This SOP describes the institutional and federal regulatory requirements related to the documentation of informed consent of participants who will participate in human subjects research at WVU.
Federal regulations require that informed consent is documented in most circumstances by using a written (paper or digital copy) consent form approved by the IRB and signed by the research participant or the participant's legally authorized representative. Consent materials used to recruit participants must include the required (and any applicable additional) elements of informed consent unless the IRB approves either an alteration of consent, use of a short form stating that the elements of consent have been presented, or a waiver of the requirements for written documentation of the consent process.
3.1. The informed consent document provides key information regarding research
participation and serves as a reference for participants or a legally authorized
representative. Although a signed consent form is usually required, the signed
form alone does not constitute an adequate informed consent process. For more information
on the informed consent process, see SOP 012: Informed Consent Requirements.
3.2. Unless waived or altered by the IRB, consent forms must include the
basic elements of informed consent, and when appropriate, any additional elements as described below
and by SOP 012: Informed Consent Requirements.
4.1. Required Elements
Consent form templates containing the basic elements of informed consent are available
on the WVU OHRP website. Using the WVU IRB-approved templates is required to streamline
the IRB’s review and assure that regulatory and institutional legal requirements
are met. The IRB can also approve the consent forms on a case-by-case basis in
other formats that may more appropriately satisfy requirements for obtaining and
documenting informed consent. The federally required consent elements are described
in SOP 012: Informed Consent Requirements.
4.2. Additional Elements
One or more additional elements of informed consent will also be provided to prospective participants during the consent process, when appropriate, or as required when
the IRB determines that the information would meaningfully add to the protection of research participants. The additional elements are described in SOP 012: Informed Consent
Requirements.
Use of short form consent documents in WVU research is limited to situations involving a prospective research participant/legally authorized representative who does not speak/understand English, and enrollment of participants speaking the specific language was not anticipated (e.g., a translated consent form in the participant’s language has not been approved by the IRB). For more information on the use of the short form consent, including witness, signature, and follow-up translation requirements, see SOP 012: Informed Consent Requirements.
6.1. FDA regulations require that a participant or legally authorized representative date the consent form at the time it is signed. Although not required by DHHS regulations, DHHS OHRP recommends that consent forms are dated to document that a participant’s informed consent was obtained before beginning research interventions or interactions. WVU’s consent form templates include a line for adding the date the consent form is signed. A copy of the consent document is to be given to the person signing the form.
6.2. The practice of a participant/LAR returning a signed paper consent
form to the researcher using a facsimile (fax) or e-mail must be approved by the
IRB as an exception. WVU recommends the use of eConsent when a participant/LAR
is not in the same physical location as the consenting researcher.
6.3. Electronic signatures may be used to document consent, in compliance
with 45 CFR 46.21 CFR 11, and applicable FDA guidance. A written copy (electronic or hard copy)
must be given to the individual signing the consent form. Electronic versions of consent
forms (when used to meet documentation requirements) must be available for review and
retention by potential participants.
Complete signed consent forms should be stored confidentially in a secure location
for at least three years after completion (or cancellation) of the research unless a longer retention period is required by other applicable university policy or contractual agreement. For more information on record retention, please see SOP 038: Research
Data Retention.
6.4. The WVU IRB requires the consenting researcher to sign the returned
consent form after participant/LAR signature for More Than Minimal Risk Research. WVU considers the consent to be “fully executed” when both the participant/LAR and the consenting researcher have signed the consent. A copy of the fully executed consent must be provided to the person who signed the consent.
6.5. For additional information on eConsent policies and procedures, please see SOP 052: E-Informed Consent.
7.1. A person who speaks and understands English but does not read and write can be enrolled in a study by “making their mark” on the consent document. An adult who is not involved in the research will witness the entire informed consent process and sign the consent document.
7.2. A person who understands English but is physically unable to talk or write can be enrolled in a research project if they are competent and able to indicate approval or disapproval by other means. The method used to communicate with the potential participant and the specific way the individual communicated agreement to participate in the research project is to be documented on the consent form. An adult not involved in the research will witness the entire informed consent process and sign the consent document as a witness on the witness signature line.
In limited circumstances, the IRB can waive the requirement for the investigator
to obtain a signed consent form for some or all research participants.
8.1. Risk of Breach of Confidentiality
The IRB can waive the requirement for written documentation of informed consent
for
non-exempt research if all of the following criteria are met:
8.2. “Only Minimal Risk” (OMR) Research
The IRB can waive the requirement for written documentation of informed consent
for non-exempt research if both of the following criteria are met:
8.3. Distinct Cultural Groups
The IRB may waive the requirement for a signed informed consent form if the participants
are members of a distinct cultural group or community in which signing forms is
not the norm for non-exempt research if both of the following criteria are met:
8.4. Additional Requirements
8.4.1. When the requirement for written documentation of consent is waived,
the IRB must review a written description of the information (i.e., a script) provided
to participants (e.g., when consent is obtained by telephone or online). This information
must include the basic elements of informed consent and any applicable additional
elements as described above and in SOP 012: Informed Consent Requirements, unless
the IRB has also approved an alteration of consent.
8.4.2. When the requirement for written documentation of consent is waived,
the IRB may also require that an investigator provide participants with a written
statement regarding the research. Examples include approved consent forms (without
signature line), cards containing researcher and/or third-party contact information,
and informational documents outlining the research procedures.
For clinical trials conducted or supported by a federal department or agency, the Final Rule (Revised Common Rule) requires that a copy of an unsigned, IRB-approved consent form be posted on a publicly available federal website (ClinicalTrials.gov). The funding awardee or federal department/agency is responsible for posting the form after recruitment is complete but no later than 60 days after the last visit. Proprietary or institutionally sensitive information may be redacted; only one consent form per research project must be posted regardless of the number of participant classes or research project sites.
WVU Policies:
SOP 012: Informed Consent Requirements
SOP 055: Electronic Informed Consent
Federal Regulations:
21 CFR 50.20
21 CFR 50.25
21 CFR 50.27
21 CFR 56.109
21 CFR 56.111
45 CFR 46.111
45 CFR 46.116
45 CFR 46.117
