Human Tissue: Ethical and Legal Issues
Professional Organisations Guidelines
Professional Organisations Guidelines
The BMA, the MRC, the Royal College of Pathologists have all published advice and recommendations for their members on practical issues relating to the retention of human tissue. A code of practice has also been introduced for Tissue Banks.
MRC Guidelines
Human tissue and biological samples for use in research.
Operational and Ethical Guidelines.
In 2001, the MRC published guidance for researchers on ethical, legal and management issues relating to the use of human biological materials for research. The main recommendations were:
- Research should only go ahead if the potential benefits outweigh any potential risks to the donors of the samples
- The human body and its parts should be treated with respect
- Samples of human biological material obtained for use in research should be treated as gifts
- The human body and its parts shall not, as such, give rise to financial gain
- Informed consent is required from the donor (or the next of kin, if the donor has died) whenever a new sample is taken wholly or partly for use in research
- Patients should always be informed when material left over following diagnosis or treatment might be used for research
- Research must be approved by an appropriately constituted research ethics committee
- Researchers should treat all personal and medical information relating to research participants as confidential
- Research participants have a right to know individual research results that affect their interests, but should be able to choose whether to exercise that right.
Many of these recommendations are in line with the conclusions reached by the Nuffield Council’s Working Party, particularly regarding informed consent and that there should not be a commercial trade in body parts.
For more information: www.mrc.ac.uk
Royal College of Pathologists
- Consensus Statement of Recommended Policies for Uses of Human Tissue in Research Education and Quality Control (1999)
This statement looks at the ethical issues and practical implications of genetic testing, including services offered direct to the public as well as the use of stored archives in research, education, audit and quality control.
Guidelines for the Retention of Tissues and Organs at Post-mortem Examination (March 2000)
The main recommendations addressed:
- training for medical staff on how to request and obtain agreement for post-mortem exams and on how to deal with relatives’ concerns about organ retention
- determining the necessity of retaining tissue in helping inform decisions of relatives
- accurate record keeping, reports of post-mortems, and recording details of tissues or organs retained
- standard operating procedures for archiving and disposing of tissues retained.
- The need for a periodic review of guidelines, taking account of medical advances, changes in legislation and public attitudes
For more information: http://www.rcpath.org/
British Medical Assocation
Interim Guidelines on retention of human tissue at post-mortem for medical education/research (amended Nov 2000)
The guidelines promote:
- Information for relatives
- An understanding of and respect for the rights for the dead, for example regarding confidentiality, or prior wishes
- Defined system for obtaining informed consent
Code of Practice for Tissue Banks
The Nuffield Council’s Report included several recommendations about tissue banks, specifically that these should be set up as not-for-profit enterprises.
The Code of Practice (tissue banks) published by the Department of Health in 2001 specifies the requirements for the activities of tissue banks that store and/or process human tissues for therapeutic use within the health service in the UK. The recommendations made are in line with the Nuffield Council’s report. These guidelines now form the basis of the Department of Health accreditation scheme, which covers quality systems, facilities, responsibilities of personnel and training requirements, donor selection, control of tissues, services and materials, process control, packaging, labelling and transport, and documentation.
www.doh.gov.uk/humantissuebanking/
For more on regulatory developments: Hospital Inquiries
Last Updated Tue, 8 August 2006