325. Informed Consent Requirements

Updated July 1, 2021

Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. This requirement is founded on the principle of respect for persons. Potential participants must be provided with information about the research project that is understandable and that permits them to make an informed and voluntary decision about whether to participate. The amount of information and the manner of presentation will vary depending on the complexity and risk involved in the research study. Informed consent is an ongoing educational interaction between the investigator and the research participant that continues throughout the study.

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. Informed consent must be legally effective. Informed consent must be sought only under conditions that a) provide the prospective participant sufficient opportunity to discuss and consider whether to participate and b) minimize the possibility of coercion or undue influence. Informed consent must be in language understandable to the participant and at a level understandable. No complex scientific or technical language should be used without an explanation in lay or common terms. The consent document should be written in language that is at or below an eighth-grade level. Researchers should inform prospective participants of required disclosures, (e.g., mandatory reporting pursuant to state law).

NOTE: Department of Health and Human Services (DHHS) informed consent requirements do not limit the ability of a physician to provide treatment or emergency medical care. See IRB policy for Food and Drug Administration (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. In general, the key information section should not be longer than two pages.
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 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 participant's...understanding of the reasons why one might or might not want to participate."
If Protected Health Information (PHI) is being collected, HIPAA requires an Authorization for Use, unless specifically waived by the IRB in its role as the privacy board.

DHHS Additional Requirements 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(b) and (c)); and
requirements for documentation of consent (at §46.117(a) and (b)).

However, at §46.116(e) and (f) 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.)

FDA Requirements for Informed Consent

The IRB determines that the required and appropriate additional elements of disclosure are included in the consent process.
The consent form includes a statement noting the possibility that the FDA may inspect the records that will be provided to each participant.
If applicable, the consent form includes a statement that a description of the clinical trial will be available on the Clinical Trials database as required by U.S. law. The website will not include information that can identify the participant. At most, the website will include a summary of the results. The participant can reach the website at any time.
When a participant withdraws from a study, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed. The consent document cannot give the participant the option of having data removed.
A researcher may ask a participant who is withdrawing whether the participant wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. The researcher must obtain the participant’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document). The IRB must approve the consent document.
If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's consent. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status.
Short-form Consent may be allowed.

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:

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(e) and (f))
- DHHS requirements for a waiver of the requirement to obtained signed consent (see §46.117(c) and IRB policy for informed consent in the case of 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:

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.
When new information (e.g., from interim research findings, publications related to the research, or communication/reports from the study sponsor) 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.
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 be 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 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/they 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.

The IRB reviews the above information and verifies that:

All required elements of informed consent are addressed as applicable to the research.
The consent process provides sufficient opportunity for the participant or the participant’s legally authorized representative to consider whether to participate.
The possibility of coercion or undue influence is minimized.
The consent form is free of exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant’s legal rights.
The consent form includes a description of how research participants can contact the research staff to ask questions about the research or express concerns or complaints about the research.

The IRB requests revisions as necessary to ensure that proposed activities and documents are clear, and the consent process meets all applicable regulatory, policy, and ethical requirements.

Posting of Clinical Trial Consent forms for clinical trials conducted or supported by a federal agency

One IRB-approved consent form used to enroll participants must be posted by the awardee (Principal Investigator) or the federal department or sponsor conducting the trial on a publicly available Federal Web site that has been established as a repository for such informed consent forms. If the Federal department or sponsor supporting or conducting the clinical trial determines certain information should not be made publicly available on a Federal Web site (e.g., confidential commercial information), the Federal department or sponsor may permit or require redactions to the information posted. The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any participants, as required by the protocol.

Use of Electronic Informed Consent (eIC)

Electronic informed consent (eIC) may be used to either supplement or replace paper-based informed consent processes. The consent process may take place at the study site when both the investigator and participant are at the same location, or it may take place remotely (e.g., at the participant’s home or another convenient venue) where the participant reviews the consent document in the absence of the investigator. The eIC materials may be provided for both on-site and remote access. Whether the eIC is obtained from the participant on-site or remotely, the eIC process must provide sufficient opportunity for the participant to consider whether to participate (see 45 CFR 46.116 and 21 CFR 50.20).

The investigator should have methods in place to ensure that the eIC process allows participants the opportunity to consider whether or not to participate and to ask questions about the study before signing consent as well as at any time during the subject’s involvement in the research. This may be accomplished by in-person discussions with study personnel or through a combination of electronic messaging, telephone calls, video conferencing, or a live chat with a remotely located investigator or study personnel. When live chat or video conferencing is used during the eIC process, investigators and study personnel should remind participants to conduct the eIC discussion in a private location to help ensure privacy and confidentiality. The eIC may use interactive electronic-based technology, which may include diagrams, images, graphics, videos, and narration.

The eIC should be appropriate for the intended audience, taking into consideration the participant’s age, language, and comprehension level. The procedure for eIC may include an electronic method to capture the signature of the participant. The Investigator must verify the identity of an individual before it establishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature or any element of such electronic signature. The electronic system must also capture and record the date that the participant provides consent. The IRB recommends that a copy of the signed informed consent form that includes the date when the eIC was signed be provided to the participant.

Best practices would request participants to take a picture or scan the entirety of the signature page, signed by the participant after the consent process took place. Using electronic signature (e-signature) software allows for better documentation of the process without the need to depend on the participant sending a good copy of the last page of the consent document. The study team should not send the consent form to participants via email unless the email is encrypted. A link to an online consent form may be sent via email. Alternatively, for in-person consent, the form may be presented to the participant via a touch-screen-enabled device.

For FDA regulated studies, investigators must use a platform that is also 21 CFR Part 11 compliant. The REDCap software is not Part 11 compliant. Researchers may use the DocuSign software if using a Part 11 compliant account.

Elements of Broad Consent

The IRB may allow broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or for non-research purposes). The study must undergo limited IRB review and meet the requirements for exempt Category 7 or Category 8. Required elements of broad consent:

A description of any reasonable foreseeable risks or discomforts;
A description of any benefits to the participant or others that may reasonable be expected from the research;
A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled;
If appropriate, a statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit;
If appropriate, for research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen);
A general description of the types of research with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect broad consent would permit the types of research conducted;
A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which could be indefinite);
Unless the participant or their LAR will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
Unless it is known that clinically relevant research results, including individual results, will be disclosed to the participant in all circumstances, a statement that such results may not be disclosed to the participant;
An explanation of whom to contact for answers to pertinent questions about the storage and use of information and specimens, and to voice comments or concerns about participants' rights, and whom to contact in the event of a research-related harm.

If a broad consent procedure is used:

The IRB may not omit or alter any of the required elements of disclosure, and when appropriate, any of the additional elements of disclosure.
If a study requests broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens, the IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.

Illiterate Participants and Participant Populations Without a Written Language

When a researcher expects to enroll illiterate participants or participant populations with no written language, the IRB may approve a consent process using an IRB approved short form written informed consent document stating that the required elements of informed consent have been presented orally to the participant.

The IRB shall approve a written summary of what is to be said to the participant. When this method is used, there shall be a witness to the oral presentation. The witness shall sign both the short form and a copy of the summary. Only the short form itself is to be signed by the participant. The person obtaining consent shall sign a copy of the summary. A copy of the summary and a copy of the short form shall be given to the participant.