

Laminates (Most Commonly Used Guidances) |
Laminate |
---|---|
Criteria for IRB Approval of Research: Medical -or- Nonmedical | |
General Requirements for Informed Consent: Medical (OHRP and FDA) or Nonmedical | |
Additional Protections for the Inclusion of Children in Clinical Investigations (FDA) | |
Guidelines for IRB Members on Conflicting Interests | |
Regulations for Waiver or Alteration of Consent Requirements | |
Significant Risk and Non-Significant Risk Medical Devices Studies | |
Research Involving Pregnant Women, Fetuses and Neonates | |
OHRP Guidance on the Involvement of Prisoners in Research | |
HIPAA and PHI | |
Emergency Use of a Test Article | |
Exempt Review Categories | |
Expedited Review Categories | |
What Qualifies as Human Subject Research | |
(1) Clinical Trials Terms (2) Commonly Used Acronyms | |
Unanticipated Adverse Device Effect (UADE) |