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 Research Risks & Benefits Subject Selection & Recruitment Consent Process Documentation of Consent Privacy & Confidentiality Monitoring for Safety & Compliance 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