Policy and Guidance
This page provides links to some of the most frequently referenced policies and guidance from the HRPP and the Health Sciences IRBs.
All UW-Madison IRBs follow policies and guidance established by the campus Human Research Protection Program (HRPP). Each IRB also has its own policies and guidance to address specific issues its investigators encounter. For a complete list of HRPP policy and guidance documents please use the Index of HRPP and IRB Policies and Procedures.
The version date listed is the date of the most recent update to the guidance document. The tracked changes PDF will be the previously approved guidance document with the new updates tracked for convenience. Only the most recent tracked change guidance document will be available—previous versions will be archived within the HS-IRBs office, and may be available by request.
Submission Type Guidance
Confirm IRB Application Submission
Document | Version Date | Tracked Changes |
Guidance on Research vs. Quality Improvement and Program Evaluation | 16-Sept-13 | N/A |
Application Type Guidance | 1-Jan-10 | N/A |
Exemption Review Guidance
Document | Version Date | Tracked Changes |
Exempt Review: Process Overview | 3-Nov-11 | N/A |
Exemption Guidance | 24-Jan-19 | N/A |
Guidance on Exemption Categories under the Revised Common Rule | 23-Jan-19 | N/A |
Guidance on Exemption: Not Human Subjects Research | 3-Aug-11 | N/A |
Do I need to get consent for my exempt study? | 24-Jan-19 | N/A |
Can changes of protocol be submitted for exemptions? | 03-Apr-18 | N/A |
Agreement for the Use of Coded Specimens | N/A | N/A |
Initial Review Guidance
Document | Version Date | Tracked Changes |
Initial Review of Convened IRB: Process Overview | 10-Apr-12 | N/A |
Initial Review of Expedited Procedures: Process Overview | 3-Nov-11 | N/A |
What Happens After a New Application Is Submitted to the Health Sciences or Minimal Risk IRB: IRB Administrative Review and IRB Pre-Review | 25-Jun-14 | 1-Apr-12 |
Emergency, One-Time-Use | 30-Nov-11 | N/A |
Protocol Development Activities (PDA) Guidance | 14-Jun-11 | N/A |
Protocol Guidance | 24-Jul-08 | N/A |
Training Grant, Umbrella Grant or Core Grant | 3-Aug-11 | N/A |
Scientific Review Requirement | 21-Feb-14 | 20-Sep-08 |
What Happens After an Application Is Submitted to the Health Sciences or Minimal Risk IRB: Scientific Review | 1-Apr-12 | N/A |
Guidance Regarding Types of Supporting Materials that Require IRB Review and Approval | 19-Nov-12 | N/A |
Change of Protocol Guidance
Document | Version Date | Tracked Changes |
Change of Protocol: Process Overview | 10-Apr-12 | N/A |
Changes to Eliminate Immediate Hazards to Subjects Guidance | 1-Jan-13 | 1-Jun-07 |
Guidance on Presenting Changes of Protocol to IRB | 29-Nov-11 | N/A |
Expedited Change of Protocol Guidance | 1-Dec-12 | 21-Jan-08 |
Personnel Change Guidance | 1-Mar-15 | 24-Jul-13 |
Timeframe for Submission of Changes of Protocol to the IRB | 1-Jan-13 | 17-Jul-12 |
Guidance on Making Editorial Changes to Recruitment Materials | 10-Oct-19 | N/A |
Continuing Review Guidance
Document | Version Date | Tracked Changes |
Continuing Review: Process Overview | 16-Jan-14 | N/A |
Continuing Review: UW-Madison Purview Enrollment Guidance | 23-Oct-13 | 1-Jan-10 |
Reportable Event Guidance
Document | Version Date | Tracked Changes |
Reporting Requirements for Studies Involving Investigational Devices | 29-Apr-10 | N/A |
Reporting Requirements for Studies Involving Other Investigational Agents, including Investigational Drugs | 7-March-17 | 20-Sep-10 |
Health Sciences IRBs Protocol Exceptions and Deviations Guidance | 1-Feb-11 | N/A |
Guidance on Presenting Noncompliance Reports to the IRB | 27-March-17 | N/A |
Other
Document | Version Date | Tracked Changes |
Protocol Closure Guidance | 10-Oct-05 | N/A |
Guidance for the Submission of Investigator's Drug Brochures (IDBs) | 28-Aug-13 | 1-Jan-13 |
Review Process Guidance
Document | Version Date | Tracked Changes |
Guidance for Analysis Centers | 24-Aug-10 | N/A |
Case Reports and Case Series Guidance | 23-Jan-07 | N/A |
Guidance on the Five Year Renewal Policy and Replacement Studies in ARROW | 21-Jul-11 | N/A |
Review Processes for Funding: Congruency Update | 25-Jul-19 | N/A |
Policies
For a complete list of HRPP policy and guidance documents please use the Index of HRPP and IRB Policies and Procedures.
Document | Version Date | Tracked Changes |
Control of Test Articles Used in Research Policy | 16-Jun-11 | N/A |
Emergency Use of Test Articles and of Humanitarian Use Devices Policy | 7-Aug-15 | N/A |
Humanitarian Use Device Policy | 7-Aug-15 | N/A |
Review of FDA-Regulated Research Policy | 5-Oct-15 | N/A |
VA Research: Health Sciences IRBs Policy for IRB Review of Human Subjects Research that Falls Under VA Purview | 7-Aug-15 | N/A |