№ lp_1_16467
File format: docx
Character count: 43685
File size: 88 KB
Model informed consent document outlining required elements, regulatory references, and example language for enrolling human subjects in FDA- and IRB-regulated clinical research studies.
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
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.
Year:
2023
Region / City:
United States
Topic:
Human Subjects Research, Institutional Compliance
Document Type:
Government Form
Organization:
U.S. Department of Health & Human Services (HHS)
Author:
U.S. Government
Target Audience:
Institutions engaged in human subjects research
Effective Period:
Ongoing
Approval Date:
[Not provided]
Amendment Date:
[Not provided]
Note:
Year
Subject:
Research Ethics, Human Subjects, IRB Review
Document Type:
Application Form
Organization / Institution:
University of Mary Washington
Target Audience:
Researchers, Faculty, Students
Year:
2020
Region / City:
Oxford
Subject:
Education, Admissions
Document Type:
Interview Guidelines
Institution:
University of Oxford
Authors:
Dalveen, Jessica Goodman, Tom Crawford, Matthew Williams, Hannah Skoda, Will Poole, Ian (Admissions Operations Team)
Target Audience:
Prospective Students
Period of Action:
2020
Approval Date:
Not specified
Revision Date:
Not specified
Year:
2026
Region / City:
United States
Topic:
Human subjects, clinical trials, enrollment reporting
Document type:
Guidelines
Organ / Institution:
NIH
Author:
Not specified
Target audience:
Researchers and investigators conducting human subjects studies
Period of validity:
01/31/2026
Date of approval:
Not specified
Date of amendments:
Not specified
Note:
Year
Subject Matter:
Human Subjects Research Determination
Document Type:
Template
Institution:
Auburn University
Target Audience:
Researchers and Investigators
Note:
File Number
Region / City:
Delaware, New Castle County, Kent County, Sussex County
Theme:
Guardianship, Consent Affidavit
Document Type:
Legal Affidavit
Authority / Institution:
The Family Court of the State of Delaware
Author:
Affiant
Target Audience:
Parents and guardians involved in custody and guardianship matters
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
Not applicable
Region / City:
Not applicable
Subject:
Research ethics and manuscript submission
Document Type:
Submission Template
Organization / Institution:
Not applicable
Author:
Not applicable
Target Audience:
Researchers, Authors submitting manuscripts
Period of validity:
Not applicable
Approval Date:
Not applicable
Date of Changes:
Not applicable
Year:
2020
Region / City:
United Kingdom
Topic:
Patient consent, publication, medical materials
Document Type:
Consent Form
Organization:
British Association of Dermatologists
Author:
Not specified
Target Audience:
Health professionals, researchers, clinicians
Period of validity:
N/A
Approval Date:
April 2020
Modification Date:
N/A
Context:
Consent form for patients or their representatives to allow the British Association of Dermatologists to use medical materials in publications, ensuring anonymity and outlining the terms of usage.
Year:
2016
Region / City:
Wisconsin
Topic:
Background Check Consent
Document Type:
Form
Organization / Institution:
Wisconsin Department of Administration
Author:
Wisconsin Department of Administration
Target Audience:
Job applicants in Wisconsin
Effective Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified