Research with Human Subjects

UW-Whitewater Institutional Review Board for the Protection of Human Subjects

The policies and procedures of the Institutional Review Board for the Protection of Human Subjects (IRB) have been developed to protect the rights and welfare of participants in research.

45 CFR 46 

The Federal policy for the protection of human subjects (Basic DHHS Policy for Protection of Human Research Subjects).

Categories of Research that may be Reviewed through an Expedited Review Procedure

An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110. Applicable research includes activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

Human Subject Regulations Decision Charts

The Office for Human Research Protections (OHRP) provides several graphic aids to clarify portions of the Department of Health and Human Services (DHHS) human subject regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46). These portions of the regulations are the subjects of frequent inquires to OHRP.

University of Wisconsin System Institutional Review Board and Human Research Protection Resources

Resources from the University of Wisconsin System Institutional Review Boards and Human Research Protection.

ESEA Information on Student Surveys

This ESEA information update pertains to criteria to follow when conducting student surveys. The information specifies the conditions that would require parents of surveyed students to be allowed to inspect the surveys. The article also discusses local education agencies.

University of Minnesota Informed Consent Training

The University of Minnesota (UMN) hosts an online tutorial that guides investigators through development of an informed consent document that conforms to 45 CFR 46. Investigators answer questions and provide pertinent contact data, research information, etc. Upon completion of the tutorial, the UMN system generates an informed consent text file that is sent via email to the investigator.

Health Literacy Studies at the Harvard School of Public Health

Provides resources for IRB's and investigators dealing with readability including advice on creating and assessing written materials for the general public and links to sites with readability assessment tools.