While all consent processes are specific to a study’s procedures, participants, and risks, there are basic elements that must be considered and present in each. Including the relevant elements in your consent forms is critical to making your study compliant with the ethical standards of the TC IRB. If you have any questions on how to implement a particular element, please contact the TC IRB office or attend office hours with one of our staff members to have your study evaluated.

What are the Basic Elements of an Informed Consent Form?

Researchers must provide specific information about the study to prospective study subjects in a way that is understandable to them.

“The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a). Also, see OHRP Informed Consent Tips. The regulations require that the following information must be conveyed to each subject:

  • a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  • a description of any reasonably foreseeable risks or discomforts to the subject;
  • a description of any benefits to the subject or to others which may reasonably be expected from the research;
  • a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  • a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  • for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  • an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
  • a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.”

Depending on the study delivery mode (e.g., online or in-person), researchers should provide answers to questions and ensure that prospective study subjects understand the research activities and their role in it. Subjects should have sufficient time to consider their decisions with clear communication that they may stop the study at any time withdraw, decline to answer specific questions, or complete specific tasks during the research 

Overall, researchers should include all pertinent information in consent forms in order to ensure every participant is given the chance to evaluate the risks and benefits associated with participation before any data is collected on them. 

Keep in mind the philosophical concept of contractarianism when determining your study design and drafting your consent forms. Contractarianism is the idea that people will weigh the pros and cons and choose the course of action that is most advantageous even at some cost. Make sure every participant is given the chance to properly evaluate those pros and cons to make the best decision for themselves. It is important to acknowledge that though you may list anticipated risks and benefits, individuals may vary in what they consider beneficial or risky to them and they may see risks where others may not. This is why giving all the information you possibly can about the study is crucial for research with human subjects to allow the participant to make an informed decision on consent. 

Furthermore, an IRB may require that additional information beyond the basic and additional elements be given to subjects during the informed consent process when in the IRB reviewer’s judgment the additional information would meaningfully add to the protection of the rights and welfare of the subjects 45 CFR 46.109(b).

Additional Considerations for Informed Consent:

Legally Authorized Representative (LAR) denotes an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, LAR indicates an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research (Protection of Human Subjects 2018). An LAR’s involvement in the consent processes for a potential participant may be necessary if it is determined that the subject does not have the capacity to consent on their own. Some examples of this may be with participants who are under the age of 18 or have other indicators of a diminished capacity to consent. However, there may be other participants who still retain the legal right to consent but may not have the cognitive capability to consent. For example, an elderly person may retain the right to consent but may need assistance from a caretaker to make the decision to participate. During the consent process, you may need to assess each individual’s needs on a case-by-case basis, part of which may be assessing the participant’s capacity to consent or even to participate. Documenting this process through a consent form signed by the participant or their legally authorized representative (LAR) is crucial to ensure there's a formal record that consent was appropriately obtained.

Exculpatory Language: Remember that no consent form can waive participant rights nor can they absolve the researcher or any other involved party from responsibility and liability. The language that violates this is called Exculpatory Language.

No informed consent, whether oral or written, may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence (45 CFR 46.116).

Examples of Exculpatory Language (consent forms cannot include exculpatory language):

  • “By agreeing to this use, you should understand that you will give up all claims to personal benefit from commercial or other use of these substances.
  • I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and interest to said items.
  • By consenting to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research.
  • I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.”

It is up to the IRB to determine in a particular instance whether some or all of the above additional elements must be included as part of the informed consent process for a particular study. The IRB will make this determination based on the nature of the research and its knowledge of the local research context. If the IRB determines that additional elements are appropriate to the research study, this additional information should be considered just as essential as the basic elements of informed consent described in the HHS regulations at 45 CFR 46.116(a).

Are There Any Other Common Elements of Informed Consent Documents?

Depending on the nature and context of the research study, there may be additional information besides what is typically required for a potential participant to be aware of while deliberating consent. Some examples may include but are not limited to:

  • A 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;
  • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent; 
  • Any additional costs to the subject that may result from participation in the research; 
  • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  • A statement that any significant new findings in the field during the study that may affect the participant’s willingness to participate will be provided to them by the research team
  • The approximate number of participants in the study
  • That biospecimens (even de-identified) will be used for commercial profit and if they will share in this profit.
  • For research with biospecimens, a statement confirming whether research will include whole genome sequencing.
  • A statement confirming whether clinically relevant results will be shared with participants.

In addition to common consent form elements, studies may also be subject to other federal requirements if they fall under the oversight of organizations such as the U.S. Food and Drug Administration (FDA). The FDA has its own set of regulations that it enforces on studies that require its approval and oversight. If your research is subject to such requirements, your consent form may also need to include:

  • The purpose should say if the study will test/collect data on an FDA-regulated product. Include if results will be shared with the FDA.
  • A description reference to FDA approval status or specific use in the study (ex: The FDA has approved this treatment/procedure for some other uses before but we are investigating new uses).
  • A statement that the FDA may look at or copy portions of the records.
  • Any applicable FDA-regulated clinical trial statement regarding registration and results posting on Clinicaltrials.gov.
  • A statement (if not covered by the Health Insurance Portability and Accountability Act - HIPAA) that if the subject withdraws early, the data collected up to that point will still be included and used in the study.
  • Language to inform participants of protections and the limits to protections.

For more information on FDA requirements for qualifying research studies, please visit the FDA website and review their guide on informed consent processes.

Additional Resources:

 

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Published Thursday, May 1, 2025