Адамдарға қатысты зерттеулер этикасын бақылайтын комитеттер

Type of committee that applies research ethics
research ethical oversight in the United States
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 (or that harms are minimal and outweighed by research benefits). Such boards are formally designated to approve (or reject), 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 purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of people participating in a research study. A key goal of IRBs is to protect human subjects from physical or psychological harm, which they attempt to do by reviewing research protocols and related materials. The protocol review assesses the ethics of the research and its methods, promotes fully informed and voluntary participation by prospective subjects, and seeks to maximize the safety of subjects. They often conduct some form of risk benefit analysis in an attempt to determine whether or not research should be conducted. IRBs are most commonly used for studies in the fields of health and the social sciences, including anthropology, sociology, and psychology. Such studies may be clinical trials of new drugs or medical devices, studies of personal or social behavior, opinions or attitudes, or studies of how health care is delivered and might be improved. Many types of research that involves humans, such as research into which teaching methods are appropriate, unstructured research such as oral histories, journalistic research, research conducted by private individuals, and research that does not involve human subjects, are not typically required to have IRB approval.

U. S. regulations identify several research categories that are considered exempt from IRB oversight. These categories include:
Research in conventional educational settings, such as those involving the study of instructional strategies or effectiveness of various techniques, curricula, or classroom management methods. In the case of studies involving the use of educational tests, there are specific provisions in the exemption to ensure that subjects cannot be identified or exposed to risks or liabilities. Research involving the analysis of existing data and other materials, where the data is either already publicly available or will be analyzed such that individual subjects cannot be identified. Additionally, research projects conducted outside of a federal government agency or government funded institution, such as a citizen science project conducted by a private individual or a group of private individuals, are generally not required to be approved by any institutional review board, unless the project is funded by the US federal government.

Although "IRB" is a generic term used in the United States by the FDA and HHS, each institution that establishes such a board may use whatever name it chooses. Many simply capitalize the term "Institutional Review Board" as the proper name of their instance. Regardless of the name chosen, the IRB is subject to the US FDA's IRB regulations when studies of FDA regulated products are reviewed and approved. At one time, such a committee was named the "Committee for the Protection of Human Subjects". Originally, IRBs were simply committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethical problems. Today, some of these reviews are conducted by for profit organizations known as independent or commercial IRBs. Anyone, including private individuals, can pay a commercial IRB for review. As IRBs are normally staffed with employees, who have to be paid, there are costs to operating them. In 2001, the cost of operating an IRB typically ranged from about $75,000 to $770,000 ($ to $, after accounting for inflation) per year, depending on the volume of research reviewed.

While the Belmont principles and U. S. federal regulations were formulated with biomedical and social behavioral research in mind, the enforcement of the regulations, the examples used in typical presentations regarding the history of the regulatory requirements, and the extensiveness of written guidance have been predominantly focused on biomedical research. Numerous complaints by investigators about the fit between the federal regulations and its IRB review requirements as they relate to social science research have been received. Broad complaints range from the legitimacy of IRB review, the applicability of the concepts of risk as it pertains to social science (e. g., possibly unneeded, over burdensome requirements), and the requirements for the documentation of participants' informed consent (i. e., consent forms). Researchers have tried to determine under what instances participants are more likely to read informed consent forms, and ways to improve their efficacy in the social sciences. Social scientists have criticized biomedical IRBs for failing to adequately understand their research methods (such as ethnography). For this reason, some large research institutions have set up multiple specialized IRBs, and may have one committee that exclusively oversees social science research. In 2003, the US Office for Human Research Protections (OHRP), in conjunction with the Oral History Association and American Historical Association, issued a formal statement that taking oral histories, unstructured interviews (as if for a piece of journalism), collecting anecdotes, and similar free speech activities often do not constitute "human subject research" as defined in the regulations and were never intended to be covered by clinical research rules. Other US federal agencies supporting social science have attempted to provide guidance in this area, especially the National Science Foundation. In general, the NSF guidelines assure IRBs that the regulations have some flexibility and rely on the common sense of the IRB to focus on limiting harm, maximizing informed consent, and limiting bureaucratic limitations of valid research.

Aspects of big data research pose formidable challenges for research ethics and thus show potential for wider applicability of formal review processes. One theme is data breaches, but another with high difficulty is potentially dangerous predictive analytics with unintended consequences, via false positives or new ways to invade privacy. A 2016 article on the hope to expand ethics reviews of such research included an example of a data breach in which a big data researcher leaked 70,000 OkCupid profiles with usernames and sexual orientation data. The IRB based approach to ethics assumes that human subject research is conducted by an institution employing researchers, and that the institution and researchers have far more power and knowledge than the participants. The researchers and the participants are seen as distinct groups, and the concern is to prevent the researchers from exploiting the participants as a means to an end. This leads to IRBs issuing requirements such as having researchers explain the research project and obtain informed consent. However, this model does not always fit citizen science projects, especially when the participants are themselves the experts and researchers. Similarly, many institutionally driven research programs are limiting or prohibiting the return of results to individuals, especially for genetic or medical studies, for fear that some participants could be harmed if they misunderstand the results. In 2005, the for profit Western Institutional Review Board claimed to conduct the majority of reviews for new drug submissions to the FDA. In a 2006 study of 575 IRB members at university medical centers, over one third reported industry financial ties, and over one third admitted they "rarely or never" disclosed conflicts of interest to other board members. In 2009 the US Government Accountability Office (GAO) set up a series of undercover tests to determine whether the IRB system was vulnerable to unethical manipulation. In one test, a fake product "Adhesiabloc" was submitted to a number of IRBs for approval for human tests. The product, company, and CVs of the supposed researchers were all fictitious and documents were forged by the GAO. The product was deliberately formulated to match some "significant risk" criteria of the FDA and was described by GAO as a "gel that would be poured into a patient's stomach after surgery to collect the bits and pieces left over from an operation." Despite this, one IRB approved the device for human testing. Other IRBs to whom the device was submitted rejected the application, one of them saying it was "the riskiest thing I've ever seen on this board". However, none of the IRBs approached detected that the company and product were fake. The GAO also set up a fake IRB and obtained requests for approval from companies. They succeeded in getting assurance approval from the HHS for their fake IRB. At the time, the US HHS has only three staff to deal with 300 IRB registrations and 300 assurance applications per month. HHS stated that it would not be worthwhile to carry out additional evaluation even if they had the staff to do it.