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
We live in a destabilizing world, where natural disasters, wars, pandemics, and other disruptive events are becoming more common. In clinical research, such disruption is detrimental to research participants and to the advances in scientific knowledge that will benefit future patients. Emergency responses, however, can be fragmented and inefficient. The COVID-19 pandemic has impressed this point on the research community, raising awareness of the need to plan ahead and adapt in response to disaster. To date, most of the attention has focused on actual responses to the pandemic – primarily setting up new, pandemic-focused trials, or calling for changes to clinical trial infrastructure in anticipation of the next pandemic. However, other types of emergencies are often left out of these discussions.
At this meeting of the MRCT Center Bioethics Collaborative, we hope to explore sponsors’ and investigators’ ethical obligations to plan for emergencies in advance. What obligations do they have to participants? How much preparation is necessary? How much is realistic? What obligations do research teams on the ground in disruptive and potentially dangerous situations have to research participants and to maintaining research protocols? Answering these questions and more will allow the clinical research community to develop the guidelines and infrastructure necessary to prepare for future emergency situations.
The MRCT Center is pleased to announce our upcoming webinar, “Promoting Global Clinical Research in Children: Informing the Future,” the conclusion of the five-part virtual conference series on Advancing International Pediatric Clinical Research.
This event will showcase select resources and materials from the pediatric clinical research initiative, including information from previous webinars.
Topic: Gene Therapies: Probing the Ethics (open to all)
There is understandable excitement about the potential for cellular products and gene therapies to transform the therapeutic landscape for many medical conditions. Although a number of cell and gene therapy therapies have already been approved and are available on the market, hundreds more are in various stages of research and development. However, this new class of therapeutics raises distinctive ethical issues that deserve careful consideration. Cell and gene therapies may have a transformative impact on research participants, manifesting not only in extended benefit but also in the need for additional safety monitoring far beyond what is typical in clinical research. Further, individuals can generally participate in only one of several clinical trials investigating possible treatments for the same condition and may need to forego alternative treatments that are developed in the future. Finally, there are issues of access to these experimental therapies. These features of cell and gene therapies can raise the stakes, making questions about how to apply traditional bioethical principles of autonomy, beneficence, non-maleficence, and justice more challenging. How can researchers and developers of cell and gene therapies design trials with due consideration for the distinct ethical issues raised by these therapies? Given the significance of the choice to receive cell and gene therapies and how this may impact and/or limit future options, what are best practices for the informed consent process? What key information should be disclosed to potential participants and caregivers and what measures should be taken to ensure comprehension? How does the acuity, instability, and chronicity of the disease impact these decisions? In this session, we will consider these ethical issues and others, assessing them in light of the need for scientifically robust research on cell and gene therapies while striving to do justice to research participants, patients, and their families.
This meeting is part of the MRCT Center’s 2023 Annual Meeting in Boston on December 13-14 and is open to all registrants at no cost. Guests are welcome to attend the entire program or individual sessions. While in-person attendance is encouraged, virtual participation is welcome.
In recent years, the use of artificial intelligence (AI) has steadily increased across many industries, including clinical research. The November 2022 release of OpenAI’s ChatGPT – a large language model that generates human-like output text in response to text input—has generated unprecedented public interest in the capabilities and potential impact of AI. Although there has been robust discussion of the use of AI in medicine, the applications of AI in clinical research, and the attendant ethical issues they raise have been relatively under-explored. The October 10, 2023, meeting of the Bioethics Collaborative will aim to clarify the current and potential uses of AI in clinical research, identify salient ethical challenges and issues, and provoke deliberation on how best to approach the development of ethical frameworks that can guide the development and use of AI in clinical research.
Research ethics since the Belmont Report has rested on the assumption that there is an ethically important distinction between clinical research and clinical care. This distinction has provided the foundation for analyses of numerous bioethical concepts, including clinical equipoise, the researcher-participant relationship, and therapeutic misconception, among many others. However, the lines between research and care are increasingly blurred, due to such developments as embedded pragmatic trials, decentralized research designs, expanded access programs, and increased appreciation of the situations in which no standard of care options exist for patients. We will assess what this blurring means for the research/care distinction and whether it should prompt us to reconsider its import.
N-of-1 trials share a common feature: they are single-subject study designs with the goal of determining how an individual patient responds to treatment intervention(s). These trials can take several forms, spanning different purposes and study populations, with their own distinctive advantages and challenges. The April 2023 Bioethics Collaborative focused on various ethical questions that arise in N-of-1 research: How do traditional research ethics principles and analyses, such as the concept of clinical equipoise and ‘social value,’ apply to N-of-1 research? How can the N-of-1 approach be generalized if each “trial” is unique to the individual? Is there a way to gain generalizable knowledge across several individual trials? How should costly N-of-1 research be prioritized against other research priorities? How do we decide, fairly and equitably, who has access to N-of-1 trials, particularly for rare or unique genetic conditions? How should we think about informed consent and make efforts to support it, given the potentially transformative nature of personalized interventions in particular?
Topic: Recent Regulatory Developments Affecting Clinical Trials in the EU and UK: EU In Vitro Diagnostics Medical Devices Regulation, EU Clinical Trials Regulation, and EMA Policy 0070
