Human Subjects

Jump to:

• Overview
• Guidelines
• Submitting protocols
• Training
• Resources
• Contacts

Overview

To protect the rights and welfare of 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 Graduate School’s Human Research Protection Program (HRPP) provides oversight and assistance in assuring compliance with policies, laws, and regulations governing Human Subject Research.

Guidelines

Human subjects are defined as living individuals about whom an 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 these 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 for approval before submitting a protocol application. (Note: This is separate from PI status approval needed 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 Protocols

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

• Social and Behavioral Sciences/Education Research (SBS/ED) IRBs
  Responsible for reviewing Human Subjects Protocols for non-medical social and behavioral sciences and education research proposals. Though SBS and ED are two separate IRBs, they are administered jointly and share the same policies and procedures.
• Health Sciences/Health Sciences Minimal Risk IRBs
  Responsible for reviewing Human Subjects Protocols for research involving medical interventions or procedures where medical expertise/knowledge of the health care setting is required for evaluation.
  • Health Sciences Protocol instructions
  • Health Sciences IRB meeting dates

Training

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 Collaborative Institutional Training Initiative (CITI):

• Instructions for completing Human Subjects Protection Training via CITI
• CITI training site log in (requires a valid NetID)

Resources

• Graduate School Human Research Protection Program: Graduate School Human Research Protection Program (HRPP) main site
• Human subjects protection training instructions: Step-by-step instructions for accessing and completing online human subjects training via CITI
• CITI training website: Login page for the Graduates School’s CITI online training website (requires a valid NetID)
• Social and 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 before the 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.

Contacts

Social and Behavioral Sciences/Education Research IRBs

608-263-2320
In-person consultations available — visit drop-in hours for more information.

Health Sciences IRBs

Health Sciences IRB knowledge base
608-263-2362