Principal Investigators All researchers should be conducting their IRB approved protocols in accordance with requirements in the Investigator Manual. This document is designed to guide you through policies and procedures related to the conduct of human research that are specific to our Institution. The IRB requires that all researchers review this manual before submitting to the IRB and researchers follow the these requirements when conducting human subjects research. Below are some answers to common questions and useful links to guide you through the process. What Are the Eligibility Requirements for a Principal Investigator? It is Einstein/MMC policy that only those with whom the organization has or intends to have an ongoing employment or contractual relationship may serve as Principal Investigator (PI) on research projects submitted to the Einstein IRB. In practice, this means: the PI must be a faculty member with the rank of instructor or above; and the PI must be properly credentialed by the facility at which the research is approved to take place; and the PI must be employed (either full- or part-time) by the institutions noted above; and if the research involves the administration of a drug or use of a device for research purposes, the PI must be a licensed physician The PI assumes the responsibility of the whole of the research study, including any responsibility delegated to study coordinators and research teams. The full scope of PI responsibilities is described in the Investigator's Agreement which you electronically sign in iRIS when you submit a study. Our policy document on Principal Investigator Requirements is available on our Policies and Procedures page. What Is the Required Training for Researchers? All PIs and key personnel must complete the required training described on the Training and Education page before they can be included on a protocol submitted to the Einstein IRB, and before they can submit in iRIS. After you have completed your training and education, you should be able to log into iRIS using your MMCAD credentials. I am the Principal Investigator. What Are My Responsibilities/Expectations? The full scope of the PI's responsibilities is outlined in the policy document [OHRA-POL-2020-006] Principal Investigator Responsibilities but can be summarized as follows: Obtain IRB approval or an exemption determination before conducting research involving human subjects. Do not start Human Research activities until you have obtained all other required institutional approvals, including approvals of departments or divisions that require approval prior to commencing research that involves additional resources. For instance when an investigational drug or biologic is involved, you are required to defer responsibility for accounting, storage and dispensing, etc. to Investigational Drug Services (IDS) Pharmacy. Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space. Ensure that Research Staff are qualified (e.g., including but not limited to training, education, expertise, credentials, protocol requirements and, when relevant, privileges) to perform procedures and duties assigned to them during the study. Personally conduct or supervise the Human Research. Protect the rights, safety, and welfare of subjects involved in the research. Comply with the current protocol as approved by the IRB. When required by the IRB, ensure that consent or permission is obtained as required by the protocol and as indicated in your submission. Do not modify the Human Research without or implement a planned deviation from the approved protocol without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subject(s). Report to the IRB all required reports within the required reporting timeframe. Submit an updated disclosure of financial interests for you and your key research staff within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest. Do not accept or provide payments to professionals in exchange for referrals of potential subjects (“finder’s fees.”) Do not accept payments designed to accelerate recruitment that were tied to the rate or timing of enrollment (“bonus payments.”) Follow applicable federal department or agency requirements when conducting human subject research funded or supported by that department or agency. Selection of qualified individuals for roles on study team Complete knowledge of protocol, investigator's brochure(s), and consent form(s) Process for oversight of study team Process for monitoring subject safety and data collection Understanding of reporting obligations to funding sources, FDA (if applicable), and IRB Understanding of scope of responsibility for multi-site studies, PI-initiated studies, federally funded studies Understanding of federal, IRB, and institutional policies and regulations applicable to the research I am part of the Study Team. What are my Responsibilities/Expecations? Understanding of federal, IRB, and institutional regulations and policies applicable to the research Appropriate knowledge (according to role) of the study's purpose(s), activities, risks, and benefits Thorough understanding of the individual's role on the study and its relation to regulations and policies Understanding of reporting obligations to the PI, IRB, and institution What Are My Responsibilities After IRB Approval? The PI/Study Team must conduct the study in accordance with the Einstein IRB-approved protocol and policies. There are reporting requirements post IRB approval that require further submission to the IRB: Amendments:Any modifications to the study must be approved by the Einstein IRB prior to implementation. Click here for the Amendments to Previously Approved Research Procedure policy document Continuing Review: IRB review is required at least annually for all non-exempt research, unless a shorter approval period was determined by the Einstein IRB. Click here for the Continuing Review Procedure policy document Reportable Events: Serious Adverse Events, Unanticipated Problems, Protocol Deviations and other events must be reported as detailed in the following Unanticipated Problems Procedure document and Other Reportable Events Procedure document Study Closure: Studies should be closed in accordance with the policies set forth by your department and chair Click here for the OHRA Record Retention Policy Helpful Links IRB Submissions Project Guidance IRB Forms Training & Education Single IRB & Reliance Investigator Roles & Responsibilities IRB Policies & Regulations
