IRB Form: Local Review Board (LRB) Recommendation
1 East Jackson Blvd.
Chicago, IL 60604-2201
orp@depaul.edu
Ph: (312) 362-7593
http://research.depaul.edu/
DePaul University
Office of Research Services
Institutional Review Board
Version 8/22/2012
See LRB Instructions for additional information. Save As your version before filling this form.
I.
II.
III.
LRB
Local Review Board: Select One
Reviewing Members (at least two required):
1.
2.
3.
Project
PI Last Name:
Project Title:
PI First Name:
LRB Recommendation – Level of Review
A. 1. If recommended for Exemption, which category(ies)? (Note: Prisoner research is not exempt.)
1. Research conducted in established or commonly accepted educational settings, involving normal
educational practices, such as (i) research on regular and special education instructional strategies, or (ii)
research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of public behavior, unless: (i) information obtained is
recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the
subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place
the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing,
employability, or reputation. (Surveys, interviews, and observations where the researcher participates in the
observed activity may only be done with adult subjects.)
Check for exemption 2:
 Would disclosure outside the research pose risks
related to criminal or civil liability,
employability, financial standing, or reputation?
 Is information obtained recorded in such a
manner that human subjects can be identified,
directly or through identifiers linked to the
subjects?
 Are children being surveyed or interviewed?
 Are children being observed during an activity
in which the researcher participates?
If Yes to both,
study is not exempt.
No
Yes
No
No
Yes
Yes
If Yes, study is not exempt.
No
Yes
If Yes, study is not exempt.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of public behavior that is not exempt under category 2, if (i)
the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal
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statute(s) require(s) without exception that the confidentiality of the personally identifiable information will
be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly available or if the information is recorded by the
investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the
subjects.
Check for exemption 4:
 Do data/documents/records/specimens all
currently exist?
 For privately held data/specimens, will
identifiers be recorded?
No
Yes
If No, study is not exempt.
No
Yes
If Yes, study is not exempt.
5. Research and demonstration projects that are conducted by or approved by federal agencies and which
study, evaluate, or examine public benefit or service programs.
6. Taste and food quality evaluation and consumer acceptance studies involving food.
For complete regulatory citations of exempt categories see:
www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101
2. Exemption application materials
The exemption application includes a clear summary of the purpose (aims and
Yes
No
goals), data to be collected, methods, recruitment process, and target population
and number.
Yes
No
Participant selection is appropriate for the research question(s).
Yes
No
Any recruitment materials (ads, scripts, e-mails) are included in the application.
Yes
No
Study measures or data collection tools have been included.
Yes
No
An information sheet or appropriate information process is included.
Human subjects training has been completed for all research personnel via CITI,
Yes
No
or under the collaborator's own institution, or an alternative process is proposed to
meet this requirement.
B. If recommended for Expedited Review, the research
(1) should present no more than minimal risk;
(2) should involve only procedures listed in one or more of the following categories;
(3) may not be used for classified research; and
(4) may not be used where identification of the subjects and/or their responses would reasonably place them
at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability,
insurability, reputation, or be stigmatizing, or involve other physical or psychological risks, unless
reasonable and appropriate protections will be implemented so that risks related to invasion of privacy
and breach of confidentiality, or to the subject in general, are no greater than minimal.
Check all that apply:
1. Clinical studies of drugs/medical devices when they do not require an investigational new drug or
investigational device exemption application under FDA regulations.
2. Collection of blood by finger stick, heel stick, ear stick, or venapuncture.
From healthy adults weighing 110 lbs and not exceeding 550 ml in 8 weeks or more than two times a
week.
From other adults (considering age, weight, and health) and children, not exceeding 50 ml or 3 ml/kg
in 8 weeks or more frequently than 2 times per week.
3. Prospective collection of biological specimens by noninvasive means.
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4. Collection of data through non-invasive procedures routinely used in clinical practice, excluding x-rays
or microwaves.
5. Research involving data, documents, records, or specimens, that have been collected for research or
nonresearch purposes, or will be collected for nonresearch purposes.
6. Collection of data using voice, video, or image recordings made for research purposes.
7. Research on individual/group characteristics or behavior or research using survey, interview, oral
history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
For complete regulatory citations of expedited review categories see: www.hhs.gov/ohrp/policy/expedited98.html
C. If recommended for Expedited Review or Full Board Review, answer the following:
1. Risk and Review Level:
Minimal risk and qualifies for Expedited Review
Minimal risk but requires Full Board Review (does not fit in expedited categories, or involves
prisoners)
More than minimal risk so requires Full Board Review
2. Is a waiver/alteration of consent or waiver of consent documentation needed?
No
Yes
i. If Yes, what type of wavier/alteration is necessary? (Check all that apply.)
Waiver of documentation (signed document)
Complete waiver of consent/assent process
Alternation of consent/assent (process or elements)
Waiver of parent/guardian permission
ii. Do the research materials include a Form A-1 and/or A-2, as appropriate?
Yes
iii. Have the requirements for a waiver/alteration been satisfied? (Refer to Form A-1, A-2.)
No
Yes
No
IV.
LRB Specific Findings (Evaluate each of the following for expedited and full review protocols.)
Yes
No
1. The research has a clear purpose, aims, or goals and these have been clearly stated.
Yes
No
2. The research has scientific merit and uses sound research design appropriate for
evaluating the research question(s), so as not to pose unnecessary risks to
participants.
Yes
No
3. The risks to participants are minimized.
Yes
No
4. Participant selection is appropriate for the research question(s) and is equitable.
Yes
No
5. Risks to participants are reasonable in relation to anticipated benefits. (Select one
or both below.)
Yes
No
The research may directly benefit participants.
Yes
No
The research involves indirect benefit and is likely to
contribute to knowledge.
Yes
No
6. The research includes plans for monitoring data collection to maintain participant
safety (unanticipated event/adverse event reporting), as necessary.
Yes
No
7. The research has adequate plans to protect the privacy of the participants and the
confidentiality of the research data.
Yes
No
8. When applicable, the informed consent documents, parent/guardian permission
documents, and assent documents (as applicable to the research) and procedures
include all necessary elements.
Yes
No
All consent, parent/guardian permission, and assent forms are
readily understandable.
Yes
No
The consent, permission, or assent process assures that
participants fully understand the study and is appropriate to
the target population.
V.
Application Completeness, for Expedited and Full Review Protocols
Yes
No
1. The research application is appropriately completed.
Yes
No
2. Any recruitment materials (ads, scripts, e-mails) are included in the application.
Yes
No
3. Study measures or data collection tools have been included.
Yes
No
4. Human subjects training has been completed for all research personnel and, when
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VI.
VII.
Yes
No
Yes
No
necessary, documentation is included.
5. As appropriate to the research, all consent, parent/guardian permission, and assent
documents are included with the application materials.
6. Where appropriate, collaborative IRB approval and letters of
collaboration/cooperation are included.
Comments
Signatures
Your signature indicates that (a) you have personally reviewed the activity recommended and (b) you endorse the
proceeding LRB evaluation and recommendations regarding IRB review and waiver/alteration of informed
consent.
Send the completed Signed form via email to orp@depaul.edu
Reviewer 1: __________________________________________
Reviewer 2: __________________________________________
Reviewer 3: __________________________________________
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