Ethical Review Processes

Establishment of early ethical codes of conduct

Prior to the Second World War research involving human subjects was, in the main, self-regulated by researchers. The first major impetus for change was the Nuremberg Code of 1947, which followed directly from the conviction for crimes against humanity of Nazi physicians involved in concentration camp medical experiments. The Nuremberg Code established that:

  • Ethical considerations and ethical review are important
  • Scientific efficacy is central to ethically sound research
  • Assessment of risk-benefit is central to ethically sound research
  • Voluntary consent of participants is essential
  • Research on vulnerable groups is questionable

In regard to voluntary consent the Nuremberg Code stated:

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

The Declaration of Helsinki, developed by World Medical Association in 1964, went further. The declaration:

  • Locates ‘respect for persons’ at the centre of research ethics – people should not be regarded as a means to an end (life, health and dignity of participants should be protected)
  • Requires best standard of care available (even in control groups)
  • Sets out guidance for inclusion of vulnerable groups (e.g. with regard to consent/assent)
  • Establishes that principles can be extrapolated to research contexts other than medicine

However, the emphasis of ethical regulation remained in the medical context. Other International Ethical Codes addressing regulation of medical ethics have included:

  • International Ethical Guidelines for Bio-medical research Involving Human Subjects – 1982, updated 2002; published by the World Health Organization (WHO) and the Council for International Organisations of Medical Sciences (CIOMS)
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (GCP) 1996 – involving regulatory authorities and experts from the pharmaceutical industry from Europe, Japan and the United States.

The Convention for the Protection of Human Rights and Fundamental Freedoms (European Convention on Human Rights), addresses broader issues of civil liberty, including the right to privacy. The Convention was drafted by the Council of Europe after the Second World War and signed in Rome in 1950, with protocols added in 1952, 1963 and 1966. Although the UK was a signatory to the convention British citizens were not able to bring claims in the European Court of Human Rights until the 1960s. The Human Rights Act of 1998 went further to enshrine the terms of the Convention in UK law.

NHS Research Ethics Committees (RECs)

The ‘Research Governance Framework for Health and Social Care’ (2001; second edition 2005) sets out the remit and responsibilities for NHS RECs:

First Edition, 2001
Second Edition, 2005

The ‘Induction Guide for New REC Members’ June summarizes the role of NHS Research Ethic Committees as follows:

Research Ethics Committees provide independent advice to participants, researchers, funders, sponsors, employers, care organizations and professionals on the extent to which proposals for research studies comply with recognised ethical standards.
The purpose of a Research Ethics Committee in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants.
RECs are responsible for acting primarily in the interest of potential research participants and concerned communities, but they should also take into account the interests, needs and safety of researchers who are trying to undertake research of good quality. It is also unethical to hinder ethical research.

www.nres.npsa.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=239

For more detailed material on NHS RECs see NHS Research Ethics Committees section.

Academic Social Science

Until relatively recently ethical protocols concerning research involving humans has been primarily focused on the medical context; and formal procedures for ethical review and regulation have developed in this context. The extension of such formal regulation to academic social science contexts is more recent. Some other countries, notably the USA, have been ahead of the UK in this regard. The US ‘National Research Act’ (1974) established Institutional Review Boards (IRBs) for studies in the fields of health and the social sciences, including anthropology, sociology, and psychology. US policy arose in response to some particularly scandalous research activities, such as the Tuskegee Syphilis Study (1932-1972) in which research participants remained untreated despite the later discovery of treatment1 and Milgram’s social psychology experiments (from 1961; widely publicised in 1974), designed to measure the willingness of participants to obey an authority figure despite being instructed to perform acts conflicting with their personal conscience.2

In the UK prompts for change have been driven by broad social changes, including increased public expectation of transparency and accountability from institutions. For universities, specific prompts for change came from the Research Council UK (RCUK) requirement to complete its ‘Annual Report on Good Research Conduct’ form and from the Council for Industry and Higher Education’s document ‘Ethics Matters: Managing Ethical Issues in Higher Education’ (http://www.cihe.co.uk/wp-content/themes/cihe/document.php?file=0509Ethics.pdf).

However, the major determining landmark came in 2005 with publication of the ESRC’s ‘Research Ethics Framework’ (REF). The document sets out principles for internal Research Ethics Committees within academic institutions and expectations for their implementation.

More detailed information about the ESRC’s REF can be found under the ‘ESRC Requirements’ tab; and the ‘University RECs’ tab.

1 "Final Report of the Tuskegee Syphilis Study Legacy Committee". Tuskegee Syphilis Study Legacy Committee. 1996-05-20. http://www.hsl.virginia.edu/historical/medical_history/bad_blood/report.cfm.

2. Milgram, Stanley (1963). "Behavioral Study of Obedience". Journal of Abnormal and Social Psychology 67: 371–378. doi:10.1037/h0040525. PMID 14049516. http://content.apa.org/journals/abn/67/4/371. Full-text PDF.

 

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