The US Department of Health and Human Services, along with more than a dozen federal agencies, issues a final rule updating on Jan 18, 2017, to extend a legal safety net for individual participating in blood and DNA research.
As per this new rule, all consent forms will begin by providing a clear and to-the-point explanation to ensure that people considering partaking in a study are made aware of all key information beforehand. These explanations may include the purpose of the study, its benefits, the risks, as well as alternative treatments the prospective subject may find to his or her advantage.
However, there will be no need for any consent whatsoever if the samples are used for other studies. This essentially means that researchers won’t be legally obliged to obtain written consent before using a subject’s DNA, blood, cell, tumor samples, or other types of biospecimens acquired in medical procedures. This rule will be applicable even when the samples carry no identifying information including the name of the subject or the study they originally partook in.
The scientific community, by and large, have welcomed this new update in the final rule as tracking down donors each time their samples are required for a new research is not exactly a practical solution — both in terms of time and resources.
“This is a big win for science and therefore a big win for patients,” said Holly Fernandez Lynch, a bioethicist from Harvard Law School.
To prevent potential misuse or abuse of the final rule, a single central ethics committee will be given the responsibility to oversee all studies.
“The bottom line is the trial has to be conducted the same way across all those sites to be scientifically valid,” said Jerry Menikoff, M.D., head of HHS’s Office of Human Research Protections.