Project Guidance

Below are the elements the IRB looks for when reviewing research. Federal regulations 45 CFR 46.111 and 21 CFR 56.111 outline the requirements for approval of non-exempt human subjects research. To obtain IRB approval, the IRB must have enough information to determine the criteria in each of the sections below are satisfied.

When applying for initial approval, review each topic to ensure the proposed research meets the requirements for approval. When modifying existing research, ensure that the proposed modifications continue to comply with the requirements.

Project Requirements

Additional Regulatory Requirements Additional IRB Requirements
Student Records & FERPA Financial Conflicts of Interest
The Common Rule Research Outside of Sites at Montefiore Einstein
Investigational Drugs & Devices (FDA)  
Medical Records & HIPPA  
Vulnerable Populations