Communication between journals, publishers, and institutions on questions of research misconduct is often lacking due to several reasons, including the speed with which journals seek to resolve these questions and institutional hesitancy to breach the confidentiality of an investigation into research misconduct. Representatives of academic journals, journal publishers, and institutions gained an appreciation for how the other parties manage questions of research misconduct and identified strategies to facilitate increased collaboration and communication between journals and institutions.
Research misconduct allegations may trigger reporting obligations to domestic and international funding agencies, health regulatory authorities, and others. R3 attendees, which included representatives from U.S. funding and regulatory agencies, academia, and biopharmaceutical companies, discussed the challenges of varying reporting requirements, including timing, content, and need for confidentiality. Attendees clarified the different responsibilities of the different entities during investigations into research misconduct and identified strategies and solutions to mitigate these challenges.
Decentralized clinical trials (DCTs) are clinical trials that are executed in part or in whole through remote modalities, such as telemedicine, smart phone applications, and health care providers who visit participant homes. Vendors engaged in DCTs may be subject to unfamiliar compliance and regulatory obligations, such as those set forth by the Common Rule or the FDA. Common Rule obligations extend beyond federally funded research if the site’s internal policy or state law require compliance with the Common Rule regardless of the funding source for the study. Part II of the meeting drew from both OHRP and FDA requirements to determine the regulatory requirements for a third-party partner who provides services in connection with a research protocol.
Topics: Part I: Direct Interactions Between Sponsors and Research Participants: A Legal Perspective; Part II: Rethinking the Workforce for Decentralized Clinical Trials: Who is Engaged and Regulatory Requirements
Decentralized clinical trials (DCTs) are clinical trials that are executed in part or in whole through remote modalities, such as telemedicine, healthcare providers who travel to participants’ homes, smart phone applications, and mobile health wearables, inter alia. Bioethics Collaborative attendees will discuss questions of justice and access, privacy, oversight for research participant safety, and the changing roles and responsibilities of various stakeholders in the research process, among other ethical challenges raised by DCTs.
Despite the potential benefits of community engagement (CE), the rigor, quality, and impact of CE are difficult to assess, in part due to the lack of a standardized understanding of what is meant by CE. Relatedly, it can be challenging to define ‘community’ in the abstract, and any decision about how to specify the relevant community will be ethically and politically significant. Other ethical challenges are connected to practical issues, such as identifying individuals who can speak on behalf of a community and/or marginalized populations within a community; engaging individuals without taxing their time or services too much; and how to ensure that there is sufficient reciprocity to the interactions. Finally, it is often difficult for sponsors, sites, and investigators and their study teams to know whether they have achieved representativeness, that is, whether they have heard from an adequate range of perspectives in a community.
Limited English proficiency (LEP) refers to a limited ability to read, speak, write, and/or understand English. The exclusion of individuals with LEP from research is a significant issue, and this exclusion raises issues of justice. Strategies to accommodate individuals with LEP in research must include consideration of the principles of autonomy and beneficence/non-maleficence; safeguards may be added to ensure that the consent and participation of individuals with LEP is informed and voluntary, and furthermore, that the safety and well-being of individuals with LEP can be maintained throughout their research participation. These ethical considerations must be weighed against the expense and delay of translation and interpreter services.
Institutional Review Boards (IRBs) are responsible for protecting research participants by reviewing the study at initial and periodic review and ensuring that risks are minimized and appropriately balanced with benefits, and that key features of research are adequately disclosed to participants. Data monitoring committees (DMCs) play a role in protecting participant safety, ensuring the integrity and credibility of a trial, identifying beneficial treatments early, and advising termination of a trial if a treatment is or is likely to be ineffective. Although IRBs and DMCs share the goal of protecting research participants, the extent to which IRB and DMC responsibilities overlap or diverge is not clear and is often difficult to navigate in practice. Further complicating the division of labor is the fact that IRBs and DMCs rarely communicate directly.
Some state privacy laws apply to specific types of data that might be used in research. Other state privacy laws, sometimes referred to as omnibus privacy laws, regulate the collection and use of personal data throughout the economy. Meeting attendees reviewed and discussed both types of laws in several states, including their applicability to organizations involved in research, exemptions for research activities, and overall impact on research.
Topics: 1) Legal and Regulatory Challenges with Diagnostic Tests in the United States (US), including Laboratory Developed Tests (LDTs), and 2) The Impact of Emerging US State Privacy Laws on Research
There has been an increase in sustained interactions between sponsors of clinical research or their designees and potential and enrolled study participants and their families. Sponsor interactions with study participants and their families raise certain legal and regulatory concerns when sponsors perform the functions of investigators, such as taking medical histories or securing records from third-party health care providers, or when interactions contribute to inaccurate participant perceptions regarding who is responsible for their participation in a study, among other things.
Topics: Part I: Direct Interactions Between Sponsors and Research Participants: A Legal Perspective; Part II: Rethinking the Workforce for Decentralized Clinical Trials: Who is Engaged and Regulatory Requirements
