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 'institutional review boards'. Sat, 03 Sep 2011 02:53:19 +0100 http://www.medworm.com/index.php?rid=4406031&cid=t_181794_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=3965704&cid=t_181794_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=3625773&cid=t_181794_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fs5ATp06PrMM%2F As part of its get-tough posture on patient safety and industry conduct, the FDA has issued a new guidance for disqualifying clinical trial investigators. The 10-page document, which the agency notes does not establish a “legally enforceable” set of responsbiliites, nonetheless, spells out the possible consequences for messing with a clinical trial. Basically, this reads like the primer it’s intended to be on agency thinking. Take a look to learn about disqualification proceedings, consent agreements and even the possibility of criminal prosecutions. Who should read this? Lots of folks - drugmakers, doctors and, of course, institutional review boards, which will likely have their hands full understanding regulations (see this). (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3625773 Thu, 03 Jun 2010 13:23:14 +0100 3625773 http://www.medworm.com/index.php?rid=3172203&cid=t_181794_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F79WEYfGWBKA%2F Another day, another deadline. But this is a busy world, after all. And what better way to prepare than to keep up with events. So, as you gird for the challenges ahead, here are a few items to help you along. As for us, we will reach for our usual cup of stimulation. Have a good day, everyone… FDA Issues New Guidance To IRBs On Multi-Site Trials (OutsourcingPharma) US Pharmacopeia Recalls New Edition Of USP-NF (statement) Glaxo Forms Global Media Team (PR Week) Blood Pressure Drugs May Cut Dementia Risk (Bloomberg News) Glaxo Sees Little Generic Threat To Advair (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3172203 Thu, 14 Jan 2010 12:01:24 +0100 3172203 http://www.medworm.com/index.php?rid=2584331&cid=t_181794_131_f&fid=35743&url=http%3A%2F%2Fthegenesherpa.blogspot.com%2F2009%2F07%2Fviva-la-revolucion-dtc-genomics.html Ok,I am not late to the party here on this one. I have been talking about this for quite some time with posts which include"We have No use for YOUR laws""Who Needs Institutional Review Boards""Steal Your Baby's Genome"I could go on and on here, but this is a natural move here.......23andSergey have decided to move the company into a space which is less likely to get them into hot water with the federal government and in fact may win them a few points with the Federales....Why? Everyone knows the end game here. A huge database of millions of phenotypes paired with millions of genotypes and millions of metabolomes and millions of demographics........With that you create the greatest query machine for human health, generate hypotheses from this and cure mankind of illness. That being said, wh... Gene Sherpas: Personalized Medicine and You blogs http://www.medworm.com/rss/comments.php?id=2584331 Wed, 08 Jul 2009 12:01:00 +0100 2584331 http://www.medworm.com/index.php?rid=2510428&cid=t_181794_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F06%2Fpracticing-clinical-trials-medicine.html Another story of dubious clinical research, this time reported by the St Petersburg (Florida, US) Times:Vladimir Martin called himself 'doctor' and ran 17 clinical trials of new drugs for major pharmaceutical companies before one patient noticed he didn't have a medical license.The patient alerted the St. Petersburg Times, whose resulting story led to a state investigation. On Saturday, Martin, 43, was arrested on charges of practicing medicine without a license. He was later released from the Pinellas County Jail on $10,000 bail. The felony charge carries a maximum sentence of five years in prison and maximum fine of $5,000.The Clearwater man, who changed his last name from Kossatchev after moving to Florida in 2003, went to medical school in the former Soviet Union and practiced in a hos... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2510428 Tue, 23 Jun 2009 18:50:00 +0100 2510428 http://www.medworm.com/index.php?rid=2306976&cid=t_181794_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=1834805&cid=t_181794_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F403964808%2F Members of institutional review boards (IRBs) that review protocols involving children may not have adequate understanding of pediatric research regulations, according to a pilot study by The Hastings Center, a nonpartisan, nonprofit bioethics research institute. The center evaluated 71 eligible IRB members, and 41 responded to five multiple choice questions. Most respondents considered themselves “well prepared” or “very well prepared” to perform common IRB tasks. However, the median knowledge score was one correct answer. Some other interesting revelations: 13, or 32 percent, replied that they did not have prior training in review of pediatric protocols. And 20, or 49 percent, responded that they did not have professional experience in child health or development.... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1834805 Fri, 26 Sep 2008 17:32:40 +0100 1834805 http://www.medworm.com/index.php?rid=1437096&cid=t_181794_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F288653659%2F The idea is to distinguish between adverse events and unanticipated problems in clinical trials, and to clarify when problems must be reported to institutional review boards, FDAnews reports. And after releasing the final guidance, the agency will “probably institute regulatory changes to make it clearer,” Jean Toth-Allen, a biophysicist with the FDA’s Good Clinical Practices Program, told the annual conference of the Association of Clinical Research Professionals, according to FDAnews. (Here is the draft guidance from last year). As you may know, a sponsor must report serious and unexpected adverse events to the FDA. While clinical investigators aren’t required to report adverse events that don’t fall into this category to the IRB, they must record all adverse events on ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1437096 Mon, 12 May 2008 12:29:10 +0100 1437096 http://www.medworm.com/index.php?rid=1432795&cid=t_181794_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F286818662%2F The FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards, marking the first FDA effort to issue regulations instead of guidances for clinical trials, FDANews reports. Existing FDA regs don’t take into account all the different types of organizations - vendors, co-investigators, site management organizations and contract research organizations - involved in conducting clinical trials, David Lepay, the agency’s senior advisor for clinical science, told the Association of Clinical Research Professionals annual conference, FDANews writes. What are some of the problems? Let’s start with the fact that FDA regs fail to account for electronic data issues, data standardization, electronic health records, electr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1432795 Fri, 09 May 2008 13:15:33 +0100 1432795