Research practices updated

Proposed federal rule changes would expedite research and add human subjects protections.

Benjamin Farniok

Researchers across the country who use human subjects may soon face stricter consent requirements and heightened levels of scrutiny if they want to get federal funding.
 
Last week, the U.S. Department of Health and Human Services and 15 other federal agencies proposed updates to the country’s human research protections. The updates vary from tightening consent requirements to changing how tissue samples are handled. 
 
The changes, which would affect the University of Minnesota and other research institutions that receive federal funding, come just months after the University updated its own human subject policies following heavy criticism. The University altered how it oversaw reporting and consent in June by requiring that researchers do more to ensure ethical conduct.
 
Parts of the federal change, which is in a 90-day comment period that will end in December, could serve to expedite low-risk research projects. For example, it would make the level of review for each study proportional to the risk the subject would encounter.
 
At the University, researchers submit research studies to the school’s Institutional Review Board, which reviews all human-subject studies.
 
The proposed federal rule would also require human subjects to approve the use of their tissue in future studies, and it would eliminate some oversight for studies that are in the data analysis stage and have already completed the testing portion of the research.
 
While the federal change does not constitute a law, an organization that receives federal funding — like the University — must comply to receive funding from participating government agencies, a practice called common rule.
 
The University is not yet ready to discuss what the rule changes might mean for its researchers, said Linnea Anderson, the school’s chief of staff for the Human Research Protection Program.
 
University officials are still looking into the proposal, she said, but they will state their position on the changes when the time is right.
 
“We all follow the basic regulations,” she said. “How it would affect the U of M would affect every other institution that is run by common rule.”
 
Four rule-exempt types of study are being added, which would not require review from a higher group like the University’s Institutional Review Board. These include low-impact adult studies, studies where sensitive information might be collected from subjects, data analysis of information not collected for the study and the storage of specimens or information provided and approved by a subject.
 
Regent Tom Devine said after the University reviewed and rebuilt human research policies this summer following a research subject’s death in 2004, the school has become an example for many research programs across the country.
 
“We’ve moved way up front in terms of what we set as new standards and new protocols,” he said.