IRB Submissions New projects must be reviewed by the IRB prior to beginning human research activities. After initial approval, researchers must maintain IRB approval by submitting post-approval applications and reports. The Einstein IRB utilizes OneAegis for all study applications. All applications will be reviewed for compliance with the criteria for approval. First Time Submitters Start Here If you are new to the process of IRB review or new to the Einstein IRB, you will need to complete a few steps before submitting to the IRB through OneAegis. Please review and complete the following tasks before submitting to the Einstein IRB for the first time: Read the OHRA Investigator’s Manual to understand your role and responsibilities, learn about the IRB review process, and possible IRB determinations Complete all required training Submission Requirements The Einstein IRB utilizes an electronic submission and project management system called OneAegis. Document Requirements Research Protocol: Templates are available for download. The IRB will also accept a sponsor or investigator’s protocol. Do not submit more than one research protocol. Additional Requirements Depending on the study design and procedures, your submission may require additional documents: Any/all subject-facing documents Recruitment Materials (e.g., flyers, advertisements) Screening Scripts Consent Form(s) (templates available) link to Forms & Templates Surveys/Interview Questions/Focus Group Prompts Study brochure/package insert (if conducting a clinical trial of an investigational product) Required Committee Approvals (Ancillary Reviews) link to Ancillary reviews page in Policies & Procedures Disclosure of any Conflicts of Interest link to COI page in Policies & Procedures Required Signatures A protocol cannot be approved by the Einstein IRB unless the appropriate administrative approvals are provided. Please refer to the Administrative Approvals for IRB Applications page to determine the appropriate signatures. All signatures must be completed electronically on OneAegis. How To Submit a New Project Every new submission requires a protocol – or scientific write-up – of the proposed study. Use our Protocol Elements Checklist or the peer-reviewed SPIRIT 2013 Guidelines to develop a protocol with all of the necessary criteria included. If this is your first time submitting to OneAegis, please make sure you have completed the steps under “First Time Submitters Start Here” before starting your application. You can build a new project in OneAegis over time; IRB analysts will not see the project until you select “Submit.” This allows you to store documents electronically while developing your project. Once all study details and documents are completed, click “Submit” for IRB review. Application for Exempt, Expedited, or Full Board Review All applications for any time of review are submitted through OneAegis. Detailed directions for using OneAegis, from creating your account to closing out your study, is available in the OneAegis Investigator Guide. Post Approval Submissions (Modify-Report-Renew-Close) Amendments/Modifications: All modifications to research must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the human subjects. Report of New Information: The Einstein IRB requires investigators to report certain events or circumstances that occur during the conduct of a study. There are specific reporting timelines. Become familiar with the requirements to avoid non-compliance. Continuing Review/Study Closure: At the time of approval, the Einstein IRB will determine if and when the approval will expire. The investigator must apply for a new approval period or study closure before IRB approval expires.
