Department of Veterans Affairs 

Office of Inspector General 

Healthcare Inspection 

Research Practices at 

Carl T. Hayden VA Medical Center 

Phoenix, Arizona 

Report No. 07-00589-118 April 20, 2007

VA Office of Inspector General 

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

Call the OIG Hotline – (800) 488-8244 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Executive Summary 

The Office of Inspector General received allegations of research improprieties at the 

Carl T. Hayden VA Medical Center in Phoenix, AZ. We substantiated that one 

unlicensed physician performed muscle biopsies, conducted history and physical 

examinations, and changed medications in accordance with research protocols. We 

identified a second unlicensed physician who had a scope of practice that allowed similar 

activities. (“Scope of practice” is a term used to describe activities that may be 

performed by health care workers, whether they are licensed independent health care 

providers or not.) Additionally, a nurse involved in the same protocol performed 

functions that were not included in her scope of practice. Laboratory data for a study 

involving non-veterans had not been reviewed in a timely manner. We substantiated that 

the facility did not maintain accurate inventories of tritium, a substance that emits low 

levels of radiation, in a manner consistent with VA policies and procedures. The facility 

failed to maintain an accurate inventory of tritium contaminated solid wastes. We could 

neither substantiate nor refute that a research official voted on his own grant as a result of 

the facility’s failure to maintain voting records; however, his position on the Board of 

Directors of the VA-affiliated nonprofit corporation could be an appearance of a conflict 

of interest. 

Based upon the issues in our review, we made the following recommendations: 

(1) prevent unlicensed physicians working in VA research from engaging in activities 

that constitute the practice of medicine; (2) establish procedures for ensuring that the 

storage, use, and disposal of radioactive wastes are managed in compliance with all 

applicable VA and Federal regulations and policies; (3) ensure that researchers have the 

requisite skills, training, and experience to conduct the research in accordance with the 

requirements of VA policy; (4) clearly delineate the responsibilities of VA laboratories 

for patient notification of abnormalities in certain situations; and (5) define conflict of 

interest in terms applicable to research activities of VA medical centers and VA-affiliated 

nonprofit corporations. 

Managers concurred with the findings and recommendations of this inspection. We 

believe that their comments, along with their corrective action plans, meet the intent of 

our recommendations. We will follow up on all planned actions until they are completed. 

VA Office of Inspector General i 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

DEPARTMENT OF VETERANS AFFAIRS

Office of Inspector General 

Washington, DC 20420 

TO: Director, Veterans Integrated Service Network (10N18) 

SUBJECT: Healthcare Inspection – Research Practices at Carl T. Hayden VA 

Medical Center, Phoenix, Arizona 

Purpose 

The VA Office of Inspector General (OIG), Office of Healthcare Inspections (OHI) 

conducted an inspection to determine the validity of allegations concerning research 

improprieties at Carl T. Hayden VA Medical Center (hereafter the facility) and its VAaffiliated nonprofit corporation, Carl T. Hayden Medical Research Foundation (hereafter 

CTHMRF). 

Background 

OHI received a complaint concerning potential violations of Veterans Health 

Administration (VHA) policy in four areas: (1) the facility’s program for the protection 

of human subjects engaged in research, (2) credentialing and privileging of research 

personnel, (3) the use and storage of radioactive materials, and (4) conflict of interest in 

the setting of a VA-affiliated nonprofit corporation (NPC)1

. 

Specifically, the complainant alleged: 

• Researchers violated human subject protection and research safety policies, 

procedures, and regulations by: (1) allowing unlicensed personnel to perform muscle 

biopsies (Protocols A, B, and C), (2) utilizing radioactive materials in a manner not 

consistent with VHA policies and procedures (Protocol C), and (3) publishing 

research not previously approved by the facility’s Institutional Review Board (IRB) 

(Protocol D). 

 

1

 VA-affiliated nonprofit corporations (NPCs) are also called nonprofit research corporations. 

VA Office of Inspector General 1 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

• The facility’s IRB inconsistently applied available penalties for these violations, 

barring one principal investigator (PI)2

 from research for publication of an 

unapproved abstract (Protocol E), while not penalizing the researchers involved in 

Protocols A through D. This is alleged to have resulted in delayed implementation of 

Protocol E, contributing to two patient deaths because they were unable to enroll in 

the study. 

• A research official used his position as a member of the Board of Directors of 

CTHMRF to vote on matters in which he had a financial interest in violation of 

VHA’s conflict of interest policies and procedures. 

• The same research official (1) attempted to rewrite minutes of the NPC’s Board 

meetings and (2) wrote correspondence for the Chairperson of the IRB and directed a 

research employee to sign it for the Chairperson without the Chairperson’s approval, 

in violation of documentation policies and procedures. 

The complainant also alleged financial mismanagement of CTHMRF. These allegations 

were referred to OIG’s Office of Audit and are not discussed further here. The following 

is a general discussion of VHA policies pertaining to the issues identified in this report. 

VA adheres to the Federal Policy for Protection of Human Subjects (often referred to as 

the “Common Rule”). This policy requires all research involving human subjects be 

approved by both the IRB and the Research and Development Committee (R&D 

Committee) at the facility conducting the research. When a research protocol involving 

human subjects is proposed, it first goes to the IRB for approval; the IRB is a 

subcommittee of the R&D Committee. If approved by this subcommittee, the protocol 

then goes to the R&D Committee for approval. 

Relevant IRB and R&D Committee Policies 

IRBs bear the primary responsibility for implementing the protections for and policies 

pertaining to human subjects. VHA Handbook 1200.5 defines IRB duties and 

responsibilities, including the initial approval of a protocol and its continuing review. 

The IRB must ensure that the benefits of the research outweigh the risks and that every 

effort is made to minimize any risk to participants. The IRB can require modifications to 

a protocol or disapprove a protocol altogether. Furthermore, protocols are reviewed on a 

continuing basis by the IRB to ensure adequate protection of human subjects at a 

frequency dependent on the degree of risk, but not less than once per year. IRBs must 

implement standard operating procedures locally that describe how the facility will 

 

2

 VHA Handbook 1200.5, Requirements for the Protection of Human Subjects in Research, July 15, 2003, defines a 

PI as “an individual who conducts a research investigation, i.e., under whose immediate direction research is 

conducted, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that 

team.” 

VA Office of Inspector General 2 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

ensure compliance with VHA Handbook 1200.5, including termination or suspension of a 

protocol for investigator noncompliance. 

The facility’s local policy in effect during the events described in the complaint was the 

R&D Committee and IRB Standard Operating Procedures Manual, 2004 edition. We 

note these procedures were revised on October 30, 2006. Both the 2004 and 2006 

policies describe the general scope of IRB authority, specifically stating that the IRB can 

“restrict, suspend or terminate an investigator’s privilege to conduct human studies.” The 

2006 version describes the degree of investigator noncompliance, defining “minor noncompliance” as the unintentional violation by an investigator of any IRB requirement, 

while “serious non-compliance” is defined to include “any actions which place a subject 

at increased risk of injury or which compromise the integrity of the data or study.” 

The facility also maintains a local policy on research performance improvement.3

 This 

policy requires assessment and improvement in compliance with certain provisions of 

VHA Handbook 1200.5, as well as in responsiveness to complaints or questions from 

human research participants. It does not, however, address performance improvement in 

such areas as the credentialing and privileging of research personnel; radioactive 

materials safety, storage, and disposal methods; fiscal accountability; VA-affiliated 

nonprofit corporation activities; or conflict of interest. 

Credentialing and Privileging of Research Personnel

VHA and facility policies do not identify specific requirements for the credentialing and 

privileging of research personnel. Credentials generally include the formal education, 

training, and licensure of an individual, while privileges commonly refer to the activities 

that a licensed independent health care provider can perform at a given facility. “Scope 

of practice” is a term that can be used to describe activities that may be performed by 

health care workers, regardless of whether they are licensed independent health care 

providers. While not specifying a means of credentialing and privileging research 

personnel, VHA Handbook 1200.5 does require the Medical Center Director to ensure 

“that IRB members and investigators are appropriately knowledgeable to conduct 

research in accordance with ethical standards and all applicable regulations.” 

VHA also has a handbook4

 for the credentialing and privileging of health care providers, 

but it applies only to those individuals “permitted by law and the facility to provide 

patient care services independently.” Only licensed personnel are permitted by law to 

provide patient care services independently. A second policy, VHA Directive 2006-067,5

applies to those individuals who are licensed, certified, or registered. There are, however, 

no research positions listed in the attachment describing applicable occupations. VHA 

 

3

 Carl T. Hayden VA Medical Center Phoenix, AZ, Policy Memorandum No. ERS/151-8, Research Performance 

Improvement, June 3, 2002. 4

 VHA Handbook 1100.19, Credentialing and Privileging, March 6, 2001. 5

 VHA Directive 2006-067, Credentialing of Health Care Professionals, December 22, 2006. 

VA Office of Inspector General 3 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

currently has no formal policy for verifying the credentials or appropriate scope of 

practice for employees without a license, certification, or registration who are engaged in 

research activities, such as unlicensed graduates of foreign medical schools.6

 The Office 

of Research and Development (ORD) does offer credentialing guidance on its website. 

This guidance states that licensed independent practitioners are credentialed through 

VetPro7

 or its paper equivalent. ORD’s guidance also states that other staff not covered 

by VetPro (in effect, individuals not licensed to function as independent practitioners) 

should have their credentials verified and should provide the research service with an 

education verification form. It does not address what procedures a facility should use to 

verify appropriate scopes of practice for unlicensed research personnel. 

Policies Pertaining to the Use of Radioactive Compounds in Research 

Unique requirements and compliance issues apply to research protocols involving the use 

of radioactive compounds. The Nuclear Regulatory Commission (NRC) is the agency 

with authority to regulate the use and storage of radioactive compounds. On March 17, 

2003, the NRC issued a Master Materials License (MML) to VA, consolidating multiple 

NRC facility licenses into a single master license. Under the MML, VA oversees 115 

facilities with permits to use radioactive materials, while the NRC maintains oversight of 

the MML. VHA Handbook 1105.18

 describes VHA policies and procedures for 

performing licensure and oversight of activities involving ionizing radiation or 

radioactive materials. VA’s National Radiation Safety Committee (NRSC) is responsible 

for regulating the acquisition, receipt, storage, distribution, use, transfer, and disposal of 

radioactive materials within VA facilities. 

At the facility level, VHA policy places primary responsibility for these activities with 

the facility’s Radiation Safety Committee (RSC) and Radiation Safety Officer (RSO). 

The RSO is defined as someone “with specific education and professional experience in 

radiation protection practice appointed by a VHA facility director and approved by the 

VHA RSC to manage radiation safety programs.” 

VHA Handbook 1105.1 also describes procedures for the management of radioactive 

wastes. It specifically requires that all radioactive materials or items contaminated with 

radioactive materials must be accounted for by inventory pending disposal. The facility 

RSO is responsible for preparing procedures for waste management in consideration of 

local factors such as available storage and type of waste. 

Two years after implementation of VHA Handbook 1105.1, in response to a request from 

the Secretary of Veterans Affairs, OHI conducted a review of security and inventory 

controls over radioactive agents on March 14, 2002. While concluding inventory 

 

6

 VHA Directive 2003-036, Credentials and Training of Employees Involved in Human Subjects Research, dated 

July 7, 2003, was rescinded on July 29, 2003. 

7

 A computerized system guiding facilities through verification of a provider’s credentials and practice history. 8 Procedures for Management of Radioactive Materials, March 13, 2000. 

VA Office of Inspector General 4 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

controls for radioactive materials “were more effective than those for managing 

biological agents and chemicals,” the report recommended that managers “reevaluate the 

extent of compliance with radiation safety and handling/delivery procedures....”9

Policies Governing Conflict of Interest in VA-Affiliated Nonprofit Corporations

To provide a more flexible funding mechanism, Congress enacted legislation in 1988 

allowing VA medical centers to create VA-affiliated NPCs to administer research funds. 

VHA policy governs the operations of NPCs, including VHA Handbook 1200.1710 which 

states that NPCs “are subject to dissolution should they not serve the best interest of VA.” 

The policy further requires that any VA employee involved “in any fashion” in the 

operations of the NPCs ensure that these institutions operate in the best interests of VA. 

VHA currently has no financial conflict of interest policy specific to research.11 All NPC 

board members, officers, and employees are subject to Federal rules and regulations 

regarding conflicts of interest and conduct of Federal employees. At the time NPC duties 

are assumed, all individuals must sign a statement “certifying awareness of and 

compliance with Federal conduct and conflicts of interest laws and regulations.” 

Scope and Methodology 

To investigate the complainant’s allegations in the areas of credentialing and privileging 

of research personnel; use, storage, and disposal of radioactive materials; human subject 

protection violations; conflict of interest; and documentation irregularities in CTHMRF, 

we conducted a site visit from December 4, 2006, through December 7, 2006. We 

interviewed the Associate Chief of Staff for Research and Development (ACOS/R&D), 

R&D Committee members, IRB members, PIs, the research compliance officer, the 

research safety and RSOs, officers of the NPC, financial personnel, and the 

administrative officer (AO) for research. 

For Protocols A through D, we reviewed IRB and R&D Committee documents. We 

examined documents pertaining to radiation safety violations associated with Protocol C, 

reviewed radiation safety committee documents, waste disposal logs, and visited the 

location used by the facility to store its hazardous wastes. On site, we physically 

inventoried certain radioactive wastes described in documents associated with Protocol 

C. We examined scopes of practice for research coordinators and other personnel 

involved in Protocols A, B, and C. We also contacted another VA medical center 

(hereafter Facility 2) for additional information concerning the scope of practice of these 

personnel while previously employed by Facility 2. We reviewed documents related to 

 

9

 Review of Security and Inventory Controls Over Selected Biological, Chemical and Radioactive Agents Owned by 

or Controlled at Department of Veterans Affairs Facilities, Report No. 02-00266-76, March 14, 2002. 10 VHA Handbook 1200.17, VA Research and Education Corporations Authorized by Title 38 United States Code 

(U.S.C.) Sections 7361 through 7368, December 17, 2001. 11 VHA Notice 2005-01 rescinded VHA Handbook 1200.13, Financial Conflicts of Interest in Research, on 

February 1, 2005. 

VA Office of Inspector General 5 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

the publication of unapproved research associated with Protocol D. We examined IRB 

documents pertaining to a fifth protocol (Protocol E) after identifying a deficiency in the 

data safety monitoring plan during the course of our inspection. Finally, we examined 

IRB and R&D committee documents pertaining to actions taken against a researcher 

involved in a sixth protocol (Protocol F). 

The inspection was performed in accordance with the Quality Standards for Inspections

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

Inspection Results 

Issue 1: Safety and Human Subject Protection in Protocols A, B, and C 

A. Performance of Health Care Activities by Unlicensed Personnel

We substantiated the allegation that one unlicensed physician (hereafter Researcher 1) 

with a scope of practice designated for a “research coordinator,” performed at least two 

muscle biopsies in Protocol A at the facility. The PI, a licensed physician supervising 

Researcher 1, did not have privileges to perform muscle biopsies at the time these 

procedures occurred. The facility identified these issues prior to the date of our 

inspection and reported them to the Office of Research Oversight (ORO). However, 

Researcher 1 also performed numerous physical examinations and in several instances 

determined when it was appropriate to increase the dosage of a diabetes medication12 in 

accordance with the protocol. These activities were not reported to ORO. The PI has 

since obtained privileges to perform muscle biopsies, and Researcher 1 is no longer 

involved with research at this facility. 

During our inspection, we determined that Researcher 1 performed muscle biopsies at 

Facility 2 prior to working for the facility. We notified Facility 2, which reviewed 

medical records and verified that 11 muscle biopsies were performed by this individual. 

Facility 2 had no completed Scope of Practice for Researcher 1. The consent form 

designated his title as M.D., which was contrary to Facility 2 and IRB policy in that 

Facility 2 considers this to represent to the research subjects that the individual is a 

licensed physician. Facility 2 stated that non-licensed physicians could be considered as 

non-credentialed non-privileged trainees in terms of their scope of practice and could 

perform procedures with supervision. Documentation provided by Facility 2 

acknowledges that there were at least five unlicensed individuals performing such 

procedures under the supervision of an attending physician as of December 8, 2006. 

Whether or not Researcher 1 operated under the supervision of a licensed physician, he 

was not in a credentialed training program such as a university-affiliated program for the 

training of resident physicians and medical students. Researcher 1 could not practice 

 

12 The medication involved was pioglitazone, an oral medication for diabetes. 

VA Office of Inspector General 6 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

medicine, regardless of supervision. State law defines the practice of medicine for 

purposes of licensure. While the definition varies from state to state, statutes generally 

include the diagnosis and treatment of disorders or disease states in their definition of the 

practice of medicine. For example, Arizona State law defines the practice of medicine as 

follows: 

“Practice of medicine” means the diagnosis, the treatment or the correction 

of or the attempt or the holding of oneself out as being able to diagnose, 

treat or correct any and all human diseases, injuries, ailments, infirmities, 

deformities, physical or mental, real or imaginary, by any means, methods, 

devices or instrumentalities.... 

Conducting a physical exam has no reasonable purpose other than to diagnose a disorder 

or to exclude its presence by negative findings. Performing a physical exam, particularly 

while wearing a name tag labeling the individual performing the exam as an M.D., could 

also constitute holding oneself out as being able to diagnose and treat medical conditions. 

At the facility, a medical record review of the records of 55 patients (10 patients who 

consented for Protocol A, 9 patients who consented for Protocol B, and 36 patients who 

consented for Protocol C) revealed that at least 1 additional unlicensed physician 

(Researcher 2) performed physical examinations on patients and interpreted laboratory 

results to determine the presence or absence of disease states. The notes were received 

by the supervising physician after the date of the patient encounter. Researcher 2 

performed these activities within the scope of practice granted by the facility on May 11, 

2005. The facility defined Researcher 2’s scope of practice to include performing 

physical examinations, muscle biopsies, and glucose clamp experiments under 

supervision. The scope of practice granted to a researcher, however, cannot supersede 

state or Federal laws or regulations prohibiting the practice of medicine without a license. 

In addition, a Registered Nurse (Researcher 3) employed by the facility as a research 

coordinator completed notes documenting preparation for muscle biopsies, muscle biopsy 

procedures, glucose and insulin infusions, and a type of exercise testing that was 

performed with electrocardiogram (EKG) monitoring. Progress notes contained no 

evidence of supervision by a licensed independent health care provider at the time of our 

inspection. Researcher 3’s scope of practice permitted her to administer intravenous 

solutions and medications, but did not indicate that she could perform muscle biopsies or 

exercise testing with EKG monitoring. We notified the facility of concerns that 

Researcher 3’s activities did not fall within the scope of practice generally accepted for 

research coordinators, or within the facility’s scope of practice for this individual. On 

December 19, 2006, and December 20, 2006, addenda were added to the progress notes 

reflecting that the muscle biopsies involved were performed by licensed physicians. 

These addenda do not, however, address whether licensed independent practitioners 

supervised the patients receiving exercise testing with EKG monitoring in Protocol B. In 

VA Office of Inspector General 7 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

some instances, the licensed physician writing the addenda was not listed on the consent 

forms as being the PI or a researcher involved in the protocol. 

When the facility initially reported the two muscle biopsies performed by Researcher 1, 

the IRB instituted an action plan on September 21, 2005. The plan required that the IRB 

initial review form contain verification that any health care practitioner participating in 

the study holds a valid license and that, in the process of initial and continuing review of 

protocols, requests to perform procedures would precipitate a review of credentials, 

privileges, and scopes of practice. ORO closed the case on October 11, 2005, based upon 

the facility’s reported action plan. Physical exams and exercise testing by unlicensed 

providers or those acting outside their scope of practice continued to occur without 

documentation of independent licensed health care provider involvement beyond the date 

of the action plan. These documentation issues persisted at the time of our inspection. 

B. Radioactive Materials Management 

We substantiated that the PI of Protocol C utilized radioactive materials in an unapproved 

area. Protocol C involved labeling glucose with a radioactive isotope, tritium,13 and 

administering it along with insulin to patients for purposes of testing how insulin affects 

enzymes present in muscle tissue. A radioactive substance, tritium, has a half-life of 12.5 

years.14 It emits very small amounts of radiation, and is a hazard only if taken internally. 

Nevertheless, tritium is regulated by the NRC. The complainant alleged that there were 

numerous irregularities in Protocol C, including use of tritium in unapproved areas. The 

facility holds a Materials Permit authorizing the facility to possess tritium among other 

radioactive materials. 

The facility has a history of violations in this area. In 1999, prior to VHA’s National 

Health Physics Program (NHPP) assuming responsibility for materials management, the 

NRC inspected the facility, noting three violations, including failure to amend the permit 

prior to utilizing radioactive materials in certain areas. In 2000, NHPP identified four 

violations, again referencing failure to obtain an amendment to the permit authorizing use 

of radioactive materials in certain areas. On November 18, 2004, the facility obtained an 

external audit of the research radiation safety and quality assurance programs. The report 

concluded that “significant effort needs to be made to bring the paperwork for the in 

vitro15 and in vivo16 use of radioactive material into compliance with your license.” It 

further stated that the VA had “no viable option” for the disposal of solid tritium 

contaminated wastes. On December 8, 2004, the minutes of the RSC state: “an audit of 

the research service was performed and there were significant problems with the 

paperwork for both the in vivo and in vitro research programs.” 

 

13 Tritium (chemical symbol H3

) is a radioactive isotope of the element hydrogen, whose chemical symbol is H. 14 Half-life is the time it takes half of the radioactive atoms to decay naturally. 15 In vitro is a term used to indicate that the substance was used in laboratory experiments but not in the body. 16 In vivo means that the substance was used within the body. 

VA Office of Inspector General 8 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

On December 13, 2004, 25 days after completion of the external audit, another inspection 

by NHPP disclosed continued use of radioactive materials in unapproved areas. The 

inspection also disclosed improper disposal of tritium contaminated laboratory supplies 

by soaking them in a commercial decontamination solution and then placing them in 

unregulated laboratory trash. Since the date of that inspection, and prior to our own, the 

facility amended the permit to include the room utilizing tritium in Protocol C. Minutes 

from the Subcommittee on Research Safety further disclose that, as of September 20, 

2006, all in vivo work at the facility is now performed with non-radioactive substances. 

Finally, the facility terminated the unapproved tritium disposal method following the 

inspection and accumulated tritium contaminated solid waste in a detached storage 

building. In a Memorandum to the Director of VHA’s NHPP dated February 10, 2005, 

the facility Director indicated that these materials would be stored in the building “until a 

specifically licensed contractor can pick up, treat, and dispose of our dry waste composed 

of disposable laboratory glassware, tubing, pipette tips, and other supplies contaminated 

with long-lived radioactive materials.” At the time of our onsite inspection, these wastes 

remained in the facility. However, the facility informed us on January 9, 2007, that a 

contractor had removed all tritium contaminated solid waste from the storage facility. 

Additional procedures governing the inventory of radioactive wastes are contained within 

the facility’s Radiation Safety Manual. The Manual requires radioactive wastes to be 

labeled with the name of the radioisotope, activity, date of disposal, and the radiation 

worker’s full name and telephone number. The Manual also requires a radioactive waste 

disposal log, stating that “[All] of this information is necessary to correctly classify the 

waste for disposal.” 

During the course of our inspection, we obtained an inventory of tritium contaminated 

solid waste held in storage at the facility. The inventory indicated storage dates in the 

building beginning in May 2004 and continuing through June 2005. This was tracked by 

e-mail, in that the individual responsible for placing the materials in the storage building 

would e-mail the Research Safety Officer with the date, number of bags, and amount of 

radioactivity of each bag placed in the building. The Research Safety Officer then 

compiled this into a list of materials deposited in the building. Together with the AO for 

Research and the Research Safety Officer, we compared the inventory list against a direct 

physical inspection of the materials in the building. One bag of tritium contaminated 

solid waste listed on the inventory could not be located in the storage building at the time 

of our inspection, and five bags in the storage building did not appear on the inventory 

list. In addition, there were discrepancies between dates on the inventory list, the e-mails, 

and the bags located in the shed. 

We requested that the facility reconcile the inventory list and e-mails pertaining to the 

storage of tritium with the physical inventory, report discrepancies to appropriate 

regulatory agencies, and follow up regarding a radioactive waste disposal plan. On 

December 13, 2006, the facility provided us with a certification and reconciliation of 

VA Office of Inspector General 9 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

waste inventory. The facility reported the missing bag of tritium contaminated solid 

waste as being present in the shed but mislabeled. The other five bags were placed in the 

building while the RSO was on extended leave. Multiple tag errors were noted 

concerning the correct amount of radioactivity. The facility stated that they reconciled all 

discrepancies and that the AO for Research contacted a manager at NHPP who said these 

were minor deficiencies that appeared to be addressed locally but suggested further 

review by the RSC. The facility also implemented an action plan which involved 

stoppage of the practice of holding a bag in the lab after it was sealed; improved 

documentation of waste bags including posting a waste log inventory sheet in the 

building to allow updates to be done when materials are placed in the building; and 

scheduling another independent audit of the Research Radiation Safety Program in the 

next fiscal quarter. 

The RSO is the official in VHA policy responsible for a facility’s radioactive waste 

management program. VHA Handbook 1105.1 outlines an extensive list of highly 

technical duties and responsibilities of the RSO as follows: 

The facility RSO is the functional and operational arm of the facility RSC for 

implementing policy, development of procedures, and ongoing oversight of local 

uses of radioactive materials as described in a permit. The RSO: 

(1) Is appointed in writing by the medical facility Director. 

(2) Investigates overexposures, accidents, spills, losses, thefts, and 

unauthorized receipt, use, transfer or disposal of radioactive materials, 

medical misadministrations...and other deviations from approved radiation 

safety practices and implements corrective actions as necessary. 

(3) Develops and recommends to the RSC local procedures in writing for 

acquisition, receipt, storage, inventory, safe use, emergency procedures, 

surveys, equipment performance checks, disposal, personnel training, and 

user and facility record keeping requirements. 

(4) Briefs medical center management at least once each year on the status 

of the facility radiation safety program. 

(5) Develops and recommends to the RSC investigational action levels for 

personnel exposures, contamination, and surveys. 

(6) Assists the RSC in the performance of its functions, including its annual 

evaluation of the facility radiation safety program. 

(7) Performs periodic onsite evaluations of all activities involving the use 

of radioactivity in the medical facility including, but not limited to, visits to 

VA Office of Inspector General 10 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

all areas of use, examination of required records, and evaluations of 

radiation safety procedures. 

To perform these duties, the Handbook specifies the RSO must have “the education and 

professional experience needed for the position.” A single RSO is listed on the Materials 

Permit for the facility. 

The facility’s Radiation Safety Manual dated June 30, 2005, however, indicates the RSO 

and the Research Safety Officer “manage the Radiation Safety program in a dual 

capacity.” The Manual specifies that both individuals will manage daily operations and 

are responsible for compliance.17 The RSO at the facility is a Board certified radiologist 

with training in nuclear medicine. The Research Safety Officer was hired as a research 

scientist. He indicated that he had received no formal training in radioactive waste 

management, had never been an RSO for the VA, and was appointed to the position 

about 2.5 years ago. Minutes from the Subcommittee on Research Safety identified that 

the “Radiation Safety Officer needs a backup who is at a senior level.” When we 

interviewed the RSO, he believed that all radiation safety issues pertaining to research or 

occurring in research areas were the responsibility of the Research Safety Officer. This 

would mean that the Research Safety Officer would be required to perform all of the 

above technical duties in research areas, despite the absence of any training in these 

areas. 

C. Publication of Research

We substantiated the allegation that a researcher at the facility (Researcher 4) presented 

the results of unapproved research in the form of a poster presentation at a professional 

society meeting. VHA Handbook 1200.5 defines research as “the testing of concepts by 

the scientific method of formulating a hypothesis or research question, systematically 

collecting and recording relevant data, and interpreting the results in terms of the 

hypothesis or question.” The Common Rule (38 CFR 16) defines research as “a 

systematic investigation, including research development, testing and evaluation, 

designed to develop or contribute to generalized knowledge.” 

Researcher 4 presented data on a case series of six patients with a relatively rare form of 

cancer. The data was obtained as part of routine medical care. No patients were harmed. 

The expressed intention of the poster presentation was to demonstrate the possibility of a 

higher incidence of this type of cancer in the VA population than previously reported. 

Researcher 4 reported the incident to the IRB on September 22, 2006. The IRB and R&D 

Committees determined that the case series did constitute research and requested that 

Researcher 4 submit a protocol so that the work could receive the appropriate approval. 

Neither committee otherwise sanctioned Researcher 4. 

 

17 The facility’s previous Radiation Safety Manual, issued in 2002, also stated that the Research Safety Officer had 

the same duties as the RSO in research areas. 

VA Office of Inspector General 11 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

D. Additional Human Subject Protection Issues

Although not an allegation, during the course of our inspection, a PI disclosed that she 

had not accessed laboratory data pertaining to Protocol E since approximately February 

of 2006. This study involved laboratory data for 309 non-veteran patients. The facility’s 

role was to analyze data in accordance with the terms of a Memorandum of 

Understanding (MOU) executed between the affiliated university and the facility. The 

laboratory data included serum concentrations of immunoglobulins.18 Significant 

abnormalities of these values can be indicative of certain rare forms of cancer and 

immune deficiencies. VHA Handbook 1200.5 requires research proposals to “make 

adequate provisions for monitoring the data collected to ensure the safety of subjects (38 

CFR 16.111(a)(6)).” Policy Memorandum ERS/151-0119 also states that “the research 

plan must make adequate provisions for monitoring the data collected to ensure the safety 

of subjects.” 

Protocol E did not have a Data Safety Monitoring Plan that addressed abnormal 

immunoglobulin levels despite being approved by the facility IRB. In addition, the MOU 

for Protocol E stated that the PI at the facility “will be responsible for, perform, or 

supervise all medical aspects of the collaborative research performed at the VAMC.” 

The PI of the study at this facility was not a clinician. The PI stated in December 2006 

that she had not accessed this laboratory data since approximately February of 2006 

because of computer access issues. By not accessing the laboratory data, this created the 

possibility that abnormal laboratory results of clinical significance would not be detected 

and communicated to the patients’ physicians in a timely manner, resulting in a failure to 

diagnose and treat those patients appropriately. In addition, because the PI was not a 

clinician, she would not necessarily have had the skills or experience to evaluate and 

recognize the clinical significance of these abnormalities even had she reviewed the 

laboratory results in a timely manner. 

We notified the facility of this issue during our onsite inspection. The facility submitted 

a Corrective Action Plan stating that the normal lab notification process did not apply 

because the patients were not VA patients and the laboratory did not have identifying 

information for the patients. The facility reviewed the data from these patients and 

determined in a report dated January 11, 2007, there were nine patients with 

abnormalities of potential clinical significance. These results were reported to the 

regional IRB for purposes of attempting to identify the patients and subsequently inform 

their primary care providers. The facility IRB completed review of the Data Safety and 

Monitoring Plan for Protocol E by December 22, 2006. Testing of blood was halted until 

clinical oversight of laboratory results could be delineated. 

 

18 Immunoglobulins are proteins that play a key role in the body’s immune response to foreign substances, including 

bacteria and viruses. 

19 Carl T. Hayden VA Medical Center Phoenix, AZ, Policy Memorandum No. ERS/151-01, Research and 

Development Committee, June 8, 2004. 

VA Office of Inspector General 12 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Issue 2: Penalties for Human Subject Protection Violations 

The complainant alleged that, while the IRB imposed no sanctions against the PIs 

involved in Protocols A through E, it barred Researcher 5 from participation in research 

activities for relatively minor non-compliance in Protocol F. In addition, the complainant 

further stated the delay and ultimate termination of Protocol F resulted in two patient 

deaths because they were unable to receive sleep studies and subsequent treatment for 

sleep apnea. We substantiated that Researcher 5 was barred from research activities at 

the facility, while the privileges of the PIs of Protocols A through D had not been 

curtailed or revoked for the infractions discussed in Issue 1. However, nothing in VHA 

or facility policy expressly limits the IRB and R&D Committee’s discretion in the 

application of such penalties. Further, while we found that two patients did not receive 

sleep studies prior to their deaths, we did not substantiate that this resulted in these deaths 

or that it was related to IRB actions affecting Protocol F. 

Researcher 5 submitted Protocol F, which was disapproved by the IRB on January 12, 

2005. This was his first submission to the facility IRB. He then resubmitted the study, 

which was tabled by the IRB because of multiple irregularities in submission forms. 

Additionally, the IRB made recommendations for changes to the protocol and informed 

consent. Researcher 5 made additional changes and the project was approved by the IRB 

on May 11, 2005, subject to minor revisions to the informed consent. The R&D 

Committee approved the protocol on May 25, 2005, but requested the addition of a plan 

for statistical analysis of the data. Researcher 5 complied with the request. 

During the course of audit activities conducted by the research compliance officer 

(RCO), the facility identified several issues with Researcher 5’s protocol. These included 

no documentation of the consent process in the medical record, use of an unapproved 

consent form for five patients, discrepancies in handling research funds, and difficulty in 

locating source data. On July 6, 2006, the R&D Committee suspended Researcher 5 

from research activities including membership in the R&D Committee until resolution of 

these issues. 

The R&D Committee also formed an ad hoc committee to review these issues, which 

subsequently found four abstracts published by Researcher 5 without IRB approval. The 

subcommittee also found that research data was taken offsite and the PI could not provide 

adequate source documentation for the published abstracts. The ACOS/R&D reported 

that, while the subcommittee “determined there was evidence to suspect research 

misconduct,” he did not find the evidence presented met the threshold of research 

misconduct. His findings were reported to ORO, which concluded that the 

ACOS/R&D’s determination was “supported by a reasonable assessment of the 

evidence.” 

The facility’s IRB and R&D Committee required that the PI find a replacement PI for his 

ongoing research study and present a safety plan providing for continuing care of patients 

VA Office of Inspector General 13 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

enrolled in the study. The IRB found the PI’s response to be inadequate and closed the 

study on August 18, 2006. The facility notified ORO of the study closure. Finally, the 

IRB, R&D Committee, Research Integrity Officer, and Medical Center Director decided 

to bar Researcher 5 from “engaging in all future research activities at the Carl T. Hayden 

VA Medical Center.” 

The complainant maintained this punishment seemed inequitable, considering that neither 

the IRB nor the R&D Committee took action against the PIs in Protocols A, B, C, and D 

for the problems identified in Issue 1. While Researcher 5 provided explanations for 

many of the above discrepancies in documentation, we are unaware of VHA or facility 

policy limiting the severity of penalties that may be imposed by the IRB or R&D 

Committee for Researcher 5’s infractions. Therefore, although we substantiated that the 

facility barred Researcher 5 from research activities, while the PIs of Protocols A through 

D had privileges to conduct research at the facility during the inspection, we note that this 

action does not appear to expressly violate VHA or facility policy. 

Finally, the complainant alleged that the facility’s action in failing to approve this 

protocol in a timely manner resulted in at least two patient deaths because of delays in 

receiving a diagnostic test known as polysomnography.20 The purpose of this test is to 

diagnose sleep apnea, a disorder that results in low oxygen levels during sleep and which 

can contribute to the development of cardiac arrhythmias and a variety of chronic health 

problems. Patients enrolled in Protocol F would have received an in-home version of 

polysomnography in accordance with the protocol. 

Researcher 5 evaluated the first patient clinically on October 25, 2005, and believed the 

patient had sleep apnea. The progress note of that date states that the patient would be 

evaluated again after polysomnography. The patient subsequently died in January 2006. 

A note entered on May 10, 2006, indicated that the patient did not undergo 

polysomnography prior to his death. Medical record documentation of the informed 

consent process occurred on May 10, 2006, after the date of the patient’s death. 

Researcher 5 evaluated a second patient clinically on September 7, 2005, and stated that 

the plan was to schedule polysomnography. The patient subsequently expired in October 

2006 without receiving this test. No documentation exists to explain why the 

polysomnography studies were not scheduled. We do not, however, substantiate that 

failure to schedule the polysomnography studies contributed or resulted in these patients’ 

deaths. Both deaths occurred outside the hospital; the patients involved had multiple 

chronic health problems. Neither received an autopsy. 

 

20 Polysomnography, or a “sleep test,” is a test in which the patient’s oxygenation is monitored during sleep for 

purposes of diagnosing sleep apnea. 

VA Office of Inspector General 14 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Issue 3: Alleged Conflict of Interest in the Operations of CTHMRF 

The complainant alleged that a member of the Board of Directors of CTHNPC violated 

VA conflict of interest policies by voting on a grant for himself that was administered by 

the corporation. We can neither substantiate nor refute the allegation that the 

complainant voted on the grant due to the failure of the facility to maintain voting 

records. 

Criminal and civil conflict of interest laws prohibit Government employees from 

participating, when the employee has a personal financial interest as defined in 18 United 

States Code, Section 208. We were not provided any evidence that the award of the grant 

benefited the researcher financially. 

Notwithstanding the issue of whether the researcher benefited financially, we can neither 

substantiate nor refute the allegation that he voted on the award he received because the 

vote was conducted by e-mail and the facility did not maintain records of the Board’s email votes. Both current and draft versions of the nonprofit’s by-laws permit the Board 

to vote “by unanimous written consent,” which specifically includes e-mail. Because the 

vote had to be unanimous, even if the researcher recused himself from the process, the 

outcome would have been the same. 

Issue 4: CTHMRF Meeting Minutes and IRB Correspondence 

We substantiated that a research official in one case altered the minutes of the Board of 

Directors’ meeting, but we found that this was to correct an error and did not violate 

VHA policy or procedure. We are unable to substantiate or refute allegations related to 

documentation irregularities in IRB correspondence. We further are unable to 

substantiate or refute whether the research official in question is solely responsible for the 

documentation irregularities. 

The complainant alleged that a research official altered minutes of Board of Directors 

Meetings. An example included one set of minutes which described events at three 

separate Board meetings. The research official provided the Executive Director with a 

summary of what transpired at one of these meetings after the Executive Director was 

asked by the research official to leave the room. E-mails provided to us indicate that at 

least one other board member disagreed with the summary of events described in the 

minutes of that meeting. This Board member was able to comment on the summary 

because it was disseminated among Board members for their comments and approval. 

Disseminating the minutes for comment would not be consistent with a deliberate attempt 

to maintain inaccurate minutes. 

However, during the course of our review of the Board of Directors Meeting minutes, we 

determined that the minutes did not consistently contain enough information to determine 

whether votes by Board members were in compliance with current by-laws (enacted in 

VA Office of Inspector General 15 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

1997) or by the draft by-laws, pending final approval by the Board at the time of our 

inspection. Both the 1997 version and the current draft of the by-laws state: “At each 

meeting, minutes shall be kept by the Secretary or someone appointed by the Chairman 

of the Board.” We found at least one instance in which three meetings were consolidated 

into one set of minutes. In addition, the by-laws require a majority vote for approval of 

motions. The minutes do not contain sufficient voting information to confirm that a 

majority of the Board voted in favor of certain approved motions. 

The complainant alleged that the same research official wrote a memorandum on behalf 

of the Chairman of the IRB and had another member of the R&D Committee sign it 

without approval of the IRB Chairman. We obtained e-mails demonstrating both that a 

draft memorandum did circulate between these individuals and that a researcher at the 

institution reported this situation to other research officials within the institution. 

However, when we interviewed the Chair of the IRB, he denied that this incident 

occurred. We therefore can neither substantiate nor refute who actually wrote the 

memorandum in question or how it came to be attached to an e-mail originating with the 

research official who forwarded it to another member of the R&D Committee for 

signature. 

Conclusion 

While not substantiating allegations of violations of VHA policies concerning certain 

documentation issues and the inequitable application of IRB penalties, the problems 

identified in the areas of credentialing and privileging of research personnel, radioactive 

waste management, reporting of clinically relevant abnormal laboratory values, and 

conflict of interest in the setting of a VA-affiliated NPC suggest systemic issues in the 

management of research activities at this facility. Complicating our review was the 

absence of VHA policy in the areas of financial conflict of interest in terms applicable to 

research activities and in the credentialing and privileging of research personnel. 

The facility has experienced significant changes in leadership recently, with both a new 

facility Director and a new Chief of Staff. We further note, the facility addressed several 

of the issues identified prior to the date of our inspection within the context of specific 

cases. However, the breadth of problems identified in the research arena at this facility 

warrant addressing deficiencies from a systems perspective. In addition, the finding that 

unlicensed research personnel performed minor procedures on patients at Facility 2 

suggests at least the possibility that this particular condition could persist elsewhere. As 

a result, OHI will include in the Combined Assessment Program (CAP) an assessment of 

the scope of practice for unlicensed research personnel, as well as an assessment of the 

physical inventory of tritium at VHA facilities. We also make the following 

recommendations: 

VA Office of Inspector General 16 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Recommendations 

We recommend the VISN Director ensure that the Facility Director: 

Recommendation 1. Prevents unlicensed physicians who work in VA research 

from engaging in activities which constitute the practice of medicine by ensuring (a) they 

have an appropriate scope of practice and (b) their research activities fall within that 

scope of practice. 

Recommendation 2. Establishes procedures for ensuring that the storage, use, and 

disposal of radioactive wastes are managed in compliance with all applicable VHA and 

Federal regulations and policies. 

Recommendation 3. Reviews the credentials of senior research managers and 

principal investigators to ensure that they have the requisite skills, training, and/or 

experience to perform their assigned or assumed administrative and research related 

duties. 

Recommendation 4. Clearly delineates in policy the duty of the facility’s 

laboratory to notify principal investigators or responsible clinicians of abnormal clinically 

significant laboratory data obtained for research purposes. 

Recommendation 5. Reviews all conflict of interest policies pertaining to the 

facility or to CTHMRF for compliance with Federal ethics rules and regulations. 

Comments 

The VISN Director and facility Director concurred with the findings and 

recommendations of this inspection. In addition, the facility Director submitted a 

detailed corrective action plan regarding notification of PIs or responsible clinicians of 

abnormal clinically significant laboratory data obtained for research purposes 

(Recommendation 4) on December 7, 2006. On December 15, 2006, the facility Director 

also submitted a detailed plan to correct and prevent problems related to tritiumcontaminated solid waste stored at the facility (Recommendation 2). Following the 

issuance of the draft report, the VISN Director and facility Director provided further 

comments and implementation plans. (See Appendix A, pages 18–24 for the complete 

text of their comments.) 

VA Office of Inspector General 17 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

We believe that the comments, along with the corrective action plans submitted in 

December, meet the intent of our recommendations. We will follow up on all 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 18 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Appendix A 

VISN Director Comments 

Department of 

Veterans Affairs Memorandum

Date: March 23, 2007 

From: Network Director (10N17), VA Southwest Health Care 

Network, Mesa, AZ 

Subject: Healthcare Inspections - Research Practices at Carl T. Hayden 

VA Medical Center, Phoenix, Arizona 

To: Assistant Inspector General for Healthcare Inspections 

THRU: Director, Management Review Service (10B5) 

I concur with the facility response. See Medical Center 

Director’s Comments for specific actions. Please contact 

Joan Funckes, Executive Assistant to the Network Director, 

VISN 18 at 602.222.2692, for any questions. 

PATRICIA A. MCKLEM 

Network Director 

VA Office of Inspector General 19 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

VISN Director’s Comments 

to Office of Inspector General’s Report 

The following VISN Director’s comments are submitted in 

response to the recommendations in the Office of Inspector 

General’s report: 

OIG Recommendations

We recommend the VISN Director ensure the Facility 

Director: 

Recommendation 1. Prevent unlicensed physicians 

who work in VA research from engaging in activities which 

constitute the practice of medicine by ensuring (a) they have 

an appropriate scope of practice and (b) their research 

activities fall within that scope of practice. 

Concur Target Completion Date: Complete 

See Medical Center Director’s Comments for specific actions. 

Recommendation 2. Establish procedures for ensuring 

that the storage, use, and disposal of radioactive wastes are 

managed in compliance with all applicable VHA and Federal 

regulations and policies. 

Concur Target Completion Date: Complete 

See Medical Center Director’s Comments for specific actions. 

Recommendation 3. Review the credentials of senior 

research managers and principal investigators and ensures 

they have the requisite skills, training, and/or experience to 

perform their assigned or assumed administrative and 

research related duties. 

Concur Target Completion Date: Complete 

See Medical Center Director’s Comments for specific actions. 

VA Office of Inspector General 20 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Recommendation 4. Clearly delineate in policy the 

duty of the facility’s laboratory to notify principal 

investigators or responsible clinicians of abnormal clinically 

significant laboratory data obtained for research purposes. 

Concur Target Completion Date: April 28, 2007 

See Medical Center Director’s Comments for specific actions. 

Recommendation 5. Review all conflict of interest 

policies pertaining to the facility or to CTHMRF for 

compliance with Federal ethics rules and regulations. 

Concur Target Completion Date: Complete 

See Medical Center Director’s Comments for specific actions. 

VA Office of Inspector General 21 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Appendix B 

Facility Director Comments 

Department of 

Veterans Affairs Memorandum

Date: March 23, 2007 

From: Medical Center Director (644/11Q), Carl T. Hayden VA 

Medical Center, Phoenix, AZ 

Subject: Healthcare Inspections - Research Practices at Carl T. Hayden 

VA Medical Center, Phoenix, Arizona 

To: Network Director, VA Southwest Health Care Network 

(10N18), Mesa, AZ 

1. The draft report of the Healthcare Inspection – Research 

Practices was reviewed. The facility’s comments and 

implementation plan are attached for the recommendations. 

2. If you have any questions regarding this report, please 

contact Ms. Sally Compton, QM Program Manager, Quality 

Management Department at 602.277.5551, ext. 6777. 

DONALD E. MOORE, R.Ph., M.B.A. 

VA Office of Inspector General 22 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Facility Director’s Comments 

to Office of Inspector General’s Report 

The following Facility Director’s comments are submitted in 

response to the recommendations in the Office of Inspector 

General’s report: 

OIG Recommendations

We recommend the VISN Director ensure the Facility 

Director: 

Recommendation 1. Prevent unlicensed physicians 

who work in VA research from engaging in activities which 

constitute the practice of medicine by ensuring (a) they have 

an appropriate scope of practice and (b) their research 

activities fall within that scope of practice. 

Concur Target Completion Date: Complete 

There have been no biopsies performed by an unlicensed 

physician since 2005. This incident was immediately 

reported to the Office of Research Oversight (ORO) and 

appropriate action was taken following ORO’s guidance. 

There have been no occurrences since 2005. 

The Research template review checklist has been changed to 

include instructions to specifically identify unlicensed 

physicians. Research scopes of practice for unlicensed 

physicians were reviewed and revised as needed. In order to 

improve the overall process, the following changes were 

made. Separate forms were designed for licensed and 

unlicensed personnel. This will assist the R&D Committee to 

identify unlicensed physicians and ensure that their scopes of 

practice are congruent with their research duties. The Chief 

of Staff and Director will approve every new or revised 

Research scope of practice. 

VA Office of Inspector General 23 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Scopes of practice for unlicensed physicians will be attached 

to protocol materials which are reviewed by R&D and IRB 

committees. A statement has also been added to the Protocol 

Checklist that asks if duties assigned to an unlicensed 

physician fall within their scope of practice. 

Recommendation 2. Establish procedures for ensuring 

that the storage, use, and disposal of radioactive wastes are 

managed in compliance with all applicable VHA and Federal 

regulations and policies. 

Concur Target Completion Date: Complete 

The Research Radiation Safety Manual has procedures for 

ensuring that the storage and disposal of radioactive wastes 

are managed in compliance with all applicable VHA and 

Federal regulations and policies and the facility’s Radioactive 

Materials permit. The use of radioactive materials is protocol 

specific in experiments to be carried out by licensed users. 

Stored long-lived radioactive waste is being picked up 

quarterly, as needed, by a licensed broker. 

Recommendation 3. Review the credentials of senior 

research managers and principal investigators and ensures 

they have the requisite skills, training, and/or experience to 

perform their assigned or assumed administrative and 

research related duties. 

Concur Target Completion Date: Complete 

Credentials of senior research managers and principal 

investigators have been reviewed and they have the requisite 

skills, training, and/or experience to perform their assigned or 

assumed administrative and research-related duties. 

The protocol review process includes a copy of the principal 

investigator’s curriculum vitae for the R&D Committee’s 

review in order to ensure that they have appropriate skills and 

research training to carry out the proposed project. 

VA Office of Inspector General 24 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Recommendation 4. Clearly delineate in policy the 

duty of the facility’s laboratory to notify principal 

investigators or responsible clinicians of abnormal clinically 

significant laboratory data obtained for research purposes. 

Concur Target Completion Date: April 28, 2007 

Facility Policy Memorandum No. CS/113-8, Procedure for 

Reporting Critical Laboratory Results, provides instructions 

on reporting critical laboratory results. A critical value 

denotes a test result that requires immediate attention by a 

responsible caregiver because the result has clinical 

significance to the patient. This policy is being amended to 

include telephonic notification to the responsible principal 

investigator if a research protocol is involved. 

Facility Policy Memorandum No. CS/113-14, Procedure for 

Reporting Abnormal Laboratory Results, will be amended to 

report abnormal laboratory results for de-identified research 

subjects via e-mail message to the principal investigator or 

designee. 

Recommendation 5. Review all conflict of interest 

policies pertaining to the facility or to CTHMRF for 

compliance with Federal ethics rules and regulations. 

Concur Target Completion Date: Complete 

The following directives and policies were reviewed to ensure 

that Research and the CTHMRF are compliant with Federal 

ethics rules and regulations: (1) VHA Directive 1200, VHA 

Research and Development, (2) VHA Handbook 1200.17, 

VA Research and Education Corporations Authorized by 

Title 38 USC Section 7361 Through 7368 Handbook, and (3) 

DVA Memorandum dated September 23, 2005 from Chief 

Research and Development Officer, Subj.: Financial Conflicts 

of Interest in Research. In addition, the CTHVAMC Standard 

Operating Procedures for R&D/IRB includes a section on 

financial disclosure and conflict of interest. 

VA Office of Inspector General 25 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona 

Appendix C 

OIG Contact and Staff Acknowledgments 

OIG Contact Andrea Buck, M.D., J.D., Medical Consultant 

Washington, DC 

(202) 565-8496 

Acknowledgments Linda DeLong, Director 

Karen Moore, Associate Director 

Maureen Regan, J.D. 

Roxanna Osegueda 

VA Office of Inspector General 26 
Research Practices at Carl T. Hayden VA Medical Center, Phoenix, Arizona

Appendix D 

Report Distribution 

VA Distribution

Office of the Secretary 

Veterans Health Administration 

Assistant Secretaries 

General Counsel 

Director, Veterans Integrated Service Network 18 

Director, Carl T. Hayden VA Medical Center 

Non-VA Distribution

House Committee on Veterans’ Affairs 

House Appropriations Subcommittee on Military Construction and Veterans Affairs 

House Committee on Oversight and Government Reform 

Senate Committee on Veterans’ Affairs 

Senate Appropriations Subcommittee on Military Construction and Veterans Affairs 

Senate Committee on Homeland Security and Governmental Affairs 

National Veterans Service Organizations 

Government Accountability Office 

Office of Management and Budget 

U.S. Senate: 

 Jon Kyl 

 John McCain 

U.S. House of Representatives: 

 Ed Pastor 

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

VA Office of Inspector General 27