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OHSRP) TABLE OF CONTENTS 6.1 PURPOSE ...................................................................................................... 2 6.2 POLICY .......................................................................................................... 2 6.3 DEFINITIONS ................................................................................................. 2 6.4 RESEARCH INVOLVING ONLY DATA/SPECIMENS, WITHOUT IDENTIFIABLE INFORMATION, THAT IS EXCLUDED FROM NIH IRB REVIEW .

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Human Research Protection Program (HRPP) Resources | HHS.gov.

The Final Rule describes the process by which the NIH Director reviews and notifies responsible parties as to whether a requested extension of the deadline for submitting results information demonstrates good cause and has been granted.

NIH is required by law (Public Health Service Act Section 492B, 42 U.S.C. Section 289a-2, added by Section 101 of Public Law 103-43 on June 10, 1993) to ensure that women and minorities are included in all clinical research as appropriate to the scientific question under study.

This Manual Chapter establishes the expectation that all NIH Intramural Research Program (IRP) principal investigators (PIs) conducting clinical trials or natural history or observational clinical studies (“NH/O studies”), as defined herein, will ensure that their clinical trials and NH/O studies are registered at ...

FDAAA, Section 801, and the Final Rule (42 CFR Part 11) refers to a federal statute established in 2007 requiring the registration and reporting of information on "applicable clinical trials" on Clinicaltrials.gov.

The HHS regulations for the protection of human subjects, in 45 CFR Part 46, implement Section 491(a) of the PHS Act and provide a framework, based on established, internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities ...

It is the responsibility of all supervisory personnel who oversee research groups, core facilities, and other entities, as well as successive levels of organizational leadership (especially Institute and Center Scientific Directors), to ensure that every NIH scientist is cognizant of these Guidelines and Policies and ...

When must I register on ClinicalTrials.gov? Applicable Clinical Trials (ACTs) and NIH funded trials are required to register on ClinicalTrials.gov within 21 days of enrollment of the first subject. Throughout the life of the record, updates must be made anytime the study plan changes, typically within 30 days.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232