Institutional Review Boards and the Belmont Principles
The Syphilis Study at Tuskegee
The United States Public Health Service conducted a study on the natural history of untreated syphilis in Tuskegee, Alabama from the 1930s until 1972. Approximately 600 African-American men (about 400 with syphilis and about 200 without syphilis) were recruited into the study without informed consent
and were misled into thinking that some of the experimental testing procedures, such as spinal taps, were "special free treatment." By 1936 it had become clear that problems were more frequent in the infected men, and after ten years it was known that the death rate was twice as high in the men with syphilis. Penicillin was shown to be an effective treatment for syphilis in the 1940s, but the study continued, and the subjects were not given penicillin or even informed about its availability. The press aired the story in 1972, and this provoked public outrage.
In the United States the outrage over the Tuskegee Study resulted in passage of the National Research Act of 1974 and the establishment of a Health and Human Services Policy for Protection of Human Research Subjects. As a result, all US research involving human subjects must now be reviewed and approved by an Institutional Review Board (IRB). Subjects must voluntarily give their informed consent to participate in a research trial. "Informed consent" means that the subjects must be fully informed and understand all aspects of the research including the nature and objectives of the study, the treatment options, the risks and benefits, the data to be collected, the methods by which treatment assignments will be made, etc. Informed consent must be obtained before assignment to a treatment group.
The Tuskegee Study also prompted the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged with identifying the basic ethical principles that should be adhered to in the conduct of research involving human subjects. In 1978, the Commission published "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," also known as the Belmont Report. The Belmont Report identified three fundamental ethical principles for all human subjects research:
Link to General Requirements for Informed Consent
The Health and Human Services Policy for Protection of Human Research Subjects in the Code of Federal Regulations defines human research as follows:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information.
Is important to note that ALL human research must be reviewed and approved by an IRB before a study is begun. This applies to observational studies and descriptive studies as well. Even if a study involves only collection of pre-existing data, e.g., based on a review of medical records, there is the possibility of harm to the subjects from research staff collecting potentially sensitive information. The definition of human research is intentionally broad, but it excludes "de-identified" information.
Link to the Policy for Protection of Human Research Subjects
Link to more on Institutional Review Boards (IRB).
Link to US Health and Human Services and Code of Federal Regulations on Protection of Human Subjects
See also:
Brief outline of IRB Application Requirements at Boston Medical Center
Article by Janice Weinberg and Ken Kleinman on Good Study Design and Analysis Plans as Features of Ethical Research with Humans
When Is IRB Approval Required?
The IRB requirement is not a general requirement but rather is required of federally funded research institutions. Thus, IRB approval is required for human research that is federally funded or is being conducted by an entity that otherwise receives federal research funding. The web site for the federal office that oversees these matters is located at the following link: http://www.hhs.gov/ohrp/. A particularly helpful page is the following link: http://answers.hhs.gov/ohrp/categories/1563, which discusses the assurance process and the kind of institutions that must have IRBs because they conduct research that is regulated by the feds. The most relevant part says,
"HHS human subject protection regulations and policies require that any institution engaged in non-exempt human subjects research conducted or supported by HHS must submit a written assurance of compliance to OHRP. The Federal wide Assurance (FWA) is the only type of new assurance accepted and approved by OHRP. FWAs also are approved by the Office for Human Research Protections (OHRP) for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question."
Link to HHS policy definition of engagement of an institution in human research
However, even if you are not required by federal requirements to have your research reviewed, the funding agency may require it. Furthermore, even if you are not required to have this research reviewed by an IRB, you should feel ethically bound to protect your subjects, and the federal rules set good standards that are worth paying attention to. The federal regulations can be found here at the following link:http://www.hhs.gov/ohrp/human subjects/guidance/45cfr46.html#46.103