22 Va. Admin. Code § 30-40-110 - HRRC records

A. The HRRC shall prepare and maintain adequate documentation of HRRC activities, including the following:

1. Copies of all research applications reviewed, scientific evaluations, if any, that accompany the applications, approved consent documents, progress reports submitted by investigators, and reports of injuries to subjects;

2. Minutes of HRRC meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the HRRC; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution;

3. Records of continuing review activities;

4. Copies of all correspondence between the HRRC and the investigators;

5. A list of all HRRC members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to HRRC deliberations; and any employment or other relationship between each member and the covered entity, for example: full-time employee, part-time employee, member of governing panel or board, or paid or unpaid consultant;

6. Statements of significant new findings provided to participants; and

7. Written procedures for the HRRC that shall include:

a. Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the department;

b. Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous HRRC review;

c. Ensuring prompt reporting to the HRRC of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which HRRC approval has already been given, may not be initiated without HRRC review and approval except when necessary to eliminate apparent immediate hazards to the subject; and

d. Ensuring prompt reporting to the HRRC and the commissioner of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the HRRC and (ii) any suspension or termination of HRRC approval.

8. The rationale for an expedited reviewer's determination under 22VAC30-40-90 A 1 that research appearing on the expedited review list described in 63 FR 30364-60367 is more than minimal risk.

9. As applicable, documentation specifying the responsibilities that the covered entity and another qualified IRB other than the HRRC, each shall undertake to ensure compliance with the requirements of this chapter when (i) nonexempt research involving human subjects or (ii) exempt research with a limited review is overseen by another qualified IRB other than the HRRC. Such documentation may include:

a. A written agreement between the covered entity and the qualified IRB that is not the HRRC;

b. Implementation of an institution-wide policy directive providing the allocation of responsibilities between the covered entity and the qualified IRB that is not the HRRC; or

c. A research protocol.

B. The records required by this chapter shall be retained for at least three years, and records relating to research which is conducted shall be retained for at least three years after completion of the research. All records may be maintained in printed or electronic form and shall be accessible for inspection and copying by authorized employees or agents of the department or federal agency at reasonable times and in a reasonable manner.

C. The HRRC shall ensure that an overview of approved human subject research projects and the results of such projects are made public on the department's website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

D. The HRRC shall have access to meeting space and sufficient staff to support the HRRC's review and recordkeeping duties.

Notes

22 Va. Admin. Code § 30-40-110

Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 25, Issue 21, eff. July 22, 2009; Amended, Virginia Register Volume 36, Issue 17, eff. 5/14/2020.

Statutory Authority: §§ 51.5-131 and 51.5-132 of the Code of Virginia.