Tips of the Week

Did you know....
...that it is the policy of the Human Subjects Protection Program to investigate all complaints received regarding human subject research conducted under its jurisdiction?  [IRB Policy II.E]
Did you know...
...that the Director of the HSPP or designee must investigate all complaints received regarding human subjects in research under the University of Arizona jurisdiction.  The level of investigation will depend on the seriousness of the situation and the potential risk to participants?  [IRB Policy II.E]
Did you know...
...complaints can come from any category of research reviewed and may include anyone involved or not directly involved in the research process/study? [IRB Policy II.E]
Did you know...
...all complaints will be handled in a confidential manner.  This includes any individual involved in notifying the University of Arizona IRB of an alleged violation of investigator compliance? [IRB Policy II.E]
Did you know...
...complaints that are substantiated will be further investigated through a directed audit conducted by the HSPP staff, and actions will be taken as deemed appropriate by the IRB? [IRB Policy II.E]
Did you know...
...the HSPP houses a suggestion box on the website to voice any suggestions, concerns or complaints.  If any concerns are emergent in nature or are such that a participant may potentially be placed at risk, the suggestion box states to please call the HSPP directly at (520) 626-6721?  [IRB Policy II.E]
Did you know...

...that an amendment you submit may have to be reviewed by the convened Institutional Review Board (IRB)? [IRB Policy III.H]

Did you know...

...that the project you submit to the Human Subjects Protection Program (HSPP) may receive a review by the convened Institutional Review Board (IRB) more than once? [HSPP Policy III.B]

Did you know...

...that all activities that meet the definition of research with human subjects and that are conducted by students must be reviewed by the IRB? [HSPP Policy VI.A]

These activities include:

Did you know...

...that the IRB must review and approve the use of data collected for non-research purposes, if it will now be used in a research context? [HSPP Policy I.B]

If an Investigator begins a non-research project and later finds that the data gathered could contribute to generalizable knowledte, the Investigator must submit an application form to the IRB for review and approval prior to publication or presentation of the data (e.g., journal article, poster session, public speech, presentation, or report).

Did you know...
...that violations that increase risk or decrease benefit, affect the participant's rights, safety, welfare, and/or the integrity of the resultant data are to be reported as an adverse event and/or an unanticipated problem to the participant or others? [IRB Policy II.F]
Did you know...
...that when a sponsor requests that the IRB be notified of a violation, but it does not increase risk or decrease benefit, affect the participant's rights, safety, welfare, and/or affect the integrity of the resultant data, it can be reviewed under the expedited review process? [IRB Policy II.F]