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"Problems with IRB review of social science" section

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The "problem" of IRB review of behavioral and social science research is not necessarily a bad fit. The most common complaint from anthropologists (the discipline of ethnography) is that the IRB membership is too biomedically oriented, doesn't understand the method, and cannot provide appropriate review. At institutions where behavioral and social science research is common, there are usually IRBs that focus exclusively on reviewing such research. Both the Belmont Report and The Common Rule were intended to accomodate behavioral and social science research (evidenced by the Exemption categories and the Expedited review procedures).

The "problem" of IRB review tends to be with humanistic research (e.g., oral history), fields like journalism, and similar "gray area" activities (e.g., program evaluation in library sciences). From my experience, complaints in this area get voiced when someone in the humanities is employing some part of ethnographic methods without much knowledge of the ethics of the discipline they are borrowing from or the institutional requirement of ethical review. The regulations were not written with the humanities in mind, and it is often difficult to figure out how to handle projects that overlap the humanities and social sciences.

Aldmatthew 16:51, 20 February 2007 (UTC)[reply]


"Dual Use Research Review"

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It seems that there's not much here about the relatively recent moves to have IBCs engage in review and oversight of dual use research. Mention can be found in the NSABB's draft, http://www.biosecurityboard.gov/ and some criticism of IBCs for this purpose is articulated in a sunshine project report, http://www.sunshine-project.org/biodefense/tspibc.pdf

Also, there is a CRS article that goes through it: http://www.au.af.mil/au/awc/awcgate/crs/rl33342.pdf

Little busy now but unless someone knows of a better place for it I think this page might be the location where mention of this additional mission should go (if it is indeed to end up being the mission of IBCs)

Epthorn 20:04, 15 August 2007 (UTC)[reply]

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The links for the source [1] are broken.68.155.181.151 (talk) 23:12, 20 February 2009 (UTC)[reply]

Thanks; it should be fixed now. WhatamIdoing (talk) 23:39, 22 February 2009 (UTC)[reply]

US-centric

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This article needs to make it clear that the IRB contraption is English-language-centric, rarely found in other countries. --Piotr Konieczny aka Prokonsul Piotrus| reply here 10:42, 28 March 2014 (UTC)[reply]

Piotrus It is found in other countries but usually at the behest of English-language countries. The sad truth is that in most places all kinds of drugs get tested on people in unethical ways and the people just accept it, and if I could make an article on that then I would. I have worked for some years trying to establish these things in the developing world but so far as I know, very little is published about them anywhere. Even good information does not exist in English except. If I find information I will add it. I am actually going to one of the biggest conferences on this topic this weekend, and I plan to look for sources there. Blue Rasberry (talk) 13:12, 28 March 2014 (UTC)[reply]
It was my understanding that the US had IRBs because they were part of the Declaration of Helsinki, which many countries have incorporated into their national laws. If this is not the case, then I agree that the article should reflect that IRBs are primarily a US phenomenon. I will look for references this weekend. TechBear | Talk | Contributions 14:30, 28 March 2014 (UTC)[reply]
Their scope may be different. For example, in social science research, it has been my experience that IRBs are also required in the US, but not in some European and Asian countries, which if they have IRBs they limit their reach to biomedical/psychological research. --Piotr Konieczny aka Prokonsul Piotrus| reply here 05:15, 4 April 2014 (UTC)[reply]
Many countries do not do IRB for medical research. I got no leads at that conference because there is no industry publication about the lack of IRB oversight that I could find. I will keep looking. Blue Rasberry (talk) 12:01, 4 April 2014 (UTC)[reply]

The issues of international harmonization, lack of oversight, etc. are really important to address, to the extent that we can identify reliable sources to cite. For example, OHRP maintains a guide to international regulations - see [1]. But, as mentioned earlier, there's very little coverage of non-medical research studies. Also, the US DoD imposes additional requirements beyond the basic DHHS rules. I'll start work on adding some new material to the article on this type of stuff. jxm (talk) 18:23, 7 August 2014 (UTC)[reply]

That sounds great. Documenting what we do know is a great first step, even if it doesn't cover every single research area. WhatamIdoing (talk) 01:01, 8 August 2014 (UTC)[reply]

Several of the sections are just verbatim extracts from the CFRs. I'll try to trim them into summaries, and also add something about DoD-funded studies. After that, we can turn our attention to broader issues like the Menlo Report, international issues, etc. jxm (talk) 14:33, 8 August 2014 (UTC)[reply]

Managing citations

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This article seems likely to be rearranged a lot. Jxm, did you get all the information in these paragraphs you added from the sources you cited at the end of the paragraph? How would you feel about me putting citations at the end of every sentence? I feel that this article should have citations at the end of every sentence. Blue Rasberry (talk) 18:35, 18 August 2014 (UTC)[reply]

Tnx fr that, Bluerasberry. In those paragraphs, I simply added a few of the high-level full/expedited differentiators, which are defined in the cited CFR title/section. By all means, go ahead and include additional elements and cites if you wish. However, here are some thoughts we might want to consider....
For a start, I worry about delving down too far into the sub-section/paragraph levels, since it may become a maint nightmare every time the code is updated, and the more detail we add, the closer we get to simply replicating the regs anyway.
Also, as you probably already know, the basic IRB regs are re-cited all over the CFRs, since they apply (with some differences) to lots of US federal agency. I used Title 45 since it sets the Common Rule as the starting point for many (but certainly not all) US federal agencies. But the more detail we add here, the bigger chance there is that a specific guide or rqmnt is locally amended by some other authority. (Which in itself is probably a reminder that we should indeed mention that very issue.)
Finally, I believe that presenting too much detail will steer us back to an overly US-centric viewpoint, which was our original problem. On that topic, it might be useful to try and explain how some of these high-level guidelines (full/expedited, number of members, etc.) are dealt with in other jurisdictions.
Thoughts?? jxm (talk) 22:01, 18 August 2014 (UTC)[reply]
Jxm My initial concern was just in getting a citation after every sentence. Remember that paragraphs will be remixed and sentences moved around, so be mindful not to rely on a single citation at the end of a paragraph especially in medicine or law and especially not at this intersection of the two. See what I did. If you like that, then this point is settled.
This is already delving too far into the original source, per WP:PRIMARY. If another human has not already published a summary of this then Wikipedia should not be the first to say such things. Replicating the regs is fine, but that could be done on Wikisource and annotated there, although I know of no one who actually does this.
Changes to regulations would not matter if we instead cited someone's own explanation of this, rather than the primary source. These citations are only problematic because they are to the original source and taboo anyway.
I am not too concerned about an overly US perspective because even in the US no commentary is readily available on these regulations, and the US has much more developed regulations than anyone else. With nothing to say even about US regulations, I expect there is even less to say about those elsewhere. So far as I know, no one has written the introductory text book on these codes for the interested non-professional. I have looked a bit.
Thoughts? Blue Rasberry (talk) 13:33, 19 August 2014 (UTC)[reply]
Hi Bluerasberry. These added cites are fine with me, albeit rather taboo as you point out. But I think I'll try to do the same with a summary of the Exempt section anyway, at least as a placeholder for now. WRT other sources, an Amazon search for '"Common Rule" IRB' produces some potentially useful texts; it turns out that I may be able to get access to some of that material. More later! jxm (talk) 17:50, 19 August 2014 (UTC)[reply]

Inverted scope of the Common Rule

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I've raised a question about the inverted format of CR scope at Talk:Common Rule. Since the CR identifies activities that are excluded from full review, rather than included, it goes against the usual legal interpretation of "what is not forbidden is permitted". However, I'm having difficulty retrieving the ref I had for this concept. Just FYI.... jxm (talk) 23:22, 28 August 2014 (UTC)[reply]

Another article required for Independent Ethics Committee

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The function of IEC is a little bit different from that of IRB. Hence I feel that it is necessary to have a separate article on IECs. Thanks. --Abhijeet Safai (talk) 11:02, 25 September 2014 (UTC)[reply]

Are you referring to IECs that are established in other countries? As the Globalize tag notes, we're not yet providing a decent worldwide viewpoint. Perhaps you can help us by defining the functional differences in a new section here. It can be expanded into a separate article later, and we'll still need a summary paragraph on this page in any case. jxm (talk) 14:50, 25 September 2014 (UTC)[reply]
IEC can review outside projects. IRB cannot do so, by definition they are institute specific. In ICH GCP I6 R1 document, they use the term IRB/IEC. In India, we use the term IEC. I have not read any term as IRB in India. Somehow IEC is more famous in India it seems. So when IEC is redirected here, there can be confusion as if both are same. Thanks. --Abhijeet Safai (talk) 06:34, 18 October 2014 (UTC)[reply]
India is a special case in a lot of ways because it does not participate in very much international clinical research, especially considering the size of its population and economy. A lot of the terms and concepts in India seem to be different from those used internationally.
There can always be another article but the biggest problem is finding sources. It is difficult to find good sources to even describe what an IRB does, and finding documentation and commentary on bureaucracy and management in India is usually more difficult. If you find the sources, the IEC article can be made. What sources can you find? Blue Rasberry (talk) 11:27, 18 October 2014 (UTC)[reply]
Perhaps we can make a start by removing the also known as item from the intro, and expand an IEC description in the International section. IEC structures and procedures vary a lot by country, so I'd be wary about simply using India as a template; as was noted, India is a special case anyway. Incidentally, even in the US, IRBs are not necessarily institution-specific. As our Conflict of Interest section notes, some commercial IRBs are external guns-for-hire types of operations. jxm (talk) 14:17, 18 October 2014 (UTC)[reply]


Dear Bluerasberry, thanks for consideration of the idea. Even suggestion of Jxm, will also serve the purpose in my opinion. Here we can find many references for IEC. At least for now. You pointed out that India does not participate in much international clinical trials. If it can be substantiated by some reference, it can be put in the articles as well. Again I was thinking to have an article of 'Clinical Research in India' etc. If there is no much research, we can at least mention so in the article if we get sources. Thanks for reading. --Abhijeet Safai (talk) 09:45, 20 October 2014 (UTC)[reply]

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Retarget of Ethics committee page

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The ethics committee page used to be a redirect to here. It has now been converted into a dab page, largely, I think, as a result of the discussions here. I think this is a mistake as it leaves us without a target for when "ethics committees" are being discussed in general without reference to a specific country. While it is true that the IRB article is US-centric, the better solution would be to wait for it to be expanded to be more inclusive. Or else create a new ethics committee article that covers the topic in general. Putting a disambiguation at the ethics committee page leaves us with a bunch of disambiguation links that can't be fixed. SpinningSpark 15:03, 12 March 2016 (UTC)[reply]

I agree with this comment. The opening sentence already includes "also known as" phraseology, and attempting to keep this article as US-centric limits our opportunities to make a more global presentation. jxm (talk) 01:25, 16 March 2016 (UTC)[reply]
I've converted ethics committee from a dab into a short article with a worldwide perspective. This article can now be as US-centric as it likes. SpinningSpark 20:53, 23 November 2016 (UTC)[reply]

What just happened with the deletion, moves, merge, etc?

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Graham87 Can you say something about what you just did with Institutional Review Board and Institutional review board? Obviously there should only be one article and it should be lower case. Blue Rasberry (talk) 15:01, 18 July 2016 (UTC)[reply]

@Bluerasberry: I just history-merged both the article and its talk page. Graham87 04:12, 19 July 2016 (UTC)[reply]
Is that a sensible thing to do? If the histories overlap it will make a nonsense of the record. Many diffs will show changes that the editor did not make. It can look like a ferocious edit war that never really happened. SpinningSpark 16:33, 6 August 2016 (UTC)[reply]
@Graham87 and Spinningspark: When this happened I was not overly concerned but just wanted a note. Graham, do you remember the circumstances of what you did? Blue Rasberry (talk) 22:34, 23 November 2016 (UTC)[reply]
@Bluerasberry and Spinningspark: Not really, to be perfectly honest. But I try to avoid overlapping edits when doing history merges, wherever possible, and only include them when they're absolutely necessary. In this case, it looks like the overlapping edits in the article are the ones with between 700 and 900 bytes before 19:41, 13 December 2005 (UTC). There are no overlapping edits on the talk page. Graham87 04:45, 24 November 2016 (UTC)[reply]
When there have been two parallel articles that have been edited independently then, in my opinion, they should not be merged, regardless of whether they overlap or not. Separate histories is a true record of what actually happened whereas a merged history is highly misleading. SpinningSpark 06:46, 24 November 2016 (UTC)[reply]
@Spinningspark: I now remember thinking at the time I did the history merge that keeping the parallel histories where they were would be fine ... and I thought *I* was conservative about this issue. :-) I could do a history swap of the parallel versions out to somewhere like Institutional Review Board, or perhaps move them to a subpage of this talk page, but I'd prefer not to do the latter because I'd prefer to keep them in the main namespace. Please Ping me if you reply. Graham87 07:14, 24 November 2016 (UTC)[reply]
My memory of this was that in earlier Wikipedia, like before 2007, there were two articles. Wikipedia was such a mess then that I am willing to compromise a lot for that time. As I remember, two IRB articles were made but one with capitol letters. At some point one was redirected to the other, and then this recent merge was to put the history of that long-time buried redirect into the history of this one. I think this is an improvement because it is implausible that anyone could have found the history of a pre-2007 article behind a redirect, as Wikipedia as no way to signal that such content exists. I do not favor that history being put in an archive, as it is also implausible to expect anyone to find it there.
History merges are often messy but in this case, I think that the log of the earlier one ended before the time that the other one started and was developed, so the blip in the log now seems like at one point the early low-quality article was rewritten as a new better article. I think that is a fair way to describe what happened, even if in Wikipedia's technical infrastructure the article's history was actually posted in two places. I am happy with no further action for this article. In the longer term, I might wish for better technical tools for merges, but I am not sure that this comes up enough to be prioritized for attention. Cleaning this merge is unlikely to provide any useful insights that I can imagine for understanding either this topic or its history of development. I would talk this through more if anyone had further thoughts. Blue Rasberry (talk) 13:01, 24 November 2016 (UTC)[reply]

Instance of problem

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Spinningspark Just added a story about Coast IRB being busted for bad behavior. While I agree this story could have a place in Wikipedia, I am not sure that this article is the best long-term home for this information. I think it is fine for here now but it is undue weight for this article. I think I would prefer it to be in its own article, and for this article to link to it. The concept of an IRB is much bigger than that small story.

Thanks for adding the content. Blue Rasberry (talk) 22:36, 23 November 2016 (UTC)[reply]

I agree that all the details of the Coast IRB story would be undue weight for this article, but I do think that that the GAO test of the vulnerability of the IRB system is highly relevant, especially in the context of IRB conflict of interest which that section is discussing. My addition was (mostly) adding information on the IRB tests and their reasons for conducting them. Coast IRB was already discussed in the article, I am not responsible for putting that in. I would be happy if they were not mentioned by name at all The other, more effective, IRBs involved are not named (but could have been, the information is publicly available). That kind of puts a negative slant on it, leading to an apparent POV on Wikipedia's part. SpinningSpark 23:26, 23 November 2016 (UTC)[reply]
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