Use of Human Subjects in Research Policy

Purpose:

This policy describes how Winona State University (WSU) safeguards the rights and welfare of human subjects participating in research conducted in university facilities or by university faculty, staff, or students on behalf of the university.

Policy/Procedure Regulation:

This policy provides guidelines and procedures for the protection of human research subjects involved in research in accord with the principles set forth in the Belmont Report, to comply with their application as required by Title 45 Part 46 of the U.S. Code of Federal Regulations — Protection of Human Subjects, and to fulfill the university’s Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services.

WSU will form a federal regulatory board, the Institutional Review Board (IRB), with the authority to approve, require modifications, or disapprove any research activities that fall within its jurisdiction and are conducted under the auspices of the university. All research protocols involving human subjects will be submitted to the IRB for review. The IRB is responsible for determining if has jurisdiction, not investigators or university officials.

Research approved by the IRB may be reviewed and disapproved by university officials; however, university officials may not approve research that has been disapproved by the IRB.

Related Documents

• U.S. Department of Health and Human Services Regulation 45 CFR 46

Related definitions:

[3-7] Federalwide Assurance (FWA):

An assurance of compliance with federal regulations for the protection of human subjects in research.

[3-7] Human subject:

A living individual about whom and investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.

[3-7] Institutional Review Board (IRB):

Administrative body established to protect the rights and welfare of human research subjects conducted under the auspices of the institution with which it is affiliated.

[3-7] Interaction:

Includes communication or interpersonal contact between investigator and subject.

[3-7] Intervention:

Includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.

[3-7] Investigator:

An individual performing various human subject research activities, such as obtaining information through intervention or interaction, obtaining identifiable private information, obtaining voluntary informed consent of individuals to participate in research, or studying, interpreting, or analyzing identifiable private information.

[3-7] Private information:

Includes information about behavior that occurs in the context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.

[3-7] Research:

Systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Authorizing Policy/Subsequent Procedure:

• 3-7A Use of Human Subjects in Research Procedure

History:

Adoption date: 01/18/2019
Implementation date: 01/18/2019