Working With Humans

The Icahn School of Medicine at Mount Sinai complies with all ethical and legal requirements for the conduct and oversight of human research. Our Institutional Review Board (IRB) is responsible for assessing and approving all research at the Medical School that is to be conducted in human subjects. The Investigator Manual outlines the general roles and responsibilities of a researcher.

What types of studies qualify as human subjects research?

Our Worksheet HRP-309: Human Research Determination can help you find out whether your research qualifies as human research and how it is regulated. It could belong under the Department of Health and Human Services or the Food and Drug Administration. You can find this algorithm on page 3 of the Investigator Manual.

If you believe your research project is exempt from IRB oversight, you can complete and submit HRP-216-FORM: Exempt Determination to the Program for the Protection of Human Subjects (PPHS) for evaluation. The second page of the form details the requirements for exemption. With your submission, include a copy of any surveys or data collection forms that you will use in conducting your research. PPHS makes the ultimate approval determination.

Who is eligible to be a Principal Investigator (PI) for human subjects research?

Any faculty member can serve as a PI. Medical School students and employees may also function as PIs as long as a faculty member joins the project as a mentor or co-investigator. Check with your department for specific policies.

What are my responsibilities as a researcher?

To become familiar with your responsibilities as a clinical researcher, you can review the Investigator Manual.

In addition, the HRP-430 Checklist Investigator QI Assessment provides details about your regulatory (study) binder; record keeping; protocol for holding an investigational new drug or investigational device exception; and other requirements.

What training do you require or recommend for clinical researchers?

As a PI or member of the research team, you will need to take three types of courses if you are involved in human subject research:

1. A one-time comprehensive basic foundations course, taken before your begin.

2. A refresher, case-based course designed to reinforce your understanding of core issues. You need to complete this within three years of the basic course, and once every three years thereafter.

3. Two Health Insurance Portability and Accountability Act (HIPAA) courses, which cover institutional policies and regulatory considerations. To receive credit, you must need to complete both courses.

What resources exist to help me?

PPHS provides guidance that will help you, to understand, interpret, and apply the appropriate regulations and policies.

In addition, the Office of Research Services’ Study-Feasibility Checklist outlines protocol development, review, and approval processes. This guidance will help ensure that you are in compliance with both institutional standards and federal regulatory requirements. You can also use the Study-feasibility Checklist as a guide.

How does the research proposal application process work?

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

We also provide a checklist that will help you determine which items to submit to the IRB.

What auditing or monitoring is required during the study?

Before starting any project, you should formulate a solid plan to assure data integrity during its collection, storage, and analysis. (Your research will have to comply with institutional recommendations.) If you do lose any data containing identifiable information, you need to file a report with the IRB within five business days, using Form HRP-224.

You should monitor any consent issues or subject complaints, and submit reports at least annually, or more frequently if the situation warrants.

Is my project exempt from IRB Review?

If you believe your project may fit into a category for exemption from IRB review, review the HRP-320 Worksheet Exempt Determination form. If your project seems to meet the criteria, complete and submit HRP-216-FROM: Exempt Determination to the PPHS for evaluation. Review the second page of the form for the limitations required to meet exemption criteria. Your submission must include a copy of any surveys or data collection forms that will be used to conduct your research.