Research involving storage and use of human tissue: how did the Human Tissue Act 2004 affect decisions by research ethics committees?

The cosmetics, detergents and food industries trial development products using healthy human volunteer studies. They also use human tissue for in vitro investigations. Hitherto, the ethics of such work has not been regulated. The UK Human Tissue Act will have legal implications on current arrangements for such studies within the industry, especially with regards to informed consent and seeking ethical review of research proposals. At present, however, it is unclear who will fund ethical review for use of ‘relevant material’ in non-medical research, and on the required status of ethics committees to review such work. The principles behind the sampling, storage and processing of ‘relevant material’ are largely identical whether it be for medical or non-medical investigations. It is argued, therefore, that this is further justification for industry and professional bodies to adopt best practice of ethical review for all studies in ‘grey areas’ outside the scope of regulations. This would follow closely those standards applied to biomedical research.

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Research ethics committees: preserving research integrity and the public trust

West Indian Medical Journal ◽

10.1590/s0043-31442007000200001 ◽

2007 ◽

Vol 56 (2) ◽

Author(s):

AM Mullings

Keyword(s):

Research Ethics ◽

Research Integrity ◽

Ethics Committees ◽

Public Trust ◽

Research Ethics Committees ◽

The Public

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Philosophers in research ethics committees—what do they think they’re doing? An empirical-ethical analysis

Medicine Health Care and Philosophy ◽

10.1007/s11019-021-10044-1 ◽

2021 ◽

Author(s):

Charlotte Gauckler

Keyword(s):

Research Ethics ◽

Applied Ethics ◽

Ethics Committees ◽

Research Ethics Committees ◽

Structured Interviews ◽

Discussion Section ◽

Philosophical Perspective ◽

Level 3 ◽

Practical Level

AbstractResearch ethics committees in Germany usually don’t have philosophers as members and if so, only contingently, not provided for by statute. This is interesting from a philosophical perspective, assuming that ethics is a discipline of philosophy. It prompts the question what role philosophers play in those committees they can be found in. Eight qualitative semi-structured interviews were conducted to explore the self-perception of philosophers regarding their contribution to research ethics committees. The results show that the participants generally don’t view themselves as ethics experts. They are rather unanimous on the competencies they think they contribute to the committee but not as to whether those are philosophical competencies or applied ethical ones. In some cases they don’t see a big difference between their role and the role of the jurist member. In the discussion section of this paper I bring up three topics, prompted by the interviews, that need to be addressed: (1) I argue that the interviewees’ unwillingness to call themselves ethics experts might have to do with a too narrow understanding of ethics expertise. (2) I argue that the disagreement among the interviewees concerning the relationship between moral philosophy and applied ethics might be explained on a theoretical or on a practical level. (3) I argue that there is some lack of clarity concerning the relationship between ethics and law in research ethics committees and that further work needs to be done here. All three topics, I conclude, need further investigation.

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Preventing ethics dumping: the challenges for Kenyan research ethics committees

Research Ethics ◽

10.1177/1747016120925064 ◽

2020 ◽

pp. 174701612092506

Author(s):

Kate Chatfield ◽

Doris Schroeder ◽

Anastasia Guantai ◽

Kirana Bhatt ◽

Elizabeth Bukusi ◽

...

Keyword(s):

Research Ethics ◽

Resource Constraints ◽

Ethics Committees ◽

Shared Responsibility ◽

Standards Of Care ◽

Primary Data ◽

Research Ethics Committees ◽

Governance System ◽

Middle Income ◽

System Resource

Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely variations in governance standards, resistance to double ethics review, resource constraints, unresolved issues in the management of biological samples, unresolved issues in the management of primary data, unsuitable informed consent procedures, cultural insensitivity, differing standards of care, reluctance to provide feedback to research communities, power differentials which facilitate the exploitation of local researchers and lack of local relevance and/or affordability of the resultant products. A reflective approach for researchers, built around the values of fairness, respect, care and honesty, is presented as a means of taking shared responsibility for preventing ethics dumping.

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