The Meaning Of Informed Consent

Questions posed by Paul Basch are very thought provoking. Some of these questions require a lot of consideration and research. Taking this course has helped me answer them to the best of my knowledge and provided me with a different perspective of global health. I would have responded to these questions the same before taking this course but my concepts have become stronger. Following are my responses to 5 questions.
3. When are we justified in conducting drug or vaccine trials in developing countries?
We can conduct drug or vaccine trial in developing countries as long as it is ethical. The standard of care for these trials should be same as for developed countries. The quality of informed consent is very important. “A cautious approach is
What is the meaning of informed consent of an illiterate person?
Informed consent means the person giving the consent has complete understanding of the procedure. The person also understands the risks and benefits of the procedures. “Informed consent is more than just a signature on a form, it is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions and measures of subject understanding”(USFDA, 2016). For an illiterate person it is very important to be able to demonstrate competency and be able to indicate acknowledgement or disapproval by other means when consistent with applicable state laws. “If (1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, they may be entered into the study. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document” (USFDA,
Culture is shared by people of the same ethnicity, language, nationality, or religion. It's a system of rules that are the base of what we are and affect how we express ourselves as part of a group and as individuals” (CTB, 2016). It is important for public health professionals and all medical professionals to understand the cultural competence. This will help in understanding different behaviors, attitudes, of a particular culture and help develop policies which work better in cross-cultural settings. People must show respect and compassion for people from a different culture. Medical professionals need to learn and understand the behaviors that are consistent with cultural