Paul Kelly

• Facility Research Compliance Officer for the Ralph H. Johnson VA Medical Center

Research at the VA

What is Research?

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

What is VA Research?

• VA research is defined as research that is conducted by VA investigators (serving on compensated, WOC or IPA appointments) while on VA time, utilizing VA resources (VA patients, VA records or VA equipment), and/or on VA property including space leased to, and used by, VA. The research may be funded by VA, by other sponsors, or be unfunded.

Who may conduct VA Research?

• Only VA Employees May Conduct Research at the VA

• VA Employees may be compensated employees, WOC (Without Compensation Employees), IPA Employees and Contract Employees

I Have a Research Project I Want to Do at the VA:

Where Do I Begin?

A proposed research project requires oversight by the VA Research and Development Committee and the Institutional Review Board (IRB).

What is the VA R&D?

The VA R&D Committee is responsible for ensuring the scientific and ethical quality of VA research projects, the protection of human subjects in research, the safety of personnel engaged in research, the welfare of laboratory animals, security of VA data, and the security of VHA research laboratories.

Responsibilities of R&D

• The R&D Committee is responsible, through the COS to the medical center Director, for oversight of the research program and for maintaining high standards throughout the R&D Program

• Research in which the facility is to be engaged may not be undertaken without review and approval of the R&D Committee and its appropriate subcommittees

Subcommittees of the Research & Development Committee

– Subcommittee on Research Safety– Institutional Animal Care and Use

Committee– Institutional Review Board (IRB)

Subcommittee on Research Safety

• Functions as the facility Biosafety Committee

• Reviewing all research activities involving biological, chemical, physical, and radiation hazards for compliance with all applicable regulations, policies, and guidelines

What is the IRB?

The IRB approves research studies, and reviews ongoing studies to ensure human subjects are protected. The IRB is a group of people such as doctors, nurses, pharmacists, scientists, ethicists and people from the local community who ensure that human research is well-planned and ethical.

Can I Just Collect Data When I Want to?

No!No! Each institution engaged in research is required to follow certain federal laws. In order to conduct a project at the Ralph H. Johnson VA Hospital, you must have approval from the IRB and full approval from the VA R&D Committee. Full approval requires approval by both the R&D and IRB Committees. Once this is done you are free to start collecting data.

Do I Need any Type of Training before Starting a

Research Project?

YES!YES! VA regulations require study

personnel (Investigators, coordinators, and technical support) to have training in Human Subject Protection, Privacy, and Information Security prior to research activities. Annual recertification is required.

Required Training

• VA CITI Human Subjects Protection training

• VA Information Security Awareness Training

• VHA Privacy Policy Training

• Information Security 201 for Research and Development Personnel

How do I get Permission to Conduct Research at the

Ralph H. Johnson VA?

Permission requires submission of a research protocol. Refer to the RHJVA web site for a Request to Review package. This package provides guidance on what information and forms are required.

VA Research Website

Located under “Services” tab of home page

Find:

• Policies & Procedures

• Forms

• Training Requirements

• IRB links

VA Research Website

• http://www1.va.gov/CharlestonVAresearch/

• Go to “For Investigators” tab to see:– QA Manual/SOPs– Forms– Committees that review research– Submission deadlines– Training links

R&D Proposal Process

• Research team must complete required training

• Submit R&D Application (Request to Review package)

• Submit IRB Application

R&D Proposal Process cont.

• Receive R&D Approval, if declined, PI works with R&D to Revise

• Submit Initial application to IRB

• Receive IRB Approval, if declined, make revisions for full approval

• Submit to R&D for Full Approval

• Start Protocol

Data Security

• Identifiable VA Protected Health Information (PHI) may not be removed from the VA without prior written approval from the VA Medical Center Director, the Associate Chief of Staff/Research, the VA Information Security Officer and the VA Privacy Officer

Data Security-VA PHI cont

• Does not apply to “VA Leased Space” such as the Strom Thurmond Building

• Does not apply when a partial off-site waiver has been obtained

• Does not apply if the data has been de-identified

Credentialing & Privileging

Physicians (MD or DO), Psychologists, Social Workers, Nurses (RN or LPN), Nurse Practioners, Physicians Assistants, Dentists, Podiatrists, and PharmDs (or any other licensable professional) must be credentialed and privileged through the VA before they begin seeing patients

Computer Access At the VA

• You must submit a separate request for computer access at the VA

• You should submit this with your WOC package

• Once you have access to the VA Computer system, you must log in every 30 days or your account will be terminated

Documenting Research Study Visits in CPRS

• All research study visits should be documented in CPRS

Documenting the Consent Process• The Research Informed Consent Process Must be

Documented in CPRS or the Study File• The following must be documented:

– The name of the study– The person obtaining the subject’s consent– A statement that the subject or the subject’s legally-

authorized representative was capable of understanding the consent process

– A statement that the study was explained to the subject, and – A statement that the subject was given the opportunity to ask

questions– An entry must also be placed in the progress note when the

human subject is actually entered into the study and when the human subject’s participation is terminated

Flagging

• Individual records of VA patients participating in research studies must be “flagged”

• Requests for exemption from this regulation must be submitted in writing to the R&D committee

Contact Personnel

• Paul Kelly

Research Compliance Officer

789-6708

• Rudell Ryant, R&D Coordinator

789-6711