2003 Archived News - Human Research Protection Program

2003 IRB News

December 8, 2003

New on-line initial UCRIHS application

The Office of Research Ethics and Standards is excited to announce the new on-line initial application and review system for the University Committee for Research Involving Human Subjects (UCRIHS). The on-line system will strengthen protection for human subjects, and at the same time, streamline the review process for researchers and reviewers. Starting February 1, 2004, all new UCRIHS initial applications must be submitted using the new on-line system.
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.

Workshops offered on how to use the new UCRIHS online initial application

The Office of Research Ethics and Standards is planning one-hour workshops to assist researchers with the new application in January. We encourage faculty, staff, and graduate students to attend. Dates will be posted as soon as determined.

Change in on-line tutorial requirements

To ensure our commitment to the Federal Wide Assurance issued to MSU's Human Research Protection Program, effective January 1, 2004, all investigators and research staff involved in the conduct of human subjects research must have received University-approved education. To fulfill this requirement MSU has developed an online tutorial that is available at http://www.humanresearch.msu.edu/training/training_index.htm. The tutorial takes approximately 20 to 30 minutes to complete. The responsible (principal) investigator's training must be current (within the past 12 months) in order to submit an application to UCRIHS. A refresher tutorial that provides updated education for investigators who have completed the initial tutorial is being developed.

Coming soon

The UCRIHS office is developing separate initial applications for Biomedical Research and Social Science/Behavioral Research.

Change in UCRIHS chair

The Office of Research Ethics and Standards (ORES) would like to thank Dr. Ashir Kumar for serving as UCRIHS Chair since 2000 and for his dedication to the Michigan State University Human Research Protection Program as a UCRIHS committee member since 1987.
ORES would like to welcome Dr. Peter Vasilenko as the new UCRIHS Chair, effective September 1, 2003. Dr. Vasilenko has been active in the development of the Community Research Institutional Review Board (CRIRB) and serves as the CRIRB Chair.

May 14, 2003

Federal-Wide Assurance approved for MSU
On May 12, 2003, Michigan State University received notice that its application for Federal-Wide Assurance (FWA) was approved by the U.S. Department of Health & Human Services, Office for Human Research Protections (OHRP).

This is recognition of MSU's demonstrated expertise in human subjects' protection and its pledge of oversight for research and training on human subjects protections. Two MSU Institutional Review Boards (IRBs) are covered by this FWA: the University Committee for Research Involving Human Subjects (UCRIHS) and the newly established Community Research Institutional Review Board (CRIRB).
The Assurance requires that all research projects involving human subjects, regardless of funding source, conducted by a Michigan State University employee be reviewed and approved by an Institutional Review Board prior to initiating any research. The IRB reviews are guided by principles found in The Belmont Report (beneficence, respect for persons and justice) and federal and state regulations on human subject research protections.
The Assurance also requires initial and continuing education on human subject protections for research investigators, IRB members and staff. Look for the updated training module on MSU's human research website and educational programs developed by Dr. Diane Doberneck, the new Research Ethics Education Coordinator in the Office of Research Ethics and Standards (ORES).
For more information visit the OHRP web site.

CRIRB established as MSU's first Community Research Institutional Review Board

The Community Research Institutional Review Board or CRIRB is now approved under MSU's new Federal-Wide Assurance with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). This is the result of several years of work by MSU and its community partners to develop this second IRB operated by MSU.

CRIRB members review multi-community human subject research projects, those performed at two or more sites, including East Lansing/Lansing. Once a research project is approved by the CRIRB, each participating institution will provide concurrence so the project can be performed at its site, with all renewals and revisions going to CRIRB. This will reduce review time by multiple IRBs, standardize human subject projects across sites and maximize human subject protections. Members of CRIRB include representatives from the participating IRBs around the state that are affiliated with MSU. The CRIRB development committee drafted its manual and operating procedures and provided education for investigators, IRB members and Chairs from all participating institutions. On May 21 CRIRB will sponsor its most recent workshop at MSU on "The New World of Using Medical Records in Research" that focuses on ways investigators and IRBs can implement HIPAA privacy rule regulations. For further information contact Dr. Peter Vasilenko, Chair, or Barbara Decker, CRIRB administrator at 355-2180, or crirb@msu.edu, bdecker@msu.edu.

New Research Ethics Education Coordinator in ORES

Diane Doberneck, Ph.D., joins the ORES as the new full-time Research Ethics Education Coordinator on June 1. In addition to editing MSU's biannual newsletter, Research Integrity, Diane will develop and maintain on-line tutorials and web pages on the ethical conduct of research, participate in and help coordinate the All-University Seminar Series in the Responsible Conduct of Research (RCR), develop curricula on RCR for faculty to use in their own courses and programs and conduct research in RCR.
Dr. Doberneck joins ORES from MSU's Bailey Scholars Program, known for its innovative approaches for involving faculty and students in teaching and learning. She can be reached at connordm@msu.edu or 432-6119.

HIPAA privacy rule affects UCRIHS procedures as of April 14, 2003

Researchers applying to UCRIHS for review of their studies will be getting "two for one" reviews if they come under the new HIPAA privacy rule that became effective April 14, 2003. If human subject researchers use information from a health care provider, health plan or health care clearinghouse their study will be reviewed by UCRIHS and Privacy Board reviewers. In most cases the reviews will be simultaneous.
Michigan State University's Office of Research Ethics and Standards (ORES) has worked to ensure compliance with HIPAA. In addition to setting up the Privacy Board as an extension of UCRIHS to expedite reviews, ORES developed a simple one page template from which researchers can create their own "valid" authorization forms. The template is currently acceptable to MSU HealthTeam and Sparrow Hospital. It will be presented at a workshop on May 21 to representatives of other mid-Michigan hospitals, researchers and IRB members.

For more information about HIPAA at Michigan State University contact Dr. Linda Triemer, Director of the Office of Research Ethics & Standards, at triemerl@msu.edu or 432-4500, or the UCRIHS office at ucrihs@msu.edu or 355-2180, or visit the HIPAA links on the new human research website: www.humanresearch.msu.edu/hipaa/hipaa_index.htm. You will find FAQs on HIPAA, the authorization form template and instructions, criteria for Waivers of Authorization, decision trees for investigators and links to important government HIPAA websites.