numc.edu - Institutional Review Board (IRB)

Institutional Review Board (IRB) - Numc

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Institutional ReviewWorkbench(IRB) - Numc Find a Doctor Ask well-nigh Financial Assistance Find a Phone Number / Contact Patient Visit A Patient / View Visiting Hours Find Directions/MapsWangleMy Medical Records Make an Appointment Refill My Prescription LearnWell-nighOur Centers of Care Thank a Staff Member or Physician Volunteer Close (x)I Want To... Nuhealth Foundation Make An Appointment  | WangleMy Medical Records  |  Refill My Prescription InsuranceWangleen español HomeAbout NuHealth Message from the CEO Our Vision Looking Forward Raising the Bar Our History Staff Executive StaffWorkbenchof Directors Department Chairs Centers of Care Nassau University Medical Center A. 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Ask well-nigh Financial Assistance Find a Phone Number / Contact Patient Visit A Patient / View Visiting Hours Find Directions/MapsWangleMy Medical Records Make an Appointment Refill My Prescription LearnWell-nighOur Centers of Care Thank a Staff Member or Physician Volunteer Institutional ReviewWorkbench(IRB) Home / Institutional ReviewWorkbench(IRB) ABOUT THE IRB The Institutional ReviewWorkbench(IRB) of Nassau Health Care Corporation (NHCC) at Nassau University Medical Center (NUMC) was constituted under the provisions of 45 CFR 46, United States Department of Health & Human Services (HHS), Protection of Human Subjects as published in the Federal Register 81 FR 732 (2016) and Food and Drug Administration Regulations, 21 CFR, Parts 50-56, 81 FR 732 (2016). IRB MISSION NHCC’s IRB has the responsibility to protect human subjects involved in biomedical research at NUMC through its review of research projects that involve human subjects. The committee IRB review serves an important role in the protection of the rights and welfare of research subjects. The purpose of the IRB is to ensure that, upon IRB review and approval, all research is conducted in vibrations with all federal, institutional and upstanding guidelines. Funded sponsored research submissions will be handled by external IRBs without review by NHCC’s Office of the IRB. All subsequent modifications must be reviewed by the NHCC IRB in wing to any external IRB.  The NHCC IRB must receive periodic summaries of the progress of all submissions, including results, wrongheaded events, unanticipated problems, and noncompliance. Unanticipated problems, wrongheaded events and noncompliance must be communicated to the NHCC IRB immediately. Applications for investigational drug or medical device use including expanded wangle must moreover be submitted to the NHCC IRB and follow FDA regulations. RESEARCH Research is specified as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. All research involving human subjects conducted at NHCC requires IRB review and approval. CATEGORIES OF RESEARCH Some research may be exempt from IRB review. The visualization to exempt a study from IRB review must be made by the IRB. Therefore, all research whether exempt or not should be submitted for this determination. When submitting a study as an exempt study, the researcher must identify the executive workable exemption (see 45 CFR 46.101 (b) (1) through (6)). An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or increasingly experienced reviewers designated by the chairperson from among members of the IRB in vibrations with the requirements set along in 45 CFR 46.110.  Research activities that (1) present no increasingly than minimal risk to human subjects, and (2) involve only procedures listed in one or increasingly of the workable HHS subcategories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. Full workbench review is required for all research involving greater than minimal risk to subjects. Standard requirements for informed consent (or its waiver, alteration, or exception) wield regardless of the type of review–expedited or convened–utilized by the IRB. EMERGENCY APPROVAL Emergency clearance of a protocol may be provided by the Chair or Vice Chair/designee without clearance by Counsel to the IRB if it meets several criteria:  it is to be used in a life-threatening situation; no standard winning treatment is available, and there is insufficient time to obtain IRB approval.  FDA Emergency use procedures and towardly IRB submissions must be followed. RESEARCHER  TRAINING All researchers planning to be involved in any human subject research activities in this institution must be trained in human subjects’ protections. The required training is the Collaborative Institutional Training Initiative (CITI) course. The CITI webpage can be accessed at https://www.citiprogram.org. The pursuit modules must be completed surpassing initiation of any research activities and undertow completion certificates submitted to the NHCC IRB with the IRB submission: Northwell Health (formerly North Shore Long Island Jewish Health System) Human Subjects ResearchUndertow(must be renewed every three years) Conflict of InterestUndertow(must be renewed every four years). MEETING SCHEDULE AND DEADLINES All completed protocols are reviewed as they are received. Completed protocols must be submitted in final form three weeks prior to the scheduled NHCC IRB Committee meeting. Meetings often convene on the second Wednesday of each month in the Library Conference Room A at Nassau University Medical Center. Completed protocols received without the deadline will be reviewed at the pursuit IRB meeting. For information, please contact the Chairman of the IRB, Dr. Gregory Haggerty at (516) 572-3079 or Vice-Chairperson Dr. Lynn A. Schaefer at (516) 572-6835 for any questions regarding intended human research.   STAFF Gregory Haggerty, Ph.D. Chairman Lynn A. Schaefer, Ph.D. Vice-Chairperson   Contact Us Office of Institutional ReviewWorkbench2201 Hempstead Turnpike Box # 29 East Meadow, NY Phone: 516-572-3079 Fax: 516-572-6120 Email: irb@numc.edu   Contact Us Careers Phone Directory Site Map Disclaimer Privacy Policy Library Professional Login Employee E-Mail Archive © NuHealth, 2201 Hempstead Turnpike, East Meadow, NY 11554 | (516) 572-0123