Question

Clinical trials are heavily regulated because they are affected by Healthcare Regulations. As a new Compliance Officer, you receive an anonymous report that clinical trials are taking place at your hospital, without proper consent from patients. Some patients are receiving placebos (no actual treatment), without being informed. Make a list of any governing agencies and their roles in Clinical Trials. Use the Internet to find some examples of Clinical Trials. Discuss your findings and defend why you chose the governing agencies and examples. For your response, choose a post that exhibits a differing opinion from your own.

Answer 1

solution:

Clinical trials are the experiments and investigation of a new medicine, diagnosis or treatment which is done on volunteers to test their effectiveness and level of safety. Clinical trials can be dangerous and hence the healthcare providers need to adhere to regulations and take approvals from certain regulatory bodies before conducting clinical trials.

some of the regulatory agencies and government bodies whose permission is critical for clinical trials are:

• Ministry of Health : It is the government body which lays down rules and regulations as well as eligibility criteria for the healthcare providers which can perform clinical trials
• Ministry of health surveillance Agency : the government auditing body which works with works with the objective of conducting random audits so as to check the compliance of the clinical trials and the authenticity and validity of the results.

in my views, both regulating and auditing bodies quite critical for the clinical trials. can put the lives of the volunteers in danger. Hence it is important that the permission for conducting the same is given only to the seasoned and experienced healthcare providers. Ministry of Health helps in this regard. they conduct a comprehensive inspection of the healthcare and accordingly give the permit and the license. After the healthcare has got the permission for clinical trials, there can be instances where it may deviate the standard norms. the Ministry of Health surveillance Agency will become active in this regard. they will conduct random audits and inspections to check compliance in such institutions. Hence the quality and safety quotient in clinical trials will not be compromised.

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