The U.S. National Institute of Health Policies for the Protection of Human Subjects (1966) established the IRB (Institutional Review Board) as a mechanism for the protection of human participants in research. In 1981, U.S. regulations required IRB approval for all drugs or products regulated by the US Food and Drug Administration (FDA), without regard to the funding source, the research volunteers, or the location of the study. In 1991, core US DHHS regulations (45 CFR Part 46, Subpart A) were adopted by most Departments and Agencies involved in research with human subjects. This Federal Policy for the Protection of Human Subjects, known as the "Common Rule.”, requires Institutional Review Board (IRB) review for all research in human subjects funded in whole or in part by the U.S. federal government.
An IRB may approve research in human subjects that meets specific prerequisites set forth by the FDA.
- The risks to the study participants are minimized
- The risks are reasonable in relation to the anticipated benefits
- The selection of study participants is equitable
- Informed consent is obtained and appropriately documented for each participant
- There are adequate provisions for monitoring data collected to ensure the safety of the study participants
- The privacy of the participants and the confidentiality of the data are protected
Every accredited medical research organization maintains an IRB. An investigator must submit his/her research plan, called the protocol, and the informed consent form to an IRB for approval prior to the conduct of the study.
The IRB also requires the investigator to provide the following:
- Progress reports on an annual basis
- Reports of any serious adverse events in the human subjects when they occur
Informed Consent Section
The principle of respect for persons implies that each study participant will be made aware of potential risks, benefits and costs prior to participating in a clinical study. To document this, study particpants (or parents/legally authorized representatives) sign an informed consent document prior to participation in a research study. The patient assents to having been informed of the potential risks and benefits resulting from their participation in the clinical study, to understanding their treatment alternatives and that their participation is voluntary. There are numerous examples of studies in which patients have been exposed to potentially or definitively harmful treatments without being fully apprised of the risk. The consent document should be presented without any coercion. Even so, ill or dying patients and their families are vulnerable, and it is questionable how much technical information about new treatments they can truly understand, especially when it is presented to them quickly.
In the United States and many other countries, an IRB must evaluate and approve the informed consent documents prior to beginning a study.
The informed consent must describe explicitly the following information:
- The research nature of the study
- The reasonable foreseeable risks and discomfort
- The potential benefits and alternatives
- Procedures for maintaining privacy
- Treatment for injuries incurred
- Individuals to contact for questions
- The voluntary nature of the study and the possibility of withdrawal at any time
- Not entering the study does not lead to loss of benefits
Research in emergency settings in which informed consent is not possible is a special situation. The FDA and the National Institutes of Health (NIH) have offered guidance for research in emergency medical situations.