PAU Faculty, students, staff &  affiliates MUST obtain IRB approval prior to engaging in research projects 

Instructions to Researchers

Does your research involve interaction with human subjects?

If you are unsure whether your research project constitutes human subjects research, please submit a Request for Human Subjects Research Determination (HSRD) xForm in IRB Manager. Once reviewed, you will be instructed on how to proceed and whether the Initial Submission for Human Subjects Research Review xForm is warranted. 

Only studies that involve intervention or interaction with living individuals about whom you will collect identifiable data require the completion of the Initial Submission for Human Subjects Research Review xForm. 

Please do not submit both forms until instructed on how best to proceed following HSRD submission.

Does your research qualify for Exempt or Expedited review?

The IRB will ultimately decide whether your study qualifies for Exempt or Expedited review. You may submit your "Initial Submission" xForm any time and your study will be reviewed on a rolling basis in the order received.  However, if your study does not meet criteria for Exempt or Expedited review, it will be reviewed by the PAU IRB full board in the upcoming meeting - see calendar schedule for further details. 

Please review the information in the links below regarding whether your study may meet criteria for Exempt or Expedited review.

Exemption Review Categories

• Exemption Decision Tree

Expedited Review Categories

PAU Students as Principal Investigators

PAU Students are allowed to submit research projects as the Principal Investigator. The student's faculty advisor identified on the IRB form will be responsible for the students research activities. 

Please note, the IRB must conduct a scientific review of all projects unless there is an external source of review (See our SOPs for more information). If you have a signed D5 form, that can count as an external review.

If there was a long delay between your D5 being signed and your Initial Submission xForm being filed, the IRB will reach out to your committee for verification that the current version of the project uses procedures consistent with sound research design, is sound enough to reasonably expect the research to answer its proposed question, and the knowledge expected to result from the research is sufficiently important to justify the risk.

Please refer to the APA guidelines here while developing study materials.

"Drawing" Language Requirement

Under the PAU's drawing policy, researchers are required to:

a. Use the term “drawing” rather than “lottery” or “raffle”

b. Provide a clear statement that any individual who contacts the researcher or who is contacted by the researcher is entitled to enter the “drawing”

c. State clearly how to enter into the “drawing”

Examples of how to update your materials can be found here

Please review the September IRB Newsletter and the updated SOPs.

Does your research involve the Gronowski Center?

Any research study planned at the Gronowski  Center, including use of existing data and/or recruitment of study subjects at the center, require clearance from the Research Directors. Please send all inquiries for research purposes at the Gronowski Center to:

Michael Richards, Ph.D. | Interim Director, The Gronowski Center

Email: mrichards@paloaltou.edu