New rules delay approval for IU research

The approval process for research involving human subjects has slowed at IU-Bloomington recently, creating problems for graduate students and others who are trying to start and complete projects.

The delayed approvals put graduation in limbo for some who had hoped to finish their work by the end of the summer sessions. For others, it threatened funding for their projects.

But the slowdown was an unpleasant side effect of a needed modification, say IU officials, as the board responsible for reviewing proposals and the university reworks its system.

The slowdown is happening because rules regarding what information researchers must submit have changed over the years, said Peter Finn, psychology professor and director of the Bloomington Institutional Review Board, or IRB, which approves and oversees projects involving human subjects.

Presently researchers are expected to provide more information, and the IRBs have a more extensive vetting process, Finn said.

For example, new information is required concerning the consent of subjects depending on their age, what researchers plan on doing to them and other factors.
But the impact of the increased requirements spreads far beyond hard sciences. A review is required for any interaction with humans, including simply observing them outside or talking with them about anything.

The normal length of the review varies from two to five weeks depending on what the
researchers plan to do.

Graduate and professional student organization moderator Nick Clark said a few students complained during the summer about the wait.

Some had delayed research, he said, and one student had to start the process over when the restructuring began. Clark said it was possible graduation could be delayed and grant money not approved.
The Graduate and Professional Student Organization advocates for graduate students to the administration. But there wasn’t much they could do in this situation, Clark said.
“The changes they made were positive changes,” Clark said, adding that if students want to get money for research at all, the new rules must be enforced.

Clark said he thinks many graduate students are angry that the new procedures aren’t thorough enough.

It’s not exactly a government requirement: Finn said it’s more of an evolutionary process, where one university adapts a rule and others follow suit, with few hard and fast limits.

“It’s not black and white,” said Steve Martin, associate vice provost for research.
Before, IU-Bloomington didn’t have a well-articulated process, Finn said. When the former director of the human subject’s office retired, he took his years of experience and operating procedures with him, he said.

Issues with the review process were brought to the attention of the University and government authorities earlier this summer.

Finn said humans weren’t in danger, but without a well-articulated process, procedures can deviate, causing problems.

IU-Purdue University Indianapolis, which has six IRBs, compared with Bloomington’s one, is accredited, which ensures the whole process is up to current standards.
The University is restructuring so all the review boards in the whole IU system fall under one office and one vice president. It’s also training the Bloomington IRB to use the same procedures as Indianapolis, while IUPUI temporarily takes on some of the Bloomington IRB’s reviews.

Graduate student Dean Van Nasdale works in a lab that uses instruments found in optometry clinics for early detection of damage from macular degeneration and diabetes.

Van Nasdale said it isn’t a big deal for him right now. He said he isn’t treated like other graduate students because he already has a doctorate in optometry. He doesn’t have to worry as much about grant funding or providing for his family. But, he still has to wait.

His request is near the bottom of the list since others need requests approved soon to get grant funding, he said.

Martin and Finn said it’s more than a month into what they expect to be a three-month process. They said some of the wait comes from researchers having to learn how to fill out new forms with more detail.

Robert Sherwood, associate dean for research in the School of Education, said the restructuring has affected his school some because most of the research involves underage students, a touchy subject for the IRBs.

He said it’s a matter of telling parents what’s going on – that they’re trying a new teaching method and there will be an extra quiz or test.

Besides the slowdown, the IRB has been helpful, going out of its way to provide education about the new procedures, Sherwood said.

“We are hoping we can help it from becoming a problem in the fall,” he said.