The National Research Ethics Service (NRES) is a UK medical quango which deals with research ethics. Principal Investigators must describe the experiment they intend to pursue to the NRES for its approval, failing which the study is prohibited. [1]
The National Research Ethics Service (NRES) is a UK medical quango which deals with research ethics. Principal Investigators must describe the experiment they intend to pursue to the NRES for its approval, failing which the study is prohibited. [1]
The NRES was launched on 1 April 2007. [2] [3]
The adjective "National" was omitted from the name at some unknown point in time. [4]
In 2009, the NRES issued a leaflet in which it described its purpose: [5]
The National Research Ethics Service (NRES) reviews research proposals to protect the rights and safety of research participants and enables ethical research which is of potential benefit to science and society.
The substance of the NRES reports can be gleaned from an approval obtained in 2011 by Stephanie Taylor, who was then Professor of Public Health and Primary Care at Queen Mary University of London. [6]
Research is "creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness to controlling sources of bias and error. These activities are characterized by accounting and controlling for biases. A research project may be an expansion on past work in the field. To test the validity of instruments, procedures, or experiments, research may replicate elements of prior projects or the project as a whole.
Morality is the differentiation of intentions, decisions and actions between those that are distinguished as proper (right) and those that are improper (wrong). Morality can be a body of standards or principles derived from a code of conduct from a particular philosophy, religion or culture, or it can derive from a standard that a person believes should be universal. Morality may also be specifically synonymous with "goodness" or "rightness".
Public policy is an institutionalized proposal or a decided set of elements like laws, regulations, guidelines, and actions to solve or address relevant and real-world problems, guided by a conception and often implemented by programs. Public policy can be considered to be the sum of a government's direct and indirect activities and has been conceptualized in a variety of ways.
A randomized controlled trial is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments.
Bioethics is both a field of study and professional practice, interested in ethical issues related to health, including those emerging from advances in biology, medicine, and technologies. It proposes the discussion about moral discernment in society and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health. Bioethics is concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, theology and philosophy. It includes the study of values relating to primary care, other branches of medicine, ethical education in science, animal, and environmental ethics, and public health.
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal. It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics. However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation. Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment.
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes.
Medical research, also known as experimental medicine, encompasses a wide array of research, extending from "basic research", – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine.
The artificial sweetener aspartame has been the subject of several controversies since its initial approval by the U.S. Food and Drug Administration (FDA) in 1974. The FDA approval of aspartame was highly contested, beginning with suspicions of its involvement in brain cancer, alleging that the quality of the initial research supporting its safety was inadequate and flawed, and that conflicts of interest marred the 1981 approval of aspartame, previously evaluated by two FDA panels that concluded to keep the approval on hold before further investigation. In 1987, the U.S. Government Accountability Office concluded that the food additive approval process had been followed properly for aspartame. The irregularities fueled a conspiracy theory, which the "Nancy Markle" email hoax circulated, along with claims—counter to the weight of medical evidence—that numerous health conditions are caused by the consumption of aspartame in normal doses.
Animal testing regulations are guidelines that permit and control the use of non-human animals for scientific experimentation. They vary greatly around the world, but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.
The Ministry of Ayush, a ministry of the Government of India, is responsible for developing education, research and propagation of traditional medicine systems in India. Ayush is a name devised from the names of the alternative healthcare systems covered by the ministry: Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy.
Secular morality is the aspect of philosophy that deals with morality outside of religious traditions. Modern examples include humanism, freethinking, and most versions of consequentialism. Additional philosophies with ancient roots include those such as skepticism and virtue ethics. Greg M. Epstein also states that, "much of ancient Far Eastern thought is deeply concerned with human goodness without placing much if any stock in the importance of gods or spirits." An example is the Kural text of Valluvar, an ancient Indian theistic poet-philosopher whose work remains secular and non-denominational. Other philosophers have proposed various ideas about how to determine right and wrong actions. An example is Immanuel Kant's categorical imperative.
The National Institute for Health and Care Research (NIHR) is the British government’s major funder of clinical, public health, social care and translational research. With a budget of over £1.2 billion in 2020–21, its mission is to "improve the health and wealth of the nation through research". The NIHR was established in 2006 under the government's Best Research for Best Health strategy, and is funded by the Department of Health and Social Care. As a research funder and research partner of the NHS, public health and social care, the NIHR complements the work of the Medical Research Council. NIHR focuses on translational research, clinical research and applied health and social care research.
Françoise Elvina Baylis is a Canadian bioethicist whose work is at the intersection of applied ethics, health policy, and practice. The focus of her research is on issues of women's health and assisted reproductive technologies, but her research and publication record also extend to such topics as research involving humans, gene editing, novel genetic technologies, public health, the role of bioethics consultants, and neuroethics. Baylis' interest in the impact of bioethics on health and public policy as well as her commitment to citizen engagement]and participatory democracy sees her engage with print, radio, television, and other online publications.
Clare Palmer is a British philosopher, theologian and scholar of environmental and religious studies who is currently a professor in the Department of Philosophy at Texas A&M University. She has previously held academic appointments at the University of Greenwich, the University of Stirling, Lancaster University and Washington University in St. Louis, among others. Palmer is known for her work in environmental and animal ethics.
The Lancet MMR autism fraud centered on the publication in February 1998 of a fraudulent research paper titled "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children" in The Lancet. The paper, authored by now discredited and deregistered Andrew Wakefield, and listing twelve coauthors, falsely claimed non-existent, causative links between the MMR vaccine, colitis, and autism. The fraud was exposed in a lengthy Sunday Times investigation by reporter Brian Deer, resulting in the paper's retraction in February 2010 and Wakefield being struck off the UK medical register three months later. Wakefield reportedly stood to earn up to $43 million per year selling diagnostic kits for a non-existent syndrome he claimed to have discovered. He also held a patent to a rival vaccine at the time, and he had been employed by a lawyer representing parents in lawsuits against vaccine producers.
Economic ethics is the combination of economics and ethics that unites value judgements from both disciplines to predict, analyze, and model economic phenomena. It encompasses the theoretical ethical prerequisites and foundations of economic systems. This particular school of thought dates back to the Greek philosopher Aristotle, whose Nicomachean Ethics describes the connection between objective economic principles and the consideration of justice. The academic literature on economic ethics is extensive, citing authorities such as natural law and religious law as influences on normative rules in economics. The consideration of moral philosophy, or that of a moral economy, is a point of departure in assessing behavioural economic models. The standard creation, application, and beneficiaries of economic models present a complex trilemma when ethics are considered. These ideas, in conjunction with the fundamental assumption of rationality in economics, create the link between economics and ethics.
Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India.
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