“Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”
Key Information and Informed Consent
On January 21, 2019, the revisions to the Common Rule (the ‘Federal Policy for the Protection of Human Subjects’), issued by the Department for Health and Human Service (HHS), went into effect. The revised regulations now require the presentation of ‘key information’ at the start of the consent form; the regulations state the following:
While there is no specific guidance from HHS’s Office for Human Research Protections (OHRP) on how to comply with this requirement, the preamble to the final rule published in the Federal Register indicates that OHRP generally expects this new requirement can be satisfied by including a brief description of the following at the beginning of a consent form:
- “the fact that consent is being sought for research and that participation is voluntary;
- the purposes of the research, the expected duration of the prospective subject’s participation, and the procedures to be followed in the research;
- the reasonably foreseeable risks or discomforts to the prospective subject;
- the benefits to the prospective subject or to others that may reasonably be expected from the research; and
- appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject.”
Based on this recommendation, the Research Subjects Review Board’s consent templates include ‘key information’ bullet points. The key to utilizing the ‘key information’ template is to bear in mind that the bullet points are guidance only; bullet points may be added or removed as necessary based on the nature of the research.
When drafting consent forms, study teams should strive for a ‘happy’ balance between meeting the additional requirements, without creating significant duplication or making the consent form unnecessarily long or more complex. The goal of the ‘key information’ is to facilitate decision-making by providing critical information to the subject ‘up front’.
higher risk or more involved research
For higher risk or more involved research, the ‘key information’ should be relatively brief, concise and focused, providing a short summary of crucial elements of information that are further explained in the consent form (e.g., identifying the most important or the most severe risks instead of all risks).
simple research with limited requirements
For simple research, with limited procedures, the ‘key information’ may be quite minimal as highlighting multiple benign points in an already brief document will not likely aid in the decision-making process. In some cases, as stated in the preamble to the final rule, “if the information included at the beginning of the consent form satisfies both [key information requirements and the elements of consent]… more generally, the information in the beginning need not be repeated later in the body of the informed consent.”
For example, for a minimal risk study requiring only a short interaction with the subject (e.g., brief interview or survey completion), it may not be necessary to duplicate a concise statement of duration of participation (e.g., ‘your participation in this study will last about 30 minutes’) and/or benefit statement (e.g., ‘you will not benefit from being in this study’), as this would not require further explanation in the body of the consent document, provided the statement(s) is provided as a ‘key information’ bullet.
additional considerations
Additional considerations to bear in mind when drafting ‘key information’ include the following:
- The University of Rochester is only applying the revised Common Rule (‘2018 Requirements’, as identified in the STUDY workspace in Click IRB) to new research approved on or after January 21, 2019 (all studies approved prior to that date remain under the old, pre-2018 Common Rule requirements), and do not require ‘key information’ in the consent form. As such, the RSRB is not requiring that ‘key information’ be added via modification to studies approved prior to January 21, 2019, unless a sponsor or other entity is requiring the revision.
- ‘Key information’ requirements do not apply to research deemed exempt; ‘key information’ does not need to be included in consent documentation (e.g. information letters) for such research.
- In the event, a consent template is provided by a sponsor or coordinating center for local IRB review and approval, study teams may defer to the ‘key information’ identified by the sponsor or coordinating center. Do not insert duplicative ‘key information’ bullets merely because these bullets are included in the RSRB consent templates. Providing two sets of ‘key information’ defeats the goal of facilitating subject understanding.