first_imgA damning report on how the University of Minnesota (UM) protects volunteers in its clinical trials concludes that researchers inadequately reviewed research studies across the university and need more training to better protect the most vulnerable subjects. It also found that a “climate of fear” existed in the Department of Psychiatry, where concerns about clinical trials first surfaced.The 97-page report, released 27 February, was prepared by a group of six experts appointed by the Association for the Accreditation of Human Research Protection Programs. It comes after years of complaints by some UM faculty members, led by bioethicist Carl Elliott. They charged that the school and its doctors failed to protect 27-year-old Dan Markingson, who died by suicide while enrolled in a psychiatric drug trial in 2004. They also expressed grave concerns about how Markingson’s death was investigated. (More on that case is here and here.)Recently, Elliott’s crusade began having an impact. In December 2013, the UM Faculty Senate called for an independent review of current practices in clinical trials. The administration agreed to open its records to outsiders. Although the review did not look back at history, it nonetheless had plenty to say about how the university handles trials, which bring in millions of dollars from drug companies along with much prestige.Sign up for our daily newsletterGet more great content like this delivered right to you!Country *AfghanistanAland IslandsAlbaniaAlgeriaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBolivia, Plurinational State ofBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCongo, The Democratic Republic of theCook IslandsCosta RicaCote D’IvoireCroatiaCubaCuraçaoCyprusCzech RepublicDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland Islands (Malvinas)Faroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and Mcdonald IslandsHoly See (Vatican City State)HondurasHong KongHungaryIcelandIndiaIndonesiaIran, Islamic Republic ofIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKorea, Democratic People’s Republic ofKorea, Republic ofKuwaitKyrgyzstanLao People’s Democratic RepublicLatviaLebanonLesothoLiberiaLibyan Arab JamahiriyaLiechtensteinLithuaniaLuxembourgMacaoMacedonia, The Former Yugoslav Republic ofMadagascarMalawiMalaysiaMaldivesMaliMaltaMartiniqueMauritaniaMauritiusMayotteMexicoMoldova, Republic ofMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorwayOmanPakistanPalestinianPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalQatarReunionRomaniaRussian FederationRWANDASaint Barthélemy Saint Helena, Ascension and Tristan da CunhaSaint Kitts and NevisSaint LuciaSaint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint Maarten (Dutch part)SlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyrian Arab RepublicTaiwanTajikistanTanzania, United Republic ofThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuela, Bolivarian Republic ofVietnamVirgin Islands, BritishWallis and FutunaWestern SaharaYemenZambiaZimbabweI also wish to receive emails from AAAS/Science and Science advertisers, including information on products, services and special offers which may include but are not limited to news, careers information & upcoming events.Required fields are included by an asterisk(*)“[T]he external review team believes the University has not taken an appropriately aggressive and informed approach to protecting subjects and regaining lost trust,” the authors write. They examined protocols from 20 active trials as well as minutes from meetings of the institutional review board (IRB). Many IRB members, the panel noted, did not regularly attend meetings from January to July 2014. “[T]here were no individuals on the IRB during this time period with expertise in adult hematology, oncology and transplant, cardiology, surgery, or neurology, although those fields taken together represented over 300 protocols. There was only one psychiatrist on the IRB, despite the fact that the Psychiatry Department submitted 85 protocols for review during the time period examined.” That doctor attended only four of the 26 medical IRB meetings at which new protocols were reviewed. “This departure not only contravenes the University’s own policy of having at least one member with ‘primary professional expertise in a scientific field relevant to the type of research reviewed by that panel,’ but also prompts concern about the quality of review.”Fueling those concerns, the authors noted that the IRB spent an average of 3 to 5 minutes discussing each protocol, and there was “little discussion of the risks and benefits to subjects.” Most of the protocol changes the IRB asked researchers to make addressed administrative issues such as misspellings or adding standard language to a consent form. Requests by researchers running trials to modify who was eligible for a study—“changes that may increase or decrease risks to subjects—were almost always approved without any documentation of related discussion,” the authors write. “The review process, as documented in the minutes, does not reflect a meaningful discussion of the risks and benefits of research protocols and the necessary steps taken to protect human subjects in the face of scientific or ethical concerns.”The outsiders made other observations. Although the university is in the process of enhancing training in basic human subjects protections for researchers, which the authors praised, they remained concerned that beyond basic instruction, “there are currently no human subjects protections training requirements for investigators, including those working with high-risk or vulnerable populations.”Along those lines, the authors touched on some of the central issues raised in the Markingson case: Dan Markingson agreed to enroll in a trial while committed involuntarily to the hospital, raising questions about his ability to consent, and the lead researcher on the trial was also his treating psychiatrist. Although vulnerable individuals like Markingson often participate in clinical trials, the authors of the review worried that Minnesota had not drawn lessons from that case. “We found only a single instance where consideration of the dual and potentially conflicting role of treating psychiatrist/investigator was addressed,” they noted. And, they added, “the external review team found no evidence that the University, Fairview [Hospital], and its investigators have taken steps to ensure a broader understanding of the implications of this very fraught situation” of enrolling patients who have been involuntarily committed into trials.A death during a clinical trial, possibly attributed to it, is every university’s nightmare. Elliott and a widening circle of others were harsh and relentless in their criticism, the reviewers acknowledge. The university’s response, they suggest, has been “assuming a defensive posture. In other words, in the context of nearly continuous negative attention, the University has not persuaded its critics (from within and outside the University) that it is interested in more than protecting its reputation and that it is instead open to feedback, able to acknowledge its errors, and will take responsibility for deficiencies and their consequences.” In the Department of Psychiatry, faculty and staff told the reviewers that they work in “a ‘culture of fear,’ ” and “[t]hey provided stories of intimidation by researchers and fear of retaliation should staff voice opposition to practices that were of concern.”As the report creates ripples across campus, the Faculty Senate is preparing to meet this Friday with University President Eric Kaler and the authors of the report. Kaler released a statement Friday thanking the outside reviewers for their advice. He stressed that they looked at a “small fraction of our clinical research enterprise,” involving individuals with diminished decision-making capacity. “[C]onsistent with our charge to them, the panel’s view and subsequent analysis was limited,” he noted. (The authors described their report as covering protection of human research participants at UM with “special attention” to adults who may lack decision-making capacity.)Kaler expressed hope that with the advice of the authors, UM could enhance its research protections. “The panel has provided us with a clear road map for making our program truly exceptional,” he wrote in his statement. “[T]he University of Minnesota has the opportunity to become a national model against which all other research institutions could be measured.” Senior administrators said in a statement that they hope to develop an “action plan” to respond to the report within 60 days.last_img read more

first_img Top Stories Football is made for masochists, the men who enjoy the taste of their own blood. It rewards oversized hearts and those who can’t imagine life without legalized violence. And if you’re hunting for talent that can’t be measured or denied, you start with small-school running backs.Like the Cardinals’ Chase Edmonds.“I’m built for the underdog role,” Edmonds said. “I’ve been playing the underdog role my whole life.” Fordham’s Chase Edmonds #22 runs the ball up the field against Holy Cross during an NCAA college football game, Saturday, Nov. 4, 2017, in Bronx, N.Y. Holy Cross won 42-20. (AP Photo/Steve Luciano) Former Cardinals kicker Phil Dawson retires Derrick Hall satisfied with D-backs’ buying and selling “Rightfully so, I believe,” he said. “This is one of the few times you’ll hear me sound proud of how far I’ve come. I like to be humble and keep my mouth shut, but when you get to sit back and realize you’ve finally accomplished a lifelong dream, with all the long days and sacrifices, and it’s finally come true … it’s something where I can actually sound proud.”The feeling won’t last long. Edmonds has reached the NFL, but he knows he hasn’t arrived. He’ll be carrying the football and a torch for all the other small-school running backs who endure the winding, anonymous path to professional football.For guys like him, the chip on his shoulder is more than a tired cliché. It’s the reason he’s here. And given the crapshoot nature of the NFL draft, it’s why players like Edmonds are a great bet.Reach Bickley at dbickley@bonneville.com.  Listen to Bickley & Marotta weekdays from 10 a.m. – 2 p.m. on 98.7 FM Arizona’s Sports Station. 20 Comments   Share   center_img The 5: Takeaways from the Coyotes’ introduction of Alex Meruelo Many rookies come to the NFL full of hopes and dreams, and they say all the right things. But something seems different about this kid. As a college football analyst, former Cardinals kicker Jay Feely immediately recognized Edmonds’ potential while covering a Fordham game, repeatedly texting Keim his full endorsement.“Some guys, their biggest mistake is trying to be something they’re not,” Edmonds said. “I’m just going to come in, shut my mouth, do my work and let the rest fall where it may. And that’s one thing I pride myself on.”Edmonds takes nothing for granted. When Fordham’s Joe Moorhead became a hot commodity in 2015, the impressionable running back decided to follow his head coach to his next destination. That ended when Moorhead became an assistant at Penn State, where Saquon Barkley was the established workhorse.He also interrogated former Fordham quarterbacks coach Joe Davis, who worked at Northern Iowa when Johnson was the resident star. Edmonds wanted to know everything about Johnson’s off-field activities, his practice habits, his leadership and his work ethic.“Anything he did, I tried to replicate,” Edmonds said.Edmonds, 22, also understands commitment and responsibility. He has a three-year old daughter who “changed my life.” His desire and ambition dwarf his talent, and he could be the biggest surprise to come out of the fourth round, a pick that has drawn rave reviews from many draft experts. Much has been made about Steve Keim’s stellar performance in the 2018 draft. The team wandered into a goldmine at a pivotal time in franchise history, plucking a franchise quarterback (Josh Rosen) and a homegrown wide receiver (Christian Kirk). But Edmonds is the sleeper of the bunch, a player who has all the intangibles and time-honored traits.Related LinksCardinals rookie Chase Edmonds: Small RB, big chip on shoulderWhen he was young, his father insisted he would one day wear a gold jacket, the piece of clothing that comes with Hall of Fame induction. He dreamed of playing college football in front of 70,000 fans, only to end up at Fordham, where his spirit couldn’t be suppressed.“Fordham is a school that is not known for football,” Edmonds said. “Teachers would always ask (students) what they want to do. You hear, ‘Wall Street.’ You hear, ‘Engineer.’ You hear all sorts of stuff. And when they heard me say the NFL, you’d get these (crazy) looks. It’s something that I brushed off and just kept working. I stayed the course.”Small-school running backs learn the hard way, away from the spotlight. They know what it feels like to be a star, even when toiling in obscurity. David Johnson, who starred at Northern Iowa, carried his football team and scrubbed toilets for $9 an hour, harboring a silent fury. The greatest of them all – Walter Payton – starred at Jackson State University, developing the need to run over every defensive player in his path. Unlike Alabama running backs who reach the NFL with significant wear on the tires, small-school running backs don’t absorb the physical pounding that comes with carrying the ball in the SEC or Big Ten. They find supreme validation when drafted by a professional franchise, but understand the burden of proof that follows them into the NFL.Edmonds is only 5-foot-9 and won’t run over opponents. But he has great vision and great skill. He rushed for over 1,600 yards in his first three seasons at Fordham and had a chance to set the FCS record for career rushing yards. He became obsessed with setting a new standard, and attempted to play through injuries as a senior rather than listening to his body.He failed to achieve that goal. Then he vowed to never let it happen again.“I don’t play this game to be second,” Edmonds said. “I try to be the hardest worker. That’s the first thing I’m going to do as a rookie to impress these vets, prove that my work ethic is second to none, even with a Hall of Famer like Larry Fitzgerald in that room.”Unlike Rosen, Edmonds isn’t brash or cocky. He says he’s going to keep his mouth shut when minicamp commences on Friday, allowing his actions tell his story. On paper, he appears to be the perfect complement to Johnson, whom Edmonds deeply admires. His temperament is perfect. Grace expects Greinke trade to have emotional impactlast_img read more