Chapter 14: The Federal Policy for Human Subject Protections (The Common Rule)

ACHRE Report

Part III

Chapter 14

Introduction

The Federal Policy for Human Subject Protections (The Common Rule)

Research Involving Ionizing Radiation

Scope of Programs of Research Involving Human Subjects

Administravtive Structures and Procedures for Research Oversight

Federal Responses to Violations of Human Subjects Protections

Protections for Human Subjects in Classified Research

Conclusion

Chapter 14: The Federal Policy for Human Subject Protections (The Common Rule)

The Common Rule applies to all federally funded research conducted both intra- and extramurally. The rule directs a research institution to assure the federal government that it will provide and enforce protections for human subjects of research conducted under its auspices. These institutional assurances constitute the basic framework within which federal protections are effected. Local research institutions remain largely responsible for carrying out the specific directives of the Common Rule. They must assess research proposals in terms of their risks to subjects and their potential benefits, and they must see that the Common Rule's requirements for selecting subjects and obtaining informed consent are met.

As discussed below, central to the process of ensuring that the rights and well-being of human subjects are protected are institutional review boards (IRBs). The Common Rule requires that a research institution, as a condition for receiving federal research support, establish and delegate to an IRB the authority to review, stipulate changes in, approve or disapprove, and oversee human subjects protections for all research conducted at the institution. IRBs are generally composed of some combination of physicians, scientists, administrators, and community representatives, usually at the local research institution, but sometimes at an agency that conducts intramural research.[7] IRBs have the authority to suspend the conduct of any research found to entail unexpected or undue risk to subjects or research that does not conform to the Common Rule or the institution's additional protections.

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.[8]

The Common Rule includes several additional elements of consent that may be appropriate under particular circumstances[9] and describes the conditions under which an IRB may modify or waive the informed consent requirement in particular research projects.[10]

When an IRB reviews and approves a research project, it must pay particular attention to the project's plan for obtaining subjects' informed consent and to the documentation of informed consent. The IRB may require changes in the investigator's procedure for obtaining informed consent and in the consent documents. The board also must be allowed to observe the informed consent process if the IRB considers such oversight important in ascertaining that subjects are being adequately protected by that process.[11]