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Human subjects research basics

What to know about obtaining approval at KU for research involving human subjects


Are you planning to conduct human subjects research?

Research involving human subjects must be approved by the HRPP.

Examples of activities that require HRPP review:

  • Biological specimen collection
  • Educational interventions
  • Interviews
  • Physical data collection
  • Pilot studies
  • Secondary research on previously collected human data
  • Surveys

Definitions

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Human subjects

A human subject is a living individual about whom an investigator obtains data through intervention or identifiable data/records.
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Research

Research is a systematic investigation — including research development, testing and evaluation — designed to develop or contribute to generalizable knowledge.

HRPP review process

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Submit applications electronically through eCompliance.

Upload all necessary documents:

  • KU human subjects research protocol form
  • Recruitment materials (emails, flyers, etc.)
  • Consent forms
  • Study measures (e.g., survey questions)

When will I receive a response from HRPP?

  • Expect an initial review response within 5-7 business days.

  • Minimal risk studies are typically approved in 12-15 business days.

Education + training

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Required human subjects training

All study personnel must complete online ethics training prior to engaging in human research. Training, provided by CITI Program, is valid for 3 years.
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Final Friday Ethics Hour

Join HRPP on Zoom at 11:30 a.m. on the final Friday of each month. These informal sessions on current topics are open to all KU-Lawrence human subjects researchers.

Collaborative research

Does your human subjects research project involve study personnel outside of KU?

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  • If your study team includes members from another institution with an HRPP, your project may require an institutional agreement to document the IRB responsible for overseeing the research.
  • If you will have study team members outside of KU who are not subject to oversight of an HRPP, they will be asked to sign an Individual Investigator Agreement to abide by the KU-Lawrence human subjects program.

Please note

  • Another institution's HRPP approval, alone, does not provide documentation of HRPP oversight for KU researchers.

Download infographic

Access the information on this webpage in infographic form. Choose from the digital version of HRPP Basics with links to related web content or HRPP Basics for Printing, which includes a QR code that leads to the HRPP website.

Visual preview of HRPP Basics infographic.