IRB Process Instructions

EXEMPT Determinaton form 10.10.12 (1)

Exempt Research Determinations process

Hi Everyone,

After many long months going back-and-forth with the IRB, we have FINALLY obtained approval from the IRB!!! From this point forward, please enroll any patient who presents with a suspected skull or elbow fracture who you are planning on ordering X-rays and/or CT scan.

The IRB was tough and we have some extra paperwork which we did not anticipate. There is a formal written consent document. However, this form is voluntary does NOT have to be signed by the patient/guardian. It does need to be given to each patient/guardian to read over though. If possible, try to have them sign it. There is a HIPAA form which DOES need to be signed by every participant.

I have printed copies of all of the required documents and bundled them together to hopefully make it easier for everyone. It seems like a lot of paperwork but it is actually not that much. I have pre-assigned a “patient #” on each form. Here is the run-down; there are 6 documents (only 4 of which will be completed/given to patient) …

The 1st 2 documents are the most important:
1st page – “Ultrasound/Fracture Data Sheet”: includes demographic info, exclusion criteria, US findings, etc; please fill out as completely as possible; attached is a copy for you to review
2nd page – “Verbal Consent/Assent Form”: 3 check boxes, then you sign; also attached

Either 3rd OR 4th document depending on patient’s age:
3rd document – Written consent document for patients aged 18 years and older; signature of patient NOT required
4th document – Written consent document for patients aged younger than 18 years; signature of guardian NOT required

Either 5th OR 6th document depending on patient’s age:
5th document – HIPAA for patients aged 18 years and older; signature of patient required
6th document – HIPAA for patients aged younger than 18 years; signature of guardian required

Right now, all of these documents are in bundles in paperclips in the Peds ED in a single hanging folder next to the PACS computer. Nicos is working on getting another hanging folder so that in the future we will have one folder for blank forms and the other for completed documents.

I am really excited to get this project underway and thank everyone for your support and for your future participation! Please e-mail or call me with any questions about the study or documents.

Lana

Hello Faculty,

We now have three clinical Sickle Cell studies that are actively recruiting subjects. Rather than post paper advertisements in the ED, we have established a Sickle Cell research pager that can be paged through a single-click order in IBEX. So I am writing to everyone to ask (beg, plead) that, if you see a patient with Sickle Cell disease, please page the SCD pager as soon as possible.

The process is easy: go into the Sickle Cell order set (or the consults order set) and click “Sickle Cell MD” then press enter. I will automatically be paged.

Don’t worry about whether or not the patient is eligible for a study. I will take care of everything. If the patient is not eligible, I will still see the patient to arrange follow up and follow the patient as an inpatient. Don’t worry about the time of day either, page me 24-7.

Once you’ve paged me, continue with standard care as usual.

Thanks so much for your help!

Jeff Glassberg

RESCUED Combined Consent and Initial Data

The GCO has changed the submission process of their paperwork.  They are not accepting any more paper copies, instead you have to do it via infoed.  Infoed is located through the Sinai Central System. Log on to:  https://sinaicentral.mssm.edu/ ; go to GCO.

Before you begin go to the following link which will help you understand how to fill out the GCO forms and other GCO forms: http://sinaiknowledge.mssm.edu/sinai_central/conflict-of-interest/gco/?searchterm=GCO..

Anyone that has a project that is coming to an end must fill out the “continuation” or “final” paperwork to the GCO again, via infoed.  If you do not close out your project(s) the GCO will not allow you to submit any other projects until you close them out.

C.O.I- Conflict of Interest form must be updated every year.  So even if you have done this already you have to do it again.  Go into the Sinai Central System at: https://sinaicentral.mssm.edu/, sign in and go to the GCO link and go to “List Forms” on the upper left hand corner.  This is mandatory for everyone that works on any kind of research.  Anyone who is named on a project has to fill this form out also.  Staff must fill also fill out this form.

EVEN if you have completed a Human Research Subject Protection you MUST read the information below and apply for a new certificate.  You will not be allowed to submit any projects until this is done.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Human Research Subject Protection

Education Requirement

Effective August 18, 2010, the only Human Research Subject Protection training course available through the PPHS office will be the CITI program. All personnel will need to complete the CITI program course requirement.

HOW THIS AFFECTS YOU

If the PPHS office has your information on file for having previously completed the Human Subjects in Research requirement, you have until December 31, 2010 to complete the CITI training. Beginning January 1, 2011, the PPHS office will not process any further submissions until this training has been completed. Please make sure all research faculty and staff complete this requirement. No one will want to spend New Years Eve doing these modules to avoid having a project be suspended on January 1, 2011.

If the PPHS office does not have your information on file for having completed the Human Subjects in Research requirement, or you are new to the Institution, you must complete the CITI training curriculum before you can engage in any human subjects research. The PPHS office will not process any submissions until this training has been completed.

If you have previously completed CITI training for any other project or institution, please log in to CITI and add “Mount Sinai School of Medicine NYC” as an affiliate in order for any of your credits to transfer. You will be required to complete the course curriculum for your credits to transfer.

HOW LONG WILL IT TAKE TO COMPLETE THE COURSE

The Basic Human Subjects course is expected to take 4-6 hours to complete. The average user breaks this down over 5 sessions. All modules must be passed and completed in order for you to fulfill the education requirement.

WHAT TO DO WHEN THE COURSE HAS BEEN COMPLETED

Please retain your certificate. You do not have to send it to the PPHS. We will be notified by CITI when you have completed the course.

HOW LOW LONG THE COURSE WILL REMAIN VALID

Beginning in January 2011, ongoing education in human subjects research will be required every 3 years.

Refresher courses will be offered through the CITI program to meet this new requirement.

HOW TO BEGIN THE CERTIFICATION COURSE

1. Go to www.citiprogram.org

2.     Click on “New Users Register Here”

3.     Under “Select your institution or organization” , select “Mount Sinai School of Medicine NYC” in the  “Participating Institutions” drop down box.

4.     Create your own username and password and select the Learner group (Researcher)

5.     Make sure to keep a copy for your own file

PCC Study synopsis is available at this link.

Sinai is part of the national REASON network (Real Time Emergency Assessment with Sonography: Outcomes Research Network).

The first data for this network now being collected is on patients in cardiac arrest.  We need to save 2 clips of cardiac (in)activity in these patients one during a pulse check and one after the code.  Preferably these would come 15 minutes apart.

Full instructions on saving clips on the M-Turbo and for the REASON study are available help.

Multimedia post with more information to come soon at the sinai ultrasound site.

As a quick reminder, please remember to call the 4DVT pager (4388) anytime you diagnose a DVT in the Emergency Department. We are doing a study with IR randomizing patients to coumadin vs coumadin+clot removal procedure. For every patient we screen, $50 goes into our residency fund. You don’t need to do anything more because the IR fellow will come in and interview/enroll the patient if eligible.

Thanks again,

Amish

Our Group Code for RefWorks is: RWMSSM .

If you do not want to remember the Group Code you can access RefWorks off-campus the same way you access the Library’s other resources by going to the Library’s website: www.mssm.edu/library, clicking on RefWorks and logging into the Library.

If you are using the Write-n-Cite program in Microsoft Word from off-campus you must use the Group Code OR you can make one quick change in Write-n-Cite, directions are here: http://library.mssm.edu/reference/refworksfaq.shtml#access (you will still need to log in to the Library).

From Elaine,

Nick Genes and I put together some resources for research on the sinaiem.org page at

http://sinaiem.org/research-guide-resources/

There are links to the forms you need for the IRB and GCO, links to descriptions of which projects need IRB approval (versus expidited approval vs exemption), some past research lectures, and a good basic reference for stats and stats calculators.  Please let Nick or me know if you think of anything else that would be helpful.

Step by step instruction sheet for performing the block here.

The Mount Sinai School of Medicine’s Departments of Geriatrics, Emergency Medicine and Anesthesiology are collaborating on a study examining the efficacy and effects of 2 regional anesthesia techniques, femoral nerve blocks (FNB) and fascia iliaca blocks (FIB), on the treatment of peri-operative acute hip (femoral neck, intertrochanteric) fracture pain.

Patients age 60 years and over presenting to two New York City emergency departments (MSMC or Beth Israel)  with hip fracture will be randomized to receive the intervention or usual care.  The intervention includes single injection FNB in the ED followed by insertion of a continuous FIB catheter within 24 hours of the single injection FNB plus “as needed” non-opioid/opioid analgesia.  Usual care patients will receive conventional therapy with regularly scheduled intravenous or oral opioids plus “as needed” non/opioids/opioids. We will examine the impact of the intervention on patients’ self reported pain intensity; systemic opioid requirements; post-operative function; incidence of delirium, treatment related side effects; and hospital length of stay and participation in physical therapy.

Inclusion criteria:

• Ages 60 and over
• Male or female
• Presenting to the emergency departments at MSMC ED from 8:00 to 20:00 with   radiographically confirmed hip fracture (femoral neck, intertrochanteric, or peri-capsular).

Exclusion criteria:

• History of advanced dementia
• Presence of multiple trauma, pathological fractures, bilateral hip fractures, or previous fracture or surgery at the currently fractured site
• Patients transferred from another hospital
• Patients with cirrhosis or liver failure

Dr. Sean Morrison is the PI on this study. For more information or questions, please contact the project manager, Taja Ferguson Taja.Ferguson@mssm.edu, or one of the study coordinators, Carla Foster Carla.Foster@mssm.edu, or Lauren Greenberg Lauren.Greenberg@mssm.edu.

If you have a hip fracture, page the study coordinator (917-205-8474).

Management of Severe Local Anesthetic Toxicity

Dear Colleagues,

The Mount Sinai School of Medicine’s Department of Psychiatry and Department of Pediatrics are collaborating on a study involving two interventions for overweight or obese adolescents.  The purpose of this federally funded trial is to compare a new family-based intervention to nutritional education counseling in addressing overweight status in boys and girls ages 13-17.  Study evaluations and interventions are offered at no cost as part of this two-year study.  The study is part of a multi-site collaboration with the University of Chicago, and is approved by the Mount Sinai School of Medicine Institutional Review Board (Protocol 07-0216; PI: K.L. Loeb).

Inclusion criteria include:
•       Ages 13-17
•       Male or female
•       Living with at least one parent or guardian who is willing to participate in the study intervention
•       A BMI percentile >85% for gender and age (e.g., overweight or obese)

Exclusion criteria include:
•       Current psychotic illness
•       Current alcohol/drug dependence
•       Active suicidality

•       Eating disorders (e.g., binge eating disorder)

•       History of bariatric surgery

•       Medication associated with significant weight changes (e.g., antipsychotics)

•       Serious medical or physical conditions resulting in significant weight changes

(e.g., pregnancy, genetic disorders).

•       Complications of obesity that contraindicate moderate physical activity

Please feel free to discuss this study with qualifying patients to gauge their interest. If they would like more information, they may contact Lauren Alfano, 212-659-8724 or Dr. Terri Bacow at terri.bacow@mssm.edu.  Please don’t hesitate to contact me (or the study coordinators) directly if you have any questions about the study.  Thank you.

Terri L. Bacow, Ph.D.

Instructor, Department of Psychiatry

Eating and Weight Disorders Program

Mount Sinai School of Medicine

1 Gustave L. Levy Place, Box 1230

New York, NY 10029

Ph: (212) 659-8891

Fax: (212) 859-1469

Email: terri.bacow@mssm.edu

From: “Hermann, Luke” <Luke.Hermann@mountsinai.org>
Date: August 15, 2008 10:20:46 AM EDT
Subject: [Emfaculty] Need help with CT-STAT study

Hello all,

A short plea to remember the CT-STAT Study for your potential ACS patients (we are an enrolling site but thus far have put very few patients into the study):

The basics:

What: Compare CT coronary angiography with nuclear stress testing

Who: patients with
–          possible ACS
–          sinus rhythm without clear ischemic changes
–          normal creatinine
–          no history of CAD

How: Page Aileen at 6780- she will evaluate the patient, consent the patient, and facilitate the appropriate test. Aileen will also be rounding in the AM on CPU patients and if she enrolls a patient may ask you to change the ordered imaging study.

I’ve placed more information in the resident room and in the ED. Any questions? Don’t hesitate to ask.

Thanks in advance,

Luke