10/11/07-The Association for the Accreditation of Human Research Protection Programs (AAHRPP) announced late last month that it was renewing accreditation to the University of Minnesota. AAHRPP is a nonprofit organization that offers accreditation to institutions engaged in research involving human participants.
The accreditation demonstrates that the University of Minnesota meets AAHRPP standards by protecting all research participants, and goes beyond the federal minimum.
“The University of Minnesota makes protection of research participants a top priority, as evidenced by AAHRPP's recognition of our high-quality human research protection program,” said Moira, Keane, director, Research Subjects’ Protection Programs at the University of Minnesota. “In pursuing AAHRPP accreditation, the University of Minnesota research community went through a rigorous process of self assessment, to show that we meet and exceed regulatory and ethical standards for protecting human subjects in research.”
The University of Minnesota is one 81 organizations accredited by AAHRPP, representing a total of 307 entities. The list is comprised of organizations in the biomedical and behavioral and social sciences research fields, including community hospitals, Veterans Affairs hospitals, teaching hospitals, independent review boards, research institutes, contract research organizations, and universities.
AAHRPP accreditation is valid for three years. Accredited organizations submit annual reports to AAHRPP on the status of their human research protection programs.
5/10/07-The Institutional Review Board (IRB) is being reorganized such that one medical committee of the IRB will now meet weekly rather than four separate committees meeting monthly. This change will substantially reduce the time for review and approval of IRB applications. In addition, the committee intends to focus on issues human subjects safety and ethics. Therefore, beginning July 1, 2007, research involving human subjects is to be reviewed for scientific validity and appropriateness prior to IRB review.
3/10/07-Researchers using Protected Health Information (PHI) in the course of their research projects are required by federal law (US Code of Federal Regulations 45 CFR 164 Security and Privacy) and University of Minnesota Policy (Administration & Oversight for Protection of Individual Health Information [HIPAA] 2.10.2) to have a study-specific HIPAA form approved by the Institutional Review Board and signed by each subject.
Research consent forms are insufficient to meet the HIPAA requirements unless the IRB has approved HIPAA related language in the text of the form. Most research projects carry a separate form for subject signature and documentation of permission. Failure to secure the proper forms is a violation of the HIPAA rules and can result in sanctions for the institution and restrictions on the study.
For further information regarding HIPAA and human subjects' research, go to http://www.research.umn.edu/irb/guidance/hipaa/.
10/24/06-Research Subjects' Protection Program has initiated a new submission process to speed review of exempt and medical record chart review applications. The process requires applicants submit their applications using their University e-mail accounts as secure electronic notification using password protected authentications has been deemed by the University of Minnesota to constitute a legal signature.
The Medical Record Chart Review (MRCR) application has been developed for researchers who plan to use medical record chart review methodologies only. This new process has been especially tailored with medical record chart review researchers in mind. No other types of research should be submitted on this form as they will be returned.
Researchers may consult eReserach Central site to track the application status.
7/1/06-Vice President for Research announces that
effective July 1, 2006 administrative support for the Institutional
Biosafety Committee (IBC) will transition from Department of Environmental
Health and Safety (DEHS) to the Research Subjects Protection Program
(RSPP), Office of the Vice President for Research. The change addresses
a need for greater direction from the Vice President for Research
regarding IBC operations and to achieve a higher level of harmonization
across the Universitys three regulatory committees (IRB, IACUC
and IBC). Associate Vice President for Research and Regulatory Affairs,
Richard Bianco, will expand his Institutional Official oversight
responsibilities to include the IRB, IACUC and now IBC.
Questions about the IBC administrative support transition should
be directed to Moira Keane, Director, RSPP at 612-626-5654. For
more information about the IBC and for updates about the changes
see: http://www.ibc.umn.edu/
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