The revised “common rule” (effective January 21, 2019) requires that the key information
be included in the beginning of the informed consent in a concise and focused presentation.
The University of Utah IRB refers to this as a “concise summary”. Informed consent
should begin with a concise summary of the key information. Key information is defined
as the information that is most likely to facilitate understanding of the reasons
why one may or may not want to participate in research.
The University of Utah IRB relies upon the limited federal guidance that has been provided. It is expected more information may be forthcoming and the UUIRB will update guidance at that time.
Studies initiated before January 21, 2019 will be grandfathered and continue to be subject to the pre-2018 Common Rule. Studies initiated (approved) on or after January 21, 2019 are subject to the revised “common rule”, also called the Final Rule. Investigators may choose to transition grandfathered studies to comply with the Final Rule. A concise summary will be required of studies subject to the Final Rule.
In general, the beginning of an informed consent would include a concise explanation of 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.
The above five points constitute the key information most likely to assist a reasonable person (or legally authorized representative) in understanding the reasons why one might or might not want to participate in research.
There may be additional information that should be provided in the concise summary depending on the nature of the specific research study. For example, if the study involves placebo, or if the study includes an investigational device or drug, that information would likely be considered key information.
The information presented in a concise summary is information that should already be provided in a consent process. There is no additional information beyond what is already required in the informed consent process.
Typically, studies with no more than minimal risk have a short consent process and consent document. For example, many main campus researchers use consent cover letters for questionnaires or interviews. A consent cover letter is typically one page. Therefore, the consent cover letter 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.
For studies with greater risks and more procedures, the key information to be presented in a concise and focused will differ greatly from those simple studies with limited risks. For example, a complicated clinical trial for cancer patients may have a consent document that is 20-25 pages. The concise summary for such a study would ideally be no more than a few pages. The most important foreseeable risks to participants could be summarized at the beginning of the informed consent, while the more comprehensive and detailed description of foreseeable risks would be presented later with the body of the informed consent.
The information included at the beginning need not be repeated later in the body of the consent. For example, if there is a statement about voluntary participation in the beginning of the consent as part of the concise summary, it would not need to be repeated later in the body of the document.
Suggestions for Writing a Concise Summary
- There is not a required format for the concise summary. It may include bullets or be written in paragraphs, but the information must be presented in complete thoughts, not "isolated facts".
- The concise summary should be at the beginning of the consent document and generally should be no longer than one (1) page of content.
- A concise summary should not be created by repeating information verbatim, or directly cutting and pasting sentences from the body of the consent document.
- Information provided in a concise summary does not need to be repeated later into the body of the document. For example, since the statement that consent is being sought for research is explained in the concise summary, it does not need to be repeated in the body of the document.
- If your consent document is no more than 2-3 pages, simply presenting the key information at the beginning before the rest of the information will satisfy the requirement for a concise summary.
- If the study’s procedures and/or risks requires extensive explanation or description, a brief summary or overview of the procedures and/or risks should be given. It should then be explained that the more comprehensive and detailed description will be provided later in the consent document.
Examples of how a concise summary of key information might appear in your consent document.