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More Comments on the Common Rule Proposal

The US Department of Health and Human Services has extended the comment period on its proposal to alter the rules that protect human research subjects, as the community has requested more time to review it, according to the National Institutes of Health's Extramural News site.

"We're in a very, very different world than when these regulations were first written," Jerry Menikoff, the head of the HHS Office of Human Research Protections, tells NPR. "The goal is to modernize the rules to make sure terrible things don't happen."

However, Elisa Hurley, executive director of Public Responsibility in Medicine and Research, says the proposal is too complicated as well as vague, NPR notes.

Under this proposed change to the Common Rule, informed consent forms would have to be shortened, though still contain information about the study that's most relevant to someone's decision to participate and present that information so a 'reasonable person' could understand it. In addition, the proposal would require secondary consent for additional research on leftover biospecimens, such as blood samples.

While that change would ensure that research participants have explicitly agreed to additional research, some researchers say it may make it more difficult to work with human tissue. "It's now going to be much more onerous to get this tissue that otherwise would just go in the trash," Johns Hopkins University dermatologist Luis Garza tells NPR.

The new rules also seek to simplify multicenter studies by allowing one centralized institutional review board to oversee them rather than IRBs at the various study sites.

And on that point, some ethicists argue that a centralized IRB might not be aware of local issues and the credentials of far-flung investigators, NPR says.

The proposal would also exempt certain low-risk studies, such as surveys, from IRB oversight, and, that too has drawn criticism.

Menikoff from HHS says that these changes wouldn't put anyone at risk, but notes that the feedback the agency receives will be considered before the rules are altered.

The new comment deadline is January 6, 2016.