Date: September 12, 2023
The 2018 revised Common Rule included a new requirement that consent forms begin with a presentation of the key information most likely to help potential participants understand why they might or might not want to participate in the research. This section must be short and be presented to facilitate comprehension. Unfortunately, many investigators are either not aware of this new requirement or are unclear about what it should include. This confusion often increases the time needed for IRB approval, leading to delays in starting the research.
What is the purpose of the Key Information section? This new requirement is in keeping with one of the goals of the revised Common Rule that information in consent forms be presented in a manner that facilitates understanding and aids the decision-making process for prospective research participants. At the same time, the requirement allows the necessary flexibility for the broad range of studies to which the Common Rule applies.
What should be included in the Key Info section? The Common Rule does not provide details about what should be included in the new Key Information section, in part because of the recognition that study-specific flexibility is necessary. However, there are several resources that provide some guidance.
- The Preamble to the revised Common Rule states that a concise explanation of the items listed below should be satisfactory for a Key Information section as they provide information most likely to assist a potential participant understand reasons for and against participation. (1) While the Preamble language is not considered to be legally binding in the same manner as the regulations themselves, it does provide an indication of OHRP’s interpretation of the key information regulation at the time the rule was put into effect.
- Be clear that consent is being sought for a research study and that participation is voluntary
- The purpose, duration, and procedures to be followed in the study
- The most important and reasonably expected risks, emphasizing how being in the study might impact risks
- Reasonably expected benefits
- Any advantageous alternative procedures or treatments that are available to potential participants outside of the research
- The Secretary’s Committee on Human Research Protections (SACHRP) provided written commentary about this section, in response to specific questions posed by the Office on Human Research Protections (OHRP) (2). Key discussion points in this document include:
- Because of the great variability in human subjects research study design, even for clinical trials, development of tools and guidelines to assist with the creation of key information sections will be difficult although work on this should continue. SACRHRP proposed a list of questions to help those writing consent documents identify key information that would be most helpful to prospective participants in deciding whether to participate:
- What are the main reasons a subject will want to join this study?
- What are the main reasons a subject will not want to join this study?
- What is the research question the study is trying to answer? Why is it relevant to the subject?
- What aspects of research participation or this particular study are likely to be unfamiliar to a prospective subject, diverge from a subject’s expectations, or require special attention?
- What information about the subject is being collected as part of this research? What are the types of activities that subjects will do in the research?
- What impact will participating in this research have on the subject outside of the research? For example, will it reduce options for standard treatments?
- How will the subjects’ experience in this study differ from treatment outside of the study?
- In what ways is this research novel?
- SACHRP also opined that many will view the preamble items to be a “safe harbor”, leading institutions to rely on it as the main guidance for creation of Key Information sections. However, SACHRP emphasized that, depending on specific study details, there may be other elements, including information not required by the regulations, which could be important for subjects in deciding whether to participate in a study. They gave as an example, the potential impact of the study on caregivers or other non-participants. Thus, this committee believes that the preamble alone may not always be sufficient for crafting the Key Information section.
- Many IRBs have informed consent templates, including templates for Key Information. Investigators should utilize these but also should consult their IRB if they believe there are other items that are important to convey about their study in the Key Information section.
Because the Key Information section is meant to aid potential research participants’ decision-making, in addition to content, there are other factors to consider that have been recognized as useful for overall comprehension in consent forms (3,4):
- The entire consent form, including the Key Info section should be presented in plain language at a reading level that subjects can understand; most IRBs recommend an eighth-grade or lower reading level
- Scientific jargon should be avoided or explained in simple terms
- The use of graphical elements like images and tables plus the use of colors and clear formatting can help highlight important aspects of the research and improve readability
A prior Learn eCORE blog “Designing Health Literate Clinical Research” provides a variety of resources for improving the comprehension of research participants.
OHRP has posted a useful video “Simplifying Informed Consent” (5) that has practical suggestions about crafting consent documents, including the Key Information section. While it stresses the features noted above to improve comprehension of consent forms, it also advocates seeking input from patient advocates or other representatives of the population groups to be studied to help identify the issues most important to potential. Empirical research has also identified the Input from patients as important for improving the comprehension of consent materials (6).
Early Experience with the Key Information Section:
Many of the published commentaries in the bioethics literature about this new regulatory requirement for informed consent (such as 7, 8, 9) have expressed hope that this new section will help fulfill the Belmont Report’s vision of consent and improve comprehension. But most also call for empirical research on the implementation of key information to develop effective guidance (10).
One published study examined consent templates from a sample of academic medical programs and Clinical Science Translational Awards recipient institutions shortly after the revised Common Rule took effect. It found that most relied only on the Preamble in constructing templates for Key Information. It also noted that more than half of the templates did not emphasize the use of best communications practices like readability and use of plain language (11). This study underscores the need for continued exploration about what constitutes “key information” and that the importance of other recognized features known to improve comprehension, like readability, need to continue to be emphasized.
In summary, effective informed consent is recognized as critical for achieving the Belmont Report principle of respect for persons by enabling potential research participants to make well-reasoned decisions regarding research participation. The newly required Key Information section of consent documents may improve the comprehension of research consent. As experience with it grows, we will hopefully learn how to maximize the effectiveness of this new feature.
- Federal Policy for the Protection of Human Subjects. Preamble pg 7214. Federal Register Vol. 82, No. 12, January 19, 2017.
- Attachment C -New “Key Information” Informed Consent Requirements. SACHRP Commentary on the New “Key Information” Informed Consent Requirements, October 17, 2018.
- Hamnes, B., et. al. 2016. Readability of Patient Information and Consent Documents in Rheumatological Studies. BMC Med Ethics 16;17(1):42. doi: 10.1186/s12910-016-0126-0.
- Fog, G. and Larson, F.L. 2016. Reading Level and Comprehension of Research Consent Forms: An Integrative Review. J Empir Res Hum Res Ethics 11(1):31–46. doi: 10.1177/1556264616637483.
- Simplifying Informed Consent (with OHRP), November 10, 2020. Video accessed on August 20, 2023, at https://www.hhs.gov/media/1691/modal .
- Raj, M., et.al. 2018. Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, And Provider Perspectives. Biol Blood Marrow Transplant 24(1):156-162. doi: 10.1016/j.bbmt.2017.08.037.
- Millum J., and Bromwich D. 2021. Informed consent: What Must Be Disclosed and What Must Be Understood? Am J Bioeth 21(5): 46-58. doi: 10.1080/15265161.2020.1863511.
- Porter, K.M., et al. 2021. Am J Bioeth 21(5): 70- 72.. Promoting Disclosure and Understanding in Informed Consent: Optimizing the Impact of the Common Rule “Key Information” Requirement. doi 10.1080/15265161.2021.1906996.
- King, N.P. 2019. Key Information in the New Common Rule: Can It Save Research Consent? J Law, Med., & Ethics. 47 (2): 203-212. doi.org:10.1177/1073110519857.
- Bazzano, L.A., 2020. A Modern History of Informed Consent and the Role of Key Information. J Clin Transl Sci (4) 4: 81-85. doi: 10.31486/toj.19.0105
- Mozersky, J., et.al. 2020. How Are US Institutions Implementing the New Key Information Requirement? J Clin Transl Sci 4(4): 365-369. doi: 10.1017/cts.2020.1.