HHS, Other Agencies Release Final Rule On Human Subject Research

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The United States Department of Health and Human Services and 15 other federal agencies released a controversial plan to impose new rules that would make it much harder to use patient blood and tissue samples in research. Although, the final Common Rule released on Wednesday omits these provisions, it leaves some other changes intact.

Biomedical and university researchers that stood up against the bio-specimen provisions are relieved. "We are very pleased at the amount of time, attention, and effort that went into reviewing the comments. The process worked," says Lizbet Boroughs, who follows biomedical research policy for the Association of American Universities in Washington, D.C.

The 26-year-old Common Rule is aimed at protecting persons who volunteer for federally funded research studies but the Department of Health and Human Services (HHS) and other agencies commenced a process in 2011 to alter how medical research is done. The changes include the use of electronic medical health records, a growing number of clinical trials, and privacy concerns raised by advances in genomics, Science Magazine.

A similar proposed rule was released in September 2015, but included some uncontroversial revisions like requirements for simpler informed consent forms and exemptions for low-risk studies such as social science and student research. However, it did not impose new rules for research using blood, tissue, urine, and other specimens leftover from clinical care or any specific study.

Currently, researchers are allowed to use these samples for new clinical and biomedical research even without the donor's consent as long as names and other identification are removed. Some researchers argue that the rule should have required written consent for broad future use of such unidentified samples, with institutions setting up systems to track the consent data.

Research organizations and scientists argued in some of the 2100 comments submitted on the proposed rule that the change should have imposed huge costs which would prevent many small hospitals and clinics from providing samples to researchers.

Opponents of the rule believe that retaining a link between samples and consent forms would create new privacy risks with a committee of National Academies of Sciences, Engineering and Medicine proposing that the federal officials withdraw the entire proposal and seek expert commission to make the Common Rule more accommodating.

The final rule states that eliminating the proposal is intended to address concerns about the complexity and lack of justification for the proposed changes, and also concerns about embarking on changes with no evidence that the changes would improve the system. The rule will take effect next year.

The proposed rules for bio-specimens were motivated by the case of a poor black woman, Henrietta Lacks whose cancer cells was widely used in research labs without her consent.HHS said the new rule is intended to balance a patient's rights with that of research institutions' concerns on undue administrative burdens. The rules for human subject study dates back to 1991, according to Reuters.

The final rule also contains a requirement that all researchers must abide by the Common Rule as long as their institution receives federal funds for clinical research. However, opponents said it would have hindered some social science and student research and should not have closed what the final rule describes as "the real gap" in regulation - institutions that get no federal funding.

Another controversial component in the final rule is that the NIH similar requirement to that of researchers conducting a clinical study across multiple institutions, who use a single institutional review board (IRB) to streamline oversight, but with few exceptions. Critics argue that it might not make sense for small studies or studies involving local communities.