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Is there an adequate process for obtaining informed consent?

Robert Hood

03/30/2008 09:58 am

Help for IRB Committee Members: Is there an adequate process for obtaining informed consent

Belmont principle Respect for Persons
Where to start: initial application Consent section
Where to start: continuing review application Continuing review question O
Required IRB determinations Unless waived or exempt, IRB members determine that the consent process will seek the legally effective consent of participants or their legally authorized representatives.
General Considerations The consent process is a discussion that should be culturally and linguistically appropriate to the study population, and not simply a consent document. IRB committee members, or reviewers using the expedited procedure, are required to determine there is an adequate process for obtaining informed consent. Reviewers should evaluate the entire process, from advertisements and recruitment materials, to discussion of the elements of consent during the consent interview or dialogue between participant, or the participant's legally authorized representative, and researcher. The goal of the process of consent is that participants understand their experience in research, and make a voluntary decision to enter into research. The outcomes--understanding, and voluntary choice--require reviewers assess whether the disclosures involved in the process will lead to understanding, and whether the participants are capable of making a voluntary decision (this is particularly a concern in the case of participants lacking decisional capacity, such as children, cognitively impaired persons, or prisoners--where the prison environment requires that reviewers insure that steps are taken to minimize the possibility of coercion or undue influence).

Evaluating the consent process

Unless the IRB authorizes a waiver, or the research is exempt, participants may not be enrolled in research unless the investigator has obtained the legally effective informed consent of the participant, or the participant's legally authorized representative (at DOH, if research involves participants who do not have decisional capacity, legal counsel will be consulted to determine who may serve as the participant's legally authorized representative). Reviewers should consider the circumstances of the consent process, such as:

  • characteristics of the participant population (who is to be enrolled? what are their ages, educational level, and with what language are they most comfortable?)
  • who will conduct the consent interview and their competence or expertise
  • the timing of obtaining consent
  • any waiting period between informing the participant and obtaining consent
  • any circumstances of the consent process that might make participants vulnerable to coercion or undue influence
  • the location where consent is obtained, and whether that location facilitates discussion with the participant (for example, will consent be obtained in a private room?)
  • will the consent discussion be in a language understandable to the participant, or the participant's legally authorized representative?
  • does the information communicated as part of the consent process include exculpatory language, where the participant appears to waive legal rights.

Consider an example. A researcher proposes to conduct research on pregnancy outcomes in minority women who have not recieved pre-natal care. The researcher reports it is likely the population includes individuals not living in the United States legally. The researcher proposes to obtain consent in the emergency department when women present in labor. Reviewers need to assess whether the process of consent proposed by the researcher would result in understanding and in a voluntary choice on the part of the participant. If reviewers are concerned about whether the proposed process of consent meets regulatory requirements, reviewers can make suggestions and ask questions of the researcher. For example, reviewers could ask the researcher whether it is possible to contact women in advance of their presentation to an emergency department so that participants would have more time to consider the question of whether to participate in research. Could the researcher work through community organizations such as churches, or individuals who might have an established relationship with the community, such as midwives who could talk with community members and facilitate enrollment in advance? Researchers might find that the effort involved in contacting participants in advance results in better recruitment, as well as better protection of the rights and welfare of participants.

Accreditation Element Element II.7.A: The Research Review Unit evaluates compliance with policies and procedures on seeking informed consent from participants or their legally authorized representatives, and assent, when possible, from participants who cannot give consent.
Regulations 45 CFR §46.111(a)(4), 45 CFR §46.116, 21 CFR §50.20, 21 CFR §56.111(a)(4)
Guidance OHRP Guidance on Exculpatory Language in Informed Consent, FDA Information Sheets: A Guide to Informed Consent, Frequently Asked Questions: Informed Consent Document Content
OHRP Guidebook OHRP Guidebook, Chapter 3: Basic IRB review: Informed Consent

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