Waivers or Changes to the Informed Consent

As with any change to your protocol, if the Informed Consent Form is changed, it must be submitted in iRIS with the changes highlighted. A revised protocol must also be submitted, if applicable, with changes highlighted there also. All changes must be approved by CPHS before implementing.

If revisions to the informed consent form are approved, then all old copies of the Informed Consent Form must be destroyed. Only informed consent documents with a CPHS statement, approval, and current date may be used when obtaining consent.

Guidelines for Enrolling Emergency Department Patients in Research Studies

The following procedure pertains when studies plan to enroll patients/subjects while in the Emergency Department (ED) of either Memorial Hermann Hospital or LBJ General Hospital.

• Before submission of your protocol for review and approval by the CPHS, you must contact the Research Director of the Division of Emergency Medicine (ED) or the Department Chair, to discuss the logistics of your study; e.g. how the investigators are to be contacted by ED personnel, how patients are to be recruited and enrolled, how informed consent will be obtained, etc.
  
  
• You must submit a letter of support from the ED for your study which will indicate to CPHS that such appropriate arrangements have been made with the Division of Emergency Medicine
  
  
• A copy of your protocol, CPHS forms, CPHS approval letter, and data collection forms must be submitted to the Director to be included in the Emergency Department's Research Protocol Book. This protocol book allows all investigators, attendings, residents, and staff rotating through the ED to be informed as to which patients are eligible to be enrolled in certain studies and the procedures to follow.
  
  
• When your study is ready to be implemented you will be responsible for providing an in-service to all relevant personnel in the ED.