What is Informed Consent?
Contemporary ethics regarding
human subject research as stated in the Belmont Report underline the moral principle of “respect for persons”. This ethical principle requires individuals in research to have the opportunity to make a conscious decision regarding what shall or shall not happen to them (autonomous agents). The application of this principle is the informed consent document by serving as an “autonomous consent” to participate in research. Information, comprehension and willingness to participate (voluntariness) are fundamental elements of the informed consent document. The consent should adequately convey all the information needed for the subject to understand the study, in addition, to being in a language understandable to the subject. A subject’s consent to participate must be free from coercion. Above all, the subject should be able to understand the information presented in order to make an informed decision.
However, true informed consent goes beyond a document. Informed consent is really a process that begins with the recruitment phase and ends in the completion of the study. An investigator and research staff should have an informative interaction with the subject throughout each phase of the research.
Often research studies involve the collection and use of health information (medical records, patient prescription, health status, disease progression, etc.) in order to successfully carry out the protocol. Whenever research involves health information, a new batter is brought to the informed consent plate…HIPAA. For more guidance regarding HIPAA authorization for research purposes click here or call ORC – North Texas Regional IRB at 817-735-0409.