DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER. Oklahoma City, Oklahoma. 02/01/2009 Center Memorandum

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1 DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER Oklahoma City, Oklahoma 02/01/2009 Center Memorandum /DJS:dt CREDENTIALING OF PERSONNEL INVOLVED IN HUMAN SUBJECTS RESEARCH 1. Summary: Center Memorandum dated February 1, 2005 is hereby reinstated with changes. 2. Purpose: To establish a service level policy that identifies the personnel involved in human subjects research that must have their credentials verified and the process for verifying such credentials consistent with VA policy. This policy assures that the education, certification(s) and license(s) of all personnel involved in human subjects research will be verified and files maintained to help assure personnel are appropriately educated, certified, and/or licensed to effectively and safely perform human research at the Oklahoma City VA Medical Center (OKC VAMC). 3. Policy: Personnel involved in human subjects research at the OKC VAMC must have their credentials verified to ensure appropriate completion of stated education, certification(s) and license(s), prior to working on Research and Development Committee (R&D) approved research projects. Participation on R&D approved research projects is contingent upon successful completion of credentialing requirements. 4. Procedures: a. Personnel involved in OKC VAMC R&D approved human subjects research projects must complete the credentialing requirements. These individuals include VAMC employees and Without Compensation (WOC) employees. Involvement in a human research project includes: (1) Research staff that interact with OKC VAMC patients via telephone or in person; (2) Research staff that collect and analyze identifiable VA patient laboratory specimens or VA patient data; (3) Research staff with a Without Compensation (WOC) appointment; b. Personnel involved in VA R&D approved human subjects research projects that are NOT required to complete the credentialing requirements: (1) Members of the research team who are strictly administrative staff, e.g., receptionist, including any individuals that may have contact with a patient for scheduling purposes only. (2) Members of the research team who are based at an affiliate or other outside institution, and who do not interact with OKC VAMC research participants and are NOT listed on the projects delegation of authority. (3) Co-investigators who do not do work at the OKC VAMC. An OKC VAMC researcher may collaborate with researchers from outside the medical center, but the VA portion of the study is conducted at the OKC VAMC with medical center personnel. The outside people may be co-investigators on

2 Page 2 of 6 a VA study, and have their names listed on the informed consent form(s) given to VA enrollees, but if the outside researchers do not come to the OKC VAMC to perform the research or enroll VA patients, OKC VAMC credentialing does not apply. (4) Outside biostatisticians, e.g. VA researchers may send their data (when all VA sensitive data requirements are met) to an affiliate or other outside-based statistician for processing. (5) Outside lab technicians (e.g., VA researcher may send approved VA specimens to be processed at an affiliate or other outside lab). (6) Volunteers from the community who serve on the R&D Committee. (7) Members of groups like Data Safety Monitoring Boards (DSMB) who are recruited from non-va institutions. (8) Clinical personnel who periodically perform tests on research patients as part of their routine jobs (e.g., x-ray, nuclear medicine, or medical laboratory technologists who occasionally perform a test on a research patient as part of their routine clinical duties). The credentials and qualifications of these individuals were validated when they were initially appointed as federal employees. c. Personnel credentialed in VetPro: (1) All health care professionals who claim licensure, certification or registration as applicable to their position within VHA. (2) All research staff that holds a degree that may make them eligible for licensure, registration, or certification. Such persons would include but is not limited to: nurses, physicians, Foreign Medical Graduates, Clinical Psychologists, and pharmacists that do not have a current active license. Note: See VHA Directive for a more complete list. (a) Clinical Privileges; If the person s license allows for independent practice and the facility chooses to allow independent practice, privileges must be granted in accordance with VHA Handbook and the facility s Medical Staff Bylaws, Rules and Regulation prior to performing the interventions covered under the privileges they have been granted. (3) All research staff including research administrative personnel, who by the nature of their position have the potential to assume patent care-related duties, or oversee the quality or safety of the patient care delivered, e.g. Research Assistants, Project Officers, etc. (4) Personnel who have been previously credentialed through VetPro do not need to complete additional credentialing requirements outlined in this policy. d. VA Employees involved with VA R&D approved human research projects (Exception: The employee is or will be credentialed through VetPro): (1) VA employees must complete and submit the following to the Research Service: (a) Scope of Practice form (Attachment A ) signed by the Supervisor/Principal Investigator; A Scope of Practice or Functional Statement outlines all the duties of employees. These duties

3 Page 3 of 6 must: 1) be consistent with the occupational category under which they are hired, 2) allowed by the license, registration, or certification they hold, 3) consistent with their qualifications (education & training), and 4) be agreed upon by the person s immediate supervisor and the ACOS. Individuals must not practice beyond the occupation they are hired/appointed into and their Scope of Practice or Functional Statement. Note: When working on specific research protocols, the Principal Investigator for each protocol must also agree. or license earned; supervised setting). (b) (c) (d) Education Verification form (Attachment B ) for each degree, certification, Release of Information Form (Attachment C ); and Copy of Professional License (if required for interaction with patients in a (2) The Scope of Practice form will be signed by the ACOS/R&D. (3) A human subjects research credentialing file for the individual will be maintained by the Research Administration Office. (4) Copy of Curriculum Vitae (if available). e. WOC employees must complete and submit the following to the Research Service: (1) Copy of Curriculum Vitae (if available); and (2) The Research Service will verify education and/or certification(s) declared. (3) The Scope of Practice form will be signed by the ACOS/R&D. (4) All documentation will be maintained in a human subjects research credentialing file for the individual by the Research Service. f. Education Verification: (1) Attendance, education, and/or degrees earned as declared by personnel on the Education Verification form will be verified at the primary source. (2) Personnel who have not completed education or received a degree from a higher source of education than high school, shall have the Supervisor provide a written declaration that the individual is capable of performing the duties required of the position and declare that the individual has or will be trained appropriately. (3) Acceptable verification sources include: (a) (b) (c) National Student Clearinghouse: AACRAO Enrollment Services: Credentials, Inc.: and

4 Page 4 of 6 (d) Direct communication (via fax, telephone, , transcript, website, etc.) with the educational institution or the appropriate record retention warehouse. (4) Two attempts will be made to verify each education component identified on the Education Verification form or VA application. If these two attempts are unsuccessful, a good faith effort has been made consistent with VA guidelines. (5) Written documentation of verification(s) should be received. If written documentation cannot be obtained in a reasonable time frame, verbal verification is appropriate. (6) All attempts of education verification will be filed appropriately in the personnel s human subjects research credentialing file. g. Without Compensation (WOC) Appointments: (1) Individuals who are not VA employees, credentialed through VetPro, or the VA Credentialing Office and are working on VA R&D approved research projects must have a WOC appointment. (2) The Research Service will initiate and follow-up on the status of the WOC appointment for individuals requiring a WOC appointment through the Research Administration Office. h. Background Investigations: Individuals involved in human subjects research must have background investigations that are related to the risk level of their position. This is part of the normal VA hiring process. Research Service will adhere to the Human Resources Division policies for background investigations, consistent with VA policy. (1) VA employees have a full background investigation. (2) All individuals with a WOC appointment must be fingerprinted. If the results of the fingerprinting are questionable, a full background investigation must be completed. i. Record Retention: Research credentialing files will be maintained for six years after the termination date of the appointment. 5. Responsibilities: a. The Medical Center Director (MCD) is responsible for ensuring that all VA research staff defined in section 4, have been credentialed, including completion of credentialing using the VetPro, according to the occupational category consistent with their education and training. In addition, the MCD is also responsible for the following: (1) Ensuring that individuals participating in VA approved research have been credentialed prior to appointment or initiation of a detail if detailed under an Intergovernmental Personnel Agreement (IPA). (2) Ensuring that appropriate resources are available for the facility to comply with credentialing requirements. for: b. The Associate Chief of Staff for Research & Development (ACOS/R&D) is responsible

5 Page 5 of 6 (1) Completing credentialing requirements as defined by national and local policy. (2) Developing and managing credentialing policies and procedures for personnel involved in human subjects research at the VA. (3) Ensuring all personnel involved in human subjects research at the VA have completed the appropriate credentialing requirements consistent with VA policy. credentialing. (4) Overseeing the development and maintenance of a tracking system for research c. The Administrative Officer for Research & Development (AO/R&D) is responsible for: (1) Overseeing the Research Service staff involved with the credentialing of personnel involved in human subjects research. (2) Reporting to the RCO any non-compliance in credentialing research staff. d. The Research Compliance Officer (RCO) is responsible for: (1) Validating the education, certification(s), and/or license(s) as reported on the Education Verification form or VA Employee Application(s) for personnel involved in human subjects research at the VA. (2) Maintaining an active database to monitor personnel compliance with the credentialing requirements. (3) Informing the AO/R&D and ACOS/R&D of areas of non-compliance with credentialing requirements. (4) Verifying annually that the license(s) and certification(s) of those individuals not in VetPro are still current and in good standing. (5) Checking with the VA Credentialing office to see if employee is credentialed through VetPro. (6) Contacting the ACOS/Education office to see if employee has a Resident Credentialing Verification Letter (RCVL) on file. e. Supervisors of research personnel are responsible for: (1) Ensuring that each individual is credentialed prior to beginning any research duties. (2) Developing a Scope of Practice for each individual. The Scope of Practice must be consistent with the position to which the individual is appointed and may not include any duties or procedures for which a license, certification, or registration is required and not held. remains appropriate. (a) The Scope of Practice must be reviewed at least annually to ensure that is

6 Page 6 of 6 (b) assigned or others deleted. (c) any changes are made to it. The Scope of Practice must be amended as applicable when new duties are Reviews of the Scope of Practice must be documented and notation made if (d) The Scope of Practice must be signed by the individual to whom it pertains, and it must be approved by the individual s supervisor and the ACOS/R&D. In addition it must also be reviewed by the Principal Investigator(s) (PI) of all protocols for which the individual perform duties or procedures. (e) PIs are responsible for the conduct of their research protocols, including ensuring that research staff supporting the protocol perform only within their individual Scopes of Practice, adhere to all protocol specifications, and comply with all other applicable requirements. f. The Purchasing Agent, Research is responsible for: (1) Identifying, initiating, processing and following-up with personnel involved in human subjects research at the VA required to have Without Compensation (WOC) appointments. (2) Monitoring personnel compliance with WOC appointments (3) Informing the RCO, AO/R&D and ACOS/R&D of areas of non-compliance with WOC requirements. 6. References: (4) Working with Human Resources to ensure the WOC appointments are complete. (5) Maintaining updated WOC files. (a) Credentialing of Personnel Involved in Human Subjects Research Memorandum from the Deputy Under Secretary for Health Operations and Management. (b) Stand down requirements website: 7. Concurrences: Endorsed by the Research & Development Committee on 03/04/ Rescission: None 9. Follow-Up Responsibility: ACOS /Research and Development (151) 10. Renewal Date: February 1, DAVID P. WOOD, MHA, FACHE Medical Center Director

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