IRB Checklist for Expedited or Full Board Review
Reviewer:
Principle Investigator:
Date of Review:
Assigned ID Number:
I. Study Design
Is the proposal research?
Yes
No
Definition 45 CFR 46.102(d): “A systematic investigation including
research development, testing, and evaluation designed to develop or
contribute to generalizable knowledge”
Participants
Age Range:
Expected Number:
Potentially Vulnerable Population:
Yes
No
[Minors, Students, Employees, Clients, Pregnant
Women/Fetuses, Mentally/Cognitively Impaired,
Economically or Educationally Disadvantaged,
Outpatients, Inpatients, Prisoners]
Method
Qualitative Research
Quantitative Research
Oral History
II. Major Ethical Concerns
List:
III. Risk Assessment
Minimal Risk
Greater than Minimal Risk (requires full board review)
What types of risks are most likely (psychological, physical, economic, breech of confidentiality, stigma, loss of status,
perceived loss of status, loss of benefits, etc.)?
Potential Benefits
Generalizable knowledge
Reduce costs
Improved treatment or system
Decrease existing risk or hazards
Other (specify):
IV. Exempt Status
Check all that apply.
Not Exempt
Category 1 [Regular or special educational instruction]
Category 2 [Educational tests, surveys, interviews, or observations of public behavior]
Category 3 [Elected officials]
Category 4 [Existing data, documents, records, or biological specimens that are publically available or unidentifiable]
Category 5 [Research or demonstration project on federal program]
Category 6 [Taste or food quality evaluation or consumer food acceptance]
V. Expedited Research Category
Check all that apply. [Most common at Grinnell College will be Categories 7, 8, and 9]
Meets exempt status.
Does not meet any expedited category and requires full board 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 (i) an investigational device exemption application (21 CFR Part 812) is
not required; or (ii) the medical device is cleared/approved for marketing 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, nonpregnant adults who weigh at least 110 pounds. For these participants, 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 children2, considering the age, weight, and health of the participants, the collection
procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these
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participants, 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. Examples include: (a)
hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care
indicates a need for extraction; (c) excreta and external secretions (including sweat); (d) uncannulated saliva collected
either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the
tongue; (e) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings.
(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.) Examples include (a) physical sensors that are applied either to the surface of the body or at a distance and
do not involve input of significant amounts of energy into the participant or an invasion of the participants privacy; (b)
weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography,
thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared
imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body
composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected
solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may
be exempt from the HHS regulations for the protection of human participants. 45 CFR 46.101(b)(4). This listing refers
only to research that is not exempt.)
(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. (NOTE: Some research in this category may be exempt from the HHS regulations for the
protection of human participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not
exempt.)
(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 participants; (ii) all participants have completed all research-related
interventions; and (iii) the research remains active only for long-term follow-up of participants; or(b) where no
participants 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 [INITIALLY A FULL BOARD REVIEW], 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.
VI. Reviewer Protocol Checklist
A. Investigator Qualifications:
 Is the investigator qualified to conduct the research (e.g., completed ethics training,
coursework, or have actual experience with this type of research)?
Yes
No
 Is there a conflict of interest?
Yes
No
B. Coercion: Does the recruitment/consent process include any possible Influence or
coercion that unduly entices participation?
Yes
No
 Examples: excessive compensation, unequal relationship [employer-employee,
faculty-student) please defer to full board if potential for coercion is substantial
C. Sensitive information: Does the protocol broach sensitive subjects?
Yes
No
 Examples: child abuse; some infectious diseases; or litigation (civil or criminal).
D. Stigmatization/Loss of Service: Does participation in the protocol put a participant
at risk of loss of entitled services or social or self-stigma?
Yes
No
E. Deception: Does the protocol include any major deception?
Yes
No
 Major: mislead participants about personal characteristic, the researchers, or purpose.
 Minor: incompletely disclose some purpose of the study to avoid biasing the results.
Grinnell College IRB Proposal Review Checklist
Comments:
Comments:
Comments:
Comments:
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F. Consent Process:
Are the procedures adequate to obtain informed consent?
Yes
No
Does the protocol adequately describe the following consent processes:
 The setting in which consent will be obtained (does the participant have adequate
time to consider and is environment appropriate)?
Yes
No
 A copy of the consent form is provided to the participant?
Yes
No
G. Consent Review
Evaluate the following elements of consent. Address concerns in the comments section.
 Research purposes: Are the protocol’s objectives clearly stated?
 A statement that the study involves research
 Participant selection: A statement is included about why the participant is being
asked to participate (PI should NOT list inclusion/exclusion criteria)?
 Voluntary nature: Is it made clear that participation is voluntary?
 Procedures: Are all procedures described adequately to inform the participant?
 Expected duration: Is the expected duration of participation stated?
 Risks/Discomforts: Are reasonably foreseeable risks adequately described?
 Benefits: Are the benefits of participation addressed adequately?
 Participant payment: Is the compensation adequately described, including how
participants will be compensated if they withdraw?
 Study withdrawal: Are the conditions under which a participant may withdraw from
the study stated clearly?
 Invitation for questions: Is the participant informed of PI and IRB contact
information so that the participant may ask questions or register complaints?
 Confidentiality: Are the measures to be taken to maintain privacy and confidentiality
clearly stated?
 Standard participant authorization: Is the following or similar statement included?
“I have read this document describing the study and understand the possible risks and
benefits of participation. I know that my participation is voluntary and that I can stop
being in the study at any time. I consent to participate.”
 Comprehension: Is the reading level appropriate to the population of participants?
 Sponsored funding: Is the research sponsor listed?
Is the consent form appropriate for this project and adequate to protect the
participants?
Yes
No
H. Types of consent waiver not allowable in expedited research: Use of proxy
consent or emergency research waiver of consent requires full board review. Is either of
these proposed?
Yes
No
I. Waiver of Consent or Elements of Consent: Does the protocol propose waiver of
informing the participants and obtaining consent?
Yes
No
If NO, proceed to question K
Category I (45 CRF 46.116 (c))
1. The research 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
2. The research could not practicably be carried out without the waiver
OR
Category II (45 CFR 46. 116 (d)) ALL MUST APPLY
1. The research involves no more than minimal risk to the participants; and
2. The waiver or alteration will not adversely affect the rights and welfare of the
participants; and
3. The research could not practicably be carried out without the waiver; and
4. Whenever appropriate, the participants will be provided with additional pertinent
information after participation.
Does the protocol meet all the criteria under Category 1 or 2?
Yes
No
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Comments:
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J. Waiver of Documentation of informed consent: Does the protocol propose waiver
of the requirement to obtain a signed consent form for some or all participants?
If NO, proceed to question K.
The IRB may waive the requirement to obtain a signed consent form (45 CFR
46.117(c) IF:
a. The only record linking the participant and the research would be the consent
document and the principal risk would be potential harm resulting from a breach of
confidentiality. Each participant will be asked whether the participant wants
documentation linking the participant with the research, and the participant’s wishes
will govern.
OR
b. The research presents no more than minimal risk of harm to participants, and
involves no procedures for which written consent is normally required outside of the
research context.
Does the protocol meet the all criteria described in a or b above?
Yes
No
K. Participant selection:
Is the selection of participants equitable?
Yes
No
Not Applicable
If any group is excluded, is there adequate justification?
Yes
No
L. Confidentiality: Are the procedures adequate to maintain confidentiality,
anonymity, security and privacy of the participants?
Yes
No
 Will the non-computer data be held in a secure manner?
Yes
No
 Will the computer data be held in a secure manner?
Yes
No
 Is a certificate of confidentiality to be used?
Yes
No
M. HIPAA: Is the PI recruiting at a site that may be covered by HIPAA Privacy
Protections?
Yes
No
Not Applicable
 Has the PI received Authorization for research evaluation?
Yes
No
 Has the PI received a Waiver of Authorization?
Yes
No
N. Study Materials: Are there study materials described in the protocol?
(advertisements, questionnaires, video)?
Yes
No
If YES, are they submitted for review?
Yes
No
Comments:
Comments:
Comments:
Comments:
Comments:
VII. Additional Comments
Application:
Advertisements:
Questionnaires or Research Instruments:
VIII. Reviewer Recommendation
Approve
Approve pending minor changes, revisions, or modifications
Return to reviewer when changes, revisions, or modifications are made
Defer to full board
Please specify changes, revisions, or modifications:
If approved or approved pending minor changes, revisions, or modifications, specify the appropriate interval for continuing
review of this project.
12 Months.
6 Months.
Other (specify:
)
If other than 12 months, provide rationale here:
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