of protocols (including scientific, financial conflict of interest, and ethical reviews); ethically sound participant-investigator interactions; on-going and risk-appropriate safety monitoring; and quality improvement and compliance activities. Furthermore, to be effective, HRPPPs should operate within environments that emphasize accountability for the provision of participant protection, assure adequate resources for robust protection activities, provide ethics education programs to those conducting and those overseeing research with humans, and seek open communication and interaction with all stakeholders in the research enterprise.

A series of recommendations focuses on improving ethics review of protocols, reforming the informed consent process, improving access to information by participants and those responsible for review and monitoring of protocols, enhancing safety monitoring, compensating those who are harmed as a result of their participation in research, and developing a standard of quality improvement in HRPPPs.

Recommendations focused at the national level include: 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 includes 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 participants1 and the capability of current procedures to ensure participant protection, the Department of Health and Human Services (DHHS) commissioned the Institute of Medicine (IOM) to perform a comprehensive assessment of the national system for providing participant protection. Specifically, the IOM was asked to make recommendations regarding mechanisms to improve the structure and function of protection activities, as well as ways to continually evaluate performance of these activities. This in-depth analysis was intended to emphasize the responsibilities and functions of the individual human participant protection program (not restricted to Institutional Review Boards [IRBs]) and was to include the prospect of accreditation as a useful tool to achieve the desired performance improvements. This task was broken into two phases.

1  

This committee has elected to use the term “participant” rather than “subject” to reflect its belief that the optimal functioning of research oversight programs necessitates the meaningful integration of research participants and their perspectives (IOM, 2001a).



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