Question

Medical Ethics:

what is the "common rule"?

Answer 1

The Common Rule is a short name for “The Federal Policy for the Protection of Human Subjects” and was adopted by a number of federal agencies in 1991. The Common Rule applies to human subjects research conducted, supported or otherwise subject to regulation.
The Common Rule:
• Describes the types of research subject to regulation
• Defines key terms such as research, human subject and minimal risk
• Requires a written assurance of compliance with the common rule
• Sets forth requirements for an Institutional Review Board’s (IRB) membership, authority, review procedures, records and criteria for approval
• Lists the general requirements for informed consent.

It is the baseline standard of ethics by which any government-funded research in the US is held; nearly all academic institutions hold their researchers to these statements of rights regardless of funding.

The Common Rule is a 1981 rule of ethics (revised in 2018) regarding biomedical and behavioral research involving human subjects in the United States. The regulations governing Institutional Review Boards for oversight of human research followed the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D.

The main elements of the Common Rule include:

Requirements for assuring compliance by research institutions

Requirements for researchers' obtaining and documenting informed consent

Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.

The Common Rule includes additional protections for certain vulnerable research subjects:

Subpart B provides additional protections for pregnant women, in vitro fertilization, and fetuses

Subpart C contains additional protections for prisoners

Subpart D does the same for children.

A prominent feature of the Common Rule is the informed consent requirement. The informed consent of a competent subject, along with adequate safeguards to protect the interests of a subject who is unable to give consent, is a cornerstone of modern research ethics, reflecting respect for the subject's autonomy and for his or her capacity for choice.

Informed consent is an ongoing process of communication between researchers and the subjects of their research. It is not simply a signed consent form and does not end at the moment a prospective subject agrees to participate in a research project.

The required elements of informed consent stipulated by the Common Rule are summarized as follows:

A statement that the study involves research, an explanation of the purposes of the research, and a description of the procedures to be followed;

A description of any reasonably foreseeable risks or discomforts to the subject;

A description of any benefits to the subjects or to others that might reasonably be expected;

A disclosure of alternative procedures or courses of treatment;

A statement describing the extent to which confidentiality of records identifying the subject will be maintained;

For research involving more than minimal risk, an explanation of the availability and nature of any compensation or medical treatment if injury occurs;

Identification of whom to contact for further information about the research and about subjects' rights, and whom to contact in the event of a research-related injury; and

A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time.