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 for getting started with our online submission system (ARROW), and advice about what to include in an IRB application. Our 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):
• Guidance on Research vs. Quality Improvement and Program Evaluation
• Elements of Quality Improvement vs. Research

Step 2--What to do if your project requires IRB review:

1. Check whether the proposed Principal Investigator (PI) meets the campus requirements for serving as a PI

• Who may serve as a principal investigator on a protocol?

Understand what your responsibilities are if you are a Principal Investigator

• Summary of Investigator Responsibilities

Take the required training

• [Link for document 34045 is unavailable at this time] (UW-Madison's training is through the CITI program)
• HIPAA Privacy Rule Training for Researchers
• [Link for document 22595 is unavailable at this time]

Determine which IRB is appropriate to review your project. UW-Madison has 3 IRBs, each with a different specialty:

• Health Sciences IRB
• Health Sciences Minimal Risk IRB
• Education and Social/Behavioral Science IRB

See IRB Purview, which describes the type of research each campus IRB reviews. If you are conducting industry-sponsored research, see information about the Western IRB.

Step 3--What to do if your project requires review by the Health Sciences or Minimal Risk IRB:

1. Develop a study summary or protocol

• Protocol Guidance
• Checklist for Investigator-Initiated Multisite Studies

The HS-IRBs Office offers free consultations with an IRB staff reviewer to provide researchers with expert assistance and advice regarding the IRB submission and review process. New investigators are strongly encouraged to schedule a consultation before submitting their first application to the HS or MR-IRB. To schedule a consultation, please fill out the request form available here: [Link for document 18204 is unavailable at this time].

Familiarize yourself with the submission process for IRB review. Some applications require scientific review prior to IRB review, such as oncology studies and more than minimal risk studies that do not undergo scientific evaluation otherwise. The Health Sciences IRBs conduct pre-reviews of applications by expert staff prior to scheduling a study for formal IRB review.

• 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 & Education

Familiarize yourself with how to use ARROW, the electronic protocol submission system the HS IRBs use

• See Health Sciences IRBs ARROW Help --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 Desk if you have problems or questions using the system at askarrow@hsirb.wisc.edu

Decide what application type in ARROW is appropriate for your application

• See Submission Type Guidance and Application Type Guidance

Familiarize yourself with the FAQs and the Policy and Guidance page the IRB has posted as you write your application

Review information about consent forms and HIPAA authorization

• See the Informed Consent guidance page, which includes consent, assent, and HIPAA templates, as well as institutionally required language.

Review information about subject recruitment

• See the Subject Recruitment and Screening Procedures Guidance Index 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 Single IRB Review page and information about [Link for document 16975 is unavailable at this time]
• 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 Events Requiring Reporting to the IRB 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