Informed Consent and Providing Information to Participants
How does this apply to my study or project?
General requirements for informed consent are described in 45 CFR 46.116. Informed consent is “shorthand for informed, voluntary and capacitated consent” (Bankert et al., 2022, p. 247). The Belmont Report identifies three basic ethical principles that guide human subjects research: respect for persons, beneficence and justice. Informed consent is one of three requirements for human subjects research described by the Belmont Report that guides IRBs (assessment of risks and benefits and fair subject selection are the other two requirements). Often when we think of informed consent, a form that participants must sign comes to mind. However, thinking about informed consent more creatively may assist researchers in making choices that align better with their studies. This guidance document will cover:
- the concept of informed consent,
- what is included in the informed consent process,
- when informed consent is needed,
- documenting informed consent and
- waivers or alterations of consent or documentation of consent.
Concept of Informed Consent
Thinking about informed consent beyond a paper form that must be signed may help us better understand what we are trying to achieve with informed consent. It may be helpful to consider informed consent as a process to share information and determine how potential participants comprehend what a research study involves. Receiving information allows potential participants to decide if they understand the potential risks and benefits and voluntarily opt in. In some cases, informed consent creates a record, especially if a participant’s decision is captured on a form. Forms that capture the decision can be written or electronic. Usually, one of the easiest ways to record a potential participant’s decision to participate is by capturing a signature.
What is included in informed consent?
Informed consent should “[f]ully explain the study, inform participants of their rights, answer your participant’s questions and take care to document consent” (Poth, 2021, p. 40). The process of informed consent should communicate the following rights to potential participants:
- Voluntary participation – Participants are not obligated to participate or answer questions they do not want to answer. Withdraw without penalty – Participants can withdraw at any time and need to know how to do this.
- Access findings – If participants will have access to the findings, they need instructions on how to do this.
- Clarify their understanding – If participants have further questions, they need to know whom to contact for more information.
(List adapted from Poth, 2021)
Unless a waiver or alteration is approved (see section below), informed consent must include the basic elements outlined in 45 CFR 46.116(b). The elements need not be presented in the order outlined by the Code of Federal Regulations (CFR), but each must be addressed.
When is informed consent needed?
Research studies classified in the full review or expedited categories [nonexempt research] must include a process to capture informed consent. Other review categories (exempt or evidence-based practice/quality improvement studies) do not require consent documentation, but the ACIRB requires that participants receive information about the study.
Waiver or Alteration of Consent
The ACIRB can alter or waive the general requirements for consent when the following apply:
- The research involves no more than minimal risk to the subjects;
- The research could not practicably be carried out without the requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
[45 CFR 46.116(f)]
This chart may be helpful in deciding if waiving or altering informed consent is appropriate.
Documentation of Informed Consent
As previously discussed, all potential research subjects must be informed about the research and provide voluntary consent to participate. Documentation of informed consent is outlined in 45 CFR 46.117. The CFR states, “…informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A written copy shall be given to the person signing the informed consent form” [§46.117(a)].
Even though the CFR says a written or electronic form must be signed and provided to the participant, if we continue to consider informed consent as a process, there are creative options to meet this requirement. The following approaches may be considered to document consent (Poth, 2021, p. 46-47):
- Participants can sign their name in writing or type their name on a consent form.
- Participants can state their name verbally. This can be especially helpful when writing is a challenge for participants, or they are not culturally accustomed to signing their names. A verbal statement of consent can be audio or video recorded.
- If data is being collected anonymously or written or verbal communication is a challenge for potential participants, they can be as to complete an overt action that is appropriately recorded as implied consent. A common example of this is asking a potential participant to click a link to start a survey.
- If the research has no other record of participant’s identities and where the main risk for potential harm would be their identity, then you may document informed consent by having a second eyewitness. This would require a waiver of documentation (see next section).
- If the research involves participants who are considered vulnerable, then a designate may provide consent verbally or in writing on their behalf.
Waiver or Alteration of Documentation of Consent
The ACIRB can waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if any of the following apply:
- That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
- That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
- If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
[45 CFR 46.117(c)]
In cases in which the documentation requirement is waived, the ACIRB may require the researcher to provide participants or the legally authorized representatives with a written statement regarding the research.
This chart may be helpful in deciding of a waiver of documentation is appropriate.
How can I get help?
Bankert, E. A., Gordon, B. G., Hurley, E. A., & Shriver, S. P. (2022). Institutional review board: Management and function (3rd ed.). PRIM&R.
Poth, C. N. (2021). Little quick fix: Research ethics. Sage.
Protection of Human Subjects, 46 C.F.R. § 116 (2019).
Protection of Human Subjects, 46 C.F.R. § 117 (2019).