Topics Map > Guidance
Information for New Investigators
This page has been created to help anyone new to the process of submitting an application to the University of Wisconsin-Madison Health Sciences Institutional Review Boards (IRBs). Included on this page are links to key guidance to help you determine if you need IRB review and what to do if you do, descriptions of the IRB review process, requirements for the conduct of human subjects research, help documents fore getting started with our online submission system (ARROW), and advice about what to include in an IRB application. The Health Sciences IRBs Office is here to help you navigate through the review process, so please do not hesitate to call, visit, or email us if you have questions or need assistance.
- Step 1--Determine if your project falls under the purview of an IRB
- Step 2--What to do if your project requires IRB review
- Step 3--What to do if your project requires review by the Health Sciences or Minimal Risk IRB
- Special Issues to Address
Step 1--Determine if your project falls under the purview of an IRB
- Not all projects involving research with or about human subjects require IRB review. Examples of projects that do not require IRB review:
- Quality assurance, quality improvement, or program evaluation projects that do not meet the regulatory definition of research
- Projects that meet the regulatory definition of research, but that do not involve human subjects
- Review the following guidance documents to help you make this decision (and call the HS-IRBs Office if you have questions):
Step 2--What to do if your project requires IRB review:
- Check whether the proposed Principal Investigator (PI) meets the campus requirements for serving as a PI
- Human Subjects Research Training (UW-Madison's training is through the CITI program)
- HIPAA Privacy Rule Training for Researchers
- What are the Human Subjects Research training (and other training) requirements?
- Health Sciences IRB
- Health Sciences Minimal Risk IRB
- Education and Social/Behavioral Science IRB
Step 3--What to do if your project requires review by the Health Sciences or Minimal Risk IRB:
- Develop a study summary or protocol
- Review the Scientific Review, Administrative Review, and Pre-Review Guidance
- What Happens After an Application Is Submitted to the Health Sciences or Minimal Risk IRB: Scientific Review
- What Happens After a New Application Is Submitted to the Health Sciences or Minimal Risk IRB: IRB Administrative Review and IRB Pre-Review
- Review the Process Overview Charts:
- Exempt Review: Process Overview
- Initial Review of Convened IRB: Process Overview
- Initial Review of Expedited Procedures: Process Overview
- Review Scientific Review Requirement and the Institute for Clinical Research Scientific Review Committee's website
- Review the powerpoint presentations at Training and Education
- See ARROW Guidance --this includes information such as the link to login to the system, videos regarding how to use the system, and FAQs about using the system
- Contact the ARROW Help Line if you have problems or questions using the system at 262-0041 or firstname.lastname@example.org
- See the Informed Consent and HIPAA Authorization guidance page, which includes consent, assent, and HIPAA templates, as well as institutionally required language.
- See the Subject Recruitment and Screening Procedures guidance page, which includes information about enrollment of vulnerable populations (e.g., children, individuals with impaired decision-making capacity) and recruitment methods
- See Completing the Subject Identification and Recruitment Section.
Special Issues to Address
- Multisite Research: If you are working with people outside of UW-Madison and they 1) do not have their own IRB or 2) you want the UW-Madison to serve as their IRB of record, additional requirements apply.
- Familiarize yourself with the Collaborative Research and IRB Reliance Basics page and information about Accessing ARROW and the NetID Process
- VA Research: If you are working with research that falls under the purview of the Madison VA hospital, familiarize yourself with with information of the VA Research - Overview.
- Special Considerations: Review IRB policies and guidance about special considerations
- See the Special Considerations guidance page, which includes information about adventitious findings, communicable disease testing, data safety monitoring plans, research involving genetic testing, pregnancy testing in minors, international research, sending and receiving specimens, images and data
- Questions About Your Application: After you have submitted your application to the HS or MR-IRB, call or email the staff reviewer assigned to your application if you have questions about your IRB application
- See HS IRBs Office: Contact Information for telephone numbers and emails of HS IRB and MR IRB staff
- Reportable Events: Familiarize yourself with the requirements for reporting non-compliance, adverse events, unanticipated problems and new information
- See the Adverse Event and Other Incident Reporting page
- Changes of Protocol and Continuing Reviews: Familiarize yourself with the continuing review and change of protocol requirements
- See Continuing Review & Changes of Protocol guidance