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Investigator Manual
Investigator Manual
Chapter 1: Introduction
A. University Park
B. College of Medicine
Chapter 2: Guiding Principles & Federal Regulations
A. Federal Regulations
B. The Belmont Report
Chapter 3: Scope and Purpose of Institutional Review Boards
A. Federalwide Assurance (FWA)
B. What Requires Review by the Institutional Review Boards (IRB)
C. The Pennsylvania State University Institutional Review Boards (IRB)
Chapter 4: Investigator Responsibilities
Chapter 5: Education and Training
Chapter 6: Levels of Review
A. Exempt Human Participant Research
B. Expedited Human Participant Research
C. Full Board Human Participant Research
Chapter 7: Consent and Assent
A. The Process of Consent and Assent
B. Standard Informed Consent Form
C. Related Documents
D. Safeguarding Confidentiality
E. Recruitment and Participant Compensation
F. Non-English Speaking Participants
G. Waivers
Chapter 8: Initial Application Submission
A. Signatures
B. General Guidance
C. Supporting Documentation
D. Application Processing
E. Notification of Approval
F. Limitations on IRB-Approved Studies
G. Appeal of IRB Decisions
H. Other University Committees Reviewing Human Participant Research
Chapter 9: Other Submission Types & Record Keeping
A. Modifications
B. Continuing Reviews
C. Unanticipated Problems Involving Risk to Participants (Adverse Events)
D. On-site Monitoring
E. Study Closure
F. Record Keeping
Chapter 10: Vulnerable Populations
A. Children
B. Pregnant Women, Human Fetuses, and Neonates
C. Prisoners
D. Decisionally Impaired Persons
Chapter 11: Special Considerations
A. Social Security Number Project at Penn State
B. Course-Related Student Projects
C. International Research
D. Students as Research Participants
E. Surveys, Questionnaires and Interview Studies
F. Research Using Data
G. Research Using Specimens
H. Research Using Tissue and Data Banks or Repositories
I. Genetic Research
Chapter 12: The Impact of the Privacy Rule on Research
A. Authorization for the Use and Disclosure of Protected Health Information (PHI)
B. Request for the Use of PHI of Decedents
C. Request for Review of PHI Preparatory to Research
D. Use of Limited Data Set/Data Use Agreement
E. Request for Waiver of Authorization
F. Request for Use of Business Associates Agreement
Chapter 13: FDA Regulated Research
A. Medical Devices
B. Drugs and Biological Products
C. Emergency Use of an Investigational Drug/Device
D. Treatment Use of an Investigational Drug/Device
E. Emergency Research Consent Waiver
F. Humanitarian Use Devices (HUD)
Chapter 14: Complaints Regarding Human Participant Research
Chapter 15: Non-compliance Investigations and Actions