Oversight on the borderline: Quality improvement and pragmatic research.

Pragmatic research that compares interventions to improve the organization and delivery of health care may overlap, in both goals and methods, with quality improvement activities. When activities have attributes of both research and quality improvement, confusion often arises about what ethical oversight is, or should be, required. For routine quality improvement, in which the delivery of health care is modified in minor ways that create only minimal risks, oversight by local clinical or administrative leaders utilizing institutional policies may be sufficient. However, additional consideration should be given to activities that go beyond routine, local quality improvement to first determine whether such non-routine activities constitute research or quality improvement and, in either case, to ensure that independent oversight will occur. This should promote rigor, transparency, and protection of patients' and clinicians' rights, well-being, and privacy in all such activities. Specifically, we recommend that (1) health care organizations should have systematic policies and processes for designating activities as routine quality improvement, non-routine quality improvement, or quality improvement research and determining what oversight each will receive. (2) Health care organizations should have formal and explicit oversight processes for non-routine quality improvement activities that may include input from institutional quality improvement experts, health services researchers, administrators, clinicians, patient representatives, and those experienced in the ethics review of health care activities. (3) Quality improvement research requires review by an institutional review board; for such review to be effective, institutional review boards should develop particular expertise in assessing quality improvement research. (4) Stakeholders should be included in the review of non-routine quality improvement and quality improvement-related research proposals. Only by doing so will we optimally leverage both pragmatic research on health care delivery and local implementation through quality improvement as complementary activities for improving health.

Consent2Share: an integrated broad consenting process for re-contacting potential study subjects.

Background and Aim: Obtaining sufficient subjects into research studies is an ongoing barrier to conducting clinical research. Privacy rules add to the complexity of identifying qualified study subjects. The process described facilitates consent of patients coming to their clinically scheduled appointments who are asked to consent to having researchers review their electronic medical records (EHR), and if they meet study criteria for future research, being contacted by those researchers and asked if they wish to be involved in a research project. Methods: An interdisciplinary group representing the Institutional Review Board (IRB), Information Technology (IT), Hospital, University and Research developed an initial paper then electronic method to consent all patients attending a medical subspecialty clinic. All consent data are integrated to the EHR to facilitate linking to clinical information. Results: Although the paper consenting method resulted in over an 80% "yes" rate of consent, it was complicated by significant procedural challenges which prevented scalability. Revising the process has resulted in nearly 28,000 patients consenting in a 3 year period and in 20 IRB approved protocols using subjects who agreed to Consent2Share. Conclusions: A multi-disciplinary effort is essential to develop a successful electronic based, integrated process to assist investigators and patients to facilitate study subject accrual. Relevance for patients: Consent2Share more efficiently assists researchers in identifying and contacting potential study subjects that meet entrance criteria. The process provides a model to comply with the proposed Notice of Public Rule Making (NPRM) where institutions will be strongly encouraged to develop broad research consent procedures.

Toward protecting the safety of participants in clinical trials.

It is a widely held belief that the current system of oversight of clinical research, particularly the means of assessing risks and minimizing harms to participants in clinical trials, could be improved. In particular, the system is inefficient with overemphasis on the monitoring ability of some groups such as research ethics review boards and investigators, underemphasis on others such as data monitoring committees (DMCs) and sponsors, confusion about responsibilities for safety and imperfect communication between these different groups. Research ethics review boards are not able to perform safety monitoring by review of individual adverse events and are often burdened by duplicative reviews of large multicenter studies. There are no standards for DMCs to ensure they can reliably identify safety issues. Sponsors may be overreliant on data audits and slow to disseminate safety data in a coherent summary. Investigators, their staffs and clinical sites may not fully appreciate all the nuances of good clinical practice or may be inattentive to the daily conduct of studies. Regulators, particularly those in the United States, have failed to completely harmonize their policies with each other or with international regulatory agencies. We recommend well-designed monitoring plans for all studies that are appropriate to their scope and risk, more centralized review of large multisite studies and closer local scrutiny of single-institution studies. In addition, sponsors should pay greater attention to monitoring adverse events and keeping up-to-date databases or investigator's brochures emphasizing safety issues. A minimal standard of education or expertise in good clinical practice should be established for investigators, their staffs and research ethics review board members. DMC composition and functions should be standardized and regulations should be harmonized nationally and internationally. Finally, there should be a concerted effort to study the efficacy of various components of the system.