Ethical Frameworks

Context

There are recognized limitations on the systems for reviewing trials particularly around efficiency (e.g. the time it takes to get a protocol reviewed) and effectiveness (e.g. the quality of the review and its ability to detect ethical problems). There are additional issues that may arise in the context of resource-poor environments with less existing infrastructure, both human and material.

Challenge

Sponsors, researchers, their institutions, patients and other stakeholders have strongly aligned interests in ensuring the protection of human research participants and fairness to the communities hosting this research. The long-term success of clinical research would be enhanced if all stakeholders could align around these shared interests.

MRCT Center Projects

In this focus area we build capacity to ensure that clinical trials are performed safely and ethically, based on a strong and efficient process of independent ethical review. We convene representatives from industry, not-for-profits, patients, and academia to create practical resources for the ethical design and conduct of multi-regional clinical trials.

Current projects in this area include:

Post-trial Responsibilities
Post-trial responsibilities refer to a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a subject’s participation has ended. This may include access to study medications and/or health care structure for study participants or entire communities for a specific time or lifelong. Read more

Protocol Ethics
Protocol ethics refers to addressing ethical issues in the design of studies and documenting their rationale in a section of the study protocol easily understood by review boards. Read more

Informed Consent Language
With the announcement of the EMA’s final policy on publication of clinical trial data in October 2014, all clinical study reports submitted after January 1, 2015 will be available for download by the public. Read more

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