Policies and Guidance
- Applicable Clinical Trial (ACT) Checklist
- Belmont Report
- COI Requirements
- CITI Program
- Definitions for 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 (HIS 1-12)
- HIS-13: Encryption and Decryption Policy
- SUNY Downstate Health Sciences University - Language Services to Patients with Limited English Proficiency
- 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)
- Common Rule (45 CFR 46) (2009 Version)
- Common Rule (45 CFR 46) (2018 requirements, effective 1/21/2019)
- Expedited Review Categories
- IRB Guidance: "111 Criteria" for IRB Approval (Full Board and Expedited Review)
- IRB Guidance: IRB Member Nomination
- IRB Guidance: Member Roles and Goals
- IRB Guidance: Member Training Energizer for IRBNet
- IRB Guidance for Full or Expedited Review
IRB Member Orientation:
- Session 1 (Roles & Goals, Regulations, General Information, Types of Applications)
- Session 2 (Informed Consent & HIPAA Requirements; Waivers & Alterations)
- Session 3 (Risk Assessment, Criteria for Approval, Actions)