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University of Edinburgh

University of Edinburgh
University of Edinburgh
Old College
South Bridge
Edinburgh
Scotland    EH8 9YL
Telephone : 0131 650 1000
Email :   communications.office@ed.ac.uk
Website :  University of Edinburgh
School of Law : Research and Ethical Approval (distance learning)
  Distance Learning     :   This course can be studied by Distance Learning
Description: For most of its history, biomedical research has been conducted in a relatively unregulated environment, with research justified solely on the basis that the activity ultimately benefits mankind. Research subjects often felt obliged to participate, with little or no hope of personal benefit. In this module, we will look at how attitudes, conditions, standards and safeguards have developed and changed over the last hundred years, including the emergence of substantial human rights protections, and protocols for protecting ‘vulnerable’ patient-subjects.

Today, modern medical research is guided by a literal profusion of codes of practice, professional association and research committee guidelines, international protocols and national legislation. Research purposes, effectiveness and methods now have to be stringently justified, subject to broad principles and high standards of good clinical practice.
Forthcoming Events: Due to the ongoing demand for the Law and Medical Ethics short-courses, the programme will be run three times a year.
Contact: e-CPD Law and Medical Ethics
Email: ecpd.law@ed.ac.uk
Further Information: The above module details are start-dates. Distance learning provides flexibility to be compatible with your existing committments to your career, family and social life. You have access to your tutors for one week per module. What time of day or week you contribute to the modules is up to you, but they estimate an average of five hours each week will allow you to cover all the core material.

Website: http://www.law.ed.ac.uk/distancelearning/ecpd/law-and-medical-ethics/Research-and-Ethical-Approval.htm
Keywords/SpecialityBy the end of this module, the student will be able to:

- Contextualise current issues in terms of the historic development of codes and principles that have arisen in direct response to events in the last century;
- Identify and design research plans that address the differences in practice between ‘medical experimentation’ and ‘medical research’, and the different requirements for ‘therapeutic’ versus ‘non-therapeutic research;
and
- Critically discuss whether research is defensible in the absence of direct or immediate benefits to the actual research subjects, and the appropriateness of research on stem cells, embryos and fetal tissue.
Aim(s): Aims & objectives

- To become familiar with standards that have been established and accepted both internationally and nationally, and gain an appreciation for both the potential benefits and problems associated with research conducted on human subjects in general;
- Survey the particular difficulties inherent in constructing ethical research protocols that require the use of ‘vulnerable’ patients, like children or the mentally incapacitated, or requiring the use of embryos, fetal tissue or stem cells;
and
- Consider the safeguards and consent requirements that need to be put in place for different 'categories' of subject, as well as the differences in the standards required when talking about ‘therapeutic’ versus ‘non-therapeutic’ research.