325. Informed Consent Requirements
Updated July 1, 2019
The consent process involves the communication that takes place when a researcher provides information about a research study to a prospective participant and the participant indicates her/his agreement to take part in the study. Researchers and research staff should understand the concept
of respect for persons and the obligation to obtain the consent of participants or their legally authorized representatives. Researchers and research staff should understand that consent is a continual process, and conduct the consent process in a way that meets the criteria for legally effective consent. Researchers and research staff should understand the difference between the consent process, itself, and documentation of the consent process. Researchers and research staff should know how to document the consent of a participant or a legally authorized representative.
Information necessary for informed consent may derive from recruitment materials, verbal instructions, question/answer sessions, and assessments of participant understanding of the research.
Both regulatory requirements and ethical considerations apply to the consent process.
NOTE: DHHS informed consent requirements do not limit the ability of a physician to provide treatment or emergency medical care. See IRB policy for FDA exceptions from consent requirements.
Basic Considerations for Informed Consent
- Research involving multiple populations may require multiple consent processes and materials.
- Participant maturity, literacy skills, and susceptibility to undue influence warrant consideration in the design of consent processes and materials.
- The study team member conducting the consent process must have sufficient knowledge to answer prospective participants' questions about the research.
- The PI remains ultimately responsible ensuring participants are fully informed about the research, even when the task of obtaining informed consent is delegated to another member of the research team.
- Minimize the possibility of coercion or undue influence.
- Communicate with the participant or the legally authorized representative in language understandable to the participant or the legally authorized representative.
DHHS General Requirements for Informed Consent
- Researchers must obtain the legally effective consent of each research participant (or a participant's legally authorized representative [LAR]) (unless the IRB waives DHHS requirements; or the research is exempt, including IRB Flex-exempt categories 7 and 8, and the IRB approves an alternative consent process).
- The consent process must provide sufficient information, time, and opportunity for discussion for the participant or LAR to make an informed decision about participation, as commensurate with risk and study procedures.
- The information provided to participants or LAR must be such that a reasonable person would want to have in order to make an informed decision about whether to participate and allow for the opportunity to discuss that information.
- The informed consent process must begin with a brief and focused presentation of this key information organized in a manner to enhance comprehension. For minimal risk and greater than minimal risk social behavioral and basic biomedical research, the information sheet and informed consent templates meet this requirement.
- For greater than minimal risk biomedical FDA-regulated clinical trials, materials such as a summary brochure, handout, or executive summary document or introduction on the consent form is necessary.
- The consent must begin with "a concise and focused presentation" of key information. Key information should include the fact that the consent is sought for research, participation is voluntary, the research purpose, the research risks and benefits, and the alternatives available to participation in the research.
- The consent process must minimize the possibility of undue influence or coercion.
- The consent discussion must be in language that is understandable to the participant or the LAR.
- The consent discussion must be free of exculpatory language (see Policy Manual Definitions).
- The participant or LAR must be informed of all required/applicable disclosures (e.g., researcher conflicts of interest, mandatory reporting).
- Informed consent as a whole must present information in sufficient detail and organized in such a way that does not "merely provide lists of isolated facts, but rather facilitates the prospective subject's ... understanding of the reasons why one might or might not want to participate."
Additional DHHS Regulations for Informed Consent
In addition to the general requirements, DHHS specifies
- nine basic and nine additional elements of informed consent that must be provided to all research participants (at 45CFR46.116(a) and (b)); and
- requirements for documentation of consent (at §46.117(a) and (b)).
However, at §46.116(c) and (d) DHHS regulations allow the IRB to waive or alter the requirements for researchers to provide the basic/additional elements for informed consent; at §46.117(c), DHHS specifies when the IRB may waive for the researchers to obtain signed consent from some or all participants. (For more information about DHHS elements for consent and documentation of informed consent see IRB policy for consent for greater than minimal risk research. For information about IRB-approved waivers for consent, see IRB policy for minimal risk, federally funded research.)
Application of Regulatory Flexibility for Informed Consent
The University IRB utilizes the flexibility in the DHHS regulations and the IRB Flexibility Policy (IRB-Flex) to optimize consent processes to ensure consent processes and materials are compliant yet commensurate with the research as follows:
1. For research conducted by University or affiliate PIs, when do the DHHS regulations for informed consent or documentation of consent NOT apply?
- When research is eligible for an exempt determination and researchers use an acceptable, alternative means to inform participants (when applicable).
- Under the University IRB Flexibility Policy, when minimal risk research is neither conducted nor supported by a federal agency, and does not involve prisoners or incomplete disclosure or deception.
NOTE: For these two types of research, investigators and the IRB to use equivalent protections for informed consent by applying the ethical considerations in the Belmont Report. (See IRB policy for informed consent for exempt and non-federal minimal risk research).
- When does the University IRB require compliance with DHHS requirements for basic and additional elements for informed consent (see §46.116) and for documentation of informed consent (see §46.117)?
- When research poses greater than minimal risk.
- When minimal risk research is conducted or supported by a federal agency.
- When minimal risk research involves prisoners or incomplete disclosure or deception, regardless of funding.
- What other regulations does the University IRB consider regarding consent for minimal risk research that is conducted or supported by a federal agency, or involves prisoners or incomplete disclosure or deception?
- DHHS criteria for waivers/alterations of the consent process (see §46.116(c) and (d))
- DHHS requirements for a waiver of the requirement to obtained signed consent (see §46.117(c) and IRB policy for Informed Consent: Federally-funded Minimal Risk Research).
- Under what other conditions does IRB-Flex affect the IRB's application of DHHS requirements for informed consent?
Under IRB-Flex, the IRB is not required to approve an alteration of informed consent when one or more select basic elements of disclosure are omitted from consent materials AND the IRB determines the elements do not apply to a given project.
- Consent materials need not list alternative procedures or treatments when no appropriated alternatives exist, from item §46.116(4).
- Consent materials need not disclose foreseeable risks or discomforts to participants when none are evident or when the risks/discomforts are minimal, from item §46.116(2).
- Consent materials need not include research-related injury statements when injuries are not reasonably anticipated or the research risks are minimal, from items §46.116(6) and (7).
- Consent materials need not specify that refusal to participate and discontinuation of participation will not involve penalty or loss of benefits when penalties or loss of benefits are not applicable to the research environment, from item §46.116(8).
- Does the University IRB allow use of a short form written consent document (as referenced in the regulations under §46.117(b)(2))?
- Yes, a short form written consent document may be used when a prospective participant or legally authorized representative cannot read the IRB-approved consent form. (For requirements, see the online HRPP Policy Manual for short form written consent).
- DHHS regulations regarding use of a short form written consent document do not apply to exempt research or (under IRB-Flex) minimal risk research that is neither conducted nor supported by a federal agency unless the research involves incomplete disclosure/deception or prisoners.
Considerations for Ongoing Consent
Situations sometimes emerge in ongoing research that may require researchers to confirm or re-obtain consent. For example:
1. When studies are of long duration (e.g., participant involvement lasts two or more years), or involve long-term follow up or multiple contacts/interactions, researchers are advised to periodically invite participants' questions and confirm continued involvement in the research.
2. When new information* emerges that may affect participants' willingness to continue their involvement in the research, researchers must inform the IRB, obtain approval for the process and materials for informing enrolled participants of the new information, and re-obtain consent from enrolled participants. Following IRB approval, consent may be re-obtained by using an amended consent document and or an addendum to the original consent document.
*New information may arise from interim research findings, publications related to the research, or communication/reports from the study sponsor.
3. A project amendment is requested that requires informing enrolled participants of changes to the research. The amendment must include the process and materials for informing enrolled participants of the amendments, and re-obtaining consent from enrolled participants. Following IRB approval, consent may be re-obtained by using an amended consent document and or an addendum to the original consent document.
Obtaining Consent in Languages Other than English
DHHS requires that informed is obtained in a language understandable to the participant. For research involving individuals who are not fluent in English, individuals who speak the participant's language must available for the consent discussion and IRB-approved content for consent materials must be translated into the participant's language (see IRB policy for research involving persons who do not speak English).
IRB Review of Consent Processes and Materials
To allow the RI (for exemptions) or the IRB to adequately assess for the requirements for informed consent, researcher forms for exempt and IRB review, and consent waivers; templates (i.e., for consent forms and information scripts/sheets); and the relevant review worksheets address the following:
- the nature and circumstances of the consent process (including who will conduct the consent interview);
- the timing of obtaining consent (i.e., time from when a prospective participant is informed to when she/he agrees to participate);
- the language in which the consent interview will be conducted and the language that is understandable to prospective participant or LAR;
- language in which consent documents will be provided to participants;
- compliance with ethical considerations and (as applicable to the research) DHHS requirements for the basic and additional elements of informed consent; and
- as applicable to the research, DHHS regulations related to waivers/alterations of the consent procedure, and waivers of the requirement for participants to sign a consent document.