Author: Robert M. Nelson
Date: 02-09-04 15:28
Source: Medical Research Law & Policy Report
URL: http://www.bna.com
Date published: December 3rd 2003
By Mary Faith Marshall, Ph.D., and Mark Barnes, J.D., L.L.M.
Reproduced with permission from Medical Research Law & Policy Report, Vol. 2, No. 23, 12/3/03, pp. 862-864. Copyright 2003 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
A new study reported in Academic Medicine has raised concerns (once again) about potential conflicts of interest related to biomedical research.1 Harvard investigators reported results from a national survey of institutional review board members showing that many medical school faculty members who serve on IRBs also serve as paid consultants for pharmaceutical companies. The fact that clinical investigators play these dual roles does not, per se, mean that IRB members make biased decisions, or that research participants (subjects) are in danger. But the problem of perceived or real conflicts of interest and the risk those conflicts may present to human subjects' safety are clearly present.
Meeting a need
Biomedical research is a critical enterprise that yields benefits for hundreds of millions of people each year. No research, however, is devoid of risk, as research, by definition, involves testing the boundaries of established and proven treatments. Other factors also may produce risk in research. For example, investigator, IRB member, or institutional conflict of interest can pose a serious hazard to the research enterprise because it may affect the inherent trust between the research participant and the investigator, and--on a larger scale--between society and the research community. The very title of the Institute of Medicine report advocating accreditation of human research participant protection programs, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs, 2 reflects the primacy of this concern.
Public interest in the adequacy of human research protection has grown in recent years (and continues to grow) due to a series of unfortunate events, including the deaths and injuries of study participants. The resulting government-ordered sanctions and skepticism among potential study participants threatens important research progress. Both the federal Office for Human Research Protections and the Food and Drug Administration have voiced support for private accreditation as a critical component of an overall strategy to better protect human research participants and to promote greater accountability on the part of investigators and research organizations.
The Institute of Medicine recommended nongovernmental accreditation programs "based on the potential for a constructive, performance-based accreditation system to facilitate within protection programs an emphasis on outcome measures as well as to provide a proactive, responsive mechanism that is able to incorporate feedback from accreditation stakeholders in order to meet evolving program needs."3 The IOM committee envisioned a private, voluntary system of accreditation with more than one, and perhaps several, accrediting agencies. The National Committee for Quality Assurance (NCQA) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP) were the first such organizations to emerge in the accreditation arena. In its report on accreditation, Preserving Public Trust, the IOM recommended the NCQA accreditation program as a pilot program for the Department of Veterans Affairs. Since that report was written, a new organization sponsored by NCQA and the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), called the Partnership for Human Research Protection Inc. (PHRP) has entered the research accreditation landscape.
In May 2003, the nation's historical and leading advocates for quality in health care, the JCAHO and the NCQA, formed PHRP to offer a new accreditation program that seeks to protect the safety and rights of participants in clinical trials and research programs in both public and private hospitals, academic medical centers, and other research facilities in the United States and abroad. The impetus for the partnership was the need to ensure that the benefits of research, and the efforts of investigators, are supported by and integral to a robust process for safeguarding research participants.
By applying a uniform set of standards across many different research settings, NCQA and JCAHO bring their decades of expertise to bear in ensuring the protection of research participants. The JCAHO and NCQA long have been dedicated to improving the safety and quality of care provided to the public. This accreditation initiative represents a major extension of these two not-for-profit organizations' combined commitment to the public interest, exemplified by the application of well-established accreditation mechanisms to human subjects research. In designing its accreditation system, PHRP has drawn on support from representatives of the research community and the public--representatives who have advocated for standardized accreditation guidelines that offer all human research protection programs the opportunity to operate from a single, level starting point. Thus, the PHRP process allows a wide variety of human research protection programs to focus on achieving both excellence and effectiveness in protecting research participants.
PHRP development
The collaboration between JCAHO and NCQA meets these needs by providing a uniform set of national standards that complement regulatory efforts, minimize the need for additional government oversight, and promote the efficient and effective use of research oversight resources. PHRP's approach focuses on best practices and continuous improvement, rather than on de minimis compliance with minimum standards, thus ensuring that protection programs become as good as they can be, rather than merely as good as they are required to be. Importantly, in several critical areas the PHRP standards exceed current regulation, based on anticipated imminent developments in national research practices. For example, PHRP standards include specific provisions relating to prevention and management of investigator and institutional conflict of interest, securing privacy for relevant data, and regulating secondary users of research data.
PHRP is a practical accreditation process for a broad range of organizations and was developed through interviews with stakeholders and rigorous site-testing. While PHRP reflects a state-of-the-art approach to establishing a new research evaluation process, its methods will be readily accessible to health care providers who already use the JCAHO accreditation process. And, because independence is as essential for an accreditor as it is for an investigator or a reviewer, it is important to note that PHRP, as the joint project of two highly independent organizations, offers human research protection accreditation whose integrity and independence from entrenched research interests is clear and straightforward.
PHRP accreditation
By design, the PHRP accreditation program specifically addresses the principal issues identified in the 2001 IOM report, Preserving Public Trust: Accreditation and Human Research Protection Programs. Thus, PHRP offers two accreditation programs: one for organizations that conduct human research (such as academic medical centers, clinical research organizations, pharmaceutical companies, or community hospitals), and one for independent institutional review boards that prospectively review and monitor, but do not themselves conduct, research. As advocated in the IOM report, the accreditation process is based on self-assessment, peer review, and education.
The purpose of the standards developed by PHRP is to establish performance goals, to provide a roadmap to their attainment and "through independent, external review" to evaluate human research protection programs in relation to those goals. The standards address both of the accreditation options for research organizations and independent IRBs. Standards cover:
organizational responsibilities,
IRB structure and operations,
consideration of risks and benefits, and
informed consent.
The PHRP accreditation process is unique in many important ways. It is designed to be clear to the user and transparent in the review and scoring process. Importantly, it also is designed to promote efficiency and effectiveness. The standards are organized into the functional categories that a human research protection program performs, and include intent statements, elements that specify how PHRP evaluates and scores the standards, specific scoring rules for each element, data sources needed to support the scoring, the scope of review for each element, and explanations and examples. Through these transparent mechanisms, the PHRP process seeks to promote institutional and IRB self-evaluation, thus making the accreditation process more predictable and self-improvement of research programs more achievable.
A key component of the PHRP accreditation process is the industry's first and only online accreditation platform, the Interactive Survey System (ISS). The easy-to-use ISS enables participating organizations to conduct a full readiness evaluation prior to their actual survey. The ISS uses a flexible Web-based platform to facilitate data compilation and communication with survey team members and to track ongoing changes. Designed to promote efficiency and to be user-friendly, the survey tool provides instant feedback, scans for errors or omissions, and eliminates the waste of time and frustration involved in the archaic process of finding and moving hard copy documents from one place to another.
PHRP helps organizations prepare for the survey process through educational offerings such as field workshops and audioconferences. Surveys occur in two stages. The first stage begins when an organization submits a completed survey tool via the Web. This is followed by an off-site review of the evaluation results and supporting documentation. The second stage consists of an on-site review during which a team of PHRP surveyors further validates performance against the standards. PHRP offers an accreditation award for a maximum of three years, and includes annual reporting requirements to assess ongoing compliance with standards. Accreditation decisions are publicly reported.
Conclusion
The general public, Congress, sponsors, and most importantly, research participants must be able to trust the research enterprise. National standards, such as those developed by PHRP, and a constructive, performance-based accreditation process are critical elements of an effective system to safeguard research participants, and, consequently, research itself. Earning PHRP accreditation helps organizations and their researchers by reducing possible liability and the likelihood of receiving regulatory sanctions. More importantly, it serves as a mark of excellence--a beacon, of sorts, to research participants, sponsors, research faculty, and the public--signaling that the accredited organization puts the research participant, and thus research, first.
For more information about domestic PHRP accreditation, contact Jessica Briefer French, assistant vice president, human research protection, NCQA, at (202) 955-5177.
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1 E.G. Campbell et al., "Characteristics of Medical School Faculty Members Serving on Institutional Review Boards: Results of a National Survey," Academic Medicine 2004; 78: 769-774.
2 D. Federman et al, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs, Committee on Assessing the System for Protecting Human Research Participants, Board on Health Sciences Policy, Institute of Medicine, National Academy Press, Washington, D.C. (2001).
3 D. Federman et al, Responsible Research: A Systems Approach to Protecting Research Participants, Committee on Assessing the System for Protecting Human Research Participants, Board on Health Sciences Policy, Institute of Medicine, National Academy Press, Washington, D.C. (2002).
Mary Faith Marshall is chair of the board of directors, Partnership for Human Research Protection Inc., and professor of medicine and bioethics at Kansas University Medical Center, Kansas City, where she directs the Institute for Bioethics, Law and Public Policy. She has served as an adviser on research ethics for the National Institutes of Health, the Department of Health and Human Services, and the Institute of Medicine. She served as chair of the HHS National Human Research Protections Advisory Committee, and as an expert adviser to the IOM Committee on Assessing the System for Human Research Participants.
Mark Barnes is a member of the PHRP board of directors and an attorney and partner at Ropes & Gray LLP, New York, specializing in informed consent issues. He represents hospitals, health care associations, physicians, social services agencies, and related organizations in regulatory, reimbursement, research, Health Insurance Portability and Accountability Act compliance, and litigation matters. He serves as a member of the Advisory Committee for Human Research Protections of the Secretary of Health and Human Services.
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