Please note that in accordance with Federal Register Guidelines and our Institutional Review policies, there is an EDUCATION REQUIREMENT for Protection of Human Research Subjects. This training must be done and renewed every two years by investigators, co-investigators and coordinators and annually for IRB members.This requirement may be fulfilled through web-based instructions and examination at http://phrp.nihtraining.com (www.citiprogram.org - biomedical course only), or through the Medical City Dallas Protection from Research Risk Program. Please provide a copy of the certificate of completion to our office with your submission.
Initial Submissions Include:
- A cover letter from the Principal Investigator
- Application for Initial Submission
- The study protocol
- An FDA approval letter with the IND or IDE number clearly stated (for all IND/IDE submissions)
- Principal investigator’s CV and updated certification in the protection of human research subjects
- Patient Informed consents and / or Assents
- Investigator Financial Interest Disclosure Form
- Patient ID Cards for clinical trial participants
All of these forms and templates may be found under the “Investigator's Guide Initial Submission Forms” tab in the red box to the right. All submissions and correspondence need to be submitted electronically to Kristye.Palmquist@MedicalCityHealth.com.
|IRB receives submission||>||Review of materials (expedited approval 2-3 days)||>||Full board review||>||If no changes, approval letter sent to PI||>||With changes, letter sent to PI with outlined changes||>||Once changes are received & reviewed final approval may be given as short as 2-3 days or up to 3 weeks following full board review|