Recently, a petition was circulated among BSEC members regarding unethical practice in a USA clinical trial leading to death of a research participant. Research is imperative in the quest for knowledge and advancement in medicines. There is now a possible break through for the cure of HIV. Likewise, research ethics has advanced significantly over the past sixty years. Clinical research, a branch of medicine to determine the safety and efficacy of medicine, has therefore evolved in how it is conducted. In developed nations, there is tremendous regulatory measures and monitoring as well as reporting of clinical trials activities. However, clinical research is still fraught with ethical challenges as highlighted by the petition and even this recent posting http://icbioethics.com/how-can-this-happen-by-alessia-minicozzi/ regarding a National Institute of Health study having inadequate informed consent.
The question was asked “How could this happen?”, hence leading me to my purpose of this blog; are unethical things happening in clinical research because ethicists have not been very active in clinical research. It would seem to me that ethicists are often “wary” of (a) clinical research, (b) clinical research organizations, and (c) pharmaceutical companies and have therefore not been creating the much needed balance between helping to achieve positive research outcomes in an ethical way. Many advertisements for clinical research coordinators, monitors, and (c) IRB members only require good clinical practice training and experience in the field. Is this enough? There are still various Caribbean countries that are still without active research ethics committees and do not have regulatory bodies with oversight for research or registration of drugs. What of clinical trials in the Caribbean, is this happening and to what extent? How much monitoring is done by regulatory bodies, if any? I am one who is definitely for clinical research as it would be hypocritical to reach for any medication, reaping the benefits without being concerned about the process by which it came, however dialogue and advocacy is needed.
Submitted by Shereen Cox