Human tissue: ethical and legal issues

There has been wide debate in the UK about the use of human tissue since the publication of the Council’s report, Human Tissue: ethical and legal issues. Follow the links below to find out about developments in the field since the report’s publication.

The Human Tissue Act 2004

The Human Tissue Act received Royal Assent in November 2004 after months of debate in the House of Lords. Many of the final amendments were a response to the concerns of the geneticists, researchers and academics regarding the restrictions on use of human tissue.

Changes included the removal of requirement for consent where material from living persons is used, or DNA analysed, for all types of education and training, including that relating to research. The new Human Tissue Authority (HTA) will be able to ‘deem consent’ for material to be used and analysed for the benefit of another person, where the donor has not responded to reasonable requests for consent (provided that there is no reason to believe that the donor has died or is incompetent).

For more information see:

• The Human Tissue Act 2004
• The Human Tissue Authority

During discussions about the Human Tissue Bill, the Council wrote to MPs calling for new legislation on Human Tissue to be clear and coherent. The Council supported the introduction of the Human Tissue Bill in principle and welcomed the emphasis given to consent as the fundamental principle guiding the lawful use of human tissue.

• Download the Council’s response
• See also the press release

Professional organisations guidelines

Medical Research Council (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.

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

British Medical Association

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.

Hospital inquiries

Two high-profile inquiries focussed on instances of improper retention of organs:

Bristol Inquiry

A public inquiry was set up to investigate children’s heart surgery at Bristol Royal Infirmary in October 1998. During this it emerged that it had been commonplace for hearts, removed from children during post-mortem examination, to be retained. In many cases this appears to have taken place without parental consent or even knowledge. This revelation caused much public concern.

Professor Ian Kennedy, Chairman of the Nuffield Council, chaired the Inquiry. The Inquiry published an Interim Report, Removal and retention of human material, in May 2000. This then became Annex C of the final report, which was published in July 2001. Recommendations in the Interim Report included:

• Emphasis on the respect for the dead child and parental concerns when considering the removal, retention, use and disposal of human material
• Medical benefits of retaining tissues should be balanced with informed co-operation of the parents
• An increasing use of alternative means for education and research, for example three-dimensional modelling and other technology, because of the emotional concerns of using human material
• Wider questions concerning the establishment and maintenance of tissue banks and commercialisation of tissue should receive urgent consideration, with a view to establishing an appropriate regulatory system

The report suggested two options for the future – either having a Code of Practice or new legislation with necessary related provisions.

Alder Hey Inquiry

It was discovered that it had been common practice to retain organs without parental knowledge and agreement Alder Hey Children’s Hospital in Liverpool. Separate research collections of children’s hearts and other organs had been accumulated over several decades.

Additionally, between 1988 and 1995, Professor van Velzen, then Professor of Fetal and Infant Pathology was responsible for the removal of all organs from all babies and children at post-mortem and their storage for intended research, without parental knowledge or agreement. In the majority of cases, these organs were never put to any useful research purpose.

A public inquiry was held, to investigate the removal, retention and disposal of human organs and tissues. The resulting Redfern report was published in January 2001 and recommended:

• Establishment of serious incident procedures to prevent future mishandling of the organ retention issue
• Medical and pathology records should be reviewed and updated and an audit trail should be developed and put in place
• New management standards to prevent a repeat of the van Velzen years
• The Human Tissue Act 1961 should be amended to provide a test of fully informed consent
• Once fully informed consent is obtained for research purposes, the researchers are entitled to remain in possession of the material retained while research continues.
• Local ethics committees should be given a supervisory role to police approved research.

The report also included specific recommendations for clinicians, coroners, pathologists and bereavement advisers.

Chief Medical Officers advice

As a result of public concern, the CMO carried out a survey of organ retention throughout the UK and produced guidance on the removal, retention and use of human organs and tissue. ‘The Removal, Retention and Use of Human Organs and Tissue from Post Mortem Examination. Advice from the Chief Medical Officer’ (2001).

The guidance was based on a survey of organ and tissue retained by pathology services and hospitals in 2000, and an investigation into consent, looking at how agreement had been obtained from relatives for this retention.

Recommendations included:

• Amendments to specific legislation including the Human Tissue Act (1961) and Coroners Rules (1984)
• Call for a broader review of law
• Introduction of a Code of Practice
• Introduction of standardised yet separate consent forms for post-mortems and retention of tissue or organs from these
• Establishment of independent oversight commission

The report also focussed on issues of consent, education and training. As a result of this report, the Retained Organs Commission was established on 1 April 2001.

International recommendations

European Group on Ethics in Science and New Technologies

Adoption of an Opinion on Human Tissue Banking (1998)

The Opinion focuses on four main areas:

Therapeutic Opportunities

The peak in use of human tissues especially for grafting purposes (e.g. corneas, tendons, bone, skin) was recognised. However it was acknowledged that limited information is available about actual practices with human tissue in EC countries, for example about collection and storage, and legislation

Safety

This was emphasised as an ethical imperative. The report recommended that Community standards be developed for the quality and safety of human tissues and proposed that a European structure for the protection of health be created in collaboration with the European Agency for the Evaluation of Medicinal Products. The report also made calls for strict controls of tissue banks’ activities, that they be subject to authorisation, and that tissues be traceable.

Donation

Must be free, anonymous (donor and recipient), based on requirement of prior consent entrenched in national legislative rules. Information should be supplied to the donor in all cases, and there should be respect for privacy or confidentiality of donors and their families.

Transparency

Periodic surveys of practices in member states should be encouraged, looking at procurement, storage, distribution of human tissues and imports. The Group felt that improved transparency would also aid equitable access to tissues.

Australia

Australian National Statement on Ethical Conduct in Research Involving Humans (2001)

For the first time this statement includes guidelines in relation to the ethical conduct of research. The recommendations were developed with reference to Nuffield report.