Recent Projects
Ethics, Conduct, and Oversight
Clarifying Data Sharing in Informed Consent
Disseminating templates for informed consent forms and data use agreement for broad data sharing purposes to use prospectively.
Capacity Building
Data monitoring committees
Identifying, recruiting and training leaders from emerging regions who have expertise in medicine or statistics and experience in clinical trials, to equip them to serve on Data Monitoring Committees (DMCs).
Ethics, Conduct, and Oversight
Representation of Diverse Populations
Developing a systematic guidance document to enhance diversity in multi-regional clinical trials
Transparency
Return of Individual Results
The MRCT Center previously developed guidelines for the return of aggregate results to research study participants; this project will focus on returning individual results to study participants.
Ethics, Conduct, and Oversight
Bioethics Collaborative
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
Transparency
Return of Aggregate Results
Providing Guidance Document and Toolkit for returning aggregate results to study participants; adapting to non-traditional medicine and non-Western culture and to returning individual results.
Focus Areas
News
Jul 30, 2018
Recent Publications
Dr. Barbara Bierer, MRCT Center Faculty Director, co-authored Development of a Plain-Language Library of Educational Resources for Research Participants, recently published in the Journal of Clinical and Translational Research.
Jun 22, 2018
Bioethics Collaborative Meeting Summary Notes Released
The MRCT Center Bioethics Collaborative is delighted to share a very brief summary of the April 24, 2018 discussion related to Return of Individual Results to Research Participants and Axes of Communication. Read the summary here
Apr 25, 2018
Successful APEC Center of Excellence Training Workshop on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP)
In April 2018, the MRCT Center held a 3 1/2-day training workshop at the Harvard Faculty Club focused on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP) as an APEC (Asia-Pacific Economic Cooperation) Pilot Center of Excellence (CoE), and specifically on ICH-E17 and ICH-E6(R2).
Resources
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Jun 11, 2018
2018-06-11 Bioethics Collaborative: Return of Individual Results to Research Participants and Axes of Communication -
Apr 19, 2018
2018-04-05 Other Resource: Essential Elements of Ethics User Statistics Dec 2017 -
Mar 16, 2018
2018-03-16 Public Comments: Regulation of New Drugs and Clinical Trials Rules: Comments and Rocommendations (LOGIN REQUIRED)
Events
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Aug 13, 2018
2nd Disclosure and Transparency for Clinical Data SummitDr, Carmen Aldinger, MRCT Center Administrative and Training Manager, will present on Sharing Aggregate and Individual Results of Clinical Trials with Study Participants.
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Sep 07, 2018
Global Clinical Research Summit 2018Dr. Barbara Bierer, MRCT Center Faculty Director, will be speaking on “Improving the Performance of Clinical Trial for Global Directives” at the Global Clinical Research Summit in Seoul on September 7th.
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Oct 24, 2018
Seventh Meeting of the MRCT Bioethics CollaborativeThe MRCT Center is planning the seventh meeting of the Bioethics Collaborative, which will be held on October 24th, 2018. The topic for discussion will be Withdrawal of a Marketed Product: Ethical, Practical, and Regulatory Considerations.