№ files_lp_3_process_7_062100
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This document provides guidelines for HRPP staff in completing the 45 CFR 46.118 request form for studies that involve human subjects and are funded by federal or non-federal sponsors.
Year:
2018
Region / City:
N/A
Subject:
Research ethics, human subjects, federal regulations
Document type:
Worksheet
Organization / Institution:
HRPP
Author:
N/A
Target audience:
HRPP staff, Principal Investigators (PIs), IRB members
Period of validity:
Until initial IRB review submission
Approval date:
N/A
Amendment date:
N/A
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Region / City:
United States
Theme:
Human Research, Ethical Approval, Research Protocols
Document Type:
Instruction Manual
Organization:
MSU Human Research Protection Program
Author:
MSU Human Research Protection Program
Target Audience:
Researchers, Investigators, IRB Reviewers
Period of Effectiveness:
Indefinite
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
Not specified
Region / City:
Not specified
Theme:
Human Research Protection Program
Document Type:
Table of Contents
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers, Institutional Review Boards (IRBs)
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A table of contents for a toolkit containing standard operating procedures, forms, templates, and other resources related to human research protection.
Year:
2026
Region / City:
Covenant Medical Center, Texas
Subject:
Research clearance procedures
Document type:
Instructional document
Institution:
TTUHSC, PSJH
Author:
TTUHSC faculty
Target audience:
TTUHSC faculty, researchers
Effective period:
Ongoing
Approval date:
2026
Modification date:
Not specified
Note:
Year
Theme:
Human Research Protection Program (HRPP)
Document type:
Procedure
Target Audience:
HRPP staff, investigators
Year:
Annual (beginning in May)
Subject Area:
Human Research Protection Program (HRPP) oversight and Institutional Review Board (IRB) evaluation
Document Type:
Procedure
Applicable Regulations:
21 CFR §56.106; 21 CFR §56.107; 45 CFR §46.107; 45 CFR §46 Subpart E
Responsible Authority:
Organizational Official
Involved Roles:
IRB Executive Chair; HRPP Administrator; IRB members; IRB Chair; IRB Vice-Chair; HRPP staff
Scope:
Evaluation of HRPP performance, IRB composition, member qualifications, training compliance, and subject outreach program
Key Activities:
Collection of updated résumés or curricula vitae; performance evaluation; review of regulatory compliance and audits; assessment of resources; update of IRB and organizational registrations
External Registry:
Office for Human Research Protections (OHRP) electronic filing system
Review Cycle:
Annual
Outputs:
Written evaluation; corrective and administrative actions; reappointment correspondence
Year:
2025
Region / City:
N/A
Theme:
Human Research Protection Program
Document Type:
Standard Operating Procedure (SOP)
Organization:
West Virginia University (WVU)
Author:
WVU OHRP Director
Target Audience:
Institutional Review Board (IRB) managers and investigators
Effective Period:
Quarterly
Approval Date:
12/15/2025
Revision History:
None
Year:
2026
Institution:
Western Washington University
Document Type:
Administrative Form
Target Audience:
Principal Investigators, Research Staff, Students
Purpose:
Requesting modifications to IRB/HRPP-approved research protocols
Submission Method:
Email attachments only
Compliance:
Federal regulations and university HRPP policy
Required Information:
Protocol number, study title, principal investigator, modification details, supporting materials
Processing Time:
5–7 business days for non-extensive reviews
Instructions:
Complete all applicable sections, attach relevant documents, submit only as Word document
Year:
2025
Region / City:
West Virginia
Topic:
Emergency response, HRPP
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
West Virginia University
Author:
WVU OHRP Director
Target Audience:
Institutional personnel, HRPP staff, researchers
Effective Period:
Ongoing
Approval Date:
12/15/2025
Revision Date:
None
Emergency Response Plans:
Yes
Scope of Document:
Procedures for HRPP emergency response
Related Documents:
HRP-040, HRP-060, HRP-063, HRP-101, HRP-108, HRP-351, HRP-352, HRP-542, HRP-801
Note:
Contextual Description
Year:
2022
Organization:
Human Research Protection Program (HRPP)
Document type:
Guidance / Procedural Notice
Audience:
Human research investigators and research staff
Region:
Not specified
Effective period:
Until further updates or resumption of normal operations
Date issued:
December 9, 2022
Related documents:
HRP-108 - FLOWCHART, HRP-351 - WORKSHEET
Year:
2024
Region / City:
Bellingham, WA
Topic:
Research Study Closure
Document Type:
Form
Organization / Institution:
Western Washington University
Author:
HRPP Office
Target Audience:
Researchers and Investigators
Effective Period:
Ongoing
Approval Date:
Not provided
Date of Last Revision:
Not provided
Year:
2025
Region / City:
USA / WVU
Subject:
Human Research Protection Program Evaluation
Document Type:
Standard Operating Procedure (SOP)
Institution / Organization:
WVU Office of Human Research Protection
Author:
WVU OHRP Director
Target Audience:
IRB members, IRB staff, Institutional Officials, Organizational Officials
Period of Validity:
Annual
Approval Date:
12/15/2025
Revision Date:
None
Note:
Year
Institution:
Western Washington University
Target Audience:
Researchers, Survey Participants
Year:
2024
Region / City:
Bellingham, Washington
Subject:
Modification Request
Document Type:
Form
Organization / Institution:
Western Washington University
Author:
HRPP
Target Audience:
Principal Investigators, Research Team Members, Students, HRPP Staff
Period of Validity:
Until modifications are approved
Approval Date:
N/A
Modification Date:
N/A
Institution:
Fred Hutchinson Cancer Center
Affiliated institutions:
University of Washington
Document type:
Model informed consent form
Research domain:
Clinical research
Regulatory framework:
45 CFR 46.116; 21 CFR 50.25
Oversight body:
Fred Hutch IRB; OHRP; FDA
Principal Investigator:
Chris Doe MD PhD
Intended use:
Consent for participation in clinical research studies
Population:
Prospective research participants, parents or guardians, legally authorized representatives
Study phases referenced:
Phase 1; Phase 2; Phase 3
Risk level:
More than minimal risk (when applicable)
Geographic scope:
United States
Language of document:
English
Year:
2024
Region / city:
China, New Zealand, Egypt, Philippines, Arab countries
Theme:
Scientific and technological cooperation, international research projects
Document type:
Agreement, Cooperation guidelines
Organization / institution:
Ministry of Science and Technology of China, New Zealand Ministry of Business, Innovation and Employment, Egyptian Ministry of Higher Education and Scientific Research, Department of Science and Technology of the Philippines
Author:
N/A
Target audience:
Government bodies, research institutions, international cooperation teams
Duration:
2-3 years
Approval date:
2024
Amendment date:
N/A
Document type:
Agreement
Institution:
Oregon State University
Program:
Human Research Protection Program
Oversight body:
Institutional Review Board
Research area:
Human subjects research
Parties:
Individual Investigator; Oregon State University
Compliance framework:
International, federal, state, and local laws and regulations
Training requirements:
Research ethics training; CITI or equivalent
Approval requirement:
Institutional Review Board review and approval
Signature fields:
Investigator; HRPP Administrator
Year:
2023
Region / city:
Not specified
Subject area:
Social Welfare, Social Work, Human Rights
Document type:
Course syllabus
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Students
Validity period:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2020
Jurisdiction:
United States
Subject area:
Human subjects research oversight
Document type:
Regulatory guidance and comparison
Issuing authority:
U.S. Department of Defense
Implementing body:
U.S. Army Medical Research and Development Command Office of Human and Animal Research Oversight
Referenced regulation:
DoDI 3216.02
Scope:
DoD-supported research involving human subjects
Affected organizations:
Non-DoD institutions receiving DoD support
Approval authority:
Office of Human Research Oversight
Focus:
IRB review, assurances, training, reporting, and protocol modifications