Trial mobile version Guidances- combined files 6_27_14 - page 13

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 NIH: Certificates of Confidentiality Kiosk
This is a detailed explanation of ‘Certificates of Confidentiality’ from the National Institutes of
Health (NIH). Certificates of Confidentiality protect identifiable research information from forced
disclosure. This resource includes ‘Frequently Asked Questions’, a ‘flow chart’ and key
information for investigators, institutional officials, and IRB members.
 NIH Data Sharing Policy and Implementation Guidance
This guidance provides the National Institutes of Health (NIH) policy statement on data sharing
including tips and information on the following topics:
 Goals of Data Sharing
 Methods for Data Sharing
 Policy on Documentation (Metadata or Codebooks) that must Accompany Data
 Examples of Data Sharing Plans
 OHRP Guidance on Engagement of Institutions in Human Subjects Research
This is a document created by the Office of Human Subjects Research Protections (OHRP). It
describes what ‘institutional engagement’ is and the regulations that must be complied with for
‘engaged institutions’. This guidance provides detailed examples and scenarios for understanding
institutional engagement.
 OHRP Institutional Review Board Guidebook (1993)
This is a resource from the Office of Human Subjects Research Protections. It is an older resource, however
there is still useful information there for Institutional Review Boards.
Chapters in the Guidebook:
Institutional Administration
Regulation and Policies
Basic IRB Review