Key Information
Overview
The revised “common rule” (effective January 21, 2019) requires that informed consent begin with a concise and focused presentation of the key information. This includes information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research. The key information section must be organized and presented in a way that facilitates comprehension.
The BYU IRB relies on the limited federal guidance currently available. Additional guidance is anticipated in the future, and the BYU IRB will update its policies accordingly once that information is released.
Research that is regulated by the FDA (i.e. subject to 21 CFR 50 and 21 CFR 56), and not conducted, supported, or otherwise subject to regulation by another federal department or agency, is encouraged but not required to include a key information section.
Key information generally includes a concise statement addressing the following:
- The fact that consent is being sought for research, and participation is voluntary
- Purpose of the research, expected duration, and procedures.
- Reasonably foreseeable risks
- Benefits that may be reasonably expected
- Appropriate alternative procedures or courses of treatment, if any.
- It should also note any appropriate alternative procedures or treatments that may be advantageous to the participant. However, depending on the specifics of a given protocol, the IRB may require additional or different information to be included at the beginning of the informed consent to meet this requirement.
There may be additional details that should be included in the concise summary depending on the nature of the particular study. For example, if the research involves random assignment to different treatment groups, that information would likely need to be included as key information.
The concise summary shouldn't contain any information beyond what's already required in the informed consent process. It simply presents that same information in a more condensed, accessible format up front.
How should key information be presented for studies involving no more than minimal risk?
Typically, studies involving no more than minimal risk have a short consent process and a short consent document. If the consent form is around one page in length, it generally provides all the key information in a concise form.
For studies with limited risks or benefits, the entire informed consent may be relatively brief. Presenting the key information as described above at the beginning of the document will meet the concise summary requirement.
How should the concise summary be presented in studies involving greater than minimal risk?
For studies with greater risk or more procedures, a concise and focused presentation of key information will look different than it would for a simple, low-risk study. For example, a study involving several study visits, biological samples, and follow-up procedures might have a consent document that runs 6-8 pages. The concise summary for such a study would ideally be no more than a page. The most important foreseeable risks to participants could be summarized at the beginning of the consent form, while a more detailed description of those risks would follow later in the body of the document.
Information included at the beginning does not need to be repeated later in the body of the consent. For example, if a statement about voluntary participation appears at the beginning as part of the concise summary, it would not need to be restated later in the document.
Tips for Writing a Key Information Section
- The concise summary should appear at the beginning of the consent document.
- It should not be created by copying sentences word-for-word from elsewhere in the consent document.
- Information included in the concise summary does not need to be repeated later in the body of the document. For example, since the explanation that consent is being sought for research participation appears in the concise summary, it doesn't need to be restated in the body of the document.
- If your consent document is no more than 2-3 pages long, presenting the key information at the beginning, ahead of the rest of the content, will satisfy the concise summary requirement.
- If a study's procedures and/or risks require extensive explanation, a brief overview of those procedures and/or risks should be provided in the summary, along with a note that a more detailed description follows later in the document.