Hi all, We have a former student wanting to work on a research study with our faculty under a non-affiliated capacity (i.e., not representing her current employer). She is not currently enrolled or employed by us. Do you allow this? What things might I need to consider if we allow this. Thanks! megankroth mkr15a@acu.edu

If an HSR application is classified as 'exempt', is an informed consent form required?

This is an anonymous post. Please reply to the list. ----------------------------------------------------------- Institution 1 develops a registry to monitor how a certain disease is affected by a second disease that is circulating in the population. Clinicians at other institutions send HIPAA-de-identified data from their patients’ medical records to the registry. The information they send is labeled only with a code. The code allows the clinicians to update the status of their patients in the registry, but the registry cannot link the code to the patients’ identifying information. The clinicians do not participate in the analyses of the data that is sent to the registry. Assume the registry is a systematic investigation designed to develop on contribute to generalizable knowledge. What is the appropriate consideration for the institutions’ IRBs that send only de-identified data to the registry? 1) Are the institutions that send de-identified information to the registry engaged in the research? OHRP guidance says they would not be engaged if they only send identifiable private information to the registry (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html) 2) Is the research that is done with the de-identified information sent to the registry, research with human subjects? The researchers at the registry are not obtaining information about living persons through an interaction or intervention, nor are they obtaining identifiable private information about them. 3) Is the research exempt? 4) Is the research non-exempt research with human subjects? Thank you. -----------------------------------------------------------

Does anyone have an IRB member and/or IRB Chair evaluation or self-evaluation form/survey they would be willing to share as an example? Thanks!

I have posted many opinions over the years and have spent considerable time writing and re-writing and, nevertheless, I have posted messages with massive typos, errors, and just plain backward reasoning. Usually, I recognize this right after pushing send. Jon has been wonderful about responding when I sent a help message or, better yet, sending back a little message saying something like, do you really want to say this?” Thank you Jon! Shortly after it started, I discovered MCWIRB (Medical College of Wisconsin IRB) moderated by Skip Nelson. I have thought many times and have said publicly that I think that forum which mutated to this one has been the single best thing to happen for the IRB world. The percentage of IRB people who can afford to go to PRIM&R annually or even once is a small sample of the IRB world. For many this may have been their only affordable learning opportunity. There are thousands of people lurking on here who have never posted but who are learning from each other. We, who do post, have our opinions and all of us are not always correct. Fortunately, it is a forum and there are enough of us discussing (fighting?) that everyone can see that there is a lot of opportunity to forge answers that are both ethically and regulatorily defensible - and to have some fun doing it. So, a very big thank you to Skip and Jon for their many years as superb moderators and a big thank you to all who have supported the conversations over these many years.

The Associate General Counsel at my hospital asked me if I could post the below at IRB Forum as he's looking for feedback, especially from those in New York State: I am co-chair of the Committee on Medical Research and Biotechnology of the NYS Bar Association. We are looking at the application of NYS Civil Rights Law Section 79-l (regarding consents to genetic testing). The original statute was written in the 1990’s and genomic technology and sciences have advanced significantly since then. Our understanding is that most academic medical centers find the application of 79-L challenging for various reasons. Our Committee is looking to understand the difficulties IRBs are encountering in the implementation of 79-L, with an eye toward possibly suggesting statewide solutions. Question for IRB Forum Members: -Would you be able to tell me what issues you have been facing with the application of 79-L? -please respond to me a samservello.barmail@gmail.com Charles Castel charcas67@yahoo.com

Thank you for participating in the IRB Forum! On [b]December 10, 2020[/b], we will be moving the IRB Forum from its current platform (which is no longer supported) to our new PRIM&R Online Community platform. This new platform is better supported, more user friendly, and allows users greater control over their notification preferences and privacy settings. In the PRIM&R Online Community, we will also be able to build on current forums and networks to add new groups, giving users the choice to participate in additional topic-focused discussions. [b]What does this mean for accessing the IRB Forum?[/b] You can continue connecting with your peers in the research ethics and oversight field for free in the PRIM&R Online Community. To access the IRB Forum, starting December 10, you will log in to the PRIM&R Online Community with your PRIM&R account (the same account you use to register for PRIM&R events or renew your PRIM&R membership). If you need to reset your password or want to check if you have a PRIM&R account under a different email address, please use the "[url=https://my.primr.org/s/login/ForgotPassword]forgot your password?[/url]" option. If you do not have a PRIM&R account, you can create a new account [url=https://my.primr.org/PRIMR]here[/url] (it’s free). [b]You will receive a link to the new PRIM&R Online Community Platform and further instructions on how to access and participate in the IRB Forum on December 10[/b]. For your convenience, the old IRB Forum platform will remain live through at least January 10, 2021, though threads will be frozen as of December 9 at 5:00 PM ET. [b]There will be a file of all discussions prior to December 10, 2020 available on the new platform[/b], but you are also welcome to explore past posts and take screenshots of any specific discussions you’d like to save before the move. After January 10, we will retire the old forum site and redirect irbforum.org to the PRIM&R Online Community site. [b]Longtime IRB Forum moderator, Jon Merz, JD, PhD, MBA, will also be retiring from moderation of the IRB Forum[/b]. We thank Jon for 18 years of dedicated service and excellent stewardship of this forum. We are deeply grateful for the invaluable service he has provided to PRIM&R and the community and we hope you’ll join us in wishing him this best. We are excited to improve and expand on the valuable discussion from the IRB Forum in the new PRIM&R Online Community! If you have any questions about this transition or about the Online Community, please email community@primr.org. Thanks! Shana Sonbolian Senior Membership Coordinator - PRIM&R

From an e-mail from PRIM&R regarding the "New platform for IRB Forum": [quote]For your convenience, the old IRB Forum platform will remain live through at least January 10, 2021, though threads will be frozen as of December 10. During this time, we encourage you to explore past posts and take screenshots of any specific discussions you’d like to have for easy access.[/quote] Take screenshots? Funny. Why don't the powers that be just move the data from the old database into the new one so we all continue to have searchable access to the collective wisdom shared on this board over many years? Alan Stockdale astockdale@edc.org

Hi friends, looking for some input into how other sites prioritize their submissions and if anyone has guidance or a tool as an example of what parameters they use to move a particular submission to the top of their list. We have a fair amount of study teams who request that their submission get special treatment and receive "priority review" ahead of other submissions that have been in our system longer. Barring an emergent patient safetly issue - how do others decide if prioritization is warranted? We want to be fair to other investigators waiting who submitted first, while also being prudent about when to "bump" a submission to the top. Hope that makes sense. We would like to provide some written guidance on this, so looking for some inspiration. Thanks!!! ElleMartin MMartin@chw.org

I'm curious where others draw the line on this subcategory of Exempt research. Clearly, a spelling or math test would fall into this subcategory, but what about reaction time tests? Certain assessments of reading or math ability are timed to see the number of problems or words within a given time. Would a study testing time to recognize words broken into groups of nouns or verbs fall into educational tests within Exempt 2? If we allow reaction time to be measured in Exempt 2 studies as an education test, what about an Implicit Attitude Test—which measures reaction time and may be paired with demographic information? What about test of perception that rely on reaction time data? Is the distinction of an education test the purpose of the measurement, or the measurement methodology itself? Eye-tracking tests are being used to diagnose Autism (or at least being tested as a method of diagnosis)*. Would that permit eye-tracking studies—either during reading, if the purpose needs to be educational or of a scene, if strictly the methodology matters—to fall into the education test subcategory? Eye-tracking fits in Exempt 3 methods of video data collection, so it's not without precedent. I guess what I'm getting at is that Exempt 2 is incredibly powerful for surveys and interviews. You can ask whatever you want (depending on your IRB's interpretation of minimal risk) and as long as you either don't collect identifiers or pass the rigors of a limited review, and it can be Exempt. However, I can't seem to find much support that an IAT or reaction time test as falling into the Exempt 2 category. Those methods do not seem more risky that a survey asking personal questions that does not collect identifiers. If there is a treasure trove of documentation that I can be pointed to in support of this, I would greatly appreciate it. Same goes for personal opinion / practice :). *https://magazine.medlineplus.gov/article/eye-tracking-technology-holds-promise-for-earlier-autism-diagnosis davidcomalli david.comalli@temple.edu