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Federal laws, regulations, policies and guidance

IMPORTANT NOTICE: GIRB applies flexible provisions to review of research that is not federally supported or FDA-regulated
 
Revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”) were scheduled to become effective January 19, 2018. However, the effective date and compliance date for the Revised Common Rule have been postponed until July 19, 2018. See the federal announcement
 
Effective May 1, 2018, GIRB review of research that is neither federally sponsored nor FDA-regulated, will apply flexible provisions adapted from the Final Revised Common Rule 45 CFR 46 Subpart A - Basic HHS policy of Protection of Human Research Subjects (January 18, 2017), specifically:

  • Adoption of revised Exemption Categories 1-6
  • Elimination of the continuing review requirement for most minimal risk research
  • Expand general requirements for informed consent (required for informed consents approved on or after May 1, 2018)

The IRB will evaluate all ongoing studies for transition to these flexible review provisions at the time of the study’s continuing review occurring on or after May 1, 2018.
 
The following policies were added or revised to include important information about these flexible review provisions:

  • HRPP Handbook
  • Continuing Review – Criteria for Removing Continuing Review Requirement
  • Exemption Categories
  • Informed Consent & HIPAA Authorization – Required Elements

For more information, see PRIM&R’s Focus on the Revised Common Rule: What Does It Mean For Me? and visit CITI Final Rule Resources where you will find helpful presentations and handouts.

Please contact Geisinger IRB staff at 570-271-8663 or irb@geisinger.edu with any questions.


 
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
  • Continuing Review - Criteria for Removing Continuing Review Requirement 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 
  • Exemption 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
  • Flow for Prompt Event Reporting Download
  • Glossary of Clinical Trials Terms Download
  • Informed Consent & HIPAA Authorization - Required Elements 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
  • Recruitment with Vulnerable Participants Download
  • Reporting Screening and Enrollment Numbers to the IRB Download
  • Requirements for Study Physician Involvement - Investigational Drug (IND) & Device (IDE) Studies 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