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:

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

  • Financial Conflict of Interest Download
  • Conflict of Interest (COI) Refresher Download
  • Conflict of Interest (Institution, Investigator, IRB) Download