Hi,
Thanks for your post. I do agree with you. According to the Belmont Report research, necessitating review board involvement is defined as an activity involving human subjects that include testing a hypothesis for conclusions to be drawn.1 The goals of the IRB’s are to protect both the patient and the institution and to review protocols of the intervention and ensure the subject and researchers are not harmed. The Keystone project clearly failed to include such processes. Furthermore, as outlined in the Nosowsky article, there were additional factors that justified the initial inquiry by the OHRP including the designation of the project by JHU as research involving human subjects and the prospective analysis of data considered to be identifiable.2
Thanks for your post. I do agree with you. According to the Belmont Report research, necessitating review board involvement is defined as an activity involving human subjects that include testing a hypothesis for conclusions to be drawn.1 The goals of the IRB’s are to protect both the patient and the institution and to review protocols of the intervention and ensure the subject and researchers are not harmed. The Keystone project clearly failed to include such processes. Furthermore, as outlined in the Nosowsky article, there were additional factors that justified the initial inquiry by the OHRP including the designation of the project by JHU as research involving human subjects and the prospective analysis of data considered to be identifiable.2