Is the purpose of the IRB review of informed consent to protect the institution or the subject?
The fundamental purpose of IRB review of informed consent is to assure that the rights and welfare of subjects are protected. A signed informed consent document is evidence that the document has been provided to a prospective subject (and presumably, explained) and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution has complied with applicable regulations.
Related Questions
- What rules protect the confidentiality of experimental subjects, and how are these kept in alignment with local IRB regulations and informed consent procedures?
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- Is the purpose of the IRB review of informed consent to protect the institution or the subject?
