Medical research and audit

Medical research and audit: principles

Students should be able to demonstrate in practice an understanding of:

  • the purposes and differences between research and audit
  • ethical, professional and legal considerations involved in medical research and audit
  • the importance of trust and integrity in research and audit
  • ethical and legal issues in conducting and reporting clinical trials
  • additional ethical and legal limitations on (boundaries of) research with children and other vulnerable individuals
  • the situations when research ethics committee approval may be required and how to seek it
  • ethics of research in developing countries
  • potential conflicts of interests in relationships with the pharmaceutical and medical equipment industries.


Medical research and audit: teaching and learning resources

General

BioCentre Academic Paper search

Films

The Constant Gardener (2005). A widower is determined to get to the bottom of a potentially explosive secret involving his wife's murder, big business, and corporate corruption (IMDB.com)

Extreme Measures (1996). Thriller about Guy Luthan (Hugh Grant), a British doctor working at a hospital in New York who starts making unwanted enquiries when the body of a man who died in his emergency room disappears. The trail leads Luthan to the door of the eminent surgeon Dr Lawrence Myrick (Gene Hackman), but Luthan soon finds himself under in danger from people who want the hospital's secret to remain undiscovered. Written by Jonathan Broxton (IMDB.com)

Books

Plomer, A 2005: The Law and Ethics of Medical Research: International Bioethics and Human Rights, London, Routledge-Cavendish Publishing.plomer a to use for web

This book examines the controversies surrounding biomedical research in the 21st century from a human rights perspective, analysing the evolution and changes in form and content of international instruments regulating the conduct of biomedical research.

Cover image used with permission of the publisher www.taylorandfrancisgroup.com

Many Taylor & Francis and Routledge books are now available as eBooks, see: www.eBookstore.tandf.co.uk

Lasagna L, Some ethical problems in clinical investigation. In Mendelsohn E, Swazey PJ, Taviss I, eds. 1972 Human Aspects of Biomedical Innovation. Cambridge Mass.: Harvard University Press: pp. 98-109 (?)

Schwartz, L, Preece P E and Hendry R A, 2002: Medical Ethics: A case based approach, Saunders, Elsevier Science pp.121-135.

Medical ethics is a topic of increased importance in the new undergraduate curriculum and this textbook will provide the only resource published in the UK which is aimed specifically at medical students, rather than experienced practitioners. Realistic case studies introduce the discussion in each chapter - highly suitable for case based courses - while there is practical coverage of all the issues likely to be of concern to students during their medical careers. This includes informed consent and refusal of treatment, confidentiality, euthanasia, advanced directives, negligence and malpractice, the new genetics, abortion and the rationing of health care.  hendry et al

This chapter was published in Medical Ethics: a case based approach, Schwartz, L, Preece, P, and Hendry R Ch. 8 'Medical Audit and Medical Research', pp. 121-135, Copyright Elsevier 2002.

 

Cover image used by permission of the publisher © Elsevier 2002.  See the book page on their website here.

Professional guidance

Research guidance: good practice in research, and consent to research, GMC

Code of practice for practitioners authorised to carry out medical treatment or research under Part 5 of the Adults with Incapacity (Scotland) Act 2000, Scottish Government

Good Medical Practice, GMC (2013). See paragraphs 70 and 71.

Other publications

Research Governance Framework for Health and Social Care, Department of Health (2010). The Research Governance Framework for Health and Social Care sets out the broad principles of good research governance.

National Research Ethics Service, The National Research Ethics Service (NRES) has a dual mission; to protect the rights, safety, dignity and well-being of research participants; and to facilitate and promote ethical research that is of potential benefit to participants, science and society.

Adults lacking capacity: on-line toolkit, National Research Ethics Service (2010)

Ethics guide: Medical research involving adults who cannot consent, Medical Research Council (2007)

Articles

Ethics committees and the legality of research, J Med Ethics 2007; 33:732-736

M Dixon-Woods, E L Angell, Research involving adults who lack capacity: how have research ethics committees interpreted the requirements? J Med Ethics 2009; 35:377-381

Buchanan, D, Miller, F, A public health perspective on research ethics, J Med Ethics 2006;32:729-733

Biggs, H, Competent minors and health-care research: autonomy does not rule, okay? Clin Ethics, December 2009; 4: 176 - 180

Cave, E, Nichols, C, Reforming the ethical review system: balancing the rights and interests of research participants with the duty to facilitate good research, Clinical Ethics 2007; 2: 74–79

Wade, D, Ethics, audit, and research: all shades of grey BMJ 2005; 330 : 468

Caplan, L A, Is there a Duty to Serve as a Subject in Biomedical Research? IRB 1984; 6 (5): 5.

McDermott, W, Opening comments to colloquium: The changing mores of biomedical research. Ann Intern Med 1967; 67: 39-42.

Giordano, S , The 2008 Declaration of Helsinki: some reflections, Journal of Medical Ethics, 36, 2010, pp.598-603