Office of Research Administration (ORA)
Information for the Researcher
The process for the review of new research study submissions to St. Luke's Research is described below. The process starts within the iMedRIS software, a web-based suite of applications designed to manage research protocols. Researchers submitting for the first time will need to contact the iMedRIS system administrator in order to obtain a user password so they can complete a new Study/Protocol Application (or request from the iMedRIS login screen, “Request New Account” button.
- iMedRIS System Administrator, 381-8917
- iMedRIS Data Entry Specialist, 381-8915
Applications will be reviewed for completeness, and incomplete applications will be returned to the researcher for follow-up action.
Completion of the review process is a collaborative effort among the researchers and research administrative support personnel. Please anticipate working closely together to share and provide information in order to finalize approval(s).
For any research involving vertebrate animals (other than humans), the studies will be presented to the designated Institutional Animal Care and Use Committee (IACUC) for review of animal subjects protections.
For any research involving human subjects, the project shall be submitted to an Institutional Review Board (IRB) which has been approved by St. Luke's Health System.
For all new submissions, the following reviews must be conducted. When human subjects are involved, these reviews will occur prior to IRB submission. Review of each of these items will be addressed concurrently.
- Contract review: A contract is required any time an external party is providing support (financial or by providing goods and/or services) and/or when an individual who is not a St. Luke’s employee is providing substantive input into the research project.
- Medicare coverage analysis (when patients are involved in the research).
- Budget analysis and, where applicable, negotiation. (Please review the Research Rate Fees list.)
- Conflict of Interest (COI) review.
- Government Grants Administration (GGA) review (for government funded studies) and copies of all GGA required forms.
- Scientific Review Committee review (for investigator initiated studies)
Once the above listed items have been finalized or have reached a stated completion that allows the project to move to IRB review, the research project may then be presented to one of St. Luke's Health System's approved IRBs for review.
In addition to the reviews outlined above, and depending on the scope and design of the research, St. Luke's Research will conduct the following reviews (these reviews can be done concurrently with the IRB review; they do not need to be completed prior to IRB submission).
- Research compliance review: This includes but is not limited to a current human subjects training certification through the Collaborative IRB Training Initiative (CITI) web-based program, current shipping of hazardous materials training (through IATA), all research personnel are appropriately credentialed to do the procedures assigned to them, all research personnel who are not St. Luke's Health System employees have on file the appropriate contractor information.
- Pharmacy review
- Biosafety Committee review
- Radiation Safety Committee review
- Genetic Safety Committee review
- IACUC review
St. Luke's Research will provide a final authorization notice to the researcher, via email, when the research project is approved. This will also serve as approval to begin enrollment of human subjects and/or to begin research activities using vertebrate animals. Notification of final approval status will also be sent to affected departments.
Please Note: Before any additional changes can be implemented to a previously approved study, those CHANGES MUST BE SUBMITTED TO THE ORA FOR APPROVAL PRIOR TO IMPLEMENTATION.