The Revised Common Rule and Informed Consent: Concise Summary
While the industry waits for additional guidance on the Revised Common Rule, there are some aspects that are worth taking note now. This is a series of posts that address various important changes for research professionals to keep in mind as they implement the Revised Common Rule.
Consent forms must facilitate comprehension by providing information that a “reasonable person” would understand in order to make an informed decision about whether or not to participate in a clinical research protocol. This includes a brief summary that is concise, focused and includes the key information about the research.
So far there has been very little guidance on the length or specific required content of the summary. It likely depends on the study itself, as well as the patient population that is being asked to participate. This will allow for flexibility in what is included in the summary.
The summary can refer to information included later in the consent, which provides the full context of a study, including its risks and benefits. Generally speaking, these five factors will most likely assist a “reasonable person” in making a decision about study participation:
- The fact that consent is being sought for research and that participation is voluntary
- The purposes of the research, the time commitment that will be expected, and the main procedures
- The most common risks or discomforts to the prospective subject
- Benefits to subject or others that are reasonably expected
- Alternative procedures or courses of treatment, if any, that might be advantageous
- Any significant costs that will be incurred
These new guidelines apply to all federally supported studies, and may also apply to other studies depending on how each institution applies the requirements of 45 CFR 46 across the board to all studies.
It will be important to note in the summary that the key information that is presented up front does not include all of the information related to the study. Potential subjects will need to be advised that in order to have all the details about the study and their participation in it, they will need to refer to the full consent form and also discuss any questions or concerns with the study doctor during the consent process.