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Institutional standard operating procedure describing requirements and administrative steps for establishing Institutional Review Boards and maintaining their registration with the U.S. Office for Human Research Protections within federally regulated human subjects research oversight.
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
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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
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
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:
Course Description
Purpose:
To provide students the opportunity to reflect on God’s presence in their lives and past/current ministerial leadership experiences.
Instructor:
Drissa Kone, Associate Professor of Conflict Resolution and Ministry
Phone:
+13475955428
Email:
[email protected]
Office hour:
Tuesday, Wednesday, Thursday 10am -4pm
Term:
Fall 2025
Year:
2025
Region / City:
Not specified
Subject:
Ministry, Spiritual Formation
Document Type:
Syllabus
Institution:
HJ International Graduate School for Peace and Public Leadership
Author:
Drissa Kone
Target Audience:
Graduate students in ministry
Period of Action:
Fall 2025
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2018
Region / city:
Genzano
Theme:
Salesian Brothers Formation
Document type:
Seminar Report
Organization / institution:
Salesian Congregation
Author:
Ivo Coelho, SDB
Target audience:
Salesians
Period of validity:
2017-2018
Approval date:
Not specified
Date of changes:
Not specified
Year:
2024
Region / City:
York
Subject:
Community garden management and regulations
Document Type:
Charter
Organization:
York Selectboard
Author:
York Community Garden Advisory Committee
Target Audience:
York community members, gardeners
Effective Period:
Ongoing
Approval Date:
2024-05-01
Amendment Date:
2024-05-01
Jurisdiction:
Texas
Governing law:
Texas Business Organizations Code
Document number:
Form 414
Document type:
Administrative guidance
Issuing authority:
Texas Secretary of State
Subject matter:
Restated certificate of formation
Applicable entities:
Filing entities under Texas law
Related forms:
Form 415
Legal references:
Sections 3.057–3.063, 21, 22, 101, 251 of the Texas Business Organizations Code
Public record status:
Public filing
Signature requirements:
Officer or authorized governing persons depending on entity type
Year:
2025-2026
Region / City:
Spokane, Washington
Topic:
Jesuit Education, Catholic Identity, Spirituality
Document Type:
Program Description
Organization:
Gonzaga University
Audience:
University Staff and Administrators
Period of Action:
2025-2026
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Contextual Description
Note:
Year
Subject:
Community Interest Companies
Document Type:
Application Form
Organization / Institution:
Companies House
Target Audience:
Individuals forming Community Interest Companies
Note:
Year
Topic:
Thermochemistry, Heat of Formation, Hess’s Law
Document Type:
Practice Problems, Educational Material
Target Audience:
Students, Educators
Year:
2022
Region / City:
Not specified
Field:
Endodontics
Document Type:
Research Article
Institution:
Not specified
Author:
Not specified
Target Audience:
Dental researchers, endodontists
Period of Action:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Contextual description:
Research article comparing dentinal crack formation using different rotary file systems for root canal preparation.
Year:
2023
Region / City:
Unknown
Subject:
Behavioral analysis and intervention plan for individuals with challenging behaviors
Document Type:
Behavioral Report
Author:
Unknown
Target Audience:
Staff involved in the care or treatment of individuals with challenging behaviors
Period of Action:
Ongoing
Approval Date:
Unknown
Date of Changes:
Unknown
Note:
Year
Author:
Val Ricks
Edition:
Third Edition
Year:
2019
Publisher:
CALI eLangdell Press
Place of publication:
United States
Type of document:
Legal casebook
Subject area:
Contract law
Subtopic:
Formation of contracts
Educational level:
Legal education
Institutional affiliation:
South Texas College of Law Houston
License:
Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International
Revision date:
July 2019
Intended audience:
Law students and legal educators
Language:
English