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Responsible Research: A Systems Approach to Protecting Research Participants
port is organized to follow a research protocol from initial review through implementation and safety monitoring to completion. In doing so, the committee targeted the HRPPP elements and functions that should be in place at each step in the process to provide and enhance participant protections. In addition, because the greatest concerns exist for studies that pose the highest risk, much of the orientation of this report is focused on creating a system of protections commensurate with the risks involved. Minimum protection requirements exist for all studies with human participants, regardless of the level of risk. However, as risks increase, so should those requirements.
Chapter 2 presents the HRPPP and its functions as a set of organizational policies and practices that ensure adequate protection of participants in any type of research. The diligent application of HRPPP policies and practices will ensure that individual participants in any research project are protected against undue risk, that they provide informed consent to the research, and that their safety, rights, privileges, and privacy are protected. The precise composition of an HRPPP within a given organizational setting depends on the applicable circumstances and context.
Chapter 3 describes the need for independent scientific, ethical, and financial conflict of interest reviews to ensure that the proposed research is meritorious, that it does not expose participants to unnecessary risk, and that the interests of the investigator, institution, or IRB are not in conflict with those of the participants. Chapter 4 focuses on the qualifications of the investigator in designing and conducting a study, the roles of the research participant, and the primary focus of their interactions—the informed consent process. Chapter 5 addresses the need for ongoing oversight and monitoring at the federal, institutional, and local levels to increase safety during the conduct of studies.
Chapter 6 focuses on organizational responsibilities to ensure the optimum performance of HRPPPs, discussing accreditation, quality assurance and improvement, and the need for role clarification within research organizations. Also included in Chapter 6 are recommendations regarding compensation for research-related injury, a topic that has been discussed for decades but never adequately addressed. Chapter 7 addresses broader issues affecting HRPPPs that should be addressed at the national level and mechanisms to provide continuing assessment of the national protection system.
This report is not intended to be comprehensive. Many important issues in human research have received extensive analysis and review by other groups or remain unresolved and deserve further discussion. Although these issues periodically emerged during committee discussions, they were beyond the scope of the committee’s mandate or were too important to be treated in a cursory fashion. For example, although the ethical obligations of researchers in conducting studies in international settings have been