Last year – as part of our ongoing charge to ensure health services research is accounted for in federal policy – AcademyHealth submitted several comments to federal policymakers. Among them were responses to the Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects (referred to as the “Common Rule”) and the NPRM on the Confidentiality of Substance Use Disorder Patient Records from the Substance Abuse and Mental Health Services Administration (SAMHSA). Those comments can be accessed on our website (here and here, respectively).
This year we’ve seen final rules on both these subjects released:
Federal Policy for the Protection of Human Subjects
The final “Common Rule” was released by the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies Wednesday, January 18. According to HHS, as “research with human participants has grown in scale and become more diverse and data has become digital,” the new regulations are updated to further safeguard individuals who participate in research.
AcademyHealth has supported modernizing these regulations, striking a balance between rigorously protecting human subjects without inadvertently creating administrative burdens that unnecessarily hinder scientific innovation and progress. In particular, our comments endorsed streamlining Institutional Review Board (IRB) review of multi-site studies and harmonizing any new guidance released by federal agencies, both of which are addressed in the final rule. The rule includes the requirement to use – in many cases – a single IRB for multi-institutional research studies, but adds “increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.” Additionally, it “creates a requirement that guidance should be issued only after consultation among the Common Rule departments and agencies, while also permitting guidance to be issued without such consultation when it is not feasible.”
Concerning differences between the proposed and final rule, many controversial provisions were dropped from the final regulation. One abandoned provision that initially caused a stir among many, including the academic community, was a proposal to change the definition of “human subject” to include non-identified biospecimens (tissue, blood, saliva, urine, etc.), meaning that research involving these biospecimens would be subject to the Common Rule and thus require informed consent. As written on Inside Higher Ed, “Current rules allow research to be performed using previously collected biospecimens without informed consent as long as the specimens are not linked to an individual.” Those against the change argued that “requiring consent for all research involving biospecimens…would substantially increase administrative burdens on investigators, research staff and institutions, and would markedly hinder the conduct of critical science.”
You can read more about the changes to the rule in this HHS press release.
It’s important to note that, despite the release of this rule, there are wheels in motion that may affect its future. The Common Rule was one of the regulations flagged by the House Freedom Caucus to repeal under the Congressional Review Act, which allows Congress to review new regulations under an expedited legislative process and overrule them through passage of a joint resolution.
How quickly the Common Rule could be repealed remains to be seen. Looking for indicators of how this process might unfold, we recently saw the House pass a bill to repeal several of President Obama’s regulations in a single vote, though the Senate has yet to consider that bill – which would need 60 votes to pass. We’ve heard Democrats are planning to make Republicans repeal those regulations “one by one…and with lots of cloture votes,” and if they follow this strategy it may be some time before they repeal the Common Rule since – we assume – there are other regulations Republicans would want to repeal first (e.g., EPA, DOL overtime rule, etc.).
Confidentiality of Substance Use Disorder Patient Records
Roughly three years ago, data about patients with substance use disorders began to disappear from Medicare and Medicaid files based on a regulation from the 1970s – and they disappeared without notice (read more from The Incidental Economist). Given the tremendous impact this would have on behavioral health services research and health services research in general, AcademyHealth monitored the situation and collaborated with advocacy partners on a strategy.
In our comments to SAMHSA, written by AcademyHealth member Nicholas Bagley and with input from other expert members, we raised two concerns about the proposed rule’s scope. On The Incidental Economist, Bagley explains those concerns – a provision on data linkages and the sharing of records relating to substance use disorders with data intermediaries – and how they were addressed in the final rule.
Regarding data linkages, a provision in the proposed rule “could have been read to say that researchers couldn’t do such linkages on their own, but would have to ask CMS to perform such linkages for them,” which would have been problematic. As explained in our comments, “CMS is overtaxed, and we are not optimistic that it will be able to expeditiously, inexpensively, and accurately do the complex work associated with linking data across disparate data sets.”
SAMHSA’s final rule rectified this point and clarified “that the data linkages provision is not intended to prohibit a researcher from linking a data set in the researcher’s possession that contains part 2 data with a data set from a third party source.”
Second, the proposed rule, as mentioned, “didn’t seem to allow records relating to substance use disorders to be shared with data intermediaries, including the all-payer claims databases (APCDs) that now exist in about 18 states.” As Bagley describes, “Because APCDs and other intermediaries aren’t providers or payers, they aren’t ‘lawful holders’ of such records within the meaning of the regulations. As such, they can’t collect those records and they can’t share them with researchers.”
In the final rule, SAMHA offered clarification that APCDs and other data intermediaries “are permitted to obtain [data on substance use disorders] under the research exception, provided that the conditions of the research exception are met,” at which point, they'd become ‘lawful holders’ and “would therefore be permitted to redisclose [those] data for research purposes.” However, there’s a rub:
“[If] you look at the new rule, it appears that APCDs and other intermediaries can’t take advantage of the research exception. Under the rule, you’re eligible for the exception only if you’re (1) a HIPAA-covered entity or (2) subject to HHS rules governing human subjects research.
APCDs and other data intermediaries don’t appear to qualify. Because they’re not providers, plans, or payment clearinghouses, they’re not ‘covered entities’ within the meaning of HIPAA. And I don’t see why APCDs or other intermediaries would be subject to the rules governing human subjects research. They’re not federal entities and, to my knowledge, their research isn’t supported by federal funds.” - Bagley, The Incidental Economist
Like the Common Rule, this rule is not yet set in stone; President Trump’s administration may still withdraw it. However, as Bagley notes in another post, “given the President’s expressed interest in curtailing the opioid epidemic, [we’re] cautiously optimistic that the rule will eventually go through. But nothing is certain.”