In a federal rulemaking endeavor that elicited more than 2,000 public comments, differences of opinion are to be expected.
But when you start to debate whether now's the time to tighten privacy restrictions over genetic material, those differences create a chasm.
Providers argued in the months since the HHS proposed changes to federal rules governing research involving human subjects that asking patients for consent every time their specimens were used would be costly and could even deter some clinicians from conducting trials.
That, said Dr. Deborah Peel, head of the Patient Privacy Rights Foundation, is “a big, fat lie.”
“It's not a technology problem—the current business model of the internet, Silicon Valley and IT startups is collecting, aggregating and selling all the data they can get about you to whatever other companies want to buy it.”
Jennifer Geetter, partner in the healthcare practice of McDermott Will & Emery, on the other hand, said the 535-page final rule on revamping the Common Rule is “huge” both in size and scope of impact to the healthcare industry.
The Common Rule—which was implemented after WWII and the 1949 Nuremberg Code to prevent the recurrence of barbaric Nazi medical experiments—will impact thousands of hospitals, pharmaceutical and medical device manufacturers, biobanks, big data analytics firms and, of course, patients.
At the heart of the matter was whether the government would classify work performed on unidentified biospecimens, such as blood and tissue samples, as human subject research and thus cover it under the Common Rule. Concurrently at issue was whether the patients and other people who provided those specimens ought to have the right to give or withhold consent for research to be performed on the specimens after their initial use.
Geetter, whose clients include hospitals, researchers, health plans and data analytics organizations, both for-profit and not-for-profit, said consent was the first thing she looked for in the rule, “because more than anything, that was the game changer for the research community.”
A proposed rule issued by the HHS in September 2015 would have added unidentified biospecimens to regulatory preview under the Common Rule and thus require patient consent for their subsequent use in research.
But during the public comment period, the plan “garnered vociferous opposition” from the research community, Geetter said.
Last year, for example, the National Academies of Sciences, Engineering and Medicine called on HHS to withdraw the entire rule. Instead, it wanted a research policy board formed to study the impact of future regulations in this area.
The Association of American Medical Colleges agreed with the NAS.
In this week's final rule, the HHS responded, stripping out the provision that would have placed unidentified biospecimens under the Common Rule, thus eliminating the consent requirement for their use.
Privacy advocates, many of whom define privacy as the right to be left alone and decide themselves about sharing their personal information, reacted with rancor.
Peel said the final rule “violates the preferences, expectations, and legal and ethical rights of the U.S. public. Most people are altruistic and willing to participate in research when asked first. But only 1% agree with unfettered research use of their personal health information. And their feelings about the hidden use of their blood and tissue are equally intense.”
Genetic information has been likened to the ultimate personal identifier, with experts arguing that it will one day be impossible to de-identify a patient medical record if it carries that patient's genome.
So far, the high cost and vast computer power required to perform genomic sequencing has been a barrier to widespread availability of genetic information in patient medical records. But with ever-increasing computer power, the cost of full genomic sequencing—now about $1,000 per patient, not counting the analysis—continues to drop.
Once the human genome is in ubiquitous clinical use—and that's not a question of if, but when—the notion of a de-identifiable medical record becomes a fallacy, some experts say.
But dealing with that now was “premature,” according to Geetter.
“Currently, the average person's sequenced data is not being used in their care,” she said. “That may be coming. It probably is coming.”
With the new rule, she said, “We have some time to think about how we're going to modify our privacy and our research protections. If we come to a place where a piece of tissue is identifiable because someone could run the sequence, we'll have to deal with that.”
The Common Rule update, the first since 1991, affects “most if not all” of the 147 U.S. medical schools and more than 400 teaching hospitals that are members of the AAMC, said Heather Pierce, the association's senior director, science policy and regulatory counsel.
The proposed change in the rule on unidentified biospecimens was their biggest worry, and Pierce said the association supports the rollback.
The proposed rule would have grandfathered in research on existing biospecimens, but “we were concerned about what that would mean to notify and get consent, and create a new privacy risk linking the specimens to the consent (documents),” she said.
The new rule won't settle the consent issue forever.
The HHS must review what is meant by an unidentified biospecimen every four years going forward.
“Right now, a tumor biopsy sitting in a freezer with nothing other than the indication of the gender and diagnosis of the patient it came from, we'd say, the identity of that person is not readily obtainable by a researcher,” Pierce said.
“If that changes in 10 years, then there is a mechanism built into the rule to change that without modifying the rule itself,” she said. “And that seems forward-thinking.”
