Research ethics committee Health Dictionary

A committee that can have a number of roles in relation to ethics. For example, it may develop policy relative to the use and limitation of treatment; serve as a resource for individuals and their families regarding options for terminal illness; or assess research projects with respect to the appropriate application of ethical principles.... ethics committee

Within most cultures, care of the sick is seen as entailing special duties, codi?ed as a set of moral standards governing professional practice. Although these duties have been stated and interpreted in di?ering ways, a common factor is the awareness of an imbalance of power between doctor and patient and an acknowledgement of the vulnerability of the sick person. A function of medical ethics is to counteract this inevitable power imbalance by encouraging doctors to act in the best interests of their patients, refrain from taking advantage of those in their care, and use their skills in a manner which preserves the honour of their profession. It has always been accepted, however, that doctors cannot use their knowledge indiscriminately to ful?l patients’ wishes. The deliberate ending of life, for example, even at a patient’s request, has usually been seen as alien to the shared values inherent in medical ethics. It is, however, symptomatic of changing concepts of ethics and of the growing power of patient choice that legal challenges have been mounted in several countries to the prohibition of EUTHANASIA. Thus ethics can be seen as regulating individual doctor-patient relationships, integrating doctors within a moral community of their professional peers and re?ecting societal demands for change.

Medical ethics are embedded in cultural values which evolve. Acceptance of abortion within well-de?ned legal parameters in some jurisdictions is an example of how society in?uences the way in which perceptions about ethical obligations change. Because they are often linked to the moral views predominating in society, medical ethics cannot be seen as embodying uniform standards independent of cultural context. Some countries which permit capital punishment or female genital mutilation (FGM – see CIRCUMCISION), for example, expect doctors to carry out such procedures. Some doctors would argue that their ethical obligation to minimise pain and suffering obliges them to comply, whereas others would deem their ethical obligations to be the complete opposite. The medical community attempts to address such variations by establish-ing globally applicable ethical principles through debate within bodies such as the World Medical Association (WMA) or World Psychiatric Association (WPA). Norm-setting bodies increasingly re?ect accepted concepts of human rights and patient rights within professional ethical codes.

Practical changes within society may affect the perceived balance of power within the doctor-patient relationship, and therefore have an impact on ethics. In developed societies, for example, patients are increasingly well informed about treatment options: media such as the Internet provide them with access to specialised knowledge. Social measures such as a well-established complaints system, procedures for legal redress, and guarantees of rights such as those set out in the NHS’s Patient’s Charter appear to reduce the perceived imbalance in the relationship. Law as well as ethics emphasises the importance of informed patient consent and the often legally binding nature of informed patient refusal of treatment. Ethics re?ect the changing relationship by emphasising skills such as e?ective communication and generation of mutual trust within a doctor-patient partnership.

A widely known modern code is the WMA’s International Code of Medical Ethics which seeks to provide a modern restatement of the Hippocratic principles.

Traditionally, ethical codes have sought to establish absolutist positions. The WMA code, for example, imposes an apparently absolute duty of con?dentiality which extends beyond the patient’s death. Increasingly, however, ethics are perceived as a tool for making morally appropriate decisions in a sphere where there is rarely one ‘right’ answer. Many factors – such as current emphasis on autonomy and the individual values of patients; awareness of social and cultural diversity; and the phenomenal advance of new technology which has blurred some moral distinctions about what constitutes a ‘person’ – have contributed to the perception that ethical dilemmas have to be resolved on a case-by-case basis.

An approach adopted by American ethicists has been moral analysis of cases using four fundamental principles: autonomy, bene?cence, non-male?cence and justice. The ‘four principles’ provide a useful framework within which ethical dilemmas can be teased out, but they are criticised for their apparent simplicity in the face of complex problems and for the fact that the moral imperatives implicit in each principle often con?ict with some or all of the other three. As with any other approach to problem-solving, the ‘four principles’ require interpretation. Enduring ethical precepts such as the obligation to bene?t patients and avoid harm (bene?cence and non-male?cence) may be differently interpreted in cases where prolongation of life is contrary to a patient’s wishes or where sentience has been irrevocably lost. In such cases, treatment may be seen as constituting a ‘harm’ rather than a ‘bene?t’.

The importance accorded to ethics in daily practice has undergone considerable development in the latter half of the 20th century. From being seen mainly as a set of values passed on from experienced practitioners to their students at the bedside, medical ethics have increasingly become the domain of lawyers, academic philosophers and professional ethicists, although the role of experienced practitioners is still considered central. In the UK, law and medical ethics increasingly interact. Judges resolve cases on the basis of established medical ethical guidance, and new ethical guidance draws in turn on common-law judgements in individual cases. The rapid increase in specialised journals, conferences and postgraduate courses focused on ethics is testimony to the ever-increasing emphasis accorded to this area of study. Multidisciplinary practice has stimulated the growth of the new discipline of ‘health-care ethics’ which seeks to provide uniformity across long-established professional boundaries. The trend is to set common standards for a range of health professionals and others who may have a duty of care, such as hospital chaplains and ancillary workers. Since a primary function of ethics is to ?nd reasonable answers in situations where di?erent interests or priorities con?ict, managers and health-care purchasers are increasingly seen as potential partners in the e?ort to establish a common approach. Widely accepted ethical values are increasingly applied to the previously unacknowledged dilemmas of rationing scarce resources.

In modern debate about ethics, two important trends can be identi?ed. As a result of the increasingly high pro?le accorded to applied ethics, there is a trend for professions not previously subject to widely agreed standards of behaviour to adopt codes of ethical practice. Business ethics or the ethics of management are comparatively new. At the same time, there is some debate about whether professionals, such as doctors, traditionally subject to special ethical duties, should be seen as simply doing a job for payment like any other worker. As some doctors perceive their power and prestige eroded by health-care managers deciding on how and when to ration care and pressure for patients to exercise autonomy about treatment decisions, it is sometimes argued that realistic limits must be set on medical obligations. A logical implication of patient choice and rejection of medical paternalism would appear to be a concomitant reduction in the freedom of doctors to carry out their own ethical obligations. The concept of conscientious objection, incorporated to some extent in law (e.g. in relation to abortion) ensures that doctors are not obliged to act contrary to their own personal or professional values.... ethics

A statutory body in the United Kingdom that promotes the balanced development of medical and related biological research and aims to advance knowledge that will lead to improved health care. It employs its own research sta? in more than 40 research establishments. These include the National Institute for Medical Research, the Laboratory of Molecular Biology, and the Clinical Sciences Centre. Grants are provided so that individual scientists can do research which complements the research activities of hospitals and universities. There are several medical charities and foundations – for example, the Imperial Cancer Research Fund, the British Heart Foundation, the Nu?eld Laboratories and the Wellcome Trust which fund and foster medical research.... medical research council

Involves the use of non-numerical data, such as those collected in unstructured and in-depth interviews, focus group discussions, participant observation, participatory research, and the study of documents.... qualitative research

Involves the use of data in numerical quantities such as continuous measurements or counts.... quantitative research

A family of research methodologies which pursue action (or change) and research (or understanding) at the same time.... action research

An independent advisory committee – launched in 1971 in the United Kingdom – composed of doctors, pharmacists and other specialists. It advises the MEDICINES CONTROL AGENCY in the UK on the safety, e?cacy and pharmaceutical quality of MEDICINES for which licences are sought and also reviews reports of ADVERSE REACTIONS TO DRUGS, including spontaneous ‘Yellow Card’ reports from doctors or pharmacists who suspect that a patient has suffered an adverse reaction from a medicine. Its predecessor, the Committee for Safety of Drugs, was set up in 1963 in response to the THALIDOMIDE disaster.... committee on safety of medicines (csm)

When a woman is treated for infertility it is necessary to nurture human embryos for a few days (until the ?rst cell divisions of the fertilised egg have occurred) in a specialised laboratory. More eggs are fertilised than are usually needed because not all fertilisations are successful. Surplus embryos may be frozen for use in later attempts to implant an embryo in the womb. Research has been done on very early embryos but the practice is controversial and some countries have either forbidden it or imposed tight restrictions. In the UK such research is controlled by the government Human Fertilisation & Embryology Authority (see ASSISTED CONCEPTION).... embryo research

The basic evaluative principles which (should) guide “good” care. Principles typically refer to respect for, and the dignity of, human beings. Basic dimensions are “autonomy” (respect for self determination), “well-being” (respect for happiness, health and mental integrity) and “social justice” (justifiable distribution of scarce goods and services). More specifically, ethics of care refer to ethical standards developed for the care professions which are designed to implement ethical principles in the practice of care provision.... ethics (of care)

(In the USA, Institutional Review Boards.) Various types of ethics committee operate in the UK, ful?lling four main functions: the monitoring of research; debate of di?cult patient cases; establishing norms of practice; and publishing ethical guidance.

The most common – Local Research Ethics Committees (LRECs) – have provided a monitoring system of research on humans since the late 1960s. Established by NHS health authorities, LRECs were primarily perceived as exercising authority over research carried out on NHS patients or on NHS premises or using NHS records. Their power and signi?cance, however, developed considerably in the 1980s and 90s when national and international guidance made approval by an ‘appropriately constituted’ ethics committee obligatory for any research project involving humans or human tissue. The work of LRECs is supplemented by so-called ‘independent’ ethics committees usually set up by pharmaceutical companies, and since 1997 by multicentre research ethics committees (MRECs). An MREC is responsible for considering all health-related research which will be conducted within ?ve or more locations. LRECs have become indispensable to the conduct of research, and are doubtless partly responsible for the lack of demand in the UK for legislation governing research. A plethora of guidelines is available, and LRECs which fail to comply with recognised standards could incur legal liability. They are increasingly governed by international standards of practice. In 1997, guidelines produced by the International Committee on Harmonisation of Good Clinical Practice (ICH-GCP) were introduced into the UK. These provide a uni?ed standard for research conducted in the European Union, Japan and United States to ensure the mutual acceptance of clinical data by the regulatory authorities in these countries.

Other categories of ethics committee include Ethics Advisory Committees, which debate dif?cult patient cases. Most are attached to specialised health facilities such as fertility clinics or children’s care facilities. The 1990s have seen a greatly increased interest in professional ethics and the establishment of many new ethics committees, including some like that of the National Council for Hospice and Specialist Palliative Care Services which cross professional boundaries. Guidance on professional and ethical standards is produced by these new bodies and by the well-established ethics committees of regulatory or representative bodies, such as the medical and nursing Royal Colleges, the General Medical Council, United Kingdom Central Council for Nursing, Midwifery and Health Visiting, British Medical Association (see APPENDIX 8: PROFESSIONAL ORGANISATIONS) and bodies representing paramedics and professions supplementary to medicine. Their guidance ranges from general codes of practice to detailed analysis of single topics such as EUTHANASIA or surrogacy.

LRECs are now supervised by a central body

– COREC (www.corec.gov.org.uk).... ethics committees

The collection of extensive narrative data on many variables over an extended period of time in a naturalistic setting in order to gain insights not possible using other types of research. For this type of research, observations are undertaken at particular points of time. Data would include observations, recordings and interpretations of what is seen.... ethnographic research

The multidisciplinary field of scientific investigation that studies how social factors, financing systems, organizational structures and processes, health technologies, and personal behaviours affect access to health care, the quality and cost of health care, and ultimately health and well-being. Its research domains are individuals, families, organizations, institutions, communities and populations.... health services research

Research dealing with the entire health system or only part of it, the object being to ensure that the system is optimally planned and organized and that programmes are carried out by the health system infrastructure efficiently and effectively and with appropriate technology.... health systems research

Research on all aspects of health, the factors affecting it, and ways of promoting, protecting and improving it. It is an essential part of national health development. It includes medical and biomedical research relating to a wide variety of medical matters and involving various life sciences, such as molecular biology and biophysics; clinical research, which is based on the observation and treatment of patients or volunteers; epidemiological research, which is concerned with the study and control of diseases and of situations that are suspected of being harmful to health; and socioeconomic and behavioural research, which investigates the social, economic, psychological and cultural determinants of health and disease with a view to promoting health and preventing disease. Often a multidisciplinary combination of the above kinds of research is needed to solve a health problem.... health research

The study of the interrelationships between humans, the tools they use, and the environment in which they live and work.... human-factor research

Research on measures of changes in outcomes, that is, health status and satisfaction, resulting from specific interventions.... outcome research

A process in which the researcher facilitates analysis by a range of stakeholder groups of the themes being investigated.... participatory research

The process by which manuscripts submitted to a publisher or research applications are evaluated by experts in appropriate fields (usually anonymous to the authors) to ensure quality.... peer review (in research)

In medicine, the collation and assessment of existing facts and knowledge, and the critical systematic investigation of the normal and abnormal functioning of the body, along with the EPIDEMIOLOGY of diseases and disorders affecting it – the aim being to increase the sum of knowledge in respect of the prevention, diagnosis and treatment of disease.

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

The procedures and methods, including ethical considerations, predetermined by an investigator, to be adhered to in conducting a research project.... research design

The Committee for safety of medicines was set up in 1963 after the thalidomide disaster. It is an advisory committee which examines drugs before clinical trials, before a product licence is granted, and when passed for marketing. A product cannot be tested in the human body without the company holding a clinical trial certificate. A product licence is renewable after five years. ... committee on safety of medicines

consideration of the moral issues attendant upon, and questions arising from, clinical practice, as distinct from research. In North America, it is common for hospitals to employ a clinical ethicist or provide a formal clinical ethics consultation service. In the UK, clinical *ethics committees are increasingly common in the NHS.... clinical ethics

an approach that is critical of the prevailing focus and methods of *medical ethics. In particular, it is argued that contemporary bioethics has replicated oppressive social structures, privilege, and power relationships at the expense of the marginalized. Moral problems are seen as determined from the social context in which they arise and narrative, care, and *empowerment are usually integral to feminist analyses of ethical dilemmas.... feminist ethics

Research misconduct is de?ned as behaviour by a researcher that falls short of good ethical and scienti?c standards – whether or not this be intentional. For example, the same data may be sent for publication to more than one medical journal, which might have the e?ect of their being counted twice in any META-ANALYSIS or systematic review; or the data may be ‘salami sliced’ to try to make the maximum number of publications, even though the data may overlap. Fraud in the context of research is de?ned as the generation of false data with the intent to deceive. It is much less frequent than carelessness, but its incidence is estimated as between

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

Peter R. Bradley MSc CChem FRSC (Chairman). Whitehall Laboratories.

Sheila E. Drew BPharm PhD MRPharms. Deputy Head of Technical Services, William Ransom & Son plc.

Fred Fletcher-Hyde BSc FNIMH. President Emeritus, British Herbal Medicine Association. President Emeritus, National Institute of Medical Herbalists.

Simon Y. Mills MA FNIMH. Director, Centre for Complementary Health Studies, University of Exeter. Hugh W. Mitchell MNIMH (Hon). President, British Herbal Medicine Association. Managing Director, Mitchfield Botanics Ltd.

Edward J. Shellard BPharm PhD DSc(Hon) (Warsaw Medical Academy) FRPharmS CChem FRSC FLS. Emeritus Professor of Pharmacognosy, University of London.

Arnold Webster CChem MRSC. Technical Director, English Grains Ltd.

Peter Wetton BSc LRSC. G.R. Lane Health Products Ltd.

Hein Zeylstra FNIMH. Principal. School of Phytotherapy, Sussex. ... british herbal medicine association, scientific committee, 1995

The following rules are amplified in the official Code of Ethics observed by members of the National Institute of Medical Herbalists. Summarised as follows:–

Rule 1. Members shall at all times conduct themselves in an honourable manner in their relations with their patients, the public, and with other members of the Institute.

The relationship between a medical herbalist and his or her patient is that of a professional with a client. The patient puts complete trust in the practitioner’s integrity and it is the duty of members not to abuse this trust in any way. Proper moral conduct must always be paramount in member’s relationships with patients. Members must act with consideration concerning fees and justification for treatment.

Rule 2. No member may advertise or allow his or her name to be advertised in any way, except in the form laid down by the Council of the Institute.

Any form of commercialism in the conduct of a herbal practice is unseemly and undesirable. Particular considerations govern commencement of practice, partnerships, assistantships, door plates, signs, letter headings, broadcasts, etc.

Rule 3. Members shall comply at all times with the requirements of the Code of Practice.

Rule 4. Members shall not give formal courses of instructions in the practice of herbal medicine without the approval of the Council of the Institute.

Rule 5. It is required that members apply the Code of Practice to all their professional activities.

Rule 6. Infringement of the Ethical Code renders members liable to disciplinary action with subsequent loss of privileges and benefits of the Institute. ... code of ethics

an approach to moral problems acknowledging that ethical analysis is frequently culture-specific and geographically limited. The international and worldwide experience of health care is the subject of study and there is commonly close attention to inequities in health and health-care provision, with frequent emphasis on *human rights, *justice, and *equality.... global ethics

a *special health authority of the NHS established following the Health and Social Care Act 2012 to promote and protect the interests of patients in health research and to simplify the regulation of research. The Health Research Authority inherited the functions of the National Research Ethics Service, which closed in 2012.... health research authority

approaches to moral questions based on the thought of the German philosopher Immanuel Kant (1724–1804). These seek to discover what is morally right by asking what basic rules all rational people (see autonomy) could adopt for themselves and then act on as an *imperative matter of *duty, regardless of their personal desires or of the possible consequences (see deontology; consequentialism). The Kantian tradition has been influential in medical ethics, especially in its insistence that every human life must be treated as an end in itself and not simply as a means.... kantian ethics

(LMC) a group of representatives of the general practitioners working in a defined geographical area. There are separate LMCs for each area, and the members speak on behalf of the local practitioners by whom they are elected. Similar arrangements and responsibilities apply for dentists, pharmacists, and optometrists practising in the NHS outside hospitals.... local medical committee

see local medical committee.... medical committee

the standards of conduct required of medical professionals and also the academic study of ethical issues arising from the practice of medicine. From the *Hippocratic oath onwards, standards are designed to reassure that professionals subscribing to them will act in the *best interests of, and will avoid harming, their patients. Today they lay greater emphasis on patient *autonomy, while the contemporary study of medical ethics is concerned with a great variety of complex societal and social issues related to medical practice and research. Medical ethics is now taught in all medical schools in the UK as an essential part of a professional training, and the wider field of *bioethics is becoming a recognized academic specialty. See also clinical ethics; feminist ethics; public health ethics; publication ethics; virtue ethics.

Guidance on good medical practice from the website of the General Medical Council... medical ethics

an approach to ethical problems and practice that involves listening to and interpreting people’s stories rather than applying principles or rules to particular situations. This context-specific empathetic approach to patient and professional life stories is often contrasted with the universalizing rationalist approach of *Kantian ethics. Narrative ethics has an obvious relevance to the doctor–patient relationship and mirrors the clinical context in which moral choices are made.... narrative ethics

(NIHR) a national organization, funded through the *Department of Health and Social Care, that coordinates, supports, and funds research within the NHS.

NIHR website... national institute for health research

(PAR) a radical approach to public health issues that actively involves communities in collaboration, reflection, data collection, and activities that empower them to improve their own health. See empowerment.... participatory action research

the standards expected from those who write, publish, and disseminate research. The International Committee on Publication Ethics (COPE), comprising the editors and publishers of most major academic biomedical journals, consults and advises on aspects of publication ethics, such as research misconduct, plagiarism, so-called gift authorship, determination of contribution to research, and peer review processes.

A detailed guide to publication ethics from COPE... publication ethics

the ethics of population (as opposed to individual) health, including issues related to epidemiology, disease prevention, health promotion, *justice, and *equality. Public health ethics is commonly concerned with the tensions between individual *autonomy and *communitarianism and/or *utilitarianism.... public health ethics

a type of scientific enquiry that focuses on developing practical application from the findings from basic scientific research. The field of translational research is sometimes described as comprising T1 research and T2 research. The former focuses on developing novel clinical treatments from laboratory-based basic science; the latter on embedding the findings of clinical trials into everyday practice. See also academic health science network.... translational research

(NSC) the body responsible for advising the NHS, the ministers of the UK government, and the three devolved governments in the UK about all aspects of screening. The NSC also has responsibility for overseeing all noncancer screening programmes in the NHS in England and monitoring their quality and effectiveness. It was formed in 1996 and became part of *Public Health England in 2013. See screening test.

National Screening Committee website: contains detailed notes on all screening programmes the committee has considered and the rationale for the decisions the committee has made... uk national screening committee

theories that emphasize the ethical importance of the virtues (e.g., honesty or courage), true happiness, and practical wisdom (compare consequentialism; deontology). In medical ethics, the traits of a ‘good doctor’ provide the moral compass by which to assess professional practice.... virtue ethics