The ?rst ‘test-tube baby’ – to use the popular, and widely used, term for such a child – was born by CAESAREAN SECTION in England on 25 July 1978. Many other children conceived in this manner have since been born, and, though only 10 per cent of women conceive at the ?rst attempt, the overall success rate is improving. Embryo transplantation and research are controversial procedures and in many countries, including the UK, are controlled by legislation. Embryo transfer and research using embryos are regulated by the Human Fertilisation & Embryology Authority (see ASSISTED CONCEPTION; APPENDIX 7: STATUTORY ORGANISATIONS).... embryo transfer
Ethics of research Although Britain has had legislation governing aspects of research on animals since the 19th century, there is no over-arching statute regulating research on humans and human material. Such activity is covered in law by the vaguely de?ned common-law concept of consent, and by piecemeal legislation such as the DATA PROTECTION ACT 1998 and the HUMAN FERTILISATION & EMBRYOLOGY ACT 1990. Nevertheless, extensive and very detailed ethical guidance on aspects of research has been published by a wide range of national and international organisations (see ETHICS COMMITTEES). Several basic principles feature in all statements about research ethics: these include the importance of ensuring that research is independently and rigorously scrutinised by appropriately constituted ethics committees; verifying that any risk to the research subject is reasonable in relation to the anticipated bene?t; and ensuring that all e?orts are made to minimise possible harm. The research subject’s willingness to tolerate some risk does not relieve researchers of the responsibility of making sure that all risks are kept to a minimum. Above all, a key feature of ethical research has involved seeking informed consent from research participants. This rule, initially applied to actual involvement by human subjects in research, has gradually been extended to include seeking informed consent from patients or from their relatives to the use of data and to the use of human organs and tissue in research, including after POST-MORTEM EXAMINATION. (See also EVIDENCE-BASED MEDICINE.)... research
0.1 and 1 per cent. A ?gure of 1 per cent means that, in the United Kingdom at any one time, maybe 30 studies are being conducted, or their results published, which could contain false information. Examples include forged ethics-committee approval, patient signatures and diary cards; fabricated ?gures and results; invention of non-existent patient subjects; or sharing one electrocardiogram or blood sample amongst many subjects.
Research fraud should be ?rst suspected by a clinical-trial monitor who recognises that data are not genuine, or by a quality-assurance auditor who cannot reconcile data in clinical-trial report forms with original patient records. Unfortunately, it often comes to light by chance. There may be suspicious similarities between data ostensibly coming from more than one source, or visits may have been recorded when it was known that the clinic was shut. Statistical analysis of a likely irregularity will frequently con?rm such suspicion. The motivation for fraud is usually greed, but a desire to publish at all costs, to be the original author of a medical breakthrough, to bolster applications for research grants, or to strengthen a bid for more departmental resources are other recognised reasons for committing fraud.
In the USA, those proved to have committed fraud are debarred from receiving federal funds for research purposes or from undertaking government-funded therapeutic research. The four Nordic countries (Denmark, Finland, Norway and Sweden) have committees on research dishonesty that investigate all cases of suspected research misconduct. In the United Kingdom, an informal system operated by the pharmaceutical industry, using the disciplinary mechanism of the General Medical Council (GMC), has led to more than 16 doctors in the past ten years being disciplined for having committed research fraud. Editors of many of the world’s leading medical journals have united to form the Committee on Publishing Ethics, which advises doctors on proper practice and assists them in retracting or refusing to publish articles found or known to be false. (See ETHICS; ETHICS COMMITTEES.) Where an author does not o?er a satisfactory explanation, the matter is passed to his or her institution to investigate; where an editor or the committee is not satis?ed with the result they may pass the complaint to the appropriate regulatory body, such as the GMC in Britain.... research fraud and misconduct
NIHR website... national institute for health research