New Regulations for Research on Human Subjects

In an attempt to strike a balance between facilitating research and protecting research subjects, the US government is proposing to change some of the long standing rules governing human subject research. These changes are prompted by the rapidly evolving technology that revolutionized contemporary research arena where lots of  genetics, genomics and biotechnologies play important roles.

Earlier calls for reforming human research subjects regulations dates back to January when President Obama assigned the Commission for the Study of Bioethical Issues Panel. For more information read our article US Panel Calls for Reform in Human Subject Protection.

The anticipated rules are supposed to accommodate new research fields such as genomics and online research and they offer more lenience to anonymous research where subjects cannot be identified. The public, as the ultimate watchdog, will have a say on the proposed changes.

It is expected that some rules will be abolished in order to encourage and facilitate research and new regulations will be put in. For instance, all research conducted in institutes receiving federal funds, from any of the 15 federal entities, will need to comply with the proposed research rules, including studies sponsored by drug companies.  Another proposed change is having a single IRB review for multi-centric studies, which would cut down on unnecessary redundancy and time and effort waste. Please refer to The Paradoxical Problem with Multiple-IRB Review for more information on the topic.

For social science research, which involves survey and observational studies, rules will be less stringent so long as the research pose minimal risk and research subjects cannot be identified.  Regulations of DNA studies are still under scrutiny, since many experts believe a person can be identified by his own DNA sequence even if the tissue sample lacks any personal identifying information.  Therefore calls for permission of use of unidentifiable blood samples for genetic studies would pose much ethical controversy before ground rules are formulated.

Reference:   Rule Changes Proposed for Research on Humans

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