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:
ensure that all research personnel (employees, co-investigators, research project coordinators or students) have been adequately trained to carry out their responsibilities,
report all research project violations and subject complaints to the HRRC,
report research project closures,
obtain HRRC approval prior to making non-emergency changes or revisions to the research project,
provide progress reports at the request of the HRRC (at least annually),
report promptly to the HRRC all unanticipated problems or serious adverse events, and
submit application for continuing review and approval 60 days before current approval expires.
B. Letter of Agreement to Participate in the Proposed Research Project
For research projects that involve DRS facilities, clients and/or employees, the PI must obtain a letter of agreement from DRS. This agreement is separate from the HRRC process and approval, and must be obtained and submitted with the DRS HRRC application. The HRRC application will be considered incomplete without this letter of agreement. PIs are encouraged to contact the HRRC Administrator or HRRC Chairperson if they need assistance in facilitating the process of obtaining division level and commissioner level agreements. The DRS Commissioner has ultimate approval authority regarding agency participation in research projects.
C. Initial Review Submissions
All initial review submissions (new applications) for HRRC review are screened by the HRRC Administrator for complete documentation. The Application Form A for new research projects is available through the HRRC website. Please submit one signed copy and one electronic copy of all application materials. A complete submission for HRRC initial review includes:
DRS HRRC Application Form A
Research Project Approval Letter from another HRRC or IRB to include the full application as submitted to the approving IRB (if applicable)
Principal Investigator's Request for Exempt Review (Supplement 1) or Principal Investigator's Request for Expedited Review (Supplement 2), (if applicable)
Photograph, video and/or audio recording permission form (if applicable)
Complete grant/research project application as submitted to funding source (if applicable)
Letter of Agreement to participate in the research project from the DRS division(s) or WWRC that will be involved in the research project (if applicable)
Each survey, interview questions, tests and/or other tools/instruments used for the research project (if applicable)
Investigator(s)/Research Project Coordinator Proof of Training in federal requirements for Human Research Protections
A list of all fields/elements that will be included in the data set OR the original instrument from which the data were obtained (if an archival data set is being used)
Other materials specific to the proposed research project (e.g., documentation related to cooperative research projects, individual investigator agreement(s), etc. (if applicable)
Complete Conflict of Interest Disclosure Form H
If the application is incomplete or otherwise not fully prepared for review, the HRRC Administrator or HRRC Chairperson will contact the investigator by phone or e-mail requesting clarification, additional information or revisions to document(s) prior to review by the HRRC.
D. Steps for Filing an Initial HRRC Application
Exempt Review Procedures for Investigators
If the investigator thinks that the research project is eligible for an Exempt Review, in addition to the Application (Form A), submit Supplement 1 form to the HRRC for final determination of the appropriate research category and/or approval. Investigators must have an approval letter from the HRRC Chairperson before beginning any research activities.
Expedited or Full Committee Review Procedures for Investigators
The application process is the same for both Expedited and Full Committee Review. However, if the investigator thinks that the research project is eligible for Expedited Review, submit Supplement 2 form in addition to Application Form A. The HRRC Administrator screens all applications to determine completeness and to assign the application to either Expedited or Full Committee Review. The Administrator then either conducts the Expedited Review or schedules a review by the Full Committee. Investigators must have a written approval letter from the HRRC before enrolling subjects in the research project. All consent forms, letters, and recruitment ads to be used must have the HRRC approval stamp before they can be used in the research project. The approval is valid for a maximum time period of one year. If not re-approved by the anniversary date, the investigator must close the research project. Note that approval of an addendum does not constitute re-approval for another year. No consent documents (consent forms/assent forms/cover letters/ads) may be used after the expiration date stamped on the form.
Please submit HRRC research applications to one of the following individuals:
Policy and Planning Division
Department of Rehabilitative Services
8004 Franklin Farms Drive
Richmond, Virginia 23229
Elizabeth Patacca, Human Research and Review (IRB) Elizabeth.Patacca@dars.virginia.gov
Department for Aging and Rehabilitative Services
8004 Franklin Farms Drive
Henrico, VA 23229-5019
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