The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued Ethical Principles and Guidelines for the Protection of Human Subjects of Research. This is the cornerstone document of ethical principles and HHS regulations for the protection of research subjects based on respect for persons, beneficence, and justice.

See The Belmont Report for more information.

Respect for persons recognizes the personal dignity and autonomy of individuals.

Respect for persons requires the following practices:

4.1 Ensuring decision making is free from coercion

Participation in a research study must be purely voluntary. Subjects should agree to participate without the researcher (or others) exerting any undue influence or coercion on them.

The IRB must review and propose any proposed recruitment materials for a study before they are used.

Incentives for participation must not create undue influence, such as assignment of grades or comparatively large sums of money. If incentives are extended to some members of a group, these must not disadvantage other, non-selected members.

If students receive extra credit in a course for participation in a research study, the instructor must also offer equivalent, non-research extra credit options.

4.2 Obtaining informed consent

Informed consent is a process of information exchange between a subject and researcher throughout the study. Informed consent should be an ongoing process, not simply the one-time reading and signing of a form. The consent form is merely a tool to assist the researcher and inform the subject.

All subjects must give consent voluntarily to participate in a study. Potential subjects must be given sufficient information in words they can understand to make informed choices about either beginning or continuing participation in a study. In order for consent to be fully informed, the subject must:

• Receive full disclosure of the nature of participation
• Indicate comprehension of the information
• Have the opportunity to either agree or refuse to participate

Usually, consent is given by signing a consent form indicating understanding of the:

• Purpose of the research
• Proposed procedures, risks, and benefits
• Subject’s rights in the situation

By signing a consent form, subjects do not give up any legal rights.

Oral consent may be appropriate for some types of research (e.g., a telephone interview).

In rare cases, the researcher may request that the IRB waive the requirement for subjects to sign consent forms such as where the subjects may be illiterate or where a signature on a consent form risks potential harm from a breach of confidentiality. However, researcher field notes should record provision of consent information to each subject and confirmation of each subject to participate in the study in lieu of signed consent forms.

Subjects must be able to withdraw from a study at any time. If subjects need to complete certain study activities in order to receive compensation or receive an incentive (e.g., enter a drawing), criteria for receiving the compensation/incentive need to be explained clearly in the consent document. For example, how much of an activity must a participant complete to qualify for a cash incentive or to be entered into a drawing?

4.3 Enacting additional protections  for those with diminished autonomy (vulnerable populations)

The following categories require Full Board review:

1. Children: persons who have not reached the legal age for consent (GSC does not permit research on people under age 18). Researchers planning to involve children/minors as subjects in a research study need to obtain consent from parents/legal guardians and assent from children, along with other special considerations. Information is available in GSC’s Guidelines.
2. Prisoners: individual involuntarily confined or detained in a penal institution, or in other facilities which provide alternatives.Studies involving prisoners raise special issues and are subject to additional safeguards. An IRB member or consultant who is a prisoner advocate must be present at the IRB review.
3. Persons with diminished capacity: individuals who may not be capable of self-determination due to a lack of cognitive capacity, either temporary or permanent, or developmental disability.When individuals have diminished capacity, additional protections including consent of legal guardians are needed.