*Public Perceptions of the Collection of Human Biological Samples: Progress to date

General documents:

*Issues in deciding capacity. Denzil Lush, Master of the Court of Protection. Capacity and Neuropsychology 15 December 1997.

*General Medical Council. Confidentiality: Protection and Providing Information

Legislation and Regulation

General

The Human Rights Act 1998

The scope of the Act covers the articles included in the European Convention: The right to life; Freedom from torture or inhuman or degrading treatment; Freedom from slavery; Liberty of person; Right to a fair trial; Prohibition against retrospective offences; Right to respect for private and family life; Freedom of thought, conscience and religion; Freedom of expression; Freedom of assembly and association; Right to marry and found a family; These rights to be enjoyed without discrimination on any ground; Derogation in time of war or public emergency.

Patient Information

The Data Protection Act 1998 Provides protection for personal data. This includes information which by itself or in conjunction with other easily obtainable information, can identify a specific person.

The Human Fertilisation and Embryology (Disclosure of Information) Act 1992 Limits the circumstances in which licensed centres may disclose information

The NHS (Venereal Diseases) Regulations 1974 The NHS Trusts (Venereal Diseases) Directions 1991 The Abortions Regulations 1991 Impose both specific obligations and formal restrictions on disclosure of information.

Regulation of Investigatory Powers Bill

Legislation relating to interception of communications, intrusive investigative techniques and access to encrypted data

Use of Human Organs and Tissues

Human Tissue Act 1961

The Anatomy Act 1984 and the attendant Anatomy Regulations 1988

Legislation covering human cadavers donated to departments of anatomy in British Medical Schools for the study or teaching of, or for research into, anatomy

Nuffield Council on Bioethics

Human Tissue: Ethical and Legal Issues - Report published in April 1995. Conclusions and recommendations available on the website.

The Royal College of Pathologists

Guidelines for the Retention of Tissues and Organs at Post-Mortem Examination

Royal College of Physicians

Statement from the Royal College of Physicians' Committee on Ethical Issues in Medicine "Research based on archived information and samples".Journal of the Royal College of Physicians (1999) 33:264-6

Medical Research Council

The MRC is formulating guidance on ethical, legal and management issues concerning human tissue and biological samples for use in research.

UK National Culture Collection

The NCC offers a number of services including the supply of quality cultures, identification of cultures, safe deposit facilities and deposit of cultures. It provides guidance on collection management and on the supply of cultures.

European Collection of Cell Cultures

ECACC provides quality cell cultures to the academic community and industry, provides guidance on culture deposition and access.

Brain Tissue

"The MRC's Role and Guidelines for MRC-funded Brain Banks" is available from the publication section of MRC

Animals

The Home Office The Animals (Scientific Procedures) Act 1986

The act

Guidance on the operation of the Act including links to electronic forms and guidance notes

The Animals Procedures Section includes links to publications on this topic as well as consultation documents for forthcoming codes of practice etc.

Other DH Requirements

Use of Human Organs and Tissues

*The removal, retention and Use of Human Organs and Tissue from Post-mortem Examination

Advice from the Chief Medical Officer

Patient Information

For the Record: managing records in NHS Trusts and Health Authorities Health Service Circular HSC 1999/053 (March 1999)

The Protection and Use of Patient Information Department of Health 1996

Using confidential patient information in the modern NHS Caldicott Report & Related Guidance (1997/98/99)

http://www.doh.gov.uk/

Local Research Ethics Committees

Local Research Ethics Committees HSG(91)5

Standards for Local Research Ethics Committees: a framework for ethical review. NHS Training Division, 1994

Standard Operating Procedures for Local Research Ethics Committees Comments & Examples Christine Bendall McKenna & Co April 1994

Briefing Pack for Research Ethics Committee Members, 1997

Multi-centre Research Ethics Committees

Ethics Committee Review of Multi-centre Research Establishment of Multi-centre Research Ethics Committees HSG(97)23

Copies of these documents for LRECs and MRECs can be obtained from the Central Office for Research Ethics Committees (COREC) - see address below.

All relevant current regulations and references concerning policy for, and operation of, RECs will be available shortly on the Research Ethics Committees web site, currently under construction.

Contacting Research Ethics Committees

Addresses for MRECs and LRECs throughout the UK can be obtained from the Central Office for Research Ethics Committees and the REC website.

COREC Room 75-77, 'B' Block 40 Eastbourne Terrace London W2 3 QR

Tel: 020 7725 3463 Fax: 020 7725 3465 MREC application forms, and guidance to researchers and dates of meetings can be obtained from COREC or found on the Research Ethics Committees website.

LREC application forms, local guidelines and dates of meetings are available from the administrators of each local committee.

Specialist National Committees

Gene Therapy Advisory Committee Information on the committee, guidance on making proposals to conduct gene therapy in human subjects and on writing patient information sheets for such studies is available at:

http://www.dh.gov.uk/ab/GTAC/index.htm

United Kingdom Xenotransplantation Interim Regulatory Authority HSC 1998/126 Clinical procedures involving xenotransplantation Information on the committee and making proposals for trials in this field is available at:

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063075

Other Established Standards

Report on the Review of Patient-Identifiable Information. The Caldicott Committee Department of Health 1997

Personal Information in Medical Research

http://www.mrc.ac.uk/

Royal College of Physicians Guidelines on the practice of Ethical Committees in Medical Research involving Human Subjects (3rd edition, August 1997) publications@rcplondon.ac.uk

Royal College of Paediatrics and Child Health Guidelines for the Ethical Conduct of Medical Research involving Children Prepared by the Ethics Advisory Committee - August 1992; Archives of Diseases in Childhood 2000, 82:177-182

Royal College of Nursing

Research ethics guidance for nurses involved in research or any investigative project involving human subjects.

Public Health Laboratory Service

Procedure for obtaining approval of PHLS Ethics Committee Involving Human Subjects

World Health Organisation Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)

http://who.int/tdr/publications/publications/pdf/ethics.pdf

Guidance relevant to ethics committees

Aspects of particular studies may give rise to ethical issues; researchers and ethics committees may wish to consult relevant guidance.

Consent

HSC 1999/031 Consent to treatment: summary of legal rulings.

The Department of Health's 1990 guidance on consent is being updated and should be published later in 20001. [Good Practice in Consent Initiative]

General Medical Council: Seeking patients' consent: the ethical considerations (1998)

Genetics

Guidance produced by the Advisory Committee on Genetic Testing, including Advice to Research Ethics Committees (October 1998) and testing for late onset disorders (1998).

Also, see other domains for references to guidance by MRC and other authorities on clinical trials, storage of samples, embryo research, use of information.

General reference manuals:

The reference manual compiled by members of the Department of Law and Medical Ethics, King's College, London contains lists of a large number of papers and publications related to Research Ethics and Ethics Committees. The Manual for Research Ethics Committees can be obtained from:

The Centre of Medical Law and Ethics King's College London Strand London WC2R 2LS Tel: 020 7848 2357