№ files_lp_4_process_3_104427
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Structured worksheet for assessing the performance of IRB Chairs and Vice Chairs, detailing both objective and subjective criteria as part of HRPP annual evaluation.
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
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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 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:
2023
Region / City:
New York
Topic:
Higher Education Administration
Document Type:
Handbook
Institution:
John Jay College of Criminal Justice
Author:
Unknown
Target Audience:
Department Chairs, Faculty Members, Administrators
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
International
Theme:
Intellectual Property, Traditional Knowledge, Traditional Cultural Expressions
Document Type:
Draft Legal Instrument
Organization / Institution:
Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC)
Author:
Lilyclaire Bellamy
Target Audience:
IGC participants, Member States, IP professionals
Validity Period:
Ongoing negotiations
Approval Date:
May 26, 2023
Date of Changes:
N/A
Year:
2020
Region / city:
Khyber Pakhtunkhwa, Pakistan
Subject:
Performance evaluation of department chairs in clinical and basic sciences
Document type:
Evaluation form
Organization / institution:
Khyber Medical College / Khyber Teaching Hospital (KMC/KTH)
Author:
Performance Evaluation (PER) Committee
Target audience:
Department chairs, senior faculty members, Dean
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2019
Region / City:
New York
Topic:
Human Rights, Treaty Bodies, Reporting Procedures
Document Type:
Note by the Secretariat
Organization / Institution:
OHCHR
Author:
OHCHR Human Rights Treaties Branch
Target Audience:
Treaty Bodies, States Parties
Period of Validity:
24-28 June 2019
Approval Date:
27 March 2019
Date of Amendments:
N/A
Note:
Summary of the document
Year:
2023
Region / City:
East of England
Topic:
Transfusion practices, healthcare management
Document type:
Toolkit
Organization / Institution:
NHS Blood and Transplant (NHSBT), East of England Regional Transfusion Committee
Author:
Nicola Jones
Target audience:
Hospital Transfusion Committee Chairs, healthcare professionals involved in transfusion
Effective period:
Ongoing
Approval date:
Not specified
Date of amendments:
Not specified
Year:
2025
Region / city:
Eastern Atlantic, Mediterranean
Topic:
Bluefin tuna management
Document Type:
Recommendation
Organization / Institution:
International Commission for the Conservation of Atlantic Tunas (ICCAT)
Author:
European Union
Target Audience:
Contracting Parties and Cooperating non-Contracting Parties, Entities or Fishing Entities
Period of validity:
2026-2028
Approval Date:
2025
Modification Date:
Not specified
Year:
2025-2026
Note:
Region / City
Subject:
Faculty Promotion and Reappointment
Document Type:
Guidelines
Organization:
Rutgers University
Target Audience:
Faculty members in the School of Arts and Sciences
Effective Period:
2025-2026
Year:
2026
Region / City:
United Kingdom
Subject:
Medical Training Assessment
Document Type:
Guidance Note
Issuing Organization:
Bradford VTS
Authors:
Dr. Simon Hall, Dr. Sandra Brinkley, Dr. Paul Johnson, Dr. Rhiannon Davies, Dr. Mike Tomson
Intended Audience:
ARCP Panel Chairs, Educational Supervisors, Clinical Supervisors
Relevant Period:
ST1–ST3 Training Stages
Key Topics:
ARCP outcomes, trainee performance assessment, documentation requirements
Year:
2022
Region / City:
Manchester, UK
Theme:
Community Partnership, GDF-process, Nuclear Waste
Document Type:
Letter
Organization / Institution:
Nuclear Free Local Authorities (NFLA)
Author:
Councillor David Blackburn
Target Audience:
Chairs and members of the GDF Community Partnerships
Period of Action:
Not specified
Approval Date:
30 November 2022
Date of Changes:
Not specified
Year:
2025
Region / City:
United Kingdom
Subject:
Aseptic pharmacy services, Quality assurance
Document Type:
Role description, Call for applications
Organization:
Royal Pharmaceutical Society (RPS)
Author:
RPS
Target Audience:
Pharmacists, pharmacy technicians, microbiologists, pharmaceutical scientists, experts in aseptic services
Period of Validity:
Indefinite
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2024
Region / City:
Ekurhuleni
Topic:
Procurement / Disaster Emergency Management
Document Type:
Formal Quotation
Organization / Institution:
Department of Finance, Department of Emergency Management Services
Author:
H. Van Schalkwyk, Ms. Nthabiseng Nkoe
Target Audience:
Bidders for procurement
Effective Period:
2024
Approval Date:
1 March 2024
Amendment Date:
14 December 2023