Our HRP-310-WORKSHEET-Human Research Determination form, found through PPHS’s Worksheets, Checklists, and SOPs, can help you find out whether your research qualifies as human research and how it is regulated. Please be aware that it could fall under the Department of Health and Human Services and/or the Food and Drug Administration definitions.

If you believe your research project is exempt from IRB oversight, submit an application to our electronic submission system. With your submission, include a copy of any surveys or data collection forms that you will use in conducting your research. PPHS will make the ultimate approval determination.

Any faculty member can serve as a PI. Students and employees at the Icahn School of Medicine at Mount Sinai may also function as PIs if a faculty member joins the project as a mentor or co-investigator. Check with your department for specific policies.

To become familiar with your responsibilities as a clinical researcher, please consult the library within RUTH. In addition, the Office for Human Research Protections and the Food and Drug Administration provide clarification and guidance relating to your responsibilities as a researcher.

If you are involved in human subject research, as a PI or member of the research team, you will need to complete three courses:

• A one-time comprehensive basic foundations course, before beginning research
• A refresher, case-based course designed to reinforce your understanding of core issues. This must be completed within three years of the basic course, and once every three years thereafter.
• Two Health Insurance Portability and Accountability Act (HIPAA) courses, which cover institutional policies and regulatory considerations. To receive credit, you must complete both courses.

For a role-based list of the first steps to getting started with research, please consult the Research Portal Getting Started resource. Once accessed, select your role under “Research Start-up Table and Required Training”.

PPHS provides guidance to help you understand, interpret, and apply appropriate regulations and policies. Additionally, the Office of Research Services’ Study-Feasibility Checklist outlines protocol development, review, and approval processes. This guidance will help ensure that you are following both institutional standards and federal regulatory requirements. You can also use the Study-Feasibility Checklist as a guide.

Before you submit an application to the PPHS office, we recommend using our Research Roadmap’s Research Wizard to ensure that you understand which institutional reviews are required, and your deadlines during the review process. You need to obtain all relevant institutional reviews and approvals before you can receive final IRB approval.

We also provide checklists as part of the RUTH library, which can also help you determine which items to submit to the IRB.

Before starting any project, PIs should formulate a detailed plan to assure data integrity during its collection, storage, and analysis. If you do lose any data containing identifiable information, you need to file a report with the IRB within five business days. This report can be filed through RUTH by submitting a Reportable New Information form. You should also monitor any consent issues or subject complaints, and submit reports at least annually, or more frequently if the situation warrants.