NYU SoM IRB Newsletter
Table of Contents
Did You Know?
Did You Know?"
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From the Desk of Elan Czeisler
I am pleased to announce our plans for moving to an electronic submission process. The key to this will be an addition to our current IRB database—allowing researchers to submit all IRB forms and paperwork to us electronically.
Our first step will involve contacting a few research groups. They will assist us with the development of our electronic submission process—the forms we develop, the help systems we need in place, the route that electronic submissions take through the different research offices, etc. In addition to developing a paperless process, we will be working in parallel on a suite of online tutorials so that NYUSOM has an easy way for all staff (current and future) to learn how to work with the IRB's electronic submission system.
This system will provide many obvious benefits for the NYU School of Medicine:
  • a huge reduction in paper use
  • less time spent walking paper to and from the IRB
  • a reduction in our physical file space requirements
  • a virtual elimination of the re-keying of information
  • better review tools for our IRB staff and reviewers
  • all of the above benefits will contribute to an overall faster turnaround for your IRB submission
  • the ability to back up IRB records off-site
  • better security for confidential information
Watch this space for further news on the IRB's electronic submission project.

Sincerely,

— Elan Czeisler, Director
NYU School of Medicine IRB
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How Not to Delay Your IRB Submission
When receiving IRB forms, we see certain problems fairly regularly—problems which can easily be fixed. Left unfixed, these problems can delay the review of your study. Most are easy to avoid.
Here follows a list of the most frequently encountered problems. We apologize in advance for the length of the article—but the devil is in the details. And here they are.
New Protocols—Common Problems
  • Incorrect and/or incomplete information on forms. Unless otherwise stated, all questions are mandatory
  • Type of subjects involved in your study is not checked to include minorities
  • Number of subjects to be enrolled on application does not match the number on the consent
  • Wrong number of copies submitted
  • Copies are not collated in the proper order
  • Required signatures are not present.
  • Investigational drug studies: frequently information is not included regarding the drug being studied
  • Principal Investigator (P.I.) is listed as the only contact for the study
  • P.I. does not have faculty appointment
  • Recruitment efforts are not adequately described in the study's protocol
  • Informed consent process is not fully described in the protocol
  • Grammatical and spelling mistakes are found in the protocol, consent forms, etc.
  • Outdated IRB forms submitted (always download the latest form from our website-do not keep IRB forms on your local computer; they change often)
  • Technical and scientific language is used in the consent form; consent forms must be written in language understandable to individuals with a 6th–8th grade education
  • All study personnel (including data entry and data analysis) must be listed on application. Only those listed and approved by the IRB may work on the research.
Continuing Reviews—Common Problems
  • Incorrect and/or incomplete applications and submissions. e.g.:
    • Details aren't provided regarding the reasons for subject withdrawals
    • The number of subjects to be enrolled and subjects enrolled do not match
  • The prior IRB-approved (stamped) documents are not submitted along with the continuation/amendment request
  • A clean copy of the latest consent form document(s) to be stamped is missing
soothing yet meaningless illustration for Submission Process section (you're welcome)
Amendments—Common Problems
  1. Description of your proposed change(s) are missing
  2. Amended documents do not include the required hi-lighting or underlining of changes made
  3. Documents are not collated
Mistakes Common to All Submission Types
These are almost always the easiest to remedy.
  • While completing IRB applications, edit and proof read one last time before sending them in to us
  • Verify that the Principal Investigator has a faculty appointment
  • Ensure that the names of all staff who should receive IRB correspondence regarding the project are listed under the Contact Person section of the application. Please note: Only the Principal Investigator and those listed in this section will receive IRB correspondence. If the section is left empty, only the PI will receive the correspondence.
  • Be sure to justify the exclusion of any subjects (gender, minorities, etc.). Federal regulations require justification for the exclusion of these populations.
All documents submitted for IRB review should be collated into packets as described below:
Submission Order for Initial Review (Full Board)
Original Packet (1 copy)
  1. Application [on top]
  2. Billing Plan (2 copies)
  3. Financial Disclosure Form
  4. HIPAA certification
  5. Consent Form (English)
  6. Recruitment materials (flyers, advertisements)
  7. Questionnaires
  8. Waiver of individual authorization/consent
  9. Protocol - Summary
  10. Protocol - Complete (protocols must have page numbers and version dates)
  11. NIH Grant
  12. Investigator's Brochure/Product Info [on bottom]
Reviewers' Packet (4 copies—placed under Original packet)
  1. Application
  2. Consent Form
  3. Protocol Summary
  4. Full Protocol
  5. Investigator's Brochure
Members' Packet (12 copies—placed under Reviewer packets)
  1. Application
  2. Consent Form
  3. Protocol Summary
Submission Order for Continuing Review (Full Board)
Original Packet (1 copy)
  1. Continuing Review Application [on top]
  2. Financial Disclosures (if applicable)
  3. Clean Consent Form
  4. Revised Consent Form (if applicable)
  5. Full Protocol
  6. Progress Reports/Safety Reports
  7. Literature Findings
  8. Investigator's Brochure (if applicable) [on bottom]
Reviewers' Packets (4 copies—placed under Original packet)
  • All of the above except Financial Disclosures
Members' Packets (12 copies—placed under Reviewer packets)
  1. Continuation Application
  2. Previously approved consent form
  3. Revised Consent Form (if applicable)
soothing yet meaningless illustration for Submission Process section (you're welcome)
Submission Order for Amendment (Full Board)
Original (1 packet)
  1. Amendment Application [on top]
  2. All revised documents; all changes must be underlined
  3. Previous version of all amended documents (changed versions on top of original versions) [on bottom]
Reviewers' Packet (4 copies—placed under Original packet)
  • All of the above
Members' Packet (12 copies—placed under Reviewer packets)
  1. Amendment Application
  2. Previously approved Consent Form
  3. Revised Consent Form
Submission Order for Expedited Reviews (all types)
  • See appropriate submission type above
  • All materials will be the same as the submission type for full board review
  • Only the Original Packet is needed for review; no other packets are required for expedited submissions
Submission Order for Serious Adverse Event
SAE Packet (Original + 2 copies)
  1. SAE Report Forms
  2. Back-up Documentation off-site and on-site
Submissions that are not fully collated in the order described above will likely be delayed. The IRB is happy to provide assistance with our (admittedly complex) application process; please don't hesitate to contact us at 212-263-4110 or irb-info@med.nyu.edu.
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Newest IRB Staff
As the IRB continues its transformation to better serve the NYU SoM research community, we are happy to introduce two new staff members: Johanna Valantin and Sonia Jawaid.
Johanna Valantin joins the IRB as the new Coordinator for Board A. Her primary responsibilities are processing study amendments and continuations and fielding general IRB questions. Prior to joining the IRB, Johanna served as the Contracts Coordinator for the Office of Clinical Trials. Johanna holds a B.A. in Communications and is currently pursuing her MBA in Health Care Management.
Sonia Jawaid rejoins the IRB as a Project Assistant and will assume the duties of Brian DeSmet, who leaves the IRB to pursue an acting career. Sonia will coordinate the agendas for Board "B" and provide general administrative support to the team, including forwarding IRB correspondence to researchers and maintaining the records of all study closures.
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Announcing IRB 101
We would like to announce a new educational series: IRB Orientation 101. This series of courses is designed for new research coordinators, data managers, students, fellows, investigators and anyone from the research community interested in learning how to manage their IRB submissions.
IRB 101 is comprised of seven courses and will be held in the Coles Lecture Hall (Room 101/109) over a series of Wednesdays.
Date and Time
Every Wednesday beginning June 14, 2006 at 12:00 PM (except the week of July 4th)
Target Audience
Research Coordinators, Regulatory Coordinators, students, fellows, investigators and any new staff involved in sending submissions to the IRB
Objectives
At the conclusion of this series, the participant will understand the IRB submission process, where to find IRB forms and what type of submissions are appropriate in a given circumstance.
Registration
To register, go to the "IRB Course Calendar" on our website (http://www.med.nyu.edu/irb). It is strongly suggested that each participant register for all courses. Registration is required to attend these courses.
soothing yet meaningless illustration for 101 section (you're welcome)
Course Calendar
6/14—Navigating the IRB
Teresa Laury & Kim Diccianni
6/21—Initial Review Process (Full Board, Exempt, Expedited)
Kim Diccianni & Helen Panageas
6/28—Amendments
Germaine Cuff & Rick Kline
7/12—Continuations
Rick Kline & Germaine Cuff
7/19—Serious Adverse Events and Terminations
Germaine Cuff & Rick Kline
7/26—Managing your Clinical Trials
Aileen Kunitz
8/2—Introduction to Ethical Challenges in Human Subject Research
Elan Czeisler
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Questions & Answers
soothing yet meaningless illustration for FAQ section (you're welcome)
Does expedited review mean a faster turn around time?
Not necessarily. In spite of the name, expedited review in research involving human subjects is not synonymous with expeditious review. The term expedited review refers to a minor change in a previously IRB-approved research study, or new research that meets the criteria outlined in one of the 9 categories of review stipulated by federal government regulations.
The categories include research that present no more than minimal risk to human subjects (such as minimal blood draws, questionnaires, collection of data from voice, video, digital, or image recordings etc). Additionally, the expedited review category #8 allows full board studies to be reviewed via expedited review at the time of continuing review, if the study meets certain criteria.
Review under these categories does not require full board review and can be done by one member of the IRB: either the IRB Chair or a designated member. A complete list and thorough description of the expedited categories can be found at http://www.hhs.gov/ohrp /humansubjects/guidance /expedited98.htm
My study doesn't involve risk of any kind. Do I still need to submit to the IRB?
IRB review of research protocols is required whenever an investigator (whether a professional or student) who is affiliated with the institution conducts research with human subjects, or when such activities utilize the facilities of New York University School of Medicine. This requirement applies regardless of the risk level of procedures.
Research is defined by 45 CFR 46.102(d) as "an activity of systemic investigation designed to develop or contribute to generalizable knowledge".
If you are conducting an activity by this definition, you are doing research. The IRB only has the authority to review "Human Subjects Research". If the research you are conducting, involves: (1) obtaining information about living individuals [45 CFR 46.102(f)]; (2) intervention or interaction with the individuals [45 CFR 46.102(f)(1),(2)]; your activity is considered human subjects research and must be submitted for review by IRB.
My project is not federally funded. Do I still need IRB approval?
Yes! All research involving human subjects as defined above must be reviewed by the IRB. NYU SoM has an assurance with the Department of Health and Human Services. In this document (called a Federal Wide Assurance (FWA)) NYU SoM agrees to extend the federal regulations to all research with human subjects, regardless of the source of funding—or lack thereof.
Do I need to submit my study's consent form when reporting a serious adverse event?
No! The IRB no longer requires that you submit your latest stamped consent form. Our brand new submission receipt makes this clear. Only a written report (for on-site SAEs) or IND Safety Report (for off-site SAEs under a multi-center study) is required, along with our SAE Submission Receipt.
Did You Know?
Have a Question?"
Do you have a question concerning the IRB or human subjects research? Send it to irb-info@med.nyu.edu so we can answer your questions in our next newsletter. The author of the best question will receive an office chair. All other entrants will receive a large bag of rubber bands and bulldog clips actually used in an IRB meeting.
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Contacting the IRB
Phone: (212) 263-4110
Fax: (212) 263-4147
eMail - general questions: irb-info@med.nyu.edu
eMail - questions for a study that has already been submitted (submit questions to the board your study was assigned to; include your study's IRB# in all communication): irb-board-a@med.nyu.edu irb-board-b@med.nyu.edu
newsletter feedback irb-it@med.nyu.edu
Recently Changed Forms
The IRB generally requires that you only submit the latest version of our forms. For this reason, we ask that you go to our website each time to download the form you need, as it may have recently changed.
  • Request for Continuation - June 1, 2006
  • Submission Receipt (New) - June 12, 2006
  • Submission Receipt (Continuation) - June 12, 2006
  • Submission Receipt (Amendment) - June 12, 2006
  • Submission Receipt (SAE/Emergency Use/Other) - June 12, 2006
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