There are two circumstances in which a research project may qualify for a waiver of the requirement to obtain documentation of informed consent under the Common Rule. The first is when the only record linking the subject and the research is the consent document and the principal risk to the subject would be a breach of confidentiality. In these cases subjects should be asked whether they want documentation linking them with the research, and the investigator should comply with their wishes and document consent accordingly. The second is when the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In these cases, the IRB may require the investigator to provide subjects with a written statement regarding the research (such as an information sheet).
These criteria are best illustrated through an example from behavioral sciences research. In this case, a researcher plans to ask women in a recovery program about their experience with addiction and their motivations to stop using illicit drugs. During a group meeting, the subjects will be asked to fill out a questionnaire and place it in a sealed box. There is no identifying information about the subjects on the questionnaire. In addition, it is made clear to the subjects that their participation in the study will in no way affect their participation in the recovery program or their future care. In this case the researcher may request a waiver of documented informed consent, since the consent document would be the only item linking the women to this drug recovery program. The risk of a breach of confidentiality (if the signed consent documents become public) is the principal risk, obviously outweighing the risks of answering a questionnaire. In this case the investigator should prepare an information sheet about the research or include the required information in one introductory paragraph on the questionnaire. The following information should be included: a description of the purpose of the research and the questionnaire (i.e., the only research procedure), the time allotted to complete the questionnaire, the assessment of minimal risk, the benefit of the research to the subject (if any), whom to contact for questions, concerns or complaints about the research, whom to contact for questions about their rights as research subjects, and a statement that the individual is under no obligation to complete the survey.
Implied Consent
The example above may also be used to illustrate the concept of “implied consent.” Implied consent is defined as a situation where the lack of an objection to research participation is considered to be the equivalent of an affirmative declaration of informed consent. In other words, if the subject fills out the questionnaire and does not say “No” to filling out the questionnaire, it means that the subject consents to be a participant. While an implied-consent process has been thought to yield high response rates due to subjects’ perception of anonymity, there are no federal regulations that support this type of consent. Failure to refuse participation does not constitute agreement to participate. IRBs will not approve studies proposing the use of implied consent. Therefore, this type of research must meet the criteria for a waiver of informed consent or a waiver of documented consent. Failure to meet those criteria requires standard informed consent documentation.