Department of Veterans Affairs 

Office of Inspector General 

Healthcare Inspection 

Scopes of Practice for Unlicensed 

Physicians Engaged in 

Veterans Health Administration 

Research Activities 

Report No. 07-01202-124 May 7, 2008

VA Office of Inspector General 

Washington, DC 20420 
To Report Suspected Wrongdoing in VA Programs and Operations 

Call the OIG Hotline – (800) 488-8244 
Scopes of Practice for Unlicensed Physicians in Engaged in VHA Research Activities 

Executive Summary 

We determined in a previous inspection that certain unlicensed physicians functioned 

outside their scopes of practice, engaging in activities that may constitute the practice of 

medicine. In an effort to identify whether this problem was systemic in nature, we 

initiated a Combined Assessment Program (CAP) focused review, which began June 1, 

2007, to evaluate whether this problem existed at additional facilities. The purpose of 

this review was to determine whether research activities performed by unlicensed 

physicians fell outside their scopes of practice, as determined by state law. 

We performed this review in conjunction with 14 CAP reviews of VA medical facilities 

conducted from June 1, 2007, through September 30, 2007. We found that 5 of the 

14 facilities did not employ unlicensed physicians in their research departments. The 

remaining 9 facilities identified 25 unlicensed physicians assigned to 59 human subjects 

research studies. 

We did not find evidence that unlicensed physicians, with the exception of one, were 

performing activities that would constitute the practice of medicine. However, the 

majority of the scopes of practice were not in compliance with the Office of Research and 

Development’s (ORD) 2003 guidance in one or more criteria and occasionally did permit 

providers to engage in activities generally performed by licensed personnel, such as 

nurses. 

We did not find uniform documentation of educational verification. The lack of a clearly 

defined, published Veterans Health Administration (VHA) policy for educational 

verification of unlicensed physicians functioning as research assistants is also 

symptomatic of the lack of policy and guidance in this area on a national level. VHA’s 

Office of Research Oversight does not consider that guidance posted on ORD’s website 

has the full force of formal VHA policy 

We recommended that the Under Secretary for Health ensure that the scopes of practice 

for all research personnel engaged in research activities do not permit activities requiring 

licensure. We further recommended that the credentialing of unlicensed personnel 

engaged in research involving human subjects complies with the requirements of VHA 

policy. 

VA Office of Inspector General i 
DEPARTMENT OF VETERANS AFFAIRS

Office of Inspector General 

Washington, DC 20420 

TO: Under Secretary for Health 

SUBJECT: Healthcare Inspection – Scopes of Practice for Unlicensed Physicians 

Engaged in Veterans Health Administration Research 

Purpose 

The Department of Veterans Affairs, Office of Inspector General (OIG), Office of 

Healthcare Inspections (OHI) completed a review of Veterans Health Administration 

(VHA) medical facilities’ unlicensed physicians’ practices in human subjects research. 

The purpose of this review was to determine whether research activities performed by 

unlicensed physicians fell outside their scopes of practice, as determined by state law. 

Background 

During the course of an inspection generated by a confidential complainant, OHI 

determined that certain unlicensed physicians involved in research studies were 

conducting activities traditionally considered to constitute the practice of medicine, such 

as performing invasive procedures, conducting physical examinations, and altering 

medications. In an effort to identify whether this problem was systemic in nature, we 

initiated a Combined Assessment Program (CAP) focused review, which began 

June 1, 2007, to evaluate whether this problem existed at additional facilities. 

Research is one of the core missions of VHA. Every research project in VHA is headed 

by a principal investigator (PI), who is ultimately responsible for protecting the rights of 

human research subjects involved in the project in accordance with the Common Rule 

(45 C.F.R.1

 46 Subpart A) as adopted by VA at 38 C.F.R. 16. 

The Common Rule is a set of Federal regulations that contains numerous requirements 

for the protection of human subjects, including the requirement that all researchers 

(known as investigators) have the requisite skills, training, and experience to conduct the 

research. PIs often have several other investigators working with them on a given 

 

1

 C.F.R. is the Code of Federal Regulations, which codifies all rules of the executive departments and agencies of 

the Federal government. It is divided into fifty volumes, which are known as titles. 

VA Office of Inspector General 1 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities 

project. Investigator refers to “an individual performing various tasks related to the 

conduct of human subjects research activities, such as obtaining informed consent from 

subjects, interacting with subjects, and communicating with the Institutional Review 

Board (IRB).”2

 

An IRB is a committee of researchers and community members that is charged with 

ensuring the protection of human subjects at a given facility. VA facilities may utilize 

their own IRB to review research involving human subjects or they may use an affiliated 

university’s IRB, providing that the university IRB complies with all applicable 

VA-specific regulations. Investigators may include research assistants, who are hired to 

perform certain tasks related to research projects. Examples of these tasks would include 

obtaining informed consent from individuals participating in a research project, asking 

research subjects questions related to the research, and compiling and managing data 

relevant to the projects. Research assistants may be licensed personnel, such as nurses or 

respiratory therapists, or they may be unlicensed personnel, such as individuals who 

obtain medical degrees in other countries but have not obtained licensure as physicians in 

the United States. Regardless of their licensure status, they are considered investigators 

within the meaning of the Common Rule if they are engaged in human subjects research. 

Research assistants, including unlicensed physicians, operate under a scope of practice. 

“Scope of practice” is a term used to describe activities that may be performed by health 

care workers regardless of whether they are licensed independent health care providers. 

The scope of practice is specific to the individual and the facility involved. 

A facility may not grant to an unlicensed individual a scope of practice permitting him or 

her to engage in activities that would otherwise require licensure or certification. We 

were unable to locate any specific guidance from the National Institutes of Health (NIH), 

the National Science Foundation, or any other Federal agency specifically addressing the 

appropriate scope of practice for unlicensed physicians functioning as research assistants. 

Activities constituting the practice of medicine are defined by state law and vary from 

state to state. 

Because unlicensed physicians are not licensed independent health care providers or 

individuals claiming licensure, registration, or certification, neither the provisions of 

VHA Directive 2006-067, Credentialing of Health Care Professionals,

3

 nor the 

requirements of VHA Handbook 1100.19, Credentialing and Privileging,

4

 clearly 

applied to the process of granting these individuals a scope of practice. We do note that 

under the revised version of VHA Handbook 1100.19, issued October 2, 2007, the 

credentialing of unlicensed research personnel must now follow the requirements of this 

 

2

 U.S. Department of Health and Human Services, Office for Human Research Protections, “Who are 

‘investigators’?” Human Research Questions and Answers, http://answers.ohrp.hhs.gov. 3

 Issued December 22, 2006. 

4

 Issued March 6, 2001. We note that the policy has since been revised as of October 2, 2007, but we applied the 

2001 version as this was in effect at the time of this review. 

VA Office of Inspector General 2 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities 

Handbook. While this version of the Handbook was not in effect at the time of this 

review, we do note that a January 22, 2007, VHA Office of Research and Development 

(ORD), Field Conference Call, stated that VHA Directive 2006-067 did apply “to all 

research staff including research administrative personnel, who by the nature of their 

position have the potential to assume patient care-related duties.” This communication 

further provided an example of an unlicensed physician performing phlebotomy, stating 

that the unlicensed physician would be required to meet all the requirements that a 

phlebotomist would have to meet. ORD also stated that it would now require that 

unlicensed physicians, among others, be credentialed through VetPro. 

VetPro is a computer program used in the VA for the credentialing of licensed 

independent health care providers. It contains information on licensure, disciplinary 

actions, and education. In addition, on March 2, 2007, VHA published 

Handbook 1200.1, The Research and Development Committee Handbook. This 

handbook requires the facility Research and Development (R&D) Committee to conduct 

an annual quality assurance review of research employees involved in human subjects 

research “to ensure the employees are working within their scopes of practice and their 

privileges allowed by the facility’s By-laws and granted to them by the facility.” 

The web-based 2003 Guidance on Verifying the Credentials of All Individuals Involved in 

Human Subjects Research,5

 which was created by ORD, stated that all individuals 

engaged in human subjects research who are not licensed independent health care 

providers must provide the facility’s Research Service or the facility Director’s designee 

with a dated copy of a curriculum vitae or resume, an education verification form, and a 

completed Standard Form (SF) 85, “Questionnaire for Non-Sensitive Positions.” The PI 

provides scopes of practice for research staff under his or her supervision. The 

requirement for verification of education applies to all “education that leads to a degree 

or certification, and any education or training that is relevant to the activities performed 

by the employee.” In addition, the guidance requires that all documents pertaining to 

credentialing be maintained and retrievable in the facility’s research office unless the 

individual is subject to credentialing and privileging by another facility’s office. VHA’s 

Office of Research Oversight (ORO)6

 does not consider that guidance posted on ORD’s 

website has the full force and effect of formal VHA policy. 

Scope and Methodology 

We performed this review in conjunction with 14 CAP reviews of VA medical facilities, 

which were conducted from June 1, 2007, through September 30, 2007. The facilities we 

visited represented a mix of facility size, affiliation, geographic location, and Veterans 

Integrated Service Network (VISN). The OIG generated an individual CAP report for 

 

5 http://www.research.va.gov/programs/pride/credentialing/guidance.cfm. 6

 ORO is the primary VHA office on matters of compliance and assurance regarding human subject protections, 

animal welfare, research safety and security, research data security, and research misconduct. 

VA Office of Inspector General 3 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities 

each facility. For this report, the data from the individual facility CAP reviews were 

analyzed as a whole for the purpose of system-wide trend identification. 

We reviewed 437 medical records of patients who consented to participate in human 

subjects research as well as R&D Committee files for those protocols. In order to 

determine if the use of unlicensed physicians complied with the national policy and 

ORD’s guidance, we reviewed each facility’s local policies and procedures, patients’ 

signed consent forms, scopes of practice, and documentation of unlicensed physicians’ 

education. 

Five of the 14 facilities did not employ unlicensed physicians in their research 

departments. The remaining nine facilities identified 25 unlicensed physicians assigned 

to 59 human subjects research studies. We validated our data during our briefings with 

facility managers at each site; all concurred with our findings. 

This review was performed in accordance with the Quality Standards for Inspections

published by the President’s Council on Integrity and Efficiency.

Results and Conclusions 

Issue 1: Activities Performed by Unlicensed Physicians That May Have Required 

Licensure. 

With the exception of one, we found no evidence that unlicensed physicians functioning 

as research assistants performed activities that could require medical licensure. The one 

unlicensed physician (hereafter Researcher 1) identified as potentially performing 

activities that required licensure performed physical examinations in the absence of a 

licensed independent provider. Initially, the facility defined Researcher 1’s scope of 

practice to include performing physical examinations. Prior to our arrival onsite, the 

facility took action to stop Researcher 1 from performing this activity. Additionally, 

facility managers revised the scopes of practice for all unlicensed physicians to exclude 

this function. 

Issue 2: Scopes of Practice of Unlicensed Research Personnel That Permitted 

Activities Generally Requiring Licensure or Certification. 

The 2003 guidance on verifying the credentialing of all individuals involved in human 

subjects research, posted on the ORD’s website, requires that the PI provide a scope of 

practice for research staff under his or her supervision. The scope of practice is granted 

and signed by the PI and reviewed and approved by the Associate Chief of Staff (ACOS) 

for R&D. All education that leads to a certification and any education or training that is 

relevant to the activities performed by the employee (such as venipuncture and 

technological skills) must be documented and verified. 

VA Office of Inspector General 4 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities 

After identifying the activities of unlicensed physicians functioning as investigators, we 

then sought to determine whether these activities were appropriate for their scopes of 

practice. All but one unlicensed physician had a scope of practice. The facility reported 

that this unlicensed physician was a PI on another study; therefore, a scope of practice 

was not deemed necessary. 

We found elements in some scopes of practice that were inappropriately granted. In total, 

16 of 25 scopes of practice were not in compliance with the 2003 guidance in one or 

more criteria. Review of the documents disclosed that unlicensed physicians were 

granted privileges to: 

• Initiate intravenous (IV) therapy and administer IV solutions and medications. 

• Perform venipuncture. 

These activities generally require licensure or specialized training. Several scopes of 

practice were not signed by the ACOS for R&D, and one was not signed by the 

unlicensed physician. 

Issue 3: Educational Verification of Unlicensed Physicians. 

We did not find uniform documentation of educational verification. All education that 

leads to a degree or certification and any education or training that is relevant to the 

activities performed by the employee must be documented and verified. If certificates are 

presented, the original should be copied and noted as authentic; it should also be initialed 

and dated by the individual making the copy. In addition, verification by an individual 

who can substantiate the individual unlicensed physician’s participation in the 

school/program should be considered and could be obtained through something 

comparable to a reference letter verifying participation. This verifying individual could 

be a professor, supervisor, or peer whose own current position can be verified. 

We found that the diplomas and certifications presented by the unlicensed physicians 

were not true certified copies. In addition, the education verification forms were not 

signed by a research official to designate completion of the verification process. While 

these deficiencies were noted in educational verification processes, however, we note that 

VHA Handbook 1100.19 now requires this process to be executed through VetPro, which 

may alleviate concerns raised by our findings in this area. 

Conclusions 

The lack of a clearly defined, published VHA policy for educational verification of 

unlicensed physicians functioning as research assistants is also symptomatic of the lack 

of policy and guidance in this area on a national level. While the revised version of VHA 

Handbook 1100.19, dated October 2, 2007, represents a significant improvement in 

policy guidance for the credentialing (including educational verification) of research 

VA Office of Inspector General 5 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities 

personnel, we are concerned about the scopes of practice identified in this report which 

permitted unlicensed individuals to perform activities which might require licensure 

under other applicable laws. VHA Handbook 1200.1, dated March 2, 2007, requires 

R&D Committees to conduct annual quality assurance reviews to ensure that research 

employees work within their scopes of practice, but does not address the problem of 

ensuring that activities permitted under an individual’s scope of practice do not require 

licensure. A scope of practice permitting an unlicensed individual to administer IV 

medications, for example, would not be consistent with the guidance of many state 

licensure authorities. We therefore made the following recommendations: 

Recommendations 

Recommendation 1. We recommended that the Under Secretary for Health ensure that 

the scopes of practice for unlicensed research personnel do not permit activities requiring 

licensure. 

Recommendation 2. We recommended that the Under Secretary for Health require 

Medical Center Directors to ensure that the credentialing of unlicensed personnel 

engaged in research involving human subjects complies with the requirements of VHA 

Handbook 1100.19, dated October 2, 2007. 

Comments 

The Under Secretary for Health concurred with the findings and recommendations and 

submitted appropriate action plans. (See Appendix A, pages 7–10, for the full text of the 

Under Secretary’s comments.) We will follow up on the planned actions until they are 

completed. 

 (original signed by:)

JOHN D. DAIGH, JR., M.D. 

Assistant Inspector General for 

Healthcare Inspections 

VA Office of Inspector General 6 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities 

Appendix A 

Under Secretary for Health Comments 

Department of 

Veterans Affairs Memorandum

Date: April 3, 2008 

From: Under Secretary for Health (10) 

Subject: OIG Draft Report, Healthcare Inspection: Scopes of Practice for 

Unlicensed Physicians Engaged in Veterans Health Administration 

Research Activities, Project No.: 2007-01202-HI-0290, 

(WebCIMS 400383)

To: Assistant Inspector General for Healthcare Inspections (54) 

1. I have reviewed the draft report, and I concur with the report and 

recommendations. I agree that scopes of practice for unlicensed individuals 

performing activities within the Veterans Health Administration should be 

consistent with the guidance of other applicable laws. 

2. To further ensure that unlicensed physicians engaged in research 

activities are not engaging in activities that require licensure, the Office of 

Research and Development will issue a new Directive that will require all 

unlicensed physicians to be credentialed through VetPro. The credentialing 

of research staff, including unlicensed physicians, has been required since 

2003, but not all are credentialed using VetPro. The new Directive will 

require that all currently employed unlicensed physicians be placed in 

VetPro within 90 days of the issuance of the new Directive. 

3. In addition, this new guidance will also require that immediate 

supervisors develop a scope of practice and a description of research duties 

for each unlicensed physician. The Associate Chief of Staff for Research 

and Development must approve the scope of practice as appropriate for the 

position held by the unlicensed physician. Further, medical center 

Directors will be required to approve the appointment of all unlicensed 

physicians and review the steps taken to credential the unlicensed 

physician. Once the Directive has been published, the Office of Research 

Oversight will be responsible for the oversight and compliance with the 

policies therein. 

VA Office of Inspector General 7 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities

4. I believe that improved guidance and increased oversight of the 

credentialing process and the scope of practice development for unlicensed 

physicians will increase compliance with VHA Handbook 1100.19, 

Credentialing and Privileging, and applicable licensure laws. Thank you 

for the opportunity to review the draft report. If you have any questions, 

please contact Margaret M. Seleski, Director, Management Review Service 

(10B5) at (202) 565-7638. 

 (original signed by:) 

Michael J. Kussman, MD, MS, MACP 

Attachment 

VA Office of Inspector General 8 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities 

Under Secretary for Health’s Comments 

to Office of Inspector General’s Report 

Action Plan in Response to OIG Draft Report, Scopes of Practice for 

Unlicensed Physicians Engaged in VHA Research Activities 

(WebCIMS 400383) 

Project No.: 2007-01202-HI-0290 

Date of Report: February 29, 2008 

Recommendations/ Status Completion Date 

Actions 

Recommendation 1. We recommended that the Under Secretary for 

Health ensure that the scopes of practice for unlicensed research personnel 

do not permit activities requiring licensure. 

Concur 

The Office of Research and Development is developing a new policy that 

will address the issue of credentialing of research staff including unlicensed 

physicians and other unlicensed research staff. In addition, the policy will 

address the concept of a Scope of Practice for research staff members. This 

Scope of Practice would describe the staff member’s research duties and 

responsibilities as well as define what research procedures they can 

perform. 

The Scope of Practice would be consistent with the occupational category 

under which the staff member was hired, consistent with their 

qualifications, and be developed by the staff member and immediate 

supervisor. It would also be reviewed at intervals and undated as 

necessary. For unlicensed physicians the content of the Scope of Practice 

would not contain any duties that would constitute the practice of medicine. 

In process Completion date: August 31, 2008 

VA Office of Inspector General 9 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities

Recommendations/ Status Completion Date 

Actions 

Recommendation 2. We recommended that the Under Secretary for 

Health require Medical Center Directors to ensure that the credentialing of 

unlicensed personnel engaged in research involving human subjects 

complies with the requirements of VHA Handbook 1100.19, dated 

March 2, 2007. 

Concur 

The new policy will address the credentialing of unlicensed personnel in 

VetPro. The medical center Director as the Institutional Official 

responsible for the facility’s research program and its compliance with all 

policies would also be responsible for this aspect of the research program 

and the compliance with VHA Handbook 1100.19, dated March 2, 2007, 

Credentialing and Privileging. 

In process Completion date: August 31, 2008 

VA Office of Inspector General 10 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities 

Appendix B 

OIG Contact and Staff Acknowledgments 

OIG Contact Marisa Casado 

Director, OHI Follow-Up 

202 461-4705 

Acknowledgments Annette Acosta 

Daisy Arugay 

Andrea Buck, M.D., J.D. 

Dorothy Duncan 

Jennifer Kubiak 

James Seitz 

Wilma Reyes 

Annette Robinson 

Christa Sisterhen 

Toni Woodard 

VA Office of Inspector General 11 
Scopes of Practice for Unlicensed Physicians Engaged in VHA Research Activities

Appendix C 

Report Distribution 

VA DistributionVA Distribution

Office of the Secretary 

Veterans Health Administration 

Assistant Secretaries 

General Counsel 

Non-VA Distribution

House Committee on Veterans’ Affairs 

House Appropriations Subcommittee on Military Construction, Veterans Affairs, and 

Related Agencies 

House Committee on Oversight and Government Reform 

Senate Committee on Veterans’ Affairs 

Senate Appropriations Subcommittee on Military Construction, Veterans Affairs, and 

Related Agencies 

Senate Committee on Homeland Security and Governmental Affairs 

National Veterans Service Organizations 

Government Accountability Office 

Office of Management and Budget 

This report is available at http://www.va.gov/oig/publications/reports-list.asp. 

VA Office of Inspector General 12