The Revised Common Rule and its Effects on Informed Consent
The Common Rule (the commonly used term for the Federal Policy for the Protection of Human Subjects, Federal Code of Regulation, 45 CFR 46, Subpart A) is the set of federal regulations for ethical conduct of human-subjects research. The revisions are intended to enhance research participants protections, increase flexibility, and reduce unnecessary burden and ambiguity for researchers.
The final revisions to the Common Rule issued by the Department of Health and Human Services (HHS) on January 18, 2017, are slated to take effect either January 19, 2018 or 2019, depending on whether a proposed bill passes to postpone their implementation. Either way, changes are coming, and the goal of this post is to help you stay ahead of the curve by highlighting the modifications that will be taking place to the informed consent process.
There are 4 changes that affect the informed consent process:
• Improving the informed consent document and process to increase subject understanding
• Requiring that consent forms for certain federally funded clinical trials be posted on a public website
• Allowing the use of broad consent for future research for secondary studies on stored identifiable data or identifiable biospecimens
• Establishing new exempt categories of research based on level of risk posed to subjects
The first change is addressed through the provision of a new component to the Informed Consent Form, an executive summary or “key information” section, that outlines the most important information that a potential participant or Legally Authorized Representative (LAR) would want to know in order to make their decision about participation in the study.
This is a required change, and specifies that the summary be no more than 3 pages in length. The following sections must be included:
• A statement that the project is research and participation is voluntary
• A summary of the research including purpose, duration, and procedures
• Reasonable, foreseeable risks or discomforts
• Reasonable, expected benefits
• Alternative procedures or course of treatment, if any
The revised Common Rule also requires that the consent form be available publicly through clinicaltrials.gov. Although technically this requirement is only for federally-funded trials, most institutions have policies in place that follow the same guidance for federally-funded and privately funded trials.
The new Common Rule also includes provisions for broad consent involving biospecimens or individually identifiable data. This can be obtained in lieu of informed consent for secondary research use, storage, and maintenance of identifiable private information and biospecimens. Additional information regarding the recommendations for broad consent can be found here.
These changes may have a significant impact on conducting research involving informed consent in the long-term care environment. The executive summary should provide a better opportunity to focus on the important factors that will influence a resident’s decision, and discussions between researchers, residents, and their LARs may be expedited by presenting the important details in a brief, descriptive, and conversational way.
Additional things to keep in mind when constructing your informed consent form for older adults is to use a large, easy-to-read font and to write with an eight-grade reading level in mind. This will ensure that your consent form is legible and easy to understand for the widest range of potential research participants as possible.
Implementing the changes coming with the revised Common Rule into Informed Consent Forms should provide potential research participants a better opportunity at making a well-informed decision about their participation. Researchers should take care in ensuring that their consent forms meet the requirements, while focusing on presenting the information in a way that does not just provide lists of individual facts. This will make research easier to understand for those deciding whether or not the risks outweigh the benefits, and hopefully lead to a more educated study sample and fewer drop-outs.