Responsible Research: A Systems Approach to Protecting Research Participants

The protection of individuals who volunteer to participate in research is essential to the ethical conduct of human research. In response to mounting concerns about the well-being of research participants and the ability of current approaches to ensure their protection, the Department of Health and Human Services commissioned the Institute of Medicine to perform a comprehensive assessment of the national system for providing research participant protection. The resulting analysis emphasizes the responsibilities and functions of human research participant protection programs (HRPPPs), providing substantive descriptions of the activities intrinsic to a robust protection program. In its work, the committee suggests a 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 a system composed of interdependent elements that come together to implement policies and practices that ensure appropriate protection of research participants. The exact structure of an HRPPP will vary among research organizations and protocols according to the protection needs intrinsic to a particular study. Despite this flexibility, however, there are basic protection functions necessary to ensure the safety of participants and it is essential that all be met. These functions include: comprehensive review 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.