Many researchers and industry trade groups say HHS' proposal of a single institutional review board (IRB) and new consent to reuse human specimens could delay new cures from reaching patients and might be too costly to implement.
The Common Rule was established in 1991 to addresses the ethical oversight of biomedical research involving humans. Proposed updates were issued by HHS and 15 other agencies this past September. The changes include clearer consent rules for the reuse of stored blood or tissue in new research unrelated to their original use. It also suggests using a centralized IRB for research involving several institutions.
HHS solicited feedback on the proposed measures, and the agency received 2,138 comments by the Jan. 6 deadline. Organizations supported some changes, while asking that additional considerations be taken.
The American Medical Association said in its comment letter (PDF) that, overall, the proposed changes address most of what concerns those involved in clinical research, in particular those with regard to clarifying the scope of the Common Rule, which would now cover all clinical trials, regardless of whether they are government or privately funded.
The AMA supports a single IRB because it would provide consistent protection for participants at all study sites. It would also reduce administrative burden, it added.
The IRB change is meant to prevent duplicate reviews, which could expedite findings.
Yale University, however, took a more measured approach to the IRB proposal. The university agreed that single IRBs could improve oversight of some multisite trials. But the university cautioned that the true positive impact of the rule change would happen if single IRBs became the norm. Until then, the university wrote (PDF), across-the-board mandate is premature and counterproductive.
Instead, Yale urged HHS to partner with other agencies to create models for and evaluate alternative implementations for single IRBs.
The trade group Biotechnology Innovation Organization has long supported the adoption of central IRBs. But it asked for further discussion and clarity to prevent disruption of ongoing research.
Some comments were sharper.
Dr. Daniel Kronish of the Dana-Farber Cancer Institute wrote (PDF) that he believes a single IRB review would actually increase the burden for researchers who deal with multiple single IRBs, involving numerous sponsors and lead institutions, each having their own policy and procedures. That could be time-consuming and could result in errors, Kronish argued.
There was also reaction to the proposed changes to subject consent. The goal there is to prevent situations where tissue or blood given voluntarily is later used without the subject's knowledge for either education or profit. For example, if the material is used to develop new drugs.
HHS proposed secondary use of biospecimens without consent be prohibited because research subjects should have control over how their biospecimens are used.
Yale said that many academic medical centers receive clinical samples collected at community hospitals that would need to implement costly technology to adhere to the new rules. Transmitting the information across platforms would require the samples to remain identifiable and that could present privacy risks, Yale wrote.
The agencies began overhauling the regulations in response to the increasingly expanded and sophisticated ways biospecimens can be analyzed, as well as in response to the collection of digital health records. It's the first change in nearly 25 years.