Committee For the Protection of Human Subjects

Use Other IRB

OTHER UT SYSTEM IRB  |  CHESAPEAKE IRB  |  BAYLOR COLLEGE OF MEDICINE IRB

(ADDITIONAL HOSPITAL APPROVALS)

OTHER UT SYSTEM IRB

In order to reduce duplicative IRB reviews, UT Houston has signed the UT System IRB Agreement that allows researchers in UT Houston to seek approval from any IRB within the UT System. You should investigate the possibility of using this agreement any time you are conducting research with any sister UT institution, either as a consultant or as a full satellite site. 

If you wish to rely on the IRB from another UT Institution:

  1. UT Houston PI  requests to rely via iRIS
  2. UT Houston CPHS reviews the request and sends a formal permission letter
  3. UT Houston PI  sends documents to lead PI:
  1. Lead PI  submits documents to Reviewing IRB
  2. Reviewing IRB sends approval letter to lead PI.
  3. Lead PI  sends approval letter and stamped documents to UT Houston PI
  4. UT Houston PI  submits approval letter and stamped documents to UT Houston CPHS
  5. UT Houston CPHS issues an Activation Letter

 

If a PI from another UT institution (also called Site PI for the purpose of this policy) wishes to rely on UT Houston CPHS

  1. Site PI submits permission to rely to their institutional IRB (in some institutions this has been incorporated within the electronic IRB system)
  2. Site PI’s IRB reviews the permission to rely and sends a formal permission letter
  3. Site PI sends documents to UT Houston PI
    • Permission from Relying IRB
    • Addition of Site Form
    • Informed Consent Form with local contact info (if applicable - for example, you may be a consultant reviewing only deidentified samples, studies, etc., in which case you would not need a local ICF.)
  1. UT Houston PI  submits documents to CPHS via the Change Request form on iRIS (or along with the other initial review materials depending on the timing)
  2. UT Houston CPHS IRB sends approval letter to UT Houston PI.
  3. UT Houston PI  sends approval letter and stamped documents to Site PI
  4. Site PI  submits approval letter and stamped documents to their own IRB
  5. Local IRB issues an Activation Letter

Links to SOPs related to reciprocity below:

Initial Submission Policy

Continuing Review

Policy for Reporting

Access forms : Addition of Site FormPermission to Rely Form


CHESAPEAKE  IRB

As of February 2012, researchers may choose to obtain IRB review and approval for industry sponsored, multi-site clinical trials from Chesapeake IRB. Researchers may choose to continue to apply to UT Houston CPHS for review and approval. Researchers must obtain written CPHS permission before applying for Chesapeake IRB review and approval.  Written permission must be sought via an iRIS application.

Process to Obtain Permission from CPHS: 
a.     Create a new study in the iRIS application. In the panel on Reciprocity Agreement, choose the option 
        "Chesapeake IRB Review”. 
b.     Upload sponsor protocol and sponsor consent document. 
c.     If the clinical trial will be conducted at a Memorial Hermann site, complete
        the Memorial Hermann Application Form. 
d.     If the application is being prepared by anyone other than the Principal Investigator, route to the Principal Investigator
         for signature. 
e.     Route to the Department Representative for signature. 
f.      Await written permission from CPHS office. 

Applying for Chesapeake IRB Review and Approval 

a.     In order to be able to submit research applications to Chesapeake IRB the user
        must first register in their electronic system, CIRBI.
b.     Any member of the study team may create and submit the application. We 
        encourage research teams to ensure that the Principal Investigator has reviewed
        the application before submitting.
c.     If the study will be conducted at a MHH site, please include Cassandra Varacalli 
        as a study contact on the CIRBI application.
d.     Chesapeake IRB will issue a written approval letter via their electronic system.
e.     Chesapeake IRB will be responsible for continuing review, change requests and
        problem reporting.

Research teams seeking approval from Chesapeake IRB must familiarize themselves
with Chesapeake Investigator Handbook for reporting requirements and other
requirements

Research Conflicts of Interest (RCOI) - In order to make sure all research personnel on the study have completed the appropriate research conflict of interest form, all key study personnel should be added to the original CPHS submission so that it can be routed for electronic signature and RCOI sign-off.  If key study personnel are added at a later date, the site is required to submit a personnel change request through CPHS as well as Chesapeake to insure RCOI is completed.

Consent documents and HIPAA Authorization –  Only consent documents that have been approved by Chesapeake IRB must be used during the course of the clinical trial. If HIPAA authorization has not been waived, the research team must obtain authorization from the participants.

Fees – It is preferable for the industry sponsor to pay Chesapeake directly for the IRB review services. In addition to the Chesapeake fees (fee schedule available in iRIS-My Assistant-Operating Procedures), CPHS will invoice an administrative fee for maintaining compliance oversight at UT Houston. CPHS administrative fee will be $1300 for initial review and no charge for continuing reviews.

All communication regarding the research must be directed to the Chesapeake IRB representative. However, researchers may contact CPHS Office for assistance or clarification. Representatives from CPHS Office will have access to all UT Houston research on the Chesapeake electronic IRB system.

CHESAPEAKE REPRESENTATIVE

Tiffani Moss
tmoss@irbinfo.com
P  1+757-871-9848
7063 Columbia Gateway Drive, Ste. 110

Columbia, MD 21046
Chesapeakeirb.com 


BAYLOR COLLEGE OF MEDICINE (BCM) IRB

If UT PI wishes to rely on Baylor College of Medicine (BCM) IRB

  1. UT Houston PI requests for permission to rely on BCM IRB via iRIS. On the Panel Determining Review Type – select ‘Request for permission to rely on IRB approval from an IRB with whom UT Houston has signed a reliance agreement.’ On the next panel ‘Permission to Rely’ select BCM IRB.
  2. UT Houston CPHS reviews the request and sends a formal permission letter
  3. UT Houston PI  sends documents to Baylor PI:
    • Permission letter from UT Houston CPHS
    • Consent with local contact info (if applicable)
  1. BCM PI submits documents to BCM IRB
  2. BCM IRB sends approval letter to Baylor PI.
  3. BCM PI  sends approval letter and stamped documents to UT Houston PI
  4. UT Houston PI  submits approval letter and stamped documents to UT Houston CPHS
  5. UT Houston CPHS issues an Activation Letter

If BCM PI wishes to rely on UT CPHS

  1. BCM  PI submits a reliance protocol to their institutional IRB via BRAIN system.
  2. BCM  IRB reviews the reliance protocol and issues a reliance letter
  3. BCM PI sends documents to UT Houston PI
    • Reliance Letter
    • Informed Consent Form with local contact info (if applicable.)
  1. UT Houston PI submits documents to CPHS via the Change Request form on iRIS (or along with the other initial review materials depending on the timing of the submission.)
  2. UT Houston CPHS IRB sends approval letter and stamped documents to UT Houston PI.
  3. UT Houston PI sends approval letter and stamped documents to BCM PI.  BCM PI may begin collaborating on research.

If you have questions, contact reliance@bcm.edu (BCM), or sujatha.sridhar@uth.tmc.edu.


CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

How can we improve this site?


Committee for the Protection of Human Subjects
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713.500.7943
Fax     713.500.7951
Email cphs@uth.tmc.edu 

IRIS Support 713.500.7960

CLINICAL TRIALS RESOURCE CENTER 

OFFICE OF RESEARCH 

ENVIRONMENTAL HEALTH & SAFETY 

CORE LABORATORIES

SPONSORED PROJECTS

TECHNOLOGY MANAGEMENT


aahrpp logo