tag:blogger.com,1999:blog-48190883696519180612024-10-07T01:30:12.274-04:00AAHRPP AdvanceThe AAHRPP Advance aims to provide practical information on accreditation. Expect to see regular features on human research protection innovations, answers to frequently asked questions, and current news—research concerns in the behavioral and social sciences, or a profile of a smaller organization that has achieved accreditation. AAHRPP’s long-term vision is to improve human research protections throughout the research community. And education is an integral component of that vision.Unknownnoreply@blogger.comBlogger115125tag:blogger.com,1999:blog-4819088369651918061.post-87660145976435654632012-09-25T10:00:00.000-04:002012-09-25T10:00:09.468-04:00AAHRPP Launches New Website <!-- /* Font Definitions */ @font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:3 0 0 0 1 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin-top:0in; margin-right:0in; margin-bottom:Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-61745765569711941122012-09-19T10:00:00.000-04:002012-09-19T10:00:10.219-04:00AAHRPP Offers Educational WebinarIRB Review of Research Involving Adults With Diminished Capacity to Consent Almost every IRB deals with research involving participants with diminished capacity to consent, in projects that either directly study such populations or affect them incidentally. This webinar will describe the AAHRPP requirements for research involving participants with diminished capacity to consent, what Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-59720267924736629772012-09-13T10:00:00.000-04:002012-09-13T12:08:30.776-04:00Two More Earn AAHRPP Accreditation: Major Clinical Research Center in India and CRO in U.S.AAHRPP has accredited two more organizations, including a third institution in India and a second contract research organization (CRO). Please join us in congratulating the newly accredited organizations: Jehangir Clinical Development Centre Pvt. Ltd., Pune, India Celerion, Lincoln, Nebraska More information is available in this news release. Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-49431780804911297822012-09-10T10:00:00.000-04:002012-09-10T10:00:04.147-04:00 Strengthening Researchers’ Role in the HRPP One of the most significant improvements in the research enterprise is the now widespread acceptance that responsibility for protecting participants rests not just with the institutional review board (IRB) but with the organization as a whole—including its researchers. This shift in perspective is often attributed to AAHRPP’s emphasis on Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-68419881026243051702012-09-06T10:00:00.000-04:002012-09-06T10:00:07.035-04:00SAVE THE DATE: April 3-5, 2013, in Miami!2013 AAHRPP Conference – Quality Human Research Protection Programs Evidence-Based Practice in a Global Environment This conference will highlight evidence-based bioethics research and its practical application in human research protection programs. We will examine successful strategies and address the increasingly global nature of research. The pre-conference day will focus on the nuts and Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-50131954185905267682012-08-30T10:00:00.000-04:002012-08-30T10:00:09.688-04:00Tapping the Expertise of Legal CounselIn an increasingly complex research enterprise, it’s not unusual for human research protection programs (HRPPs) to look to legal counsel to help strengthen standard operating procedures (SOPs), interpret state law, and educate institutional review board (IRB) members and researchers about federal and state laws and regulations that pertain to research. Larger organizations can often turn to Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-85387775836988414302012-08-27T10:00:00.000-04:002012-08-27T10:00:11.152-04:00Conference in Bangalore, India: November 3-4, 2012AAHRPP is co-organizing with Manipal Hospitals and Pfizer a conference entitled Practical Solutions to Challenges in Research Ethics. The Manipal Hospitals are the first in India to achieve AAHRPP accreditation, and the focus of the conference is on strengthening human research protection programs, sharing solutions, and thinking about the challenges ahead. It is intended for hospitals, Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-61942599928681632142012-08-23T10:00:00.000-04:002012-08-23T10:00:03.439-04:00New draft guidance being distributed by the FDA for comment purposes:Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials (Revision 1) This guidance revises the draft guidance issued in September 2010 regarding the prospective assessment of suicidality in clinical trials. Comments and suggestions pertaining to this document should be submitted within 60 days of the notice announcing the availability of the draft guidance in theUnknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-65615918212310571622012-08-20T10:00:00.000-04:002012-08-20T10:00:00.237-04:00Succeeding at Community EngagementTwo organizations share their innovative approaches Organizations often tell us they’re unsure how best to meet AAHRPP requirements for community involvement. Two institutions—Rush University Medical Center and the University of New Mexico Health Sciences Center (UNM HSC)—achieve this standard by tapping into community networks, drawing on researchers’ connections, and reaching out to Unknownnoreply@blogger.com1Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-12781031122587920962012-08-16T10:00:00.000-04:002012-08-16T10:00:10.583-04:00Registration Has Begun for the 2012 Advancing Ethical Research Conference in San DiegoDon’t forget to register for the AER Conference on December 4, 5, and 6, 2012, in San Diego. Those of you considering AAHRPP accreditation or already in the application process have an opportunity to take advantage of the “Accreditation of HRPPs Track.” Five highly practical workshops and didactic sessions will focus on various aspects of the accreditation process. For organizations that are Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-43435541538602445282012-08-13T10:00:00.000-04:002012-08-13T10:33:15.783-04:00Adaptive Clinical Trials: Scientific and Ethical Issues to ConsiderArticle of Note: Journal of the American Medical Association JAMA, June 13, 2012 – Vol. 307, No. 22 A recent issue of JAMA features two articles expressing viewpoints about adaptive trials in clinical research that may be of interest. An adaptive clinical trial is one in which key characteristics, such as randomization ratio, number of treatment arms, and number of interim analyses conducted, Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-49637327694570424232012-08-09T10:00:00.000-04:002012-08-09T10:00:07.542-04:00IRB Innovation: Streamlining Approvals Through Collaboration, RegionalizationAAHRPP Advance is an ideal forum for sharing innovative practices that have proved successful and can serve as a model for other research organizations. The following Advance post highlights the University of New Mexico Health Science Center’s (UNM HSC) institutional review board and its statewide and regional collaborations. UNM HSC has turned to collaboration—with community-based organizationsUnknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-58910914442778201382012-08-06T10:00:00.000-04:002012-08-06T10:00:03.564-04:00 Organizations Cite Positive Changes After Completing AAHRPP Process Organizations that complete the AAHRPP accreditation process say they see fundamental, positive changes throughout their human research protection programs (HRPPs) and across their institutions. Many of the changes, such as stronger research and standardized procedures, were expected. Others, such as a more Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-80572673836403295522012-08-02T10:00:00.000-04:002012-08-02T10:00:08.554-04:00Responding to GlobalizationA framework for protecting participants worldwide International markets are now home to more than half the world’s clinical trials, including 40 to 65 percent of studies investigating U.S. Food and Drug Administration (FDA)-regulated products. Bioethicists and others have expressed concerns that monitoring has not kept pace with global growth. At the same time, they recognize that the trend Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-38002386987699729172012-07-30T10:00:00.001-04:002012-07-30T10:00:02.396-04:00A Path to an Even More Effective Social-Behavioral and Educational Research ProgramCase Study: Utah State University AAHRPP Accredited Since 2009 The Situation Utah State University (USU) focuses its human research portfolio primarily on social-behavioral and educational research (SBER) and has one institutional review board (IRB). The university became interested in AAHRPP accreditation early on “because we thought it was the right thing to do,” says Russ Price, Federal Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-83953400765541656162012-07-26T10:00:00.001-04:002012-07-26T10:00:05.611-04:00Transforming the Research Review Process and Faculty PerceptionsCase Study: University of California, Los AngelesAAHRPP Accredited Since 2009 The Situation The University of California, Los Angeles (UCLA) has long been regarded as one of the nation’s top public research universities. Within the university, however, several years ago researchers developed a marked dissatisfaction with the institutional review board (IRB), which often was viewed as Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-8382392300961450842012-07-23T10:00:00.001-04:002012-07-23T10:00:03.382-04:00AAHRPP President and CEO Writes Commentary on Labeling IRB MembersIn the July 2012 issue of Academic Medicine, Marjorie Speers, President and CEO, AAHRPP, and Susan Rose, Executive Director, Office for the Protection of Research Subjects at the University of Southern California, wrote a commentary titled, “Labeling institutional review board (IRB) members does not lead to better protections for research participants.” They assert that the confusion about Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-90122581617407811652012-07-19T10:00:00.000-04:002012-07-19T10:00:00.334-04:00Network for Excellence in Neuroscience Clinical Trials—NeuroNext—Uses AAHRPP-Accredited Centralized IRBA recent NIH initiative expands capability for exploratory (phase II) trials of treatments for neurological diseases. The National Institute for Neurological Disorders recently made awards to 25 U.S. clinical sites, a clinical coordinating center, and a data coordinating center to build a “network of excellence” to speed the translation of advances in neuroscience research into clinical practice.Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-30522097587799060812012-07-16T10:00:00.000-04:002012-07-16T10:00:00.617-04:00AAHRPP Welcomes Summer Korean FellowsThe two-month fellowship is a collaborative effort of AAHRPP and the Korean Association of IRBs (KAIRB). The training program supports two fellows from the field of human research protection to work with staff at AAHRPP to learn how to build their own human research protection programs (HRPPs). Fellows will explore how to initiate quality improvement programs that enhance protections for Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-2583553274480350762012-07-12T10:00:00.000-04:002012-07-12T10:00:10.379-04:00Misconceptions About Payments to Research ParticipantsA recent article in Bioethics by Largent, Grady, Miller, and Wertheimer argues that IRB members’ concerns about payments to research subjects are based on conceptual or ethical misconceptions. As a result, unnecessary limits may be placed on payments to participants, hindering valuable research without ethical cause. The authors report on the first national survey of IRB members and HRPP Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-61872146931628171282012-07-09T10:00:00.000-04:002012-07-09T10:00:10.812-04:00Using AAHRPP Accreditation to Guide Expansion Case Study: Schulman Associates Institutional Review Board AAHRPP Accredited Since 2008 The Situation Schulman Associates Institutional Review Board (IRB) had built a reputation as one of the nation’s leading independent IRBs. For decades, the Ohio-based company was known primarily as a reviewer of multicenter phase 2 and phase 3 clinical trials. In 2009, Schulman decided to branch out Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-124077715591250562012-07-05T10:00:00.000-04:002012-07-05T12:27:56.691-04:00Article of Note: How Closely Do Institutional Review Boards Follow the Common Rule?In a recent article appearing in Academic Medicine, Lidz and Applebaum, et al., describe how closely institutional review board discussions reflect the criteria for approval of research specified in the federal regulations to protect human research subjects (45 CFR 46). The authors observed, audio-recorded, transcribed, and coded protocol reviews from 20 IRB meetings at 10 leading academic Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-32956437591704514332012-07-02T10:00:00.001-04:002012-07-05T12:03:39.608-04:00From De Minimis to Gold Standard Case Study: Lehigh Valley Health Network Accredited Since 2009 The Situation Lehigh Valley Health Network routinely oversees approximately 400 research protocols. Most involve Phase 3 clinical trials designed to provide patients with treatment alternatives for chronic or life-threatening conditions. Back when Lehigh Valley Health Network began looking at accreditation, the Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-16715549994596918902012-06-28T10:00:00.000-04:002012-06-28T10:00:01.333-04:00 &nbsp;&nbsp;&nbsp; Accreditation Then and Now When we issued the first AAHRPP-accreditation standards, our goal was to strengthen human research protections and, in the process, improve the quality of research. A decade later, AAHRPP has succeeded beyond expectations. Equally important, with support from AAHRPP-accredited organizations around the globe, we continue to find new ways to Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373tag:blogger.com,1999:blog-4819088369651918061.post-32288112929446155712012-06-25T10:00:00.000-04:002012-06-25T10:00:02.233-04:00New 2011 Metrics Data PublishedPromoting continuous quality improvement of human research protection programs (HRPPs) is a top priority for AAHRPP. From data supplied by client organizations in 2011, AAHRPP has compiled an information database to help research organizations, research sponsors, and government agencies identify and support high-quality practices for their HRPPs. These benchmarking “metrics,” as they have become Unknownnoreply@blogger.com0Washington, DC, USA38.8951118 -77.036365838.7962463 -77.1942943 38.993977300000005 -76.8784373