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Executive Summary
Pages 1-28

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From page 1...
... In its work, the committee suggests ~ systems approach to providing protection, offers several broad recommendations for reform, and proposes practical suggestions to improve the oversight of human research at the institutional level. In the committee's framework, the HRPPP is ~ system composed of interdependent elements that come together to implement policies and practices that ensure appropriate protection of research participants.
From page 2...
... Recommendations focused at the national level income: extending federal requirements for protection to include every research project involving human participants, regardless of funding source or research setting; collecting, assessing, and disseminating data about the overall system; and establishing an independent, nonpartisan advisory body that incomes the perspectives of participants, scientists, ethicists, and research administrators to ensure that the national protection system receives objective and ongoing assessment. In response to mounting concerns about the well-being of research participants]
From page 3...
... The committee's first report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs, provided a foundation for establishing an HRPPP, but was unable to provide much more than a sketch of the intended program (IOM, 2001a)
From page 4...
... . 6The Senate Committee on Health, Education, Labor, and Pensions held a hearing on protecting research participants on April 23, 2002.
From page 5...
... The committee envisions a three-part strategy to achieve this goal, including refocusing the mission of the IRB on the thorough ethical review and oversight of research protocols; recognizing research participants' contributions and integrating them into the system; and maintaining high standards for and continuing review of HRPPP performance. Specific recommendations are organized around these themes in the following summary.
From page 6...
... The diligent application of HRPPP policies and practices will ensure that participants in any research project are protected against undue risk, that informed consent to participate in the research is provided, and that all efforts are made to ensure that participants' rights, privileges, and privacy are protected throughout the entire research process. Therefore, protection requirements should be extended to include every research project that involves human participants, regardless of funding source or research setting.
From page 7...
... (Recommendation 2.2J Establishing the appropriate research culture will require ongoing efforts to educate researchers, research administrators, IRB members, and participants about research ethics and participant protection issues, as well as continuous QI activities. The Office for Human Research Protections (OHRP)
From page 8...
... Adequate resources are essential for the protection of research participants and are a real part of the cost of doing research. Therefore, to assure successful protection programs, public and private research sponsors and research organizations should partner to develop benchmark guidelines for critical functions and to provide the necessary funding sources (see Recommendation 2.3~.
From page 9...
... Recommendation: The Institutional Review Board (IRB) , as the principal representative of the interests of potential research participants, should focus its full committee deliberations and oversight primarily on the ethical aspects of protection issues.
From page 10...
... Furthermore, there is a need to ensure that no financial or other interests on the part of the investigator, research organization, or the Research ERB (as a body or as individual members) will distort the conduct of research with human participants.l2 While there are nonfinancial self-interests intrinsic to the pursuit of research questions, the frequency and complexity of potential financial conflicts of interest in research are expanding, and the federal government and relevant professional and industry groups should continue to consider their potential ramifications and pursue rigorous policies for handling them (see Chapter 6~.
From page 11...
... The focused reviews of scientific merit and potential financial conflicts of interest should inform the ethics review process for each protocol (see Figure ES.1~. Recommendation: Research organizations and research sponsors should ensure that Human Research Participant Protection Programs utilize distinct mechanisms for the initial, focused reviews of scientific and financial conflicts of interest.
From page 12...
... To better clarify regulatory intent and appropriate ethical practices, OHRP and the National Human Research Protections Advisory Committee (NHRPAC) ~5 should convene conferences and establish working groups to develop and disseminate best practices, case presentations, and conference proceedings for local HRPPPs, their Research ERBs, and research investigators (Recommendation 3.8 )
From page 13...
... Recommendation: The informed consent process should be an ongoing, interactive dialogue between research staff and research participants involving the disclosure and exchange of relevant information, discussion of that information, and assessment of the individual's understanding of the discussion. (Recommendation 4.1J The informed consent conversations, as well as the written consent document, should not be obscured by language designed mainly to insulate the institution from liability.~6 Rather, the process should ensure that participants clearly understand the nature of the proposed research and its potential risks and benefits to them and society.
From page 14...
... To ensure that information about all clinical trials is available, the committee proposes the creation of a comprehensive and soundly structured clinical trials registry for use by the public. Material submitted to Research ERBs could serve as the backbone of this registry.l9 The committee believes that although the challenges and resource requirements involved in such an undertaking are significant, clinical trials are of such public concern that the effort should be pursued (see Recommendation 7.2~.
From page 15...
... To guide public policy and accreditation standard development in this area and to help establish the potential magnitude of such claims, DHHS should assemble data on the incidence of research injuries and conduct economic analyses of their costs (see Recommendation 6.7~. It is the committee's impression that many research organizations conducting clinical trials agree to provide at least short-term medical care for those who suffer research-related injuries (DoD, 2002; IOM, 1994a; NIH CC, 2000; 38 CFR 17.85)
From page 16...
... An area of intense concern regarding the ongoing safety monitoring of research protocols, particularly high-risk clinical trials, is the ability of protection programs and their Research ERBs to appropriately collect, interpret, and report adverse event information (see Chapter 5~. Federal oversight agencies, therefore, should harmonize safety monitoring guidance, develop standardized practices for defining and reporting adverse events, and monitor all federally regulated studies that pose substantial risks to participants with equal rigor and scrutiny (see Recommendations 5.3 and 5.5~.
From page 17...
... Manage Potential Conflicts of Interest Confidence about the current system of participant protection is undermined by the perception that harm to research participants may result from conflicts of interest involving the researcher, the research organization, and/ or the research sponsor. This concern is particularly acute regarding financial conflicts of interest, as the relationships between the academic and private research enterprises continue to evolve.
From page 18...
... In both instances, conflict of interest information should be communicated in a timely and effective manner to the Research ERB, which should make the final assessment with regard to ensuring participant protections. ~ he Impact ot ~nst~tut~onai conflicts ot Interest as well as nonfinancial conflicts of interest at all levels of the research enterprise have not been explored sufficiently and are issues that, like the development of professional norms for individual conflicts of interest, should be rigorously pursued by federal agencies and appropriate interest groups.
From page 19...
... The recommendations offered within this report are intended to guide HRPPPs and policy makers as they work to guarantee that research participants' safety and rights are protected throughout their involvement in any research study and that the national research enterprise is worthy of the public's trust and continued support.
From page 21...
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From page 28...
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