Guidance & Forms

A-Z Index

Browse this A-Z index for HRPO Guidance. The links will connect you directly to the guidelines, forms, checklists, training, and resources you need. For any topic that might be missing from this index, please email askirb@pitt.edu.

• A

  • AAHRPP Site Vist 2022
  • Acknowledgement of Unregulated Research Activities
  • Activities Not Under the Pitt IRB Jurisdiction
  • Adverse Events Log (download doc)
  • Advertisements
  • Audit by Federal Agency

• B

  • Belmont Report
  • Blood Drawings for Human Subject Research
  • Blood Drawings - SOP for Phlebotomy Stations Outside of Clinical Care Areas

• C

  • Case Reports
  • Certificate of Confidentiality Guidance
  • Certificate of Confidentiality NIH
  • Children in Research
  • Child Clearances
  • Children's Online Privacy Protection Act (COPPA)
  • CITI Training
  • ClinicalTrials.gov
  • Cohort Discovery
  • Common Rule [45 CFR 46]
  • Common Rule 2018
  • IRB Community Member Frequently Asked Questions
  • Continuing Review - OHRP Guidance
  • Coordinating Center Applications and Responsibilities
  • Coordinating Center Application Supplement [Word]
  • COVID-19 Human Subject Research FAQ
  • COVID-19 Information Sheet for Participants
  • COVID-19: Research Participant Screening Questions

  Consent Guidance

  • Building Your Consent Document
  • Child Research Signature Lines
  • Consent Forms in Medical Records
  • Consent Form Posting for Federally Funded Clinical Trials
  • Decisional Impairment and Proxy Signature Lines
  • Family Members Information
  • Key Information
  • Low Literacy and Disabled Participants
  • Not Reasonably Available
  • Obtaining Informed Consent
  • Reconsent
  • Short Form Consent Documents
  • UPMC Cost Language

• D

  • Data and Safety Monitoring Plan
  • Data and Safety Monitoring Board/Committee
  • Data Management-University Guidelines
  • Data Risk Classification and Compliance
  • Data Security-Pitt Information Technology Research Resources
  • Data Security for Researchers
  • Data Security Management Tips
  • UPMC Data Use Agreement for Limited Data Set
  • Data Use Agreement (DUA)
  • Decedent Research
  • Decisional Impairment Checklist [Word]
  • Declaration of Helsinki
  • Department of Defense (DOD) Checklist [pdf]
  • Device (PittPRO)
  • Drug Evaluation and Research - FDA Guidance
  • Drug (PittPRO)
    • Drug - IND Determination

• E

  • Electronic Data Management Tips
    • Data Risk Classification and Compliance
    • Data Security - Research Services, Pitt Information Technology
  • Electronic Signatures

  Emergency Use (EU) and Single Patient Expanded Access

  • EU Consent Template
  • Expanded Access Drug or Biologic FDA
  • Expanded Access Medical Device FDA
  • Engagement of Institutions in Human Subjects Research
  • Exempt Review (2018 Revised Rule)
  • Exempt Review - NIH Infographic
  • Expedited Review Categories OHRP

• F

  • Faculty Mentor Responsibilities
  • Faculty Mentor Quick Reference
  • FDA: Medical Devices
  • FDA: Medical Apps
  • FDA: Drugs
  • FDA: Good Clinical Practice
  • FDA: Guidance for IRBs, Clinical Investigators, and Sponsors
  • FDA: Decisions for Investigational Device Exemption Clinical Investigations(issued 8.19.2014)
  • FDA: MedWatch
  • FDA Online Label Repository
  • Family Educational Rights and Privacy Act (FERPA)
  • Federal Wide Assurance -DHHS
  • Federal Wide Assurance (FWA) and Engaged in Research
  • Finder's Fees and Recruitment Incentives

• G

  • Genetic Information Nondiscrimination Act (GINA)
  • Genomic Repository Guidance (dbGaP/Other NIH-designated)
  • GDPR (European Union General Data Protection Regulation)
  • Guidelines for Researchers Returning to UPMC Facilities

• H

  • HIPAA
  • HIPAA Checklist: Example Language
  • HIPAA Privacy Rule - Databases and Research Repositories - NIH Guidance
  • HIPAA Privacy Rule Information for IRBs - NIH Guidance
  • HIPAA Privacy Rule Information for Researchers - NIH Guidance
  • HIPAA Safe Harbor vs Limited Data Set
  • Honest Broker
  • Honest Broker Application [Word]
  • Honest Broker Assurance Form

• I

  • Innovative Practice
  • Institutional Review Boards-FDA [21 CFR Part 56]
  • Internet and Human Subject Research - DHHS
  • International Compilation of Human Research Standards
  • International Research
  • Introductory Script Sample

• J

• K

  • Key Information in Consent Form

• L

  • Leaving the University Checklist
  • Log for Adverse Events
  • Log for Noncompliance / Deviations

• M

  • Material Transfer Agreements (MTA)
  • Memo of Cultural Appropriateness
  • Mentor Quick Reference
  • Mobile Medical Device-FDA
  • Mobile App-IRB Review

• N

  • Non-English Speaking Participants
  • Noncompliance/Deviation Log

• O

  • Obtaining Informed Consent
  • Off-Label Drugs and Biologics

• P

  • Paper Submission Forms
  • Payment Procedure for Human Subjects - Vincent

  PittPRO Information

  • Drug Section
  • IND Determination
  • Device Section
  • Protection of Pupil Rights Amendment (PPRA)
  • Prisoners: OHRP Guidance on the Involvement of Prisoners in Research
  • Privacy and Confidentiality for Research Participants
  • Protection of Human Subjects (FDA) 21 CFR 50

• Q

  • Quality Improvement Activities FAQ - OHRP

• R

  • Radiation Guidance
  • Research Restart (Archived)
  • Returning to UPMC Facilities: Guidelines for Researchers

  Reliance Guidance

  • Individual Investigator Agreement (IIA)
  • IRB Fee Sheet
  • Overview of Reliance Request System Content [pdf]
  • Pitt Cede IRB Review [pdf]
  • Pitt IRB of Record [pdf]
  • Reliance Request System
  • sIRB Overview

  Reportable New Information

  • Reportable New Information FAQs
  • Log for Adverse Events
  • Log for Noncompliance / Deviations

• S

  • Scientific Reviewer Quick Reference
  • Short Form Consent Documents
  • Site Permission Letter
  • Social Media Playbook
  • Student Researchers
  • Study Status

• T

  • Telephone Screening Script
  • Tip Sheet for OSIRIS Conversions
  • Transition of Data Analysis Only and Long Term Follow Up to PittPRO
  • Translator Certification Form

• U

  • UPMC Fiscal Form
  • Returning to UPMC Facilities: Guidelines for Researchers

• V

  • Vincent Exception Requests
  • Visitors on Campus (Academic and Research)

• W

• X

• Y

• Z