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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 methodology proposed for research involving human subjects, to ensure that the projects are ethics. 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 , 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 consent 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.The Office of Human Research Protection. Institutional Review Board Guidebook. "Chapter 3, Section A: Risk/Benefit Analysis." pp. 1-10 [1] Retrieved May 30, 2012
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 are appropriate, unstructured research such as Oral history, journalistic research, research conducted by private individuals, and research that does not involve human subjects, are not typically required to have IRB approval.
The result of these abuses was the National Research Act of 1974 and the development of the Belmont Report, which outlined the primary ethical principles in human subjects review; these include "respect for persons", "beneficence", and "justice". An IRB may approve only research for which the risks to subjects are balanced by potential benefits to society, and for which the selection of subjects presents a fair or just distribution of risks and benefits to eligible participants. A bona fide process for obtaining informed consent from participants is also generally needed. However, this requirement may be waived in certain circumstances – for example, when the risk of harm to participants is clearly minimal.
In the United States, IRBs are governed by Title 45 Code of Federal Regulations Part 46. These regulations define the rules and responsibilities for institutional review, which is required for all research that receives support, directly or indirectly, from the United States federal government. Specifically, research on human subjects that is conducted by any institution must be reviewed by that institution's review board if it is not an exempt type and it also involves:
Additionally, the states of California and Maryland have more expansive rules for reviewing research that is conducted within those two states. Many institutions that engage in substantial amounts of research, such as research universities and research hospitals, have their board reviews all research programs, even though it is not required, as a matter of their own internal policy.
IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS). Additional requirements apply to IRBs that oversee clinical trials of drugs involved in new drug applications, or to studies that are supported by the United States Department of Defense. In the United States, the Food and Drug Administration (FDA) and the OHRP have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are "scientific", "ethical", and "regulatory". The equivalent body responsible for overseeing U.S. federally funded research using animals is the Institutional Animal Care and Use Committee (IACUC).
In addition to registering its IRB with the OHRP, an institution is also required to obtain and maintain a Federalwide Assurance or FWA, before undertaking federally funded human research. This is an agreement in which the institution commits to abiding by the regulations governing human research. A secondary supplement to the FWA is required when institutions are undertaking research supported by the U.S. Department of Defense. Human Research Protection Program (HRPP). This DoD Addendum includes further compliance requirements for studies using military personnel, or when the human research involves populations in conflict zones, foreign prisoners, etc. HRPP Information Sheet for DoD Addendum.
Generally, human research ethics guidelines require that decisions about exemption are made by an IRB representative, not by the investigators themselves.Ritter, F. et al, Running Behavioral Studies with Human Participants, Sage Publications Inc. 2013., .
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.
Originally, IRBs were simply committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethics 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. The responsibilities of these IRBs are identical to those based at academic or medical institutions, and within the US, they are governed by the same US federal regulations.
While its composition varies, it often includes a balance of academia and non-academia members. This serves to provide a greater scope of understanding which helps ensure ethics in research. In the US, regulations set out the board's membership and composition requirements, with provisions for diversity in experience, expertise, and institutional affiliation. For example, the minimum number of members is five, at least one scientist, and at least one non-scientist. The guidance strongly suggests that the IRB contain both men and women, but there is no regulatory requirement for gender balance in the IRB's membership. The full requirements are set out in 21 CFR 56.107.
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.
An expedited review may be carried out if the research involves no more than minimal risk to subjects, or where minor changes are being made to previously approved research. The regulations provide a list of research categories that may be reviewed in this manner. An expedited review is carried out by the IRB chair, or by their designee(s) from the board membership. In the US, research activity cannot be disapproved by expedited review.
Here is a summary of several key regulatory guidelines for oversight of clinical trials:
The reviewers may also request that more information be given to subjects when, in their judgment, the additional information would add meaningfully to the protection of the rights, safety and/or well-being of the subjects. When a non-therapeutic trial is to be carried out with the consent of the subject's legally acceptable representative, reviewers should determine that the proposed protocol and/or other document(s) adequately address relevant ethical concerns and meets applicable regulatory requirements for such trials. Where the protocol indicates prior consent of the trial subject or the subject's legally acceptable representative is not possible, the review should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials (i.e., in emergency situations).
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. IRB members have been criticized for assuming that surveys about past trauma has a re-traumatizing effect. 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 history, 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.. See also An Update on the Exclusion of Oral History from IRB Review (March 2004). In 2017, the federal government announced that effective January 2018, the regulations would no longer cover "Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected."
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.
However, many academic journals require proof of IRB approval for all human-subject research, even when it is not legally required, which means that citizen scientists may be unable to publish scientific papers describing their findings. Citizen scientists who expect to need IRB approval for publication or to comply with the terms of a research grant can pay a commercial IRB company. In the US, a standard initial review often costs a few thousand dollars; a review to determine that the project is less expensive.
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. In such cases, a requirement to explain the project means participants would absurdly be informing themselves of their own plans. In a citizen science project, the boundaries between the researcher and the participant are blurred. 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 this restrictive model, the participant never finds out their test results, or they can only find out their test results if the researchers carefully explain the results to them. But in a citizen science project, learning the results is a highly desired reason for participating, and, since the researchers are themselves participants, it would be impossible to prevent them from obtaining the results.
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.[6]
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