№ lp_2_3_38403
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This document is a checklist to assist IRB members or designated reviewers in evaluating research proposals involving children, ensuring regulatory compliance in areas such as risk assessment, parental consent, and the appointment of an advocate for children who are wards of the state.
Note:
IRB Number
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2025
Region / City:
University of Minnesota
Topic:
IRB Research Review
Document Type:
Worksheet
Organization / Institution:
University of Minnesota
Author:
Not specified
Target Audience:
IRB members, researchers
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A worksheet outlining the criteria for approval of research by an Institutional Review Board (IRB), detailing the required considerations and safeguards for participant protection during research studies.
Document type:
Institutional Review Board checklist
Subject matter:
Waiver of written documentation of informed consent
Regulatory framework:
Human subjects research regulations
Related worksheet:
Criteria for Approval (HRP-314)
Review procedures:
Initial review, continuing review, modification, convened IRB review, expedited review
Applicability:
Research involving waiver of written documentation of consent
Risk level referenced:
Minimal Risk
FDA regulation status:
Not FDA-regulated
Rule referenced:
2018 Rule
Issuing body:
IRB Office
Responsible party:
Designated Reviewer or convened IRB
Consent provisions:
Oral consent script and written information requirements
Signature required:
Yes
Year:
2026
Document Type:
Checklist
Institution:
Institutional Review Board (IRB)
Target Audience:
IRB Members, IRB Chair, Vice Chair, Research Compliance Administrator
Scope:
Research involving prisoners as subjects
Application:
Initial review, continuing review, modifications, expedited review
IRB Number:
Specified per protocol
Risk Assessment:
Minimal risk required for subjects
Selection Procedures:
Fair and random selection of prisoner participants
Information Delivery:
Comprehensible language for subjects
Follow-up Provision:
Arrangements for post-participation care considered
Prisoner Representation:
Included in review and documentation
Year:
Not specified
Region / City:
Not specified
Subject:
Human subjects research
Document type:
Instructional form
Organization / Institution:
Baylor University
Author:
Not specified
Target audience:
Researchers, IRB members
Effective period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2025
Region / city:
Bozeman, Montana
Field:
Plant Science, Ecology, Environmental Science, Agriculture
Document Type:
Scholarship application
Organization / institution:
Gallatin Empire Garden Club
Author:
Helen Tobol
Target audience:
Sophomore, junior students
Application deadline:
April 1 2025
Required documents:
Montana State University Transcript, two references, short story
Additional information:
$1000
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
Year:
2022
Region / City:
New York, NY
Topic:
Data Safety Monitoring Plan (DSMP) for human subjects research
Document Type:
Guidance
Institution:
Institutional Review Board (IRB)
Author:
Not specified
Target Audience:
Researchers and Investigators conducting human subjects research
Effective Period:
Not specified
Approval Date:
03.07.2022
Amendment Date:
Not specified
Note:
Year
Topic:
Human subjects research, participant compensation, IRS regulations
Document Type:
Institutional Policy
Institution:
Purdue University
Target Audience:
Researchers, Institutional Review Board
Year:
2021
Region / City:
MCW
Topic:
Quality Improvement, Human Subjects Research
Document Type:
Checklist
Organization / Institution:
Medical College of Wisconsin
Author:
Not specified
Target Audience:
Researchers, Medical Professionals
Effective Period:
Not specified
Approval Date:
7/1/2021
Date of Changes:
7/1/2021
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.