| Clinical research is defined as trials that evaluate an | | | | ethical conduct of a clinical trial. Also the declaration |
| investigational drug, biological, or medical device on | | | | clearly specifies that "all protocols must be submitted |
| patients in a strictly, scientifically controlled setting in | | | | to an ethics committee for review, which must be |
| order to test the safety and efficacy of an | | | | independent of the investigator, the sponsor or any |
| experimental entity. Clinical research involves | | | | other kind of undue influence". |
| controlled use of humans in medical experiments. As | | | | The Indian Council for Medical Research (ICMR) |
| clinical research involves human participants there is a | | | | Ethical Guidelines for Biomedical Research on Human |
| risk of them getting exploited in the name of science, | | | | subjects expects that all institutions in India which |
| hence sponsors and investigators are legally and | | | | carry out any form of research involving human |
| ethically obligated to protect them. | | | | beings should follow the guidelines to protect the |
| In clinical practice a physicians use interventions | | | | safety and well being of all subjects. |
| (medications) that are designed to cure a disease and | | | | A subject taking part in any clinical trial is protected |
| with the sole purpose of enhancing the well being of | | | | by a written informed consent and ethics committee |
| an individual. But, clinical research is designed to test a | | | | review. A question generally asked is that- which |
| new medication, its effectiveness, to answer useful | | | | type of research needs ethics review? Clearly any |
| questions about human health, diseases and it cure. | | | | trial involving humans must be carried out with |
| Here, the participant in a clinical trial may not get the | | | | permission from an ethics committee. It could |
| best available treatment and therefore the | | | | experimental study involving a new drug or new |
| responsibility of investigator towards the subject s | | | | device or a "simple" questionnaire-based study, in |
| are more. | | | | normal subjects or in patients, as long as it involves |
| The Declaration of Helsinki by World Medical | | | | humans, the investigator must obtain ethics |
| Assembly forms the basis of ethical guidelines for | | | | committee permission. If the trial has to be |
| clinical research today. It involves 32 principles and | | | | internationally acceptable, papers have to conform to |
| informed consent is an essential requirement for | | | | these guidelines. |