Brooklyn Campus of the VA New York Harbor Healthcare System

Research and Development Program GUIDE TO THE INVESTIGATOR: INITIAL STUDY PACKAGE • General Information • Research Staff Training Checklist • Authorization to Transport and Utilize VA Sensitive Information Outside Protected Environments • Principal Investigator Checklist for Initial IRB Submissions • Tissue Banking Requirements • Funding Source Codes • Abstract Guidelines • Guidance on Research Studies Using Investigational Drugs • Investigational Drug Management Fees (see office secretary) • Codes & Instructions for Investigator Data Sheet • Appendix C (Data Security Checklist for Principal Investigators ) & D (Principal Investigator’s Certification: Storage& Security of VA Research Information) REQUEST TO REVIEW INITIAL STUDY PACKAGE • Conflict of Interest Disclosure Form • Request to Review Research Proposal/Project • Pharmacy Support Form • Budget Form: Non-VA Research Funding • pg 18 - Investigator Data • Form 10-9012, Investigational Drug Information Record HUMAN STUDIES FORMS • VAF 10-1086, VA Research Consent Form • Human Studies Questionnaire (HSQ) • HSQ without Supplement Pages • HSQ Supplement IIHI Use • HSQ Supplement Investigative Device • HSQ Supplement IRB Waiver 1 • HSQ Supplement IRB Waiver 2 • HSQ Supplement IRB Waiver 3 • Human Studies Questionnaire Sample Answers • Protocol Amendment IRB Submission Form • Human Subject Enrollment Log • Research Coordinator Scope of Practice • Research Coordinator Scope of Practice (Non-VA Paid) • Application for an Off-Site Tissue Banking Waiver • Certification of Compliance with HIPAA Privacy Rule Requirements for Use of PHI Preparatory To Research ANIMAL STUDIES/IACUC FORMS • Animal Component of Research Protocol (ACORP) • ACORP Appendix 1 - NON-VA Animal Facility • ACORP Appendix 2 - Antibody Production • ACORP Appendix 3 - Test Substances • ACORP Appendix 4 - Antemortem Specimen Collection • ACORP Appendix 5 - Surgery • ACORP Appendix 6 - Special Husbandry & Procedures • ACORP Appendix 7 - Request to Use Pt Care Procedural Areas • ACORP Appendix 8 - Request to Use Explosive Agents • ACORP Appendix 9 - Additional Local Information RESEARCH SAFETY SUBCOMMITTEE FORMS • VA Biohazard & Safety Information Form ANNUAL REVIEW IRB FORMS: HUMAN STUDIES • IRB Continuing Review Checklist • VAF 10-1086, VA Research Consent Form • Adverse Event Report • Request for Continued Approval of Human Use Form • Research Staff Training Checklist ADDITIONAL R&D FORMS • Informed Consent Checklist • Informed Consent Template • Request for Expedited Review • Certification of Exemption • Addition of Research Personnel • Application for Case Report Review • Request for Study Closure COMMITTEE FORMS • IRB Initial Review Checklist • IRB Continuing Review Checklist • RD Initial Review Checklist • RD Continuing Review Checklist Related Links • R&D Home • VA Research Programs Services Services Barber Shop Daycare Center Community Living Center Home Based Primary Care Homeless Veterans Hoptel Units Mental Health Pharmacy Readjustment Research Shuttle Bus Service Social Work Visual Impairment Program Women's Health   Page Content Provider: Marna Abarientos Brooklyn Campus Home | Services | Patient Information | Visitor Information | Contact Us Volunteer | Careers | About Brooklyn | Site Index | Plug-Ins | Webmaster