Children at a small private orphanage were separated into two groups – a control group, who received positive reinforcement, and the experimental group, who were harangued about their speech. The majority of the latter group became chronic stutterers. While the study findings eventually led to the development of a theory that has helped many children overcome childhood stuttering, it unwittingly condemned many uninformed, vulnerable study participants to a life of pain and suffering with a serious speech impediment. If you wish to learn more about this incident, often referred to as the Tutor Study, here is a link to a thoughtful web-based resource that discusses the case as well as a number of other questionable human subjects studies:
- N. Johnson. (2002) “Retroactive Ethical Judgments and Human Subjects Research: The 1939 Tudor Study in Context” Avail. URL: http://www.uiowa.edu/~cyberlaw/writing/CUNY1213.html
If your research project will involve studying people (observation, survey, medical records, blood or tissue samples, etc.) whether the work is funded or unfunded, then you will need to submit your research protocol for approval to the Institutional Review Board (IRB) before you can begin work to determine whether or not your work adequately addresses these important issues. This is a federal requirement mandated by the United States Department of Health & Human Services’ Office for Human Research Protections (HSS - OHRP) intended to protect the safety and rights of the human subjects involved in federally funded research studies.
First, you should obtain a written copy of your institution’s human subjects policies and procedures and make sure that you understand them. Next, you will need to file an application for study approval through your local IRB (see below). Once your application is approved, you can begin your study.