Random reviews of IRB protocols to begin

The Office of Research Compliance and Ethics has established a committee for random reviews of approved IRB studies to support quality assurance efforts for the protection of human subjects.

Review of human subjects research protocols approved by the IRB in 2010 will begin next week. Principal investigators will receive a letter from the Protocol Review and Education Program (PREP), notifying them that their study has been randomly selected for post-approval review. The letter will include details on how to schedule the review, the names of the committee member to contact, and what the review will involve.

PREP conducts not-for-cause reviews, therefore protocols are not selected on the basis of suspicion that the investigator is or is not in compliance with IRB regulatory standards. Results of the reviews are reported in aggregated format unless an issue requires a report to the federal Department of Health and Human Services.

Dr. Robin Liles serves as chair of the committee and can be reached at 336 285-4390 or by email.

Worth reading: Suit over fatal lab fire at UCLA

From one of the very informative blogs at Scientific American:

“Generally, scientists doing research that involves hazardous materials do what they can to find out how to mitigate the hazards. They learn appropriate ways of handling the materials, of disposing of them, of protecting themselves and others in case of accidents.

“But, knowing the right ways to deal with hazardous materials is not sufficient to mitigate the risks. Proper procedures need to be implemented. Otherwise, your knowledge about the risks of hazardous materials is mostly useful in explaining bad outcomes after they happen.”

Assessing the damage in Yankaskas case

The News & Observer wraps up the story of Dr. Bonnie Yankaskas of UNC-CH and the computer security breach that cost the epidemiologist her job and a significant amount of money.  It also put the future of her 15-year research project, the Carolina Mammography Registry, in doubt.

UNC-CH, Yankaskas reach settlement

UNC-CH has settled a case in which it was attempting to fire a faculty member over the the hacking of a cancer research database.  Dr. Bonnie Yankaskas has agreed to retire, and the university has agreed to restore her rank and salary, which were reduced in the wake of the hacking of her project’s database.  The UNC-CH campus newspaper reported this week that the settlement was announced last Friday.  In 2009, it was discovered that the personal information of some 180,000 patients and research subjects had been exposed when a hacker successfully attacked the database of the Carolina Mammography Registry. Yankaskas, as the PI on the project, was held responsible.  She contended that the security of her database wasn’t her responsibility.

Research controversy vs. football controversy: Comparing two high-profile cases in Chapel Hill

Scandal comes to Chapel Hill, and what happens?  Epidemiologist Bonnie Yankaskas gets punished.  Football coach Butch Davis gets a big hug from the chancellor.  How different are the two cases? The editor of The News & Observer gives his opinion.

UNC-CH Chancellor Holden Thorpe, in the "Carolina" jacket, and Butch Davis after the coachs scandal-ridden football team beat Duke last fall.

Vulnerability of research database results in controversial demotion of UNC-CH prof

Here’s a wake-up call for PIs who collect personal information about people participating in their research projects:

A cancer researcher at UNC-CH is being held responsible for a vulnerability in her project’s database that allowed a hacker to access 180,000 patient files.  Epidemiologist Bonnie Yankaskas has been demoted from professor to associate professor; her pay was cut almost in half.  But it could have been worse — the university initially wanted to fire her.

The case is going into mediation, so it’s unclear what the ultimate outcome will be for Yankaskas.  But for now, at least, the researcher is being held personally responsible for the security of her research data.   A group of faculty members at Chapel Hill and elsewhere have signed a petition supporting her.  Click here for details from The News & Observer.

Research news: Research dollars are getting tight, so agencies are tightening their processes

With federal research funds declining, agencies are streamlining and tightening up their review procedures.  Getting the proposal right the first time has never been more important.  What does this mean for you?  We have answers for you in the next issue of the research newsletter.  It will arrive in the mailboxes of faculty and grad students soon, but it’s available today right here through the PDF below.

Other items of interest: an overview of A&T’s research compliance committees on human subjects, animal care and use, biosafety and radiation safety; news of a new requirement from NSF on data sharing; and July and August funding awards.

NEWSLETTER — 2010-09 Final

Supplement — Research compliance committees membership lists 2010-09

Supplement — Links to NSF data-sharing information 2010-09

Training scheduled for new animal-care application process

The Institutional Animal Care and Use Committee has scheduled training for its new electronic application for proposed animal research.  Use of the new system will become mandatory on November 1.  Training will be on Monday September 27th in the Fort IRC, Room 410.  One-hour sessions will be held throughout the day, starting at 10 a.m., 11 a.m., 1 p.m., 2 p.m. and 3 p.m.  Anyone using or expecting to use animal models in research, teaching, testing or demonstration should attend this training.  To sign up, go to  http://www.doodle.com/gwxwdr6wupu97rak

Contact Dr. Tonya R. Hargett, Compliance Officer, at trharget@ncat.edu or 334-7995 for additional information.

Research news: Training, deadlines and more

A major new training initiative is under way for researchers funded by NIH and NSF. Training is also coming on the new electronic application for using animals in research.  An Undergraduate Research Symposium is scheduled for September 21-22.

Oh … and the Office of Sponsored Programs would like to have a word with you about deadlines for research proposals.

Faculty members and grad students will be receiving information on all of these of these subjects in the first monthly edition of the Research A&T newsletter for the 2010-11 academic year.  It will be arriving via campus mail as early as today.  If you can’t wait to see it, here’s a PDF version.

NEWSLETTER — August 2010