CRITERIA FOR IRB APPROVAL OF RESEARCH
45
CFR 46.111 and 21
CFR 56.111
POINTS TO CONSIDER
RISKS
TO SUBJECTS ARE MINIMIZED
(a)(1) 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.
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Have the rationale and basis for the study hypothesis
been provided in the background information?
-
Has the research been preceded by adequate laboratory
and/or animal studies?
-
Are the design of the research and the proposed research
procedures adequate to answer the research questions
posed?
- Can
data from procedures or tests being performed for diagnostic
or treatment purposes be used in lieu of procedures
or tests being performed solely for research purposes?
-
Could procedures that involve less risk be used to answer
the research question?
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Is the sample size (number of subjects) adequate?
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Is the method proposed for selecting and assigning subjects
to treatment groups unbiased?
-
Are the study endpoints and methods of data analysis
appropriate for the study?
RISK/BENEFIT
RATIO
(a)(2) 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.
-
What are the anticipated physical, psychological, social,
legal, or economic risks to individual subjects?
-
What are the potential benefits, if any, to individual
subjects?
-
What information is likely to result from the research
and what impact, if any, will the information have on
furthering the understanding of human physiology or
diagnosis or treatment of the disease or condition being
studied?
-
Are there any groups of people who might be more susceptible
to the risks presented by the study and who therefore
ought to be excluded from the research? Are the procedures
for identifying such individuals adequate?
-
Are there adequate plans to exclude subjects who are
vulnerable to injury during the period of withdrawal
of active and effective therapy, if that is part of
the research design?
EQUITABLE
SELECTION OF SUBJECTS
(a)(3) Selection of subjects is equitable.
-
Does the nature of the research require or justify using
the proposed study population?
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Will the solicitation of subjects avoid placing a disproportionate
share of the risks and discomfort as well as inconvenience
of the research on any single group of individuals?
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Are women of childbearing potential eligible for participation
or, if not eligible, has their exclusion been justified?
-
Has the selection process overprotected potential subjects
who are considered vulnerable so that they are denied
opportunities to participate in research?
-
Are any payments to subjects reasonable, based upon
the complexities and inconveniences of the study and
the particular subject population?
INFORMED
CONSENT PROCESS
(a)(4) 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 45
CFR 46.116 and 21
CFR 50.25.
-
Who will be explaining the research to potential subjects?
Should the principal investigator or physician co-investigators
be required to obtain consent? Should someone in addition
to or other than the investigator be involved in the
consent process (e.g., subject advocate)?
-
Does the investigator serve a dual role that may pose
a conflict of interest?
-
Will the consent process take place under conditions
most likely to provide potential subjects an opportunity
to make a decision about participation without undue
pressure?
DOCUMENTATION
OF INFORMED CONSENT
(a)(5) Informed consent will be appropriately documented,
in accordance with, and to the extent required by 45 CFR
46.117 and 21 CFR 50.27.
-
Are the language and presentation of the information
to be conveyed appropriate to the subject population,
taking into consideration the reading level, use of
complex sentence structure and use of technical terms
as well as the need for translation into languages other
than English?
-
Do the consent documents describe the study design (including
plans for randomization, use of placebos, and the probability
that the subject will receive a given treatment) and
conditions for breaking the code (if the study is masked)?
-
Do the consent documents describe the risks and benefits
of each of the proposed interventions and alternative
courses of action available to the participants?
-
Do the consent documents clearly describe the extent
to which participation in the study precludes other
therapeutic interventions?
DATA
AND SAFETY MONITORING
(a)(6) When appropriate, the research plan makes adequate
provision for monitoring the data collected to ensure
the safety of subjects.
-
How will the trial be monitored? Is the plan appropriate
given the risks, size, type and complexity of the trial?
- How
will decisions about stopping the trial be made? By
whom? On what basis?
PRIVACY
AND CONFIDENTIALITY PROTECTIONS
(a)(7) When appropriate, there are adequate provisions
to protect the privacy of subjects and to maintain the
confidentiality of data.
-
Do the methods for recruiting and consenting subjects
adequately protect their privacy?
-
Are study related discussions or interviews conducted
in a private setting?
-
If the investigator wants to review existing records
to select subjects for further study, are subjects recruited
through their physician or health care provider involved
in their care?
-
Will the investigator(s) be collecting sensitive information
about individuals (e.g., related to sexual practices,
substance abuse, or illegal behavior)? If so, have they
made adequate provisions for protecting the confidentiality
of the data through coding, destruction of identifying
information, limiting access to the data, or whatever
methods that may be appropriate to the study?
-
If the information obtained about subjects might interest
law enforcement or other government agencies to the
extent that they might demand personally identifiable
information, should a certificate of confidentiality
be sought from a federal or state agency to protect
the research data and the identity of the subjects from
subpoena or other legal process?
-
Are there adequate plans to protect participants from
the risks of breach of confidentiality and invasion
of privacy? If the protocol involves an epidemiologic
study, will subjects or their relatives be protected
from learning inappropriate information?
VULNERABLE
POPULATIONS (Refer to policy)
(b) When some or all of the subjects are likely to be
vulnerable to coercion or undue influence, such as children,
prisoners, pregnant women, mentally disabled persons,
or economically or educationally disadvantaged persons,
additional safeguards have been included in the study
to protect the rights and welfare of these subjects.
CLINICAL
INVESTIGATIONS OF DRUGS OR BIOLOGICAL PRODUCTS, OR MEDICAL
DEVICES
-
Is the research being conducted under an IND? If not,
is an IND required? (Refer to IND policy)
-
Is the research being conducted under an IDE? If not,
is an IDE required, i.e., is this a significant risk
device study or a nonsignificant risk device study?
(Refer to IDE Policy)
-
Is this being conducted under a sponsor-investigator
IND/IDE? If so, Partners
Quality Improvement Program must meet with investigator
to review responsibilities of IND/IDE holders, if they
have not already done so.
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