Protocol Review Wizard | Icahn School of Medicine

Welcome to the Protocol Review Wizard for submissions through the Icahn School of Medicine

This tool is intended to navigate you through our internal research administrative processes specifically for new projects.

The Wizard will require you to answer between 7-15 questions. You must answer all of the questions in order to see your project's requirements.

Once all questions have been answered, click on the "Submit form" button to see your project's requirements.

Should you have any questions or need guidance with projects that are continuations, modifications, requests for additional funding, etc., please contact the appropriate research office for assistance.

1. Funding Source?

2. Does your project involve Human Subjects?

For assistance in determining if your project involves Human Subjects, you can use this WorkSheet or: contact the PPHS at 212-824-8200 If your project involves Stem Cells, please contact the IRB for additional requirements.

3. Does your project require the consenting of research subjects?

If you are unsure, please contact the PPHS at 212-824-8200 before continuing.

4. Is your study Cancer Related?

5. Is your project a Clinical Trial?

Hint: A Clinical Trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.

6. Is your Clinical Trial a Multi-Site Study where Mount Sinai is issuing payments to other sites?

7. Do you have to buy a drug, device, or other medical product that is being investigated?

Hint: If the drug, device, medical product is free answer no.

8. Will you be giving investigational agents, approved drugs that are not given under routine care guidelines, or FDA approved drugs/biologics that are supplied or paid for by the research grant or company?

9. Does your project require any tests involving ionizing radiation (such as CT scans, x-rays for any purpose, fluoroscopy, nuclear medicine tests, angiography, DEXA, PET, or SPECT) or the use of radiation for therapy, as part of research or for standard of care associated with the research?

If you are unsure, please contact the Radiation Safety Committee Analyst at (212) 824-8200 for assistance.

10. Will you be Utilizing the Clinical Research Unit?

For more information about the CRU, please contact 212-241-6045

11. Does your project involve Vertebrate Animals?

12. Does your project involve the use of BioHazards, Recombinant DNA, Gene Therapy?

13. Will you be using any radioactive materials?

If you are unsure, please contact Radiation Safety at (212) 241-2269 for assistance.

14. Will you be using any Class 3 or Class 4 Lasers?

Hint: If you are using lasers and unsure of its classification, please contact Radiation Safety at (212) 241-2269

15. If any of the following questions below are true choose "Yes" to the dropdown

a) Will you be giving any external entity or person access to MSSM intellectual property OR will you be receiving intellectual property from outside of MSSM? Hint: Intellectual Property consists of inventions, patents, copyrights, novel materials etc. b) Will you be exchanging confidential information with the party interested in funding your research or providing materials for your research? Hint: Are new ideas or materials that are not yet published or patented being shared with companies to determine their interest in research collaborations? c) Will the scope of work to be carried out be based on your input and ideas? Hint: Did the company and PI develop it together or did the PI develop and present the scope of work to the company who is choosing to fund it?

16. Are you developing software or using third-party information technology and/or software in your research study?