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New Consent Form Requirements for Non-Exempt Research, Updated to Include New 2018 Federal Regulation Requirements

This page has has been revised to include new "key information" and other required elements to meet the 2018 Common Rule requirements. 

Under the revised 2018 Common Rule, the requirements for informed consent for non-exempt research projects will change, with the addition of: 

  • "Key information" to be presented at the beginning of the consent form
  • New consent elements

Research that falls into an Exempt Category is still required to present information to subjects but that information does not require the Key Information section or the new consent elements. Examples describes the requirements for Exempt research. RIT uses the term Informed Consent Process and Informed Consent for the information given to research subjects regardless of whether they are participating in an Expedited, Exempt, or Board-reviewed category of research.

KEY INFORMATION

This requires that "key information" be included in the beginning of the informed consent in a concise and focused presentation. How the information is presented will depend on the nature of the specific research study and in most cases will be relatively short. This section of the consent could, in appropriate circumstances, include a summary of relevant pieces of information that are explained in greater detail later in the consent form. Key information consists of these five elements:

  • A statement that the project is research and participation is voluntary
  • A summary of the research, including:
    • purpose
    • duration
    • list of procedures
    • Resonable, foreseeable risks, or discomforts
    • Reasonable or expected benefits
    • Alternative procedures or course of treatment, if any.

    How you apply the "key information" requirement, and to what level of detail, will depend on the complexity of the research project.  Many social/behavioral research projects already employ a brief informed consent document, so including a "key information" section may be redundant.  The Final Rule preamble includes some considerations regarding the application of this requirement, but further federal guidance is expected at a later date.

     

    New Consent Elements

    New required element Include in the informed consent...
    The collection of identifiable private information or identifiable biospecimens

    A statement indicating whether:

    • identifiers may be removed, and
    • de-identified information or biospecimens may or may not be used or shared for future research

    Additional Optional Elements that may not be relevant to all studies but should be included when appropriate

    Use of biospecimens

    A statement indicating whether:

    • biospecimens may be used for commercial profit, and
    • the subject will share in that profit
    Clinically relevant results

    A statement indicating whether the clinical results, including individual research results, will be returned to the subject, and if so, under what conditions

    The intent of these changes is to facilitate the subjects' understanding of the proposed research and also ensure that they understand how their data and biospecimens may be used.

    The information provided to potential subjects will be evaluated in light of the risks and benefits of the proposed research procedures.

    • Review is from the subject's perspective: what facts would a prospective subjects want to know before deciding whether or not to participate in the research?
    • Does the information inform prospective subjects as clearly as possible? Are there any coercive (intimidating) aspects which might impede free choice? In cases where there is reason for special concern about pressure (e.g., when students or employees are asked to participate in research conducted by their professors or supervisors), the researcher may be required to provide some form of monitoring (such as the presence of an impartial observer).
    • Obtaining informed consent is an educational process; researchers should do everything they can to enhance the prospective subject's understanding of the information presented.

    Review of the Informed Consent Process considers:

    • the characteristics of the subject population,
    • the type of information that will be given to the subjects, and
    • the circumstances under which the consent process will take place (e.g., method, timing, place, and personnel involved).

    After considering all of these items, the HSRO may suggest changes in the wording of the consent documents or in the timing or location of an investigator's contact with potential subjects. These requests are made to provide subjects with as much relevant information as possible to ensure they take part as informed and voluntary participants.

    Federal regulations on informed consent specify the information that must be disclosed to prospective subjects Basic Elements of a Consent Form. The IRB will review the consent document(s) in relation to these regulations.