Federal laws, regulations, policies and guidance
Geisinger Federalwide Assurance, IRB Registration, and Accreditation
- 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
- Advertisements - Appropriate Language for Recruitment Material
- Adverse Events Decision Tree
- Assessment of Capacity to Consent
- Children and Consenting Minors and Assent
- Consent Form Lay Language
- Data and Safety Monitoring
- Data Monitoring Committees
- Emergency Use of a Test Article
- Employees as Research Subjects
- Evaluating Sound Study Design
- Exempt Studies: Post Exempt Determination Submission Requirements
- Exemption Categories
- Expanded Access Program (EAP) for Drugs
- Expedited Review Categories
- Glossary of Clinical Trials Terms
- Informed Consent & HIPAA Authorization - Required Elements
- Humanitarian Use Device (HUD)
- IDE Early/Expanded Access for Devices
- IRB Members on Conflicting Interests
- IRB Review of Medical Device Research
- IRB Roster Letter
- IRB Study Closure
- Parental Permission
- Patient Complaints/Other to HRPP
- Payment – Ethical Considerations
- Privacy vs. Confidentiality: What’s the Difference?
- Recruitment with Vulnerable Participants
- Reporting Screening and Enrollment Numbers to the IRB
- Requirements for Study Physician Involvement - Investigational Drug (IND) & Device (IDE) Studies
- Requirements when a Researcher Leaves Geisinger but Will Continue Working on a Study
- Research Involving Pregnant Women, Fetuses, and Neonates
- Retention of and Access to Research Data and Records
- Short Form Consent Process
- Significant Risk and Non-Significant Medical Device Studies
- Special Considerations for the Oversight of Research Protocols in FDA regulated Drug or Device Studies
- Sponsor-Investigator Research Requirements (When a Geisinger investigator holds the IDE)
- Sponsor-Investigator Research Requirements (When a Geisinger Investigator holds the IND)
- Sponsor-Investigator Research Requirements (When a Geisinger investigator is the sponsor on a non-significant risk device study)
- Telephone Screening of Potential Subjects
- Waiver of consent/authorization and waiver of documentation of consent
- Women as Subjects in Research
Regulations and Other Resources
- 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
Content from General Links with modal content