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 Visit
  • Acknowledgement of Unregulated Research Activities
  • Activities Not Under the Pitt IRB Jurisdiction
  • Adverse Events Log [Word]
  • Advertisements
  • Artificial Intelligence Technologies
  • Artificial Intelligence: Permission Letter to Deploy AI [pdf]
  • 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
  • Closing a Study
  • Cohort Discovery
  • Common Rule [45 CFR 46]
  • Common Rule 2018
  • Community Based Participatory Research
  • IRB Community Member Frequently Asked Questions
  • Continuing Review - OHRP Guidance
  • Continuing Review - Research Milestones
  • Coordinating Center Applications and Responsibilities
  • Coordinating Center Application Supplement [Word]
  • Crowdsourcing Platforms

  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
  • e-Consent
  • Family Members Information
  • Informed Consent for Secondary Research with Data and Biospecimens (NIH Sample Language)
  • Key Information
  • Low Literacy and Disabled Participants
  • Not Reasonably Available
  • Obtaining Informed Consent
  • Reconsent
  • Short Form Consent Documents
  • Top Ten Tips to Improve Consent Form Readablity
  • UPMC Cost Language

• D

  • Data and Safety Monitoring Plan
  • Data and Safety Monitoring Board/Committee
  • Data Retention-University Guidelines
  • Data Risk Classification and Compliance
  • Data Security-Pitt Information Technology Research Resources
  • Data Security Management Tips
  • UPMC Data Use Agreement for Limited Data Set [Word]
  • Data Use Agreement (DUA)
  • Decedent Research
  • Decisional Impairment Checklist [Word]
  • Declaration of Helsinki
  • Department of Defense (DOD) Checklist [pdf]
  • Devices (PittPRO Instructions)
    • Use of Investigational Medical Devices in Human Subject Research 
    • Device Software Functions and Mobile Applications in Human Subject Research
  • Drugs (PittPRO Instructions)
    • Drug - IND Determination
    • Drug Evaluation and Research - FDA Guidance

• E

  • Electronic Data Management Tips
    • Data Risk Classification and Compliance
    • Data Security - Research Services, Pitt Information Technology
  • Emergency Risk Mitigation Planning Guide for Human Subjects Research
  • Engagement of Institutions in Human Subjects Research
  • EPIC Research Documentation [pdf]
  • Exempt Review (2018 Revised Rule)
  • Exempt Review - NIH Infographic
  • Exempt Study Modifications
  • Expedited Review Categories OHRP
  • Emergency Use (EU) and Single Patient Expanded Access
    • Single Patient Expanded Access (Emergency Use and Compassionate Use) for an Investigational Device
    • Single Patient Expanded Access (Emergency Use and Non-Emergency Use) for an Investigational Drug or Biologic
    • Expanded Access IDE Consent Template [Word]
    • Expanded Access IND Consent Template [Word]
    • FDA Guidance - Expanded Access Drug or Biologic
    • FDA Guidance - Expanded Access Medical Device

• 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 Data Sharing Guidance (dbGaP/Other NIH-designated)
  • GDPR (European Union General Data Protection Regulation)

• 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
  • Human Subjects Research Determination Tool

• 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 [pdf]
  • IRB Fees 
  • IRB Fees Sheet
  • IRS - Sample Participant Notification: Updates to IRS Tax Reporting Threshold [Word]

• 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)
  • Membership on the Pitt IRB
  • Memo of Cultural Appropriateness
  • Mentor Quick Reference
  • Mobile Medical Device-FDA

• N

  • New NIH Data Management and Sharing Policy
  • NIH Data Management and Sharing (Pitt HSLS Resources)
  • Non-English Speaking Participants
  • Noncompliance/Deviation Log
  • Not Research and Not Human Subjects Projects

• O

  • Obtaining Informed Consent
  • Off-Label Drugs and Biologics

• P

  PittPRO Information

  • Paper Submission Forms
  • Payment Procedure for Human Subjects - Vincent
  • Drug Section
  • IND Determination
  • Device Section
  • Photovoice Use in Research
  • 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 Data Management
  • Research Ethics Consult Service (RECS)
  • Research on Medical Students (ROMS)
  • Research Participants
  • 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
  • Reporting Requirements Table [pdf]
  • Log for Adverse Events
  • Log for Noncompliance / Deviations

• S

  • Scientific Reviewer Quick Reference
  • Short Form Consent Documents
  • Site Permission Letter [pdf]
  • Student Researchers
  • Study Closure
  • Study Status-Research Milestones

• T

  • Telephone Screening Script
  • Translator Certification Form

• U

• V

  • Vincent Exception Requests
  • Vincent Payments to Study Subjects
  • Visitors on Campus (Academic and Research)

• W

  • Waivers of Informed Consent and HIPAA

• X

• Y

• Z