№ files_lp_4_process_3_104436
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Template for preparing a biomedical research protocol including study rationale, design, participant criteria, ethical safeguards, and procedural instructions for conducting research in compliance with institutional and federal regulations.
Year:
2026
Institution:
West Virginia University
Department:
Office of Human Research Protections (OHRP)
Document Type:
Protocol Template
Intended Audience:
Research teams preparing biomedical study protocols
Document Version:
Draft/Template
Sections Included:
Study Summary, Background, Objectives, Participant Criteria, Vulnerable Populations, Recruitment Methods, Consent Process, HIPAA, Study Interventions, Data Management, Safety Monitoring, Appendices
Regulatory References:
NIH, FERPA, HIPAA
Instructions:
Remove italicized guidance and mark non-applicable sections as “N/A”
Usage Notes:
Maintain electronic copy and update revision history for approved studies
Price: 8 / 10 USD
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Year:
2016
Region / City:
United States
Topic:
Electronic Informed Consent (eIC)
Document Type:
Guidance
Agency / Institution:
Office for Human Research Protection (OHRP), Food and Drug Administration (FDA)
Author:
Office for Human Research Protection (OHRP), FDA
Target Audience:
Researchers, IRBs, Clinical Investigators, and Study Participants
Period of Validity:
Ongoing
Approval Date:
December 2016
Date of Revisions:
Not specified
Jurisdiction:
United States
Regulatory framework:
DHS HHS OHRP 45 CFR 46 §46.116
Thematic area:
Human subjects research ethics
Document type:
Compliance checklist
Subject matter:
Required and additional elements of informed consent
Target audience:
Investigators and research institutions
Scope:
Clinical trials and research involving human participants
Key provisions:
Basic elements of informed consent; Additional elements as appropriate; Disclosure regarding ClinicalTrials.gov
Year:
2023
Region / City:
Nashville, TN
Topic:
Institutional Review Board, Human Research Protection
Document Type:
Committee Meeting Information
Organization:
Vanderbilt University
Author:
Vanderbilt Human Research Protection Program
Target Audience:
Vanderbilt researchers, medical professionals, committee members
Effective Date:
July 3, 2023
Meeting Time:
Every Thursday at 11:00 AM
Alternate Members:
Listed for different specialties
Contact Information:
VHRPP office (322-2918)
Year:
2024
Region / City:
Vanderbilt
Topic:
Human Research Protection
Document Type:
Meeting Schedule
Organization / Institution:
Vanderbilt University
Author:
Vanderbilt Human Research Protection Program
Target Audience:
Institutional Researchers, IRB Members
Effective Date:
April 9, 2024
Meeting Frequency:
Weekly
Voting Members:
10
Alternate Members:
30
Context:
This document lists the members and details of the Health Sciences Committee 3 for the Vanderbilt IRB, including meeting information and roles of voting and alternate members.
Year:
2023
Region / City:
Morgantown, West Virginia
Subject:
Social Work
Document Type:
Application Form
Institution:
West Virginia University School of Social Work
Author:
West Virginia University School of Social Work
Target Audience:
Prospective Social Work Students
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Year
Year:
2026
Institution:
West Virginia University
Document Type:
Guidelines / Instructions
Target Audience:
Student organizations
Required Documents:
Constitution/Bylaws, Tax ID Number, Student Organization Certification Form, Letter of Authorization, Meeting Minutes, Identification Forms
Process:
By appointment only
Contact:
Lexis Ring ([email protected])
Deadline:
Prior to appointment scheduling
Year:
2026
Institution:
West Virginia University
Protocol Number:
HRP-502g
Document Type:
Research Authorization Form
Author:
West Virginia University Office of Human Research Protections
Target Audience:
Research participants
Scope:
Use and disclosure of protected health information for clinical research purposes
Expiration:
End of the research project or upon written cancellation
Regulatory Compliance:
HIPAA, FDA (if applicable), U.S. Department of Health and Human Services, Foreign Regulatory Agencies (if applicable)
Year:
2025
Institution / Department:
West Virginia University (WVU), Office of Human Research Protections (OHRP)
Document Type:
Standard Operating Procedure (SOP)
Purpose:
Ensure awareness of updates approved by external IRBs or local investigator changes
Owner:
WVU OHRP Director
Approver:
WVU Vice President of Research
Responsible Staff:
Reliance Coordinator, IRB Staff
Scope:
External IRB submissions and local site modifications
Revisions:
None
Materials Referenced:
HRP-024, HRP-055, HRP-309, HRP-441, HRP-830, HRP-859
Procedures:
Submission of RNI and Site Modifications, review of updates, personnel qualification checks, COI and HIPAA compliance, ancillary reviews, local event reporting, finalization of documents and letters
Compliance Requirements:
IRB reliance agreements, sIRB reporting, local oversight responsibilities
Year:
2020-2021
Region / City:
Morgantown, West Virginia
Topic:
Disabilities, Education, Training
Document Type:
Handbook
Institution:
West Virginia University
Author:
Not specified
Target Audience:
WVU students pursuing health and human service degrees, trainees, and staff
Duration:
2020-2021 academic year
Approval Date:
Not specified
Modification Date:
Not specified
Year:
Not specified
Region / City:
Not specified
Subject:
Software Licensing Agreement
Document Type:
Legal Agreement
Organization / Institution:
Schrödinger, L.L.C.
Author:
Schrödinger, L.L.C.
Target Audience:
Licensee, Users
Effective Period:
3 years
Approval Date:
Not specified
Amendment Date:
Not specified
License Type:
Not specified
Year:
Not specified
Region / City:
Not specified
Theme:
Wood doors specification for construction projects
Document Type:
Specification
Organization / Institution:
Simpson Door Company
Author:
Not specified
Target Audience:
Designers and builders
Period of validity:
Not specified
Approval Date:
Not specified
Date of amendments:
Not specified
Year:
2015
Region / City:
Winchester
Subject:
Affordable Housing, Urban Planning
Document Type:
Planning Supplementary Document (SPD)
Authority / Organization:
Winchester City Council
Author:
Not specified
Target Audience:
Housing developers, urban planners, local authorities
Validity Period:
Not specified
Approval Date:
February 2008
Amendment Date:
Not specified
Year:
2025
Region / City:
Geneva
Subject:
Plant variety protection, Test Guidelines
Document Type:
Report
Institution:
International Union for the Protection of New Varieties of Plants (UPOV)
Author:
UPOV Technical Committee
Target Audience:
UPOV members, plant variety protection authorities
Period of Validity:
2025
Approval Date:
October 2, 2025
Date of Amendments:
None
Year:
2022
Region / City:
N/A
Topic:
Accreditation Standards, Program Evaluation
Document Type:
Checklist
Organization / Institution:
ACEND
Author:
N/A
Target Audience:
Institutions seeking accreditation
Period of Validity:
N/A
Approval Date:
N/A
Date of Modifications:
N/A
Year:
2015
Region / city:
Saudi Arabia
Topic:
Launch of SECB electronic portal, regulation of service charges
Document Type:
Circular
Organization / institution:
Saudi Exhibition and Convention Bureau (SECB)
Author:
Saudi Exhibition and Convention Bureau (SECB)
Target Audience:
Companies, institutions organizing exhibitions and conferences, hotel managers, exhibition and conference venues managers, event hall managers
Effective Period:
2015 onwards
Approval Date:
8 November 2015
Modification Date:
Not specified
Year:
2023-2024
Region / city:
Kazakhstan
Theme:
External audit remuneration
Document type:
Report
Organization / institution:
JSC NC KTZ, Deloitte LLP
Author:
Not specified
Target audience:
Internal stakeholders, auditors
Period of validity:
2023-2024
Approval date:
Not specified
Date of changes:
Not specified
Note:
Summary
Note:
Year
Topic:
Research Study
Document Type:
Consent Form
Institution:
University of Granada
Target Audience:
Participants of the research study