MYTH #1: I do not need IRB approval to use data in the medical records of my own patients for research purposes.
MYTH #2: As long as a study subject signs a consent form for my research project I have done my duty to obtain informed consent.
FACT: Although you
clearly do not need IRB approval to utilize the data in your patients' medical
records for their medical management, you DO need IRB approval to utilize those
same data for investigational/research purposes. Furthermore, you may need separate
informed consent from these patients to utilize data in their medical records
for research purposes. The need for this additional informed consent can be
determined only after IRB review.
FACT: Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject. Obtaining informed consent is not just giving a prospective study subject a consent form and getting it signed. If consent is to be informed, the subjects must genuinely understand the study. Study subjects should be able to verbalize what they are consenting to. Since subjects retain the right to withdraw from a study, consent is an ongoing process. It starts before any forms are signed and continues until the subject's participation is complete. The informed consent process should involve meeting a potential subject, finding out whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation. The consent form formalizes the agreement to participate and should be designed to document the process. [Tips on Informed Consent provided by OPRR]
research@meduohio.edu