There may be circumstances under which the IRB may request that a third party observe the informed consent process of research participants.
The UCLA IRBs have the authority to observe the consent process of an ongoing study as part of its quality assurance and quality improvement activities. Observation of the consent process may be delegated to a staff member of the Quality Improvement Unit or any other qualified individual designated by the IRB.
Consent Monitoring Procedures
The person (or persons) assigned to observe the consent process must be thoroughly familiar with the informed consent requirements for research as well as the specific consent requirements for the protocol for which monitoring will occur.
The consent monitor has five principal duties which include to:
- Listen to the consent process and exchange between the investigator and the subject, and the subject’s family is involved.
- Observe the communication between the investigator and the subject.
- Be prepared to ask questions in order to facilitate comprehension on the part of the research participant and help assure the research participant is making a knowledgeable decision about participation. Questions should elicit a response from the potential participant that requires some consideration and thought about the research rather asking questions that can be answered by a simple yes or no.
- Document the interactions, questions, answers, and the decision making process.
- Along with the potential participant and the investigator, evaluate whether the subject
- should be enrolled in the research,
- provided additional time to consider participation in the research, or
- should not be enrolled.
After the Observation of the Consent Process
After the observation of the consent process, the person(s) monitoring the process will
- Review the observations with the investigator and provide additional training if needed.
- Provide a summary of the observations to the IRB for review.
References and Regulations
DHHS Regulations and Guidance:
- 45 CFR 46.109(g)
- 45 CFR 46.111(b)
- U.S. Office for Human Research Protections' (OHRP) Protecting Human Research Subjects Guidebook (1993)
FDA Regulations and Guidance:
- 21 CFR 56.109(f)
- 21 CFR 56.111(b)
- FDA, IRB Information Sheets Frequently Asked Questions, September 1998.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research, April 18, 1979.
Page Last Updated: May 27, 2011