ABOUT THE IRB
The Institutional Review Board (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).
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 accordance with all federal, institutional and ethical guidelines.
Funded sponsored research submissions will be handled by external IRBs after review by NHCC’s Office of the IRB. All subsequent modifications must be reviewed by the NHCC IRB in addition to any external IRB. The NHCC IRB must receive periodic summaries of the progress of all submissions, including results, adverse events, unanticipated problems, and noncompliance. Unanticipated problems, adverse events and noncompliance must be communicated to the NHCC IRB immediately. Applications for investigational drug or medical device use including expanded access must also be submitted to the NHCC IRB and follow FDA regulations.
Research is defined 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 decision 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 controlling applicable 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 more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110. Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the applicable 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 board review is required for all research involving greater than minimal risk to subjects.
Standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review–expedited or convened–utilized by the IRB.
Emergency approval of a protocol may be provided by the Chair or Vice Chair/designee after approval by Counsel to the IRB if it meets several criteria: it is to be used in a life-threatening situation; no standard acceptable treatment is available, and there is insufficient time to obtain IRB approval. FDA Emergency use procedures and appropriate IRB submissions must be followed.
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 following modules must be completed before initiation of any research activities and course completion certificates submitted to the NHCC IRB with the IRB submission:
- Northwell Health (formerly North Shore Long Island Jewish Health System) Human Subjects Research Course (must be renewed every three years)
- Conflict of Interest Course (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 generally convene on the second Wednesday of each month in the Library Conference Room A at Nassau University Medical Center. Completed protocols received after the deadline will be reviewed at the following IRB meeting.
For information, please contact the Counsel to the Institutional Review Board (IRB), Karen G. Leslie, Esq at (516) 572-4754 or the Chairman of the IRB, Dr. Amgad Makaryus at (516) 296-4949 for any questions regarding intended human research.
|Amgad N. Makaryus, MD
|Karen G. Leslie, Esq.
Counsel to the Institutional Review Board (IRB)