National Academies Press: OpenBook
« Previous: The VA and NCQA Accreditation Process
Suggested Citation:"Self-Evaluation." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
×
Page 51

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

MODELS OF ACCREDITATION 51 Eligibility Criteria and an Application Process The accreditation body must specify who can be accredited, set fees to cover its costs, and establish an application process. The NCQA accreditation of VA facilities will be done, at least initially, by self-selection. Because the VA hospital system is relatively closed, the applicant pool is clear. The eligibility criteria for HRPPPs beyond VA, including the nascent AAHRPP, have not been specified in detail. It is clear that academic or independent research centers that have an operating IRB would be eligible. The stated intention is to also invite applications from private independent IRBs. It is not clear whether larger consortia of institutions that are organized as a collaborative unit would be eligible, such as cooperative clinical trials groups,3 the Multi-Center Academic Clinical Research Organization,4 independent contract research organizations, or site management organizations. Self-Evaluation Applying for accreditation requires considerable preparation. This typically involves the organization that is seeking accreditation to gather information relevant to the standards that will be used and to analyze how well prepared it is to address questions and concerns that may arise. This preparation can consume enormous efforts of a few staff members and draws on the resources of many parts of the organization. The mere process of self-study can reveal previously unknown weaknesses or sometimes strengths and can suggest administrative remedies. It can also draw the attention of senior administrators to the need for more resources, new programs, or management changes and can reveal the strengths and weaknesses of key personnel. Many organizations involved in accreditation processes regard the self-study as the most valuable element of the accreditation process precisely because it focuses the attention of senior administrators. The process of self-evaluation of HRPPPs appears to be especially promising as a way to improve the system. Self-assessment combined with systematic, continual use of quality improvement programs could, for example, identify features common to many “excellent” HRPPPs, and those features could, over 3 The Office for Human Research Protections maintains a list of cooperative protocol research programs that might be accredited, but for which a somewhat different process and set of standards would be required. (For more information see http://ohrp.osophs.dhhs.gov/humansubjects/assurance/cprp.htm). 4 Multi-Center Academic Clinical Research Organization, or MACRO, brings together five major academic health centers—Baylor College of Medicine, Harvard Clinical Research Institute, the University of Pennsylvania School of Medicine, Vanderbilt University, and Washington University School of Medicine—under a collaborative agreement that includes an agreed upon system for protocol review by IRBs among the institutions (for more information, see http://www.mc.vanderbilt.edu/ctc/macro.html).

Next: External Evaluation »
Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Get This Book
×
Buy Paperback | $60.00 Buy Ebook | $47.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  6. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  7. ×

    View our suggested citation for this chapter.

    « Back Next »
  8. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!