The Virginia Department for Aging and Rehabilitative Services is committed to protecting the rights and ensuring the safety of DARS consumers and employees participating in research. This is done through the Human Research Review Committee (HRRC). The Committee oversees all research conducted or authorized by DARS and Wilson Workforce and Rehabilitation Center.
Additionally, independent living centers and sheltered workshop/employment services organizations (ESO) may affiliate with the DARS HRRC for any human research that is not funded or sponsored with federal resources.
Research investigators interested in submitting an application for HRRC review should read the quick start for investigators.
It is recommended that DARS consumers who are considering volunteering to participate in research read the pamphlet entitled "Becoming a Research Volunteer" before you sign any informed consent document.
DARS has a Federal wide Assurance (FWA# 00008936) which expires, March 26, 2023.
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]
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."
Systematic means "characterized by order and planning; not haphazard; a series of orderly actions"
For the purposes of these procedures, 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.
Unless they are covered by some other provision, the following kinds of research are exempt from full committee review:
Research conducted in established or commonly accepted education settings, involving commonly used educational practices, such as:
Research involving solely the use and analysis of the results of standardized psychological, educational, diagnostic, aptitude, or achievement tests, if information taken from these sources is recorded in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.
Research involving survey or interview procedures, unless responses are recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants; and either:
Research involving solely the observation (including observation by participants) of public behavior, unless observations are recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants, and either:
Research involving solely the collection or study of existing data, documents, records, or pathological or diagnostic specimens, if the sources are publicly available, or if the information taken from these sources is recorded in such a manner that participants cannot be identified, directly or through identifiers linked to the participants. Note: Based on the federal definition of "existing data", research conducted on biological or pathological specimens obtained prospectively and/or taken strictly for research purposes or from future discarded clinical samples DOES NOT qualify for exempt review.
The regulation establishes protocols to approve research proposal involving customers of the Department of Rehabilitative Services (DARS), Wilson Workforce and Rehabilitation Center, employment services organizations (sheltered workshops) or centers for independent living as mandated by state and federal law. The regulations establishes a human research review committee to implement these protocols, requires researchers to divulge their research plans to the HRRC to obtain approval for the research, and provides that human participants will be provided with information regarding the action and know consequences of the research.
Be advised that this site is being redone with updated Policies and Forms that will reflect the changes of the New "Common Rule". For HRRC questions or to receive the new forms not yet posted,
contact Elizabeth Patacca at Elizabeth.Patacca@dars.virginia.gov
To obtain any forms needed, contact
Elizabeth Patacca at Elizabeth.Patacca@dars.virginia.gov
Policies and Procedures for the Protection of Human Subjects Involved in Federally Funded or Sponsored Research
HRRC Data/Specimen Repository Plan Application, Form
If you are planning to establish a Data or Specimen repository for research purposes, complete this form and submit it to the HRRC for review and approval prior to establishing the repository. You should also review the "HRRC Policy: Research Involving data Repositories".
HRRC Application, Form A
Use Form A to submit an initial application for Committee review of a proposed research project.
Continuing Review, Form B
Use Form B to: (1) request a continuing review, (2) request amendments or revisions to an HRRC-approved project, OR (3) report unanticipated problems, adverse events or complaints.
Research Project Closure, Form F
Use Form F to notify the HRRC when your research project is completed.
Report Inquires, Form C
Use Form C to report inquiries, comments and/or concerns from human research subjects, the community, and others.
Individual Investigator Agreement, Form D
Form D provides a permissible mechanism under which an institution holding an Office for Human Research Protections (OHRP)-approved Federalwide Assurance (FWA) (hereafter referred to as the assured institution) may extend - for one or more research protocols - the applicability of its FWA to cover two types of collaborating individual investigators: collaborating independent investigators and collaborating institutional investigators.
Assent Template, Form E
Form E is meant to help investigators in preparing assent forms; the use of this template is not required.
Confidentiality Certificate, Form G
At the discretion of the Chairperson or her/his designee, persons may be permitted to attend/observe HRRC meetings as guests.
Use Supplement 1 if you are requesting Exempt Review. Be sure to attach this supplemental form to the completed "Application Form A".
Use Supplement 2 if you are requesting Expedited Review. Be sure to attach this supplemental form to the completed "Application Form A".
Conflict of Interest Disclosure Statement, Form H
Conflict of Interest Disclosure Supplement, Form H Supplement
Use Form H and Form H Supplement to disclose or deny any financial interest(s) in the research project.