№ files_lp_4_process_3_104424
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Checklist document detailing the required composition, qualifications, and diversity standards for IRB members to ensure adequate review of human subjects research.
Year:
2025
Document Type:
Worksheet
Institution:
Institutional Review Board (IRB)
Purpose:
Evaluate IRB membership and composition
Target Audience:
IRB staff
Scope:
Human subjects research, including vulnerable populations
Regulations Referenced:
FDA, DOJ, Pre-2018 Common Rule
Requirements:
Voting members only, diversity in gender, profession, and expertise
Special Considerations:
Inclusion of unaffiliated members, prisoner representation, alternate members, chair presence
Review Categories:
Objective composition, subjective composition, additional requirements, prisoner research review, scope and composition
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Year:
2025
Organization:
West Virginia University (WVU)
Department:
Office of Human Research Protections (OHRP)
Document Type:
Standard Operating Procedure (SOP)
Author:
WVU OHRP Director
Approver:
WVU Vice President of Research
Purpose:
Establish process to maintain IRB records
Scope:
Applies to all IRB records, protocols, and associated documentation
Revision Status:
None
Related References:
AAHRPP elements I.1.A, I-9, II.5.A
Audience:
IRB staff and administrators
Record Categories:
Protocol files, IRB meeting minutes, correspondence, member rosters and files, policies and procedures, consent documents, progress reports, reports of unanticipated problems, amendments, data and safety monitoring board reports
Procedure Summary:
Filing, storing, and maintaining all IRB records and associated documentation in electronic and physical formats
Compliance:
Follows federal regulations including the 2018 Rule
Year:
2025
Form Type:
IRB Member Information Form
Document Code:
HRP-202
Purpose:
Collection of IRB member details for appropriate committee composition
Intended Audience:
IRB staff and members
Fields Included:
Personal information, education, contact details, experience with vulnerable populations, employment and affiliations
Signature Required:
Yes
Date of Issue:
7/11/2025
Year:
2025
Organization:
West Virginia University (WVU)
Department:
Office of Human Research Protections (OHRP)
Document Type:
Standard Operating Procedure (SOP)
Author:
WVU OHRP Director
Approver:
WVU Vice President of Research
Purpose:
Establishes the procedure for obtaining consultants for IRB review
Scope:
IRB staff, convened IRB, Non-Committee Review
References:
21 CFR §56.107(f), 45 CFR §46.107(f), AAHRPP elements I.1.F, I-9, II.1.D, II.1.E, II.2.E-II.2.E.2
Revisions:
None
Document ID:
HRP-072
Date:
7/11/2025
Owner:
WVU OHRP Director
Approver:
WVU Vice President of Research
Institution:
West Virginia University (WVU)
Department:
Office of Human Research Protections (OHRP)
Document Type:
Standard Operating Procedure
Subject:
Institutional Review Board records retention
Policy Scope:
Retention and destruction of IRB records
Responsible Personnel:
IRB staff members
Record Format:
Electronic records
Minimum Retention Period:
Three years after research protocol closure
Related Policy:
WVU Policy G-1 Record Retention Policy and Schedule
Regulatory References:
Common Rule; FDA regulations
Accreditation References:
AAHRPP elements I.1.A, I-9, II.5.A, II.5.B
Applicability:
Research protocols reviewed by the Institutional Review Board
Document code:
HRP-080
Date:
7/11/2025
Owner:
WVU OHRP Director
Approver:
WVU OHRP Vice President of Research
Organization:
West Virginia University Office of Human Research Protections (WVU OHRP)
Document type:
Standard Operating Procedure (SOP)
Subject:
Institutional Review Board formation and federal registration procedures
Regulatory scope:
Human subjects research oversight
Responsible staff:
IRB staff members
Appointing authority:
Institutional Official / Organizational Official (IO/OO) or designee
Related records:
HRP-082 SOP IRB Membership Addition; HRP-202 Form IRB Member Information; HRP-304 Worksheet IRB Composition; HRP-601 Database IRB Roster
Associated systems:
OHRP IRB registration system; Federalwide Assurance (FWA)
Regulatory references:
45 CFR §46.103; 45 CFR §46.107; 45 CFR §46.108; 45 CFR §46.115(a)(5); 21 CFR §56.107; 21 CFR §56.115(a)(5)
Accreditation reference:
AAHRPP Elements I.1.A; II.1.A–C
Review cycle:
IRB registration renewal every 3 years; FWA renewal every 5 years
Geographic scope:
United States
Year:
2025
Document Type:
Worksheet
Purpose:
Annual performance evaluation of IRB leadership
Target Audience:
Institutional Official/Organizational Official or designee
Scope:
IRB Chairs and Vice Chairs
Associated SOP:
HRP-060 - Annual Evaluations of the HRPP
Date:
7/11/2025
Evaluation Criteria:
Objective and Subjective measures for leadership, meeting participation, protocol review, education, and communication
Year:
2025
Document Code:
HRP-410
Date:
7/11/2025
Document Type:
Compliance Checklist
Subject:
Waiver or Alteration of Informed Consent in Research
Related Document:
HRP-314 – Worksheet – Criteria for Approval
Regulatory Context:
IRB Review Requirements
Institutional Body:
Institutional Review Board (IRB)
Intended Users:
IRB Members and Designated Reviewers
Review Stages Covered:
Initial Review, Continuing Review, Modifications, Expedited Review, Convened IRB Review
Scope:
Determinations and protocol-specific findings required for approving waiver or alteration of the consent process
Applicable Regulations:
FDA Regulations and Federal Human Subjects Research Regulations (including 2018 Rule references)
Content Elements:
Submission information, reviewer identification, study details, regulatory criteria checklists, protocol-specific justification fields
Year:
2025
Document Type:
Checklist
Subject:
Pediatric Research
Applicable Regulations:
21 CFR §50.51-50.54 / 45 CFR §46.404-46.407
Intended Users:
IRB Members, Designated Reviewers
Review Types:
Initial, Continuing, Modification, Expedited, Convened IRB
Protocol Reference:
HRP-314
Completion Date:
7/11/2025
Submission Information:
Includes IRB Number, Study Title, Investigator, Person Completing Checklist
Year:
2025
Region / City:
Not specified
Topic:
Research Ethics / Human Subjects
Document Type:
Checklist
Organization / Institution:
Institutional Review Board (IRB)
Author:
Not specified
Target Audience:
IRB members, Designated Reviewers
Applicable Period:
As indicated in protocol reviews
Approval Date:
Not specified
Amendment Date:
Not specified
Regulatory Reference:
HRP-314, HRP-410
Research Scope:
Adults with impaired decision-making capacity
Review Procedures:
Initial, Continuing, Modifications, Expedited, Convened IRB
Submission Requirements:
Completed checklist to be attached to protocol file
Note:
Year
Topic:
Chemistry, Laboratory Experiment
Document Type:
Educational Text
Intended Audience:
Learners, Students
Purpose:
Educational
Description:
Practical guide for determining the percentage of CuCO3 in a copper(II) carbonate sample, focusing on safety, accurate measurement, and chemical reaction analysis.
Year:
2023
Region / City:
Australia, New Zealand
Topic:
Trans fats, food policy, public health
Document Type:
Policy Options Paper
Organization / Institution:
Food Regulation Standing Committee (FRSC)
Author:
Not specified
Target Audience:
Stakeholders in food policy, health organizations, government officials
Period of Validity:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Document type:
Regulatory form
Subject:
Quantitative and qualitative composition of medicinal products
Version:
4.0
Valid from:
01.01.2025
Identification number:
ZL000_00_032
Regulatory framework:
TPLRO, HMV4
Scope:
Human and veterinary medicinal products
Product category:
Medicinal products
Applicable substances:
Chemical, biological, herbal, homeopathic, anthroposophic, gene therapy, transplant products
Change history period:
Versions 1.0–4.0
Issuing context:
Marketing authorisation and regulatory submission
Year:
2024 (implied by chapter numbering and structure)
Jurisdiction:
State of Maine, United States
Issuing body:
Maine Labor Relations Board, Department of Labor
Document type:
Administrative rules / regulatory chapter
Subject:
Representation petitions, bargaining unit composition, elections, and certification/decertification procedures
Scope:
Public sector labor relations
Related forms:
MLRB Form 1 (Agreement on Appropriate Bargaining Unit), MLRB Form 3 (Voluntary Recognition Form)
Key topics:
Unit determination, majority sign-up, elections, unit clarification, unit merger, bargaining agent merger, intervention, exclusionary designation
Legal nature:
Board rules and procedures
Note:
Year
Document Type:
Syllabus
Institution:
Virginia Tech
Target Audience:
Students enrolled in ENGL1105
Contextual description:
Syllabus outlining course objectives, materials, grading criteria, and policies for the ENGL1105: First-year Writing I course at Virginia Tech.
Note:
Year
Contextual description:
Practical activity for GCE Chemistry A and B (Salters) specifications, focusing on determining the percentage by mass of CuCO3 in copper(II) carbonate basic.
Year:
2018
Region / city:
European Union
Topic:
Railway interoperability
Document type:
Compliance test report
Organization / institution:
European Union Agency for Railways
Author:
European Union Agency for Railways
Target audience:
Railway operators, infrastructure managers, and regulatory bodies
Period of validity:
N/A
Approval date:
22/11/2018
Modification date:
N/A
Year:
Not specified
Region / City:
Jardim Gramacho
Theme:
Documentary film analysis
Document type:
Film analysis
Organization / Institution:
Not specified
Author:
Not specified
Target audience:
Film students, documentary enthusiasts
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Note:
Contextual description
Year:
N/A
Region / city:
N/A
Document type:
Instructional template
Organization / institution:
European Union
Author:
N/A
Target audience:
Investment firms
Validity period:
N/A
Approval date:
N/A
Amendment date:
N/A
Year:
Fall 2025
Region / City:
Ball State University
Topic:
Music Composition
Document Type:
Syllabus
Institution:
Ball State University | College of Fine Arts | School of Music
Instructor:
Dr. Chin Ting CHAN
Target Audience:
Students in the School of Music
Period of Effect:
Fall 2025 semester
Approval Date:
N/A
Date of Revisions:
N/A