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Human research rules might change

October 31, 2011

MSU officials and students have said proposed federal changes to human subject research regulations could impact university research in both positive and negative ways.

In July, the Department of Health and Human Services announced it would begin accepting feedback from university researchers about whether or not to pursue changes to regulations dictating treatment of human participants in research studies. The department’s deadline for accepting feedback from universities and other institutions was Oct. 26.

Possible changes would come from national response on about 74 questions related to data protection of subject results, multisite studies and other rules, some of which could impact MSU research.

The regulations possibly could include streamlining the consent process for human subjects and requiring different types of written permission forms, depending on how experiment results could be used.

At MSU, the Department of Psychology and other units within the College of Social Science regularly conduct studies about human behavior using human subjects, said Kristen Burt, an administrative associate in the Office of Regulatory Affairs.

Psychology senior Zoe Caron — the vice president of MSU’s Psychology Club — said, in her experience, getting full permission from a research subject is an essential step in the scientific process. Caron said it could be carried out further, however.

Caron currently is working on conducting studies related to domestic violence and also has participated in studies working with newborn babies and mothers.

“Consent is one of the most important things we do,” she said. “I think we do a really good job about that.”

Burt collected and compiled feedback about the proposed changes from MSU researchers in a 60-page document sent to government officials on behalf of the university earlier this year.

She said the response at MSU generally was positive.

“Individuals were supportive of the changes,” she said. “One of the things that people really emphasized was protecting humans who participate in research.”

Joseph Haywood, the assistant vice president of the Office of Regulatory Affairs, said the entire process — from accepting public comments to making a decision about federal regulation changes — could take about two years at the most.

“The … proposed questions to the research community would be the most sweeping regulatory changes that we have seen in my experience,” he said in an email. “Many of the changes would have the effect of reducing regulatory burden for investigators. … All would cause some level of change throughout the system.”

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