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Ethics, Conduct, and Oversight

Ethics, conduct, and oversight

Context

There are recognized limitations of efficiency and effectiveness in the conduct of global clinical trials. Sponsors must navigate both ethical and pragmatic questions when designing protocols for multi-regional clinical trials. Additional issues may arise in the context of resource-poor environments with less existing infrastructure, both human and material.

Challenge

Governments, sponsors, researchers, institutions, the public, and other stakeholders all wish to protect human research participants and to treat host communities in a just and equitable manner.

MRCT Center Projects

In this focus area, we build capacity to ensure that clinical trials are performed safely and ethically by rigorous methodology. We convene representatives from government, industry, IRBs/RECs, not-for-profit entities, patients, and academia to create practical resources for the ethical design, conduct, and oversight of multi-regional clinical trials.

Current projects in this area include:

Bioethics Collaborative
The MRCT Center Bioethics Collaborative is a neutral forum to foster the discussion of bioethical issues among stakeholders involved in global clinical trials for drug and device development. Read more. 

Health Literacy
Prospective research participants should be provided with comprehensible, individually meaningful, and culturally-relevant information about clinical research and the implications of research participation. The MRCT Center is working on clinical research-oriented tools and resources for stakeholders responsible for communicating clinical research materials to the participants. Read more.

Impact of GDPR on Clinical Research
The European Union’s General Data Protection Regulation (GDPR) took effect on May 25, 2018. The regulation focuses on the processing of personal data of individuals located in any member state of the European Economic Area (EEA). The GDPR applies extraterritorially in a broad range of circumstances and has disrupted US-based research. The MRCT Center is leading an effort to understand the key issues and implications of the GDPR on multi-regional clinical trials, clinical research, and public health. Read more

Post-trial Responsibilities
Post-trial responsibilities refer to a wide range of possibilities for providing continued access to study interventions (and potentially other care) after a trial has ended or a participant’s time on trial has completed. The MRCT Center has developed and disseminated principles, a guidance document, and a toolkit. Read more

Proactive Safety Surveillance
Convened by the MRCT Center in collaboration with others, the Proactive Safety Surveillance Initiative aims to improve upon the current safety surveillance systems by creating a global, cooperative model for a more proactive, predictive safety surveillance approach. Read more

Protocol Ethics
Protocol ethics refers to addressing ethical issues in the design of clinical trials and documenting their rationale in an identified section of the study protocol easily understood by institutional review boards/ research ethics committees. The MRCT Center has developed a protocol ethics toolkit and e-learning course for sponsors and investigators to enhance ethical considerations in study design and protocol documents. Read more

Representation of Diverse Populations in Multi-Regional Clinical Trials
Ideally, the participant population enrolled in clinical trials reflects the composition of the general population or of those affected by the disease, so that the research yields generalizable knowledge pertinent to the population that will use the product. In most clinical trials, however, the sex, race, ethnicity, and age of the participant population are not representative of the population at large.  The MRCT Center is working on a clear set of ethical principles and a conceptual framework that promote understanding of the goals of diversity, addressing current barriers to progress, and exploring solutions to common scientific and sociocultural barriers to meaningful diversity in clinical trials. Read More

Research, Development, and Regulatory Roundtable (R3)
A cooperative endeavor of the MRCT Center and Ropes & Gray LLP, the R3 is a neutral forum wherein policymakers, legal counsel, academicians, industry representatives, and global regulators may present, discuss, and deliberate pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Read more