MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'irb'. Sat, 03 Sep 2011 02:22:25 +0100 http://www.medworm.com/index.php?rid=5050579&cid=t_155167_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fincreasing-government-oversight-of-irbs-could-help-prevent-seeding-trials%2F2011.07.21 I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go. Recall that in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements. Now, it has come to light that Parke Davis’ marketing department sponsored... Better Health blogs http://www.medworm.com/rss/comments.php?id=5050579 Thu, 21 Jul 2011 14:00:20 +0100 5050579 http://www.medworm.com/index.php?rid=4622503&cid=t_155167_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_nQ1_zS9Qoc%2F As we know, doctors who sign up as clinical trial investigators have certain responsbilities. These include, but are not limited to, protecting the rights, safety and welfare of participants; ensuring the control of drugs used in the trial, personally conducting the trial and supervising other activities. However, while certain tasks can be delegated, general responsibilities may not. But one doctor failed to follow through. To wit, he relied on a research nurse to carry out all sorts of things back in 2007. Such as? The nurse signed his name on protocol documents, including a financial disclosure form and two serious adverse event reports. Meanwhile, two of four subjects did not meet eligibility criteria. Yet, the doctor was apparently unaware until another research nurse told him. As the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4622503 Tue, 22 Mar 2011 21:12:28 +0100 4622503 http://www.medworm.com/index.php?rid=4455485&cid=t_155167_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJX184xjbHIA%2F In December 2009, the Anesthesia & Analgesia journal published a study by Joachim Boldt, a prominent German anesthesiologist, but a few readers raised questions about the data and, after some digging around by the editor, the article was retracted last October. Now, though, a state medical association in Germany, where the research was supposedly conducted, investigated a long list of studies attributed to Boldt and released some startling findings. To wit, Boldt failed to take a required step: there was no evidence that he obtained Institutional Review Board approval to conduct research for 92 articles - count ‘em, 92. As you might imagine, this suggests dozens more retractions may be in the offing and further reviews have been under way, according to this letter from the edito... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455485 Wed, 09 Feb 2011 13:17:42 +0100 4455485 http://www.medworm.com/index.php?rid=4429225&cid=t_155167_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0bIqSuEDX98%2F It seems to remain true that some people just can’t count. Take the folks at West Coast IVF Clinic in Beverly Hills. A corporate entitly that is connected to the operation, which endeavors to help couples conquer infertility, received a warning letter from the FDA for violating rules pertaining to Institutional Review Boards. And these were rather basic rules. To wit, federal law requires that IRBs have at least five members and one must be primarily concerned with so-called non-scientific matters (in other words, someone with a different background and mission). Also, no IRB member is allowed to participate in reviewing any project in which this person may have a conflict of interest. But an FDA inspection of the Napoli LLC, which is housed in the same Wilshire Boulevard location as... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4429225 Wed, 02 Feb 2011 15:02:40 +0100 4429225 http://www.medworm.com/index.php?rid=4406031&cid=t_155167_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSXdVGulP3Q4%2F Remember that sting operation in which the US Government Accountability Office conducted nearly two years ago of some Institutional Review Boards? The undercover operation involved creating a fictitious company, which then applied to three for-profit IRBs to approve a trial of a non-existent surgical adhesive gel. The episode made a splash, because one IRB - Coast IRB - actually approved the study, a gaffe that was discussed in detail at a Congressional hearing where the sting was revealed. Well, the FDA has issued an alert that some fictitious applications were submitted to several IRBs and the agency says it “appears” that the name and address of the clinical investigator listed on a required FDA form are the same as that used in the GAO sting. “The current and previous... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4406031 Thu, 27 Jan 2011 18:31:47 +0100 4406031 http://www.medworm.com/index.php?rid=4386275&cid=t_155167_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F01%2F22%2Ffda-duped-into-approving-fake-product-for-human-testing%2F When a drug or a vaccine is approved for testing on humans we naturally expect all the paperwork to be thoroughly checked. We assume that background checks have been made and the doctors involved will have had their credentials investigated. To ensure that this task is undertaken correctly the FDA use the skills of Institutional Review Boards. IRB’s are committees designated by an institution to approve, monitor, and review biomedical and behavioural research. They approve all of the vaccines and drugs for use in human trials. The IRB committees are made up typically of medics, persons from the criminal justice, education, physiology, and public health. The primary purpose of such a review is to assure the protection of the rights and welfare of the human subjects. IRBs are a quality... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4386275 Sat, 22 Jan 2011 08:57:12 +0100 4386275 http://www.medworm.com/index.php?rid=3965704&cid=t_155167_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0BKEg-uDqt0%2F Hello, everyone. Nice to see you again. We hope you enjoyed the weekend, which amounted to an extended break, in our case. In any event, the routine has now returned and, of course, we are brewing the mandatory cup of stimulation to help us along. Please join us with a cup of your own, or a water bottle, perhaps, we scan the news of the world. Have a great day and stay in touch… IRB Delays Frustrate Investigators (OutsourcingPharma) India Becomes A Hub For Counterfeit Meds (The Washington Post) Genzyme Sells Genetics Unit For $925M To LabCorp (Associated Press) An Eli Lilly Scout Discusses Social Media (140conf) AstraZeneca And UCL Sign Stem Cell Deal (The Guardian) Hopes Fade For Roche And Ipsen Diabetes Drug (Reuters) Mcgarrybowen Wins Creative Duties On Pfizer Advil Account (AdWee... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965704 Mon, 13 Sep 2010 11:56:12 +0100 3965704 http://www.medworm.com/index.php?rid=2674249&cid=t_155167_87_f&fid=34935&url=http%3A%2F%2Fmedicine.com.my%2Fwp%2F%3Fp%3D7604 Joke sent via my favorite Psycho, and kiddies, no this is not a real resuscitation manoeuvre A father walks into a restaurant with his young son.. He gives the young boy three 10 sen coins to play with to keep him occupied. Suddenly, the boy starts choking and going blue in the face .. The father realises the boy has swallowed the coins and starts slapping him on the back.. The boy coughs up 2 of the 10 sen coins but is still choking. Looking at his son, the father is panicking, shouting for help. A well dressed, attractive, and serious looking woman, in a blue business suit is sitting at a coffee bar reading a newspaper and sipping a cup of coffee. At the sound of the commotion, she looks up, puts her coffee cup down, neatly folds the newspaper, places it on the counter, gets up from her... Malaysian Medical Resources blogs http://www.medworm.com/rss/comments.php?id=2674249 Tue, 04 Aug 2009 23:00:00 +0100 2674249 http://www.medworm.com/index.php?rid=2306976&cid=t_155167_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F03%2Fsham-studies-and-commercial-irbs-that.html We have occasionally posted about the activities of for-profit contract research organizations (CROs). These are commercial entities that conduct human research, including clinical trials for pharmaceutical, biotechnology and device companies. More clinical research is being done by such CROs rather than by academic investigators. CROs seem to operate under the radar of most physicians, academics, and policy makers, but sometimes stories surface that raise questions about them.For example, we discussed the trials by SFBC International (now PharmaNet Development Group) in Miami that enrolled immigrants, often undocumented, under questionable circumstances and in Montreal that resulted in the transmission of active tuberculosis (see post here and links backward); and the trial by Parexel Int... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2306976 Tue, 31 Mar 2009 19:07:00 +0100 2306976 http://www.medworm.com/index.php?rid=1686211&cid=t_155167_109_f&fid=34752&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPsychsplash%2F%7E3%2F357499413%2F URL: http://www.citiprogram.org/default.asp?language=englishHello all, and welcome to my first posting here at PsychSplash! I hope to continue on the road that Dr. Gareth paved so well. My first inclusion in to the land of PsychSplash involves Human Research Subjects Training. As a Ph.D. Student who is almost finished with his proposal, I am working on the IRB as well, and this can be a daunting task sometimes to keep the principles of the human research participant combined with my own wanting to get the proposal done. To that end, I have found in my research the Collaborative Institutional Training Initiative, which helps keeps participants up-to-date on IRB and research training. For: Clinicians, Consumers, Researchers, Students, TeachersTopics: Clinical Psychology, Clinicial Trials, Me... PsychSplash blogs http://www.medworm.com/rss/comments.php?id=1686211 Wed, 06 Aug 2008 19:09:47 +0100 1686211 http://www.medworm.com/index.php?rid=1537884&cid=t_155167_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F06%2Fclinical-trials-torture-economy.html Two recent commentaries in major medical journals on the same topic failed to get the recognition they deserved. Both were about exploitation of the poor in clinical research, usually in Phase I drug trials conducted by contract research organizations (CROs), supervised by for-profit institutional review boards (IRBs), and both paid by pharmaceutical, biotechnology or device companies.The first article was by Carl Elliott and Roberto Abadie. [ Elliott C, Abadie R. Exploiting a research underclass in phase I clinical trials. N Engl J Med 2008; 358: 2316-7. Link here.] Per Elliott and Abadie, the context is:Over the past decade, clinical trials have moved from universities to private testing sites, the pressure to recruit subjects quickly has intensified, and ethical oversight has been outso... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1537884 Mon, 23 Jun 2008 19:26:00 +0100 1537884 http://www.medworm.com/index.php?rid=1220870&cid=t_155167_99_f&fid=35344&url=http%3A%2F%2Fzackarysholemberger.blogspot.com%2F2008%2F02%2Funintended-irb-humor.html From the directions to an IRB form I'm filling out:Describe potential benefit(s), if any, for subjects participating in the research. If there are no anticipated benefits, this should be stated. [Note: Payment to subjects is not considered to be a benefit of research (see Payment section below)].What is payment to subjects if not a benefit? (Shades of "Guinea-pigging.") (Source: Zackary Sholem Berger) Zackary Sholem Berger blogs http://www.medworm.com/rss/comments.php?id=1220870 Sun, 10 Feb 2008 15:51:00 +0100 1220870 http://www.medworm.com/index.php?rid=1003664&cid=t_155167_122_f&fid=35372&url=http%3A%2F%2Fsomatopsychic.blogspot.com%2F2007%2F10%2Finstitutional-review-board.html The Institutional Review Board (IRB) is charged with overseeing human subjects research , which is mandated by federal law. That is to say, if the university was to conduct research without IRB review we could lose all federal funding. The IRB is made up of other researchers here at the university that will review experimental proposals for ethical and other practical concerns. However there is an additional layer of review for my department however. We have a departmental review board that looks over everything before sending it to the IRB as sort of a stop-gap measure to make sure that we (as a department) only submit good proposals to the IRB. Recently I submitted a research proposal to this group, and while it is frustrating to be met with resistance, it is also very productive to get ... Somatopsychic blogs http://www.medworm.com/rss/comments.php?id=1003664 Wed, 24 Oct 2007 16:16:00 +0100 1003664