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Laminates (Most Commonly Used Guidances) |
Laminate |
|---|---|
| Criteria for IRB Approval of Research: Medical -or- Nonmedical | |
| General Requirements for Informed Consent: Medical -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) |
