Human Research Protections- Standards & Regulations - page 4

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U NITED S TATES HUMAN RESEARCH S UBJECTS
PROTECTIONS POLICIES & REGULATIONS
 Data & Resource Sharing:
 NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources
This website provides details of NIH policy regarding the requirement for recipients of NIH funding
to make the results of their work available to the research community and public at large. This
includes but is not limited to policies and guidances related to data – sharing, data repositories,
and genome-wide association studies.
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 Drug Research and Investigational Drugs:
 U.S. Food and Drug Administration (FDA) Investigational New Drug Application (IND)
This website contains the U.S. Food and Drug Administration (FDA) policy regarding the
‘investigational new drug application’ (IND); including details of when the application is needed,
definitions of the phases of an ‘investigational new drug’ investigation and information on
reporting requirements.
Excerpts:
Subpart A- General Provisions (including scope and applicability)
Subpart B- Investigational New Drug Application
Subpart D-Responsibilities of Sponsors and Investigators