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Balance of Research and Safeguards

Proposed changes to the Common Rule, which protects human research subjects, might make anonymous samples unusable, some researchers tell Stat News.

Currently, researchers can use samples that have been collected from patients without obtaining informed consent as long as those samples have been stripped of identifying information. But, as genetic data can increasingly be used as an identifier and as there's been increased awareness of samples like those from Henrietta Lacks that have been used without permission, Stat News notes there's been a move toward increased safeguards.

The proposed rule change would require researchers o obtain consent from patients to use nearly all types of specimens, even if they've been divorced from patient data, Stat News says.

Some scientists, though, say this would restrict research as scientists would either have to track patients down to obtain their consent or not use older samples and would have to keep track of the informed consent status of each new sample.

"If you're sitting in the researcher's seat, you may be concerned because of the extra burden," Mark Fleury from the American Cancer Society tells Stat News. "But if you're sitting in the patient's seat, you're more concerned about how your data might be used and shared and shared for things you might not agree with."

The US government says that a broad consent obtained at sample collection would be sufficient, though others argue that such broad consent is often too vague to be meaningful.