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2 A Systematic Approach to Human Research Participant Protection Programs
Pages 45-69

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From page 45...
... To sustain the current level of research, the protections that are thought to be essential should be reviewed and a more responsive and flexible organizational structure that will better assure that the necessary protections are in place should be created. This chapter describes what the committee has termed a "Human Research Participant Protection Program" (HRPPP)
From page 46...
... and the committee members' own experiences as research , _ , , _ , participants, investigators, and research administrators, the committee believes that the goals of an effective program are to ensure that · Participant welfare is of central concern to the investigators and staff and that researchers take steps to minimize the level of harm to which participants may be exposed and treat participants with respect and dignity throughout the study. · The investigators who designed the study, those who will collect the data, and others who interact with participants are appropriately trained and well qualified to conduct research with humans and to perform all study procedures.
From page 47...
... Recommendation 2.1: Adequate protection of participants requires that all human research be subject to a responsible Human Research Participant Protection Program (HRPPP) under federal oversight.
From page 48...
... In its first report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (IOM, 2001a) , the committee adopted the term "HRPPP" to embrace a set of functions somewhat broader than is represented in the customary emphasis on the Institutional Review Board (IRB)
From page 49...
... ,4 ombudsman programs, and data collection centers. The program's most basic function is to develop and implement policies and practices that ensure the adequate protection of research participants.
From page 50...
... Thus, although systems-based protection programs could take many forms, currently, it is likely that a significant portion of them
From page 51...
... The committee acknowledges that the research process itself is a complex and adaptive one and that efforts to integrate an additional complex system within it will be challenging and could create bureaucratic and administrative distractions rather than contribute value and enhance performance. However, the committee has concluded that appropriate participant protection can best be assured through a systemic approach that utilizes diversified and distributed elements with clearly defined and articulated responsibilities.
From page 52...
... It is important that the respective responsibilities at each level are reflected in the composition of any individual HRPPP, and to ensure the optimum performance of protection programs, the perspectives of the various stakeholders should be effectively balanced. Although formal operating and communication procedures are essential to achieving such balance, the establishment by program leadership of an ethically sound research culture throughout the program is critical to ensuring the comprehensive protection of research participants.
From page 53...
... Human Research Participant Protection Programs (HRPPPs) have a direct responsibility for the safety of those enrolled in studies carried out under their purview.
From page 54...
... Accountability Recommendation 2.2: The authority and responsibility for research participant protections should reside within the highest level of the research organization. Leaders of public and private research organizations should establish a culture of research excellence that is pervasive and that includes clear lines of authority and responsibility for participant protection.
From page 55...
... Participants are best protected if all organizations and individuals involved share equally in that responsibility, particularly because research organizations and investigators are more directly and closely involved with the research participants than would be a remote sponsor.
From page 56...
... Communication between the organizations sponsoring, reviewing, and conducting human research and the overseeing regulatory agencies provides the primary framework within which protections are provided.5 Thus, programs should establish mechanisms for ensuring that effective communication occurs between all entities. lust as individual program components are accountable to the senior leadership of research organizations, the overall program is accountable to the appropriate federal oversight officers)
From page 57...
... . Resources Recommendation 2.3: Research sponsors and research organizationspublic and private should provide the necessary financial support to meet their joint obligation to ensure that Human Research Participant Protection Programs have adequate resources to provide robust protecton to research participants.
From page 58...
... The committee anticipates that some government agencies will argue that the funds for obtaining ethical review of individual protocols are pro7RAND has published a report, "Paying for University Research Facilities and Administration," that addresses the "indirect" cost issues of research, but not the costs of research involving human participants explicitly (Goldman, 2000)
From page 59...
... However, the committee asserts that because sufficient resources are fundamental to implementing a robust participant protection program, providing the needed funds is a real cost of doing research. Private foundations, which frequently provide much lower indirect costs than federal grants, should also provide money for HRPPP review within their yearly project budgets.
From page 60...
... The Office for Human Research Protections, with input from a variety of scholars in science and ethics, should coordinate the development and dissemination of core education elements and practices for human research ethics among those conducting and overseeing research. Education regarding the research process and the ethical issues intrinsic to research involving human participants is essential at every level of accountability in the program.
From page 61...
... Research investigators and key personnel should be versed in the ethical foundations underlying research participant protection, the regulatory requirements for carrying out such research (including confidentialiyv issues)
From page 63...
... In some cases, individuals serving on the board are providing a nonscientific, community perspective in the protocol review process and are likely to need a general knowledge of the research process to facilitate their IRB activities.9 To be effective, IRB members should understand the ethics and history of research with humans, the current structure and funding of research projects, and the regulatory structure of research, including local laws (see Chapter 3 for an elaboration of IRB education needs)
From page 64...
... These documents include explanations of the clinical trial process and the phases of research, factors to consider and questions to ask before participating, what a participant should expect from study staff, how to evaluate the consent form and the participant's consent obligations, the potential costs of participating in research, what do to if things go wrong, and how to find and enter clinical trials. Transparency Recommendation 2.5: Human Research Participant Protection Programs should foster communication with the general public, research participants, and research staff to assure that the protection process is open and accessible to all interested parties.
From page 65...
... Public education is a key component in the promotion of transparency and the sustenance of public trust in the research process. At the second level, prospective research participants should be provided access to detailed, project-specific information, which may include more information about the overall protection process and relevant financial conflict of interest information regarding the investigators or institution.
From page 66...
... FUNCTIONS INTEGRAL TO THE PROTECTION SYSTEM This chapter has focused on defining the purpose and structure of the HRPPP and the conditions necessary to ensure a viable system that will protect research participants. The remaining chapters will provide details about the four essential functions of a participant protection program comprehensive protocol review; ethically sound participant-investigator interactions; ongoing safety monitoring; and quality improvement and compliance (see Figure 2.4~.
From page 67...
... 67 FIGURE 2.4 The Essential Functions of a Human Research Participant Protection Program Four functions are fundamental to the protection of research participants and must be carried out by any assembled Human Research Participant Protection Program. These functions include comprehensive protocol review, ethically sound participant-investigator interactions, ongoing safety monitoring, and quality improvement and compliance.
From page 68...
... In addition, mechanisms are needed to monitor adverse events, unanticipated problems, and changes to a protocol and their subsequent incorporation into the informed consent process. Programs could better meet these responsibilities with improved federal guidance and funding and through some restructuring of the review and monitoring processes.
From page 69...
... Protection programs should be structured so that information regarding their general operations and specific protocol-related activities is accessible in a format useful to the public and, in particular, to current and potential research participants. In addition, research organizations and sponsors should ensure that all functions are carried out by responsible parties in order to fully protect research participants.


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