Noncompliance: OHRP says IRBs can't "e-mail" it in
Investigation focuses on electronic meetings
Haverford College of Haverford, PA, has spent more than a year dealing with a problem that IRBs do everything they can to avoid: a research noncompliance investigation requested by the Office for Human Research Protections (OHRP). "OHRP sent us a letter back in November, 2007," says Robert C. Scarrow, PhD, professor of chemistry at Haverford College and IRB chair. "The main thing OHRP had done was look at our procedures, which are posted on the Web site, and they thought we were using electronically-convened meetings."
The IRB had conducted some meetings through email communication, and OHRP determined that the email process outlined in the college's IRB procedures did not satisfy the provisions of HHS regulations at 45CFR, part 46.108(b) that require IRBs review research at convened meetings except when an expedited review procedure is used, according to a letter OHRP sent to Haverford College Provost Linda A. Bell, PhD, on Sept. 15, 2008.
The IRB had thought that holding email meetings would allow for a faster turn-around time on the handful of proposals that needed a full review each year, Scarrow notes.
"So I came up with this idea that we were in the 21st century, and I'd send around proposals for review, and then I'd ask everyone to get their comments to me in written form within the first week," Scarrow explains.
Then Scarrow would redistribute the comments to see if there were any concerns. Eventually the seven IRB members would reach a consensus, he adds. "When we got a proposal we needed to review, we would discuss them over a 48-hour period by email exchanges," Scarrow says. "OHRP said it was okay to have telephone conferences, but they told us it wasn't okay to have meetings by email."
So the college responded by changing its procedures and holding a meeting where all proposals that had been approved by full review using email-convened meetings were revisited, Scarrow says. "We distributed each proposal and discussed these again in a convened meeting in 2007," he adds.
The IRB receives about two research proposals per month, and most of these are approved by expedited review, Scarrow says.
"For us this means that at least one person reviews it," Scarrow says. "Often, I send it out to two IRB members, including one who is a human protections administrator, and someone else in the same discipline as the proposal."
OHRP officials had a number of questions and comments about the college's research policies and procedures, including the following:
• Training: "They asked us questions about what sort of training we had," Scarrow says. "They wanted to make sure we were training ourselves in human subjects research regulations."
This prompted research officials to review regulations and Web site training. They decided to require all research personnel to take the training module, Scarrow says.
"We now require the chair of the IRB, our human protections administrator, executive assistant, and provost signatory official to take that training," Scarrow says. "That's in line with OHRP, and it's in line with what they say we should be doing."
• Prompt reporting: In OHRP's Sept. 15, 2008, letter, officials wrote that Haverford College would need to include more details about its procedures for ensuring prompt reporting to the IRB of proposed changes in a research activity and for ensuring that any changes in approved research may not be initiated without IRB review and approval except when necessary to eliminate immediate hazards to subjects.
Also, the OHRP letter requested more detailed procedures for ensuring prompt reporting to the IRB of any unanticipated problems involving risks to subjects and any serious or continuing noncompliance with 45CFR, part 46.
"So we've added several paragraphs to our procedures to say what to do if an investigator has an unexpected risk or if a subject makes a complaint," Scarrow says. "That hasn't happened in the four-and-a-half years I've been the chair."
Most of the college's research proposals involve very low risk, he adds.