HS-IRBs News September 2013

Determining whether a project constitutes human subjects research rather than quality improvement or program evaluation involves multiple factors.  Furthermore, this is an important distinction to make because it determines whether IRB review and oversight of a project is needed since IRB oversight is limited to human subjects research. 

Often, IRB review of quality improvement and program evaluation projects isn’t required; however, formal IRB determinations that the projects do not require IRB oversight are requested in anticipation of such documentation being required for journals, conferences, funding sources and others.

To address these needs, the HS IRBs Office has updated previous guidance in order to assist study teams in determining whether a project requires submission to the IRB as a research project involving human subjects. In addition, to address the issue of documentation, the HS IRBs Office has developed a Research Decision Tool that can provide certification that the project does not require IRB review and oversight.  The new guidance materials are available on the Guidance on Research vs. Quality Improvement and Program Evaluation  page of the HS-IRBs' website.

If you have any questions regarding the guidance materials or use of the Research Decision Tool, please contact the Health Sciences IRBs Office at 263-2362 for assistance. 

Last IRB for Beginners Workshops for 2013

A few slots remain for the last IRB for Beginners workshops for 2013. These 90-minute workshops will be held in the HSLC computer lab and give participants a first-hand view of the resources available on the HS-IRBs website as well as basic tools and tips for the ARROW electronic application submission system.  The workshop will also introduce participants to the IRB’s review process and procedures.  This workshop is designed to help people who are new to the HS-IRBs review process. 

A few openings remain for the workshops scheduled for the following dates:

Registration is required. Please email Brooke Mechelke at bmechelke@medicine.wisc.edu to reserve your spot in one of the future sessions.  Space is limited and the workshops fill up quickly.

Coming Soon: HS-IRBs Education and Outreach Survey

To help the HS-IRBs office develop additional education and outreach opportunities for the research community, we will soon be sending out a short survey asking for your input. We will be seeking feedback on outreach services currently provided by the HS-IRBs office as well ideas for future educational opportunities. Please stay tuned for more details.

Revised Investigator's Drug Brochure (IDB) Guidance

The Guidance for the Submission of Investigator's Drug Brochures (IDBs) and Package Inserts has been revised to clarify when study teams must provide the IRB with an IDB versus a package insert. The revised guidance now includes a decision tree to help study teams to determine which type of document should be provided to the IRB for review. The revised guidance now explains the following:

• If a research study involves testing or evaluating a drug or drugs, an IDB should be provided to the IRB for any drugs for which an IND was issued at the time of initial review. Updates to these documents should be provided to the IRB as described below.
  
• For any drugs being tested or evaluated as part of the research that are FDA-approved, the study team should provide the IRB with package inserts rather than IDBs. Revised package inserts that contain information relevant to the research study should be provided to the IRB.  Revised package inserts can be submitted as a New Information Reports when no changes to the IRB application or other study materials are required. If updates to the IRB application or other materials are needed, the revised package insert should be submitted as a Change of Protocol.
• In some cases, IDBs are created for drugs under study even if the drugs are FDA-approved. IDBs are required to be provided to the IRB in these cases only if the study sponsor requires the study team to do so or there is substantive information in the IDB (e.g., efficacy and safety of the drug in the subject population for the study) that is not within other documents provided to the IRB.