Author: Robert M. Nelson
Date: 02-09-04 15:40
Source: Medical Research Law & Policy Report
URL: http://www.bna.com
Date published: January 21st 2004
By Marjorie A. Speers, Ph.D.
Reproduced with permission from Medical Research Law & Policy Report, Vol. 3, No. 2, 1/21/04, pp. 55-56. Copyright 2004 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
Voluntary accreditation of human research protection programs--a means to ensure that organizations conducting or reviewing human research do so with the protection of research participants as their top priority--is a model that has growing support.
In its comprehensive final report, "Ethical and Policy Issues in Research Involving Human Participants," the National Bioethics Advisory Commission made wide-ranging recommendations for revamping the oversight system. The overarching goal of the national oversight system should be to protect research participants, while at the same time promoting ethically sound research. The need for a culture of concern and respect throughout the entire research community was stressed as the goal. A private sector response, along with a revised governmental focus, was called for; accreditation was one recommendation as a means to ensure the protection of research participants.1
The Institute of Medicine's deliberations in Preserving Public Trust: Accreditation and Human Research Participant Protection Programs advocated for accreditation as one element among many for improving participant protections.2
Most recently, the Secretary's Advisory Committee on Human Research Protections summarized its findings to date in an interim report: "The [Accreditation] Subcommittee supports the concept of accreditation of Human Research Protection Programs (HRPPs) for the protection of human subjects in research. Accreditation promises to be a useful mechanism for all organizations involved in human research that, like education and certification, leads to self-improvement of systems and outcomes." In its deliberations, the subcommittee interviewed Health and Human Services Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) officials, representatives from other types of accrediting bodies, and institutional officials from two organizations accredited by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP).
The idea of accrediting human research protection programs developed during an era of concern. Unnecessary deaths of research participants at two prestigious universities and complaints by participants at others led to investigations by the HHS Office of Protection from Research Risks, now OHRP. In each case, the office found systemic problems with the human research protection program and suspended research at the institution. The enforcement of federal regulations governing research clearly had amplified, and research organizations would need to demonstrate anew their commitments to protecting research participants. Since 2001, three organizations have initiated accreditation programs: AAHRPP, the Partnership for Human Research Protection Inc., and the National Committee for Quality Assurance (NCQA) with its Department of Veterans Affairs (VA) human research protection accreditation program.
Since May 2003, AAHRPP has awarded accreditation to a university, a hospital, two independent review boards, a VA medical center, and the research arm of a health care system. Many organizations are committed to seeking accreditation and are at various stages in the process. Accreditation increasingly is viewed by research organizations as a viable mechanism for demonstrating their commitment to human research
protections.
Multiple Values
There are many potential benefits to accreditation. Accreditation can help organizations improve their protection programs, achieve regulatory compliance, and advance research quality. These benefits, in turn, can bolster the public's trust in research and instill confidence in sponsors. The benefits an organization derives will depend on the approach of the accrediting program it chooses.
Federal regulations governing human research are the basis for AAHRPP's accreditation standards; the standards go beyond simple documentation requirements to evaluate systems, processes, and management in ways readily identifiable to experts in the field. Thus, AAHRPP-accredited organizations can be assured that their programs are in regulatory compliance.
Dr. Frank Zieve, associate chief of staff for research at Hunter Holmes McGuire VA Medical Center in Richmond, Va., whose institution first was accredited through the NCQA mandatory VA program and then by AAHRPP, attested to the basic value of accreditation at the December 2003 Public Responsibility in Medicine & Research conference in Washington, D.C. No matter which accreditation program an institution chooses to employ, Zieve said, improvements in human research protections are going to occur.
"From my perspective, the accreditation process was a constructive exercise that resulted in an improved program," wrote David Wynes, assistant vice president for research at the AAHRPP-accredited University of Iowa, in the Nov. 24, 2003, Research USA. "I am quick to point out that we didn't win an award for the best human research protection, rather we demonstrated that we have a solid, peer-reviewed program," Wynes said.3
Accreditation can be a nonthreatening, non-adversarial approach for organizations to improve the protections they provide to research participants. AAHRPP, for its part, maintains a confidential process, but also a transparent one. Organizations know clearly what is expected, from the first step of completing a self-assessment to the final one of responding to a site visit report. "It is important to note," wrote Wynes, "that there were no surprises."
Accreditation also can be a method to address pressing concerns that have not been codified in federal regulation. Institutions, for example, are grappling with how to manage institutional and investigator financial conflicts of interest. Guidance has begun to emerge from federal agencies, as well as from entities such as the Association for American Medical Colleges and the Association of American Universities, although no clear consensus on how to manage conflicts of interest has yet emerged.
In AAHRPP's accreditation standards, institutions must address how financial conflicts of interest are dealt with and managed--by the organization, investigators, and the institutional review board (IRB). Therefore, it would be difficult for an institution to become accredited if some procedures were not in place for dealing with each. The process of accreditation will motivate many organizations to take action on conflicts of interest sooner rather than later. This outcome ultimately will benefit research participants and the public, and will occur sooner than it would through federal rulemaking or legislation.
Finally, voluntary accreditation has perhaps the strongest potential for bringing about real changes in organizations' human research protection programs--helping to create that new culture of concern and respect. In November 2003, Rep. Diana DeGette (D-Colo.) introduced the Protection of Participants in Research Act of 2003 (H.R. 3594). Among its numerous provisions for improving the oversight system is one calling for voluntary accreditation of institutions and IRBs by private accrediting entities.
DeGette has said that she believes voluntary, rather than mandatory, accreditation to be a preferable strategy for making real improvements in human research participant protection. Her bill would allow the HHS secretary to recognize accrediting entities, but not to establish their standards or procedures.
Evaluation
Accreditation programs were launched in recent years in an environment of concern. The NCQA VA program grew out of a congressional inquiry into research protections at VA medical centers. The AAHRPP program was a response to the suspensions of federally funded research at major research universities. Now that these accreditation programs are in place, evaluating their effectiveness in improving research protections is a clear priority.
The IOM report on accreditation, as well as the follow-up report, Responsible Research: A Systems Approach to Protecting Research Participants, recommends that, after a five-year period that allows it to be implemented, accreditation be substantively reviewed and evaluated.4
AAHRPP also has initiated evaluation activities. The Centers for Disease Control and Prevention recently awarded AAHRPP a three-year grant to assess the role of accreditation in enhancing the protection of participants in public health research. Pilot measures will be developed and implemented in several locations, then refined and made available to document and evaluate the impact of accreditation. Because public health research spans the spectrum from clinical trials to epidemiology to community intervention, as well as behavioral and social science surveys, the final measures of effectiveness should be applicable to most, if not all, types of research.
Through voluntary accreditation, a large number of organizations will step forward in the next three to five years to show their commitment to doing the right thing--protecting research participants. Voluntary accreditation will provide research participants with the protections to which they are entitled, and also will allay concerns about the need for more governmental regulatory oversight.
Accreditation, taken as one component of a national oversight system, should help greatly to reduce the known problems within it. Accreditation is based on the motivation and good will of organizations that seek it; therefore, it holds the potential to bring about significant, sustainable change.
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1 National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants; Volume I: Report and Recommendations of the National Bioethics Advisory Commission, Bethesda, Md. (2001).
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. Wynes, "De-mystifying the human research accreditation process," Research USA (Nov. 24, 2003).
4 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).
Marjorie Speers is executive director, Association for the Accreditation of Human Research Protection Programs Inc. She served as National Bioethics Advisory Commission project director for the report on the national oversight system from 1999-2001, and was associate deputy director for science at the Centers for Disease Control and Prevention from 1995-2000.
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