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Common Rule Update Says No Consent Needed for De-Identified Clinical Discards

January 25, 2017

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Last week, as the outgoing Obama administration neared its final hours, they ruled on a pivotal decision affecting biomedical researchers – whether or not the Department of Health & Human Services’ (HHS) ‘Common Rule’, instituted in 1991, would be updated to require patient consent for the use of de-identified clinical discards in research. The decision was made to leave that portion of the rule unchanged, allowing research to proceed as usual where those types of specimens are concerned. According to a January 18 HHS press release, “The final rule maintains the current practice with respect to oversight of these specimens.” In terms of other types of biospecimens, such as those proactively given by volunteers, the Common Rule will now require concise synopses of key consent information at the top of the consent documents, making it easier for donors to understand the information presented to them.

Proposed changes to the consent requirements for clinical discards came after years of advancements in genetics, with many proponents of the proposed changes saying those advances might one day enable re-identification of the patient. Opponents of the proposed changes feared the consent provision would stifle low-risk (in terms of privacy) research endeavors in an environment that already sees biospecimen acquisition as a challenge. In fact, according to one National Cancer Institute study, 81% of researchers reported limiting the scope of their work due to a shortage of both the quality and quantity of human biospecimens.

“The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research,” the HHS news release continued.

iSpecimen is committed to fostering efficient research, biospecimen access, and patient privacy. We have always offered consent programs for our partner sites who choose to implement them for de-identified clinical discards. Many of our partners feel good about informing and asking their patients for use even though the law does not require it. Based on our own third-party study, we found that overwhelmingly patients do want to contribute their de-identified clinical discards to research – more than 80%, in fact – but they do appreciate being asked.

iSpecimen will continue to operationalize consent for our partners that choose to apply it to discards. For partners that choose not to, they may carry on, with the HHS ruling stating, “researchers can continue to use such biospecimens in the way they are currently using them.”