When was the last time you reviewed an Informed Consent Form in an international collaborative research and wondered ‘why is this form so long? How can an illiterate, poor and sick patient understand all this information?’
The answer is: numerous times. The concern was also on the minds of panelists of the 5th meeting of the Commission for the Study of Bioethical Issues which was assigned by President Obama to ensure the safeguard of research subjects participating in federally funded research. The meeting was held on 18 -19th of May in Warwick New York Hotel, USA
The panelists concurred that the current system is too bureaucratized with loads of rules and regulations to a degree that the initial aim of protecting human subjects was lost. Now, the researchers and academics are more concerned with protecting their institutions from legal liabilities than actually safeguarding research subjects.
The informed consent is now a 15 pages long document, full of legal jargon and is too confusing for research subjects. A simple way to resolve the issue is rearranging the document so important information, such as the risks vs benefits, is highlighted and are presented in the beginning.
Investigators in international research are also concerned, because they are lost amid host country regulations, ethical concerns, local customs and agencies’ own rules. They are left with two choices, either to choose the least tedious path or resort to ‘cutting corners’.
The panelists concluded there were enough regulations to protect research subjects, but they needed to be implemented better and it is up to the Commission to improve the system. The meetings are continuing and next up for the Commission is to discuss transnational standards and European outlook.
References: Nature News