Informed consent should be obtained from patients to use products (skin substitutes) and dressings containing biological material
- 1Department of Plastic Surgery, University Hospitals of South Manchester, Manchester, UK
- 2Department of Plastic Surgery, Alder Hey Children’s Hospital, Liverpool, UK
- 3University Hospitals of South Manchester, Manchester, UK
- Correspondence to: Mr S Enoch Wound Healing Research Unit, University Department of Surgery, Medicentre, University of Wales College of Medicine, Cardiff CF14 4UJ, UK;
- Received 12 June 2003
- Accepted 7 August 2003
- Revised 30 July 2003
Background: Biological products (tissue engineered skin, allograft and xenograft, and biological dressings) are widely used in the treatment of burns, chronic wounds, and other forms of acute injury. However, the religious and ethical issues, including consent, arising from their use have never been addressed in the medical literature.
Aims: This study was aimed to ascertain the views of religious leaders about the acceptability of biological products and to evaluate awareness among healthcare professionals about their constituents.
Methods: The religious groups that make up about 75% of the United Kingdom population were identified and a questionnaire on 11 biological products was sent to its leaders. Another questionnaire concerning 17 products (11 biological and 6 synthetic dressings) was sent to 100 healthcare professionals working in seven specialist units in the UK.
Results: All religious leaders (100% response rate) replied, some after consultation with international bodies. Among them, 77% said that patients should be informed of the constituents of the biological products and consent obtained. Some leaders expressed concerns about particular products including the transmission of viral and prion diseases, cruelty to animals, and material derived from neonates. None of the healthcare professionals (73% response rate) surveyed knew the constituents of all the products correctly.
Conclusion: Ignoring religious sensitivities and neglecting consent in the usage of biological products could have very serious implications, including litigation. Hospitals and manufacturers should take immediate measures to enlighten healthcare professionals of the constituents of these products so that they can obtain informed consent from patients.
This paper won the joint first prize for oral presentation at the 36th British Burn Association Annual Conference in Edinburgh, UK (22–25 April 2003) and has been presented as posters at the 13th European Tissue Repair Society Annual Meeting in Amsterdam, the Netherlands (21–23 September 2003) and the British Association of Plastic Surgeons Winter Scientific Meeting in London, UK (3–5 December 2003).