145. Additional VA Requirements: Recruitment and Consent
Updated Nov. 2, 2020
- 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 Department of Veterans Affairs (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 are 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 Electronic Format
Email is not inherently confidential and VA researchers should have no expectation of privacy when using government email systems. VA Investigators can use VA email to recruit prospective VA participants and to communicate with VA participants who have consented to participate in a VA research study as described in the IRB-approved research protocol. VA Investigators may not utilize their personal email accounts (e.g., Google).
Text messages can be used by VA investigators to recruit prospective participants and to communicate with VA participants who have consented to participate in a VA research study as described in the IRB-approved research protocol. VA Investigators may not utilize their own personal devices, such as personal cellphones, personal Instant Messages (IMs), or university owned devices to send and receive text messages with prospective or consented VA participants. The University IRB abides by recruitment practices 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 email 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.
- Sending recruitment messages to a prospective participant or communicating with consented VA participants using the recipient’s personal, university, or commercial email accounts should always convey that no Personally Identifiable Information (PII) should be sent by email or text messaging to the VA research team.
- Study reminders can be sent by a VA research team without including information that would require encryption. The content should not include any information that would indicate the type of appointment or the specific location, or specific diagnosis or condition; the content must be reviewed by the IRB as part of the IRB approval of the VA research study.
- The use of VA email in a VA research study must be evaluated by the IRB. When research studies utilize email or text messaging, the IRB must review the content of standardized communications. Emails and text messages sent and received by a VA Investigator and the VA research team are federal records subject to the Veterans Health Administration (VHA) Record Control Schedule. Copies of the email communications and text messages sent and received by a VA Investigator and the VA research team must be maintained in accordance with the VHA Record Control Schedule (RCS 10-1) as part of local VA Investigator records
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 the 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.
The University IRB applies Department of Health and Human Services (DHHS) general requirements for informed consent and requirements for documentation of informed consent with the additional requirements for VA Research outlined below. VHA Directive 1200.05(1) updates VHA’s national policy on informed consent in accordance to the revised Common Rule for the Protection of Human Subjects (the 2018 Requirements).
At this time, neither the University nor its Affiliate sites, including the VA Sierra Nevada Health Care System (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.
Informed Consent Process
Informing the Patient. During the informed consent process, the practitioner must engage the patient (or surrogate) in a discussion about the treatment or procedure. Provide information that a reasonable person in the patient’s situation would expect to receive in order to make an informed choice about whether or not to undergo the treatment or procedure. Describe the recommended treatment or procedure in language that is understandable to the patient. Ideally, the informed consent discussion is conducted in person; however, face-to-face discussions are not always possible. The informed consent discussion may be conducted by telephone, video conference, or other VA-approved electronic modalities if it is not possible to conduct the informed consent discussion in person or if it could introduce infection control issues, or if the patient expresses a preference for one of these modalities.
- For treatments and procedures that are low risk and are within broadly-accepted standards of medical practice, it is sufficient to obtain oral consent for the entire treatment or procedure without explicitly discussing each of its component elements; for example, a practitioner may obtain consent for a panel of routine blood tests without explicitly discussing that the panel includes tests for sodium, potassium, and chloride.
- For tests that provide information that is extremely sensitive or that may have a high risk of significant consequences (e.g., physical, social, psychological, legal, or economic) that a patient might reasonably want to consider as part of the consent decision, the informed consent discussion must include information a reasonable person in the patient’s situation would expect to receive in order to make an informed choice about whether or not to undergo the test. These tests include, but are not limited to, specific tests to identify illicit drug use, alcohol intoxication, Methicillin-Resistant Staphylococcus Aureus (MRSA), and inheritable genetic abnormalities. For these tests, practitioners must obtain specific consent and follow the informed consent process as outlined in the remainder of this paragraph. Signature consent is not required; oral informed consent noting each specific test discussed is sufficient and must be documented in the patient's electronic health record.
The practitioner must not unduly pressure or coerce the patient into consenting to a particular treatment or procedure, but must instead convey that the patient is free to choose among any recommended treatments and procedures, including no treatment, or to revoke a prior consent without prejudice to the patient’s access to future health care or other benefits.
- 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. The format should mirror the Consent Form VA Template located in the IRBNet library.
- VASNHCS researchers conducting other types of research posing greater than minimal risk must use the Consent Form VA Template located in the IRBNet library with the required VA language.
- VASNHCS researchers conducting minimal risk research may use the Consent Information Script or Sheet Template located in the IRBNet library with the required VA language about contacting the VA Research Compliance Officer (VA RCO) 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.
Documenting the Informed Consent Process
Prior to undertaking any treatment or procedure, the practitioner must obtain informed consent and document the informed consent process in the patient’s electronic health record. A properly-executed VA authorized consent form is valid for a period of 60 calendar days from the date signed. If during this 60-day period there is a significant change in the patient’s condition that would reasonably be expected to alter the diagnosis or therapeutic decision, the consent is automatically rescinded and the informed consent process must be repeated for subsequent treatment.
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.
- 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, Consent Information Sheet or Script, and Consent Form VA Template are located in the IRBNet library. 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.
Contact Information and Community Outreach
The VA consent templates should 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.