Ethics 2: Working with Human Subjects, 1st Edition
Author: Gary Roper
Reviewer: Professor Richard Ashcroft
Group: Research Skills 1
Published: 18/02/07
Cat. number: RS 005
Length: 90 minutes

This comprehensive course aims to help researchers understand the main considerations when conducting any research that involves human subjects.

As well as extensive information on key themes and legislation, it also has a series of engaging documentaries on some of the great 'research scandals'. There is also a comedy sketch on the importance of using 'plain English' with research subjects.

The course contains separate simulations for medical students and social scientists, but it is appropriate for any researcher working with human subjects.

Syllabus

  • Defining a human participant
  • Types of participation
  • Ethics and regulation
  • Tuskegee syphilis study (documentary)
  • Nuremberg Code (documentary)
  • Declaration of Helsinki
  • Thalidomide scandal (documentary)
  • Alder-Hey organ scandal (documentary)
  • Medicines for Human Use (Clinical Trials)
  • Human Tissue Act
  • Mental Capacity Act
  • Informed consent
  • Medical research and social science research
  • Dependent relationships
  • Communicating effectively
  • Presenting information
  • Consent and children
  • Gillick competency
  • Children and experimental medicine
  • Adults with learning or communication difficulties
  • Confidentiality
  • Liability and inducement

Author - Gary Roper, Imperial College

Gary Roper is the Research Governance Manager for Imperial College London and has been responsible for setting up and managing the governance systems for human health-related research and integrating systems with partner NHS Trusts. He assisted in the development, and is a member of, Imperial's Research Ethics Committee. He sits on the Good Clinical Practice Consultative Committee for the Medicines and Healthcare products Regulatory Authority (MHRA), and is a member of the NHS R&D Forum Representatives Group.

Expert Reviewer - Professor Richard Ashcroft, Queen Mary College

Richard Ashcroft is Professor of Biomedical Ethics at Queen Mary, University of London. His main research interests are in ethical issues in epidemiology and clinical trials. He is a Deputy Editor of the Journal of Medical Ethics. He has extensive experience as a member and trainer of research ethics committees, and has published widely on issues in research ethics.

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