Lindsay McNair

The history of clinical research is, unfortunately, filled with examples of research studies that took advantage of and harmed research participants, to fulfill the research goals of scientists. Over time, we have created a system of ethical codes, principles, and regulations that are designed to prevent these abuses and to ensure that the rights and welfare of research participants are protected and honored. This review article will provide a brief history of clinical research ethics and ethical codes, outlining how those codes developed into the current regulatory requirements for the ethical oversight of clinical research. Understanding the current human subject protection systems will allow researchers to use best practices for planning and conducting rigorous, scientifically valid and ethical clinical studies. Understanding the history, principles, and foundations of the development of this system will equip researchers to understand what resources are available to them and how to make the best decisions when confronted with unique ethical situations in the conduct of their research.

In the current epidemic of opioid use disorders, there is both a scientific and ethical imperative to develop effective medical and behavioral treatments for opioid addiction. Research in subject populations with active and ongoing drug addictions bring unique ethical considerations and challenges. Sponsors, researchers, and institutional review board (IRB) members should be familiar with these unique ethical and medical issues as they design, review, and conduct research planned for this population. Issues include those of informed consent and decision-making capacity of research participants, compensation for participation and concerns about undue inducement, forces that threaten the voluntary nature of research participation including the scarcity of available drug treatment programs, and ensuring that participants are aware of and understand risks that may continue after research participation such as increased risk of overdose after research-mandated drug abstinence. This manuscript discusses the current thinking on these issues.

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval.

Objective: In 2008, a Position Statement of the Society of University Surgeons (SUS) recommended the creation of institutional surgical innovation committees (SICs) to ensure appropriate oversight of surgical innovations. The purpose of this study was to determine the level of awareness of the position statement, and how innovations are handled in academic departments of surgery. Methods: An electronic survey was designed to determine the level of awareness of the SUS recommendations among members of the Society of Surgical Chairs; the existence and characteristics of SICs; and alternative means of oversight of surgical innovations. Results: The survey was distributed to 150 persons, and 65 (43%) surveys were returned; 84% reported their institution promoted innovative surgery as a strength, but 55% were unaware of the SUS recommendations; 23% reported that their institution has an SIC, and 20% said their institution has discussed or plans an SIC. Existing SICs have a median of 7 members; 57% reviewed 3 or fewer procedures in the prior year; and only 7% reviewed 10 or more. The majority of respondents reported alternative mechanisms of oversight, including morbidity/mortality conferences (88%), peer review (77%), and outcomes registries (51%). Conclusions: A minority of Surgery Department Chairs is aware of the SUS Position Statement. Although most reported surgical innovation was an institutional strength, only 23% had an SIC and most rely on other mechanisms of oversight. It is unclear whether academic surgical departments are committed to providing education and awareness of the appropriate development and implementation of surgical innovations.