Factors that relate to research performance Improved clinical trial performance and protection for research participants will result from better trial design and adherence cause and enhanced institutional support of conducting clinical trials through a HRPP. Quality research and sound ethics are intractably intertwined: Improvement in performance cannot occur without improvement in participant protection. Likewise, if one domain suffers, so does the other. Whereas, many factors contribute to the success of a clinical trial in terms of producing high-quality data and protecting research participants, some are most likely more important. Excellent protocol design, stringent criteria for selecting investigative sites, well-trained investigators and staff, effective post-approval monitoring of trials, and strong EC are essential factors.
At all levels ?? institutional or national ?? research is only as strong as the weakest link in this complex system. And, whether one is discussing improvement in data quality or participant protections, virtually the same factors are offered as the ones most important to the quality. Research design Although much attention is placed on obtaining voluntary, informed consent as the primary means to protection research participants, and consent processes will be discussed shortly, the expertise and experience of the EC, protocol compliance, and monitoring and reporting of safety are equally important.
Participant protection begins with the design of the clinical trials, is followed by an expert review of the protocol (including the qualifications and experience of the investigative site) and determination that the clinical trial is ethically justified by the EC, and Carfilzomib then followed by the voluntary informed consent of prospective participants. Consent of participants never makes a poorly designed trial or an inadequate EC review ethical. And, voluntary informed consent is only valid throughout the clinical trial if investigators conduct the trial according to the terms stipulated in the protocol. Post-approval monitoring of trials and quality improvement processes are vital to ensuring the ethical soundness of trials because they ensure that the protocol, though which the EC and in which the participant agreed to enroll remains valid. This intertwined web of players and processes is supported through the HRPP locally at the investigative site and the government regulatory system nationally. As one can see, no player in research may focus exclusively on merely one role, but instead, must understand his or her role in the context of a complicated system, often referred to as the research enterprise. Consent Consent, more accurately, the consent document, receives far more attention than it deserves.