Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
Currently Skimming:
Executive Summary
Executive Summary
Pages 1-22
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 1... ...
With respect to human research review programs, those tasks are to review and consider proposed performance standards, recommend standards for accreditation, and recommend an approach to monitoring and evaluating the system for protection of human research participants. The committee reviewed and considered available draft standards developed independently by Public Responsibility in Medicine and Research (PRIM&R)
|
From page 2... ...
The committee further recommends that (1; the organizations formulating accreditation standards and carrying out the accreditation process be independent, nongovernmental organizations; (2) the formulation of accreditation standards, the accreditation process, and human research participant protection program operations directly involve research participants; and (3)
|
From page 3... ...
l p A R T C p A N T S RESEARCH ORGANIZATIONS Examples: academic health centers, survey research organizations, contract research organizations, cooperative groups, research management unit of sponsor's organization INVESTIGATORS 1 PERFORMANCE ASSESSMENT Monitoring Education and Feedback Including in Including data vestigators, IRB safety and members and monitoring staff, and boards, data community centers, adverse members event reporting, ombudsman programs Quality Improvement Including selfassessment of program function, outcomes, and support 1 ~ ~ ~ L RESEARCH INVOLVING HUMAN PARTICIPANTS FIGURE 1 Human research participant protection programs. The components in the large box are all parts of an HRPPP.
|
From page 4... ...
The review system as a whole, however, has not transformed or adapted to the vast growth in the scale and complexity of research. Research carries with it inherent risk, but it must always be conducted so that risk to research participants is reduced to the minimum necessary and the rights of the volunteers who participate in the research are respected by the entire system of research sponsors, institutions, and investigators (the HRPPP)
|
From page 5... ...
Accreditation of HRPPPs was one of the ideas that emerged from these discussions. THE COMMITTEE'S TASK One component of the DHHS effort to examine the system for the protection of human research participants was to ask the Institute of Medicine (IOM)
|
From page 6... ...
First, the accreditation standards should be formulated in a "bootstrap" process, with strong feedback between the formulation of standards and direct experience with the implementation of HRPPP standards. Second, accreditation bodies should be accountable for their standards as well as their accreditation processes.
|
From page 7... ...
Failure to include privately sponsored research reviewed by independent IRBs would not only exclude a significant fraction of research with humans but would also call into question whether the accreditation process was skewed in favor of academic health centers. It is premature to judge how accreditation can work for these organizations, but it is critical to include them in any credible accreditation system.
|
From page 10... ...
RECOMMENDATIONS Recommendation 1: Pursue Accreditation Through Pilot Testing as One Approach Accreditation of HRPPPs should be pursued as one promising approach to improving the human participant protection system. The first step is implementation of pilot programs to test standards, establish accreditation processes, and build confidence in accreditation organizations.
|
From page 11... ...
An accreditation process should directly involve the kinds of institutions being accredited, but an accreditation organization should not be beholden to any particular stakeholder or interest group. Accreditation bodies for HRPPPs will require input Tom academic health centers, organizations representing research sponsors, nongovernmental research organizations, private firms developing products and services tested in studies with humans, participants, IRB members and staff from both academic and nonacademic institutions, research administrators in both academic and nonacademic institutions, and individuals Mom a range of research fields appropriate to the intended range of applicant institutions.
|
From page 12... ...
that the privacy and confidentiality of research participants are protected; and 11. that the HRPPP is transparent so that participants can judge the research process to be trustworthy.
|
From page 13... ...
The committee believes that the draft NCQA standards are close to meeting the criteria in Recommendations 3 and 4 for pilot testing in VA facilities, and if they are modified as suggested under Recommendation 9, they could be used as the basis for pilot tests of HRPPP standards outside VA facilities. Recommendation 5: Accommodate Distinct Research Methods and Models Within Accreditation Programs The accreditation process should accommodate other research organizations in addition to the traditional models provided by academic health centers and VA facilities.
|
From page 14... ...
Independent IRBs do not directly conduct research, for example, and so entire sections of the proposed standards are inapplicable to them. To be credible, the accreditation process should expand to include independent IRBs; cooperative groups; contract research organizations; site management organizations; units within federal research agencies that conduct their own research; and units of pharmaceutical, medical device, and biotechnology firms that carry out research with human participants.
|
From page 15... ...
Those in the best position to judge this will be organizations devising the accreditation processes, not this committee or the federal government. Whether to develop one set of standards or a few sets of standards specific to a few different classes of research organizations should not be decided by fiat but should be decided in light of experience gained through pilot accreditation programs that include medical and nonmedical sites.
|
From page 16... ...
, and at least 3 agencies that conduct human research remain outside of the rule.8 The current regulatory system is demonstrably unresponsive to dramatic changes in how research is conducted; a nongovernmental accreditation ~ OPRR noted three agencies that appeared to sponsor research with human participants but that were not signatories to the Common Rule: the National Endowment for the Humanities, the U.S. Department of Labor, and the Nuclear Regulatory Commission, as cited in a draft report forthcoming from the National Bioethics Advisory Committee (NBAC, forthcoming-lo)
|
From page 17... ...
The operations of organizations seeking accreditation will also evolve. The parallel evolution of accreditation standards and HRPPP operations should be an iterative process, with the formulation of standards efficiently informed by knowledge acquired in the accreditation process.
|
From page 18... ...
Standards should also reflect stronger participant involvement beyond securing signatures on informed-consent documents. Recommendation 9: Use Modified NCQA Standards to Initiate Pilot Programs Pilot accreditation programs should start from the accreditation standards and processes proposed by NCQA for VA facilities, as adapted for use in other organizational contexts.
|
From page 19... ...
mechanisms by which research institutions and, where applicable, research sponsors can be held accountable for ensuring sufficient funding, structural support, and professional rewards for HRPPPs. The NCQA standards, if improved as recommended, could also be used by NCQA, AAHRPP, or other accreditation organizations as the basis for the development of accreditation standards for non-VA research organizations.
|
From page 20... ...
If multiple accreditation bodies emerge, the evaluation should compare their effectiveness. The HRPPP accreditation process should be evaluated not only according to whether it has improved protections for human research participants but also according to whether resources devoted to accreditation could be spent to equal or better effect on other ways to improve HRPPP oversight such as education, research monitoring, and improved feedback mechanisms.
|
From page 21... ...
Further, any accreditation standards must encompass an assessment of participant involvement in local research oversight, greater specificity about the responsibilities of research sponsors, and integration of research monitoring, professional education, and quality improvement into the oversight system. Second, with respect to the development of accreditation standards, the committee believes that the NCQA draft standards should be adopted as a starting point.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.