tag:blogger.com,1999:blog-5841910768079015534.post443353209525748857..comments2024-03-29T05:00:28.897+00:00Comments on BishopBlog: The expansion of research regulators: an evolutionary perspectivedeevybeehttp://www.blogger.com/profile/15118040887173718391noreply@blogger.comBlogger17125tag:blogger.com,1999:blog-5841910768079015534.post-54607343862428514192018-03-28T10:06:52.006+01:002018-03-28T10:06:52.006+01:00Not sufficient. Need to consider other outcomes, e...Not sufficient. Need to consider other outcomes, esp those arising because research is just not done - and in some cases people leave the field altogether. Hard to quantify.Dorothy Bishophttps://www.blogger.com/profile/00981443081362703179noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-35743008800535223362018-03-28T09:41:45.500+01:002018-03-28T09:41:45.500+01:00Uncertainty - So we need to conduct a randomised c...Uncertainty - So we need to conduct a randomised controlled trial: regulation vs no regulation with an end point of incidence of research harm Hugh Davies - a regulator!!!!http://www.reviewingresearch.comnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-59784106408746462582015-09-01T05:35:57.617+01:002015-09-01T05:35:57.617+01:00Love it! Thank you so much for sharing this one v...Love it! Thank you so much for sharing this one very helpful and peaceful info share by blogger, Love it Thanks again. - <a href="http://www.epharma-global.com/courses/good-clinical-practice.html" rel="nofollow">good clinical practice training</a><br />Anonymoushttps://www.blogger.com/profile/09611586000008536957noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-5745443498266136232014-09-08T09:43:02.766+01:002014-09-08T09:43:02.766+01:00I would like to use this blog as a discussion open...I would like to use this blog as a discussion opener with students and fellow researchers at UCL if you are happy with that.<br />we all know that every country has its own regulations, laws and <a href="http://www.thegreenbook.com/products/regulators/" rel="nofollow"> Regulators </a> bodies or agencies governing the manufacturing, sales, marketing and distribution of products within the country.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-30098370247269903052012-06-06T04:55:43.337+01:002012-06-06T04:55:43.337+01:00This is just a quick note of thanks for all your s...This is just a quick note of thanks for all your support here to i-dealzone.com It's been a challenging year for many, however we've manage well and we could not have achieved that without our wonderful customers just like you.wordpresshttp://www.istockdiary.com/coupons/istockphoto-coupon-code/noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-21078578432260956232011-11-15T11:27:09.990+00:002011-11-15T11:27:09.990+00:00I meant Hobbes of courseI meant Hobbes of courseAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-39738831441806983732011-11-15T11:26:16.333+00:002011-11-15T11:26:16.333+00:00Just found this excellent post which mirrors ny ow...Just found this excellent post which mirrors ny own brain-numbing experiences of NHS ethics and R&D. One could boil it down to a contrast between the philosophies of Hobbes and Locke. <br /><br />Hobbes: People are inherently bad and need tight regulation to prevent them doing ill<br /><br />Locke: People perform best if trusted, given resources and left to their own devices.<br /><br />Clearly Locke has won this celebrity deathmatch!Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-48075684016169832592011-08-14T09:17:48.154+01:002011-08-14T09:17:48.154+01:00I'm currently suffering through the excruciati...I'm currently suffering through the excruciating process of NHS ethics approval, with additional complications that I'm performing UCL research in a GSK laboratory. This is my first time encountering this kind of bureaucracy and I've just been astonished at how long it's taken - I'm 9 months in and still haven't submitted to a REC yet. Horrendous. Thankfully I've found things to do for most of this time, but conceivably I could have been twiddling my thumbs for the last year or so - a stupendous and criminal waste of time.M. Wall (@m_wall)http://computingforpsychologists.wordpress.com/noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-73666074796224514762011-06-02T05:36:19.981+01:002011-06-02T05:36:19.981+01:00I am interested about the book of Rebecca Skloot’s...I am interested about the book of Rebecca Skloot’s book, ‘The Immortal Life of Henrietta Lacks’ and Dominic Streatfeild’s. That there are terrible examples of studies where research participants were infected, hurt or humiliated without realising what was happening or giving their consent. I am excited to read this book..NotCathyhttp://www.asseenontvlife.com/supplements-enhancers/procera-avh-memory-enhancer-review-complaint.htmlnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-6309791224737841032011-04-09T11:10:00.723+01:002011-04-09T11:10:00.723+01:00Every country has its own regulations, laws and re...Every country has its own regulations, laws and regulatory bodies or agencies governing the manufacturing, sales, marketing and distribution of products within the country.plumbing supplieshttp://www.bes.co.uknoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-50344748648754862982011-04-01T12:59:19.937+01:002011-04-01T12:59:19.937+01:00This is a wonderful summary Dorothy! I have been i...This is a wonderful summary Dorothy! I have been increasingly frustrated with people's apparent confusion between deciding what is ethical and anticipating every possible undesired outcome (no matter how low the probability). <br /><br />A gem from one ethics committee meeting I attended to discuss my research: a committee member queried whether I should be allowed to conduct the study as I could not be sure of my findings in advance...<br /><br />I would like to use this blog as a discussion opener with students and fellow researchers at UCL if you are happy with that.Essi Vidinghttp://www.ucl.ac.uk/psychlangsci/staff/cehp-staff/e_vidingnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-54504126753115655182011-03-31T06:38:15.183+01:002011-03-31T06:38:15.183+01:00I was very pleased to hear that the UK government ...I was very pleased to hear that the UK government has responded positively to the report by Academy of Medical Sciences, and life may improve for researchers as a consequence, see budget statement:<br />http://www.acmedsci.ac.uk/index.php?pid=118&pressid=78<br />TGGP: many thanks for pointing me to those sources. Lovely thing about blogging is getting put in touch with other relevant views you'd not normally come across. Yeah!deevybeehttps://www.blogger.com/profile/15118040887173718391noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-50943245696304304032011-03-31T02:59:13.581+01:002011-03-31T02:59:13.581+01:00Sounds like Robert Higg's "ratchet effect...Sounds like Robert Higg's "ratchet effect" from "Crisis & Leviathan".<br /><br />You might want to check out Robin Hanson's post <a href="http://www.overcomingbias.com/2011/03/against-irbs.html" rel="nofollow">Against IRBs</a>.TGGPhttps://www.blogger.com/profile/11017651009634767649noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-31069616710609783632011-03-29T12:20:31.406+01:002011-03-29T12:20:31.406+01:00Brilliant analysis! Thanks for sharing this.Brilliant analysis! Thanks for sharing this.Guillaume Nicoulaudhttps://www.blogger.com/profile/18327218552388699334noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-65217970288599108172011-03-23T15:39:48.590+00:002011-03-23T15:39:48.590+00:00This mirrors some common grumbles with regards to ...This mirrors some common grumbles with regards to regulators for animal research as well - I suppose we're all in the same (slowly sinking) boat in that sense. I suppose there's a chance you'll find discussion of animal research on here inappropriate - feel free to remove the following if so...<br /><br />There are some interesting differences and similarities with regards to your evolutionary principles: <br /><br />1. Our increasing regulation is not, imho, driven by catastrophe, but rather a slow drip of protest and objection to the approach. We therefore don't have the majority public clamour for regulation that arose after Shipman etc, and actually the public attitude (as displayed in numerous surveys) is more like "do the work if it's necessary, avoid suffering where possible, and don't tell us about it: we like the proceeds but don't want to hear about the methods".<br /><br />2. I think you actually argued that regulators do have a form of predation - they have to continue to justify their existence to budget hawks. This, I find, has an interesting effect on the regulators. They feel that they have to continue to shift the boundaries, increasing the requirements and regulations, almost as if they need to be seen to be doing something. <br /><br />The effect is that there never seems to exist a status quo in which you are doing your experiments with best possible practice and all possible precautions - every time you refine successfully, they seek the next refinement. Refinement in animal work is a process that has to have a logical endpoint - you can't do experiments with a monkey if he's in a forest in Malaysia - but there is never a question of agreeing an endpoint at which the regulators will be happy that the best possible is being done, and so if standards are maintained, the research can continue unencumbered by further changes. My view before I left was that the regulation in the UK was getting close to the move from pushing changes that are positive for the animals (btw many refinements of the last 20 years are excellent, there is no doubt) to ones that are neutral for the animals but obstructive to the researchers. More recent changes seemed to be only driven by the need to continue to make researchers refine.<br /><br />3. I don't have an equivalent of this effect, but I do note that the presence of the UK system appears to have heavily influenced the Europe-wide changes that are going to arrive in the next few years. <br /><br />4. Solutions: In animal research we have a sort of driving licence - the Home Office issues personal licences to researchers after completion of a course and exam. I suppose it is possible that this saves us some of the burden you have described. We also have numerous (and often spurious) attempts to apply cost-benefit-like structures to the research. I'm afraid it doesn't seem to reduce the rate at which regulation increases.Charlie Wilson @crewilsonnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-83463753835594696082011-03-21T13:44:21.490+00:002011-03-21T13:44:21.490+00:00Captures all my recent frustrations with the proce...Captures all my recent frustrations with the process, thank you. It took me some time to realise how stupid I had been when I entered into the 'Integrated Research Application System' and thought it meant it was integrating things to make it easier for me. Doh, it wasn't for my benefit. And it wasn't integrated. <br />A few pointers from a recent REC panel have been helpful, and the administrator did her best to help me in the paperwork madness - but you're right, these things do not make up for the sheer frustration and time it all takes. It ends up being a more ethical issue that patients don't get the results of research more speedily. <br />I also was suddenly told by the local R&D that I had to have a GCP certificate, but then wasn't allowed to access GCP training because my study wasn't part of a portfolio. It was pure Kafka (and I've only got through this stage by the help of a different R&D person who's understood something about the 'spirit' of the law as opposed to abiding by the 'letter').<br />It's been a while since I directly did research in the NHS myself and it gave me even more admiration for our students who plough on through all of this - it might just have put me off doing more again (but I hope not).Helen Jonesnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-70379006006374323342011-03-20T17:02:30.215+00:002011-03-20T17:02:30.215+00:00Dorothy – this is an excellent analysis of a probl...Dorothy – this is an excellent analysis of a problem that has become far more than just an irritation. I’d like to pick up on a point concerning clinical trials, not least because this is a journey on which I too am about to embark. At a meeting of scientists and clinicians at our Institute, one of the clinicians described a recent discussion with a pharma company who wanted to know whether they could set up a small trial of a licensed drug within six weeks. For licensed drugs the paperwork can be processed relatively quickly, but in the UK that probably means 6 months, and 9 months is more realistic. Needless to say, the drug company chose to conduct the clinical trial elsewhere. <br /><br />This excessive regulation associated with conducting trials in the UK has been cited as contributing to the decision of Pfizer to close its Sandwich plant. I don’t know whether it was a factor in the Novartis closure, but these days most clinical trials in the UK are small Phase I/II trials undertaken by academics such as us who generally lack the funds and capacity to consider alternatives overseas. As you mention, the Academy of Medical Sciences has been pushing for change, and a few days ago Andrew Miller MP, who chairs the Commons Science and Technology Committee, wrote to David Willetts on the subject of the Pfizer closure. Willetts is due to respond publicly this week on government strategy with regard to the UK pharma industry, and it will be interesting to see if he has anything to say on clinical trials.<br /><br />I would certainly have thought that the regulations could be simplified without endangering the lives of patients or trial volunteers, and I like your suggestion that something akin to a driving test might be used to ensure that scientists/clinicians properly understand the ethics of studies involving patients. One would hope that a more pragmatic approach, together with the threats that already exist of prosecution and a custodial sentence for investigators who fail to abide by the rules, would lead to a more sensible alignment of the level of risk with the level of regulation.Stephen Mosshttps://www.blogger.com/profile/05546277450594524992noreply@blogger.com