Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 9, 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.
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.
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:
Monday October 14th 11:00 - 12:30 PM (HSLC Room 2121)
Tuesday November 5th 3:00 - 4:30 PM (HSLC Room 2121)
Registration is required. Please email
Brooke Mechelke at firstname.lastname@example.org to reserve your spot in one of the future sessions. Space is
limited and the workshops fill up quickly.
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.
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:
Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.