Informed Consent: Regulatory Background
Over the next several months the LSA Ethics Blog will host a discussion of informed consent by posting a number of case studies for comment. I am getting the ball rolling here today with a brief overview of the U.S. regulatory requirements for informed consent so that we have a shared understanding of institutional review board (IRB) decision making mechanisms and importantly, so that we might more readily separate the regulatory requirements from the varying ethical (and perhaps for some, moral) responsibilities we have as researchers of language. My review of the regulations is cursory so please feel free to ask questions if you have them.
The U.S. federal research regulations, also know as 45CFR46, don’t define informed consent, but instead provide a list of the elements that informed consent should include and the ways in which researchers might document that consent has taken place. As an IRB administrator and a generally hopeful human being, I take this as evidence that the federal regulators really do want researchers and IRBs to have flexibility when it comes to approvable consent materials. We will discuss ways in which you and your IRB might use this flexibility in the upcoming posts.
The canonical model
One thing to keep in mind about the regulations and about IRB review in general is that research projects are viewed through the lens of a canonical (and hypothetical) norm. For example, an IRB might see the canonical model for an interview study as one in which the researcher interviews subjects (generally strangers), audio records the interview, transcribes the recordings, removes all identifiers from the transcripts, and then erases the audio-recordings. Though this is not the only model, it is the starting point for IRB review. If an interview study varies from this model, the IRB needs to document how and why. The regulations governing consent work much in the same way. They describe a signed written consent form as the norm and when a study varies from this model the IRB has to document how and why.
Three regulatory “types” of consent
There are three regulatory “types” of consent.
I. Written documentation of consent. This is the default type of consent and it what most people think of when they hear “informed consent.” Written documentation of consent is a written document that research participants (or their representatives) sign to indicate that they have been informed about the study and agree to participate. Sometimes researchers will sign these too.
II. Waiver of written documentation of consent. This is a consent process that does not involve a written signed consent form. A researcher would need to request this waiver in order to use a consent process that is not signed by the subject. This is relevant for studies that have oral consent, consent letters, and information statements. Researchers need to supply the IRB with written versions of the consent process they will use. (Much more on this below.)
III. Waiver of informed consent. This is a consent process that does not require researchers to inform subjects’ of their participation in research. This will not likely apply to much linguistic work or to the case studies that we present, but I would be remiss if I didn’t fill out the Big Three consent regulations. Some research studies can be conducted without any type of informed consent at all. Studies that meet the threshold for waiving informed consent are nearly always those that are using identifiable secondary data in which the researcher will not have contact with the study subjects—like a review of identifiable medical records. Some IRBs use this as the threshold for opt out consent.
What the regulations say might/should be included in consent
The regulations list a number of elements that an IRB should take into consideration as they review a consent document. During the review, the IRB has the choice to either require these elements or waive their inclusion. Here are a few examples of the elements of consent:
- Statement of the research purpose
- Statement describing the study procedures
- Statement explaining how long participation may take
- A description of any reasonably foreseeable risks
- Approximate number of subjects in the study
For a full list of consent elements see 45CFR46.116.
Justifying a waiver of written documentation of consent
In order for a research project to use a consent process that does not include a consent form signed by subjects, an IRB must document in their files that they have granted a “waiver of documentation of informed consent.” The are two regulatory grounds on which an IRB can grant such a waiver:
45CFR46.117 (C) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
(2) That 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.
A waiver request needs to respond to either (1) or (2) but not both. For nearly all linguistic research point (2) is the point to address.
A note on parental consent & minor assent
Parental permission for participation of a minor in a research follows the same model described above and requires written documentation of consent, a waiver of documentation of consent, or an informed consent waiver. A study might require two parent signatures or it might only require one parent signature. The consent process for minors is called “assent” and there are no regulatorily required elements, the IRB can determine what is appropriate. See 45CFR46.408.