PWS Attachment D - Consent of Participants Standard Operating Procedure.pdf

Human Systems Integration (HSI)

SOP HSI-2025-01 November 2024

Consent of Participants Standard Operating Procedure

1. PURPOSE: Provide guidance on when it is necessary for HSI staff members to obtain a signed audiovisual consent form (VA Form 10-3203) and/or instances where an informed consent form is required.

2. BACKGROUND: Procedures for obtaining consent may not have been clearly communicated in the past. This policy will clarify to HSI staff members, collaborators and contractors when a signed audiovisual consent form or informed consent form is required according to VA/VHA policy and Federal Law.

3. DEFINITIONS:

a. Research - A systematic investigation, including research, development, testing, or evaluation, designed to develop or contribute to generalizable knowledge (Department of Veterans Affairs, 2019).

b. Operations Activities - Operations activities are administrative, financial, legal, quality assurance, quality improvement and public health endeavors that are necessary to support VHA’s missions of delivering healthcare to the Nation’s Veterans, performing medical education, and contributing to national emergency response. Operations activities may or may not constitute research (Department of Veterans Affairs, 2019).

4. STANDARD OPERATING PROCEDURE: Proper use of VA Form 10-3203 and informed consent forms.

5. ACTION:

1. Receive a determination from the VAEDA determination system (Department of Veterans Affairs, 2024).

2. Determine if video or audio recording is required.

a. If video or audio recording is required:

i. Use VA Form 10-3203.

1. VA Form 10-3203 Always Required: For HSI studies when recording audio or visual of the participant which includes participant video or audio (not for screen capturing).

b. If Video / Audio is Not Required: For HSI studies when the Veteran, VA employee or non-VA employee is not being recorded by audio or video.

i. Use an informed consent form or study information sheet.

1. Informed Consent Form Always Required:

a. If it is the practice of the program office, business owner, or site to obtain written permissions from participants.

b. If the project meets the Federal definition of “research” and unless the IRB waived the documentation of informed consent.

c. If an informed consent to take a photograph, video and or audio recording cannot be waived by the IRB – VHA Directive 1200.05(3) – 2019.

2. Informed Consent Form Not Required: For studies deemed quality improvement and not research, there is normally not a need for informed consent. However, the staff member is ethically obligated to inform the participant of any risks involved in their participation, what to expect, and that their participation is voluntary. This information should be communicated to the participant or their representative (caregiver / family member) via a “study information sheet” in lieu of a signed informed consent form.

3. Collection of Verbal Consent.

Verbal Consent Always Required: When any HSI project involves recording audio or video from a participant (either Veteran or VA employee), verbal consent from the study participant should be sought. The participant should be told that the evaluation is on the performance of the system, product or method and is not reflective of the participant’s capabilities. The participant should be notified that their participation is voluntary and that the recordings will only be used for the purposes communicated to the participant, for which they must agree to, for the recording to occur. If they decline, they may continue to be part of the study, but no recording can be made, and only personal notes can be used. For VA employees, this is sufficient authorization; as noted, for other participants, use of Form 10-3203 is required in addition to obtaining verbal consent. In the case of uncertainty, seek an IRB ethics determination or review.

• Understand the documentation and storage requirements.

• Records retention period.

• Per the VA records retention schedule (10-1, 2021) need to be maintained 6 years post study activity.

• Format of records: whether the record is physical or electronic, the 6-year period still applies (VHA Directive 1907.1(1) - VHA Health Information Management and Health Records, 2021). If a record is electronic, safeguards need to be put in place to limit access to appropriate staff and team.

• Responsibility for Records.

• Although work can be done by a contractor, the final responsibility for records management (ex. post contract, auditing) is the federal POC, since the documents are archived as study documents.

• In the event that the federal point of contact (POC) is leaving the organization, a transferring of the designation of federal POC will be necessary to ensure there is a responsible party for the duration of the record.

6. REFERENCES:

a. Department of Veterans Affairs. (2019, January 9). VHA Operations Activities That May Constitute Research.

https://www.research.va.gov/resources/policies/ProgramGuide-1200-21-VHA- Operations-Activities.pdf

b. Department of Veterans Affairs. (2020, July 1). VA form 10-3203.

https://www.va.gov/vaforms/medical/pdf/VA Form 10-3203 Fill.pdf

c. Department of Veterans Affairs. (2021, November 29). Privacy of Persons Regarding Photographs, Digital Images and Video or Audio Recordings. VHA Directive 1078.

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9547

d. Department of Veterans Affairs. (2024, May 29). VA Electronic Determination Aid (VAEDA). https://www.research.va.gov/programs/epros/vaeda.cfm

e. Department of Veterans Affairs (2010, January 12). Collections of Information. VHA Handbook 6309.

https://ba.va.gov/policy/viewer/paKMOE000000094K4AQ

f. VHA HSI Study Information Sheet Template

g. VHA HSI Sample Study Information Sheet

7. FOLLOW-UP RESPONSIBILITY:

a. HSI Practice Advancement is responsible for the content of this document.

b. VA Form 10-3203 will be provided to the Veteran or Non-VA employee electronically, or in person by contractors supporting the HSI Division. If the individual has not returned the signed VA Form 10-3203 prior to the study session, every effort should be made to collect the form prior to recording.

This situation is the rationale for seeking verbal consent as standard practice, even from Veterans; the practitioner should still attempt to gain a signed form, even after the session has concluded through email.

c. Study Leads may also need to follow steps required for OMB approval, as defined in the Paperwork Reduction Act, depending on sample size. That approval process is outside of the scope of this SOP.

8. RESCISSIONS: This supersedes SOP HFE 2017-01.

9. RECERTIFICATION: This SOP will remain in effect until rescinded or significant changes warrant an update.

11/6/2024

X Darren P. Wilson

Darren P. Wilson, CHFEP

Director

Signed by: Department of Veterans Affairs