Full AAHRPP Accreditation

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Mailing Address:
Michigan State University, 202 Olds Hall
East Lansing, MI 48824.

Phone: (517) 355-2180
Fax: (517) 432-4503
Email: irb@msu.edu

Office Location:
202 Olds Hall.
Olds Hall is located between the Administration Building and MSU Main Library. Campus Map

Michigan State University
 

2004 IRB News

December 21, 2004

UCRIHS has voted to move their meetings to the second Monday of every month effective January 2005. This change is reflected in the posted meeting dates.

UCRIHS
Meeting Dates Submission Deadlines - 5:00 P.M.
December 6, 2004 November 17, 2004
January 10, 2005 December 17, 2004
February 14, 2005 January 28, 2005
March 14, 2005 February 25, 2005
April 11, 2005 March 25, 2005

 

October 5, 2004

The next Crosstalk with UCRIHS will be held October 19, 2004 from 12PM - 1PM at 191 Comm Arts--Deeb Conf. Rm. Investigators, research staff and graduate students are invited to attend this one-hour open forum. The session is designed to present the latest updates from UCRIHS and provide a forum for investigators to offer feedback and discuss issues. All departments are welcome at all sessions.

 

September 28, 2004

The next IRB Educational Conference, Protecting Minors In Research, will be held on October 22, 2004 at the MSU Union. The overview, agenda, and registration form are available on the Education page.

 

August 10 , 2004

The next Crosstalk with UCRIHS will be held August 17, 2004 from 12PM - 1PM at 103 Berkey Hall. Investigators, research staff and graduate students are invited to attend this one-hour open forum. The session is designed to present the latest updates from UCRIHS and provide a forum for investigators to offer feedback and discuss issues. All departments are welcome at all sessions.

The next IRB Educational Conference will be held on October 22, 2004 at the MSU Union. Please check back for more details, including the program agenda and registration information.

We are pleased to announce that reminders for projects' renewal will now be sent by email. We will no longer be sending the reminders through the mail.

Forms for reporting adverse events, unanticipated problems and closure are now available for use at http://www.humanresearch.msu.edu/applications/applications_index.htm. The revision and renewal form have been revised and are available at http://www.humanresearch.msu.edu/applications/applications_index.htm.

 

April 30 , 2004

Starting in the summer of 2004, UCRIHS will be holding Crosstalk with UCRIHS sessions offered by the UCRIHS Chair and staff. Investigators, research staff, and graduate students are invited to attend these one-hour open forums. The sessions are designed to present the latest updates from UCRIHS and provide a forum for investigators to feed back and discuss issues. The locations of the sessions will rotate through different departments/areas on campus, but all departments are welcome at all sessions.

MSU applied for accreditation to the Association for the Accreditation of Human Research Protection Programs (AAHRPP) on April 16th. The application described MSU policies on human research protections and referenced multiple documents that detail how these policies are implemented. Many documents are available on this and other MSU websites, e.g., UCRIHS Handbook, Academic Program Catalog, Faculty Handbook, etc. This summer AAHRPP will send a team of evaluators to MSU to meet with individuals involved in all aspects of the program from administrators and IRB members to investigators and participant representatives.

UCRIHS has adopted the following policies on research involving public data files, de-identified human tissues, and de-identified human cell lines. These policies clarify previous uncertainty, and facilitate research using these methods while maintaining human subject protection. All three policies require investigators to inform UCRIHS of their research projects and to submit an appropriate certification form to the UCRIHS office. These simple one page forms inform UCRIHS of the research and require investigators to assure that they using deidentified materials and they will not attempt to ascertain the identify of any individuals.

It is UCRIHS policy that research involving secondary analysis of pre-approved public data files does not require UCRIHS approval. UCRIHS, however, must be informed of the conduct of the research involving these pre-approved public data files and requires certification of the use of an approved database through the submission of a Use of An Approved Public Data File form.

The five currently pre-approved public data files are:

(1) Inter-University Consortium for Political and Social Research (ICPSR)
(2) U.S. Bureau of Census
(3) National Center for Health Statistics
(4) National Center for Education Statistics
(5) Bureau of Labor Statistics

Researchers may request the registration of a database as an approved public data file by submitting a Registration of a Database as an Approved Public Data File form.

Use of Human Tissues from Commercial Sources or Tissue Banks

In accordance with OHRP policy regarding the use of human cell tissues, research involving the in vitro use of de-identified human tissues does not require IRB approval. UCRIHS, however, must be informed of the conduct of the research project and requires certification of the use of the human tissue through the submission of a Use of De-Identified Human Tissues form.

Use of Commercially Available, De-Identified Human Cell Lines
In accordance with OHRP policy regarding the use of human cell lines, research involving the in vitro use of de-identified human cell lines does not require IRB approval. UCRIHS, however, must be informed of the conduct of the research project and requires certification of the use of the human cell line through the submission of a Use of De-Identified Human Cell Lines form.

UCRIHS has adopted the following policies in order to clarify the types of research that require review by Institutional Review Boards. Neither Clinical Case Reports in Medicine nor research involving Human Cadaver Tissues and Cells requires IRB review.

Clinical Case Reports in Medicine
It is the opinion of UCRIHS that a clinical case report on a single patient is not research. A case report does involve a human subject by definition, and may contribute to generalizable knowledge by presentation or publication. However, a clinical case report in medicine does not meet the definition of a systematic investigation and thus does not meet the definition of research. They may be used to fulfill a requirement for "scholarly activity." If, however, case reports are considered research by the author or program or used to fulfill a "research" requirement, then IRB approval is needed.

Human Cadaver Tissue and Cells
The federal regulation of human subjects research by institutional review boards (IRBs) pertains to living human subjects. Consequently, when a research subject is deceased, such research is generally not covered by IRB regulations. If the research on the deceased subject extends to include information obtained from living individuals (e.g., relatives) then that research is subject to IRB review since contact with living individuals is occurring.

March 24, 2004

The UCRIHS staff extended the deadline for accepting paper and e-mail intial applications until April 1, 2004. After April 1, only applications submitted through the online system will be accepted.

Renewals, revisions, adverse event reports and closures should still be submitted in hard copy using forms available on the UCRIHS website, www.humanresearch.msu.edu. On-line reporting for these forms is still under development. For additional information about on-line submission, please contact UCRIHS staff at 355-2180.

 

2004 IRB News Archive
 

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