Informed Consent In The Shrivelstatin Study

Informed consent in the Shrivelstatin study has issues in the way it was obtained. It was mentioned that Dr. Rammit's best study nurses (Beth Botch) implemented the informed consent to Mrs. Sandra Godwin explaining her the risks, benefits and study procedures within the given time she had. Here, we do not know if the subject had enough time to understand the risks and benefits and take a decision to get onto the study. It was also mentioned that Mrs. Sandra got convinced to get on to the study and thought that the treatment would work, even after the counselling she received as part of a informed consent process. This makes me think that she is a vulnerable subject who was under coercion to get on to the study as this study gave her a hope
The informed consent was not documented appropriately, according to 45 CFR 46.115 and 21 CFR 56.111, the IRB should have an appropriate documentation of the IRB-approved informed consent Records from the inspection showed that there were several instances where the clinical investigator failed to submit consent form changes, and there was no administrative action which is a huge mistake during the informed consent documentation process. The role of IRB is to review and approve changes in the clinical investigation, revisions of the consent form and any accompanying changes to the protocol. The role of the the investigator is to ensure that an investigation is conducted according to applicable regulations and protecting the rights, safety and welfare of the subjects as well as obtaining the informed consent according to 21 CFR 50.25 In case of changes to the informed consent, the investigator should revise the consent form to address changes to the protocol or new information, such as significant new
In this case it was mentioned that Dr. Giantonio who was the sub PI on this study signed the informed consent as the person who explained the informed consent, but did not document this in the medical record. This is the act of sheer negligence of the sub PI which would effect the subjects on the study. According to the Shrivelstatin study protocol, any serious study drug related toxicities will be followed for 30 days after the last dose of SAP until resolution (to baseline or grade 1) or until they are deemed irreversible, it was the responsibility of the study staff to follow this study protocol. But in this study a follow up call was made only after a month and it was revealed that she had become very depressed after the study, and was also believed to have brain metastases, which was not even compliant to what the protocol stated. In general during any fatal or life threatening event the sponsor should report to the FDA within 7 day calendar report, which I don’t think was followed in this study. (Aulwes, Clinical Studies -IND,