Federal laws, regulations, policies and guidance

Revised Common Rule Compliance date – January 21, 2019

Geisinger IRB has revised its policies and procedures to be compliant with HHS Final Rule (2018 Revisions to the Federal Policy for the Protection of Human Subjects or “Common Rule”), which is effective January 21, 2019. These revisions to the Common Rule are intended to modernize and clarify human subjects research regulations, improve protections of research participants and reduce administrative regulatory burden. 

Geisinger applied the regulatory changes in the revised Common Rule to research that was neither federally-supported or FDA-regulated on May 1, 2018. These Common Rule revisions will now also apply to federally-supported research approved by the IRB on or after January 21, 2019. All research (unless FDA-regulated) approved before January 21, 2019 will be evaluated for transition to Final Rule requirements at the time of the study’s next annual continuing review. This transition will be reported to researchers in each study’s Initial or Continuing Review IRB Approval letter. 

The following policies were revised to comply with these 2018 requirements: 

• HRPP Handbook
• Informed Consent & HIPAA Authorization – Required Elements
• Exemption Categories
• Continuing Review – Criteria for Removing Continuing Review Requirement
• Waiver of Consent/Authorization and Waiver of Documentation of Consent

The following resources provide summaries of revisions to the Common Rule:

• OHRP guidance on Revised Common Rule
• CITI Program guidance on Revised Common Rule
• NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule)
• HRP Consulting Group Summary of Changes – Revised Common Rule

Please contact Geisinger IRB staff at 570-271-8663 or irb@geisinger.edu with any questions about the impact of these revisions on your research.

• The Common Rule, 45 C.F.R. 46
• HHS, 45 C.F.R. 46 Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
• HHS, 45 C.F.R. 46 Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
• HHS, 45 C.F.R. 46 Subpart D: Additional Protections for Children Involved as Subjects in Research
• The Belmont Report
• FDA, 21 C.F.R. 50 and 21 C.F.R. 56
• OHRP Guidance

Geisinger HRPP Policies and IRB Membership Information

• Geisinger Federalwide Assurance
• Geisinger FWA IRB Accreditation Information
• Geisinger HRPP GCP Compliance
• HRPP Handbook
• Geisinger Policy on Financial Conflicts of Interest in Research
• Geisinger Human Research Protection Program Policy
  

Geisinger Single IRB Policies and Procedures

• Geisinger IRB Investigator’s Guide for sIRB
• Geisinger sIRB Intake Form
• Geisinger sIRB Fees
• Geisinger sIRB Relying Site Application
• Geisinger sIRB Relying Site Continuing Review Form

Geisinger Relying on an External IRB

• Geisinger IRB Investigator’s Guide for Relying on an External IRB
• Complying with Geisinger Consent Form Requirements when Geisinger is a Relying Institution

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
• Data and Safety Monitoring Download
• Data Monitoring Committees Download
• Department of Defense Supported Research: Investigator Responsibilities Checklist Download
• Department of Defense Supported Research: Key Points for Investigators Download
• Emergency Use of a Test Article Download
• Employees as Research Subjects Download
• Evaluating Sound Study Design Download
• Exempt Studies: Post Exempt Determination Submission Requirements Download
• Exemption Categories Download
• Expanded Access Program (EAP) for Drugs Download
• Expedited Review Categories Download
• Glossary of Clinical Trials Terms Download
• Informed Consent & HIPAA Authorization - Required Elements 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
• IRB Roster Letter Download
• IRB Study Closure Download
• Parental Permission Download
• Patient Complaints/Other to HRPP Download
• Payment – Ethical Considerations Download
• Privacy vs. Confidentiality:  What’s the Difference? 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
• Requirements when a Researcher Leaves Geisinger but Will Continue Working on a Study 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
• Waiver of consent/authorization and waiver of documentation of consent Download
• Women as Subjects in Research Download