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Jackson Clinical Research Review Committee



intro

Investigators, JHS and the University of Miami have been partners in quality clinical research for many years.  Recently, this partnership has seemingly become more complicated due to concerns about research finances and management.  Such concerns led JHS to establish a Clinical Research Review Committee (CRRC) to determine whether JHS will permit a JHS study to be implemented at its sites and to provide oversight of financial and management issues.

JHS policies define JHS research as that which includes any of the following:

  1. medical intervention within a JHS patient
  2. review of JHS patient records
  3. recruitment activity conducted within JHS or directed toward JHS patients
  4. use of the JHS pharmacy or other JHS facilities

JHS and the Public Health Trust are committed to such research and continue to encourage its presence at all JHS sites.  

The Human Subject Research Office (HSRO) and JHS have worked together to modify the submission process for JHS studies to facilitate JHS permission and IRB approval and to ensure that these occur in a timely manner.



submission process

JHS Study – Submission Process

  1. All investigators proposing new studies within the HSRO's eProst system will be asked whether the study involves JHS as a recruitment or performance site.  If the study does not involve JHS, investigators will encounter no changes from current practices
  2. If the study does involve JHS, then the eProst system will forward the submission to the CRRC (on behalf of JHS) concurrently with the forwarding of the study to the HSRO for IRB review and approval.  The process to accomplish this will differ from that currently on-going for "ancillary committees" in that CRRC review occurs in parallel to IRB Review. In cases where CRRC permission is granted after IRB approval, the JHS Informed Consent documents will be held until such time as JHS apprval has been provided in eProst.

Ms. Eve Sakran is the Director of the JHS Clinical Trials Office and coordinates CRRC review.  The JHS Clinical Trials Office is located at Jackson Medical East tower, Room 1107E (phone – 305-585-7596)



Confidentiality

Confidentiality

In order for the CRRC to review studies on behalf of JHS, confidential information must be provided to that committee.  This sharing of study-related materials with JHS must be understood and agreed upon by all parties.  To ensure that this occurs, investigators are reminded that:

  1. Investigators are not authorized to enter into contracts on behalf of UM or JHS.  This includes confidentiality and non-disclosure agreements with sponsors
  2. For all studies initiated by UM faculty, confidentiality agreements must be routed to Ms. Suzanne Page who directs the UM Clinical Research Initiation Service (CRIS) Office and is responsible for review and signature of confidentiality agreements.  The UM CRIS is located on the 10th Floor of Dominion Tower (phone --- 305-243-7704)
  3. For new studies initiated by UM faculty that involve JHS, confidentiality agreements will state that information will be shared with JHS
  4. For continuing studies by UM faculty that involve JHS, current clinical trial agreements or confidentiality agreements should be examined by the UM CRIS Office to determine whether they inform that information will be shared with JHS.  The UM CRIS Office is the only UM office authorized to share contract information with JHS.  If agreements do not include JHS as a party receiving study-related information, these agreements must be amended prior to sharing confidential documentation with JHS.  Faculty or department administrators should work with CRIS to seek amendments with sponsors as needed to permit disclosure to JHS


JHS CTO form title

Jackson Clinical Research Review Committee Forms


Documents

Word JHS Clinical Trials Office Application Form
Last Modified:  1/15/2014 2:44 PM
 
Excel JHS Clinical Trials Office Study Calendar
Last Modified:  1/15/2014 2:44 PM
 


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