Institutional review board
Encyclopedia
An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB), is a committee
that has been formally designated to approve, monitor, and review biomedical and behavioral research
involving human
s with the aim to protect the rights and welfare of the research subjects. In the United States
, the Food and Drug Administration (FDA) and Department of Health and Human Services
(specifically Office for Human Research Protections
) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.
, for example defining IRBs and requiring them for all research that receives support, directly or indirectly, from what was the Department of Health, Education, and Welfare at the time, and is now the Department of Health and Human Services (HHS). IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within HHS. IRBs were developed in direct response to research abuses earlier in the twentieth century. Two of the most notorious of these abuses were the experiments of Nazi physicians
that became a focus of the post-World War II Doctors' Trial
, and the Tuskegee Syphilis Study
, a project conducted between 1932 and 1972 by the U.S. Public Health Service on black men in rural Alabama. Title 21 part 56 has additional requirements for IRBs that oversee clinical trials of drugs involved in new drug application
s.
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Originally, IRBs were committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethical
problems.
Today some IRB reviews are conducted by for-profit organizations known as independent or commercial IRBs. The responsibilities of these IRBs are identical to those based at academic or medical institutions, and they are governed by the same federal regulations. The composition of an IRB for the FDA's requirements is set in 21 CFR 56.107.
1 The IRB must have at least five members.2 The members must have enough experience, expertise, and diversity to make an informed decision on whether the research is ethical, informed consent is sufficient, and appropriate safeguards have been put in place.3 If the IRB works with studies that include vulnerable populations, the IRB should have members who are familiar with these groups. It is common for an IRB to include an advocate for prisoners when considering research that involves them.1 The IRB should include both men and women, as long as they aren't chosen specifically for their gender.2 The members of the IRB must not be all of the same profession. The IRB must include at least one scientist and at least one non-scientist. These terms are not defined in the regulations. The IRB must include at least one person who is not affiliated with the institution or in the immediate family of a person affiliated with the institution. These are commonly called "Community Members." IRB members may not vote on their own projects. The IRB may include consultants in their discussions to meet requirements for expertise or diversity, but only actual IRB members may vote.
In order to vote on a proposal, more than half of the members of the board must be present and there must be a non-scientist present. There are exceptions for expedited review, where only the chair of the committee or a designee reviews research, but these are relatively narrow.
and the social sciences, including anthropology
, sociology
, and psychology
. Such studies may be clinical trials of new drugs or devices, studies of personal or social behavior, opinions or attitudes, or studies of how health care is delivered and might be improved.
The purpose of an IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare
of human subjects of research. The chief objectives of every IRB protocol review are to assess the ethics of the research and its methods, to promote fully informed and voluntary participation by prospective subjects who are themselves capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy) and to maximize the safety of subjects once they are enrolled in the project.
an IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects, such as pregnant women, children, prisoners, the elderly, or persons with diminished comprehension. The primary ethical principles in human subjects review are outlined in the Belmont Report
, and include "respect for persons", "beneficence," and "justice." The IRB may only approve research for which there is a bona fide
informed consent process for participants, 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.
The IRB/IEC should obtain the following documents:
trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator proposes for use in the trial, subject recruitment procedures (e.g., advertisements), written information to be provided to subjects, Investigator's Brochure (IB), available safety information, information about payments and compensation available to subjects, the investigator's current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfill its responsibilities.
The IRB/IEC should review a proposed clinical trial
within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates for the following:
According to ICH GCP the IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.
According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year.
The IRB/IEC may request more information
than is outlined in paragraph 4.8.10 be given to subjects when, in the judgment of the IRB/IEC, 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 (see 4.8.12, 4.8.14), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials. Where the protocol indicates that prior consent of the trial subject or the subject's legally acceptable representative is not possible (see 4.8.15), the IRB/IEC 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). The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject.
According to ICH GCP (good clinical practice
) the IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified.
There have been numerous complaints by investigators about the fit between the federal regulations and its IRB review requirements as they relate to social science research. 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' consent i.e., consent forms). Often these concerns are based on an IRB misunderstanding the social science and/or failing to apply the flexibility which is permitted in the regulatory framework. Social scientists have appropriately criticized biomedical IRBs for failing to adequately understand their research methods (such as ethnography). In 2003, 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 federal agencies supporting social science have attempted to provide guidance in this area, especially the National Science Foundation. In general, the FAQ assures 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.
This article incorporates text from the U.S. Food and Drug Administration, which is in the public domain
.
Committee
A committee is a type of small deliberative assembly that is usually intended to remain subordinate to another, larger deliberative assembly—which when organized so that action on committee requires a vote by all its entitled members, is called the "Committee of the Whole"...
that has been formally designated to approve, monitor, and review biomedical and behavioral research
Research
Research can be defined as the scientific search for knowledge, or as any systematic investigation, to establish novel facts, solve new or existing problems, prove new ideas, or develop new theories, usually using a scientific method...
involving human
Human
Humans are the only living species in the Homo genus...
s with the aim to protect the rights and welfare of the research subjects. In the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, the Food and Drug Administration (FDA) and Department of Health and Human Services
United States Department of Health and Human Services
The United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America"...
(specifically Office for Human Research Protections
Office for human research protections
The Office for Human Research Protections is a small office within the United States Department of Health and Human Services that deals with ethical oversight of clinical research conducted by the department, mostly through the National Institutes of Health.The office's primary duty is the...
) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.
U.S. mandate
In the United States, IRBs are governed by Title 45 CFR (Code of Federal Regulations) Part 46. These regulations implement provisions of the National Research Act of 1974National Research Act
The National Research Act was enacted by the 93rd United States Congress. It created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to oversee and regulate the use of human experimentation in medicine. It was partly a response to the infamous...
, for example defining IRBs and requiring them for all research that receives support, directly or indirectly, from what was the Department of Health, Education, and Welfare at the time, and is now the Department of Health and Human Services (HHS). IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within HHS. IRBs were developed in direct response to research abuses earlier in the twentieth century. Two of the most notorious of these abuses were the experiments of Nazi physicians
Nazi human experimentation
Nazi human experimentation was a series of medical experiments on large numbers of prisoners by the Nazi German regime in its concentration camps mainly in the early 1940s, during World War II and the Holocaust. Prisoners were coerced into participating: they did not willingly volunteer and there...
that became a focus of the post-World War II Doctors' Trial
Doctors' Trial
The Doctors' Trial was the first of 12 trials for war crimes that the United States authorities held in their occupation zone in Nuremberg, Germany after the end of World War II. These trials were held before U.S...
, and the Tuskegee Syphilis Study
Tuskegee Syphilis Study
The Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the U.S...
, a project conducted between 1932 and 1972 by the U.S. Public Health Service on black men in rural Alabama. Title 21 part 56 has additional requirements for IRBs that oversee clinical trials of drugs involved in new drug application
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
s.
Exemptions
While IRBs can be more inclusive or restrictive, under the statute, exemptions to IRB approval include research activities in which the only involvement of human subjects will be in one or more of the following categories:1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
- research on regular and special education instructional strategies, or
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
- the human subjects are elected or appointed public officials or candidates for public office;
- federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
- public benefit or service programs;
- procedures for obtaining benefits or services under those programs;
- possible changes in or alternatives to those programs or procedures; or
- possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Naming and composition
Although "IRB" is a generic term used by the FDA and HHS, each institution that establishes an IRB may use whatever name it chooses. Regardless of the name chosen, the IRB is subject to the FDA's IRB regulations when studies of FDA-regulated products are reviewed and approved.Originally, IRBs were committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethical
Ethics
Ethics, also known as moral philosophy, is a branch of philosophy that addresses questions about morality—that is, concepts such as good and evil, right and wrong, virtue and vice, justice and crime, etc.Major branches of ethics include:...
problems.
Today some IRB reviews are conducted by for-profit organizations known as independent or commercial IRBs. The responsibilities of these IRBs are identical to those based at academic or medical institutions, and they are governed by the same federal regulations. The composition of an IRB for the FDA's requirements is set in 21 CFR 56.107.
1 The IRB must have at least five members.2 The members must have enough experience, expertise, and diversity to make an informed decision on whether the research is ethical, informed consent is sufficient, and appropriate safeguards have been put in place.3 If the IRB works with studies that include vulnerable populations, the IRB should have members who are familiar with these groups. It is common for an IRB to include an advocate for prisoners when considering research that involves them.1 The IRB should include both men and women, as long as they aren't chosen specifically for their gender.2 The members of the IRB must not be all of the same profession. The IRB must include at least one scientist and at least one non-scientist. These terms are not defined in the regulations. The IRB must include at least one person who is not affiliated with the institution or in the immediate family of a person affiliated with the institution. These are commonly called "Community Members." IRB members may not vote on their own projects. The IRB may include consultants in their discussions to meet requirements for expertise or diversity, but only actual IRB members may vote.
In order to vote on a proposal, more than half of the members of the board must be present and there must be a non-scientist present. There are exceptions for expedited review, where only the chair of the committee or a designee reviews research, but these are relatively narrow.
Purpose and use
IRBs are most commonly used for studies in the fields of healthHealth
Health is the level of functional or metabolic efficiency of a living being. In humans, it is the general condition of a person's mind, body and spirit, usually meaning to be free from illness, injury or pain...
and the social sciences, including anthropology
Anthropology
Anthropology is the study of humanity. It has origins in the humanities, the natural sciences, and the social sciences. The term "anthropology" is from the Greek anthrōpos , "man", understood to mean mankind or humanity, and -logia , "discourse" or "study", and was first used in 1501 by German...
, sociology
Sociology
Sociology is the study of society. It is a social science—a term with which it is sometimes synonymous—which uses various methods of empirical investigation and critical analysis to develop a body of knowledge about human social activity...
, and psychology
Psychology
Psychology is the study of the mind and behavior. Its immediate goal is to understand individuals and groups by both establishing general principles and researching specific cases. For many, the ultimate goal of psychology is to benefit society...
. Such studies may be clinical trials of new drugs or devices, studies of personal or social behavior, opinions or attitudes, or studies of how health care is delivered and might be improved.
The purpose of an IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare
Quality of life
The term quality of life is used to evaluate the general well-being of individuals and societies. The term is used in a wide range of contexts, including the fields of international development, healthcare, and politics. Quality of life should not be confused with the concept of standard of...
of human subjects of research. The chief objectives of every IRB protocol review are to assess the ethics of the research and its methods, to promote fully informed and voluntary participation by prospective subjects who are themselves capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy) and to maximize the safety of subjects once they are enrolled in the project.
Responsibilities
According to ICH-GCPICH-GCP
International Conference on Harmonisation - Good Clinical Practice ICH-GCPClinical studies should be carried out according to International Conference on Harmonisation / WHO Good Clinical Practice standards...
an IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects, such as pregnant women, children, prisoners, the elderly, or persons with diminished comprehension. The primary ethical principles in human subjects review are outlined in the Belmont Report
Belmont Report
The Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission...
, and include "respect for persons", "beneficence," and "justice." The IRB may only approve research for which there is a bona fide
Bona Fide
Bona Fide is a studio album from rock band Wishbone Ash. It is the first studio album in six years and is the only studio album to feature guitarist Ben Granfelt...
informed consent process for participants, 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.
The IRB/IEC should obtain the following documents:
trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator proposes for use in the trial, subject recruitment procedures (e.g., advertisements), written information to be provided to subjects, Investigator's Brochure (IB), available safety information, information about payments and compensation available to subjects, the investigator's current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfill its responsibilities.
The IRB/IEC should review a proposed clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates for the following:
- approval/favourable opinion;
- modifications required prior to its approval/favourable opinion;
- disapproval/negative opinion; and
- termination/suspension of any prior approval/favourable opinion.
According to ICH GCP the IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.
According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year.
The IRB/IEC may request more information
Information
Information in its most restricted technical sense is a message or collection of messages that consists of an ordered sequence of symbols, or it is the meaning that can be interpreted from such a message or collection of messages. Information can be recorded or transmitted. It can be recorded as...
than is outlined in paragraph 4.8.10 be given to subjects when, in the judgment of the IRB/IEC, 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 (see 4.8.12, 4.8.14), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials. Where the protocol indicates that prior consent of the trial subject or the subject's legally acceptable representative is not possible (see 4.8.15), the IRB/IEC 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). The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject.
According to ICH GCP (good clinical practice
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
) the IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified.
Problems with IRB review of social science
While the federal regulations and Belmont principles 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.There have been numerous complaints by investigators about the fit between the federal regulations and its IRB review requirements as they relate to social science research. 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' consent i.e., consent forms). Often these concerns are based on an IRB misunderstanding the social science and/or failing to apply the flexibility which is permitted in the regulatory framework. Social scientists have appropriately criticized biomedical IRBs for failing to adequately understand their research methods (such as ethnography). In 2003, OHRP, in conjunction with the Oral History Association
Oral History Association
The Oral History Association is a professional association for oral historians and others interested in oral history. It is based in the United States but has international membership. Its mission is "to bring together all persons interested in oral history as a way of collecting and interpreting...
and American Historical Association
American Historical Association
The American Historical Association is the oldest and largest society of historians and professors of history in the United States. Founded in 1884, the association promotes historical studies, the teaching of history, and the preservation of and access to historical materials...
, issued a formal statement that taking oral histories
Oral history
Oral history is the collection and study of historical information about individuals, families, important events, or everyday life using audiotapes, videotapes, or transcriptions of planned interviews...
, 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 federal agencies supporting social science have attempted to provide guidance in this area, especially the National Science Foundation. In general, the FAQ assures 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.
See also
- Clinical trialClinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
- Ethics CommitteeEthics Committee (European Union)The Ethics Committee, according to Directive 2001/20/EC, is an independent body in a Member State of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility it is to protect the rights, safety and well being of human subjects involved in a clinical...
(European UnionEuropean UnionThe European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
) - Human experimentation in the United StatesHuman experimentation in the United StatesThere have been numerous experiments performed on human test subjects in the United States that have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects....
- IRB: Ethics & Human ResearchIRB: Ethics & Human ResearchIRB: Ethics & Human Research is a peer reviewed academic journal covering bioethics in the United States. It is published six times each year by the Hastings Center in Garrison, New York since 1979. Karen J. Maschke is the current editor....
- Informed consentInformed consentInformed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
- Data Monitoring CommitteesData Monitoring CommitteesA Data Monitoring Committee — sometimes called a Data and Safety Monitoring Board — is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.- Need for a DMC :...
- Declaration of HelsinkiDeclaration of HelsinkiThe Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association . It is widely regarded as the cornerstone document of human research ethics...
- Office for human research protectionsOffice for human research protectionsThe Office for Human Research Protections is a small office within the United States Department of Health and Human Services that deals with ethical oversight of clinical research conducted by the department, mostly through the National Institutes of Health.The office's primary duty is the...
- Ethical problems using children in clinical trialsEthical problems using children in clinical trialsIn 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....
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchNational Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchNational Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape bioethics policy in the United States....
External links
- Office for Human Research Protections (OHRP) at HHS
- IRB: Ethics & Human Research – a peer-reviewed journal of The Hastings Center
- Drug Industry Human Testing Masks Death, Injury, Compliant FDA, Bloomberg News Special Report, November 2, 2005
- Ethics for Sale: For-profit ethical review, coming to a clinical trial near you, Carl Elliott and Trudo Lemmens, Slate, December 13, 2005
This article incorporates text from the U.S. Food and Drug Administration, which is in the public domain
Public domain
Works are in the public domain if the intellectual property rights have expired, if the intellectual property rights are forfeited, or if they are not covered by intellectual property rights at all...
.