One of the basic principles of research ethics is respect for persons, which requires that subjects, to the degree they are capable, be given the opportunity to make an informed decision on whether or not participate in a research study. Effective May 16, 2016, Memorial Hermann and UTHealth requires that all research staff involved in the informed consent (coordinators and nurses) process must have informed consent training. This training will be in addition to the CITI human subjects training.
This is a one-time training requirement. Continuing education is encouraged but not required under this policy.
As of May 16, 2016, CPHS staff and MHH CIRI staff will check all new research protocols and continuing review submissions to ensure that all research staff listed on the protocol who are authorized to conduct informed consent discussion have completed the required training.
***NOTE: Only licensed physicians and nurses are allowed to conduct the informed consent process at Memorial Hermann Hospital for interventional trials conducted under an IND or IDE and for interventional trials involving experimental procedures.
A variety of options for informed consent training will be available. A list of these training opportunities will be posted on the CPHS and CTRC websites. This list will be continually updated as new training opportunities become available. If research staff have completed training that is not listed, they can submit details of the training to the CTRC staff who will decide if the training meets the requirements of this policy.
The following training opportunities are available to meet this training requirement:
- Watch OHRP video on Participant-Centered Informed Consent Training.
- If your research involves working with participants who have mental health issues, watch the NIMH video, Elements of Successful Informed Consent.
- Attend the Clinical Research Education Course by Texas Medical Center - TMC Clinical Research Education
- Read the AHRQ Informed Consent And Authorization Toolkit for Minimal Risk Research: AHRQ Informed Consent Toolkit.
Following your review of the above provided educational videos and websites, take the exam. If you receive a score of 80% or more, you will receive a completion certificate by email. If you receive a score of <80%, you will be invited to attend an in-person training with Research Compliance staff.
Take the exam here: UTHealth Consent Training Exam
Questions?
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