Sample of weekly headlines (from 12/11/08)

NIH Seeks Input on Grant Forms, Issues Notice About Use of Adobe Forms

OHRP Extends Use of Form Pending Renewal

Grants.gov Posts Reminders About Transition to Adobe, System Notices

VA Audit Finds Problem With Human Subjects Research Documentation

ORI Finds Research Misconduct by Former Grad Student

DHS Issues Final EIS on Proposed Bio and Agro-Defense Lab, Recommends Kansas as Site

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From the Archives...

NIH Implements Public Access Policy, Delays Release of Peer Review Plans (4/15/08)

As expected, the National Institutes of Health on April 7 implemented its controversial public access policy, despite medical publishers’ doom-and-gloom predictions about the effect it will have on their industry. The policy requires authors to submit their papers based on NIH-funded research to the agency for deposit in its PubMed Central database, to appear there within 12 months of publication in a peer-reviewed journal.But RRC has learned that the NIH has delayed action on another controversial matter — changes to the agency’s all-important peer review system, which were expected to be announced around the middle of this month.Some of the suggestions a peer review study panel made in late February to NIH Director Elias Zerhouni have become a flash point for criticism, particularly the recommendation that principal investigators be required to allocate a minimum of 20% effort to each of their grants. At least two organizations have said that such a mandate “could compromise the science.”There is no new date for when Zerhouni will announce which recommendations in the peer review panel’s report he plans to act on. And the agency’s hands are clearly full with blowback from the public access policy....

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Privacy Rule Is Creating Havoc, Yet Offers No Added Protection, Researchers Tell IOM (10/15/07)

Despite the federal privacy rule being in effect for four years, with presumed compliance by universities and researchers, potential research subjects do not feel secure in releasing information to be part of a study, according to a new national survey presented at a recent meeting of an Institute of Medicine committee investigating the impact of the privacy rule on research.Speaking at the meeting, Robert Califf, vice chancellor for clinical research at Duke University Medical Center, said he believed the privacy rule and other regulations are contributing to the slow death of research itself — and of people suffering from illnesses. “Because of the paralyzing effect of the interpretation of HIPAA, and other associated regulatory issues, it is likely that thousands to tens of thousands of Americans are dying or becoming disabled needlessly,” Califf told the 15-member Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule at its meeting on Oct. 1, 2007...

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