№ lp_1_2_19854
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This document is a checklist for IRB members or Designated Reviewers to evaluate and document determinations required by regulations when the consent process in research involves a waiver or alteration.
Year:
2025
Region / city:
Not specified
Topic:
Research ethics, Consent process
Document type:
Checklist
Organization / institution:
Not specified
Author:
Not specified
Target audience:
IRB members, Designated Reviewer
Validity period:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
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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
Note:
Region / City
Subject:
Limited IRB Review, Research Ethics
Document Type:
Checklist
Target Audience:
IRB Members, Designated Reviewers
Contextual Description:
Checklist for Limited IRB Review in research studies with conditions for exemption, detailing required determinations and methods for documentation.
Note:
IRB Number
Year:
2025
Document Number:
HRP-081
Author:
Huron Consulting Group
Approver:
HRPP Director
Purpose:
Establish process for removing an IRB
Scope:
Internal and external IRBs at VA medical facilities
Related Policies:
HRP-601 - DATABASE - IRB Roster, HRP-561 - LETTER - IRB Member Thank You
References:
45 CFR §46.107, 45 CFR §46.103(b)(3), 45 CFR §46.115(a)(5), 21 CFR §56.107, 21 CFR §56.115(a)(5), AAHRPP elements II.1.A, II.1.C, VHA Directive 1200.05(3), VHA Directive 1058
Revision Date:
08/07/2025
Responsibilities:
IRB staff members
Procedure Type:
SOP
Context:
Standard operating procedure outlining the step-by-step process for unregistering an IRB and updating related records in VA medical facilities.
Note:
Year
Organization / Institution:
Department of Housing and Public Works
Context:
Form used by external organizations to request installations or alterations to properties leased from the Department of Housing and Public Works.
Year:
2023
Region / City:
United States
Topic:
Aviation, Airport Construction
Document Type:
Official Notice
Authority / Institution:
Federal Aviation Administration (FAA)
Author:
Federal Aviation Administration (FAA)
Target Audience:
Airport operators, aviation authorities, contractors
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
Not specified
Note:
Year
Year:
1998
Region / city:
United States
Topic:
Repair and alteration services
Document type:
Contract Terms and Conditions
Agency / institution:
Federal Government
Author:
Not specified
Target audience:
Contractors, Government Agencies
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Note:
Year
Region / City:
Olympia, WA
Topic:
Liquor License Alterations
Document Type:
Form
Organization / Institution:
Washington State Liquor and Cannabis Board
Author:
Washington State Liquor and Cannabis Board
Target Audience:
Liquor license holders in Washington State
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Date:
Click to enter a date
To:
District Location & Design Engineer
From:
[Not specified]
Project Information:
UPC: [Not specified]
State Project Number:
[Not specified]
Federal Project Number:
[Not specified]
District:
[Not specified]
Project Description:
[Not specified]
Start Location:
[Not specified]
End Location:
[Not specified]
Funding Source:
[Not specified]
Road Information:
Road Name: [Not specified]
Route Number:
[Not specified]
Functional Classification:
[Not specified]
VDOT GS Standard:
[Not specified]
Design Speed:
[Not specified]
Posted Speed:
[Not specified]
Pedestrian Facility Elements:
[Types and criteria not specified]
Form Submission Certification:
Required
Independent Policy Completeness Review:
Required
District Approval:
VDOT Approval by District Location & Design Engineer
Year:
2013
Region / City:
Reedy Creek
Subject:
Construction Fire Safety
Document Type:
Checklist
Organization / Institution:
Reedy Creek Fire Department
Author:
Not specified
Target Audience:
Construction teams, general contractors, fire safety managers
Period of Validity:
Ongoing until updated
Approval Date:
Not specified
Date of Amendments:
Not specified
Note:
Year
Context:
A formal document used to notify and approve alterations in the network, detailing project, scope, and approval processes.
Year:
2023
Region / City:
Tasmania
Subject:
Electrical Work Request
Document Type:
Form
Organization:
Hydro Tasmania
Author:
Momentum Energy
Target Audience:
Customers requesting electrical connection, metering change, or service alteration
Period of validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Note:
Year
Subject:
HIPAA Privacy, Research Compliance
Document Type:
Checklist
Target Audience:
HIPAA Research Privacy Officers, IRB Members
Year:
2026
Region / City:
Malta
Theme:
Marine Fuel Station Design
Document Type:
Technical Proposal
Institution:
Malta Environment and Planning Authority (MEPA)
Author:
Competent Person
Target Audience:
Regulatory Authorities, Engineers, Developers
Period of Effectiveness:
N/A
Approval Date:
N/A
Date of Last Changes:
N/A
Type of document:
Formal correspondence
Subject:
Employment termination threat related to mandated vaccination
Related legislation or policy:
Public Health Directive; workplace vaccination policy
Parties involved:
Employee; Employer
Issue addressed:
Potential termination or prejudicial alteration of employment
Request made:
Reconsideration of termination; extension of decision deadline
Date referenced:
Friday, 22 October 2021
Context:
Covid-19 vaccination requirement in the workplace
Year:
2011
Region / City:
Brisbane
Subject:
Stage rail removal and safety permit
Document Type:
Permit
Organization:
BCEC
Author:
BCEC Risk Department
Target Audience:
Event organizers, contractors, exhibitors
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Document type:
Survey report form
Issuing authority:
National Regulator
Purpose:
Monitoring and recording initial construction or alteration of vessel accommodation and arrangement
Scope:
Operating stations, personnel safety, navigation signals, accommodation spaces, access, escape and evacuation
Applicable standard:
NSCV Table 30
Subject:
Vessel compliance assessment
Intended users:
Accredited surveyors
Information required:
Minimum set of information expected by the National Regulator
Assessment outcome:
In order / Not in order / Not applicable
Year:
2025
Region / City:
Milwaukee, WI
Subject:
Construction, Alteration, or Repair Contracts
Document Type:
Solicitation
Issuing Organization:
Department of Veterans Affairs
Author:
Great Lakes Acquisition Center
Target Audience:
Contractors, Service-Disabled Veteran-Owned Small Businesses (SDVOSB)
Period of Validity:
5 years
Approval Date:
2025-02-28
Modification Date:
N/A