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Informed consent is a principle in medical ethics, medical law and media studies, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclose a person's medical information.
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, diets or other medical treatments.
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. These four values are not ranked in order of importance or relevance and 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.
Clinical psychology is an integration of human science, behavioral science, theory, and clinical knowledge for the purpose of understanding, preventing, and relieving psychologically-based distress or dysfunction and to promote subjective well-being and personal development. Central to its practice are psychological assessment, clinical formulation, and psychotherapy, although clinical psychologists also engage in research, teaching, consultation, forensic testimony, and program development and administration. In many countries, clinical psychology is a regulated mental health profession.
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 at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical. The main goal of IRB reviews is to ensure that study participants are not harmed. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances. Most countries use some form of IRB to safeguard ethical conduct of research so that it complies with national and international norms, regulations or codes.
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.
The Clinical Trials Directive is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.
In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment. Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories. Additionally, and by extension, protocols have the advantage of facilitating the assessment of experimental results through peer review. In addition to detailed procedures, equipment, and instruments, protocols will also contain study objectives, reasoning for experimental design, reasoning for chosen sample sizes, safety precautions, and how results were calculated and reported, including statistical analysis and any rules for predefining and documenting excluded data to avoid bias.
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).
The African Malaria Network Trust (AMANET) is a pan-African international NGO headquartered in Dar es Salaam, Tanzania. It originally started its activities as African Malaria Vaccine Testing Network (AMVTN) in 1995 with the primary goal of preparing Africa in planning and conducting malaria vaccine trials. In order to widen the scope in malaria interventions, AMVTN was succeeded by AMANET on 14 March 2002. Although the primary goal of AMANET has remained malaria vaccine development, the organization in its expanded role includes other intervention measures such as antimalaria drugs and vector control.
In health care, a clinical trial is a comparison test of a medication or other medical treatment, versus a placebo, other medications or devices, or the standard medical treatment for a patient's condition.
A glossary of terms used in clinical research.
The following outline is provided as an overview of and topical guide to clinical research:
Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics. Notable – and in some cases, notorious – human subject experiments performed in the US include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment and Stanford prison experiments and Project MKULTRA. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the institutional review boards.
Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.
A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who voluntarily participates in human subject research after giving informed consent to be the subject of the research. A research participant is different from individuals who are not able to give informed consent, such as children, infants, and animals. Such individuals are preferentially referred to as subjects.
Covert medication, the covert administration of medicines is when medicines are administered in a disguised form, usually in food or drink, without the knowledge or consent of the individual receiving the drug. The decision-making processes surrounding covert medication should be in the best interests of the patient, transparent and inclusive.
The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016 and then signed into law on December 13, 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health. The act was supported especially by large pharmaceutical manufacturers and was opposed especially by some consumer organizations.
References
- ↑ "Intrusive research". oxfordreference.com. Oxford University Press. 18 February 2016. ISBN 978-0-19-179223-6.
- ↑ bsd4. "Research involving adults lacking mental capacity — University of Leicester". www2.le.ac.uk. Retrieved 2019-10-15.
{{cite web}}: CS1 maint: numeric names: authors list (link) - ↑ Brindle, Nick; Branton, Tim; Stansfield, Alison; Zigmond, Tony (2013). A Clinician's Brief Guide to the Mental Capacity Act. London: RCPsych Publications. p. 62. ISBN 9781908020635.
- ↑ "ed.ac.uk" (PDF).
- ↑ Britain, Great (2005). Mental Capacity Act 2005: Chapter 9; Explanatory Notes. London: The Stationery Office. p. 18. ISBN 978-0-10-560905-6.
- ↑ McLaughlin, Hugh (2009). Service-User Research in Health and Social Care. Los Angeles, CA: SAGE. p. 51. ISBN 9781847870711.
- 1 2 Kirby, Mark (2000). Sociology in Perspective. Oxford: Heinemann. pp. G-358. ISBN 0-435-33160-4.
- ↑ Morris, Alan (2015). A Practical Introduction to In-depth Interviewing. Thousand Oaks, CA: SAGE. ISBN 978-1-4739-2698-1.
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