Over the last decade, there have been increasing calls for more and higher quality evidence related to clinical effectiveness including evidence of how technologies or other health care innovations impact health outcomes and clinical care in the """"""""real world"""""""". These calls have manifested themselves through a variety of concepts such as the Learning Healthcare System,3 Evidence-Based Medicine,4,5 Quality Improvement,6,7 and most recently through Comparative Effectiveness Research.2,8 A central component of each of these strategies is the integration of clinical research into clinical practice. More specifically, efforts are increasingly underway to systematically gather evidence from ordinary or slightly modified clinical encounters to better learn what does or does not work in ongoing clinical practice. This shifting clinical research paradigm in which clinical research is more closely integrated with clinical care raises a number of unique and interesting ethical issues that must be addressed to ensure that these new methodologies are introduced and used in socially and morally acceptable ways. Much of the ethics literature to date has focused on ethical issues in traditional clinical trials, while newer literature has begun to address ethics and the use of data from electronic medical records for research purposes, including how to manage privacy and confidentiality and whether informed consent is required from patients. However, relatively little has been written about whether current standards of signed and written informed consent should always be required for prospective effectiveness research, including pragmatic randomized control trials (PCTs). PCTs are randomized trials designed to demonstrate how effective health technologies are in routine clinical settings and as such, these trials are designed to be more closely integrated with clinical practice.9,10 Because many of these trials will compare technologies that have already received regulatory approval and because many will be viewed as both low risk and low burden for patients, it may be the case that a range of models of consent, disclosure, and authorization may be considered socially and morally acceptable for these types of trials. To explore which models of consent, disclosure, and authorization are both socially and morally acceptable for PCTs comparing approved and widely available therapies, this study will engage patients in focus groups and institutional review board members and comparative effectiveness researchers in in-depth interviews to explore their perceptions of various models of consent, disclosure, or authorization described to them. Focus group and interview discussions will focus on two case studies describing phase IV PCTs comparing therapies a) for migraines;and b) for hypertension. Results from these focus groups and interviews will be integrated with a rigorous moral and policy analysis to develop a set of recommendations regarding acceptable strategies for informed consent, disclosure or authorization for pragmatic CER trials in the future.
Increased interest in and funding for comparative effectiveness research (CER) has been accompanied by attention to the need to design and implement prospective, pragmatic clinical trials (PCTs) that compare the effectiveness of different approved and widely available health technologies and that are more closely integrated with clinical practice than are traditional phase I, II, and III clinical trials. By comparing therpies already proven to be effective, and by being more closely integrated into practice, questions emerge whether traditional means of individual, prospective, signed, written informed consent will always be required in PCTs. This study is designed to examine that question.
| Whicher, Danielle; Kass, Nancy; Faden, Ruth (2015) Stakeholders' Views of Alternatives to Prospective Informed Consent for Minimal-Risk Pragmatic Comparative Effectiveness Trials. J Law Med Ethics 43:397-409 |
