IU officials say problems with research delays getting better

After serious delays in approving human research this summer, problems with getting projects approved are getting better, Steve Martin, associate vice president of research administration, said Tuesday.

But it’s a struggle to find a balance between the needs of the researcher and the bureaucracy, said Stephen Burns, chair of the research affairs committee at IU.

The Bloomington Faculty Council met Tuesday, and one of the topics on the agenda was an update on the delays in approval for human research subjects.

During the summer and the early part of this semester, the Bloomington campus implemented the same procedures used by accredited Institutional Review Boards, or IRBs, which caused the delays. This slowed down work for researchers who were waiting on approval as they – and the reviewers – grappled with the new, more complicated procedures.

Researchers have to submit proposals for any research that involves humans, even when just observing or talking with them. It isn’t limited to the hard sciences – education, folklore and many other departments are affected.

Research approval over the summer was “pretty dismal,” Martin said. In parts of July and August, Martin said only four projects were approved a week, compared to about 50 projects approved last week.

He said he hopes to get to the point where the number of projects being approved exceeds the number coming in, to take care of the backlog.

No humans were ever in danger, but, Burns said, procedures need to be followed to ensure continued government grant funding. The complicated forms ensure the committee has enough information to know that the subjects have enough information to consent.

Researchers are confused and frustrated by new forms, procedures and complex language, Burns said, though the administration has made efforts to educate researchers about the forms and procedures.

The tug of war isn’t unique to IU, Burns said. He said all the procedures are designed to make sure subjects know what they’re getting into.

“It’s all about making sure people can make informed decisions,” Burns said.
To fix IU’s specific research issues, Martin said, there are 20 people working at Bloomington’s IRB who are trying to push through research approvals, project amendments and yearly reviews.

Martin said he doesn’t know if the number of workers will decrease. Four of them are from IU-Purdue University Indianapolis, working on a part-time basis.

An IRB from the Indianapolis campus provided support for Bloomington’s campus during the summer and earlier in the semester.

Peter Finn, chair of IU-Bloomington’s IRB, said the Bloomington campus is more self-sufficient than it had been during the transition.

He also said 95 percent of proposals going through are approved with minimal problems, which he contributed partly to University-provided education about the new forms and procedures.

The change in procedures resulted from problems with the way the IRB office was processing research proposals, Burns said.

He said because of the delays, some researchers have waited to submit proposals until things get better, which might cause more backlogging.

Martin said not all the problems are fixed. Finn said he is taking suggestions to alleviate those problems that are leftover.

“We fully expect that there are additional changes we need to make,” Martin said.