330. Informed Consent - Greater than Minimal Risk Research

Updated July 1, 2021

The University IRB applies all Department of Health and Human Services (DHHS) requirements for informed consent to greater than minimal risk research:

  • DHHS general requirements (at 45 CFR 46.116) (see informed consent requirements in the online IRB Policy Manual).
  • DHHS basic and additional (as applicable) elements for legally effective informed consent (at §46.116(b) and (c)); and
  • DHHS requirements for documentation of informed consent (at §46.117).

DHHS Basic Elements of Informed Consent

DHHS regulations require that all research participants be provided with the following basic elements of informed consent (at §46.116(b):

  1. a statement that the study involves research, an explanation of the purpose of the research, the expected duration of participation, a description of the procedures, and identification of the experimental procedures
  2. a description of any reasonably foreseeable risks or discomforts
  3. a description of any benefits to the participant or to others that might be reasonably expected from the research
  4. disclosure of appropriate alternative procedures or courses of treatment, if any, that may be advantageous to the participant
  5. a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained including as appropriate:
    • what records may be examined by the sponsor, the IRB, other University personnel, FDA, or other regulatory agencies:
    • whether or not the data collected will be retained, and, if so, for what purpose and for what period of time, or when the data will be de-identified and/or destroyed,
    • what procedures will be put in place to ensure that unauthorized individuals will not have access to this information, and
    • the limitations (if any) to these confidentiality procedures such as legal reporting requirements for specific diseases and in the case of suspected child or elder abuse;
  6. for research involving more than minimal risk, an explanation as to whether any compensation and medical treatment are available if injury occurs to the participant and if so, what they consist of or where further information may be obtained
  7. identification of whom to contact for answers to questions about the research and the research participants' rights including whom to contact when the investigator may be unavailable or to discuss any other questions, complaints or concerns and whom to contact if the participant sustains a research-related injury
  8. a statement that research participation is voluntary, that the participant may discontinue participation at any time, and that the participant's refusal to take part or withdraw will not involve a penalty or loss of benefits to which the participant is otherwise entitled
  9. When the research involves the collection of identifiable private information or identifiable biospecimens one of the following statements must be included:
    • Identifiers might be removed and the de-identified information or biospecimens used for future research or distributed to another investigator without additional informed consent from the participant; or,
    • The participant's information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.

The IRB Consent Form and Consent Parent Permission Templates(available in IRBNet researcher libraries) include the required basic elements of informed consent, with the exceptions authorized through the IRB Flexibility Policy (IRB-Flex). Briefly, IRB-Flex does not require the IRB to approve an alteration of consent when select basic elements of informed consent are omitted from consent documents and the IRB determines these do not apply to the research project.

DHHS Additional Elements of Informed Consent

DHHS regulations also require that when appropriate, research participants are provided with one or more of the following additional elements of informed consent (at §46.116(c)).

The need to inform participants of DHHS additional elements is determined by research design, participant populations, and level of risk. Investigators and the IRB must assess these factors for each project when considering if any of the additional elements are appropriate to ensure participants are fully informed.

When appropriate, as determined by the Principal Investigator (PI) or IRB, the following must be provided to participants:

  1. a statement that the 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 unknown or currently unforeseeable
  2. anticipated circumstances under which the volunteer's participation may be terminated by the investigator without regard to the participant's consent or willingness to continue to participate;
  3. additional costs to the participant (or third-party payer) that may result from taking part in the research
  4. the consequences of the participant's decision to withdraw from the research and procedures for safe and orderly termination of participation
  5. a statement that significant new findings developed during the research which may relate to the participant's willingness to continue to participate will be provided to the participant
  6. the approximate number of participants involved in the study
  7. a statement that 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.
  8. a statement about whether clinically relevant research results, including individual research results, will be disclosed to participants, and if so, under what conditions.
  9. a statement about whether the research project will or might include whole genome sequencing.

The Consent Form Instructions (available in IRBNet researcher libraries) address the additional elements, including circumstances in which the additional elements may apply.

DHHS Requirements for Documentation of Informed Consent

For greater than minimal risk research, the University IRB applies the DHHS regulations at §46.117(a) and (b) that require researchers to document informed consent by through use of an IRB-approved written consent form that is signed by the participant or the participant's legally authorized representative.

The IRB will not approve a consent form unless it includes the DHHS basic elements, appropriate additional elements, and (for clinical investigations) FDA additions to DHHS required elements.

The investigator must ensure that the participant or legally authorized representative has adequate opportunity to read the form. Alternatively, the investigator may read the form to the participant or her/his representative before it is signed.

The University IRB requires that both the person giving consent and the person obtaining consent sign and date the consent form. The dates of the signatures on the consent document permits verification that consent was obtained before the participant began participation in the study.

Researchers must give a copy of the consent document to each participant. Regulations do not require participants be given a signed copy but a photocopy with signatures is preferred.

Use of Witnesses for Documentation of Informed Consent

The IRB may require that informed consent be witnessed; for example, for studies involving invasive interventions or investigational drugs or devices AND participant risks are substantial.

  • When a witness' signature is required, the informed consent form will contain spaces for the witness' signature and date.
  • The witness observes only the participant's or legally authorized representative's signature, not the consent process, unless the Sponsor or IRB requires the witness to observe the consent process.
  • The witness cannot be the person who obtained consent from the participant.

Electronic Signatures

Federal regulations allow electronic signatures when the documentation process is approved by the IRB. The IRB will approve the use of a secure system for electronic or digital signature when the system provides an encrypted identifiable "signature" compliant with federal regulations.

As with handwritten signatures, both the participant/LAR and the individual obtaining consent must provide an electronic signature.

A paper or electronic copy of the consent must be provided to the participant. The electronic copy can be provided on an electronic storage device, through a document sharing program or via email. However, only secure email should be used when the consent document includes identifiable health information or other sensitive information.

If the electronic consent document includes one or more hyperlinks to information on the Internet, the hyperlinks should be maintained and information should be accessible to participants until study completion. If the hyperlinks or other web sites or podcasts convey information specifically related to the informed consent process, the information in these hyperlinks must be included in any printed paper copy, if one is provided.

Whether using handwritten or electronic signatures, Research Integrity recommends that researchers document the steps completed during the consent process in the research record as outlined above.

Investigator Storage of Signed Consent Forms

PIs must ensure signed consent forms are securely stored.

When knowledge of study participation is essential for making health care decisions, or where consent is required to obtain copies of medical or other individual records, a copy of the signed consent form may be included in participants' medical or other confidential records.

Signed consent forms must be available for review by the IRB, DHHS, FDA, or Sponsor.

Investigators must keep signed informed consent forms for a minimum of three (3) years following completion of the research (or longer if required by the IRB, FDA, or Sponsor).

Waiver of Documentation of Informed Consent for Greater than Minimal Risk Research

Under DHHS regulations at §46.117(c)(1) and (2), the IRB may approve a waiver of the requirement for the investigator to obtain signed consent from some or all participants. Only the waiver found at §45.117(c)(1)) may apply to greater than minimal risk research, and only when the following are true:

  • The IRB finds that the only record linking the participant and the research would be the consent document.
  • The principal risk would be potential harm resulting from a breach of confidentiality.
  • Each participant will be asked whether she/he/they wants documentation linking her/him/them to the research; the participant's wishes will govern.

For the IRB to waive the requirement for documentation of consent, researchers must provide the IRB with written descriptions of what participants will be told about the research and how they will be informed. The IRB will assess for the criterion for the waiver and may require researchers to provide participants with a written statement or information sheet describing the research.

IRB Review and Approval of Informed Consent Documents

Consent forms, consent addenda, and other consent documents must be approved by the IRB.

Approved versions of consent documents are date-stamped by Research Integrity and published as Board Documents in IRBNet. Only stamped, approved versions of consent materials may be used to enroll participants.

Date-stamped versions of approved consent materials remain in effect until changes to the documents are submitted and approved by the IRB through an amendment request. Following approval of an amended document, an updated date-stamp is placed on the approved version of the revised document and the date-stamped document is published as a Board Document in IRBNet.