Clinical and Research Centers
The Department of Orthopedic Surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center includes world-renowned experts who specialize in the care of children and adults with musculoskeletal disorders. Our orthopedic department provides the most advanced care for the full range of orthopedic conditions and are committed to providing world-class training for the next generation of orthopedic surgeons. In addition, researchers at NewYork-Presbyterian/Columbia Orthopedics are in the vanguard of developing new and better treatments for musculoskeletal disease.
This guide will provide you basic and essential information on departmental and institutional research procedures. It is intended to help you with the process and to avoid most common mistakes.
First time researchers should read this guide carefully and reach out for help before submitting protocols or proposals.
ORTHOPAEDIC RESEARCH 101 - DEPARTMENTAL GUIDE
- First Time Researchers
- Administrative - Basics
- Principal Investigators
- Human Subject Research
- Grants & Contracts
- Clinical Trials
- Animal Research
- Chart Reviews
- Patient Data Reports
- Unrestricted Research or Educational Gifts/Grants
The Department of Orthopedic Surgery processes orders and pays invoices. However, Principal Investigators (PIs) are ultimately responsible for maintaining compliance and financial records. PIs are also responsible for tracking grant expenses and providing progress and final reports as well as for financial reporting. Resident PIs have the same responsibilities.
Center for Hip and Knee Replacement:
Todd Morrison
Tel: x5-8193
e-mail: tm2362@columbia.edu
website: www.hipnknee.org
Center for Orthopedic Research:
Esperanza Soriano
Tel: x5-5974
e-mail: ecs2@columbia.edu
website: http://columbiaortho.org/cor/cor.htmlCenter for Pediatric Research:
Hiroko Matsumoto,
Tel: x5-5028
e-mail: hm2174@columbia.edu
website: http://www.childrensorthopaedics.comCenter for Shoulder and Elbow Surgery:
Shaileena Chougle
Tel: x6-8188
e-mail: lw2322@columbia.edu
website: http://www.nyp.org/columbiaortho/
research/sports_med.html
Trauma Training Center:
Lee Ann Finno
Tel: x5-6392
e-mail: lf120@columbia.edu
website: http://www.nyp.org/columbiaortho/
research/dep_tra.html
Animal Research:
Yelena Akelina
Tel: x5-0992
e-mail: ya67@columbia.edu
- Institutional Information for Applications
www.columbia.edu/cu/researchadministration/instinfo.htm
- Rascal: A rascal protocol must be created on the Grants and Contracts module. The rascal website is http://www.rascal.columbia.edu
If your study is a clinical trial, you must select Clinical Trials in the Submitting to drop down menu on the General instructions page. All others select Health Sciences or Morningside as appropriate. - Info Education: NIH proposals and budget must be processed in InfoEd. For information visit the Research Administration website at
http://www.columbia.edu/cu/researchadministration/
infoed_intro.html - Departmental Approval: The Chairman has designated Esperanza Soriano as the rascal departmental approver for IRBs, Grants and Contracts, Clinical Trials and Animal Research. Please add her to the approvers list. Her UNI is ecs2 and the rascal role should be departmental administrator. Please do not add the Chairman to your approvers list. Esperanza is the departmental liaison
- AWARD LETTERS: TO ENSURE GRANTS FUNDS WILL BE AVAILABLE WHEN NEEDED, FORWARD A COPY OF THE AWARD LETTER TO ESPERANZA SORIANO.
- Only Faculty can be the principal investigator of record in rascal. This is a University Policy. Note: rascal is an internal tracking system. Grants and Contracts officers are aware that residents will be PIs on resident grant applications
- All human subject research must be approved by the Institutional Review Board (IRB).
- Human subject data should not be collected prior to IRB approval or during expiration gaps. Any data collected prior to approval or while the protocol is expired should be excluded from the study analysis and/or publications.
- All research personnel must have a current conflict of interest and Good Clinical Practice certification in rascal. Training is available online in rascal: http://www.rascal.columbia.edu
- Institutional Information for Applications
www.columbia.edu/cu/researchadministration/instinfo.htm - The Office Grants & Contracts must review and sign off all applications at least 5 days before agency submission deadline. You must bring the rascal data sheet, application and budget. (Note: please check with our project officer re: NIH and other federal agencies as these may need to be in G&C earlier).
Our project officer and financial officer in Grants & Contracts contact information is listed below.
Victor Cabrera
Sr. Project Officer, Research Administration
722 West 168th Street, 4th Flr, R430K,
NY, NY 10032
212.342.0256 tel;
212.305.3694 fax
vc2104@columbia.edu
- Please add indirect costs (IC) to your budgets. For private industry, the average is 25% to your total budget. For guidance on this, please contact Esperanza Soriano. If the funding agency does not allow indirect cost, please attach a copy of their policy to your budget.
- If the Chairman's signature/letter is required, please write a draft letter and email it/drop it off with me or Theresa Milianta for review/signature. Please include the application and other information with the letter.
- Please follow the same procedure as you would use for the rascal protocol. The rascal website is: http://www.rascal.columbia.edu
If your study is a clinical trial, you must select Clinical Trials in the Submitting to drop down menu on the General instructions page. (not Health Sciences)
Animal Research
When you have an idea for a project –complete a literature search,
the librarian Anca Meret (e-mail: aom1@columbia.edu) could help you make your search more comprehensive.
Dr. Yelena Akelina also should be included in all the animals protocols as a Staff Researcher. Please keep in mind that it could take up to 3-6 months from writing to an approval of your animal use protocol. So give your self a lot of time. For any questions regarding animal research please contact:
Yelena Akelina
Tel: x5-0992
e-mail: ya67@columbia.edu
Dr. Manu Sebastian is a veterinary pathologist who could give you advice on histological aspects of your study.
Please contact: ms3658@columbia.edu
SIGN-UP FOR
- IACUC TRAINING:
- Occupational Health
- Rodent Lecture
- Rodent Wet-lab
- Large Animal Training
- RASCAL:
Please follow the instruction to write the Animal Use Protocol and if you have any question please contact the Rascal Help Line.
Animal Use Protocol Submission:
For questions related to the protocol submission process, protocol approval, deadlines, or using the protocol form please contact:
Ranjana Hernandez
e-mail: rh2039@columbia.edu
Tel: 212-305-8644
Stephanie Espinal
e-mail: se232@columbia.edu
Tel: 212-305-9307
Compliance and Training Coordinator
Jo Ann Henry
e-mail: jah2158@columbia.edu
Tel: 212-305-8199
- Please follow medical records requests protocol attached.
- Billing has limited time to pull reports so channel these requests through your project coordinators or me so we get what is needed the first time.
Unrestricted Research or Educational Gifts/Grants
- Please call me if you are applying for unrestricted gifts/grants. Depending on what the funding source requires, most of these grants do not need to go through the office of Grants and Contracts.
