№ files_lp_4_process_2_68697
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Guidance document detailing criteria for assessing when an organization is considered engaged in non-exempt human research under federal regulations, including FDA-specific exceptions.
Year:
2025
Document type:
Worksheet
Regulatory focus:
Human Research Protection and Engagement
Applicable regulations:
DHHS Common Rule, FDA regulations
Intended users:
Designated/Staff Reviewers
Purpose:
Determining organizational engagement in Human Research
Scope:
Non-exempt Human Research
Reference documents:
HRP-401 Checklist, FDA Information Sheet January 1998
Date issued:
12/16/2025
Retention requirement:
Not required
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2021
Region / City:
Work Zone
Topic:
Traffic Safety
Document Type:
Technical Specification
Agency / Organization:
NCDOT
Author:
Unknown
Target Audience:
Engineers, Contractors
Effective Period:
Until 12/16/2025
Approval Date:
5/10/2021
Amendment Date:
12/16/2025
Note:
Contextual Description
Document code:
HRP-301
Date:
12/16/2025
Document type:
Worksheet
Subject:
Institutional Review Board review materials preparation
Topic:
Human research oversight and protocol review documentation
Purpose:
Guidance for preparing materials for IRB review processes
Institutional body:
Institutional Review Board (IRB)
Audience:
IRB staff, IRB members, designated reviewers, scientific or scholarly reviewers, consultants
Related forms and documents:
HRP-310, HRP-311, HRP-312, HRP-314, HRP-314a, HRP-315, HRP-316, HRP-317, HRP-318, HRP-320, HRP-321, HRP-323, HRP-333, HRP-334, HRP-410, HRP-411, HRP-412, HRP-413, HRP-414, HRP-415, HRP-416, HRP-417, HRP-418, HRP-419, HRP-441
Review stages covered:
Initial review, continuing review, review of modifications, review of new information
Special review categories:
Humanitarian Use Device (HUD)
Regulatory references:
DHHS approved protocol and consent documentation; HIPAA authorization waiver
Content structure:
Checklist of required materials for different IRB review roles and submission types
Year:
2024
Region / City:
Beirut
Theme:
Water Supply, Stakeholder Engagement
Document Type:
Plan
Institution:
Government of Lebanon, World Bank
Author:
Not specified
Target Audience:
Stakeholders, Government Agencies, World Bank
Duration:
2024-2025
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2024
Region / city:
Arlington, VA
Topic:
High-leverage practices in education
Document type:
Guide
Institution:
CEEDAR Center, Council for Exceptional Children
Author:
T. C. Aceves, M. J. Kennedy, A. L. Archer, C. A. Hughes, A. I. Hashey, T. L. Kaczorowski, D. M. DiCesare
Target audience:
Educators, Special Education Teachers
Period of validity:
Not specified
Approval date:
Not specified
Date of revisions:
Not specified
Context:
A guide outlining strategies for promoting active student engagement through teacher questioning methods, with specific tools and resources for educators to use in various instructional phases.
Year:
2024
Region / City:
Doncaster
Topic:
Community Engagement, Environmental Sustainability
Document Type:
Grant Application Form
Organization:
Climate Doncaster
Target Audience:
Community Organizations
Period of Activity:
November 2024 – February 2025
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2022
Region / city:
Afghanistan
Subject:
Stakeholder Engagement Plan
Document type:
Plan
Organization / institution:
Food and Agriculture Organization of the United Nations (FAO)
Author:
FAO
Target audience:
Stakeholders involved in Afghanistan Emergency Food Security Project
Period of validity:
2022-2023
Approval date:
March 2022
Date of changes:
N/A
Contextual description:
A plan outlining the stakeholder engagement process for the Afghanistan Emergency Food Security Project, detailing the strategies for identifying, engaging, and communicating with various stakeholders, including vulnerable populations.
Year:
2019
Region / City:
Uganda
Theme:
Stakeholder Engagement, Environmental Protection, Climate Change
Document Type:
Framework
Organization:
Ministry of Water and Environment
Author:
Ministry of Water and Environment
Target Audience:
Stakeholders, Government Agencies, Environmental Organizations
Effective Period:
October 2019 – January 2020
Approval Date:
20 December 2019
Date of Changes:
Not specified
Year:
2022
Region / City:
Horn of Africa (Kenya, Somalia, Ethiopia, Sudan, Djibouti)
Topic:
Groundwater management, Climate change resilience
Document Type:
Stakeholder Engagement Plan
Agency / Institution:
Government of Kenya, Ministry of Water & Sanitation and Irrigation
Author:
Not specified
Target Audience:
Stakeholders involved in water and groundwater management
Period of Validity:
Ongoing
Approval Date:
January 2022
Date of Changes:
Not specified
Year:
2025
Region / City:
Queensland, Australia
Topic:
Stakeholder Engagement
Document Type:
Template
Organization / Institution:
Department of Housing and Public Works, Queensland Government
Author:
Department of Housing and Public Works, Queensland Government
Target Audience:
Government agencies
Period of validity:
2025 onwards
Approval Date:
2025
Date of Changes:
August 2025
Organisation:
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Type of document:
Early market engagement briefing
Sector:
Healthcare
Specialty:
Orthopaedics
Geographic scope:
North West England
Location:
Wrightington Hospital, Wigan
Year:
2024
Purpose:
Exploration of partnership opportunities for private orthopaedic patient services
Partnership model:
Strategic multi-phase public–private partnership
Current private provision:
John Charnley Wing
Private patient income:
£6.6 million (2024/25)
Strategic framework:
Wrightington Strategy 2023–2030
Regulatory context:
NHS Foundation Trust
Market focus:
UK private orthopaedic healthcare market
Target partners:
Experienced private healthcare providers
Source type:
Institutional briefing and market engagement material
Year:
2020
Region / City:
Kenya
Subject:
Education
Document Type:
Stakeholder Engagement Plan
Institution:
Ministry of Education, State Department of Early Learning and Basic Education
Author:
Ministry of Education, State Department of Early Learning and Basic Education
Target Audience:
Stakeholders in the education sector, including government officials, teachers, learners, and development partners
Period of Effectiveness:
September 2020 onwards
Approval Date:
September 2020
Amendment Date:
N/A
Year:
2023
Region / City:
Ethiopia
Theme:
Human Capital, Education, Health, Nutrition, Crisis Response
Document Type:
Stakeholder Engagement Plan
Organization / Institution:
Ministry of Finance, Government of Ethiopia
Author:
Ministry of Finance
Target Audience:
Project stakeholders, including government agencies, NGOs, private sector, and affected communities
Period of Validity:
April 2023 - ongoing
Approval Date:
April 2023
Date of Amendments:
Not specified
Country:
United Republic of Tanzania
Ministry:
Ministry of Finance
Project:
Financial Access for Sustainable and Transformational (FAST) Growth (P500471)
Type:
Draft Stakeholder Engagement Plan
Date:
April 2024
Target Audience:
Project stakeholders including SMEs, start-ups, and financial institutions
Scope:
Tanzania Mainland and Zanzibar
Components:
Access to finance for SMEs, credit infrastructure, value chain financing, grievance mechanism, monitoring and reporting
Year:
2023
Region / City:
Accra, Ghana
Topic:
Stakeholder Engagement, Financial Stability, Government Policies
Document Type:
Plan
Organization / Institution:
Ministry of Finance, Ghana
Author:
Ministry of Finance
Target Audience:
Stakeholders in the financial sector, regulatory agencies, government institutions
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2023
Region / City:
Canberra
Topic:
Media Communications and Engagement
Document Type:
Policy
Organization / Institution:
Canberra Health Services
Author:
Policy Team
Target Audience:
CHS employees, Media Team
Period of Effectiveness:
Ongoing
Approval Date:
10/08/2023
Date of Amendments:
10/08/2023
Year:
2020
Region / City:
Queensland
Subject:
Youth Engagement, Government Policy, Aboriginal and Torres Strait Islander Youth
Document Type:
Charter
Organization / Institution:
Queensland Government
Author:
Queensland Government
Target Audience:
Young people, government officials, community organizations
Effective Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2024
Region / city:
Victoria, Australia
Theme:
Stakeholder engagement, community consultation, cultural heritage
Document Type:
Report
Organization / institution:
AusNet
Author:
Unknown
Target Audience:
Stakeholders, Traditional Owners, governmental and regulatory bodies, community members
Period of validity:
Ongoing
Approval Date:
November 2024
Date of changes:
Not specified