Policies and Guidance

• Policy IRB-01 (2/3/2021)
• Summary of updates (2/3/2021)

• Applicable Clinical Trial (ACT) Checklist
• Belmont Report
• COI Requirements
• CITI Program
• Definitions for Clinical Research and Clinical Trials
• Determining which IRB to Use, which Agreements are required, and which IRB fees to budget
• Enrolling or Excluding Pregnant People, Contraception, Pregnancy Testing, and Partners of Participants Who Become Pregnant
• FDA Guidance
• Fee Schedule
• Form 11-A4 Guidance (How to successfully submit and get approval for Form 11-A4: Application for Determination Letter (IRB Decision Aid) for "Not Research, Not Human Research, or Institution Not Engaged in Human Research"
• Genome-Wide Association Studies (GWAS- NIH)
• GWAS FAQs (NIH)
• ICH GCP (E6-R2) 2016
• Information Security
• IRB Member Nomination
• Injury Language
• IRBNet (IRB Application and Reporting System)
• Lay-Person Summary
• Levels of IRB review
• Local Context for Reviewing (External) IRB
• Military Health System Research Protections (DHA Office of Research Protections)
• Obtaining Legally Effective Informed Consent and HIPAA Research Authorization
• Office for Human Research Guidance (Alphabetical List)
• Quality Assessment Program
• Quality Assessment Program -Template Letters to PI
• Qualtrics Survey Software
• Recruitment, Referral, Screening, Advertising, and Incentives
• Rescinding COVID-19 Risk Mitigation Strategies
• REDCap: Research Data Capture and Analysis System
• Students, Residents, Fellows, Volunteers, or Employees as Research Participants
• Training Requirements
• Veterans Affairs Office of Research and Development
• Zoom to Teams/Doxy.Me IRB Amendment

• UHD Policies
• RFDMC-01: Research Conflict of Interest Policy
• PHA-11: Investigational Drug/Dispensing and Utilization
• SUNY Downstate Office of Compliance and Audit Services
• SUNY Downstate Health Sciences University Information Services Policies and Procedures
• SUNY Downstate Health Sciences University - Language Services to Patients with Limited English Proficiency
•  Downstate HealthStream Policy Manager
• SUNY Downstate Responsible Use of Social Media
• SUNY Downstate HIPAA (Health Insurance Portability and Accountability Act) Policies and Forms
• Select HIPAA policies and forms:
  • Researcher Certification for Reviews Preparatory to Research
  • Certification for PHI of Decedents
  • Business Associate Agreements (BAA) Policy (HIPAA-3)
  • BAA Template Form
  • HIPAA De-Identification of Information (HIPAA-6)
  • Minimum Necessary Guidelines (HIPAA-15)
  • Use of Limited Data Sets (HIPAA-27)
  • Data Use Agreement (DUA) Template
  • Uses and Disclosures for Research Purposes (HIPAA-28)

• SUNY RF Policies A to Z
• SUNY RF Acceptable Use and Security of RF Data and Information Technology
• SUNY RF Human Subject Payments
• SUNY RF Records Access Policy
• SUNY RF Records Management Policy

• NYC H+H Kings County Clinical Research Office Memo
• NYC H+H Kings County Human Subject Research Protections Program (180-9)
• NYC H+H Kings County System to Track and Approve Research (STAR)

• Common Rule (45 CFR 46) (Current Version)
• Common Rule (45 CFR 46) (2009 Version, for grandfathered studies)
• Expedited Review Categories
• FDA Guidance Search Website
• FDA Regulations 21 CFR 50 (Protection of Human Subjects)
• FDA Regulations 21 CFR 56 (Institutional Review Boards)
• FDA Regulations 21 CFR 312 (Investigational New Drug Applications)
• FDA Regulations 21 CFR 320 (Bioavailability and Bioequivalence Requirements)
• FDA Regulations 21 CFR 812 (Investigational Device Exemptions)
• FDA Regulations 21 CFR 814 (Premarket Approval of Medical Devices)
• Full or Expedited Review Guidance
• ICH Harmonized Guideline for Good Clinical Practice E6 (R3)
• IRB Guidance: "111 Criteria" for IRB Approval (Full Board and Expedited Review)
• IRB Member Nomination
• IRB Member Roles and Goals
• IRB Member Training Energizer for IRBNet
• Orientation Slides:  (PDF Version) or (Power Point Version)
• The Who, What, Why, and Where of IRB Meetings and Membership

• IRB Records and Destruction
• Records Management Certificate of Destruction
• Records Management Certificate of Destruction – Supplement Form A

• Statement of Compliance
• Federal Wide Assurance
• Electronic Signature Statement