Boston College Institutional Review Board
Office for Research Protections
140 Commonwealth Avenue, Waul House
Chestnut Hill, MA 02467
(617) 552-4778 Fax: (617) 552-0498
E-mail: irb@bc.edu
IRB Member Checklist - Initial Review
Expedited or Full Board Review
Instructions: This checklist may only be altered in the grey boxes. To complete the form, directly “click” on the grey areas or use
the “tab” button on your keyboard to advance through the questions.
Reviewer:
Principal
Investigator:
Faculty
Advisor:
Study Design/Methods
Qualitative Research
Quantitative Research
Oral History
Controlled
Randomized
Therapeutic Intent
Other:
Date of Review:
Protocol
Number:
Sponsor:
Blinding
Double
Single
Evaluator
None
Invasive Procedures :
(see IRB Application
Question 6)
Participant Age Range:
Blood Draw
surface recordings
ultrasound
Other: Please explain
Are they Adequately Justified: Yes
No
Please Note: X-rays/radiographs not allowed in expedited review
Major Ethical Concerns:
Risk Assessment:
Minimal Risk
Greater than Minimal Risk (requires full board review)
What type 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
Improve treatment or system
Reduce costs
Other (Please identify):
Decrease existing risk or hazards
Vulnerable Research Subjects: Enrolling vulnerable research subjects requires additional protections. Check each category of
subjects listed below that will be enrolled in this research study:
Student
Employee
Client
Pregnant women/fetuses
Children
Economically or educationally disadvantaged
Prisoners (full board only)
Outpatient
Inpatient
No vulnerable subjects
Not applicable – existing data or specimens
Mentally/Cognitively Impaired
Expedited Research Categories: Please check all that apply
(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 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 children2, 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
BC IRB Expedited Reviewer Checklist
Rev. 08/18/10
Page 1
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: (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) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and
external secretions (including sweat); (e) 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; (f) placenta removed at delivery; (g) amniotic fluid
obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus,
provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or
swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
(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: (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 subject or an invasion of the subjects 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 subjects. 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 subjects. 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 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 [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.
None of the above categories apply. Requires Full Board review.
Reviewer Protocol Checklist
Comments
A. Investigator Qualifications:
Is the investigator qualified to conduct the research (they have completed human participant
training, coursework on research 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 [provider-patient, employeremployee, 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, violence; some infectious diseases; report of conditions could affect
insurability, compensation, economic standing, employability or litigation (civil or criminal).
D. Stigmatization/Loss of Service: Does participation in the protocol put a participant at risk
of loss of insurance or entitled services, social or self stigma, screening or diagnosis of
diseases with significant potential for loss of insurance or other services( e.g., carrier of an
incurable genetic disease, HIV) ? Yes
No
BC IRB Expedited Reviewer Checklist
Rev. 08/18/10
Page 2
E. Genetic research: Does the protocol propose genetic research and research using blood
and other body tissues? Yes
No
Risks of genetic research include stigmatization, self-stigmatization, loss of insurance,
discovered misattributed paternity, etc. The protocol must (1) omit identifiers, or inform
subjects of all risks and (2) not grow perpetual cell lines or disclose that prospect in the
consent form allowing subjects to opt out of growing cells.
F. Deception: Does the protocol include any elements of deception? Yes
No
Major: mislead subjects about their health status, the researchers, or research purpose.
Minor: incompletely disclose some purpose of the study to avoid biasing the results.
G. Radioactive Drugs/Recombinant DNA: Are radiation or recombinant DNA used in this
research? Yes
No
H. Consent Process:
Are the procedures adequate to obtain informed consent? Yes
No
Does the protocol adequately describe the following consent processes:
1. How the person obtaining consent will be trained? Yes
No
2. The setting in which consent will be obtained (does the subject have adequate time
to consider and is environment appropriate? Yes
No
3. How the subjects’ autonomy and comprehension is assessed? Yes
No
4. A copy of the consent form is provided to the subject? Yes
No
I. Consent Review
If a consent form is provided, please evaluate the following standard elements of consent. If
the answer to any of the questions is negative, please address any concerns in the comments
section. If no consent form is included, but should be created by the PI please note this on
the last page of the review check list.
a.
Research purposes: Are the protocol’s objectives clearly stated?
b.
A statement that the study involves research: e.g., “You are being asked to take
part in a research study” or similar statement.
c.
Subject selection A statement is included about why the subject is being asked to
participate (PI should NOT list inclusion/exclusion criteria)? Is the number of subjects
to be recruited at this site stated?
d.
Procedures paragraph: Does it begin with “If you agree to participate, you will be
asked to…” or a similar statement? Is it made clear that participation is voluntary?
e.
Procedures: Are all procedures or treatments described adequately to inform the
participant.
f.
Expected duration: Is the expected duration of subject participation stated?
g.
Experimental treatments: Are any experimental procedure(s) or treatment(s)
adequately described?
h.
Risks/Discomforts: Is there and adequate description of reasonably foreseeable
risks/discomforts? Is the following or similar statement included “The study may
include risks that are unknown at this time.”
i.
The Alternatives (for protocol including treatment only): Are the alternatives to the
research’s diagnostic method or treatment clearly stated?
j.
Benefits: Are the benefits of participation addressed adequately?
k.
Financial factors: Any extra costs to participants clearly stated?
l.
Sponsored funding: Is the research sponsor listed?
m. Subject payment: A statement that subjects will be compensated or not
compensated, and if compensated and they withdraw from the study, the
compensation will be pro-rated?
BC IRB Expedited Reviewer Checklist
Rev. 08/18/10
Page 3
n.
Study withdrawal: Are the conditions under which a PI may withdraw a participant
from the study stated clearly?
o.
Invitation for questions: Is the participant informed of PI and ORP contact
information so that the participant may ask questions or register complaints?
p.
Confidentiality: Are the measures to be taken to maintain privacy and confidentiality
clearly stated? Is the participant informed that research sponsors and university
officials may have access to their data?
q.
Standard participant authorization: Is the following or similar statement included?
“I have read this paper about the study or it was read to me. I understand the
possible risks and benefits of this study. I know that being in this study is voluntary. I
choose to be in this study: I know I can stop being in the study and I will still get the
usual medical care. I will get a copy of this consent form.”
r.
Comprehension: Is the reading level appropriate to the population of participants
and likely to be understandable to the subject?
Is the consent form appropriate for this project and adequate to protect the
participants?
Yes
No
J. Types of consent waiver not allowable in expedited research: Use of proxy consent,
or emergency research waiver of consent requires full board review. Are either of these
proposed? Yes
No
K. Waiver of Consent or Elements of Consent : Does the protocol propose waiver of
informing the subjects and obtaining consent? Yes
No
If NO, proceed to question L
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 subjects; and
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
and
3. The research could not practicably be carried out without the waiver and
4. Whenever appropriate, the subjects will be provided with additional pertinent
information after participation.
Does the protocol meet all the criteria under Category 1 or 2? Yes
BC IRB Expedited Reviewer Checklist
Rev. 08/18/10
No
Page 4
L. Waiver of Documentation of informed consent: Does the protocol propose waiver of
the requirement to obtain a signed consent form for some or all subjects? If NO, proceed
to question M.
1. The IRB may waive the requirement to obtain a signed consent form (45 CFR
46.117(c) IF:
a. The only record linking the subject and the research would be the consent document,
and the principal risk would be potential harm resulting from a breach of confidentiality.
Each subject will be asked whether the subject wants documentation linking the subject
with the research, and the subject’s wishes will govern .
OR
b. The research presents no more than minimal risk of harm to subjects, 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
M. Subject selection:
Is the selection of subjects equitable? Yes
No
Not Applicable
If any group is excluded, is there adequate justification? Yes
No
N. Confidentiality: Are the procedures adequate to maintain confidentiality, anonymity,
security and privacy of the subjects? Yes
No
1. Will the non-computer data be held in a secure manner? Yes
No
2. Will the computer data be held in a secure manner? Yes
No
3. Is a certificate of confidentiality to be used? Yes
No
O. 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
Has the PI received a Waiver of Authorization? Yes
No
No
P. Study Materials: Are there study materials described in the protocol? (advertisements,
questionnaires, video)? Yes
No
If YES, are they submitted for review? Yes
No
Q. Compliance Reporting: Should BC IRB validate reports of compliance from sources
additional to principal investigator? Yes
No
Examples: BC IRB site visit to PI, impartial observer to consent process.
R. Continuing Review Interval: What is the appropriate interval for continuing review for
this project?
12 MOS.
6 MOS. OTHER
BC IRB Expedited Reviewer Checklist
Rev. 08/18/10
Page 5
Additional Reviewer Comments
Application:
Advertisements :
Questionnaires or
Research Instruments:
Consent Form:
Have you provided an
edited consent form?
Yes
No
Other Comments:
Reviewer
Recommendation:
Approve.
Approve with Scripted Changes.
Return to Reviewer When Changes are Made.
Defer to Full Board.
Please specify changes or revisions:
BC IRB Expedited Reviewer Checklist
Rev. 08/18/10
Page 6