Informed consent plays a vital role in biomedical research. It is used as a mechanism to convey the study information to potential subjects so that they are given the right to determine what will be done with their body. The question whether informed consents are relevant for biomedical research is a controversial one. However, I strongly agree with the view that informed consents are very relevant and necessary for biomedical research.
Biomedical research has increased the longevity of humans over the past century. It has generated a wealth of new discoveries that are improving our health, extending our lives and raising our standard of living. It has transformed our understanding of medical science and has given new ways to prevent, treat and cure disease. Major threats to public health have been significantly reduced.
Improvements in the prevention and treatment of illness have also reduced the cost of illness. Research in biomedical sciences, conducted on humans, will continue to help mankind discover new drugs and therapeutic strategies. Nonetheless, biomedical research that is performed on humans must strictly comply with medical ethics that are sanctioned in the Declaration of Helsinki and other applicable ethical laws. Informed consent plays a major role in ensuring the rights; safety and wellbeing of the study subjects.
Informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial, including potential risks and benefits and alternative management options that are relevant to the subject’s decision to participate.
All the ethical principles that defines research on human subjects, such as, the Nuremberg Code, the Declaration of Helsinki, The Code of Federal Regulations (45 CFR 46) and ICH GCP E6 guidelines, altogether emphasize the fact that a medical practitioner must not undertake medical procedures on patients without their...