1. What to Expect 
    1.  

    The Research Committee holds its meetings on the 1st of April, August, and December to evaluate proposed studies that have been submitted during the respective application periods. In cases where the committee necessitates additional clarification or more information, it is recommended to allocate a minimum of one month for the approval process. Following this, preparations for data collection should begin approximately two months after the proposal submission deadline, in accordance with the application window schedule. 

    The committee may take the following actions:

    • The committee may approve the proposal as submitted.
    • The committee may request that certain changes be made and ask that the applicant consider submitting a modified proposal. Modified proposals will be processed as they are received.
    • The committee may issue a conditional approval, pending successful negotiation of a fee-for-service schedule regarding the administrative data requested.
    • The committee may issue an approval with the caveat that executing a Research Data Privacy Agreement will be necessary before administrative data can be transferred.
    • The committee may deny approval on the grounds that, in the judgment of the committee, it would be inappropriate to conduct the proposed research study. Deficiencies will be outlined for the applicant.

     

    Resubmission

    In the event of a proposal submission being declined, it is imperative that the provided feedback is thoroughly addressed before making a resubmission in a future window. The HISD IRB will assess the resubmission as an entirely new proposal, devoid of any connection to the previous submission. It is important to bear in mind that an application fee is mandatory for each submission and for each window.

     

    Types of IRB Review

    New Requests to Conduct Research in HISD

    The Research Committee receives a request for permission to conduct research from the principal investigator. The committee is expected to complete its action prior to making a review decision. The review action must be completed within 30 days after the submission date. 

    Amendments for Approved Projects

    The investigator must report to the committee for review any problems or proposed procedural changes that may affect the status of the ongoing program with regard to the established Criteria for Approving Studies.

     

    IRB Decisions 

     

    Decisions are based on the majority approval of the committee. At least three of the five committee members must agree that a proposal meets criteria for approval. 

  • IRB Review Process [Draft 22 January; subject to revision]

    Flow Chart