PI / RTM Responsibilities

For each project a plan must be developed specifying how, where, and by whom the informed consent process will be presented to a prospective participant. An important feature of any plan is that the PI is in charge of, and has responsibility for, the IC Process. Every project will be different, and so will its IC procedures. Although the PI may delegate some aspects of participant education and IC documentation to other Research Team Members (RTM), important duties should not be delegated without supervision. The PI selects the research staff, directs their training, defines their roles, and determines their working environment. The PI also sets expectations and is responsible for maintaining quality standards in the conduct of the research, including the IC Process. Ultimately, it is the PI's responsibility to ensure that the research staff has what they need to do their jobs, and that they are doing them correctly. For an inexperienced PI the complexity of this responsibility can be a bit daunting.

The PI must supply the research staff with the education and training to do the job. This training should make the RTM conversant with medications and their actions in a biomedical study, or interventions in a behavioral study, any anticipated adverse effects, techniques required (e.g. blood drawing), and the lines of authority and responsibility for each person on the team. For the informed consent process, this training also includes an understanding of the components of consent, the rationale for each, their applications, and the barriers to their effective implementation. Mentoring and monitoring, especially during early application of these skills, can speed the acquisition of proficiency and assure quality and accountability. Once training has been completed, trained and knowledgeable RTM become a valuable resource for the institution.