Federal laws, regulations, policies and guidance

 
Geisinger HRPP Policies

Guidance Documents

  • Advertisements - Appropriate Language for Recruitment Material Download
  • Adverse Events Decision Tree Download
  • Assessment of Capacity to Consent Download
  • Children and Consenting Minors and Assent Download
  • Consent Form Lay Language Download
  • Contract Administration Standards for Industry Sponsored CTA Download
  • Data and Safety Monitoring Download
  • Data Monitoring Committees Download
  • Definitions for the HRPP Handbook Download
  • Emergency Use of a Test Article Download
  • Employees as Research Subjects Download
  • Evaluating Sound Study Design Download
  • Event Report Summary Download
  • Exempt Review Categories Download
  • Exemption Eligibility Checklist Download
  • Expanded Access Program (EAP) for Drugs Download
  • Expedited Review Categories Download
  • Findings for Waiver or Alteration of Consent Requirements Download
  • General requirements for Informed Consent Download
  • Glossary of Clinical Trials Terms Download
  • Letter regarding Geisinger Clinical Trial Agreements Download
  • Humanitarian Use Device (HUD) Download
  • IDE Early/Expanded Access for Devices Download
  • IRB Members on Conflicting Interests Download
  • IRB Review of Medical Device Research Download
  • Parental Permission Download
  • Patient Complaints/Other to HRPP Download
  • Payment – Ethical Considerations Download
  • Privacy vs. Confidentiality:  What’s the Difference? Download
  • Prompt Event Reporting to the IRB Download
  • Prompt Reporting Flow Recruitment with Vulnerable Participants Download
  • Research Involving Pregnant Women, Fetuses, and Neonates Download
  • Retention of and Access to Research Data and Records Download
  • Short Form Consent Process Download
  • Significant Risk and Non-Significant Medical Device Studies Download
  • Special Considerations for the Oversight of Research Protocols in FDA regulated Drug or Device Studies Download
  • Sponsor-Investigator Research Requirements (When a Geisinger investigator holds the IDE) Download
  • Sponsor-Investigator Research Requirements (When a Geisinger Investigator holds the IND) Download
  • Sponsor-Investigator Research Requirements (When a Geisinger investigator is the sponsor on a non-significant risk device study) Download
  • Telephone Screening of Potential Subjects Download
  • Unanticipated Problems vs. Adverse Events Download
  • Use of Human Subjects in Pilot Studies, Oral Histories and QA/QI Projects Download
  • Waiver of consent/authorization and waiver of documentation of consent Download
  • Women as Subjects in Research Download