For years we have called the change/renewal/termination language as modification/continuation/summary. I think it is just a local custom that was in place before the official language and we have just not changed language. But the intent and process is identical.
Annette Annette Kujawski Taylor, Ph. D. Professor, Psychological Sciences University of San Diego 5998 Alcala Park San Diego, CA 92110 [email protected]<mailto:[email protected]> ________________________________ From: [email protected] [[email protected]] Sent: Wednesday, October 06, 2010 5:14 PM To: Teaching in the Psychological Sciences (TIPS) Subject: Re: [tips] IRB Question A distinction should be made between truly anonymous data, that is, data that are irreversibly unlinked to the individual Ss, and de-identified data, which are data that are no longer linked to individual Ss but that could be linked to Ss in some way through, for example, the existence of a list of names with accompanying codes with which Ss' response sheets are identified. I believe that your IRB is concerned with the latter type of data. It seems to me that the analysis, reanalysis, or even the torturing of truly anonymous data until they finally confess to some statistically significant effect does not represent human subjects research. Miguel ----- Original Message ----- From: "Blaine Peden" <[email protected]> To: "Teaching in the Psychological Sciences (TIPS)" <[email protected]> Sent: Wednesday, October 6, 2010 7:47:48 PM Subject: Re: [tips] IRB Question Annette's comments are interesting so I checked our IRB website (see below): http://www.uwec.edu/ORSP/IRB/guide/submit.htm We do not have "a summary report" document and IRB Form V says Project Status Form - Change/Renewal/Termination It appears to me as if there is no sensible alternative like the one Annette enjoys (data collection done, other work possible). The only choice seems to be renew or not do any work on the project!? In this case, we have no intent to collect further data (the student collaborator graduated), but to be prohibited from any further analysis or presentation is extreme. Blaine ------- What to submit to IRB Please follow the instructions provided to prepare and submit your proposal of research to the IRB. You will find links to the needed forms on the provided pages. A complete application for the IRB review and approval will contain the following: 1.. Request for Review of Human Subject Research (IRB Form I) 2.. Checklist for Exempt/Expedited Review 3.. Summary Sheet for Protection of Human Subjects (IRB Form II) 4.. Proposal Description Form (IRB Form III) 5.. Cover Letter 6.. Informed Consent Document 7.. Proposed survey, questionnaire, or interview questions (if applicable) Change/Renewal/Termination UW-Eau Claire policy requires all principal investigators to notify the IRB immediately of any changes to an approved human subjects protocol. In addition, principal investigators must complete a Project Status Form (IRB Form V) at least once per year following initial project approval. ----- Original Message ----- From: "Annette Taylor" <[email protected]> To: "Teaching in the Psychological Sciences (TIPS)" <[email protected]> Sent: Wednesday, October 06, 2010 4:28 PM Subject: RE: [tips] IRB Question I also thought this made no sense but here is the response from our IRB administrator to whom I posed this question: (and I did not ask his permission to pass on this information but "assume" that since it's in a public email to me it is now up to me to decide what I do with it) =================================== "IRBs are required to review all active research projects at least annually. The situation in question appears to be what happens when a researcher fails to submit anything to the IRB before the year is up, i.e. if neither a summary report nor a continuation request is submitted, then what? In that case I would agree with the IRB chair that the study is automatically terminated and no further work on the study can be done. I thinks this is different that the situation where you have submitted a summary report indicating that the human subjects research part of the study is complete. In that case the study is not terminated but rather enters a phase of data analysis and publication that does not involve further interaction with human subjects, and which also follows whatever confidentiality/anonymity agreements the researcher made with the subjects." ===================================== I guess this makes sense if you consider that a study for which no paperwork is filed in a timely fashion violates and negates the original contract between the researcher and the IRB. Having said all of this. I have to say that our IRB is WONDERFUL! They work actively with researchers when they see something problematic and take the approach that their "job" is to teach researchers, as much as to oversee the protection of human subjects. Our turn-around times are phenomenally fast--sometimes less than 24 hours for expedited and exempt reviews. But, on the other hand, as you can see from the above, they do play by the rules. Annette Annette Kujawski Taylor, Ph. D. Professor, Psychological Sciences University of San Diego 5998 Alcala Park San Diego, CA 92110 [email protected] --- You are currently subscribed to tips as: [email protected]. To unsubscribe click here: http://fsulist.frostburg.edu/u?id=13150.302fb879d23a9f8b8b43c453fd3bfed3&n=T&l=tips&o=5442 or send a blank email to leave-5442-13150.302fb879d23a9f8b8b43c453fd3bf...@fsulist.frostburg.edu --- You are currently subscribed to tips as: [email protected]. 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