ORA/IRB Information For the Researcher

New Submissions

There is a two part process, for the review of new submissions, involving the Office of Research Administration (ORA) and the Institutional Review Board (IRB). The majority of protocols require a full review. The application starts with the ORA study initiation form. 

NOTE:  If you are submitting a protocol for a study that will be conducted at Mercy Medical Center you do not need to complete the ORA portion.

ORA Submission

The ORA review is required by the institution (St. Luke’s) to assure the proposed research fits the mission statement of the hospital and includes a due diligence review.  This due diligence review includes evaluation and negotiation of: contracts, budgets, establishment of a billing plan, as well as an evaluation of the impacts that the research may have on St. Luke’s (the departments where the research will occur (Research Process Committee)(RPC)).  Once the ORA review is complete, the study is ready for submission to the IRB.

Due diligence and IRB reviews incur a cost to conduct.  These costs are typically reimbursed by the sponsor.  If you have a student project, personal project, limited grant, or a competitive grant please contact the ORA office to discuss sliding fees or a fee waiver.

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

1. Submit the study initiation form with complete documentation to the ORA via electronic format (e-mail). Once an initial ORA review is conducted you will be notified regarding the study status and time frames for IRB submission.  The ORA charges a one-time initial review fee of $1875.00.  The principal investigator is responsible for arranging payment by the sponsor.
2. After your study has been reviewed by the ORA you will be notified when you can submit your application and study to the IRB.  The IRB charges a one-time initial review fee of $2000.00. The principal investigator is responsible for arranging payment by the sponsor.

IRB Submission

1. Carefully read the apllication form(s). Call the IRB if you are unsure whether your study qualifies for Exempt, Expedited, or Full Board Review. Make sure all questions are answered, if a question does not pertain to your research protocol put N/A.  Make sure all required materials listed on the application 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.)   Three hard copies of the IRB application and all required materials should be submitted to the IRB.
2. After your IRB application is received the IRB will make a final assessment as to the type of review your study will require.  The types of reviews are as follows:
   • IRB exempt
   • Expedited review
   • Full Board review
3. If your study requires a Full Board review, and your application packet is complete your study will be placed on the IRB agenda for the next available meeting.  Please see the attached schedule listing meeting dates and submission deadlines. (Note: For Full Board Reviews, 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 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.

IRB Information for the Researcher

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 Chairperson or other qualified IRB member 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 Questionaire 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.

 

HIPAA Regulation for Researchers and Research Staff

Definitions

Protected Health Information (PHI): Protected health information includes all individually identifiable health information transmitted or maintained by an organization covered by the HIPAA regulations (a “covered entity”), regardless of form.  Specifically, it is Individually Identifiable Health Information (IIHI) that is:

• Transmitted by electronic
• media Maintained in any electronic media;
• or Transmitted or maintained in any other form or medium (e.g., paper or oral).

Covered Entity (CE): Covered Entities are health care providers, health plans, and health care clearing houses.  St. Luke’s is a covered entity.

Authorization: This is the HIPAA equivalent of consent to use and disclose data.

What are the Types of Health Information?

There are three categories of health information and the requirements for use are different for each category:

1. Individually Identifiable Health Information (IIHI)
2. De-Identified Information
3. Limited Data Set

HIPAA Authorization

The HIPAA “authorization” is the equivalent to the consent form.  It is the process through which a patient allows researchers to access protected health information.  The HIPAA Authorization can be incorporated into the research consent form or be a separate document. 

1. Authorization Requirements
2. Waiver of Authorization
3. HIPAA Addendum Template

A waiver of HIPAA Authorization may potentially be granted for fully de-identified research data.  Requests for a waiver of HIPAA Authorization must meet certain criteria.

IMPORTANT INFORMATION YOU MAY NEED:

IRB Registration # IRB00002113

St. Luke’s Federal Wide Assurance (FWA)# 00004341
Expiration date 1/9/2012

For ORA submission related questions please call the ORA at (208) 381-5126

For IRB submssion related questions please call the IRB at (208) 381-1406