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.
If an HSR application is classified as 'exempt', is an informed consent form required?
Thank you! So good to know we are doing things correctly. I echo the importance of this forum for us newbies!
I think this depends on which exempt category. My read is that exemption 3, and of course 7 and 8, require consent. Exemption 4 expressly does not. We do require it as good practice for 1, 2 and 5, but they may apply for a waiver if applicable.
If exempt, then an IRB-approved consent form would not strictly be required for compliance with the Common Rule... however, exempt from the regulation does not mean exempt from good ethics and extant practices within a scientific field, and exemption should not be interpreted to mean that, as the President's Commission put it, express or implied consent is unnecessary for certain social sciences research. See President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Protecting Human Subjects: The Adequacy and Uniformity of Federal Rules and Their Implementation. Appendix D (December, 1981) (this was commentary provided by the Commission to DHHS on the 1979 draft rules -- what a decade later became the Common Rule).
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?
Here is my opinion.
3) Yes - NHSR (big exemption - these are not human subjects)
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?
Hi, Jessica -
We recently conducted self-assessment of our IRB with a tool from SMART IRB. I believe the tools are available to the public. It was a comprehensive 85 question assessment.
We just did something new this year - sent out a surveymonkey survey to our membership and asked them questions about how they felt their Chair was performing in a couple different areas, how the IRB staff support was, how they felt about our system upgrade... we used 1-5 star rating scales for the questions. Was good to get some data to support our evaluation, and also got nice comments and helpful feedback from the members. If interested I can send you a "preview" version.
Echoing Jessica's request. I know in the past these were circulated via email. If someone could forward the compilation, that would be a huge help.
Susan - I searched through the SMART IRB website and couldn't find the self-assessment. Could you provide the direct link?
My apologies as I incorrectly identified the authoring agency! We used the [url=https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-program-fundamentals/ohrp-self-assessment-tool/index.html]OHRP self-assessment tool[/url] available at
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 firstname.lastname@example.org
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 email@example.com.
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?
The email I received yesterday didn't mention anything about having access to the current forum archives after January 10 next year, and this morning as I was groggily waking up I was literally thinking of starting a forum post asking for everyone's favorite old threads/posts to try to get a relatively fresh archive of most popular/useful discussions.
My top post was going to be Jeff Cooper's wry comment in "[url=https://www.irbforum.org/read.php?3,58269]Exempt determination not good enough for a foundation?[/url]" from May 2015, prior even to the NPRM coming out:
I agree with Dean. The usual reason for this behavior is not reading the regulations. Many believe that research on novel educational strategies cannot be exempt #1, that survey research that collects sensitive information cannot be exempt #2, that retrospective chart review research that identifiers cannot be exempt #4, or that research that involves vulnerable populations cannot be exempt. These criteria come from oral tradition instead of reading the regulations. Do a Google on IRB exemption policies and see for yourself.
Many of the problems of \"regulatory burden\" raised in the OHRP ANPRM would be solved by following the regulations as they are written. There is a sad irony in the idea that this problem can be fixed by changing the regulations."]
Oh well, guess having easy access long-term will prevent us from collectively amassing our favorites and sharing them this week. No big loss.
I didn't even join IRB Forum until 2018, and I have found the archive enormously useful. So glad it will be continue to be accessible.
Jon, will you continue to be around and participate? I don't even know the amount of work you have put in here, but I for one have been both grateful for your minor edits of my posts and of others, and moreover for your ready contributions to these discussions!
thanks for the bon mots Dan.... i will be on the new list, but i will not have a moderator role... 18 years is enough. i should thank Skip Nelson for his innovation in starting the Forum, and for trusting me when he turned his baby over to me in early 2003. it's been a great run, and i've appreciated the educational aspects, the opportunity to help the community, and the chance to get to 'meet' everyone over the years. ;-)
the new list will not be moderated as was the Forum, though volunteer moderators will be available to deal with posts flagged as being problematic.
hi, as noted in the PRIMR email, there will be a downloadable flat text file of the entire Forum discussion content, which will be quite searchable.
file download will of course be subject to the confidentiality assurances (e.g., necessity for securing consent from any individual before quoting them from Forum content) of this list and the forthcoming PRIMR list...
Jon Merz Wrote:
> hi, as noted in the PRIMR email, there will be a
> downloadable flat text file of the entire Forum
> discussion content, which will be quite
> file download will of course be subject to the
> confidentiality assurances (e.g., necessity for
> securing consent from any individual before
> quoting them from Forum content) of this list and
> the forthcoming PRIMR list...
The e-mail I received didn't include any mention of a downloadable flat text file of the entire Forum archive. That would be good.
I second Dan's expression of gratitude for all the work you have put into maintaining this Forum over the years. The Forum has been an invaluable resource. Thanks.
The following was probably posted to the IRB Forum main page after Dan and Alan's posts here, but for anyone who missed it:
[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.[u]Past message threads from the IRB Forum will be preserved on the new platform in an IRB Forum Library[/u], 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."]
This (the threads being preserved) is good news. It has been an invaluable resource. Not having a dedicated moderator (and Jon Merz in particular) will be a loss, but forum contributions from you knowledgeable veterans will continue to be a useful source of information. Thank you all.
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!!!
We generally process first-come-first-served like everyone else, but we know things happen that require special handing. We give priority to Just In Time submissions, and we also gave priority to COVID-related submissions for the first few months of pandemic. We still give priority to any vaccine-related COVID submissions.
Beyond that, we know that mistakes happen and RUSH protocols come in for one reason or another. So if someone is about to lose funding because they didn't get the submission in on time or if someone won't graduate, then we try to work with them. We keep an eye on our frequent flyers for this, and sometimes have discussions outside of the emergency so that they understand the ramifications.
Also, sometimes it doesn't mean they are bumped to the "top". Sometimes it may mean that they are just bumped higher, depending on what we already have in the loop.
We don't have this entire process in writing because we don't want people to abuse it, but we do tell people what to do if they are dealing with a Just In Time review or a vaccine-related COVID protocol (we have an online submission system so we have them put "JIT" or "COVID" at the front of their title, so that we know by looking at the title that it is a rush). If we've spoken to them prior to submission, we'll have them put "RUSH" in the title.
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 :).
We generally tend to interpret it broadly, so studies primarily get pushed to expedited 7 if they involve children, focus groups, or interventions that don't fit under exempt 3. Curious how others interpret it.
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