Sample questions from IRB presenter guidelines
Presenters touch on eight main points
The office of protocol research at the University of Texas M.D. Anderson Cancer Center in Houston, TX, has created comprehensive guidelines that IRB members can use as they present their findings and opinions of protocols.
Here is a sample selection from the section on informed consent:
Informed consent document
- Is the consent document edited to the appropriate grade level?
- Are all procedures included in the consent document? If not, please clarify which items are missing.
- Are risks, side effects, and benefits adequately explained to the participant?
- Are alternative treatments for this patient group described adequately in the consent document?
- Has an assent section been included within the informed consent document (ICD) for pediatric participants (if needed)?
- Does the ICD need to be translated into a language, other than English (based on the proposed patient population? Has a non-English ICD already been included with the study?
- If this protocol has a waiver, is this an appropriate request?
- Does the ICD include any information about tissue banking? If so, where will the bank be housed and who will have access to the bank?
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