1An 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 humans 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.
1 U.S. mandate
2 Naming and composition
3 Purpose and use
5 Problems with IRB review of social science
6 See also
8 External links
 U.S. mandateSee also: Human subject research legislation in the
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 1974, 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 applications.
 ExemptionsWhile 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
1. Research conducted in established or commonly accepted educational
settings, involving normal educational practices, such as
1.research on regular and special education instructional strategies, or
2.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:
1.information obtained is recorded in such a manner that human subjects can
be identified, directly or through identifiers linked to the subjects; and
2.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:
1.the human subjects are elected or appointed public officials or candidates
for public office;
2.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:
1.public benefit or service programs;
2.procedures for obtaining benefits or services under those programs;
3.possible changes in or alternatives to those programs or procedures; or
4.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 compositionAlthough "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
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.
(a)1 The IRB must have at least five members.
(a)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.
(a)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
(b)1 The IRB should include both men and women, as long as they aren't
chosen specifically for their gender.
(b)2 The members of the IRB must not be all of the same profession.
(c) The IRB must include at least one scientist and at least one non-
scientist. These terms are not defined in the regulations.
(d) 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."
(e) IRB members may not vote on their own projects.
(f) The IRB may include consultants in their discussions to meet
requirements for expertise or diversity, but only actual IRB members may
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 useIRBs 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 devices,
they may be studies of personal or social behavior, opinions or attitudes,
or they may be 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.
 ResponsibilitiesAccording to ICH-GCP 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:
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 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.
 Problems with IRB review of social scienceWhile 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 times 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.
 See alsoClinical trial
Ethics Committee (European Union)
Human experimentation in the United States
IRB: Ethics & Human Research
Data Monitoring Committees
Declaration of Helsinki
Office for human research protections
Ethical problems using children in clinical trials
National Commission for the Protection of Human Subjects of Biomedical and
 References1.^ 
2.^ See 7 C.F.R. § 1c.101
3.^ "PART 56 - INSTITUTIONAL REVIEW BOARDS". Food and Drug Administration (
United States). 28 June 1991. http://cfr.vlex.com/vid/56-107-irb-membership-19703309. Retrieved 2009-05-12.
4.^ Ritchie, Don; Shopes, Linda (2003). Oral History Excluded from IRB
Review: Application of the Department of Health and Human Services
Regulations for the Protection of Human Subjects at 45 CFR Part 46, Subpart
A to Oral History Interviewing. Oral History Association. Archived from the
original on 17 January 2008. http://web.archive.org/web/20080117043701/http://alpha.dickinson.edu/oha/org_irb.html. Retrieved 31 December 2008 . See also An Update on the Exclusion of Oral History from IRB Review (March 2004).
5.^ Frequently Asked Questions
 Thaddeus Mason Pope, "Multi-Institutional Healthcare Ethics Committees:
The Procedurally Fair Internal Dispute Resolution Mechanism," 31 Campbell
Law Review 257-331 (2009).
 External linksOffice for Human Research Protections (OHRP) at HHS
IRB: Ethics & Human Research – a peer-reviewed journal of The Hastings
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.
2Frequently Asked Questions About the IRB:
The following is a compilation of questions frequently asked regarding
Institutional Review Boards, human subject protection and compliance with
federal regulations. These questions are organized according to whether they
I. Institutional Review Board regulations;
II. Informed Consent regulations;
III. Clinical investigations involving drugs;
IV. Clinical investigations involving medical devices; and
I. INSTITUTIONAL REVIEW BOARD REGULATIONS:
What is an Institutional Review Board (IRB)?
An IRB is a board, committee, or other group formally designated by an
institution to review, to approve the initiation of, and to conduct
continuing review of biomedical research involving human subjects in
accordance with FDA regulations. An IRB has the authority to approve,
require modifications in (to secure approval), or disapprove this research.
The purpose of IRB review is to assure that:
Risks to subjects are minimized: (i) by using procedures which are
consistent with sound research design and which do not unnecessarily expose
subjects to risk, and (ii) whenever appropriate, by using procedures already
being performed on the subjects for diagnostic or treatment purposes.
Risks to subjects are reasonable in relation to anticipated benefits, if any
, to subjects and the importance of the knowledge that may be expected to
Selection of subjects is equitable.
Informed consent will be sought from each prospective subject or the subject
's legally authorized representative and will be documented in accordance
with, and to the extent required, by FDA's informed consent regulations.
Where appropriate, the research plan makes adequate provision for monitoring
the data collected to ensure the safety of subjects.
There are adequate provisions to protect the privacy of subjects and to
maintain the confidentiality of data.
Appropriate additional safeguards have been included in the study to protect
the rights and welfare of subjects who are members of a particularly
Do IRBs have to be formally called by that name?
No, IRB is a generic term used to describe a committee whose function is to
review research and to assure the protection of the rights and welfare of
the human subjects in accordance with FDA regulations. Each institution may
use whatever name it chooses; regardless of the name chosen, the committee
is subject to the FDA IRB regulations when the use of FDA regulated products
is reviewed and approved.
Whom can an IRB contact to determine whether an investigational new drug
application or investigational device exemption (IND or IDE) is required for
a study of a drug or device?
For clinical investigations involving a drug, the IRB can contact the
Document Management and Reporting Branch, Center for Drug Evaluation and
Research (CDER), (301) 443-4320; for a biological product, the Division of
Biological Investigational New Drugs, Office of Biologic Research and Review
, Center for Biologic Evaluation and Research (CBER), (301) 443-4864; and
for a medical device, the Office of Device Evaluation, Center for Devices '
and Radiological Health (CDRH), (301) 427-8162. If the IRB is unsure about
whether a test article is a "drug" or a "device," the IRB may contact the
Office of Health Affairs, (301) 443-1382.
May a clinical investigator be an IRB member?
Yes. However, the IRB regulations (21 CFR 56.107(e)) prohibit any member
from participating in the IRB's initial or continuing review of any project
in which the member has a conflicting interest, except to provide
information requested by the IR-B.
The IRB regulations require an IRB to have a diverse membership; can one
member satisfy more than one membership category?
Yes. For example, one member could be female, otherwise unaffiliated with
the institution, and with a primary concern in a non-scientific area. This
individual would satisfy three of the membership requirements of the
regulations if there is a male member on the committee.
Must an institution conducting research involving human subjects establish
its own IRB?
No. Although IRBs frequently exist in an institution which conducts research
involving human subjects, this is not required by FDA regulations.
Generally, however, institutions engaged in research involving human
subjects will have their own IRBs to review that research conducted on the
premises or elsewhere by the staff of the institution.
Can a hospital IRB review a study that will be conducted outside of the
Yes. Although a hospital IRB is not required to review studies conducted
outside the jurisdiction of its institution, the IRB may choose to do so
with the institution's approval.
Can IRB members be paid for their services?
The regulations do not discuss payment of IRB members. There is nothing in
FDA regulations to preclude a member from being compensated for review
services rendered, for example as a consultation fee. Travel expenses may
also be reimbursed.
What is the FDA role in IRB liability in malpractice suits?
As discussed in the preamble to the FDA IRB regulations (46 FR 8961), FDA
regulations do not address the question of IRB or institutional liability in
the case of malpractice suits. Moreover, FDA does not have the authority to
grant limited liability to IRBs or their members.
What happens during an FDA inspection of an IRB?
FDA field investigators interview institutional officials and examine the
IRB's records to determine whether the IRB is in conformance with FDA
regulations. See the information sheet entitled: "FDA Institutional Review
Board Inspections" for a complete description of the inspectional process.
The FDA IRB regulations exempt emergency use of a test article from
prospective IRB review "... provided that such emergency use is reported to
the IRB within five working days. Any subsequent use of the test article at
the institution is subject to IRB review." (Section 56.104) What does "
subsequent use" mean?
Under this provision, in an emergency, that is, in a situation in which use
of a test article at an institution was not foreseeable, an investigator may
administer the required course of treatment for the investigational drug to
one patient without prospective IRB review, provided that use is reported
to the IRB within 5 days. Any use of the same drug in another patient in the
institution would be considered a "subsequent use" and be subject to
prospective IRB review.
An investigational drug may be administered by sever al investigators in an
institution under this emergency use provision, without an individual
investigator knowing that the drug had previously been administered in the
institution under the emergency use provision. If an IRB, during
retrospective review, finds that a given test article is used in justifiable
emergency situations by several investigators, or if further justifiable
emergency situations are anticipated, the IRB should request that a protocol
be developed for prospective IRB review, listing all investigators who may
use the article in the institution in the future. By reviewing and approving
this protocol prospectively, subsequent use of the test article would not
be subject to the emergency use provision for those investigators.
What is expedited review?
Expedited review is a procedure through which certain kinds of research may
be reviewed and approved without convening the full IRB. The FDA IRB
regulations (21 CFR 56.110) permit, but do not require, an IRB to review
certain categories of research, which appear on a list published in the
Federal Register on January 27, 1981 (46 CFR 8980), through an expedited
procedure if the research involves no more than minimal risk. The IRB may
also use the expedited review procedure to review minor changes in
previously approved research during the period covered by the original
approval. Under an expedited review procedure, review of research may be
carried out by the IRB chairperson or by one or more experienced members of
the IRB designated by the chairperson. Reviewers may exercise all the
authorities of the IRB except that they may not disapprove the research.
Research can only be disapproved following review by the full committee. The
IRB is also required to adopt a method of keeping all members-advised of
research proposals which have been approved through the expedited review
Section 56.115(a)(1) requires that the IRB maintain copies of "research
proposals reviewed." Is the "research proposal" the same as the formal study
protocol which the investigator receives from the sponsor of the research?
Some institutions only require the investigator to submit the formal study
protocol for review. Others require the investigator to submit an
institutionally-developed form which, when completed, provides the IRB with
all of the information it needs to review the study. Still others require
some variation or combination of the above. At least one member of the IRB
must review the entire protocol. Others may receive a summary form, but the
complete protocol must be available to them on request. Regardless of the
system used, the IRB must receive sufficient information upon which to base
approval/disapproval of the study (see the criteria for IRB approval in 21
CFR 56.111). Copies of all information reviewed are to be maintained for at
least three years after completion of the research.
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II. INFORMED CONSENT REGULATIONS:
Is the purpose of the IRB review and of informed consent to protect the
institution or the subject?
The fundamental purpose of IRB review and of informed consent is to assure
that the rights and welfare of subjects are protected. A signed informed
consent form is evidence that the information contained in the form has been
provided to a prospective subject. IRB review of the form to ensure that
the subject is given adequate information concerning the study serves a dual
function--protection of the subject and documentation that the institution
complied with applicable regulations.
Is getting the subject to sign a consent form all that is required by the
informed consent regulations?
No. The consent form itself is merely an aid to ensuring that adequate
information is provided to the subject. The signed consent form provides
documentation of a subject's consent to participate in a study. The entire
informed consent process involves giving a subject adequate information
concerning the study, providing adequate opportunity for the subject to
consider all options, responding to the subject's questions, ensuring that
the subject has comprehended this information, and, finally, obtaining the
subject's voluntary consent to participate. To be effective, the process
must provide an opportunity for the investigator and the subject to exchange
information and ask questions. The consent form, therefore, is not an end
point; it is one step in this communicative process.
Section 50.27(a) of the FDA informed consent regulation requires a copy of
the consent form to be given to the person signing the form. Does this copy
have to be a photostat of the form with the subject's signature affixed?
No. The copy of the form given to the subject need not be a copy of the
signed form, but may be a copy of the form given to the subject to sign. The
purpose of providing the person signing the form with a copy of the consent
form (21 CFR 50.27(a)) and with a copy of the written summary of the
information presented in the case of a "short form" (21 CFR 50.27(b)(2)) is
to allow the subject continuing access to the information provided.
If an IRB uses a "fill-in-the-blank" consent form, does the IRB need to
review the filled out form for each study?
Yes. A fill-in-the-blank form provides only a format for presenting the
relevant study information to the subject. The IRB must review a completed
sahiple form, individualized for each study, to ensure that the consent form
, in its entirety, contains all the information required by 21 CFR50.25 in
language the subject can understand. Many IRBs reprocess or retype the
completed form to enhance its readability by the subjects. The form finally
approved by the IRB should be an exact copy of the form that will be
presented to the research subject. The IRB must also review the "process" of
informed consent, e.g., the circumstances under which consent will be
The informed consent regulations (Section 50.25 (a)(5)) require the consent
form to include a statement describing the extent, if any, to which
confidentiality of records identifying the subject will be maintained and to
note the possibility that FDA may inspect the records. Is the statement
concerning FDA access to records a waiver of the subject's legal right to
No. FDA does not require any subject to "waive" a legal right. Rather, FDA
requires that subjects be informed that the "legal right" to complete
privacy does not apply in the context of research involving FDA regulated
products. Under the authority of the Federal Food, Drug, and Cosmetic Act,
FDA can inspect and copy clinical records in order to verify information
submitted by a sponsor. Ordinarily it is not necessary that a subject's name
be revealed to the FDA investigator unless a more detailed study of the
case is required or there is reason to believe that the records do not
represent the actual cases studied or results obtained. When an individually
identifiable medical record is copied and reviewed by the Agency, the
record is properly safeguarded within FDA and is used or disseminated under
conditions that protect the privacy of the individual consistent with laws
relating to public disclosure of information and the law enforcement
responsibilities of the Agency. It should be noted that the records referred
to are not those usually kept by the IRB.
Does an IRB or institution have to compensate subjects if injury occurs as a
result of participation in a research project?
No. The FDA informed consent regulation (21 CFR 50.25(a)(6)) requires that
for research involving more than minimal risk, the subject must be told
whether any compensation and any medical treatments are available if injury
occurs and, if so, what they consist of, or where further information may be
obtained. Institutional policy, not FDA regulations, determines whether
compensation and medical treatments will be offered and the conditions that
might be placed on subject eligibility for compensation or treatments.
Can an IRB require that the sponsor of the study and/or the clinical
investigator study's be identified on the study's consent form?
Yes. The FDA requirements for informed consent are the minimum basic
elements of informed consent that must be presented to a research subject (
21 CFR 50.25). An IRB can require that any additional information be
provided which it considers important to a subject's decision to participate
in a research study.
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III. CLINICAL INVESTIGATIONS INVOLVING DRUGS
Does a physician conducting a clinical investigation of an investigational
drug in a private practice need to obtain IRB approval?
Yes. The regulations require that an IRB approve any clinical investigation
of an investigational drug, whether or not it involves institutionalized
subjects. The private practitioner may seek this approval from a hospital
IRB where he or she may have staff privileges, from an independent IRB, or
from an IRB established by the sponsor to review the study. (For further
information see the information sheet entitled: "Clinical Investigators
Unaffiliated with an Institution with an IRB".)
Does a treatment IND under 21 CFR 312.34 require prior IRB approval?
Ordinarily yes. However, if an emergency exists, as defined by 21 CFR 56.102
(d), the procedures described in 56.104(c) can be followed. In addition, the
sponsor or sponsor/investigator may request a waiver of the IRB
requirements in accord with 21 CPR 56.105. (For further information see the
information sheets entitled: "Emergency Use of an Investigational Drug," "
Waiver of IRB Requirements," and "Treatment INDs.")
Does a clinical investigation involving a marketed product require IRB
review and approval?
Yes. See the information sheet entitled "Investigational Use of Marketed
Products" for more information.
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IV. CLINICAL INVESTIGATIONS INVOLVING MEDICAL DEVICES
What is a medical device?
A medical device is any instrument, apparatus, or other similar or related
article, including component., part, or accessory, which is:
recognized in the official National Formulary, or the United States
Pharmacopeia, or any supplement to them;
intended for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or other
intended to affect the structure of any function of the body of man or other
does not achieve any of its principal intended purposes through chemical
action within or on the body of man or other animals and is not dependent
upon being metabolized for the achievement of its principal intended
Approximately 1,700 types of medical devices are regulated by FDA. The range
of devices is broad and diverse, including bandages, thermometers, ECG
electrodes, IUDS, cardiac pacemakers, and hemodialysis machines. (For
further information, see the information sheet entitled: "IRBs and Medical
Are in vitro diagnostic products drugs or devices?
The definition of a "device" includes all in vitro diagnostic products--
devices that aid in the diagnosis of disease by using human or animal
components to cause chemical reactions, fermentation, and the like. Some
medical devices are intended for use in the diagnosis of conditions other
than disease. An example of this would be a device used to diagnose
Can a committee established to review intraocular lens (IOL) studies review
research involving other FDA regulated products?
Yes. As long as the committee meets the membership and procedural
requirements of the FDA regulations (21 CFR 56), it can review any study
involving an FDA-regulated product.
What are the IRB's general obligations towards IOL clinical investigations?
An IRB is responsible for the initial and continuing review of all IOL
clinical investigations conducted at its institution. Each individual IOL
style is subject to independent review by the IRB. However, this does not
preclude the IRB from using prior experience with other IOL investigations
in considering the comparative merits of a new lens style. All IOL studies
are also subject to FDA approval. No investigational IOL may be in clinical
use in an institution without IRB review and approval.
Considering the large number of IOLs under investigation, how does an IRB
approach the review of a new IOL style?
The IRB is responsible for ensuring that the rights, health, and welfare of
subjects are protected. FDA recognizes that the IRB's determination of the
risks and benefits of IOLs is complicated by the large number and complexity
of lens styles under investigation. In addition, investigations of IOLs
utilize a two phase approach called the core and adjunct phases which are
subject to differing levels of control. The core phase is a typical well
controlled study, while the adjunct phase is a minimally controlled,
expanded distribution of lenses. A modified core phase is replacing the
adjunct phase, which is being eliminated.
Full IRB review is required for all new IOLs that exhibit major departures
from available lenses. Minor changes to existing lenses can be approved
through expedited review. FDA designates new IOL styles as either major or
minor changes based upon a predetermined classification scheme and advises
the sponsor of its determination. The sponsor, through the investigator,
must provide the IRB with the investigational plan which designates the FDA
study requirements, i.e., full versus expedited review, core versus adjunct
phase, as well as the informed consent form and other comparative
information on the proposed lens which describes its characteristics. It is
the IRB's prerogative to request any relevant information on a new IOL in
order to arrive at a decision or to be more rigorous in its evaluation than
FDA considers minimally required.
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What is a "general assurance"? Is it required by FDA?
The term "general assurance" is now referred to as a "multiple project
assurance"; a "multiple project assurance" is an assurance issued in
accordance with Department of Health and Human Services (HHS) regulations on
or after January 26, 1981. HHS regulations require a written assurance from
an institution that for research involving human subjects conducted by HHS
or supported in whole or in part by HHS (e.g., by grant, contract,
cooperative agreement, or fellowship) the institution will comply with the
HHS protection of human subjects regulations (45 CFR 46). The assurance
mechanism is described in 45 CFR 46.103. Once an institution's assurance has
been received by the Department, an assurance number is assigned to the
institution. The assurance may be for a single project or for multiple
projects; multiple project assurances which have been accepted are published
in a cumulative list. The Office for Protection from Research Risks,
National Institutes of Health, is responsible for implementing the HHS
regulations. Its address and telephone number are: 9000 Rockville Pike,
Bethesda, MD 20205; (301) 496-7005. FDA regulations (21 CFR 50 and 56) apply
to research involving products regulated by FDA--federal funds do not need
to be involved for the FDA regulations to apply. Although the HES (45 CFR 46
) and FDA regulations (21 CFR 50 and 56) are very similar (see the
information sheet entitled: "Significant Differences in HHS and FDA
Regulations for IRBs and Informed Consent"), FDA regulations do not require
an assurance. However, when research involving products regulated by the
Agency is funded by HHS, an institution would need to comply with both the
NHHS and FDA regulations.
Does an IRB need to register with FDA?
Currently, FDA does not require registration.
【在 s**********8 的大作中提到】
: Frequently Asked Questions About the IRB:
: The following is a compilation of questions frequently asked regarding
: Institutional Review Boards, human subject protection and compliance with
: federal regulations. These questions are organized according to whether they
: pertain to:
: I. Institutional Review Board regulations;
: II. Informed Consent regulations;
: III. Clinical investigations involving drugs;
: IV. Clinical investigations involving medical devices; and
: V. Other