Determine if IRB review is required or exempt and if your project meets the federal definition of research involving "human subjects". Any research that involves either the participation of human subjects or the use of medical charts, specimens, or databases with identifying information about humans is considered human subject research and requires review.] See the IRB Policies and Procedures for definitions. [Note: IRB review and approval or certification of an exemption must be obtained prior to any contact with human subjects or any use of their specimens, records, or data.] If still unsure, contact the IRB office for guidance.
Complete training courses: All investigators and key research personnel who work with human subjects must complete the Collaborative Institutional Training Initiative (CITI) online human subjects protections training before the IRB gives final approval of a project. When registering at CITI (https://www.citiprogram.org/), remember to affiliate with this institution. You can find a definition of key personnel in the IRB policies and procedures (PDF).
Training requirements relate to the type of research you are submitting and include:
Human subjects training (biomedical, social/behavioral, or data/specimen only) every three years.
Health information security and privacy (HIPS) for either the investigator or clinician one time.
For studies, involving FDA regulated research Good Clinical Practice (with FDA focus) is required to be taken once.
Additional financial conflict of training modules are required for Public Health Service research projects every four years.
Gather important documents and consider operational issues: Examples of required documents for the study may include: protocols, site specific consenting/assenting tools, recruitment plans, advertisements, surveys/questionnaires, investigator brochures for investigational drugs, instructions for use for devices, financial conflict of interest documents, Form 1572 for drug studies, and FDA approval documents for investigational device studies. Contact the departments likely to be involved in your research to discuss potential operational issues.
Obtain any institutional clearance prior to IRB submission: Clearances and contracts are handled via the Office for Human Research.
Complete IRB submission process. The electronic IRB system can be located internally at irb.mhs.net. If you do not have access, you can click on the link "Request New Account" and complete the information requested.
Meet scheduled deadlines: In order to keep your review on schedule meet all scheduled deadlines (PDF) for pre-review activities and schedule submissions. The IRB meets on the 2nd Monday of each month, with exceptions made for holidays. Deadlines are posted in the electronic IRB system under the "My Assistant" tab. IRB attendance is required for principal investigators for non-exempt projects.
Allow sufficient time: the length of time for review depends on the type of human subject, complexity of ethical or technical questions that arise during the review, and level of risk. Pre-review is required for non-exempt projects and subcommittee review meeting will be scheduled.
Please ask questions at any stage of the process. Contact us by email or call 954-265-1857.
