AMITA HEALTH POLICY
TITLE: Institutional Review Board (IRB)
Initial Review
NUMBER: 203
EFFECTIVE
DATE: 10/1/2015
REVISION
DATE:
PAGE: 1 OF 7
PURPOSE
To describe the AMITA Health Institutional Review Board’s (IRB) initial review process
and define minimum criteria that must be met before research can be approved.
POLICY
1.
Definitions and Determination of Risks
1.1
Definition
1.1.1 Significant Risk (SR) in an investigational study is defined as one
that presents a potential for serious harm to the health, safety or
welfare of the subject.
1.1.2 Non-Significant Risk (NSR) is defined as one that does not pose
significant risk for serious harm to the health, safety or welfare of
the subject.
1.1.3 Minimal Risk: The probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves
than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or
tests. [45 CFR 46.102(i)
1.1.4 Minor modifications: Any change(s) to the study materials and/or
clarifications requested by the IRB that do not affect the IRB’s
assessment of risks and benefits to subjects.
Changes or
clarifications that would assist the IRB in its initial assessment of
risks and benefits to subjects are not considered minor.
1.1.5 Medical Device
1.1.5.1
A medical device is defined as a diagnostic or therapeutic
article that does not achieve its principal intended
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1.1.5.2
1.1.5.3
1.2
purpose through a chemical action or by being
metabolized within or on the body. Examples of medical
devices are: surgical lasers, sutures, pacemakers,
vascular grafts, intraocular lenses, orthopedic pins, and
diagnostic aids such as reagents and test kits for in-vitro
diagnosis of disease.
A Significant Risk (SR) device is defined as an
investigational medical device which presents a potential
for serious harm to the health, safety or welfare of the
subject, and (a) is intended as an implant used in
supporting or sustaining human life, or (b) is of
substantial importance in diagnosing, curing, mitigating or
treating disease, or (c) otherwise presents a potential for
serious harm to the health, safety or welfare of the
subject.
A Non-Significant Risk (NSR) medical device is defined
as a device that does not pose significant risk for serious
harm to the health, safety or welfare of the subject.
Determination of Risk
1.2.1 The sponsor initially assesses the risk level of a device or drug
study. The sponsor will provide the IRB an explanation of its
determination with supporting documentation, and any other
information that may assist the IRB in evaluating the risk of the
study.
1.2.2 If an investigator proposes the initiation of a claimed NSR
investigation to the IRB, and if the IRB agrees that the study is NSR
and approves the study, the investigation may begin at the
institution immediately.
1.2.3 If the IRB determines that an investigation for the use of a claimed
NSR study is of significant risk, it will notify the investigator and,
where appropriate, the sponsor.
2.
The IRB will conduct a full board review of all research involving more than
minimal risk to human subjects. Specifically, this will include all research not
described in the categories for exempt or expedited review [See related AMITA
Health policies, “Expedited Review” and “Exempt Review”]
3.
Minimal Criteria for Approval of Research
3.1
In order for a research project to be approved, the IRB must find that:
3.1.1 Risks to subjects are minimized. For example, the IRB evaluates
whether procedures to be performed on subjects are consistent
with sound research design and do not unnecessarily expose
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3.1.2
3.1.3
3.1.4
3.1.5
3.1.6
3.1.7
3.1.8
4.
subjects to risk, and whether they are already being performed 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
reasonably be expected to result. In evaluating risks and benefits,
the IRB should consider only those risks and benefits that may
result from the research (as distinguished from risks and benefits of
therapies subjects would receive even if not participating in the
research). The IRB should not consider possible long-range effects
of applying knowledge gained in the research (for example, the
possible effects of the research on public policy) as among those
research risks that fall within the purview of its responsibility.
Selection of subjects is equitable, taking into account the purposes
of the research study and the setting in which it will be conducted
and being particularly cognizant of the special problems of research
involving vulnerable populations.
Informed consent will be sought from each prospective subject or
the subject’s legally authorized representative, in accordance with,
and to the extent required by appropriate state and federal
regulations. [See related AMITA Health policy “Informed Consent”]
Informed consent will be appropriately documented as required by
state and federal regulations.
When appropriate, the research study makes adequate provision
for monitoring the data collected to ensure the safety of subjects.
When appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
Appropriate additional safeguards have been included to protect
the rights and welfare of subjects who are likely to be vulnerable to
coercion or undue influence (e.g., children, prisoners, pregnant
women, mentally disabled persons, or economically or
educationally disadvantaged persons).
Additional Criteria for Approval of Research Involving Children
4.1
The IRB may approve a research study involving children only if it falls into
one of the following four categories:
4.1.1 Research involving no greater than minimal risk;
4.1.2 Research involving greater than minimal risk but presenting the
prospect of direct benefit to an individual subject, provided that the
risk is justified by the anticipated benefit to the subject and the
relationship of risk to the anticipated benefit is at least as favorable
to the subject as that presented by available alternative
approaches;
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4.2
5.
4.1.3 Research involving more than minimal risk with no prospect of
direct benefit for the individual subject, including a monitoring
procedure that is not likely to contribute to the well-being of the
subject, provided that the risk represents a minor increase over
minimal risk, the intervention or procedure presents experiences to
subjects that are reasonably commensurate with those inherent in
their actual or expected medical, dental, psychological, social, or
educational situations, and the intervention or procedure is likely to
yield generalizable knowledge about the subject’s disorder or
condition that is of vital importance for the understanding or
amelioration of the subject’s disorder or condition; or
4.1.4 Research that is not otherwise approvable but which presents an
opportunity to understand, prevent, or alleviate a serious problem
affecting the health or welfare of children and the Secretary of the
Department of Health and Human Services (only required if the
study is directly or indirectly funded by DHHS) and/or the FDA
Commissioner (if applicable) determines that the research in fact
satisfies one of the three conditions above or that the research
presents a reasonable opportunity to understand, prevent, or
alleviate a serious problem affecting the health or welfare of
children and the research will be conducted in accordance with
sound ethical principles.
In addition, the study must include adequate provisions for soliciting the
assent of children and the permission of their parents (or legally
authorized representative). [See related AMITA Health policies “Informed
Consent” and “Assent”]
Primary Reviewer System
5.1
This policy authorizes the use of a “Primary Reviewer System.” Under this
system, studies will be assigned in advance to two IRB members who
shall conduct a full review of all materials. Primary reviewers shall
receive:
5.1.1 Full protocol;
5.1.2 Proposed informed consent document;
5.1.3 IRB application
5.1.4 Any relevant grant applications(s);
5.1.5 Investigator brochure or Instructions for Use (if one exists); and
5.1.6 Any recruitment materials, including advertisements and websites
intended to be seen or heard by potential subjects.
5.2
Members who are not assigned primary reviewer responsibility will
receive, at a minimum:
5.2.1 Protocol summary;
5.2.2 Proposed informed consent document; and
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5.3
5.4
5.2.3 Any recruitment materials, including advertisements and websites
intended to be seen or heard by potential subjects.
Complete documentation will be available to all IRB members upon
request.
At the next convened IRB meeting, the primary reviewers will present their
findings, and after a discussion by all IRB members, a vote will be taken.
[See “IRB Voting” policy]
6.
Physicians wishing to perform clinical investigations of drugs or devices, or
wishing to perform behavioral research within AMITA Health must submit an
initial application (See Application to Conduct Clinical Investigation at AMITA
Health form) to the IRB along with the following supplementary material:
6.1
The name of the principal investigator and current curricula vitae (CV) or
other document describing the investigator’s professional qualifications to
perform the research.
6.2
A list of all proposed sub-investigators and their CVs.
6.3
A copy of the investigative protocol complete with background information
on any animal or human studies demonstrating safety and efficacy of the
product, the proposed investigation, attendant laboratory, radiologic and
other diagnostic procedures involved in the use of the investigative drug or
device, and any known adverse reactions or side effects to the use of the
device or product or from participation in the behavioral research.
6.4
A copy of the proposed Informed Consent document.
6.5
A completed copy of the Informed Consent Element Checklist
6.6
Any relevant grant application(s).
6.7
Investigator Brochure (if available) or Instructions for Use (if one exists).
6.8
Any recruitment materials, including advertisements and websites
intended to be seen or heard by potential subjects.
7.
All members of the research team as listed on the application who are involved in
the design, conduct, or reporting of the research are required to complete training
in human subject protections. Certificates or other evidence of completion of
training must be submitted before final approval by the IRB. The following
websites are potential resources to fulfill this requirement:
NIH (National Institute of Health):
http://cancer.gov/clinicaltrials/learning/page2 (Protecting Human Research
Participants)
The Collaborative Institutional Training Initiative website:
https://www.citiprogram.org/ (Human Subjects Research Basic Course:
Biomedical Module or Social-Behavioral-Educational Module)
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Note that there may be additional requirements from research sponsors,
institutions or other regulatory bodies.
8.
The primary investigator (or his/her physician alternate) may be required to be
present at the meeting to discuss the protocol and answer committee members’
questions.
9.
Notice of Decision. The IRB may take any of the following actions:
8.1. Approve
8.2
Approve with Minor Modifications
8.3
Table
8.4
Disapprove
10.
All IRB decisions will be documented in the meeting minutes in accordance with
the IRB Recordkeeping policy. The AMITA Health IRB signatory official will be
provided with minutes of all IRB meetings.
11.
The IRB may not approve a research study for more than one year. However, at
the time of initial review or during any continuing review period the IRB can set a
more frequent review interval for any study that it determines warrants more
frequent review. Such determinations may be based on the initial risk and
benefit factors, the investigator’s experience, and new findings, knowledge or
adverse effects that come to light during the course of the study.
PROCEDURE
A.
Investigators must submit a completed “Application to Conduct Clinical
Investigation at AMITA Health” form along with the protocol, the informed
consent document and any other documents requested, to the IRB Coordinator
for submission to the IRB.
B.
It is the IRB Coordinator’s responsibility to provide all applicable documentation
to IRB members in accordance with section 5, above. The documentation must
be forwarded significantly in advance of the meeting to allow for adequate
review.
C.
The IRB Coordinator will document all IRB decisions and deliberations in the
meeting minutes in accordance with the AMITA Health Recordkeeping policy and
forward a copy to the IRB signatory official of AMITA Health.
References:
A. 45 CFR 46.111
B. 21 CFR 56.108, 56.111
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Documentation (Documents & Forms):
A. Application to Conduct Clinical Investigation at AMITA Health
Other Related Policy/Procedures:
A. Expedited Review
B. Exempt Review
C. Informed Consent
D. Assent
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