| Recent changes at the federal level have dictated changes in some of the policies and procedures
pertaining to Montana State University research involving human subjects, according to Stephen
Guggenheim of the WWAMI/ Medical Program at MSU.
Perhaps the most significant change is mandatory instruction in the ethical conduct of human
research and the protection of human subjects, he said. All investigators involved in any
proposed research using human subjects must complete this instruction, which can be acquired
on-line through the National Cancer Institute.
Principal investigators can go to http://cme.nci.nih.gov/ and complete the on line program
called "Human Participant Protections, Education for Research Teams." PIs can then print a
certificate that the Human Subjects Committee will accept as documentation of the necessary
instruction. A certificate for each PI should be submitted with the application for normal or
expedited review of a research proposal.
The committee will accept documentation of instruction from other sources if the content equals
or exceeds that of the National Cancer Institute site. Guggenheim said the committee also may
require additional instruction if investigators are conducting human research associated with
"unusually complex ethical issues."
Human research carrying little or no risks for subjects may be exempt from committee review,
but the committee must give written concurrence of such an exemption. The committee chair or human subjects administrator
will respond with a memo indicating concurrence or requesting a full application for review.
Instruction certificates as described above are not required if the research is indeed exempt
from committee review.
In other changes, Single Project Assurances are no longer necessary and will not be provided
by the Human Subjects Committee. MSU now has a Federal Wide Assurance number (FWA00000165)
that can be used on grant applications and can be used in place of a Multiple Assurance
number as well.
And last, Mark Quinn of the Veterinary Molecular Biology Department is the new chair of the
Human Subjects Committee. He replaces Guggenheim, who has become the human subjects administrator.
The committee's office will continue to be in the WWAMI Medical Program, 308 Leon Johnson Hall,
994-4411, where Guggenheim will maintain responsibilities for office operations and record keeping.
Cheryl Johnson is providing administrative support.
For more information on any of these changes or on the MSU Human Subjects Committee in general,
go to http://www2.montana.edu/irb/.