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-19N/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

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

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

N/A
Vulnerable Populations Guidance 17-Jun-16

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

N/A



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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