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EDITORIALS: Haleema Shakur, Ian Roberts, Lin Barnetson, and Tim Coats Clinical trials in emergency situations BMJ 2007; 334: 165-166 [Full text]

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UK Amendment to Emergency Research

Mark H Wilson   (15 February 2007)

UK Amendment to Emergency Research 15 February 2007
Mark H Wilson, director of medical ethics Health Research Associates, Ottawa,k2b 6j4 Send response to journal: Re: UK Amendment to Emergency Research	The need for emergency research can not be stressed enough. A successful effort by the research community to amend UK regulations has paved the way for emergency research that is approved by research ethics committees (RECs). A similar event occurred in the US in 1996. FDA rules were amended to waive informed consent in certain contexts. This placed more governance weight on the shoulders of RECs who act in the public interest to determine whether research protocols are based on good science and are ethical in design. But as the recent high profiled PolyHeme trial in the US indicates, RECs can face formidable challenges in emergency research. The trial assessed PolyHeme, an artificial blood product that was tested on non consenting emergency subjects. The PolyHeme trial has been controversial and has invited congressional inquiry. (1) It was reported that life threatening adverse events associated with the blood product when it was tested in an earlier trial had not been made public.(2) Concerns were raised about the character of community consultations. 3) While the community (public) does not have the governance power to reject a CT, community consultations are required under US regulations. The consultations provide the local community and the community targeted for research with information that is germane to research being conducted in an emergency setting.This offers the public an opportunity to reflect on proposed research and to provide possible feedback to RECs who assess the trial. However, what that information should be and how it is conveyed to the public has been a matter of considerable discussion and has invited greater regulatory clarity and guidance. (4) The PolyHeme trial has heightened concerns that propriety rights and confidentiality statements signed between REC members and sponsors can hamper the exchange of important information between stakeholders in emergency research and has reinforced the call for a more transparent and independent ethics review (5) Indeed it has revealed a governance community deeply divided over a trial that was thrust into the public spotlight. Lessons from the PolyHeme trial have been drawn and the FDA has sought input to strike a better balance in meeting the challenges of emergency research and serving the public governance interest. (1) While the governance landscape in the US and UK are clearly not mirror reflections, discussion surrounding the PolyHeeme trial might offer the UK research community and regulators further insight into the complexities and challenges facing some emergency research and how they might hopefully be resolved. 1.J. Sugarman, Examining the Provisions for Research without Consent in the Emergency Setting. Hasting Center Report, Jan/Feb. 2007. 2. T. Burton, Despite Heart Attack Deaths, PolyHeme Still Being Tested On Trauma Patients. The Wall Street Journal (republished by DeFrance Inc.). 2006-02-22. http://www.defrance.org/artman/publish/printer_1531.shtml 3. K. Holloway. Accidental Communities: race, emergency medicine, and the problem of Polyheme. American Journal of Bio-ethics . 2006;15:10. Available from http://www.bioethics.net/journal/pdf/UAJB_A_166839.pdf 4. M Barnes, C Hermes, S Herrick. FDA Draft Guidance on Emergency Research: Additional Issues Left Unanswered. Medical Research & Law report, Vol. 5, No 18 09/20/06. pp.634-639. 5. H. Mann. How Confidential Trial Negotiations and Agreements Between the Food and Drug Administration and Sponsors Marginalize Local Institutional Review Boards, and what to do about it. American Journal of Bio-ethics. 2006 May-Jun;6(3):22-4 6. See Senator Charles Grissley's letter to the Honorable Michael Leavitt, Secretary of US Department of Health and Services, for insight into different governance bodies contrasting views on the PolyHeme trial http://finance.senate.gov/press/Gpress/2005/prg031306.pdf Competing interests: None declared