145. Additional VA Requirements - Recruitment and Consent

Updated June 29, 2021

Recruitment

Researchers must ensure that prospective participants are contacted in person or by letter prior to initiating telephone contact unless written documentation verifies that a prospective participant is willing to be contacted by telephone about the study in question or a specific kind of research.
Researchers making initial contact with prospective participants must provide a telephone number or other means for prospective participants to verify that the study is VA research.
PIs must ensure that subsequent contacts by research team members adhere to the following conditions:
Telephone calls to participants begin with references to previous contacts.
Telephone calls to participants reference information provided in the consent document (as applicable).
Telephone calls to participants re limited to topics outlined in IRB-approved protocols and consent documents.
PIs must ensure that research team members abide by prohibitions against requesting social security numbers by telephone.

Recruitment via Public Web Sites

NOTE: The University IRB abides by information regarding the current position of the VHA Office of Research & Development’s (per email from Karen Jeans dated 01/03/14) related to use of Craigslist as a recruitment tool for VA research. The email confirms the use is acceptable if it is consistent with applicable laws, regulations, and policies regarding privacy, information security, and human research protections and the following caveats:

Proper mechanisms are utilized to prevent sensitive information from being sent electronically by the prospective participant.
Recruitment ads invite communication with prospective participants by phone, mail, or other methods but do not invite personal e-mail or social media messaging.
The text of the recruitment script and the context in which the recruitment takes place are subject to prior review and approval by the University IRB.
Recruitment ads placed on public sites specify that the study is recruiting Veterans who qualify for the study unless the IRB has approved the inclusion of non-Veterans into the study.

Recruitment for non-VA Research

To improve Veterans’ access to non-VA research, advertisements for research not conducted at a VA facility may be posted, provided facility director ensures there is a formal process to review and approve recruiting documents, flyers, and advertisements prior to being posted or distributed.
A VA facility may not use Facebook as a method of advertising non-VA studies.

Informed Consent

The University IRB applies DHHS general requirements for informed consent and requirements for documentation of informed consent with the additional requirements for VA Research outlined below.

IMPORTANT NOTE: Currently, neither the University nor its Affiliate sites, including the VASNHCS, actively conduct or manage planned emergency research; therefore, the University does not have policies in place for such research. Investigators interested in conducting planned emergency research must contact Research Integrity to discuss the possibility of engaging in this type of research. As warranted, the IRB will develop and publish policy for planned emergency research. The policy will specify the IRB will not approve a waiver of consent for planned emergency research that is subject to VA requirements.

The VASNHCS Research Office requires PIs to submit a Functional Statement outlining each team member’s roles on the project, including obtaining consent; the PI is responsible for ensuring team members have the necessary training to carry out their assigned roles.
If the PI does not personally obtain consent, the PI must formally and prospectively designate to another research team member in writing the protocol or the application for IRB approval the responsibility for obtaining consent.
VASNHCS researchers conducting clinical investigations may use the consent template (ICD) provided by the sponsor but must use the Consent Form Checklist* to revise the sponsor template to comply with VA and University requirements.
VASNHCS researchers conducting other types of research posing greater than minimal risk must use the applicable University Consent Form Template* and related Consent Form Instructions* with the required VA language.
VASNHCS researchers conducting minimal risk research may use the Consent Information Script or Sheet Template* with the required VA language about contacting the VASNHCS Research Compliance Officer or Research Integrity.
When images, voice, or video will be recorded for research purposes, information about the purpose, collection, and use of such recordings must be included in consent documents. Consent to take a photograph, video, or audio recording for research cannot be waived by the IRB.

NOTE: Disclosure of image, voice, or video recordings outside of the VASNHCS may require HIPAA authorization.

VASNHCS researchers must use the current, IRB-approved, date-stamped version of the consent form* to enroll participants (unless the requirement to obtain signed consent is waived).
Participants or participants’ legally authorized representative (LAR) and the person obtaining consent will sign and date the consent form. (At this time, no provisions exist for electronic signatures on consent documents.)
The original, signed and dated consent forms must be readily retrievable and securely maintained in the PI’s research files.
The consent form must include the following:
- A statement that in the event of a research-related injury the VA must provide necessary medical treatment to a participant injured by participation.
- Any payments the participant is to receive for participating in the study.
- Any real or apparent conflict of interest by the researchers where the research will be performed.
- A statement that VA will provide treatment for research related injury in accordance with applicable federal regulations.
- A statement that informs VA research participants that they or their insurance will not be charged for any costs related to the research.
- A statement that a veteran-participant will not be required to pay for care received as a participant in a VA research project except in accordance with federal law and that certain veterans were required to pay co-payments for medical care and services provided by VA.
Consent for research must describe any photographs, video, or audio recordings obtained for research purposes; how they will be used, and whether they will be disclosed outside the VA.

*The Consent Form Checklist, Consent Form Templates (including a VA Consent Form Template), Consent Form Instructions, and Consent Information Sheet or Script are available in the Researcher Library in IRBNet. After IRB approval has been finalized, the IRB-approved, date-stamped consent document is available in IRBNet as a Board Document.

NOTE: To ensure compliance with requirements for obtaining and documenting informed consent, the VASNHCS Research Compliance Officer routinely audits consent forms for most research studies and selectively evaluates the consent process for some studies. Deficiencies are reported to the IRB as an audit finding.

Informed Consent - Considerations Regarding Prospective Participants Who Cannot Give Consent or Whose Decision-making Capacity is in Question

If a person has been formally found incapable of consenting on their own behalf via a court order signed by a judge:

Consent by a legally authorized representative is limited to situations where the prospective participant is incompetent or has impaired decision-making capacity, as determined and documented in the person’s medical record in a signed and dated progress note.
If there is any question as to whether a potential adult participant has decision-making capacity, and there is no documentation in the medical record that the individual lacks decision-making capacity, and the individual has not been ruled incompetent by a court of law, the researcher must consult with a qualified practitioner (who may be a member of the research team) about the individual’s decision-making capacity before proceeding with the consent process.
Individuals, who because of a known condition, are at high risk to temporary or fluctuating lack of decision-making capacity must be evaluated by a qualified practitioner to determine the individual’s ability to provide consent. This evaluation must be performed as described in the IRB-approved protocol.
If the individual is deemed to lack decision-making capacity at the time of their participation in the study, a legally authorized representative must provide consent.
If the participant regains decision-making capacity, the researcher must repeat the consent process with the participant and obtain the participant’s permission to continue with the study.
Disclosures to be made to the participant must be made to the participant’s legally authorized representative.
The participant’s legally authorized representative must be told that that his or her obligation is to try to determine what the participant would do if able to make an informed decision. If the prospective participant’s wishes cannot be determined, the legally authorized representative must be told that she/he/they is responsible for determining what is in the participant’s best interest
Have the researcher explain the proposed research to the prospective participant when feasible even when the participant’s legally authorized representative gives consent.
Have the practitioner explain the proposed research to the prospective participant when feasible.
Ensure the study includes appropriate procedures for respecting dissent. Prohibit participants from being forced or coerced to participate in a research study.

Unaffiliated Contact and Community Outreach

The VA consent templates include information for prospective, current, and past participants to contact the VASNHCS Research Compliance Officer and University Research Integrity (as entities that are informed, but unaffiliated with the specific research plan) to express their concerns and ask questions about the research study.

The VASNHCS is responsible for providing and evaluating activities and opportunities to enhance understanding of human research by participants, prospective participants, and the local community.