№ files_lp_3_process_7_062101
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A regulatory compliance checklist outlining required determinations and documentation procedures for IRB review of research protocols involving prisoners as human subjects under federal and Department of Defense regulations.
Document Type:
Regulatory compliance checklist
Subject:
Institutional Review Board review criteria for research involving prisoners
Applicable Regulations:
Common Rule Subpart C and Subpart D; Department of Defense regulations
Review Types Covered:
Initial review; continuing review; modification review; expedited review; convened IRB review
Responsible Body:
Institutional Review Board (IRB)
Administrative Office:
Human Research Support Office (HRSO/HSRO)
Related Worksheet:
HRP-314 - WORKSHEET - Criteria for Approval
Scope:
Research involving prisoners as subjects, including federally funded and DOD or DHS supported research
Risk Thresholds Referenced:
Minimal risk; greater than minimal risk
Special Requirements:
Consultation with Prisoner Representative for federally funded research
Documentation Requirement:
Attachment to Submit Non-Committee Review or Submit Committee Review activity; retention in protocol file
Sections Included:
Non-DOD or DHS regulated research with post-enrollment incarceration; DOD and DHS supported research with post-enrollment incarceration; research enrolling prisoners as subjects
Form Fields:
IRB Number; Investigator
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2011
Region / City:
Washington, D.C.
Topic:
Educational characteristics of prisoners
Document Type:
Working Paper
Organization / Institution:
U.S. Census Bureau
Author:
Stephanie Ewert, Tara Wildhagen
Target Audience:
Researchers, policymakers, and individuals concerned with incarceration and educational attainment
Period of Validity:
N/A
Date of Approval:
N/A
Date of Changes:
N/A
Year:
2025
Region / City:
Australia
Theme:
Prisoner Release Procedures
Document Type:
Operating Policy and Procedure
Authoring Agency:
Department of Justice
Target Audience:
Correctional staff and affiliated agencies
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2014-2015
Region / City:
Somaliland
Theme:
Mental health, human rights
Document type:
Report
Author:
Human Rights Watch
Target audience:
General public, policymakers, health professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Contextual description:
Report on the poor treatment and human rights abuses faced by individuals with mental health conditions in Somaliland, based on visits to hospitals and other facilities.
Year:
2024
Region / city:
Ukraine, Russian Federation
Theme:
Human rights, prisoners of war, torture
Document type:
Report
Organization / institution:
Office of the United Nations High Commissioner for Human Rights
Author:
United Nations
Target audience:
Policymakers, human rights organizations, international community
Period of validity:
1 June to 31 August 2024
Date of approval:
2 October 2024
Date of changes:
N/A
Year:
2019
Region / City:
England and Wales
Theme:
Drug recovery, Prison systems
Document type:
Research Article
Institution:
University of York, Centre for Substance Use Research, University of Cambridge
Authors:
Charlie Lloyd, Geoff Page, Neil McKeganey, Christopher Russell, Alison Liebling
Target Audience:
Researchers, policymakers, social workers, professionals in drug recovery
Period of validity:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Title as printed:
21st21stPrayers for Eritrean Church leaders, Prisoners and Families
Thematic focus:
Religious persecution and imprisonment in Eritrea
Geographical focus:
Eritrea
Document type:
Prayer appeal and advocacy text
Referenced publication:
“Prayer the Mightiest Force in the World” by Frank Laubach
Primary subjects:
Detained Christian leaders and unnamed prisoners
Named individuals:
Rev. Haile Naizge; Dr. Kuflu Gebremeskel; Rev Million Gebreselassie; Dr Futsum Gebrenegus; Rev Dr Tekleab Menghisteab; Rev. Gebremedhin Gebregiorgis; Rev Kidane Weldou
Period referenced:
Detentions since 2004–2005; UN findings 1991–2016
Key themes:
Indefinite detention; enforced disappearance; torture; incommunicado imprisonment; faith and prayer
Biblical references cited:
Psalms 105:8; Isaiah 45:2; Acts 16:26; Psalm 139:7–10; Deuteronomy 31:8; Isaiah 35:4; Psalm 10:12; Chronicles 20:12; Jeremiah 29:12
Call to action:
Pray in Faith; Speak in Love; Act in Unity; #Voices4Justice
Year:
2026
Location:
Maynooth, Co Kildare
Sector:
Religious/Charity
Document Type:
Job Description
Author:
Irish Catholic Bishops’ Conference
Target Audience:
Job Applicants
Start Date:
2026
End Date:
2029
Approval Date:
2026
Amendment Date:
N/A
Year:
2025
Region / city:
Australia
Topic:
Aboriginal prisoners management, cultural support in corrections
Document Type:
Policy and Procedure
Agency / institution:
Department of Justice
Author:
Not specified
Target audience:
Department of Justice staff, prison management
Effective period:
Ongoing
Approval date:
Not specified
Amendment date:
Not specified
Year:
2018
Region / city:
Australia
Theme:
Disability, Corrections, Justice System
Document type:
Policy and Procedure
Agency / institution:
Department of Justice
Author:
Department of Justice
Target audience:
Prison staff, Disability Coordination Team
Period of validity:
2018-2023
Approval date:
2018
Date of amendments:
None mentioned
Year:
2018
Region / City:
Australia
Topic:
Prison Management, Education, Legal Defence
Document Type:
Policy
Author:
Department of Corrective Services
Target Audience:
Prison management, prisoners, legal representatives
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2018
Region / city:
Australia
Topic:
Prisoner healthcare, terminal medical condition
Document type:
Policy and procedure
Organ / institution:
Department of Justice
Author:
N/A
Target audience:
Correctional staff, medical professionals
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2013
Region / City:
California, United States
Document Type:
Editorial
Author:
Wilbert Rideau
Target Audience:
General public, policymakers, prison reform advocates
Period of Validity:
Ongoing
Approval Date:
July 16, 2013
Date of Changes:
N/A
Year:
2026
Institution:
NYU Langone Health
Document type:
Research appendix
Target population:
Prisoners and involuntarily detained individuals
Regulatory compliance:
NYU Langone Human Research Protections Policy and Procedure Manual
Approval body:
Institutional Review Board (IRB)
Risk categories:
1, 2, 3, 4
Includes minors:
Yes/No (depending on study)
Permissions:
Facility and authorities approval required
Follow-up care:
Provision for post-participation examination or care
Coercion considerations:
Evaluation of participation advantages relative to general prisoner population
Selection fairness:
Procedures for subject selection within the prison
Information clarity:
Materials provided in understandable language
Parole considerations:
Participation does not affect parole decisions
Year:
2026
Region / City:
Pine Ridge Indian Reservation, South Dakota
Theme:
Indigenous Rights, Colonial History, U.S. Government Treaties
Document Type:
Testimonial, Legal and Historical Analysis
Organization / Institution:
Bureau of Indian Affairs
Author:
Mani 9 (Wowitan Yuha, David Swallow, Jr.)
Target Audience:
Native American Communities, Legal Experts, Activists
Period of Application:
1800s - Present
Date of Approval:
1980s
Date of Changes:
1990s
Context:
A historical and legal analysis of the loss of the Black Hills by the Lakota people, highlighting the violation of treaties and their continued struggle for sovereignty and rights over the sacred land.
Year:
2025
Region / City:
Isle of Man
Document Type:
Church Newsletter
Author:
Father Philip
Effective Period:
12th October 2025
Approval Date:
12th October 2025
Modification Date:
None
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