Human Subjects


OverviewBack to Top

In order to protect the rights and welfare research subjects, all research involving human subjects must comply with applicable institutional policies, laws, and regulations.

Generally, this involves gaining Institutional Review Board (IRB) approval for your research and completing appropriate training.

Human Research Protection Program (HRPP)

At UW-Madison, the Office of the Vice Chancellor for Research and Graduate Education (OVCRGE)’s Human Research Protection Program (HRPP) provides oversight and assistance in assuring compliance with policies, laws, and regulations governing Human Subject Research.

GuidelinesBack to Top

Human Subjects are defined as living individuals about whom and investigator obtains data through intervention or private information.

Research involving Human Subjects, as defined above, is subject to HRPP policy and requires approval of a Human Subjects Protocol by an Institutional Review Board.

This includes Human Subject research that meets ANY of the following criteria:

  • Sponsored by the UW
  • Conducted by or under the direction of any UW employee
  • Uses UW property/facilities
  • Uses UW non-public information to identify or contact subjects
  • Student research (including Senior/Master’s theses, Doctoral dissertations, and UW sponsored student awards) submitted for publication
  • Any sponsored survey

Investigator Requirements

  • Ensure that personnel complete appropriate Training (training must be completed before protocol is submitted)
  • If the PI is not a tenure-track faculty member, complete a PI Request Form, and ensure that it is signed by the Department Chair/Dean and submitted to the IRB office with the protocol. (Note: this is separate from PI status approval needed in order to submit proposals)
  • Submit a Human Subjects Protocol for review by the appropriate IRB
  • Obtain legally effective informed consent from subjects, as stipulated by your Protocol
  • Report adverse events to the IRB

Submitting ProtocolsBack to Top

Human Subject Protocols are reviewed and approved by subject-specific Institutional Review Boards (IRBs). Each IRB determines its own protocol submission procedures – visit the website of the appropriate IRB for information on protocol submission.

UW Madison IRBs

TrainingBack to Top

All personnel listed on a Human Subjects Protocol must complete Human Subjects Protection Training.

Training must be completed before the protocol is submitted for review.

This training is completed online through the Graduate School’s Collborative Institutional Training Initiative (CITI):

ResourcesBack to Top

UW-Madison Campus Resources
OVCRGE Human Research Protection Program OVCRGE Human Research Protection Program (HRPP) main site
Health Sciences IRBs Instructions for Obtaining IRB Approval Step-by-step guide to completing the IRB approval process, from the HRPP site
ED/SBS IRB Office Instructions for IRB Approval Step-by Step guide to completing IRB approval from the ED/SBS IRB
Human Subjects Research Protection Program (HRPP) Policy HRPP Resources for Researchers
Bio Safety Trainings Required online Bio Safety Trainings at Learn@UW
Social & Behavioral Sciences and Education Research IRB  SBS/ED IRB website
Health Sciences and Health Sciences Minimal Risk IRB Health Sciences IRB website
ARROW Login Login page for IRB protocol submission tool
Human Subjects PI Request Form Form needed when an academic staff member serves as PI on a human subjects research protocol. Must be submitted at time of protocol application.
103 Payments to Research Participants Outlines the payment mechanisms that can be used to make payments to human subjects participating in research studies and to determine when gathering of research participant tax information is required.
Policy on Data Stewardship, Access, and Retention The UW-Madison policy to assure research data is appropriately maintained, archived, and available for review.

ContactsBack to Top

General Compliance Questions

Cheryl Deering
CALS Research Compliance Specialist
(608) 262-2536
cdeering@cals.wisc.edu

Social & Behavioral Sciences/Education Research IRBs

(608) 263-2320

In person consultations available – see http://www.irb.wisc.edu/contactus-help.htm for more information.

Health Sciences IRBs

(608) 263-2362
asktheirb@medicine.wisc.edu

In person consultations available – see https://kb.wisc.edu/hsirbs/20861 for more information.

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