CONCLUSION There is need

CONCLUSION There is need selleck chemicals Erlotinib for explicit guidelines regarding compensation to research subjects ?Cs for both trial participation as well as for research-related injuries, to be in place. The compensation guidelines for research-related injuries is already underway, with the government being committed to bringing about the much-needed change in the clinical research industry and its functioning. It would be helpful if it is not limited to guidelines and becomes a law to ensure compliance by the parties concerned. It would also help to have written guidance regarding compensation for trial participation as well. Also, certain innovative ways of offering health benefits to research participants and motivating them for participation rather than simply offering monetary benefits may also be evolved; however, it would be like lending a different perspective to the same issue.

The intent behind the compensation is more important than the means. The dictum of ??do no harm?? that guide a clinical researcher should not be overridden by the forces of compensation. In a scenario laden with competition, time constrains and paucity of eligible subjects for clinical research, it is easy to use compensation as a bait to lure potential subjects. One needs to understand that clinical research is the process for transforming the biomedical research done by today’s generation for the improved medical practice of the generation of tomorrow.

Spreading awareness that the basic objectives of clinical research are improvement of disease outcome and improvement of quality and efficiency of the healthcare system could help in changing the perception of research participants as guinea pigs and could help mitigate the researcher’s problems to a certain degree. The ideal situation would be when subjects volunteer for the altruistic reasons rather than for the material gains. Until then, let us learn from the debates and experience and remember the ethical concerns that guide clinical research. Footnotes Source of Support: Nil Conflict of Interest: None declared
Globalization of clinical research introduced several new challenges to the major stakeholders. These emerging aspects are dealt by regulators by providing and updating Entinostat guidelines, making recommendations, formulating and amending laws to safeguard the trial participant and assure the ethical conduct of clinical research. These issues do not end with the completion of the clinical trial as, the researchers and sponsors are facing another challenge of providing post-trial access (PTA) to the trial participants. There are several difficult questions for the health law and policy makers regarding providing access to investigational new drug.

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