Human Research Review Committee (HRRC)

...

CORONAVIRUS (COVID-19) RESPONSE • Have you downloaded COVIDWISE, Virginia's COVID-19 exposure notification app? Add your phone to the fight here. For up-to-date information, assistance, and resources from across state government, click here.

Overview

The Virginia Department for Aging and Rehabilitative Services (DARS) is committed to protecting the rights and ensuring the safety of DARS clients and employees participating in research. This is done through the Human Research Review Committee (HRRC). The HRRC oversees all research conducted or authorized by applicable covered entities, which include DARS, the Wilson Workforce and Rehabilitation Center, area agencies on aging, employment services organizations, and independent living centers.

The purpose of the HRRC is to ensure that human research involving covered entities maintains an individual’s rights to privacy and protection from harm or risk. The HRRC reviews research proposals and requests to determine how federal and state human research subject laws and regulations apply to proposed research activities. The HRRC conducts competent, complete, and professional review of human research activities conducted or authorized by covered entities to ensure the privacy and protection of human subject participants.

  • Principal investigators interested in submitting an application for HRRC review should start by reading Research Defined, Letters of Agreement and Investigator Responsibilities below, and submit information about their research project using this online form
  •     • Following the submission of the form the HRRC Co-Chair/Administrator will follow-up with guidance on next steps, as applicable
  • It is recommended that DARS consumers and employees who are considering volunteering to participate in research, review the following resources:
    About Research Participation and Questions to Ask
  • DARS has a Federal wide Assurance (FWA# 00008936) which expires, March 26, 2023

When determining whether to submit an application to the HRRC please start by considering the following questions:

Is the project considered research?

Research means "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities" [45 CFR 46.102(d) & 22 VAC 30-40-10].

Systematic means "characterized by order and planning; not haphazard; a series of orderly actions."

General knowledge is synonymous with generalizable knowledge which means that the intent of collecting the information is to learn and apply what is discovered to a wider group of individuals than those included in the study and to publish the results in an outside publication such as a journal, trade magazine, conference proceedings, or periodical.

Does the project involve human subjects?

Human research means "any systematic investigation which utilizes human participants who may be exposed to physical or psychological injury as a consequence of participation and which departs from the application of established and accepted therapeutic methods appropriate to meet the participant's needs."

Human participant means "a living individual about whom an investigator (whether professional or student) conducting research obtains (i) data through intervention or interaction with the individual or (ii) identifiable private information. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the participant or participant's environment that are performed for research purposes."

If you answered yes to one or both of these questions then review by the HRRC may be required. If you have not already done so please submit information about your research project using this online form. If you answered no to both of these question review by the HRRC is not required.

If you think your project may qualify as quality improvement rather than human subjects’ research please contact the HRRC Co-Chair/Administrator for assistance ( devin.bowers@dars.virginia.gov).

The HRRC is authorized to review and approve proposed research conducted or authorized by covered entities as directed by:

  1. 45 CFR Part 46 Protection of Human Subjects;
  2. 34 CFR Part 97, as applicable;
  3. Code of Virginia§ 32.1-162.16 et seq. and 51.5-132;
  4. 22 VAC 30-40-10 et seq. Protections of Participants in Human Research
  5. Policies and Procedures for the Protection of Human Subjects for DARS (Policy Manual)

Please contact the HRRC Co-Chair/Administrator ( devin.bowers@dars.virginia.gov) for copies of the forms outlined in appendix A of the policy manual.

For research projects that involve DARS facilities, clients and/or employees, the Principal Investigator (PI) must obtain a letter of agreement from the agency. This agreement is separate from the HRRC process and approval, and must be obtained and submitted with the application. The HRRC application will be considered incomplete without this letter of agreement. PIs are encouraged to contact the HRRC Co-Chair/Administrator ( devin.bowers@dars.virginia.gov) if they need assistance in facilitating the process of obtaining division-level and/or commissioner-level agreements. The DARS Commissioner has ultimate approval authority regarding agency participation in research projects.

The Principal Investigator (PI) is ultimately responsible for the safety and welfare of research subjects and the conduct of the research project. The PI must:

  • Not start any aspect of research involving human subjects (e.g., recruitment, screening, etc.) until they have received written notification of HRRC approval
  • Comply with other laws and institutional rules (such as compliance with HIPAA, FERPA, biosafety regulations, etc.) and must provide documentation of any other reviews to the HRRC upon request
  • Ensure that all research personnel (employees, co-investigators, research project coordinators and/or students) have been adequately trained to carry out their responsibilities
  • Meet progress and closure reporting requirements:
        1. For projects deemed exempt, submit a Research Project Status Report every three years and notify the HRRC Co-Chair/Administrator via email within 30 days of project closure
        2. For projects receiving an expedited review, submit Research Project Status Report annually on the date original approval was received and submit a Research Project Closure Report within 30 days of project closure
        3. For cooperative research under the review of an external IRB via an authorization agreement, notify the HRRC Co-Chair/Administrator via email within 30 days of project closure
        4. For projects requiring continuing review, submit Continuing Review and Adverse Event Report annually 60 days before the date of approval expiration and submit a Research Project Closure Report within 30 days of project closure
  • Report all unanticipated problems, safety issues or other serious, unexpected adverse effects or events to the HRRC using the Continuing Review and Adverse Event Report
  • Report inquiries, comments and/or concerns received from participants, the community and others to the HRRC using the Research Inquiries, Comments or Concerns Report
  • If the project experiences a change in PI, protocol, subject population, consent procedure, treatment procedures (etc.) a Modification Request must be submitted to the HRRC
  • Please contact the HRRC Co-Chair/Administrator ( devin.bowers@dars.virginia.gov) for copies of the reporting forms.

Click the links to below to download a PDF of each annual report.

For annual reports older than the last five years, please email a request to the HRRC Co-Chair/Administrator ( devin.bowers@dars.virginia.gov).

Unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia), results of research projects will be made available here as they become available.

  • Internships Model and Autism_2020
  • Competitive Employment and Autism_2020


  • © Virginia Department for Aging and Rehabilitative Services, Commonwealth of Virginia

    Return to Top