145. Additional VA Requirements: Recruitment and Consent

Updated Oct. 4, 2019

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 subject.
  • Recruitment ads invite communication with prospective subjects 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: At this time, 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 RI 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 RCO or RI.
  • 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.

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’ 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 Checklist, Consent Form Templates, 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 RCO 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.

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.