4 Comments
Ensuring that individuals are protected when they participate as research subjects is vital to maintaining the public’s trust in the research we support. This week, the Department of Health and Human Services published a notice announcing that the federal government is considering ways to enhance the regulations that deal with the protection of human research subjects. These rules went into place more than two decades ago and many things have changed, both technologically and in the type of research that is conducted, so it is time to look at the effectiveness and efficiency of the current regulations.
The notice describes potential changes to the Federal Policy for the Protection of Human Subjects or the “Common Rule” that are currently under consideration. This rule outlines the basic requirements for institutional review boards, informed consent, and assurances of compliance. Managing research with human participants is highly complex and affects those of you who do this research on a daily basis, thus your input into how the regulations can be updated is important to us. So, please, let us know what you think. Submit your comments to regulations.gov by September 26, 2011.
Human research as we all know is a valuable way of creating and researching drugs and medications for human conditions, but I believe that most research bodies never fully divulge the whole risks to the test subjects which result in very severe damage and possible loss of human lives.
I pray those in authority or in decision making corridors to make it mandatory for the research bodies to come clean and tell the human test subject the whole truth before any testing commences. It should be made a condition if when breached can lead to prosecution and withdrawal of funding and possible blacklisting of the research body.
This might serve to save lives of the test subjects who have given up themselves as ‘human guinea pigs’ in a bid to make the world a better place for others.
Thanks for the comment but please make sure to submit it to regulations.gov to make sure that it is recorded and considered. Click on the “submit your comments” link above for instructions.
The current regulatory environment is more adroit at protecting universities, drug companies, and the FDA than on the protection of human subjects. Consent forms read like legal documents and contracts. We acutely need regulatory simplification based on common sense and the protection of subjects that supports an accessible and equitable review procedure less focused on process and more on upholding the rights and dignity of humans. To conduct a medical experiment on a human should require extensive review, focused primarily on the welfare of the subjects and less on the legal protection of the investigator and institution.
Thanks for your comments. Please submit them to regulations.gov so they can be recorded and considered when the proposed rule is drafted. Click on the “submit your comments” link in the post above.