2001 Archived News - Human Research Protection Program

Office Hours:
Monday - Friday,
8am - 5pm

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

2001 IRB News

December 13, 2001

Revised 45 CFR 46, amending Subpart B -published as Final Rule by the Department of Health and Human Services became effective December 13, 2001. These regulations provide additional protections for pregnant women and human fetuses involved in research. The final rule continues the special protections for pregnant women and human fetuses that have existed since 1975 and makes limited changes in terminology referring to neonates, clarifies provisions for paternal consent when research is conducted involving fetuses, clarifies language that applies to research on newborns of uncertain viability, and correct technical errors.

December 3, 2001

The Department of Health and Human Services' Office of Human Research Protection (OHRP) December 3 issued a new "Federalwide Assurance of Protection for Human Subjects." This simplified assurance covers all of each institution's federally supported human subject research, and eliminates the need for other types of assurance documents. OHRP has suspended processing of Multiple Project Assurances (MPA) and Cooperative Project Assurance (CPA) renewals. All existing MPAs and CPAs will remain in force until further notice. OHRP will provide an "Assurance Education Module" on-line in the next few days. In the interim, OHRP will accept federalwide assurances of protections for human subjects (FWA) with the understanding that the institutional Signatory Official, Human Protections Administrator, and Institutional Review Board (IRB) personnel will complete the module within 30 days of filing. The full announcement of this action can be found on the OHRP website.

November 16, 2001

The Office for Human Research Protections of the Department of Health and Human Services offers the following guidance for Institutional Review Boards (IRBs), investigators and sponsors considering research activities involving human embryonic stem cells (HESCs), HESC-derived test articles, human embryonic germ cells derived from fetal tissue, and/or human embryonic germ cell-derived test-articles at the OHRP web site.