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