E. Informed Consent Process

The purpose of the Research Plan is to describe the proposed research in sufficient detail so that the Institutional Review Board (IRB) can determine if approval criteria for human subjects research defined in federal regulations (45 CFR Part 46 and 21 CFR Parts 50, 56, 312 and 812) is met.

The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every protocol submitted for IRB review

 

Print Research Plan Guidance

The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every protocol submitted for IRB review.

  • When drafting the Research Plan, follow the format and use the section headings (i.e. A – I) provided below, refer to the bulleted items for section content.
  • For each section, this guidance includes a description of why the information is important for IRB review (in italics).

E. Informed Consent Process

Informed consent is a process, not just a form and obtaining informed consent is a central protection for human participants. The IRB must ensure the informed consent process clearly discloses and facilitates the understanding of all information needed to make an informed decision to participate while promoting the voluntariness of participation.

Below are the key components of the informed consent process. In some cases it may be appropriate to seek a waiver or alteration of informed consent or a waiver of documentation of informed consent from the IRB.

1.  Informed Consent Process

  • Describe the informed consent process, including:

    • How the required elements of informed consent will be conveyed to participants (e.g.., informed consent document, verbal script, online statement, letter, etc.).

    • Where and when the informed consent process will take place (e.g., in-person in private room, phone, etc.).

    • Any cultural considerations (e.g., tribal or group permission requirements, age of majority, technological limitations, etc.).

    • Steps that will be taken to ensure voluntary participation and to minimize the possibility of coercion or undue influence.

    • Which research roles (e.g., PI, Research Assistant, etc.) will conduct the consent process and how that person will be trained (e.g. previous experience or related training, one-on-one training with PI, etc.).

    • If multiple participant groups or consent procedures are to be included, these need to be clearly delineated.

  • In certain circumstances, the IRB may approve a consent process which does not include, or which alters, some or all of the elements of informed consent or waive the requirements to obtain informed consent. See the RCS Waiver or Alteration of Informed Consent Guidance for the criteria that must be met and information that must be included in this section to request consideration of a waiver or alteration of informed consent by the IRB.

2.  Facilitate Understanding

  • Describe how the investigator will ensure that the participants understand all aspects of their involvement in the research (e.g., will participants be asked questions about the procedures, or encouraged to ask questions).

  • Describe any special provisions for individuals who might have trouble comprehending the consent information.

  • If any participants do not speak English, describe:

    • Whether or not the researcher is fluent in the language.

    • Whether or not and how a translator will be used.

    • Whether or not translated consent materials will be used.

    • Whether or not there are any differences in the consent process for different populations based on the language they speak.

  • Describe the process by which the investigator will ensure ongoing consent.

3.  Documentation

  • Describe how the researcher plans to document that each participant has provided informed consent and/or assent.

  • In certain circumstances, the IRB may waive the requirement to obtain a signed consent form based on specific criteria. See the RCS Waiver or Alteration of Informed Consent Guidance for the criteria that must be met and information that must be included in this section to request consideration of a waiver of documentation from the IRB.

4.  Additional Considerations

     If the research involves:

  • Minors (those under the age of majority) or individuals of diminished capacity:

    • Describe the capacity of the participant and their ability to assent.

    • Describe how assent to participate will be obtained and documented.

    • Explain how the permission of the parent(s), guardian(s), or legally authorized representatives will be obtained and documented.

      • If a waiver of permission or waiver of permission documentation is being requested, provide justification.

  • Deception:

    • Explain how participants will be deceived and why it is necessary for the study.

    • Deception is an alteration of informed consent; provide justification for how the use of deception meets the criteria for alteration of informed consent. See the RCS Waiver or Alteration of Informed Consent Guidance for the criteria that must be met and information that must be included in this section to request consideration of a waiver or alteration of informed consent by the IRB.

    • Describe the debriefing process and provide a script.

  • Protected Health Information:

  • Clinical Trials:

    • For a study that meets the definition of a clinical trial, one IRB approved informed consent form used to enroll subjects must be posted on a publicly available Federal Web site that has a repository for such informed consent forms. More information about the posting requirement and definitions can be found on our website here.

    • Describe in this section of the Research Plan where the consent form will be posted and acknowledge the required timeframe for posting (e.g., clinicaltrials.gov or the regulations.gov document portal).  NOTE: the investigator will be responsible for demonstrating at the time of continuing review, progress reporting, and/or closure of the study that this requirement has been satisfied.