糖心logo

While from the Department of Health and Human Service鈥檚 Office for Human 糖心logo Protections (OHRP) on this requirement is currently under review, the indicates that this requirement can be satisfied by including a brief description of the following at the beginning of a consent form:

• 鈥渢he 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鈥檚 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.鈥�

Based on this recommendation, the 糖心logo Subjects Review Board鈥檚 consent templates include 鈥榢ey information鈥� bullet points.聽The key to utilizing the 鈥榢ey information鈥� 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 鈥榟appy鈥� balance between meeting the additional requirements, without creating significant duplication or making the consent form unnecessarily long or more complex. The goal of the 鈥榢ey information鈥� is to facilitate decision-making by providing critical information to the subject 鈥榰p front鈥�.

higher risk or more involved research

For higher risk or more involved research, the 鈥榢ey information鈥� 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 鈥榢ey information鈥� 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, 鈥渋f the information included at the beginning of the consent form satisfies both [key information requirements and the elements of consent]鈥� more generally, the information in the beginning need not be repeated later in the body of the informed consent.鈥�

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., 鈥榶our participation in this study will last about 30 minutes鈥�) and/or benefit statement (e.g., 鈥榶ou will not benefit from being in this study鈥�), as this would not require further explanation in the body of the consent document, provided the statement(s) is provided as a 鈥榢ey information鈥� bullet.

additional considerations

Additional considerations to bear in mind when drafting 鈥榢ey information鈥� include the following:

• The University of Rochester only applies the revised Common Rule (including the provisions for key information) 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 鈥榢ey information鈥� in the consent form.
• 鈥楰ey information鈥� requirements do not apply to research deemed exempt; 鈥榢ey information鈥� 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 鈥榢ey information鈥� identified by the sponsor or coordinating center. Do not insert duplicative 鈥榢ey information鈥� bullets merely because these bullets are included in the RSRB consent templates. Providing two sets of 鈥榢ey information鈥� defeats the goal of facilitating subject understanding.