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The Scarlet & Black

IRB revises regulations on the use of human subjects


On March 20, the Institutional Review Board (IRB) published changes to the regulations for researchers using human subjects. It will go into effect January 21 of next year for all institutions of higher learning. Many of these changes were made to the Common Rule for human subjects testing that receives federal funding. Grinnell College is affected by these changes as research done at the College is federally funded. Professors and students will experience the change in regulations differently, due to the nature of their research. However, the effect of the changes for student research, like MAPs, will streamline the review process and actually allow for more exemptions to the regulations.

Changes include new and revised exemptions to human subject regulations, specifically highlighting what is not counted as human subject research. It is the responsibility of each college or university to implement and adhere to the changes. Norm Braaton, research compliance manager for Grinnell College, ensures that all research done at the College is in line with federal policies. 

Previously, this work was done by an IRB Chair. Because of high turnover in IRB Chairs, Braaton was put in this position to provide continuity. 

“One of my major tasks has been with the human subjects committee. … [Administration] thought ‘if we get someone who has that expertise and can provide that, it takes quite a bit of burden off the faculty,’” Braaton said.

If research is exempt from IRB oversight, it means that it is of such low risk that the IRB does not need to monitor what is studied. If expedited, it means that the research is also minimal risk, but it does have oversight at the college or federal level. 

Another change that helps to make research more streamlined is what is and is not considered research. These activities include oral history, journalism, biography, literary criticism, legal research, historical scholarship, health surveillance, criminal investigation, operational activities (as determined by each agency) in support of intelligence, homeland security, defense or other national security missions.

“We hope that the process becomes a little bit more streamlined as a result of this,” Braaton said.

Ann Ellis, chair of the psychology department, also feels that the changes in the human subject testing will streamline minimal risk student research. “We won’t need to check back with the IRB if the research is exempt. … It makes it more likely for minimal risk to not require any oversight by the College IRB,” Ellis said. 

In psychology, low-risk surveys and interviews and low-risk psychology experiments will now be exempt. 

“More things will be able to be exempt from review, but that doesn’t mean you don’t have to submit IRB proposals, because the only way a piece of research can be deemed exempt if someone puts in a proposal,” Ellis said.

Despite these many changes, student research is not seriously impacted. Student research will most likely be more streamlined if it is minimal risk and may otherwise go unaffected.

“I don’t think there’s going to be a really big impact, because you’ll still have to develop your proposal, send your proposal to the IRB, make sure you’re following all the ethical standards for research with human participants. It just means from the college level that there will be less watching of people’s different projects,” added Ellis. “I don’t think it’s going to have much of an effect on MAPs, honestly.”

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