protocol. The research organization through which he or she is engaged in the project should ensure that only qualified investigators are given the privilege of doing research with human beings.

The voluntary informed consent of research participants is essential for ethically sound research involving humans. In order to ensure that participants provide truly informed consent, the informed consent process should be interactive and ongoing, rather than focused on the signing of a written consent form. Research staff should ensure that participants understand the risks and benefits of the study as well as their responsibilities as participants.

Participants can play useful roles in the generation of new research ideas, in the evaluation of protocols for their impact on patients, and in guaranteeing a participant-focused review, particularly by serving on Research ERBs. In addition, potential research participants should be aware of the responsibilities necessary to maintain compliance with a protocol in order to prevent harm to themselves or the invalidation of the study. In this sense, participants have an important social responsibility that is as critical to the validity of human research as the scientific design itself.

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