Manual for the Institutional Review Board DRAFT

The manual for the IRB prescribes the policies and procedures of Minnesota State University, Mankato (hereafter known as the Institution or the University) for the protection of human participants in research and related activities conducted at, sponsored or co-sponsored by the Institution. It also serves to implement the Department of Health and Human Services' (DHHS) assurance of compliance with federal and state of Minnesota policies, regulations and laws relating to the protection of human participants in research. For the purposes of this document, research is broadly defined as a systematic investigation designed to develop or contribute to generalizable knowledge.

The policies and procedures described herein apply to all research and research-related activities involving human participants for which the Institution is a responsible participant regardless of the source of funding or whether or not there is funding. In some cases, the regulations at Minnesota State University, Mankato are more stringent than federal guidelines.

Safeguarding the rights and welfare of participants in research and related activities is primarily the responsibility of this Institution, which receives or is accountable for any funds awarded for the support of the activity. It is also the policy of this Institution that approval by the Institutional Review Board for the Protection of Human Subjects (IRB) be received before a proposal is submitted for funding. In order to meet this institutional responsibility, it is the policy of this University that no research activity involving human participants shall be undertaken unless the IRB has reviewed and approved such activity or unless the IRB has provided an approved exception. This Institution will make available documentation of these review processes as necessary in accordance with federal policies.

The IRB may refer questions regarding the applicability of policies and procedures to legal counsel.

This document constitutes the policies and procedures under which the IRB shall operate.