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Human Subjects, Use of in Research

Policy
Purpose: 

To protect the rights, well-being, and personal privacy of individuals; to assure a favorable climate for the conduct of scientific inquiry; and to protect the interests of the University of Kansas; to ensure compliance with the Public Health Service Act (Pub. L. 93-348), as amended; Department of Health and Human Services, 45 CFR 46.101-.409; and the federal-wide Common Rule, “Federal Policy for the Protection of Human Subjects,” (56 Fed. Reg. 28004).

Applies to: 

Researchers whose project is sponsored in any way by the University of Kansas or conducted by anyone connected with the University of Kansas (this includes all Lawrence Campus students, faculty, administrators, and other employees) whose research involves interviews, observation, surveys or any other form of information gathering about humans, either as individuals or members of groups.

Campus: 
Lawrence
Edwards
Parsons
Juniper Gardens
Yoder
Topeka
Policy Statement: 

All research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship must be approved by the Human Subjects Committee-Lawrence (HSCL) if one or more of the following apply:

  1. The research is sponsored by this institution, or
  2. The research is conducted by or under the direction of any employee or agent of this institution in connection with an employee or agent's institutional responsibilities, or
  3. The research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
  4. The research involves the use of this institution's non-public information to identify or contact human research subjects or prospective subjects.
  5. The research is carried out by an organization which has a FederalWide Assurance (FWA) and which has indicated HSCL as their IRB of record.

The term "research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition may be funded or unfunded, or may be conducted as a component of another program not usually considered research. For example, demonstration and service programs may include evaluation components, which constitute research activities under this definition.

See the Human Subjects Committee Lawrence (HSCL) Handbook for elaboration of policies and procedures relevant to research involving humans.

KU-Lawrence researchers may request permission to use the Human Subjects Committee on the medical school campus (KUMC-HSC) if the proposed research meets one of the following criteria: (a) the research will be conducted solely on the KUMC, (b) the research will be conducted on both the KUMC and KU-L campuses, or (c) the research involves the use of the KUMC campus’s non-public information to identify or contact human research subjects or prospective subjects.

For additional details on requests to rely on the KUMC-HSC see Investigator Documents.

Exclusions or Special Circumstances: 

Precedent and practice have established the principle that certain kinds of activities that might be called "human subjects research" do not require review for the protection of human subjects. The following kinds of activities do not require such review:

  1. accepted and established service relationships between professionals and clients where the activity is designed solely to meet the needs of the client;
  2. research using only historical documents; and
  3. research using only archeological materials or other historical or pre-historical artifacts. Pilot studies, pre-tests, and other "preliminary" investigations are considered research, and must be reviewed unless they fall into one of the excluded categories listed above.
Consequences: 

HSCL has authority to suspend or terminate approval of research that is not being conducted in accordance with the HSCL's requirements or that has been associated with unexpected serious harm to subjects. External funding agencies may withdraw funding for sponsored projects.

Contact: 

Human Subjects Committee
785-864-7429
HSCL@ku.edu

Approved by: 
Humans Subjects Committee Lawrence; Approved by the Office of Human Research Protections
Approved on: 
Tuesday, August 16, 2005
Effective on: 
Tuesday, August 16, 2005
Review Cycle: 
Annual (As Needed)
Background: 

Ethical Principles and Guidelines for the Protection of Human Subjects of Research (“The Belmont Report”), National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Department of Health, Education, and Welfare, April 18, 1979.

Definitions: 

IRB: Institutional Review Board

HIPAA: Health Insurance Portability and Accountability Act

Keywords: 
Human subjects; human experimentation; institutional review board; Human Subjects Committee Lawrence; IRB; HSCL
Review, Approval & Change History: 

07/08/2016: Updated to remove gendered pronouns.

12/05/2014: Policy formatting cleanup (e.g., bolding, spacing); published updates to contact information and links.

10/21/2014: Updated contact information and links.

10/22/2013: Updated contact information and links to research.ku.edu.

Operational Categories: 
Health & Safety
Research and Sponsored Projects Category: 
Research and Sponsored Projects

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