№ lp_1_2_03141
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Internal worksheet and checklist defining required review materials and references for IRB members and reviewers across multiple categories of human subjects research oversight.
Document type:
Worksheet
Subject:
Institutional Review Board review materials
Organization:
Institutional Review Board
Audience:
IRB staff, IRB members, designated reviewers, scientific or scholarly reviewers, consultants
Scope:
Convened IRB meetings and non-committee review
Review types covered:
Initial review, continuing review, review of modifications, problem review, humanitarian use device review
Regulatory references:
HIPAA, FDA, Veterans Administration research
Revision history period:
2014–2023
Latest revision date:
11/15/2023
Source type:
Internal review guidance
Reference identifiers:
HRP-211, HRP-212, HRP-213, HRP-314, HRP-317, HRP-318, HRP-320, HRP-321, HRP-323, HRP-401, HRP-410, HRP-411, HRP-412, HRP-413, HRP-414, HRP-415, HRP-416, HRP-417, HRP-418, HRP-419, HRP-441
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Year:
2021
Region / City:
N/A
Subject:
IRB protocol review process
Document Type:
Worksheet
Organization / Institution:
Institutional Review Board (IRB)
Author:
N/A
Target Audience:
IRB staff and members, scientific reviewers, consultants
Effective Period:
N/A
Approval Date:
N/A
Modification Date:
N/A
Contextual Description:
A worksheet to guide IRB members in reviewing materials for convened meetings, listing required documents and checklists for initial, continuing, modification reviews, and unexpected problems.
Note:
Year
Year:
2025
Region / City:
WVU
Subject:
Non-Committee Review Process
Document Type:
Standard Operating Procedure (SOP)
Institution / Organization:
WVU OHRP
Author:
WVU OHRP Director
Target Audience:
Designated Reviewer, Staff Reviewer, IRB Staff
Period of Validity:
Ongoing
Approval Date:
12/19/2025
Date of Last Revision:
None
Year:
2026
Institution:
University of Kansas Medical Center (KUMC)
Document Type:
IRB Request Form / Research Protocol Submission
Target Audience:
Principal Investigators and Research Staff
Applicable Regulations:
45 CFR 46, 34 CFR 97, HHS Common Rule
Research Type:
Minimal Risk Behavioral and Biomedical Studies, Secondary Data Analysis
Submission Method:
myIRB Electronic Application
Required Materials:
Completed Form, Data Collection Sheets, Consent Forms, Recruitment Materials
Notes:
Includes guidance for flexible IRB review eligibility and types of research activities
Note:
Year
Subject:
IRB Member Performance Evaluation
Document Type:
Worksheet
Organization / Institution:
University of Miami
Target Audience:
IRB Chairs, IRB Managers
Period of Effectiveness:
Annual
Document type:
Institutional review form
Organization:
University of New England Institutional Review Board
Jurisdiction:
United States
Scope:
International human subjects research
Applicable research formats:
In-person research; Online-only research
Intended submitter:
Principal Investigator
Regulatory framework:
U.S. federal human subjects research regulations
Review body:
Institutional Review Board
Contact information:
[email protected]
Version date field:
Yes
IRB number field:
Yes
Target audience:
Faculty, staff, and student researchers
Geographic focus:
Research conducted outside the United States
Compliance topics:
Ethics approval, informed consent, data protection, export control regulations
Note:
Year
Document type:
Checklist
Target audience:
Investigators, IRB staff
Context description:
A checklist for investigators and IRB staff to assess and ensure regulatory compliance in clinical and non-clinical research studies.
Year:
2025
Region / City:
Louisiana
Topic:
Alcohol and Drug Survey
Document Type:
Guidelines
Organization / Institution:
Louisiana Board of Regents
Author:
Dr. Allison Smith
Target Audience:
IRB administrators, researchers, university staff
Period of Validity:
2025
Approval Date:
October 4, 2024
Amendment Date:
November 15, 2024
Year:
2023
Region / City:
Emory University
Topic:
IRB Determination for Research Involving Minors
Document Type:
IRB Determination Checklist
Organization:
Emory University
Author:
Emory Institutional Review Board (IRB)
Target Audience:
Researchers, IRB members, Clinical researchers, Academic institutions
Effective Period:
Ongoing
Approval Date:
2023
Date of Changes:
Not specified
Note:
Study Summary 1.1 Please provide a brief summary of the study in the table below. A complete description of the study with detailed information should be provided in the body of the protocol. For sections not applicable to the study, mark them as N/A. Study Title Study Design Primary Objective/Purpose Secondary Objective(s)/Purposes Research Intervention(s) ClinicalTrials.gov NCT # Study Population Sample Size Study Duration for individual subjects Study Specific Abbreviations/ Definitions
Background 3.1 Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how will it add to existing knowledge. :
this section should be limited to only information directly related to the research questions and objectives. Do not include your full dissertation proposal. 3.2 Describe any relevant preliminary data (e.g. pilot data).
Procedures Involved 5.1 Describe and explain the study design. 5.2 Please select the methods that will be employed in this study (select all that apply):
☐ Audio/Video Recording ☐ Psychophysiological Recording ☐ Behavioral Interventions ☐ Record Review - Educational ☐ Behavioral Observations and Experimentations ☐ Record Review - Employee ☐ Deception ☐ Record Review- Medical ☐ Focus Groups ☐ Record Review - Other ☐ Interviews ☐ Specimen Collection or Analysis ☐ Investigational Medical Device – (e.g. Medical Mobile Applications) ☐ Surveys and/or Questionnaires ☐Psychometric Testing ☐ Other Social-Behavioral Procedures Provide a description of all research procedures being performed and when they are performed. (Upload any surveys, questionnaires, interview scripts, focus group scripts, debriefing scripts, psychometric tests, stimulus materials, intervention manuals, and data collection forms on the Local Site Documents page in the IRB application.) 5.3 Describe the procedures or interventions that are going to be conducted as part of the research project, but that would have been conducted anyway, even if the research was not occurring (i.e. standard of care procedures, activities that would occur in a classroom). 5.4 Describe the procedures performed to lessen the probability or magnitude of risks of items selected in 5.2.5. 5 If accessing or collecting existing data, describe: The data that will be collected during the study (e.g. demographics, medical history, etc.). Attach the data capture sheet(s) on the Local Site Documents page in the IRB application. How the data will be obtained, including how you have the authority to access the data. The source or location of the data (e.g. USF Epic, TGH Epic, Hillsborough County School records, CANVAS records, publicly available databases, etc.). 5.6 If collecting and/or analyzing biological specimens, describe: How the biological specimens will be or have been collected. How the biological specimens will be stored. How long the biological specimens will be stored. How the biological specimens will be used. The laboratories that will be used. Whether the collected biological specimens will undergo genetic testing. If so, indicate if this study is part of a Genome Wide Association Study (GWAS) and whether the data will be forwarded to the NIH dbGaP. 5.7 If there are plans for long-term follow-up (once all research related procedures are complete), what data will be collected during this period.
Data and Specimen Storage for Future Research 6.1 If data or specimens will be banked for future research studies, describe where the data or specimens will be stored, how long it/they will b:
the process to request a release, approvals required for release, who can obtain data or specimens, and the data to be provided with specimens.
Note:
Year
Document Type:
Checklist
Author:
Dr. Twyla Williams-Damond
Context:
A checklist for ensuring all components are complete for an IRB application, including informed consent, recruitment templates, and readability reports.
Note:
Year
Document Type:
Checklist
Target Audience:
IRB members, researchers, committee staff
Context description:
A checklist for ensuring that IRB meeting minutes fulfill specific requirements related to protocol reviews and compliance with regulatory standards.
Year:
2023
Region / City:
Boston
Topic:
Quality Improvement, Research Ethics, Institutional Review Board
Document Type:
Guideline
Organization / Institution:
Boston Medical Center
Author:
Nicholas Cordella, MD
Target Audience:
Faculty, Staff
Period of Validity:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2022
Region / City:
N/A
Topic:
VA Informed Consent Addendum, NCI CIRB, Boilerplate Language Revision
Document Type:
Guidance
Organization / Institution:
Department of Veterans Affairs (VA)
Author:
ORD, Office of Research Oversight (ORO), NCI CIRB
Target Audience:
VA Facilities, Research Community
Effective Period:
N/A
Approval Date:
April 6, 2022
Date of Updates:
May 12, 2022
Contextual description:
Guidance document on revisions to VA boilerplate language for NCI studies overseen by the NCI CIRB, detailing required actions for VA Facilities.
Note:
Year
Topic:
Human Research, IRB Oversight
Document Type:
Guidance
Target Audience:
Investigators conducting Human Research
Contextual description:
A guidance document for investigators conducting human research, outlining obligations and procedures for IRB oversight and approval.
Year:
Not specified
Region / City:
Not specified
Topic:
IRB approval, research oversight
Document Type:
Policy
Organization / Institution:
University of Colorado Denver
Author:
Not specified
Target Audience:
UCD faculty, staff, researchers, external IRB teams
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A policy document detailing the procedure and criteria for utilizing an external Institutional Review Board (IRB) for studies involving UCD faculty and staff.