145. Additional VA Requirements - Recruitment and Consent

Updated June 7, 2024

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 w88.
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 w88.
PIs must ensure that subsequent contacts by w88 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 w88 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 w88 & Development’s (per email from Karen Jeans dated 01/03/14) related to use of Craigslist as a recruitment tool for VA w88. The email confirms the use is acceptable if it is consistent with applicable laws, regulations, and policies regarding privacy, information security, and human w88 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 donotinvite 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 recruitingVeteranswho qualify for the study unless the IRB has approved the inclusion of non-Veterans into the study.

Recruitment for non-VA w88

To improve Veterans’ access to non-VA w88, advertisements for w88 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 w88 outlined below.

IMPORTANT NOTE: Currently, neither the University nor its Affiliate sites, including the VASNHCS, actively conduct or manage planned emergency w88; therefore, the University does not have policies in place for such w88. Investigators interested in conducting planned emergency w88 must contact w88 Integrity & Security to discuss the possibility of engaging in this type of w88. As warranted, the IRB will develop and publish policy for planned emergency w88. The policy will specify the IRB will not approve a waiver of consent for planned emergency w88 that is subject to VA requirements.

The VASNHCS w88 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 w88 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 theConsent Form Checklist* to revise the sponsor template to comply with VA and University requirements.
VASNHCS researchers conducting other types of w88 posing greater than minimal risk must use the applicable UniversityConsent Form Template* and relatedConsent Form Instructions* with the required VA language.
VASNHCS researchers conducting minimal risk w88 may use theConsent Information Script or Sheet Template* with the required VA language about contacting the VASNHCS w88 Compliance Officer or w88 Integrity & Security.
When images, voice, or video will be recorded for w88 purposes, information about the purpose, collection, and use of such recordingsmustbe included in consent documents. Consent to take a photograph, video, or audio recording for w88 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 w88 files.
The consent form must include the following:
- A statement that in the event of a w88-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 w88 will be performed.
- A statement that VA will provide treatment for w88 related injury in accordance with applicable federal regulations.
- A statement that informs VA w88 participants that they or their insurance will not be charged for any costs related to the w88.
- A statement that a veteran-participant will not be required to pay for care received as a participant in a VA w88 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 w88 must describe any photographs, video, or audio recordings obtained for w88 purposes; how they will be used, and whether they will be disclosed outside the VA.

*TheConsent Form Checklist, Consent Form Templates(including a VA Consent Form Template),Consent Form Instructions, andConsent Information Sheet orScriptare 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 w88 Compliance Officer routinely audits consent forms for most w88 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 w88 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 their 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 they are responsible for determining what is in the participant’s best interest
Have the researcher explain the proposed w88 to the prospective participant when feasible even when the participant’s legally authorized representative gives consent.
Have the practitioner explain the proposed w88 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 w88 study.

Unaffiliated Contact and Community Outreach

The VA consent templates include information for prospective, current, and past participants to contact the VASNHCS w88 Compliance Officer and University w88 Integrity & Security (as entities that are informed, but unaffiliated with the specific w88 plan) to express their concerns and ask questions about the w88 study.

The VASNHCS is responsible for providing and evaluating activities and opportunities to enhance understanding of human w88 by participants, prospective participants, and the local community.