Informed Consent Document (ICD) as Educational Tool for Medical School

Background: India is fast becoming a hub for clinical research. A lot of clinical research is being done at all levels of the health care system and Physician assumes a central role in it. There is even shift of focus about imparting clinical research training to medical students, as at some stage of their practice they will be involved in clinical research. Informed Consent Document forms a central basis of ethical clinical research and is considered a priority as per Schedule Y, ICH-GCP guidelines and Declaration of Helsinki. Therefore it was considered worthwhile to assess the awareness of medical students about Informed consent document before and after imparting training to the medical students.Materials and Methods: This prospective study was conducted in the Department of Pharmacology, Gian Sagar Medical College, Patiala. 95 medical students in the final year of their MBBS course were enrolled in the study and were given a questionnaire before and after imparting training about informed consent document as per Schedule Y, ICH-GCP guidelines and Declaration of Helsinki.Results: The students were assessed on their knowledge and attitude about informed consent document. After the training, the students were significantly (p 0.05) more aware about the role of the Informed consent document as per guidelines. Also, there was a significant difference (p 0.05) in the pattern, behaviour and outlook of students after training was imparted to them.Conclusion: Training medical students about informed consent document significantly increased their knowledge, understanding and attitude.