The increasing complexities of medical research, expanding treatment options, and rapid changes in the healthcare delivery system have led to changes in how we conduct research. Traditional placebo-controlled, investigator- and industry-initiated research is not generating the essential data necessary for patients and their caregivers to make individualized, evidence-based healthcare decisions from among the variety of available choices. This has led to the growth of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER).
As PCOR and CER studies proliferate, several challenges in the conduct of human-subjects research oversight are likely to arise. Among them are: (1) those conducting clinical trials will begin to move into spaces largely unfamiliar to them, such as surveys, medical record review, data repositories, and the like; (2) patients and their caregivers will become more actively involved as researchers, not just subjects; and (3) the use of big data will raise issues of data privacy and security. We propose a comprehensive mixed-methods (qualitative and quantitative) examination of the human subject-related oversight issues in PCOR/CER.
In order to address these concerns, we propose to describe the oversight challenges posed by PCOR and CER and to learn how stakeholders—including IRBs, investigators, and patient partners in major research institutions—are responding to those challenges (or not). We will conduct interviews, focus groups, and case studies, and then we will survey chairs and senior administrators of IRBs at major academic institutions. Based on the results of our empirical data gathering, a critical review of the literature, a formal consensus process, and regular input from our stakeholders and patient advisors, we will prepare a white paper of guidelines and recommendations for IRBs and investigators to employ when designing or reviewing human-subjects research aspects of PCOR and CER.