IRB Information For the Researcher

New Submissions

The majority of protocols require full review and is a two-part process requiring approval by the Institutional Review Board (IRB) and the Research Process Committee (RPC).  You may obtain these approvals concurrently. The application covers requirements for both committees. 

NOTE:  If you are submitting a protocol for a study that will be conducted at St. Luke’s Magic Valley RMC or Mercy Medical Center you do not need to complete the RPC portion.

The RPC is required by the institution (St. Luke’s) to assure the proposed research fits the mission statement of the hospital and to serve as a liaison to assist the researcher in proper notification and in-servicing of all departments and personnel that will be involved in the research project.

Qualified Minimal Risk Study

In accordance with regulations, St. Luke’s IRB uses an expedited review process to review certain minimal risk studies meeting specific regulatory criteria. If a proposed minimal risk study qualifies to be reviewed by expedited review, or is qualified as exempt, the IRB Manager can approve the research or conditionally approve with minor modifications.  For more information regarding minimal risk studies, please contact the IRB Office at 381-1406. 

Human Subjects Protection Training

In order to conduct human research, all researchers and their support staff are to complete the on-line CITI human subject protections training program. 

For more information, please see Education.

Conflict of Interest 

Conflict of interest refers to any situation in which financial, professional, or personal obligations may compromise or present the appearance of compromising an individual’s professional judgment in designing, conducting, analyzing or reporting research.  All investigators, co-investigators, and sub-investigators must disclose any conflict of interest when submitting a new protocol and thereafter on an annual basis and as new reportable financial interests arise.

See conflict of interest under forms.

Research Misconduct

Research Misconduct is broadly defined as any conduct that violates the requirements of St. Luke’s (human) research program, funding source regulations, or local, state, or federal research regulations.  Research Misconduct as defined by the federal government means fabrication, falsification or plagiarism in proposing, performing, or reviewing research, or in reporting research results.  Principal investigators are responsible for reading the policy, informing their research staff of the policy and their obligation to comply with it.  

See Research Misconduct Policy and Research Misconduct Declaration under forms.

 Research Protocol Processing

For expedient processing of your research protocol please complete the following steps:

1. To secure a place on the IRB agenda for the month you wish to present your protocol by calling the IRB (381-1406) with your name, protocol title and contact number. Please see the attached schedule listing meeting dates and submission deadlines. (Note: The Principal Investigator or Sub-Investigator must be present at the IRB meeting, the Coordinator/Administrator cannot present for the PI.) All IRB meetings are held at 5:00 p.m. in the Ada 1 Room in the Anderson Center on the 5th floor of Mountain States Tumor Institute South Tower. The PI may present via teleconference if they are at a satellite site and cannot travel to the meeting.

2. The IRB charges a one-time initial review fee of $2000.00. The principal investigator is responsible for arranging payment by the sponsor. If you have a student project, personal project, limited grant, or a competitive grant please contact the IRB office to discuss sliding fees or a fee waiver.

 3. Carefully read the application form. Make sure all questions are answered, if a question does not pertain to your research protocol put N/A. Five copies he following forms are required to be submitted:

• Study Protocol
•  Amendments/Addendums (if applicable)
•  Consent Form
•  HIPAA Form
•  IRB Application Form
• Assent for (For Pediatric Protocol)

Make sure all required materials are submitted, if a required material does not pertain to your research protocol mark N/A. If you are not sure if a required material pertains to your study, please call the IRB to discuss it before you turn in your application. (Note: Any incomplete submission packages will be returned.)

IMPORTANT INFORMATION YOU MAY NEED:

IRB Registration # IRB00002113

St. Luke’s Federal Wide Assurance (FWA)# 00004341
Expiration date 2/9/09

Please call the IRB Manager if you have any questions regarding the above information at (208) 381-1406.