Training and education
Geisinger requires all individuals involved in the conduct of research with human participants to complete ethics training. IRB submissions will not be accepted if these training requirements are not met. The Responsible Conduct of Research (RCR) seminar series helps keep Geisinger's research community apprised of developments in research ethics and regulation.
Presentations of interest:
HHS Final Rule
- Implementation of the HHS Final Rule Effective 1/21/2019 Download
IRB & IRB Review
- Overview -HRPP, IRB & iRIS Download
- Geisinger Research Process … From Idea to Approval Download
- Introduction to IRB & IRB Membership Download
- Research Determination & IRB Review Categories Download
- Criteria for IRB Approval Download
- IRB Review of Social Media Download
- Non-Compliance, Protocol Violations, Unanticipated Problems and Adverse Events Download
- Data Safety Monitoring Board (DSMB) Download
Informed Consent & HIPPA Authorization
- Informed Consent & HIPAA Authorization Download
- Informed Consent: Applying the Regulations in the MyCode Consent Form Download
- Obtaining and Documenting Assent Download
FDA
- What to Expect During an FDA Audit Download
- Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) Download
- Single Patient Investigational New Drug (IND) Download
- Emergency Use of Investigational Devices / Drugs Download
- Planned Emergency Research – Exception from Informed Consent Download
Conflict of Interest in Research