№ lp_2_1_20792
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Regulatory compliance checklist outlining mandatory and additional informed consent elements for human subjects research under U.S. federal regulations, including disclosure requirements for clinical trials registration.
Jurisdiction:
United States
Regulatory framework:
DHS HHS OHRP 45 CFR 46 §46.116
Thematic area:
Human subjects research ethics
Document type:
Compliance checklist
Subject matter:
Required and additional elements of informed consent
Target audience:
Investigators and research institutions
Scope:
Clinical trials and research involving human participants
Key provisions:
Basic elements of informed consent; Additional elements as appropriate; Disclosure regarding ClinicalTrials.gov
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Year:
2016
Region / City:
United States
Topic:
Electronic Informed Consent (eIC)
Document Type:
Guidance
Agency / Institution:
Office for Human Research Protection (OHRP), Food and Drug Administration (FDA)
Author:
Office for Human Research Protection (OHRP), FDA
Target Audience:
Researchers, IRBs, Clinical Investigators, and Study Participants
Period of Validity:
Ongoing
Approval Date:
December 2016
Date of Revisions:
Not specified
Year:
2023
Region / City:
Nashville, TN
Topic:
Institutional Review Board, Human Research Protection
Document Type:
Committee Meeting Information
Organization:
Vanderbilt University
Author:
Vanderbilt Human Research Protection Program
Target Audience:
Vanderbilt researchers, medical professionals, committee members
Effective Date:
July 3, 2023
Meeting Time:
Every Thursday at 11:00 AM
Alternate Members:
Listed for different specialties
Contact Information:
VHRPP office (322-2918)
Year:
2024
Region / City:
Vanderbilt
Topic:
Human Research Protection
Document Type:
Meeting Schedule
Organization / Institution:
Vanderbilt University
Author:
Vanderbilt Human Research Protection Program
Target Audience:
Institutional Researchers, IRB Members
Effective Date:
April 9, 2024
Meeting Frequency:
Weekly
Voting Members:
10
Alternate Members:
30
Context:
This document lists the members and details of the Health Sciences Committee 3 for the Vanderbilt IRB, including meeting information and roles of voting and alternate members.
Year:
2026
Institution:
West Virginia University
Department:
Office of Human Research Protections (OHRP)
Document Type:
Protocol Template
Intended Audience:
Research teams preparing biomedical study protocols
Document Version:
Draft/Template
Sections Included:
Study Summary, Background, Objectives, Participant Criteria, Vulnerable Populations, Recruitment Methods, Consent Process, HIPAA, Study Interventions, Data Management, Safety Monitoring, Appendices
Regulatory References:
NIH, FERPA, HIPAA
Instructions:
Remove italicized guidance and mark non-applicable sections as “N/A”
Usage Notes:
Maintain electronic copy and update revision history for approved studies
Year:
2002
Date Issued:
04/01/2002
Date Revised:
02/06/2020
Jurisdiction:
Commonwealth of Pennsylvania
Organization:
Health & Human Services Delivery Center
Issuing Authority:
Direction of the Chief Technology Officer
Authorizing Officer:
Jon Arnold
Document Number:
STD-DHS001
Domain:
Appendix II
Category:
Summary of IT Environment
Document Type:
Information Technology Standard
Subject:
Information technology infrastructure and standards
Scope:
Department-wide
Intended Audience:
Information technology contractors and vendors
Coverage:
Desktop platforms, servers, operating systems, software, databases, and applications
Source Type:
Government technical standard
Department:
Department of Health and Human Services
Issuing body:
Office of Management and Acquisition, Office of Acquisition and Grants Management
Document type:
Contracting guide
Subject matter:
Management and control of government property under HHS contracts
Applicable regulations:
Federal Acquisition Regulation
Audience:
Contractors under HHS contracts and grants
Scope:
Government-furnished property and contractor-acquired property
Contract types covered:
Cost-reimbursement contracts, fixed-price contracts
Replaced document:
Control of Property in the Possession of Contractors (1974 edition)
Chapters:
Introduction; Contractor Responsibility and Liability; Contract Start-Up; Contract Administration; Contract Close-Out; Special Considerations; Forms and Instructions
Property categories:
Personal property, supplies, materials, real property, leased and rented items
Administrative roles:
Contract Property Administrator
Note:
Year
Document Type:
Template
Year:
2010
Region / City:
County of Marin
Subject:
Aerosol Transmissible Diseases (ATD) Compliance
Document Type:
Compliance Guidelines
Organization / Institution:
County of Marin, H&HS
Author:
Richard Bolmen – Safety Officer
Target Audience:
Employers, Health and Safety Officers, Occupational Health and Safety Professionals
Period of Validity:
Ongoing since 2009
Approval Date:
August 5, 2009
Date of Changes:
Not specified
Year:
2021
Region / City:
New York
Topic:
Interprofessional Education, Health Professions
Document Type:
Academic Resource
Organization / Institution:
CUNY
Author:
Not specified
Target Audience:
Health professionals, educators, researchers, students
Effective Date:
Not specified
Date of Approval:
Not specified
Date of Changes:
Not specified
Year:
Not specified
Country:
United States
Issuing authority:
U.S. Department of Health and Human Services
Administering agency:
Centers for Medicare & Medicaid Services
Form number:
CMS-10321
OMB control number:
0938-1087
Program:
Early Retiree Reinsurance Program
Document type:
Government application form
Subject:
Employer-based health plan reimbursement for early retiree medical costs
Applicants:
Plan sponsors including government, union, religious, commercial, or non-profit organizations
Required information:
Plan sponsor data, authorized representative details, account manager details, plan information, benefit options, chronic and high-cost condition programs, reimbursement estimates, intended use of reimbursements
Estimated completion time:
35 hours
Legal reference:
Paperwork Reduction Act of 1995
Associated institution address:
CMS, 7500 Security Boulevard, Baltimore, Maryland 21244-1850
Year:
2019
Region / City:
United States, Massachusetts
Subject:
Healthcare / Medicare & Medicaid
Document Type:
Contract
Organization / Institution:
United States Department of Health and Human Services; Centers for Medicare & Medicaid Services; Tufts Health Public Plans, Inc.; Commonwealth of Massachusetts
Parties:
United States Department of Health and Human Services, Centers for Medicare & Medicaid Services, Commonwealth of Massachusetts, Tufts Health Public Plans, Inc.
Effective Date:
August 1, 2019
Contract Model:
Capitated Payment
Year:
2026
Institution:
College of Health and Human Sciences, Kansas State University
Document Type:
Funding program guidelines
Target Audience:
Doctoral candidates in Health and Human Sciences, Personal Financial Planning, or Human Nutrition
Purpose:
Financial support for dissertation research projects
Maximum Funding:
$1,000 from Dean’s Office with required matching funds from mentor/school
Eligibility Criteria:
Successful defense of dissertation proposal, no prior award from this mechanism
Application Components:
Cover page, project description, methodology, references, budget and justification, CVs of student and mentor, mentor recommendation letter
Submission Deadline:
October 15 for Fall Semester, March 15 for Spring Semester
Funding Usage:
Research supplies, travel for research, human subject payments, undergraduate/statistical assistant payroll
Review Process:
Committee of faculty from the college including at least one from applicant’s school
Publication Requirement:
Research findings expected to be published in a peer-reviewed journal within 12 months