Intrusive research is the gathering of data from individuals through interviewing, observation, or surveying, [1] when consent is legally required, yet the test subjects don't have the capacity to give such consent due to mental illness or developmental disability. It is a legal issue addressed by the United Kingdom Mental Capacity Act 2005.
UK's Mental Capacity Act 2005 criminalizes intrusive research if it was carried out without securing the consent of the person involved, who has the mental capacity to make the decision. [2] It is also unlawful to involve a person lacking mental capacity without the approval of an "appropriate body". [3] The appropriate body pertains to the authority appointed by the Secretary of State in England and the National Assembly for Wales (e.g. Research Ethics Committee). [4] [5] The Act also applies to non-interventional research such as observational research. The law provides the statutory framework and provisions for the participation of people without the capacity to give consent in intrusive research. [6]
The Act also applies to clinical trials of treatments and procedures, but doesn't apply to trials of medicinal products, for which there is a separate regulation (The Medicines for Human Use Regulations, 2004).
The Mental capacity Act code of practice, 2007, gives examples of intrusive research:
A broader conceptualization defines intrusive research as a method of data gathering that entails the participation of the investigator as opposed to non-participant observation. [7] It includes various types of interviews such as structured interview and in-depth interview. [7] [8]
Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information. A health care provider may ask a patient to consent to receive therapy before providing it, or a clinical researcher may ask a research participant before enrolling that person into a clinical trial. Informed consent is collected according to guidelines from the fields of medical ethics and research ethics.
A randomized controlled trial is a type of scientific experiment that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. There may be more than one treatment group or more than one control group.
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.
Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are 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 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.
Qualitative research relies on unstructured and non-numerical data. The data include field notes written by the researcher during the course of his or her observation, interviews and questionnaires, focus groups, participant-observation, audio or video recordings carried out by the researcher in natural settings, documents of various kinds, and even material artifacts. The use of these data is informed by various methodological or philosophical assumptions, as part of various methods, such as ethnography, discourse analysis, interpretative phenomenological analysis and other phenomenological methods. Qualitative research methods have been used in sociology, anthropology, political science, psychology, social work, and educational research.
Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research 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 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 type of 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.
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—or in some cases electronically recorded—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 which 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.
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the Department, mostly through the National Institutes of Health (NIH).
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.
Respect for persons is the concept that all people deserve the right to fully exercise their autonomy. Showing respect for persons is a system for interaction in which one entity ensures that another has agency to be able to make a choice.
A mental health tribunal is a specialist tribunal (hearing) empowered by law to adjudicate disputes about mental health treatment, primarily by conducting independent reviews of patients diagnosed with mental disorders who are detained in psychiatric hospitals, or under outpatient commitment, and who may be subject to involuntary treatment.
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