Schmitt, Brandi; Wacker, Charlotte; Ikemoto, Lisa JD, LLM; Meyers, Frederick J. MD; Pomeroy, Claire MD, MBA
Human anatomical specimens are essential to fulfill educational and research needs at universities with biomedical missions. Most commonly, cadavers are used in anatomical dissection courses to teach anatomy, physiology, and other basic sciences. Translational research has increased demand for well-phenotyped anatomical material. Some universities, including the University of California (UC), may allocate human specimens to students and researchers in disciplines outside biomedicine, such as engineering, exercise science, and anthropology.
Universities often obtain human specimens from (1) donations to academic whole-body donation programs or state anatomy boards, (2) noninstitutional donation programs, (3) institutional or noninstitutional tissue banks, or (4) existing collections. Individuals undergoing surgical procedures that result in specimens sent to clinical pathology for diagnosis, or who serve as human subjects in clinical trials, can also provide specimens. Once an institution has control of a human anatomical specimen, it is responsible for ensuring the specimen’s appropriate and ethical use and disposal or return.
In past years, incidents regarding human anatomical specimens have occurred at several UC campuses, in some cases leading to investigations, civil suits, and criminal prosecutions. In 1999, an internal audit at UC Irvine revealed financial fraud and improprieties with the collection of specimen loan fees and recordkeeping in the School of Medicine’s willed body program.1 Multiple civil cases were filed after university officials revealed the improprieties, resulting in two published opinions (Conroy v Regents Univ. of Cal. 45 Cal. 4th 1244, 203 P.3d 1127, 91 Cal. Rptr. 3d 532 ; and Melican v Regents Univ. of Cal. 59 Cal.Rptr.3d 672 ). In a second incident, in 2003, body parts discovered off-site led to a conviction and 32-month prison sentence for an employee of a pathology support company that provided services for the UC Davis Medical Center; the employee had stolen human body parts intended for cremation or disposal from the Department of Pathology’s laboratory. During a parallel civil suit, an investigation determined that inadequate disposition tracking allowed specimens to fall outside of the university’s control. In 2004, the discovery of irregularities in the willed body program at UCLA resulted in, first, its former director pleading guilty to conspiracy to commit grand theft and, later, a co-conspirator being convicted of embezzlement, conspiracy to commit grand theft, and tax evasion. Both were sentenced to prison time and ordered to pay restitution to UCLA. Civil suits were also filed in that case.
Financial fraud, forgery, black market activities, misuse, and misappropriation of human tissues and body parts have also occurred around the country at other universities, noninstitutional donation programs, tissue banks, biomedical companies, medical waste disposers, funeral homes, and medical examiner offices. In many of these cases, potential profit in the underregulated, lucrative market for human tissues may have motivated the crimes.2 One high-profile case involved a physician on the East Coast who sold body parts from people known to have contagious diseases and from those who had not consented. In 2008, he pleaded guilty to charges of enterprise corruption, reckless endangerment, and body stealing.3 Such incidents reinforce the importance of institutional policies and guidelines that can achieve educational and research missions while mitigating institutional risks.
In 2004, in response to these events, the UC Office of the President (UCOP) created a taskforce to establish standards and guidelines for the use of human anatomical specimens in research and education. Taskforce members included representatives of the five UC campuses with donor programs; internal and external experts in law, medical education, donor program management, policy regulation, and compliance; stakeholders, including faculty and researchers, who require human specimens for their educational missions; an independent consulting group; and a former California governor. Within a year, the taskforce issued a report that highlighted a lack of institutional oversight and transparency in administration and operations that varied across campuses. It was also noted that although the UC programs have similar missions, their day-to-day operations were accomplished in a variety of ways.
In 2005, to facilitate and coordinate implementation of the taskforce’s recommendations, the UCOP established a position for a system-wide director of anatomical services. The director, who reports to the senior vice president for health sciences and services or his or her designate, oversees the standardization and coordination of the UC system’s whole-body donation programs, develops and implements appropriate policies and guidelines, ensures compliance with existing UC policies, and recommends guidelines for the ethical acquisition, use, and disposition of anatomical materials for education and research.
At the same time, the UCOP established a system-wide policy for UC that contains standards and guidelines to help formally manage administration and operations of the system’s five anatomical donation programs (UC ADPs).4 The policy established a dual reporting structure: The manager/director responsible for daily operations at each campus program reports both to his or her campus leadership and to the system-wide director.
The Human Anatomical Specimens and Tissue Oversight Committee at UC Davis
The UC Davis Human Anatomical Specimen and Tissue Oversight Committee (HASTOC), now responsible for implementing the system-wide policy, was formed shortly after the 2003 theft of anatomical specimens at UC Davis, but before the UCOP’s directives. It was developed in conjunction with an internal review and restructuring of the campus’s body donation program. At its first monthly meeting, the HASTOC set the goal of developing a robust oversight system that would protect the many diverse stakeholders that contribute to and benefit from the use of anatomical specimens. In 2005, the HASTOC formally implemented its Anatomical Specimens Policy.5
Public trust and accurate information are integral to preserving donation programs and, thus, access to human specimens. The ethical treatment of a donor who gives his or her body for the betterment of humanity—often cited as the ultimate gift—is critically important. Although authorization in a donation agreement essentially gives the receiving institution rights to make use and disposition arrangements accordingly, care and consideration must be given to the values—social, cultural and religious—of the donor’s family and survivors.3 The HASTOC’s oversight system aims to balance those concerns with the need to ensure that institutions have access to high-quality human anatomical specimens for teaching and research.
UC Davis’s HASTOC provides a definition for “recognizable human anatomical specimens,” and its jurisdiction covers two uses—education and research. Any use of human anatomical specimens in research that entails interaction/intervention with a living human subject (or identifiable private information about a living individual) is governed by institutional review board policies, as well as other state and federal laws, rules, and regulations. Certain Native American remains (e.g., those Native American remains other than those freely given or naturally shed from the individual from whose body they were obtained) are subject to the Native American Graves Protection and Repatriation Act, established in 1990, and, therefore, are not included in the HASTOC policy.
The dean of the UC Davis School of Medicine chairs the HASTOC and appoints other committee members for three-year terms. Members represent the various types of experts involved in specimen use at a research university and include the responsible executive officer and the director of the body donation program, the university’s research compliance officer, the system-wide director of anatomical services, and representatives from the Pathology Department, the campus or health science counsel’s office, and the Environmental Health and Safety Department, as well as representative users of anatomical specimens from the main and health sciences campuses, the director of the institutional review board, a public representative, and an ethicist.
Early HASTOC discussions identified several institutional goals:
* to address ethical concerns, particularly those arising from past incidents at UC campuses,
* to institute best practices for health and safety purposes,
* to maintain public trust,
* to assure donors and families that anatomical gifts would be treated with respect and appreciation, and
* to prevent potential reluctance to donate anatomical specimens for education and research.
Several organizations, such as the American Association of Clinical Anatomists and the Association of Academic Health Centers, have developed best practices, standards, or guidelines that reflect the HASTOC’s goal of having a robust and transparent oversight system for anatomical specimens used in education and research.6–9 Additionally, calls for bioethical consideration in oversight are noted in the literature.10
One of HASTOC’s first tasks was to establish a campus-wide Anatomical Specimens Policy that delineates
standards and procedures for the procurement, inventory, use, management, transfer, transportation, and disposition of human anatomical specimens to support the appropriate educational and research use of human anatomical materials by faculty, staff, students, and residents.5
The policy includes four components for oversight: (1) a training program for all users of anatomical specimens, (2) a centralized mechanism and procedure for inventory, (3) tracking and use authorization, and (4) a reporting and enforcement component.
Additional oversight and management complexities of human tissue research repositories and collections were identified after the policy was implemented. Faculty and researchers who change academic employers often desire to relocate human specimens that have been used in their university research and/or teaching; further, transfers of a collection or components may be desired by collaborating researchers at nonaffiliated institutions. In the case of Washington University v. Catalona et al (490 F.3d 667 [8th Cir. 2007], cert. denied, 128 S.Ct. 1122 ), the court found that neither donors nor research investigators controlled the use and custody of the donations; rather, these rights and responsibilities belonged to the institution to which the donation was made. Through the review of related case law such as this, the HASTOC acknowledged the importance of proper consent/authorization language as well as procedural verification processes to mitigate risk in these various activities. Consideration of the same was made when modifying the application process.
Because no specific California law governs all aspects of human tissue repositories and collections, the HASTOC elected to review each application or existing inventory on a case-by-case basis, reviewing consent, transfer, and disposition processes in order to determine the appropriateness of the desired activity. This type of review process occurs when a request is made to move any human anatomical specimen to or from UC Davis.
Policy Training Program
The training program component of UC Davis’s HASTOC’s Anatomical Specimens Policy was created to educate researchers both about the specifics of the policy itself and about appropriate and ethical use of human anatomical specimens in general. The training provides guidance for processes such as acquisition, use, tracking, disposition, compliance, and remediation and is designed to ensure that users of anatomical specimens understand their responsibilities.
Initially, the HASTOC provided training in the form of a two-hour course with an examination, but, even with the offer of continuing medical education (CME) credit, participation was low. A new training protocol was introduced, which provides policy training, and participants receive CME credit within the context of grand rounds. This facilitates a more tailored approach to disseminating expectations and policy requirements. The trainer can individualize concepts to specific departments and users within the scope of their educational and research activities, thus making the training reflect their particular needs. Many individual or situation-specific questions can be addressed directly with the anatomical specimen user in this scenario, and this approach also allows attendees to become acquainted with the institution’s anatomical specimen management personnel.
Training refreshers are required of all anatomical specimen users on campus and can be completed through the grand rounds process or via an online training session. The online training is currently offered through the UC Learning Web site. This is an internal training and development Web site that can be linked to position titles or can be taken electively by the entire heath system. Both online training sessions require that participants pass a self-assessment quiz in order to receive the required biennial training verification. The UC Learning course will automatically e-mail the HASTOC designee when training is complete. The HASTOC will also provide training to address specific departmental schedules or needs on request.
A process for tracking specimen acqui sition and disposal is well established. Specimens are requested by using the Anatomical Materials Request Application—a form that all end users, internal and external, must submit to obtain human specimens from any of the UC ADPs, which include five campus whole-body donation facilities. The request application requires the applicant to provide a detailed description of the specimen(s) being requested, billing information, an IRB-approved research proposal as applicable, signatures to affirm the applicant’s understanding of the user’s responsibilities and willingness to abide by the institution’s policies, and contact information for the principal investigator, his or her supervisor, and the relevant finance officer. Institutional policies and requirements as well as relevant laws are included in order to cover topics such as health and safety, transfer, storage and segregation, photography, and publication specifi cations. Each request application is subject to committee review; once approved, specimen collection and allocation procedures commence.
If the local program or another UC ADP cannot provide the specimens, the researcher may request permission to obtain them from an alternate source by filling out an appendix to the original application. The appendix requires information relevant to the specimen source and may include contact information, consent language examples, laboratory testing protocols, and transportation or disposition methodologies. Site visits of user premises are also required, in which security, cleanliness, and general compliance with health and safety regulations are ascertained. Approvals of appendix applications occur on a case-by-case basis. If approval is granted, specimen identification tags are typically provided by the program, and the related database is updated accordingly. Identification tags must be maintained throughout every stage of allocation, use, transportation, and return. At the conclusion of use, the principal investigator contacts the program, which is responsible for facilitating disposition, either through cremation, return to the original source, or another preapproved method.
The program staff is responsible for tracking all specimens that originate from its program, all specimens from other UC ADPs, and specimens acquired from other non-UC sources. Tracking is accomplished through the Digital Donor Library (DDL), a system-wide database accessible to all UC ADPs, the system-wide director, and other personnel with compliance responsibilities. A CO2 laser barcode printer and specialized software are used to create external specimen identification tags for tagging and tracking of human remains within each of the UC ADPs. These tags have unique identification sequences with codes specific to the facility, year, serial number, specimen group, and name. The DDL tracks donations and every specimen thereof from registration through final disposition and includes a module for tracking acquired specimens (those that are sourced outside of the UC system, grown from culture, etc.). Its capabilities include a report generation function, various queries, and an audit function. The Pathology Department is responsible for tracking specimens originating from internal clinical operations. Some exceptions can be requested and approved for departments that have the capacity to meet data requirements for tracking specimens internally; this is true for some tissue bank collections, research repositories, or large teaching collections of human anatomical specimens.
Reporting and Enforcement
Reporting of violations and enforcement of policy parameters are critical to the oversight functionality. Issues continue to be identified, and review and change of policies are implemented as necessary. The case histories in Box 1 ar11e examples of the implementation process.
Box 1 Case Study Examples of the Implementation of the University of California (UC) Davis Human Anatomical Specimen and Tissue Oversight Committee (HASTOC)’s Anatomical Specimen Policy, Issued in 2005 Cited Here...
Case 1: Relationships with non-UC organizations
A UC Davis researcher wanted to send specimens to a non-UC colleague in Europe as part of a grant-funded research project. Because of the special circumstance of sending these materials abroad, HASTOC was approached for guidance on transfer, transport, and disposition of the specimens. Specifically, HASTOC deliberated the question of whether the European university should be given responsibility for disposition after completion of the project. HASTOC decided that the specimens could be disposed of by the European university, with the requirement that documentation of the disposition be sent to the originating department and to HASTOC. After the request was approved, the campus department and the anatomical donation program worked together to properly ship the specimens. As approved by HASTOC, the program acted as the contact point for both universities, using the Anatomical Specimens Policy as a guide.
Case 2: Specimen retrieval from noninstitutional vendors
As part of a grant from a noninstitutional, community-based, nonprofit organ donation program, a department within the UC Davis School of Medicine began receiving specimens, deemed, because of serology or social history exclusionary factors, to be not viable for transplantation or other clinical uses. When an internal department asks to receive specimens from a noninstitutional vendor, the standard procedure of checks and balances requires the campus purchasing department to inform HASTOC in compliance with Personnel Policy Manual 220-03. In this case, however, the specimens had not gone through a purchasing review, as they were given directly and free-of-charge to the researcher. The department’s designated anatomical specimen coordinator reported the incident to HASTOC immediately on learning of it; subsequent specimen transfers were halted until the department’s principal investigator successfully completed the request process. Additional training on PPM 220-03 for this investigator and department ensued, and the investigator was able to acquire the specimens needed through a combination of sources (the university’s anatomical donation program and a noninstitutional program).
Case 3: Protocol for preexisting specimen collections
At the request of the dean of the UC Davis School of Medicine, inventories of all anatomical specimens present on both the general and health sciences campuses were reported to HASTOC at its inception and again in the early period of policy implementation. One such inventory included a large research unit’s collection of nearly 2,000 brain specimens. The specimens had been stored by a private entity that subsequently refused to enter into a contractual agreement with the university. HASTOC tentatively approved the department’s request to use these specimens, but an assessment of the private entity’s acquisition, storage, and transport methods were found insufficient for risk mitigation. HASTOC required the department to retrieve all specimens from the noncontracted entity and, with the assistance of the anatomical donation program, to inventory the collection, determine which specimens were needed, locate an appropriate storage area, and dispose of any nonuseful specimens. Ultimately, 25% of the specimens were retained for use and 75% were properly disposed. The program and HASTOC supported the department in all stages of this process. A new secure storage location was found, and contracts for future procurement and transportation were completed.
As with the implementation of any new policy, challenges surfaced. Raising campus-wide awareness and ensuring effective training was difficult, either because of the ineffective dissemination of information (e.g., notification of policy implementation went to department chairs, not to all end users directly) or nonresponsiveness. It was found that policy training and education should include department chairs in order to achieve the greatest degree of compliance.
It is essential that ongoing notification, reminders, and policy training be conducted regularly. The decision to provide trainings at grand rounds proved effective in capturing a larger audience and filling potential gaps in outreach. Compliance and reporting are dependent on cooperation of the university community, and success appears to be directly related to notification and training. Cooperation comes with increased understanding of both the ethical issues and the fact that policy creation and procedural changes benefit and protect the university community, and as program staff are present to facilitate the policy and its concepts. With time and ongoing diligence, it is anticipated that policy awareness, compliance, and thus reporting to the HASTOC will occur more routinely, with less proactive monitoring required.
Although Davis was the first UC campus to create and implement a policy governing all human anatomical specimens used in education and research, all UC campuses are dedicated in their regulatory and compliance efforts. Each UC campus with a program has an anatomical advisory board that advises the campus on policy and makes recommendations regarding program activities. HASTOC fills that role at UC Davis and extends further to create and implement policies for all specimens used in education and research on the campus, regardless of the source. Other UC campuses are emulating this model and are in varying stages of implementation. Contributions by the system-wide director of anatomical services and the system-wide divisions of Health Sciences and Services, the Office of General Counsel, Risk Management, and Ethics, Compliance and Audit Services—as well as significant contributions of the HASTOC members, each with their own subject matter expertise—are essential components of effective policy implementation.
The Uniform Anatomical Gift Act, modified by each state, governs donations for education and research as well as transplant and therapy.11 However, it is silent on the components vital to successfully fulfilling academic/research missions and mitigating risk at an academic health center including requests, uses, tracking, storage, safety, and training. The University of Pennsylvania is one of a few academic health centers that have created policies for all human specimens used in education and research.12 Therefore, having policies in place at academic health centers with regard to human anatomical specimens is necessary to effectively create and maintain leadership awareness and also serves to prevent, mitigate, and control the risks inherent with these complex and vitally important resources.
Acknowledgments: The authors would like to thank the individuals who donate their bodies for the advancement of education and research, the University of California (UC), Davis Human Anatomical Specimen and Tissue Oversight Committee members, and the members of the UC System-wide Anatomical Materials Review Committee.