I'd like to start off by sharing one of the changes the IRB has recently made to our policies and procedures for reviewing research involving children.

One of the most significant changes to the policy is a clearer delineation of the New York State regulatory requirements when performing research on subjects who are considered to be wards of the state. Specifically, the definition of wards now clearly includes foster children.

Our Application for New Protocol Review now requires you to provide additional information when you intend to include wards in your research. Federal regulations require special protections for this class of research subject. The inclusion of wards in research is also of special interest to the DHHS' Office of Human Research Protections (OHRP).

The IRB policy has been updated and the changes can be found in the IRB Policies and Procedures Manual and our Investigator's Guide. It is important that as a researcher you familiarize yourself with our policy changes. As always, the IRB staff is available to assist you if you have any questions.

The IRB Office is in the process of reviewing all of our current IRB policies, procedures, forms and templates. As significant revisions are being considered, we will solicit comments from members of the research community. Once the changes are adopted, they will be in this newsletter.

One last note: many of you may have seen the IRB's "How Are We Doing?" quality/feedback campaign. We appreciate all your comments-please keep them coming!

— Elan Czeisler, Director

NYU School of Medicine IRB

A number of questions have been coming into the IRB office regarding the above (very cumbersome, we agree) titled IRB actions. This article should help clear up the problems we see most often.

When it's time to close your study, and you aren't sure what to do, here are some helpful tips. To determine if your study is really closed ask yourself:

• have all subjects have completed their procedures?
• have all chart reviews, questionnaires, surveys, follow-up procedures etc. have been completed?
• has all data analysis been complete?

If you can't answer all these questions in the affirmative, your study isn't ready to be closed. In other words, your study is not closed:

• if data analysis is still on-going
• if all participants have not completed all follow up exams
• if you still have some information to collect from medical charts

Once you have determined your study is closed, proceed to the next steps:

• Fill out the IRB's Request for Final Study Closure in its entirety
• Do not answer "N/A" for any of the questions; all questions need to be answered
• If there have been no SAEs reported, answer this question by stating "no SAEs reported"
• give as much detail as possible; be clear with all your statements
• Attach your Final Study Report/Summary of Final Results to the IRB Request for Final Study Closure. This describes the Investigator's or Sponsor's view of the findings collected from the study
• If a Final Study Report/Summary of Final Results is not included, your submission will be delayed until it is complete

If you need help with any aspect of closing your study, please contact the IRB office.

The Department of Health and Human Services (DHHS) Regulations 45 CFR 46 require that "an IRB shall conduct continuing review covered by this policy at intervals appropriate to the degree of risk, but not less than once per year..."

When a study is approved by the IRB it is assigned an approval period. This approval period may vary depending on degree of risk but cannot be less than once/year. An Expired study is one that has not been reviewd since the last approval.

There is no grace period extending the conduct of the research beyond the expiration date of IRB approval. If the IRB does not re-approve the research by the specified expiration date, all activities must cease pending re-approval of the research by the IRB.

Once your project has lapsed, the IRB will email the P.I. an Expiration Notification letter. This letter informs the P.I. that their project is no longer approved and must immediately halt. Once that letter is received, the following information must be submitted:

1. You must contact the IRB if any continuing involvement with human subjects is necessary
2. A new application and review will be required to reinstate the study

If there is no response from the P.I. after 5 business days, the Director will contact the P.I. and a copy of the Expiration Notification will be sent to the P.I.'s department chairperson.

The IRB may, at its discretion, allow the continuation of already-enrolled study subjects when halting research-related interventions could harm the subjects. The P.I. must request this continuance in writing. The request must be addressed to the IRB Chair and submitted to the IRB office. There is no form for this procedure - just call the IRB at (212) 263-4110 or email IRB-INFO@med.nyu.edu immediately.

Expirations typically result from:

• The IRB receiving a Request for Continuation less than eight weeks before the study's approval end-date
• The IRB receiving an incomplete Request for Continuation which isn't resolved (I.E.: the IRB's questions and your answers) aren't finalized within the eight weeks before your study's approval end-date
• The IRB receives nothing before your study's approval end-date
• The IRB sends courtesy expiration reminders every 2 weeks, starting about 91 days before a study is about to lapse. These reminders are send via email to the P.I. only, and it's up to the P.I. to make sure their current email address is correct in the NYU SoM Directory (which is where we obtain the P.I.'s address)
• Although the IRB makes every effort to notify the P.I. of expiring studies, it is solely the P.I.'s responsibility to keep track of the IRB approval end-date and make sure that their continuation is submitted eight weeks proior

The IRB will administratively withdraw studies that have not been finalized with 60 days. What that means is that after the IRB sends the P.I. the Reviewer's/Board's determination, you must respond within 60 days. If we haven't heard from you after that, we'll administratively withdrawal your study, requiring a completely new submission if you wish to pursue it later.

IRB Orientation 101 has been received by the Research Community with open arms. The IRB would like to take the opportunity to thank you all for your support, attendance and participation in these sessions.

Date and Time: Every Wednesday June 7-August 2, 2006 at 12:00 PM

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. It is strongly suggested that each participant register for all courses. Registration is required to attend these courses.

7/26 - Managing your Clinical Trials

Aileen Kunitz

8/2 - Introduction to Ethical Challenges in Human Subject Research

Elan Czeisler

Keep the emails coming with your suggestions on the education you need for your research and staff needs. All suggestions are reviewed and taken into consideration.

Case Studies are comprised of one or more cases collected and presented to highlight an interesting medical condition, treatment, presentation or outcome. One of the first questions you should think of when you're considering a Case Study is: does this need to be reviewed by the IRB?

The answer revolves around a few key definitions:

• Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
• Human Subject(s): Human subject means a living individual 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.

If your "Case Study" includes a hypothesis, methods/procedures, analysis and/or an outcome, you're probably conducting research. If human subjects are involved in any way (as defined above), you need an IRB review before you start.

A real Case Study is something that is only used to present interesting information to an audience. There is no systematic analysis done. If this sounds like what you're creating, you probably do not need IRB review before starting it.

So do you think you can determine if your Case Study needs to be submitted? If you can't, don't worry. Contact the IRB and we will help you.

Not necessarily. The form should be submitted to the IRB only when there is a potential conflict of interest. A Financial Interest Disclosure Form is required, and will be reviewed by the Conflict of Interest Committee.

The due dates and board meeting dates for all IRB boards can be found on our website at http://www.med.nyu.edu/irb/schedule/

No. Don't send any old elements; only submit the latest materials to the IRB in your Request for Initial Review. You should not submit an amendment and an initial application together. This way only the latest protocol and/or consent forms (the most recently amended documents) are the documents the IRB reviews and approves.

Phone: (212) 263-4110

Fax: (212) 263-4147

Web: http://www.med.nyu.edu/irb

  Meeting Schedule: http://www.med.nyu.edu/irb/schedule/index.html

  Contact List: http://www.med.nyu.edu/irb/contact.html

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-feedback@med.nyu.edu

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 Initial IRB Review - July 24, 2006

Request for Initial IRB + GCRC Review - July 24, 2006

Submission Receipt (New) - July 10, 2006

Submission Receipt (Continuation) - June 29, 2006

Submission Receipt (Amendment) - June 29, 2006

Submission Receipt (SAE/Emergency Use/Other) - June 29, 2006