Suffolk University
Office of Research and Sponsored Programs
Reviewer Name:
Institutional Review Board
Reviewer Worksheet
Date:
Protocol Number:
Protocol Title:
Principal Investigator:
Co-Investigator:
Is this a full board or expedited review (Determination Made BY Chair and/or designated OHRP staff)?
If Full, go to Part 2
☐Full
If Expedited, go to Part I
☐Expedited
PART 1: §46.111Criteria for an Expedited Review
§46.110(b)(1) An IRB may use the expedited review procedure to review research if it determines the following:
1. Does the research present no more than minimal risk to subjects?
If YES continue.
If NO STOP; cannot be reviewed via expedited review.
☐Yes
☐No
2. Can the identification of subjects and/or their responses reasonably place them at risk of
criminal or civil liability or damage the subject’s financial standing, employability,
insurability, reputation, or be stigmatizing?
If YES 2.1.
If NO skip to 3.
2.1 Will reasonable and appropriate protections be implemented so that the risk of
invasion of privacy and breach of confidentiality are no greater than minimal?
If YES continue.
If NO  STOP; cannot be reviewed via expedited review.
3. Is the research classified?
If NO continue.
If YES STOP; cannot be reviewed via expedited review.
☐Yes
☐No
4. Does the research involve only procedures listed in one or more of the following
categories?
If YES check applicable categories.
If NO STOP; the research cannot be approved via expedited review
☐Yes
☐No
☐Yes
☐No
☐Yes
☐No
Categories (1) through (7) pertain to both initial and continuing review.
☐
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
☐(a) Research on drugs for which an investigational new drug application (21 CFR Part 312)
is not required. (Note: Research on marketed drugs that significantly increases the risks or
decreases the acceptability of the risks associated with the use of the product is not eligible for
expedited review.)
☐(b) Research on medical devices for which an investigational device exemption application
(21 CFR Part 812) is not required; or the medical device is cleared/approved for marketing
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Office of Research and Sponsored Programs
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and the medical device is being used in accordance with its cleared/approved labeling.
☐
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
☐(a) From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects,
the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur
more frequently than 2 times per week; or
☐(b) From other adults and children, considering the age, weight, and health of the subjects,
the collection procedure, the amount of blood to be collected, and the frequency with which it
will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or
3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times
per week.
☐
3. Prospective collection of biological specimens for research purposes by noninvasive means.
☐
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited
review, including studies of cleared medical devices for new indications.)
☐
5. Research involving materials (data, documents, records, or specimens) that have been collected, or
will be collected solely for non-research purposes (such as medical treatment or diagnosis)
☐
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
☐
7. Research on individual or group characteristics or behavior (including, but not limited to, research
on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices,
and social behavior) or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies.
☐
8. Continuing review of research previously approved by the convened IRB as follows:
☐(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all
subjects have completed all research-related interventions; and (iii) the research remains
active only for long-term follow-up of subjects; or
☐(b) where no subjects have been enrolled and no additional risks have been identified; or
☐(c) where the remaining research activities are limited to data analysis.
☐
9. Continuing review of research, not conducted under an investigational new drug application or
investigational device exemption where categories two (2) through eight (8) do not apply but the IRB
has determined and documented at a convened meeting that the research involves no greater than
minimal risk and no additional risks have been identified.
DOES THE PROJECT MEET THE CRITERA FOR EXPEDITED REVIEW?
If Yes  What categories
If Yes or No  please continue onto PART 2.
If No, please notify the ORSP and Chair that it needs to go to the full board.
Protocol Specific Comments:
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PART 2: §46.111 Criteria for IRB Approval of Research.
In order to approve research covered by this policy the IRB shall determine that all of the following requirements
are satisfied. NOTE: If any of the responses is “NO” the study cannot be approved.
(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.
Protocol Specific Comments:
☐Yes
☐No
☐N/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. 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.
Protocol Specific Comments:
☐Yes
☐No
☐N/A
(3) Selection of subjects is equitable. In making this assessment the IRB should take into
account the purposes of the research and the setting in which the research will be
conducted and should be particularly cognizant of the special problems of research
involving vulnerable populations, such as children, prisoners, pregnant women, mentally
disabled persons, or economically or educationally disadvantaged persons.
Protocol Specific Comments:
(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 §46.116. If
waived, please complete waiver worksheet.
Protocol Specific Comments:
5) Informed consent will be appropriately documented, in accordance with, and to the
extent required by §46.117. If waived, please complete waiver worksheet.
☐Yes
☐No
☐N/A
☐Yes
☐No
☐N/A
☐Yes
☐No
☐N/A
Protocol Specific Comments:
(6) When appropriate, the research plan makes adequate provision for monitoring the data
collected to ensure the safety of subjects.
☐Yes
☐No
☐N/A
Protocol Specific Comments:
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and
to maintain the confidentiality of data.
☐Yes
☐No
☐N/A
Protocol Specific Comments:
(8) §46.111(b) When some or all of the subjects are likely to be vulnerable to coercion or
undue influence, such as Suffolk University students, 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.
Protocol Specific Comments:
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☐Yes
☐No
☐N/A
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Are criteria for IRB Approval satisfied (i.e., only yes’s or NA’s checked) ?
☐Yes
☐No
Protocol Specific Comments:
§46.116 General Requirements of Informed Consent (IC)
IC1a. Investigator will obtain the legally effective informed consent of each prospective
subject or subject’s legally authorized representative (LAR).
If “Yes” continue to IC1b.
☐Yes
☐No
☐Requesting
Waiver
If “No” and not requesting a waiver of informed consent stop here. The protocol cannot be
approved.
If Requesting a Waiver of informed consent, did the investigators submit a WAIVER OF
SOME OR ALL THE REQUIREMENTS OF INFORMED CONSENT and does the
study meet criteria C1 and C2 OR criteria D1-D4 Specified Below:
☐Yes
If yes, consent can be appropriately waived. Please provide a brief summary of the
rationale for waiving consent in the Comments Section Below and skip to Part III
☐No
If no, waiving consent is not appropriate. Stop here.
C1: The research or demonstration project is to be conducted by, or subject to the approval
of, state or local government officials, and is designed to study, evaluate, or otherwise
examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or
services under those programs; (iii) possible changes in or alternatives to those programs or
procedures; or (iv) possible changes in methods or
levels of payment for benefits or services under those programs; and
C2: The research could not practicably be carried out without the waiver or alteration.
D1: The research involves no more than minimal risk to the subjects;
D2: The waiver or alteration will not adversely affect the rights and welfare of the subjects;
D3: The research could not practicably be carried out without the waiver or alteration; and
D4: Whenever appropriate, the subjects will be provided with additional pertinent
information after participation.
IC1b. Investigator will document the participants consent by having him/her sign the
informed consent form and collecting the signed consent form from the participant?
If “Yes” continue to IC2.
If “No” and not requesting a waiver of documentation of informed consent stop here. The
protocol cannot be approved.
If Requesting a Waiver of documentation of formed consent, did the investigator submit
WAIVER OF SOME OR ALL THE REQUIREMENTS OF INFORMED CONSENT
and is the rationale for waving documentation of informed consent adequate:
☐Yes
If yes, documentation of consent can be appropriately waived. Please provide a
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☐Yes
☐No
☐Requesting
Waiver
Suffolk University
Office of Research and Sponsored Programs
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Reviewer Worksheet
brief summary of the rationale for waiving consent in the Comments Section
Below and skip to Part III
☐No
If no, waiving consent is not appropriate. Stop here.
Comments:
IC2. Investigator will seek such consent only under circumstances that provide the
prospective subject or the representative sufficient opportunity to consider whether or not to
participate and the possibility of coercion or undue influence is minimized.
☐Yes
☐No
IC3. The information that is given to the subject or the representative is in language
understandable to the subject or the representative.
☐Yes
☐No
IC4. Informed consent, whether oral or written, does not include language through which
the subject or the representative is made to waive or appear to waive any of the subject’s
legal rights, or release or appear to release the investigator, the sponsor, the institution
or its agents from liability for negligence.
Comments:
☐Yes
☐No
IC 5. §46.116 (a) Basic Elements of informed Consent. In seeking informed consent the following
information shall be provided to each subject. If you answer “NO” and such element is not appropriately
waived under §46.116(d) then the informed consent form is not approve able.
IC5A.. (1) A statement that the study involves research
☐Yes
☐No
IC5B. (2) An explanation of the purposes of the research
☐Yes
☐No
IC5C. (3) The expected duration of the subject's participation
☐Yes
☐No
IC5D. (4) A description of the procedures to be followed
☐Yes
☐No
IC5E. (5) Identification of any procedures which are experimental
☐Yes
☐No
☐N/A
IC5F. (6) A description of any reasonably foreseeable risks or discomforts to the subject
☐Yes
☐No
IC5G. (7) A description of any benefits to the subject or to others which may
reasonably be expected from the research
☐Yes
☐No
IC5H. (8) A disclosure of appropriate alternative procedures or courses of treatment, if
any, that might be advantageous to the subject
☐Yes
☐No
☐N/A
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IC5I. (9) A statement describing the extent, if any, to which confidentiality of records
identifying the subject will be maintained
☐Yes
☐No
IC5J. (10) For research involving more than minimal risk, an explanation as to whether
any compensation and an explanation as to whether any medical treatments are available
if injury occurs and, if so, what they consist of, or where further info may be obtained
☐Yes
☐No
☐N/A
IC5K. (11) An explanation of whom to contact for answers to pertinent questions
about the research and research subjects' rights, and whom to contact in the event of a
research-related injury to the subject
☐Yes
☐No
IC5L. (12) A statement that participation is voluntary
☐Yes
☐No
IC5M. (13) Refusal to participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled
☐Yes
☐No
IC5N. §46.116 (b) Additional elements of informed consent. When appropriate, one or more of the
following elements of information shall also be provided to each subject. If you answer “NO” it means the
element is required but was not met by the informed consent document
(1) A statement that the particular treatment or procedure may involve risks to the
subject (or to the embryo or fetus, if the subject is or may become pregnant) which are
currently unforeseeable;
☐Yes
☐No
☐N/A
(2) Anticipated circumstances under which the subject's participation may be
terminated by the investigator without regard to the subject's consent;
☐Yes
☐No
☐N/A
(3) Any additional costs to the subject that may result from participation in the
research;
☐Yes
☐No
☐N/A
(4) The consequences of a subject's decision to withdraw from the research and
procedures for orderly termination of participation by the subject;
☐Yes
☐No
☐N/A
(5) A statement that significant new findings developed during the course of the
research which may relate to the subject's willingness to continue participation will be
provided to the subject; AND
☐Yes
☐No
☐N/A
(6) The approximate number of subjects involved in the study.
☐Yes
☐No
☐N/A
IC5. Summary
Are criteria for the basic elements 1-13 (Items IC5A-IC5M), when applicable, satisfied
(i.e., only yes’s or NA’s checked in these items) and criteria for additional elements,
when applicable, satisfied i.e., only yes’s or NA’s checked for these items)?
☐Yes
☐No
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If “yes”  continue to next section.
If “no”  did the investigator request a waiver for any of the required elements of
informed consent as specified on a “WAIVER OF SOME OR ALL THE
REQUIREMENTS OF INFORMED CONSENT” form:
☐Yes If “Yes”, please summarize the rationale for this waiver of one of the
required elements of informed consent in the comments box below and
continue.
☐No The consent process must be altered to meet the basic and additional,
when applicable, requirements of informed consent.
Comments:
☐Approved
☐Referred to Full Board
☐Requires Information or Modifications
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