What information does the IRB look for in a human subjects protocol?
A protocol will not be approved unless it contains adequate information for the IRB to determine the following: · That the participation of all the subjects is voluntary. · That the rights and welfare of all the subjects will be adequately protected. · That the consent process will be conducted in accordance with federal regulations. · That the potential harms (risks) to the subjects are outweighed by the potential benefits to science and society. This determination can only be made if the protocol contains a robust description of the study procedures. Therefore an inadequately prepared protocol will be returned to the investigator for revision/clarification.
Related Questions
- I am a student and will serve as Principal Investigator for a protocol that involves research with human subjects. Does my faculty advisor have to complete the Human Subjects Certification Program?
- What is the relationship between HIPAA and the human subjects protection regulations of the Common Rule for which IRB review was established?
- Must investigators obtain IRB approval before involving human subjects in nonexempt research?
