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

Initial Review Guidance

Change of Protocol Guidance

Continuing Review Guidance

Reportable Event Guidance


Review Process Guidance


Special Considerations/Other

Document Version Date Tracked Changes
Adventitious Findings Language 29-Apr-10 N/A
Audio Recordings, Video Recordings, Photographs Guidance 1-Jan-10 N/A
Clinically Relevant Information and Reporting Guidance 4-Aug-11 N/A
Communicable Disease Guidance 17-July-17 N/A
Data Repository, Recruitment Registry, and Tissue Repository Guidance 3-Oct-16 N/A
Data Safety Monitoring Plans (DSMP) Guidance 3-Aug-11 N/A
Deception in Research Guidance 13-Oct-16 N/A
Devices Implanted or Applied to Subjects Guidance 4-Aug-11 N/A
Documenting Consent Electronically or for Remote Subjects Guidance 21-Sep-17 N/A
Email for Research Purposes Guidance 13-Feb-17 N/A
Endorsement and Approval of VA Research 1-Aug-11 N/A
Family Education Rights and Privacy Act (FERPA) Guidance 7-Dec-12 N/A
Gene Transfer Studies Guidance 12-Feb-14 16-Jun-11
Genetic Information and Nondiscrimination Act (GINA) Guidance 31-May-12 N/A
Guidance on FDA Regulation of Medical Mobile Apps 10-Jul-14 N/A
Guidance on Research Involving Focus Groups 10-Jul-14 N/A
Guidance Regarding Drug Shortages and Substitutions that Occur During the Conduct of Research Studies 16-Jul-12 N/A
Guidance Regarding Research that Involves the Collection of Information about Illegal Substance or Alcohol Abuse 14-Nov-12 N/A
Guidance on Requirements by the FDA for the Investigator as a Sponsor 14-Jun-11 N/A
Guidance for X-Ray Radiation Use in Research Studies for Non-Healing Arts Purposes 28-Jan-15 12-Nov-14
Guidelines for Genetic Research and the Use of Storable Tissues 16-Feb-98 N/A
HIV Testing in Research Guidance 17-July-17 N/A
Identifiability Guidance 11-Aug-16 N/A
Identification of Suicidality or Major Depression Guidance 4-Aug-11 N/A
International Research Guidance 15-Aug-10 N/A
Investigational Software Guidance 9-May-13 N/A
Key Personnel Guidance 3-Aug-11 N/A
MRIs and Pregnancy Status Guidance 20-Mar-09 N/A
Outline of the Endorsement Process 1-Aug-11 N/A
Pregnancy Testing in Minor Research Subjects 3-Aug-11 N/A
Re-Consenting Subjects Guidance 10-Oct-05 N/A
Requesting Student Records Information for Research 9-May-10 N/A
Scientific Review: UW Comprehensive Cancer Center (UWCCC) Protocol Review Monitoring Committee (PRMC) 1-Aug-11 N/A
Sending or Receiving Specimens/Data/Images Guidance 23-Mar-15 13-Dec-12
Decision Guide: Sharing Data, Samples, or Images with a Non-UW Site for Research Purposes 26-Nov-11 N/A
Stem Cell Logic Tree to Determine When SCRO Review Required (for research involving human embryonic stem cells or pluripotent stem cells) 24-Mar-10 N/A
Summary of Investigator Responsibilities 8-Nov-13 13-Mar-12
Telephone Recruitment and Screening Guidance 15-Jul-10 N/A
Understanding the NIH Genomic Data Sharing (GDS) Policy 09-Oct-17


Using Specimens/Information from Decedents: The Common Rule and FDA Regulations 19-Nov-12


Vulnerable Populations Guidance 17-Jun-16


Washout Period or Withholding/Postponing Standard Treatment Guidance 17-May-16


Keywords:submission type, special consideration, process guidance, HRPP, human research protection program, program evaluation, research, QI, QA, quality improvement, quality assurance, review flowchart, process overview, stem cell, washout, witholding, postponing, change, change of protocol   Doc ID:18837
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-06-14 18:00 CSTUpdated:2020-11-30 08:23 CST
Sites:Health Sciences IRBs
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