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University of Wisconsin–Madison

For Researchers

This page provides investigators and personnel involved in human subjects research links to key guidance and resources for conducting research, from study initiation to study closure.

The first step is to develop a plan for how you want to conduct your research. In addition to the IRB application, this plan could include the creation of documents such as a protocol, consent form(s), study data collection instruments, and instructions (e.g. standard operating procedures).

Getting Started

ED/SBS IRB
Getting Started

HS/MR IRB
Information for New Investigators

Protocol Development

HS/MR IRB
Protocol Guidance

Other Links
ICTR Clinical Research Toolkit ("Before You Begin a Study" tab)
ICTR Protocol Development Office

Informed Consent Development

ED/SBS IRB
Informed Consent Guidance
Research with Minors Guidance

HS/MR IRB
Informed Consent Guidance
Informed Consent Templates
Informed Consent Model Language Samples
Vulnerable Populations Guidance 

Other Links
Informed Consent Requirements  (video)
Effective Consent Forms and the Process (video)
Strategies for Improving the Process (video)
OHRP: General Informed Consent Requirements (video)
Informed Consent Wizard
Combined Consent HIPAA Wizard
ICTR Clinical Research Toolkit (Before You Begin a Study tab)
Research with Vulnerable and Underrepresented Populations (panel discussion)

IRB Submission

ED/SBS IRB
Initial Review Application Help
Top Ten Tips
Checklist to Avoid Delays

HS/MR IRB
ARROW Initial Review Help
Protocol Guidance
Application Type Guidance

Other Links
Practical Regulatory Issues in Human Subjects Research (video)

The final step is initiating the IRB closure process and ensuring proper retention of study records.

Study Closure & Data Retention

ED/SBS IRB
Post Project Procedures & Data Retention Guidance
End of a Study Guidance

HS/MR IRB
Protocol Closure Guidance
How to Close Studies

Other Links
Campus Policy on Data Stewardship, Access, and Retention
Lab Close-Out Checklist
UW Archives and Record Management