Have someone read the material and provide you feedback on how to make it more understandable. Having someone else read the material may also assist in detecting the multitude of careless errors that the IRB finds in may proposals. Every investigator should be familiar with the federal requirements for informed consent . There is also MCO-specific information that must be contained in each informed consent document . For investigators doing studies that involve children, there is MCO-specific requirements for informed consent documents for investigators doing research with subjects who are children .
Parenteral consent is required for research involving research subjects who are children.
Failure to incorporate all of the above required information will result in delayed approval of your IRB application.