Informed Consent Writing Tip Sheet

Informed consent is one of the central protections the regulations provide to research participants. This tip sheet outlines the regulatory requirements for research informed consent forms (ICFs).  The regulatory requirements for informed consent will vary depending upon which regulations apply to the conduct of a particular study.

Note: Individual institutional review boards (IRBs) may have their own specific policies regarding how ICFs should be formatted, how to address certain regulatory criteria, and other considerations. Always check with your IRB of record to confirm you understand its requirements.

To print this checklist, right-click and select ‘Print’. You can then use this checklist offline as a PDF if desired.

Informed consent’s function is to provide the potential participant with sufficient information regarding a research study’s:

• Purpose
• Potential risks
• Potential benefits

Part C of the Belmont Report contains three requirements for the informed consent process:

• Information
  • Provide information to help potential participants understand the study’s risks and benefits to help them decide whether they wish to participate in the research
• Comprehension
  • Provide information in a way that is meaningful to potential participants. Investigators should be able to confirm the potential participant truly comprehends the presented information
• Voluntariness
  • Avoid coercion (i.e., threat of harm) and undue influence (excessive, improper, and/or inappropriate reward) when informing potential participants about the study

Language and Reading Level

Ensure the ICF is written in a way that will make sense to the study’s specific participant population. U.S. regulatory agencies recommend written ICFs contain easy-to-read and understandable information so a lay person can make an informed decision about participating in a study. Many aim for a sixth-grade or eighth-grade reading level; before proceeding with a specific approach, make sure it is appropriate for your study. Flesh-Kincaid readability tools can help with grade level assessments.

If you are targeting a community that includes a sizable number of non-English speakers: Have translated ICFs available for when English is not a potential participant’s first language. Whenever possible, have translated ICFs available ahead of time so you don’t have to wait to have the consent conversation with a potential participant.

If your study will enroll children younger than the legal age of majority in in your area: Consider whether assent documents are appropriate (in addition to the standard ICF) and/or whether it may be suitable to add an assent signature line to the standard ICF.

Basic Elements of Informed Consent

The regulations are very specific regarding what to include in the ICF and what to exclude. The basic elements of informed consent are mandated by the Common Rule (i.e., Department of Health and Human Services [DHHS] Office of Human Research Protections [OHRP] regulations) and Food and Drug Administration (FDA) regulations at 45 CFR 46.116 and 21 CFR 50.25 respectively. To remain compliant with the International Council of Harmonization’s good clinical practice guidelines (ICH-GCP), also consider the ICH basic elements.

Remember that it is only necessary to include the regulatory elements applicable for a given study. For example, an FDA regulated study would not need to comply with the Common Rule unless there is also DHHS funding involved.

FDA and Common Rule Elements of Informed Consent

• For research regulated by the Common Rule: ICF should begin with a concise and focused presentation of the key information most likely to assist a prospective participant in understanding the reasons why one might/might not want to participate in the research
• A statement that the study involves research
• An explanation of the purposes of the research
• The expected duration of the individual’s participation
• A description of the procedures to be followed
• Identification of any experimental procedures
• A description of any reasonably foreseeable participant risks or discomforts (cross-reference ICF language with all risks in the protocol document)
• A description of any benefits to the participant (or to others) which may reasonably be expected from the research
• Disclosure of appropriate alternative procedures or courses of treatment (if any) that might be advantageous to the participant
• A statement describing the extent (if any) to which confidentiality will be maintained for records identifying the participant
• For research involving more than minimal risk: An explanation as to whether any compensation and/or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained
• Whom to contact for answers to pertinent questions about the research and research participants’ rights
• Whom to contact in the event of a research-related injury to the participant
• A statement that participation is voluntary
• A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled
• A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled

ICH-GCP Elements of Informed Consent

• The trial involves research
• The trial’s purpose
• The trial treatment(s) and the probability for random assignment to each treatment
• The trial procedures to be followed, including all invasive procedures
• The participant’s responsibilities
• The experimental aspects of the trial
• The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant
• The reasonably expected benefits (when there is no intended clinical benefit to the participant, the participant should be made aware of this)
• The alternative procedure(s) or course(s) of treatment that may be available to the participant and their important potential benefits and risks
• The compensation and/or treatment available to the participant in the event of trial-related injury
• The anticipated prorated payment, if any, to the participant for participating in the trial
• The anticipated expenses, if any, to the participant for participating in the trial
• The individual’s participation in the trial is voluntary, and the participant may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the participant is otherwise entitled
• The monitor(s), the auditor(s), the IRB/institutional ethics committee (IEC), and the regulatory authority(ies) will be granted direct access to the participant’s original medical records for verification of clinical trial procedures and/or data, without violating the participant’s confidentiality, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the participant or the participant’s legally acceptable representative is authorizing such access
• Identifying participant records will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available; if the results of the trial are published, the participant’s identity will remain confidential
• The participant or the participant’s legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant’s willingness to continue participation in the trialThe person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury
• The foreseeable circumstances and/or reasons under which the individual’s participation in the trial may be terminated
• The expected duration of the participant’s participation in the trial
• The approximate number of participants involved in the trial

Additional Elements of Informed Consent

Note: These elements are instance-specific, and their applicability is at the IRB’s discretion. To help streamline the review process, sponsors and sites should communicate with the IRB regarding the circumstances informing the addition or omission of these elements.

FDA/Common Rule Additional Elements of Informed Consent

• A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable
• Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent
• Any additional costs to the participant that may result from research participation
• The consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant
• A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant
• The approximate number of participants involved in the study
• A statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will/will not share in this commercial profit
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to participants, and if so, under what conditions
• For research involving biospecimens: Whether the research will (if known) or might include whole genome sequencing

For more information on informed consent, review: 21 CFR 50.20, 21 CFR 50.25, 45 CFR 46.116, 45 CFR 46.117, ICH Good Clinical Practice (GCP), FDA Information Sheet: Informed Consent, OHRP Informed Consent FAQs, Belmont Report, PlainLanguage.gov, NCCN Informed Consent Language Database

Back to Resources