Clinical Trial Startup Bootcamp Session 4: Administering Informed Consents: Special Populations/Panel Discussion (2016)

In this session, we will discuss the significance of informed consent before ending with a panel discussion.

Tagged: regulatory science, research ethics, informed consent, special populations

Ethics Consultation #1: Dealing with conflicts with your mentor

In this brief dramatization, a young researcher concerned her mentor/supervisor is conducting research in a scientifically improper manner seeks advice from an SC CTSI ethics consultant.

Tagged: research ethics, responsible conduct of research

Introduction to Clinical and Translational Research: Introduction to Research Ethics - Session 6

This online lecture reviews the history and development of the guidelines and federal regulations addressing ethical considerations associated with clinical and translational research.

Tagged: research ethics, responsible conduct of research

Pharmacovigilance and Safety Reporting Boot Camp Session 8: Wrap up (2018)

In this series, we will discuss pharmacovigilance and safety reporting in clinical trials. Case studies are presented throughout the series.

Tagged: regulatory science, research ethics, responsible conduct of research, clinical trials

Regulatory Aspects of Clinical Trial Design Bootcamp Session 3: Classic and Novel Designs Used in Regulatory Approvals (2018)

In this session, we will discuss how classic and novel designs are used in regulatory approvals and the benefits and consequences of utilizing these types of designs.

Tagged: regulatory science, research ethics, clinical trials, legislations

Regulatory Aspects of Clinical Trial Design Bootcamp Session 4: Unique Designs for Medical Device Trials (2018)

In this session, we will discuss how medical device trials are conducted in Europe and the United States and how these trials differ from pharmacological trials.

Tagged: device development, regulatory science, research ethics, clinical trials

Regulatory Science Series (2013)

Six lecturers provide in-depth reviews of the federal FDA and other regulations and guidelines that govern all aspects of clinical and translational research on new drugs and biomedical devices.

Tagged: device development, drug development, regulatory science, research ethics, responsible conduct of research

Research Ethics Forum: Ethical Challenges in Trials of Human Genome Editing and Gene Therapy

In her 60-minute presentation, Professor Charo addresses Ethical Challenges in Trials of Human Genome Editing and Gene Therapy, as gene therapy and genome editing clinical trials involve ethical challenges not always found in other areas of research.

Tagged: research ethics

Research Ethics Forum: Returning Research Results and Incidental Findings: The Challenge of Translational Science

During this 60-minute forum we discuss how the last decade has seen a revolution in research involving human participants; return of research results and incidental or secondary findings (RoR) is now routinely considered. This session addresses the current state of this transformation, ongoing debates, and the central role of RoR in translational science.

Tagged: research ethics, ethics

Research Ethics Forum: Vulnerability and Autonomy in Research

Research Ethics Forum - Vulnerability and Autonomy in Research: Lessons from Pediatric Studies

Tagged: research ethics, pediatrics, ethics, pediatric research

Special Populations Bootcamp Session 4: Research - Engaging Adolescents and Young Adults (2017)

In this session, we will discuss the importance and concerns of dealing with adolescents in clinical trials.

Tagged: regulatory science, research ethics, social media/internet research

Special Populations Bootcamp Session 5: Clinical Research in Pregnant Women and Neonates (2017)

In this session, we will discuss the special population research and behaviour on women and neonates.

Tagged: regulatory science, research ethics, clinical trials, special populations

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