National Academies Press: OpenBook

Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)

Chapter: NEED FOR STANDARDS REGARDING ROLES AND RESPONSIBILITIES OF RESEARCH SPONSORS

« Previous: NEED FOR STANDARDS TO ENHANCE THE ROLE OF RESEARCH PARTICIPANTS
Suggested Citation:"NEED FOR STANDARDS REGARDING ROLES AND RESPONSIBILITIES OF RESEARCH SPONSORS." 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 75

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.

STANDARDS FOR ACCREDITATION 75 some conditions, however, are less well organized and may require funding from research sponsors, both public and private, to build the capacity for research oversight. Accreditation programs can systematically solicit desired outcomes from research participants. In his book on accreditation, Michael Hamm (Hamm, 1997) alluded several times to the desirability of having a focus on outcomes and performance rather than process and structure. The outcomes most desired in an HRPPP are an independent review of risks and benefits and a genuine process of informed consent. Participants are directly relevant to the informedconsent process in particular. The literature on empirical studies of the informed-consent process suggests that investigators often do not know what participants hear, and investigators are poor judges of what participants understand. Those who develop accreditation standards would do well to directly involve focus groups, consent monitors, and participant representatives (e.g., those who themselves have been involved in past studies or who are educated about the research process and ethical standards but who are also familiar with the interests of a constituency) in specifying the desired outcomes to be incorporated into accreditation standards. Accreditation bodies could invite private voluntary health organizations and other organizations representing research participants5 to help formulate points to be considered in the development of accreditation standards and modification of the standards as they evolve. NEED FOR STANDARDS REGARDING ROLES AND RESPONSIBILITIES OF RESEARCH SPONSORS Neither the PRIM&R nor the NCQA draft standards address standards for sponsors. The PRIM&R document defines sponsor as, “Any entity that provides funds or other resources to support the research. This entity could be a federal agency, corporation, foundation, institution or an individual” (see Appendix B, Glossary). It is noteworthy that in most cases it will not be the sponsor that is seeking accreditation as an HRPPP. However, there will be some examples in which the research institution that conducts and reviews the studies is also paying for a particular research project. In addition, when the sponsor is a federal agency, the assurance process results in an agreement between the sponsor and the research institution that federal regulatory requirements will be met. The committee recognizes that it would be difficult to incorporate such standards into the accreditation programs for HRPPPs; however, it believes that such standards should exist. These standards would provide research institutions, investigators, and IRBs with a set of expectations that should be met when 5 For research not on a particular medical condition, the constituency may be, for example, veterans at VA facilities or representatives of the general public familiar with research methods and ethical canons for general population studies.

Next: REVIEW OF AVAILABLE DRAFT STANDARDS »
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!