Institutional Review Board Frequently Asked Questions

Who can do research at Saint Luke’s Health System?

The SLHS HRPP policies and procedures apply to:

  • Clinical investigations involving Human Subjects Research conducted by faculty/staff at SLHS;
  • Students of affiliated academic institutions engaged in Human Subjects Research being conducted at SLHS;
  • Agents of SLHS (i.e., individuals engaged by SLHS to conduct Human Subject Research on behalf of SLHS);
  • Individuals conducting research at entities who have a formal written agreement with SLHS for review and approval of their Human Subjects Research.

When is IRB Review required?

When an activity meets the definition of “research” and involves “human subjects”, the Department of Health and Human Services’ (DHHS) regulations regarding the protection of human subjects apply, with limited exceptions. Investigators whose research meets these criteria must submit a protocol to the IRB for review and approval.

Federal regulations (45 CFR 46 and 21 CFR 50) state that research involving human subjects, directly or through the use of records, tissues, or other indirect means, must receive IRB review and approval prior to implementation. 

At SLHS, these regulations are met by submitting a formal protocol to the IRB. If the activity meets the definition of “research” involving “human subjects,” the protocol will be reviewed and approved in accordance with federal regulations in one of the following review categories: Exempt, Expedited or Full Board review.

When an activity meets the definition of “clinical investigation” and “human subject,” the FDA regulations regarding the protection of human subjects also apply (e.g. 21 CFR 50, 21 CFR 53, 21 CFR 312, 21 CFR 812).

(Note: Failure to obtain our approval for Human Subjects Research prior to engaging in the research will result in a finding of noncompliance with the Federal regulations and institutional policies.)

What is a Not-Human Subjects Research (NHSR) determination?

Activities that do not meet the definition of human subjects research in the HHS/FDA regulations may qualify for the designation of "Not Human Subjects Research" (NHSR) by the SLHS HRPP office. Examples of projects that may be determined to be NHSR include: quality improvement/program evaluation projects, case reports, publicly available data repositories, and decedent data. 

The HRPP office is available for consultation related to NHSR determinations. Please email irb@saint-lukes.org to request a consultation.

What is the IRB Review Process?

Please submit via iMedRIS for formal IRB review. During submission, if you have any questions, please contact us at irb@saint-lukes.org. Once a submission has been received, the submission will undergo pre-review. This ensures that the submission is review ready and helps to determine an initial review pathway. If a submission requires full committee review, it will be assigned to the next available meeting once it is determined review ready. For continuing review submissions, in order to prevent a lapse in IRB approval, please submit within 60-90 days prior to the expiration date. 

When do the IRB Committees meet?

IRB meetings occur twice a month, on the second and fourth Tuesday at 2 p.m. Research considered “greater than minimal risk” or research that does not otherwise meet OHRP and/or FDA requirements for “expedited review” per 45 CFR 46.110 and 21 CFR 56.110 are scheduled for full committee review. 

The SLHS IRB consists of two committees that are equally constituted, Board One and Board Two. 

Staff Contact List

Ryan McDowell, MS
Director, Human Research Protection Program (HRPP)
816-932-1815
rmcdowell@saint-lukes.org

Melissa Nowicki, MS, CCRP
Manager, Human Research Protection Program (HRPP)
816-932-1809
mnowicki@saint-lukes.org

Jeni O’Keefe, MS, CIP
HRPP Analyst II
816-599-9366
jenokeefe1@saint-lukes.org

Megan Brame
HRPP Analyst I
816-932-0280
mbrame@saint-lukes.org