1. IRB Basics Helen Panageas New York University School of Medicine Institutional Review Board Portion of slides courtesy of Suzanne M. Smith, University of Pennsylvania

2. Introducing the NYU SoM IRB The Institutional Review Board (IRB):  Operates under federal regulations.  Charged with protecting the rights and welfare of people involved in research.  Keeps pace with the ever changing environment of human subjects research.  Facilitates and strengthens human subjects research conducted by investigators at the institution.

3. What does the IRB do? Oversees all research that involves human subjects. Mandated by:  HHS: 45 CFR 46  FDA: 21 CFR 50 & 56 Ethical Guidance:  Nuremburg Code  Declaration of Helsinki  Belmont Report

4. When is IRB review required? IRB review is required for all human subjects research:  Federally funded research  Research involving FDA regulated products  Research not federally funded or not involving FDA regulated products, i.e. “in house” studies, not funded, research conducted under departmental grants

5. How is a ‘Human Subject’ defined? Definition of HUMAN SUBJECT according to 45 CFR 46:  “living individual (s) about whom an investigator (whether professional or student) conducting research obtains… (1) data through INTERVENTION or INTERACTION with the individual OR (2) identifiable PRIVATE INFORMATION obtained for this research in a form associable with the individual (that is, the identity of the subject is or may readily be ascertained or associated with information)

6. Is the activity ‘Research’? regulations define “research” as “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”  “Systematic” means that research methods are employed to test a hypothesis and draw conclusions.  “Generalizable” refers to the dissemination of or intent to disseminate findings to a scientific or professional audience. This generally includes the following: Masters and doctoral theses Presentation at a scientific or professional meeting or conference, including poster presentation and abstract submissions Submission to or publication in a professional or scientific journal Generalizable knowledge is usually that which is disseminated through presentation and/or publication, put in the public domain, or innovative

7. How does the IRB review research? Initial Review – 3 Types:  Exempt  Expedited  Full Board Continuing Review:  IRB decides renewal term At least once annually Amendments:  Changes to study: protocol, consent, ads, etc. Unanticipated Problems  Protocol Deviation, Adverse Events, New Information, Subject Complaint Terminations  Study end, final report

8. Review Types & Risk Level Exempt  All research procedures must fall into one or more of the exemption categories  Do not need to inform IRB of any changes that occur during the course of an exempt study unless the change affects the review level and/or risk to subject.  Use the Request for Exemption form (found on IRB website) Expedited  Reviews studies that are no more than minimal risk AND where are research procedures fall within one of the expedited categories of research Full Board  Any study that is considered more than minimal risk is reviewed by a fully convened IRB (8-15 people)

9. Submission Basics Cover Letter IRB Submission Application Protocol Summary Full Protocol Informed Consent HIPAA Authorization or Waiver Human Subjects protection training for PIs and study staff (CITI) Recruitment materials: ads, radio announcements, brochures Study questionnaires and surveys IND/IDE information Investigational brochure or product labeling (drug/device studies) Conflict of interest documentation For federally funded research: grant application For All Submissions (Administrative Acknowledgement, Exempt, & Expedited Review, Full Board):  Original + 2 copies

10. Helpful Submission Hints Include protocol number and PI name on all submissions Include fax and email of PI and primary study contact Ensure page numbers are on all documents Update version date on all revised documents Include both versions of revised documents:  Copy with changes highlighted or tracked  Clean copy with changes incorporated but not highlighted Maintain communication with your IRB throughout the life of the study

11. IRB New Happenings IRB Changes:  PI Attendance at Board Meetings  Members receive small compensation  Board C – March 2008 Electronic submission (InfoEd) – Spring 2008  PI & Administrator access to summary screens - March CITI Tutorials – Human subject and GCP Quality Improvement/Education Program 2008 Symposium – coordinated by NYU SoM IRB and NYU Dental School

12. Where is the IRB located? 423 East 23 rd Street (VA Building) 10 th floor West Wing For general questions, call the IRB Office at 212-263-4110 or email irb-info@med.nyu.edu Website: http://www.med.nyu.edu/IRB.htmlhttp://www.med.nyu.edu/IRB.html

13. FAQ’s Where should I go if I have questions?  Consult the IRB website When do I submit my protocol? How long will the review take?  When submission packet is complete, you can submit to IRB for initial review. Allow IRB 2-3 working days to process review packet.  Turn around time frame depends upon the type of proposal, when it is submitted, and when the next committee review meeting will convene. When should I submit for continuing review?  PI’s will be notified by IRB when their study is due for continuing review.  CR’s should be submitted 8 weeks prior to the approval expiration date. What should I do if my approval expires?  All study activities should stop (interviews, data collection, recruitment, etc.).  If the study expires, you must contact the IRB administrator for further instruction on resubmission.

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