Institutional Review Board Forms

This form should accompany all new protocols and if there is change in the research team.

This form is required on all approved active studies and at closure of the study. The annual report is due one month prior to the expiration date of study approval. Failure to submit the annual report can cause interruption or discontinuation of the study. Final reports are due within six months of the termination of the research project or clinical investigation.

Adverse Event(AE) / Unanticipated Problems(UP) Reporting Form

Adverse Events(AE) and/or Unanticipated Problems(UP) may be serious, unexpected and related to participation in the research protocol by the human subject. These events must be reported to the Driscoll Children’s Hospital(DCH) Institutional Review Board(IRB) Office listed below, in writing within 14 calendar days of such an incident. Please use the DCH IRB Adverse Event(AE) / Unanticipated Problems(UP) Reporting Form to report your event. The FDA Medwatch Adverse Event Reporting Form may also be used for reporting purposes. This form can be found at http://www.fda.gov/medwatch/SAFETY/3500a.pdf. The DCH IRB will address AE's and UP's as they occur and at the time of Coninuing Review, which is annually.

IRB Request ofr Waiver or Alteration of Consent Approval

DCH IRB Office
c/o Jucel Nazareno, R.N., IRB Monitor
3533 South Alameda St.
Corpus Christi, TX, 78411
Phone: (361) 694-4619

or

Email to:

or

Print then Fax the form to (361) 694-5466.

This completed form must be submitted electronically or in writing as soon as possible but within 5 days of the event.

How to Reach Us

The Driscoll Children's Hospital Institutional Review Board is available to provide information and guidance to participants in clinical research studies and their families regarding their rights as Human Research Subjects. The Institutional Review Board is available to advise and inform investigators who are submitting clinical research protocols and monitor approved research activities in its jurisdiction.

Jucel Nazareno, BSN, R.N., IRB Monitor
(361) 694-4619
Fax: 361-694-5466

Institutional Review Board
Driscoll Children's Hospital
3533 South Alameda St.
Corpus Christi, TX 78411
(361) 694-5000

Institutional Review Board Forms

How to Reach Us

Institutional Review Board

For Patients and Parents

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