Institutional Review Board (IRB)

New IRB Regulations are in effect as of 1/21/19. Please use the new versions of forms, and the instructions on this website or in the revised IRB Guide (in Forms).

What is the Common Rule?

Federal policy for the protection of human subjects – known as “The Common Rule” – requires that Wellesley College establish an IRB.  The Common Rule requires an institution that is conducting research to assure the federal government that it will provide and enforce protections for human subjects of research conducted under its auspices. The Common Rule was first promulgated by the U.S. Department of Health and Human Services (then known as DHEW) in 1974, and extended to 16 U.S. governmental agencies in 1991. The Common Rule was revised in 2018; these revisions went into effect, as the Revised Common Rule, as of 1/21/19.

The Common Rule is based on the ethical principles articulated in The Belmont Report (issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). The three basic principles are:

[a] Respect for persons: [1] individuals should be treated as autonomous agents, capable of making autonomous choices; [2] persons with diminished autonomy, such as children and prisoners, are entitled to protection -- the extent of protection (ranging from ensuring that activities are undertaken freely and with an awareness of possible adverse consequences to “extensive protection”) depends on the risk of harm and likelihood of benefit, as well as the capacity for self-determination of the individual.

[b] Beneficence: [1] do no harm -- when there is a risk of harm, this is only justifiable when the benefits are considered to outweigh the harm; [2] maximize possible benefits and minimize possible harms.

[c] Justice: the benefits and burdens of research should be justly and fairly distributed.

The goal of the Wellesley College IRB is to assist Principal Investigators at Wellesley College in their efforts to protect the rights and welfare of individuals who participate in research conducted at or under the auspices of the College, and to ensure Wellesley College’s compliance with federal regulations regarding the protection of human subjects. See Forms for the full Wellesley College IRB Guidelines.

To meet these goals, the IRB provides the Wellesley College community with information about IRB regulations and ways to protect human subjects, reviews all planned research involving human subjects prior to initiation of the research, approves research that meets established criteria for protection of human subjects, and monitors approved research to ensure ongoing protection of human subjects. The IRB does not review the scientific merit of research studies; however, the IRB does evaluate the risks to subjects in light of the potential benefits of the study, which requires a consideration of the scientific merit of the study.