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2003 Guidance on Verifying the Credentials of All Individuals Involved in Human Subjects Research
Verifying the credentials of all individuals involved in human subjects research
Purpose: To implement a credentialing process for all VA research employees working with human subjects and to detail their functions and responsibilities during the conduct of human studies through the development of a Scope of Practice/ Functional Statement.
Who is covered? All individuals involved in human subjects research. Not just the principal investigators, and not just those members of the research team who work directly with patients. This guidance covers research staff who interact with patients on the phone and those who collect and analyze individually identifiable data (including lab data or samples). This guidance applies regardless of pay status, appointment type, and length of time in the VA facility and includes research staff with a Without Compensation (WOC) appointment. This process does not replace the WOC appointment process at your facility.
What is Credentialing? Credentialing is the formal, systematic process of verifying, screening, and evaluating qualifications and other credentials that include education, licensure, relevant training and experience, current competence and health status.
Who is responsible? A Memorandum dated March 6, 2003 and signed by the Deputy Under Secretary for Health (10A) and the Deputy Under Secretary for Health for Operations and Management (10N) ultimately tasked the Network Directors through the facility Directors with the achievement of the goals set out in the Stand Down. Therefore the ACOS/R should immediately make an appointment with the facility Director [and the Chief of Human Resource Management] to review this guidance and determine which office(s) will be responsible for the completion of the credentialing goals set out in the March 6 memo.
What do I need to do? For purposes of credentialing, research staff fall into two broad categories: licensed independent practitioners and other staff, with each category requiring a slightly different process.
Licensed Independent Practitioners (LIP) The term Licensed Independent Practitioner is any individual permitted by law and the facility to provide patient care services independently; i.e., without supervision or direction, within the scope of the individual’s license and in accordance with individually granted clinical privileges. NOTE: Only licensed independent practitioners may be granted clinical privileges. All such individuals will be credentialed through VetPro or it’s paper equivalent. [for additional guidance please see VHA Handbook 1100.19 Credentialing and Privileging, March 6, 2001]
Some facilities have not yet fully credentialed all LIPs through VetPro. You must therefore verify that your research LIPs are in fact in VetPro. Working with your local credentialing office and medical center Director, sites are encouraged to give priority to processing research staff through VetPro so that facilities can meet the goals of the 90-Day Stand Down. The mandate of the Stand Down is to have all individuals involved in human subjects research credentialed by the 90-day deadline.
- Licenses should be confirmed annually
Note: Any research personnel who perform independent clinical activities (judgment based independent of the research protocol) as part of their research activities will be allowed to conduct such activities only if they are credentialed and privileged to provide those activities on patients by the standard credentialing and privileging process of the local facility. Based on state laws and local policy, facilities may vary on who they credential and privilege and who is therefore covered by VetPro. For purposes of this Stand Down, if a clinician would require credentialing through VetPro to perform their activities on patients in a non-research, clinical capacity, VetPro must credential them for purposes of research, and their license status should have been confirmed within the past year.
For all staff engaged in human subjects research and not covered by VetPro, their credentials must also be verified. All such staff will complete an appropriate application(s). Nurses may use VA Form 10-2850a, Optional Application for Federal Employment OF 612 in conjunction with the Declaration for Federal Employment OF 306.
Staff engaged in human subjects research and not covered by VetPro, will provide research service or the medical center director’s designee the following:
The Principal Investigator will provide for each research staff under their supervision:
The Research Service or the medical center director’s designee will verify the following for each research staff:
- Education (that resulted in a degree, certification or license)
- Current Licenses and Certifications
- Create and compile a list of all research employees, check names against Exclusionary Lists
Verification of Education, Certifications and Licenses All education that leads to a degree or certification, and any education or training that is relevant to the activities performed by the employee (such as survey methods, interview skills, etc.) must be documented and verified. Sites are encouraged to work closely with their local credentialing office, which has significant experience in documenting prior education. A modified copy of the Atlanta VA Medical Center Education Verification form is included with this guidance. Sites are welcome to use this form in part or in its entirety. The Education Verification form not only provides the information that you will require to verify educational attainment, but also gives authorization to obtain written verification of the education and other credentials. The form provides space for documenting the verification and the source of the data.
Given the volume of verification required during the Stand Down period, sites are encouraged to initially contact educational sites by mail, with a telephone follow-up 2-3 weeks later. A modified copy of a form letter from VetPro that may be used for this purpose is enclosed. A number of the schools that you may be interested in contacting may be accessed electronically through the National Student Clearinghouse. For a fee (generally $5/verification), you can verify degrees from participating institutions. Clearinghouse records are considered a "Primary Source" and are approved for credential verification by Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Committee for Quality Assurance (NCQA).
If the search for documents is unsuccessful or primary source documents are not received after a minimum of two requests, full written documentation of these efforts, in the form of a report of contact will be placed in the folder in lieu of the documents sought. It is recommended that the individual be contacted and involved in the attempt to obtain necessary documentation. If certificates are presented, the original should be presented and copied and noted as an authentic copy, initialed and dated by the individual making the copy. In addition, verification by an individual who can substantiate the individual's participation in the school/program should be considered and could be obtained through something comparable to a reference letter verifying participation. This individual could be a professor, supervisor, or peer whose own current position can be verified.
If written verification of education is not possible in the time permitted, the employee/applicant's education and degree may be verified over the telephone. Those doing the verification should use the Verification of Education - Report of Contact, which is a paper version of the electronic Report of Contact used by VetPro. It is very important that all the information requested be completed along with the date of the institutional contact. The person contacting the institution should sign the Report. Every effort to get written verification of education/degrees should be made. The written confirmation of education/degree should be placed in the credentialing file when it is received. If written confirmation of education/degree is not possible, this should be explained in the space provided.
If the primary source verification(s) of credentials for an individual are on file (paper or electronic database) at a VA facility, those credentials that were verified at the time of initial appointment, can be considered verified.
- Licenses or certificates that need to be renewed must be confirmed annually
Scope of Practice The Scope of Practice outlines the duties, which the Principal Investigator authorizes the research employee to perform during the conduct of a research project. A Scope of Practice is used for RNs and those with other/advanced medical certifications (NP’s, PA’s, etc.), as well as those staff with no specific clinical certifications but who are engaged in human subjects research. A scope of practice should be developed for each employee, and not each protocol. Research staff involved in multiple studies should have one scope of practice that encompasses all of the routine duties that they are authorized to perform. The Scope of Practice is granted and signed by the Principal Investigator(s) and reviewed and approved by the ACOS/R. A copy of the Atlanta VA Medical Center Scope of Practice for Research Coordinators is included with this guidance. Sites are welcome to use this form in part or in its entirety.
Maintenance of Credentialing Files A copy of all documents, forms, certifications, resumes, and Scope of Practice should be maintained and be retrievable in the research office, or appropriate designated area. For employees subject to credentialing and privileging by another medical center office, the research office need not maintain a separate credentialing file but must be able to attest that all required staff have been credentialed. All current certifications and licenses should be updated and verified at the time of expiration or annually. Any new educational degrees, licenses or certifications, obtained since the last verification should also be confirmed during the next annual review.
Human Resources Process This credentialing process does not relieve VHA medical treatment facilities from any appointment requirements as defined by the Human Resources Management requirements. The HRM Officer will serve as a technical advisor, provide administrative support and training of staff, maintain records and files according to OPM and VA record keeping procedures, and verify that all appointment are made in accordance with appropriate VA policies and procedures.
Exclusionary Lists The List of Excluded Individuals and Entities (also known as the LEIE), the sanctions list or the exclusionary list, is a list of persons and organizations that have been excluded from participation in federal health care programs, e.g., Medicare, Medicaid, VA health care. It is maintained by the Department of Health and Human Services, Office of Inspector General (HHS OIG). Individuals are place on the LEIE for such things as conviction for defrauding Medicare or Medicaid, Patient Abuse, Licensing board actions, or default on government-sponsored student loans. The list is publicly accessible via the HHS website and is updated monthly, though there can be a lag time between when someone is formally "excluded" (or removed from exclusion), and when this is reflected on the website.
The Debarment List is maintained by the Food and Drug Administration (FDA) and includes individuals or firms barred from participating in the drug industry because they have been convicted of crimes related to FDA’s regulation of drugs. From the FDA’s web site you can also review the Disqualified/ Restricted/Assurances List for Clinical Investigators . This list identifies clinical investigators who have, or have agreed to, certain restrictions on their conduct in future studies, as well as access to The Public Health Service Administrative Actions, a list of researchers who have had administrative actions imposed against them by the Office of Research Integrity (ORI).
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