In the Belmont Report, the basic ethical principle of “respect for persons” has two rules:

1. individuals should be treated as autonomous agents, and
2. persons with diminished autonomy are entitled to protection.

The application of this principle during the consent process includes the essential elements of disclosure of information, comprehension by the prospective participant and voluntariness of participation. The assertion is that withholding information from participants about a research study, when there are no compelling reasons to do so, shows a lack of respect and denies participants the ability to make decisions for themselves.

However, the principle recognizes a problem may arise during the consent process when informing participants of a specific portion of the research is likely to impair the validity of the study.

Belmont Report: Ethical Principles and Guidelines

Prospective Agreement

For many studies it is sufficient for researchers to include prospective agreement to the deception or incomplete disclosure in the consent process. That is, researchers should inform prospective participants that they are being asked to enroll in research in which some portions will not be explained until the study has ended.

Exempt Research

Deception or incomplete disclosure is acceptable in exempt research studies with the use of a prospective agreement.

Benign Behavior Intervention 

Requests for research under Exempt Category 3 (benign behavioral interventions in adults) cannot be granted unless participants provide prospective agreement and are informed that they will be unaware of or misled regarding the nature or purpose(s) of the research, if applicable.

Alteration of Consent

The Institutional Review Board (IRB) may approve a request for a consent process that alters or omits some the required elements of informed consent, as long as the study meets the following requirements:

• The research involves no more than minimal risk.
• The research could not practicably be carried out without the requested alteration.
• If the research involves using identifiable, private information or identifiable biospecimens, the research could not practically be carried out without using such information or biospecimens in an identifiable format.
• The alteration will not adversely affect the rights and welfare of the participants.
• Whenever appropriate, the participants will be provided with additional pertinent information after participation.

The IRB will not approve a request for an alteration of consent in the following cases:

• The consent process omits all or alters most of the elements of informed consent.
• Informed consent is sought under circumstances that do not provide the prospective participant sufficient opportunity to discuss and consider whether or not to enroll in the study, and that minimize the possibility of coercion and undue influence.
• The information that is given to prospective participants is not in a language that is understandable to the participant.
• The prospective participant is not provided with the information that a reasonable person would want to have in order to make an informed decision about whether to volunteer, and an opportunity to discuss that information.
• The study is regulated by the U.S. Food and Drug Administration (FDA).

The Belmont Report states that all research studies using deception or incomplete disclosure should have an adequate plan for debriefing participants when it is appropriate.

Debriefing is defined as explaining to participants that investigators intentionally provided them with misleading information about the study or that information about the study was withheld from them.

The goal of debriefing participants is to reduce the harm of the deception or incomplete disclosure. Investigators should design a respectful and thoughtful debriefing process with this goal in mind.

The investigator, in collaboration with the Human Research Protection Program team and the IRB will determine if a debriefing process is appropriate for the participants.

Debriefing Process

The debriefing process should be simple, clear and informative. To meet this goal, investigators should:

• explain the nature of the deception or incomplete disclosure;
• remove any effects of false information participants may have been given;
• disclose all elements of the study that may have been withheld;
• educate participants about the research process, why the deception or incomplete disclosure was necessary and how false beliefs can sometimes continue after participation;
• ask permission to use the participant’s information if it is identifiable;
• allow participants to ask questions; and
• thank participants for their time and making them feel they are an important part of the research process.

The debriefing process should occur within a reasonable amount of time after the participant has completed study procedures. If a participant withdraws from the study prior to the study’s completion and the consent document does not specify that their data will be destroyed if they withdraw, they should receive the same debriefing process as the completed participants.

If debriefing participants after they complete study procedures could compromise study results, investigators may request that the process be delayed until study completion. Based on the type of study, deception or incomplete disclosure, the debriefing process may be conducted by phone or online for a conversation between the participant and a researcher or by mail, e-mail or via a link to a website where they can read the debriefing information at a date upon which the information will be available.

When Not to Debrief Participants

It may not be appropriate to debrief participants if informing them about the deception or incomplete disclosure may cause more harm than the deception or incomplete disclosure itself.

If a participant withdraws from the study prior to the study’s completion and the consent document specifies that their data will be destroyed if they withdraw, they do not need to have a debriefing process like completed participants, as their data will be destroyed.

When requesting to conduct research that involves deception or incomplete disclosure, investigators must ensure that the research meets their discipline’s professional code of ethics and convey in their protocol to the HRPP/IRB how the particular consideration has been given to the consent and debriefing processes, and risk/benefit ratio of the research.

The HRPP/IRB protocol must:

• justify the reasons for deceiving or withholding information from participants;
• explain why the deception or incomplete disclosure is necessary;
• describe how the potential benefits of the research justify the deception or incomplete disclosure;
• outline the debriefing process, including (a) when, (b) how, and (c) by whom the information will be provided to participants; and
• include a copy of the debriefing script.

HRPP/IRB Considerations

When reviewing research that involves deception or incomplete disclosure, the HRPP team and IRB must evaluate the information provided by the investigator and consider the following:

• The prospect of alternative procedures to the deception or incomplete disclosure
• The likelihood that the deception or incomplete disclosure will unduly influence or coerce people to enroll in the study
• The possibility of causing harm from the deception or incomplete disclosure, and the ability to remove that harm through the debriefing process
• The potential of the deception or incomplete disclosure to facilitate unwanted and inappropriate invasions of participant privacy
• Whether the investigator has the expertise and resources to minimize potential participant concerns and/or distress caused when the participant is debriefed

The HRPP team and the IRB will not approve:

• Deception for greater than minimal risk research
• Incomplete disclosure for research that requests to withhold information that would be important to a person’s decision to enroll in the study
• Alteration of consent for the purposes of deception or incomplete disclosure for FDA-regulated research (Expedited Category 1 or Category 9, when applicable)

HRPP staff and IRB members must determine that the research qualifies for an alteration of consent, in accordance with the criteria provided in the federal regulations in 45 CFR 46.116(f).