№ files_lp_4_process_3_104411
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Defines the step-by-step process for identifying, contacting, and utilizing consultants to provide specialized expertise for IRB protocol reviews, including procedures for managing conflicts of interest and documentation.
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
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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
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
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
Year:
2020
Region / City:
Florida
Topic:
Field Testing, Field Sampling, Environmental Monitoring
Document Type:
Standard Operating Procedures (SOP)
Organization / Institution:
Florida Department of Environmental Protection (FDEP)
Author:
Not specified
Target Audience:
Field technicians, environmental scientists, laboratories
Effective Period:
Ongoing
Approval Date:
Not specified
Date of Changes:
2020
Note:
Year
Topic:
Household Hazardous Waste, Battery Management, Safety
Document Type:
Standard Operating Procedure
Agency / Institution:
MPCA (Minnesota Pollution Control Agency)
Target Audience:
Household Hazardous Waste Program Staff, Facility Managers
MMU Human Tissue Act Document Control Standard Operating Procedure (SOP), Version 1.2, February 2025
Institution:
Manchester Metropolitan University
Regulatory framework:
Human Tissue Act 2004
Document type:
Standard Operating Procedure
SOP number:
MMUHTA_017
Version:
1.2
Effective date:
February 2025
Review due date:
February 2027
Superseded version:
1.1
Superseded version date:
3 March 2023
Author:
Jake Pogson
Author role:
Person Designated
Author date:
18 July 2024
Reviewer:
Garry Pheasey
Reviewer role:
Person Designated
Reviewer date:
24 February 2025
Approver:
Hans Degens
Approver role:
Designated Individual
Approval date:
28 February 2025
Read groups:
Staff, Visitors, Students and Participants
Scope:
Manchester Metropolitan University staff involved in work with relevant material
Subject area:
Human tissue governance and document control
Associated documents:
HTA Codes of Practice and Standards
Period covered by changes:
2023–2025
Note:
Year
Note:
Year
Contextual description of the document:
Instructions for reviewing, updating, and printing a Standard Operating Procedure (SOP) document for safety and operational guidelines regarding the use of machinery.
Note:
Year
Topic:
Safety and Operational Guidelines
Document Type:
Standard Operating Procedure
Target Audience:
Users operating bandsaw equipment
Note:
Year
Topic:
Safety instructions, Equipment operation
Document type:
Standard Operating Procedure (SOP)
Target audience:
Equipment operators, Safety personnel
Context:
Instructions for reviewing, updating, and printing an SOP for the safe operation of machinery with a focus on personal protective equipment and operational safety checks.
Year:
2023
Region / City:
Not specified
Topic:
Equipment safety, SOP update
Document type:
Instructional procedure
Organization:
Not specified
Author:
Not specified
Target audience:
Operators and users of the equipment
Period of validity:
Annual review
Approval date:
Not specified
Revision date:
Not specified
Note:
Context description
Year:
2024
Region / City:
New York State
Topic:
Screening, Identification, Placement, Review, and Exit Criteria for English Language Learners (ELLs)
Document Type:
Standard Operating Procedure (SOP)
Institution:
New York State Department of Education
Author:
Not specified
Target Audience:
School administrators, teachers, and support staff involved in the education of English Language Learners (ELLs)
Effective Period:
Ongoing
Approval Date:
Not specified
Date of Changes:
Annually reviewed for updates
Year:
2024
Organization:
MCW Office of Research (OOR), CTSI Adult Translational Research Unit
Document Type:
Standard Operating Procedure (SOP)
Authors:
David R. Friedland, MD PhD; Renee N. Dex, RN, BSN; Jennifer Brown, CCRP
Scope:
MCW, Froedtert Hospital, Children’s Wisconsin and CTSI Partner Institutions faculty and staff involved in human research
Purpose:
Recruitment and enrollment of limited or non-English proficient research subjects
Revision Date:
7/2/2024
Origin Date:
4/1/2024
Target Audience:
Investigators and research staff handling human subjects with limited English proficiency
Procedures Included:
Informed consent process, interpreter and translation services, back-translation, documentation requirements
Note:
Year
Topic:
Household hazardous waste management
Document type:
Resource guide
Organization / institution:
US Environmental Protection Agency, Minnesota Pollution Control Agency
Target audience:
HHW Program staff, county officials, hazardous waste collectors