Early on, this view of ECs made sense because it selleck inhibitor was the only group of individuals within an institution that considered ethics issues associated with a particular research study and considered research in terms of what was in the best interests of research participants rather than investigators or the institution. However, in a series of evaluations of EC (also referred to institutional review boards or IRBs) conducted in the United States in the 1990s it became clear that EC were often isolated within their institutions, not respected, and generally viewed as a hindrance to the research process. In general, these perceptions could be explained by a lack of resources provided to most EC. EC, though, were not and still in many instances are not performing as they were intended to do resulting in diminished protections for research participants.
Today, the research community recognizes that the responsibility to protect research participants is a shared responsibility of the institution, the EC, and investigators at the local level and more broadly, of sponsors and government agencies. The EC has the sole responsibility for determining that a proposed research study is ethically justifiable. The EC makes this judgment by determining, among other things that the risks are reasonable in relation to the anticipated benefits and there is a process in place to obtain voluntary consent from prospective participants. However, there are many other functions that are the responsibility of investigators or of the institution.
For example, investigators must carry out the research according to the terms specified in the protocol. They must follow the inclusion and exclusion criteria for enrolling participants, administer procedures and intervention as specified in the protocol, and maintain confidentiality of identifiable data to name a few responsibilities. Ensuring that investigators and EC members are competent through education is an institutional responsibility as is negotiating clinical trials agreements, identify and eliminating financial conflict of interest, and quality improvement. This expansive thinking about the roles and responsibilities of the primary players in research is now referred to as a HRPP.[1,2] Objectives of a HRPP are more comprehensive than those of an EC.
They include: Establish a formal process to monitor, evaluate, and continually improve the protection of human research participants, exercise oversight Carfilzomib of research protection, education investigators and research staff about their ethical responsibility to protect the research participants, ensure the organization maintains the resources necessary to support the research infrastructure and intervene selleck bio in research and respond directly to concerns of research participants, when appropriate.