Introduction
P
rotecting the rights and welfare of research participants is the major ethical obligation of all parties in the oversight system, who, to meet this obligation, must demonstrate competence in research ethics by being able to conduct, review, or oversee research involving human participants in an ethically sound manner. Such competence entails not only being knowledgeable about relevant research ethics issues and federal policies but also ensuring that conflicting interests for institutions, investigators, or Institutional Review Boards (IRBs) are disclosed and managed so that there is no question that research participants are being protected. Finally, the oversight system must include a robust monitoring process so that lapses by institutions, IRBs, and investigators can be remedied.This chapter addresses measures needed to ensure that all parties involved in the research enterprise are competent with regard to protecting research participants and are reliably carrying out their responsibilities in this area. They include measures:
■ to educate all parties involved in research with human participants about the substantive and procedural requirements of the system of protections (which includes demonstrated competence in research ethics);
■ to provide ongoing mechanisms to ensure that institutions, IRBs, and investigators are in compliance with regulations, guidance, and procedures pertaining to the protection of research participants; and
■ to manage conflicts of interest of investigators, IRBs, and institutions.
Education and Competence in
experienced IRB members and administrators (President’s Commission 1983, 135–136). ACHRE highlighted the importance of education by linking the protection of the rights and interests of research participants to the ability of investigators to “appreciate sufficiently the moral aspects of human…research and the value of institutional oversight” (ACHRE 1995, 817). In two previous reports, NBAC recommended that professional associations develop topic-specific educational materials (NBAC 1998; NBAC 1999).
Despite this enduring recognition of the important role of education, the educational function of the oversight system has been only minimally implemented through federal programs. The former Office for Protection from Research Risks (OPRR) devoted most of its limited resources to negotiating assurances and overseeing com-pliance. Aside from the educational activities associated with obtaining an assurance, regional workshops sponsored in conjunction with the Food and Drug Administration (FDA) were OPRR’s only other sustained educational program. The lack of focus on education at the federal level was repeated at the local level, with insti-tutions often failing to provide educational programs to their investigators, research staff, and IRB members. It should not be surprising, therefore, that the lack of appropriate educational programs and the resulting lack of knowledge about the ethical principles and procedures relevant to protecting research participants are among the deficiencies identified in audits and suspensions of research programs by OPRR, now the Office for Human Research Protections (OHRP) (OHRP 2000). A National Institutes of Health (NIH) survey of IRB chairs, mem-bers, administrators, institutional officials, and investiga-tors at institutions holding Multiple Project Assurances (MPAs) found strong support for additional, improved education (Bell et al. 1998).
Some efforts are currently under way to increase educational opportunities. In 1997, two NIH-sponsored educational programs were initiated as part of the government’s apology to the victims and families of the Tuskegee Syphilis Study. In one program, investigators receive grants to participate in ethics training programs tailored to meet their research needs; in another, program grants are awarded to individuals to develop courses in
research ethics.1 In addition, in 1998 OPRR hired its first director of education to develop computer-based education programs for IRB administrators and institu-tional officials. Outside government, organizations, such as Public Responsibility in Medicine and Research (PRIM&R) and the Association of American Medical Colleges, have traditionally provided education to their constituents. Recently, PRIM&R developed a new “IRB 101” course, which is offered before its annual meeting and at the request of institutions throughout the year.2 In addition, some academic institutions have developed their own courses (Dunn and Chadwick 1999; Sugarman 2000).
Recently, NIH implemented a funding eligibility requirement that all individuals submitting grant appli-cations provide evidence that they have been trained in research ethics.3 This requirement has increased the number of education programs academic institutions offer to faculty and staff with the goal of raising the level of knowledge about and awareness of research ethics among investigators. Although NIH provides a model education program on its website, no requirements or guidance are provided regarding what constitutes appro-priate training. Investigators and institutions have considerable discretion in fulfilling the NIH requirement.
This activity has generated a beneficial exchange of ideas on how best to teach research ethics to different audiences.
Educational programs should focus on ethical prin-ciples, their relationship to ethical standards, and the procedures necessary to implement them. It is critical to emphasize the links among these three components.
Because each research study is different and some raise new ethical issues, investigators and IRBs must be able to refer to and apply general ethical principles. Yet, it is equally true that research ethics cannot be taught or learned entirely in the abstract. As one expert cautioned:
“rote memorization of guidelines, principles, and regu-lations, absent the ability to apply such concepts in practical situations, will not ensure the protection of [research participants].”4 Educational programs should include problem-solving components in which investi-gators and IRB members learn ways in which to identify, discuss, and resolve ethical issues pertinent to specific types of research studies.
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For the behavioral and social sciences, IRB members and investigators should be educated in the ethical stan-dards and associated procedures that are appropriate to human participant research in these disciplines. In addi-tion, IRB members should be familiar with standards in professional societies’ codes of ethics, particularly for fieldwork in anthropology or survey research in sociology or psychology. Such standards address issues of privacy and confidentiality, informed consent, and community protection. Complex questions concerning deception or stigmatization of individuals or communities may need particular attention, particularly in the context of research involving individuals with vulnerabilities.
NBAC supports the independence of institutions and other entities that would enable them to design their own education programs. However, it is important that all educational programs provide appropriate coverage of the ethical principles and standards and current federal regulations and guidance related to human participant research.
Although the primary focus of education is on those parties involved in the daily conduct of research (e.g., investigators and IRBs), other groups that carry impor-tant ethical responsibilities are also imporimpor-tant targets for education. For example, sponsors—whether public or private—often are directly involved in providing advice and supervision to grantees and contractors. Federal agencies that have their own oversight offices (see Chapter 2) also should be competent in research ethics, regulations, and guidance.
If investigators are to conduct research ethically and research participants are to be able to make informed decisions about participation, education about the ethical conduct of research needs to be an integral part of science education in the United States (Pritchard 1999). Even for those students who do not pursue careers in science or research, education in research ethics could make them better informed in terms of future research participation or in terms of understanding the nature of the research enterprise. The American Association for the Advance-ment of Science (AAAS 1993) and the National Academy of Sciences (National Research Council 1995) have pro-duced documents outlining content standards for science education, including standards for the ethical treatment of research participants.
While some curricula include courses or lectures on research ethics, such education generally is missing from most undergraduate and graduate school science curricula and is seldom required, including for medical and other health professions education (Coughlin et al. 1999;
Mastroianni and Kahn 1998). This phenomenon is particularly disturbing because many students conduct research involving human participants as part of their graduate educational experience (Gunsalus 1997).
Moreover, a large number of scientists and many health professionals expect to conduct human research. For example, in a survey of all graduating medical students conducted in 1996, 78.3 percent responded that they expect to be involved in research at least somewhat dur-ing their medical career, and 11.9 percent responded that they expected to be involved exclusively or significantly involved during their medical career.5 Given the role of physician-investigators within academic medical centers and the growing number of community physicians conducting research or referring patients to research, education in research ethics and human research pro-tection should be a meaningful component of medical education. Professional societies should assist institutions in developing educational programs and curricula.
The need for education in research ethics in graduate curricula extends beyond the health fields. Graduate pro-grams in social sciences and the humanities also should incorporate curricula relevant to the specific discipline, which could take advantage of the fact that professional societies have developed codes of ethics that deal specif-ically with conducting research involving human beings.
Education also can be extended to other groups likely to be involved in research. Patient advocacy organizations can, and often do, provide education to their members.
Informing groups about rights of research participants, protections afforded, and points to consider in deciding whether to enroll in research can empower a large number of prospective research participants.
Recommendation 3.1:All institutions and sponsors engaged in research involving human participants should provide educational programs in research ethics to appropriate institutional officials, investi-gators, Institutional Review Board members, and Institutional Review Board staff. Among other
issues, these programs should emphasize the obligations of institutions, sponsors, Institutional Review Boards, and investigators to protect the rights and welfare of participants. Colleges and universities should include research ethics in curricula related to research methods, and professional societies should include research ethics in their continuing education programs.
Recommendation 3.2:The federal government, in partnership with academic and professional societies, should enhance research ethics education related to protecting human research participants and stimulate the development of innovative educational programs. Professional societies should be consulted so that educational programs are designed to meet the needs of all who conduct and review research.
The federal government should use a variety of incen-tives to encourage the enhancement of research ethics education.
Demonstrating Competence Certification of Individuals
Educating all parties in research ethics and human research protections is effective only when it results in competence to design and conduct ethically sound research, including analyzing, interpreting, and dissemi-nating results in an ethically sound manner. Such com-petence, however, cannot be assumed to follow from exposure to an educational course or program. As the complexion of research continues to change, new and challenging ethical dilemmas emerge with advances in technology, and as more people become involved in research as investigators or in roles particularly related to oversight, it becomes increasingly important for all parties to demonstrate their competence in the ethics of research involving human participants.
Currently, there is no regulatory requirement to demonstrate competence, even when the level of risk is high or the participants are vulnerable. In recent years, there has been much discussion about the need to implement regulations consistently, set standards for IRBs and measure performance in meeting those standards (OIG 1998a), and measure the competency of investigators (Cohen 2000).
Many IRBs and investigators have suggested that investigators should be required to demonstrate a certain level of competence in order to conduct human research.6 NBAC supports this view. All individuals directly involved in the protection of human research participants should be certified, including investigators and research staff, IRB members and staff, and sponsors.
Individuals employed by sponsors also should be certi-fied when they are directly involved in the conduct or oversight of research—for example, grants or contracting officers who might make decisions relevant to human participant protections. Further details regarding just which individuals require certification will, of course, be context dependent.
Because roles vary substantially and among investiga-tions the diversity in research design and subject matter is great, several certification options should be available.
For example, certification of investigators may need to be specialized for particular disciplines or in relation to cer-tain subject matter in order to increase its effectiveness.
Different mechanisms for certification should be tested and evaluated. Currently, under the NIH requirement, certification of investigators is left entirely up to the institution. Certification of IRB staff and members is not required; however, there is a voluntary certification program for IRB administrators. The Council for Certification of IRB Professionals (CCIP) was formed to promote IRB administration practice and to advance the quality of research participant protection programs through the certification of qualified IRB professionals.
CCIP administered the first certification examination in October 2000 and announced recently that 107 profes-sionals were certified based on the results of these exams.7 Certification efforts can surely be improved.
Overall, the goal of such programs should be to ensure competence and consistency that is relevant to the performance of the particular individual parties.
Recommendation 3.3: All investigators, Institutional Review Board members, and Institutional Review Board staff should be certified prior to conducting or reviewing research involving human participants.
Certification requirements should be appropriate
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to their roles and to the area of research.
The federal government should encourage organizations, sponsors, and institutions to develop certification programs and mechanisms to evaluate their effectiveness. Federal policy should set standards for determining whether institutions and sponsors have an effective process of certification in place.
Accreditation of Institutions and Independent IRBs Related to measuring competence in individual inves-tigators and IRB members and staff is measuring a core set of competencies in independent IRBs or institutions.
In this arena, accreditation programs might be the most effective mechanisms for measuring compliance of such entities to a set of standards (Hamm 1997). In this report, the term accreditationrefers to programs directed toward institutions, and the term certificationrefers to programs directed toward individuals.
Although accreditation and certification do not guar-antee desired outcomes, they can be helpful in improving performance. These programs generally involve experts and peers developing a set of standards that represents a consensus of the best practices in the profession.
Therefore, the choice of standards and the criteria for evaluating whether an institution has met them are critically important. The emphasis of these programs should be on education, on assuring that appropriate protections are in place, and on avoiding excessively bureaucratic procedures. Accrediting programs may lose their value if they are seen as merely another administra-tive burden.
Despite concerns that accreditation might add another layer of bureaucracy to an already regulated environment, several advantages of accreditation pro-grams have been noted. They are generally voluntary and represent a profession’s desire to self-regulate. Many accrediting programs strive to meet higher standards than are required by law, so that having the credential implies a higher level of competence than what may be minimally required. Properly governed and organized, accrediting bodies can improve competence (and thus performance) within a profession, which helps to achieve the goals of the profession and build public trust (Hamm 1997). In addition, accreditation serves an educative role.
Institutions seeking accreditation, for example, usually go through a periodic review process involving a self-study and a site visit from a team of experts in the profession. The self-evaluation of the institution in preparation for a site visit helps it identify strengths and weaknesses in its programs and make improvements.
The site visit can be an especially useful learning expe-rience that encourages the institution to sustain best practices.
Accrediting programs are widely used in the fields of health and education. These programs are seen as having a major and generally positive influence (Hamm 1997).
One highly regarded accrediting program in research is the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). This private, non-profit organization “promotes the humane treatment of animals in science through voluntary accreditation and evaluation programs.” AAALAC accreditation is regarded as a validation of having a high-quality operation, and research programs are willing to spend resources to obtain such accreditation. AAALAC accreditation demonstrates that an institution is going beyond the minimum required by law, achieving excellence in animal care and use (Bayne 1998).
Recently, the Association for the Accreditation of Human Research Protection Programs (AAHRPP) was incorporated to “provide a process of voluntary peer review and education among organizations concerned with research involving humans.” The overall goal of this accrediting organization is to improve protection of human research participants by developing “best practice”
performance standards and by recognizing institutions that meet those standards. AAHRPP expects to begin accrediting institutions in the near future.8
The Department of Veterans Affairs (VA) requires all institutions involved in conducting research sponsored by the VA to be accredited (VA 2000), but it is the only federal agency that requires institutions or IRBs to become accredited. OHRP is also moving in the direction of accreditation. Commissioned by OHRP to conduct a study on accreditation and other human participant research issues, the Institute of Medicine issued a report on the use of accreditation programs and offered recom-mendation regarding standards (IOM 2001).
Moving toward accreditation and certification is a positive step in ensuring improved oversight of human research. As the proposed oversight system evolves to in-clude accreditation and certification programs, flexibility in testing different models and methods of accreditation and certification should be allowed to ensure that when these programs become fully functioning they are sensi-tive to the needs of the system and responsive to the various entities seeking accreditation certification. For example, institutions that do not have IRBs but that are conducting research involving human participants should be eligible for accreditation because they have education, monitoring, and accountability responsibilities;
and independent IRBs that might not perform all the functions of an institution conducting research also should be eligible for accreditation to carry out their more limited responsibilities.
Given the diversity among institutions that might seek accreditation and the fact that there are likely to be several accrediting organizations, the proposed federal oversight office should set criteria for government approval of accrediting bodies. In addition, the federal oversight office should develop a mechanism for moni-toring accrediting bodies, and accrediting bodies, in turn, should be monitoring the institutions they accredit for continued competency. In the end, the office should be able to evaluate the effectiveness of accreditation.
Although the establishment of accreditation programs is likely to improve protections to human participants, such programs will be costly. In addition to the cost of accreditation itself, all institutions seeking accreditation will need to devote additional resources and staff to sup-port new functions or strengthen existing functions. For example, some institutions might need to add educa-tional programs or add monitoring functions. However, the potential improvements in the system justify these additional costs.
Recommendation 3.4:Sponsors, institutions, and independent Institutional Review Boards should be accredited in order to conduct or review research involving human participants.
Accreditation should be premised upon
demonstrated competency in core areas through accreditation programs that are approved by the federal government.