Patient Illiteracy Case Studies

A 40-year-old Indian male went to the ER after a week-long pain on his right forearm. He had a big accident a week earlier that cause him multiple minor injury with a big laceration on his forearm. His brother gave him a first aid burn cream that control the pain but not the wound. After the wound checkup followed by all the lab results he was ready to leave the hospital. A research doctor approach to him because he meets inclusion criteria for a research study to evaluate the efficacy of a newly developed suture material. His primary language was Hindi and he was in the hospital by himself. He speaks some limited English but cannot read any language at all. While questioning about his interest on the research, he replies “Yes” only. This research was in the beginning phase and researcher are using multiple medication. Some of the medication was newly invented and have some side effects. The research assistance approach the patient and request his signature on an informed consent document to participate in the research protocol. Due to the brevity of the conversation, the research assistance was unaware of the patient illiteracy and did not use any translator to notify the potential risk and benefit of the participation. Patient though that it was the part of his treatment process and he willingly signed the document. When the patient came for follow up after two week, it was found that those medication that were used in research had very bad side effect to the wound.
1.
Does this research assistance use the appropriate way to notify patient about the research protocol?
2. Did this patient made any kind of mistake by just signing the informed consent document?
3. How is informed consent for a clinical trial or research study different from consent for standard