№ files_lp_4_process_3_104433
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Structured form for IRB evaluation of consent processes and research interactions involving adults with impaired decision-making capacity, detailing criteria for studies with and without anticipated direct benefits.
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
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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
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:
2026
Region / city:
Nordic region
Topic:
TV Accessibility, Accessibility Services
Document Type:
Guidelines
Organization:
NorDig
Author:
NorDig
Target audience:
Manufacturers, broadcasters, distributors, and other stakeholders in the TV industry
Period of validity:
Ongoing
Approval date:
November 2025
Date of last revision:
Not specified
Year:
2021
Region / City:
Vancouver
Topic:
Assistive technology, iPad usage for visually impaired students
Document Type:
Manual
Organization / Institution:
Washington State School for the Blind
Author:
Bruce McClanahan, Assistive Technology Specialist
Target Audience:
Visually impaired students and educators
Period of Validity:
Ongoing
Date of Approval:
January 2021
Version:
9
iOS Version:
14.3 or later
Organization:
Virginia Department for the Blind and Vision Impaired
Address:
397 Azalea Avenue, Richmond, Virginia 23227-3600
Policy type:
Equal Employment Opportunity and Affirmative Action Policy
Jurisdiction:
Commonwealth of Virginia, United States
Legal basis:
Virginia Executive Order Number One (2018); DHRM Policy Number 2.05; Virginia Personnel Act of 1942 (revised 1985); U.S. Constitution; Civil Rights Act of 1964 and 1991; Age Discrimination in Employment Act of 1967; Equal Pay Act of 1963; Vietnam Era Veterans Readjustment Act of 1974; Rehabilitation Act of 1973; Virginians with Disability Act of 1985; Americans with Disabilities Act of 1990
Scope:
Employees and applicants for employment
Prohibited grounds of discrimination:
race, sex, color, national origin, religion, sexual orientation, gender identity or expression, age, political affiliation, disability
Affirmative action focus:
minorities, women, disabled persons, older Virginians, veterans
Enforcement body:
Human Resources Office of DBVI
Signatory:
Raymond E. Hopkins, Commissioner
Approval date:
January 15, 2018
Effective policy date:
January 15, 2018
Year:
2022
Region / City:
Virginia
Theme:
Human Resources
Document Type:
Policy Manual
Organization / Institution:
Department for the Blind and Vision Impaired
Author:
Department for the Blind and Vision Impaired
Target Audience:
DBVI Employees, External Stakeholders
Period of Validity:
Ongoing
Approval Date:
October 21, 2022
Modification Date:
Not specified
Note:
Year
Region / city:
Lancaster, PA
Theme:
Legal, Disability Accommodation
Document Type:
Request Form
Organization / Institution:
Lancaster County Court of Common Pleas
Target Audience:
Litigants, Attorneys, Individuals with Disabilities
Year:
2013
Region / City:
Kansas
Topic:
DUI Tracking System, Court Disposition Filing Interface
Document Type:
Technical Report
Organization / Institution:
Kansas Bureau of Investigation, Kansas Department of Transportation
Author:
Analysts International Corporation (AIC)
Target Audience:
Government Agencies, Law Enforcement
Period of Validity:
Ongoing
Approval Date:
12/02/2013
Modification Date:
Not specified
Note:
Year
Subject:
Licensing Agreement
Document Type:
Agreement
Organization / Institution:
Lifeway Christian Resources of the Southern Baptist Convention
Target Audience:
Church leaders, individuals requiring accessible formats
Validity Period:
Three years
Note:
Year
Subject:
Employment, Vocational Rehabilitation, Disability Services
Document Type:
Form
Organization / Institution:
New Jersey Department of Human Services, Division of Developmental Disabilities, Division of Vocational Rehabilitation Services, Commission for the Blind and Visually Impaired
Target Audience:
Individuals eligible for the Division of Developmental Disabilities (DDD)
Year:
2020
Region / city:
Geneva
Theme:
Marrakesh Treaty, accessibility, copyright
Document type:
Assembly Report
Institution:
World Intellectual Property Organization (WIPO)
Author:
Santiago Cevallos
Target audience:
Member States, stakeholders in accessibility, visually impaired persons
Period of validity:
Ongoing since 2016
Date of adoption:
December 15, 2020
Date of amendments:
Not mentioned
Year:
2017
Region / city:
Marrakesh
Subject:
Access to Published Works for Persons with Disabilities
Document Type:
Report
Author:
WIPO Secretariat
Target Audience:
WIPO Member States, Policy Makers, Organizations Supporting the Visually Impaired
Period of Validity:
Ongoing
Date of Approval:
December 14, 2017
Date of Changes:
None
Note:
Contextual Description
Year:
2017
Region / City:
Geneva
Subject:
Marrakesh Treaty
Document Type:
Report
Organ / Institution:
WIPO
Author:
Secretariat
Target Audience:
Member States of WIPO, National Authorities
Period of Effect:
Since September 30, 2016
Approval Date:
August 2, 2017
Date of Amendments:
None
Context:
Report on the status, promotion, ratification, and implementation of the Marrakesh Treaty to facilitate access to published works for persons who are blind, visually impaired, or otherwise print disabled.