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NIH Investigator Manual for Human Subjects Research

Chapter 4 - Writing Your Consent Document

Overview

Key points

  • When you will be submitting your proposed consent form to the NIH IRB, use the related guidance, instructions, and templates found on the OHSRP website to ensure you are including all of the required information.

  • You must include a key information section at the beginning of the consent form.

  • The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate.

  • Additional information can be found in NIH Policy 3014-301, Informed Consent.
What does informed consent mean and what is its purpose?
  • Informed consent is the agreement by a subject (or their Legally Authorized Representative) to participate, or continue participation, in human subjects research.

  • It includes the ongoing process of information exchange that takes place between the subject and the investigator throughout research participation.

  • The purpose of informed consent is to provide the subject information about the research (e.g., the purpose, a description of the research interventions, risks and benefits, if any) in a manner that facilitates the subject's comprehension, so that the subject can make an informed and voluntary decision whether to participate or continue participation in the research, or to withdraw from the research.
What ethical concerns should I think about when writing the informed consent document?
  • The ethical imperative for informed consent is based on Belmont principle of respect for persons: "Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them."

  • The information presented in the informed consent document and during the consent process helps the individual determine if the research is consistent with their own goals and values.
What information am I required to have in my consent form?
  • Using the consent form templates that are available on the OHSRP website, will ensure that you have the required elements of consent included in your consent form.

  • Information that needs to be included in the consent form as required by federal regulations includes the following:
    • MUST include:
      • That the activity is being conducted for research purposes
      • The purpose and duration of the research
      • Study procedures and identification of any procedures that are experimental
      • Any anticipated risks or benefits
      • Any appropriate alternatives procedures or courses of treatment that might be advantageous to the subject
      • How confidentiality of the subject's identifiable records will be maintained
      • Compensation (including when none is offered)
      • Name and contact information for one of the investigators who should be contacted for questions or research-related injury
      • That participation is voluntary
      • If identifiable private information or specimens will be collected, one of these statements is needed:
        • Identifiers might be removed from the identifiable information or biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility. 
          OR
        • Subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

    • IF RELEVANT to the research, the investigator must also address the following topics in the consent information:
      • Statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable
      • Circumstances under which a subject's participation may be terminated by the investigator
      • Costs, if any, that a subject may incur as a result of participation (these are unlikely at the NIH)
      • Any consequences of a subject's decision to withdraw from the research, and procedures for orderly termination
      • Statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject
      • Approximate number of subjects involved in the study and how many people will participate
      • Statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
      • Statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
      • Whether research involving biospecimens will or might include whole genome sequencing
      • Where data belonging to participants will be stored. [Note: At the Clinical Center (CC), if participants' data is being entered into Clinical Records Information System (CRIS), the data will also be available in Biomedical Translation Research Informatics (BTRIS), and you must state this in your consent.]
In addition to the information in the consent form that is required by regulation, what other information might need to be included?
  • Refer to the relevant consent templates on the OHSRP website that list additional information that you may need to include in your consent form. This may include, but is not limited to:
    • NIH Genomic Data Sharing Policy: If your research protocol involves generating large-scale genomic data that must be deposited in a repository such as the database of Genotypes and Phenotypes (dbGaP), or a similar repository, clearly state this in the consent along with the following:
      • If the genomic data will be available in a database through controlled access, this must be described in the consent.
      • If the genomic data will be available in a database as open access, this must be described in the consent.

    • As applicable, radiation risk language, or other consent language required by other ancillary review committees (e.g., Institutional Biosafety Committee)

    • NIH required language
What information must be included in the informed consent document for FDA-regulated research, as appropriate?
  • Comply with the requirements described in 21 CFR 50 Subpart B and, when the research involves children, also comply with requirements described in 21 CFR 50 Subpart D.

  • Include a description of procedures that are experimental.

  • Include a statement to identify the test article as "investigational" or "not approved by the FDA," if the test article under study is not FDA-approved for the proposed use. If the test article is approved, include statement as to whether it is being used according to its labeled indications.

  • Make no claims which state or imply, directly or indirectly, that the test article is safe or effective for the purpose(s) under investigation or that the product is in any way equivalent or superior to another product.

  • Comply with section E.2.g. in Policy 301, Informed Consent regarding inclusion of information about ClinicalTrials.gov, if appropriate.

  • Include information about data retention in the event of a subject's withdrawal from the research. Explain that the subject's data collected to the point of withdrawal remains part of the study database and will not be removed.  Further, the investigator may not continue to access the subject's medical record or other confidential records for additional research purposes unless the subject has provided consent for this purpose.

  • If the subject is withdrawn from the primary study intervention but will remain on the study in a more limited manner (e.g., for safety or long-term follow-up), and the original consent does not describe this limited participation, the investigator must obtain consent for this limited participation. Further, this consent should distinguish clinical outcomes from research procedures and must be approved by the IRB. Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
  • If the subject declines to participate in further follow-up or to provide clinical outcome information, the researcher may continue to use the subject's data in the research database collected prior to the subject's withdrawal consistent with the informed consent document.

  • Any use of electronic signature must be compliant with 21 CFR part 11.
What is the key information section of the consent form, and what should be included in that section?
  • A key information section is required for protocols subject to the 2018 Common Rule. This requirement was added because it was generally believed that consent forms had become too long, complex and legalistic. This requirement provides a chance to reconsider how to discuss research with potential subjects so that they can decide if the study is compatible with their own goals and values.

  • The key information section can be used to provide the most important information that subjects need to decide whether or not to participate and should be based on the needs and perspective of the specific group of subjects who will be considering study enrollment. In writing the consent document, consider if there any special or unique features that might determine what is important to that group of people.

  • The informed consent form must begin with a concise and focused presentation of key information to assist prospective subjects in understanding reasons to enroll in a protocol or not.

  • These items would generally be considered key information (but are not explicitly required as such by the regulations):
    • Consent is being sought for research and participation is voluntary.
    • Purposes of the research, the expected duration of the prospective subject's participation, and the procedures to be followed in the research.
    • Reasonably foreseeable risks or discomforts to the prospective subject.
    • Benefits to the prospective subject or to others that may reasonably be expected from the research.
    • Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject.

  • Other items that might be key information for subjects in certain studies might include:
    • Design features such as randomization, placebo, discontinuation of other treatments.
    • How trial intervention is or is not similar to clinical care.
    • Significant costs of participation.
    • Compensation for research-related injury.
    • Impact on future clinical care.
    • Impact on others (e.g., caregivers, family members, partners).
    • Post-participation access to the study drug or intervention.

  • While risk information is likely to be key in many protocols, there are situations where it may not be. For example, in a minimal risk study, it may not be necessary to list any risks.
What is the reasonable person standard and how does it affect writing the consent form?
  • The 2018 Common Rule requires that the prospective subject or the legally authorized representative be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate.

  • The reasonable person standard is interpreted to mean the relevant information that a hypothetical ordinary person with average knowledge, skill and judgement would need to decide on participation.

  • The reasonable person standard is distinct from the professional standard which holds that professional practices determine adequate disclosure.

  • The reasonable person standard shifts the decision about what information should be provided to the potential subject away from what the physician believes should be disclosed, based on professional standard, to information that a reasonable, ordinary person would want in order to decide whether to participate in the research or not.

  • Investigators with knowledge of their subject population should include information that they know will likely be important to this group of individuals in deciding whether they want to participate in the research or not.

  • The reasonable person standard means you should also include reasons why the subject might not want to participate.
In what format do I submit my proposed consent in the electronic IRB system and what grade reading level should I target?
What should I know about the consent process if I will be enrolling children in my study?
  • Unless waived by the IRB, agreement for the child's participation must be obtained from the child's parent or guardian. The regulations use the term "permission" rather than consent when the parent/guardian provides this agreement.

  • Unless waived by the IRB, assent of the child who is the potential subject is also required. Assent is the affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

  • The IRB may determine that the assent of the children is not a necessary condition for proceeding with the research if either:
    • The capability of some or all of the children is so limited that they cannot reasonably be consulted.
      or
    • The intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research.
Where can I find information about creating an assent form for use with minors who I hope to enroll on my study?
  • Information about assent and a template for the assent form can be found on the Assent Template and Assent Information page of the OHSRP website.

  • The assent form does not need to contain all the elements required in a consent document, but use of the NIH assent template will assist you in the important information that should be communicated in the assent document.

  • The investigator should take into account the nature of the proposed research activity and the ages, maturity, and psychological state of the children involved when considering the proposed assent procedure as well as the form and content of the information conveyed to the prospective subjects.


Chapter 5 - Submitting Your Initial Review