№ files_lp_4_process_3_104432
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Checklist for determining risk levels, benefits, and regulatory compliance for research studies involving children as subjects.
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
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Note:
IRB Number
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
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:
2022
Region / City:
Cheshire and Merseyside
Subject:
Child Protection, Family Law
Document Type:
Practice Note
Issuing Authority:
His Honour Judge Steven Parker, Designated Family Judge for Cheshire and Merseyside
Period of Application:
2022-2023 (pilot phase)
Approval Date:
9th March 2022
Amendment Date:
None
Year:
2025
Region / City:
Northern Territory
Theme:
Research Ethics, Mental Health
Document Type:
Protocol
Organization / Institution:
Charles Darwin University
Author:
Claire Burke Draucker, Donna S. Martsolf, Candice Poole
Target Audience:
Researchers, Indigenous Communities, Mental Health Professionals
Period of Validity:
Ongoing
Approval Date:
October 2009
Date of Last Revision:
2025
Note:
Year
Topic:
Research Ethics
Document Type:
Form
Target Audience:
Research participants
Note:
Year
Institution:
Bath Spa University
Target Audience:
Staff, students, and event organizers
Note:
Year
Topic:
Incident Reporting
Document Type:
Report Form
Organization:
NHS
Target Audience:
NHS Staff, Contractors
Year:
2023
Region / City:
Florida
Theme:
Legal Procedure
Document Type:
Statutory Instruction
Authority / Institution:
Florida State
Author:
Unknown
Target Audience:
Legal Professionals
Period of Validity:
Not specified
Approval Date:
December 15, 2023
Modification Date:
December 15, 2023
Form number:
UST-8
Jurisdiction:
North Carolina, United States
Issuing authority:
North Carolina Department of Environmental Quality, Division of Waste Management, UST Section
Document type:
Regulatory notification form
Legal basis:
Federal and state underground storage tank regulations; N.C.G.S. 143-215.94C
Subject matter:
Registration and notification of underground storage tank systems
Intended submitters:
UST system owners and operators
Scope of application:
Regulated and commercial underground storage tank systems
Geographic applicability:
State of North Carolina
Administrative purpose:
Collection and updating of ownership, location, construction, and operational data for UST systems
Associated processes:
Permitting and annual operating fee assessment
Year:
2022
Region / City:
Potchefstroom, South Africa
Theme:
Animal Research Ethics
Document Type:
Application Form
Organization / Institution:
North-West University
Author:
North-West University Animal Care, Health and Safety Research Ethics Committee
Target Audience:
Researchers, Postgraduate Students, Faculty Members
Period of Validity:
From approval date until study completion
Approval Date:
July 2022
Date of Changes:
N/A
Note:
Year
Topic:
Research ethics
Document type:
Form
Organization / Institution:
Sheffield Hallam University
Target audience:
Students and supervisors conducting research involving human participants
Contextual description:
Form used for ethical scrutiny of higher risk research projects involving human participants, particularly those involving biological samples, food/nutrition, and high-intensity sport science evaluation.