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  • Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy

    Abstract Full Text
    JAMA. 2017; 317(20):2061-2062. doi: 10.1001/jama.2017.4624

    This Viewpoint describes measures needed for an effective NIH policy in which a single IRB would work with multiple local IRBs to ensure protection of participants in multisite trials.

  • Characteristics and Dissemination of Phase 1 Trials Approved by a UK Regional Office in 2012

    Abstract Full Text
    free access
    JAMA. 2017; 317(17):1799-1801. doi: 10.1001/jama.2017.1471

    This study describes characteristics of phase 1 trials, frequency of harms, and communication between investigators and research ethics committees about adverse events to characterize the safety and improve the regulatory review of UK phase 1 trials.

  • Ensuring Respect for Human Research Participants: Institutional Review Boards and Sharing Results From Research

    Abstract Full Text
    JAMA. 2016; 316(11):1149-1150. doi: 10.1001/jama.2016.7970

    This Viewpoint proposes that institutional review boards play a larger role in ensuring timely public reporting of clinical trial results, with the goals of promoting medical innovation, reducing publication bias, and maximizing the value of clinical trials.

  • Digital Multimedia: A New Approach for Informed Consent?

    Abstract Full Text
    JAMA. 2015; 313(5):463-464. doi: 10.1001/jama.2014.17122

    This Viewpoint discusses use of digital multimedia as a strategy to enhance study participants’ understanding of research information.

  • International Research Ethics Education

    Abstract Full Text
    JAMA. 2015; 313(5):461-462. doi: 10.1001/jama.2015.203

    This Viewpoint discusses the challenges of building research ethics capacity in low- and middle-income countries, reviewing the developments since 2000 and the vision for future research ethics education.

  • Research on Peer Review and Biomedical Publication: Furthering the Quest to Improve the Quality of Reporting

    Abstract Full Text
    free access
    JAMA. 2014; 311(10):1019-1020. doi: 10.1001/jama.2014.1362
  • Prevalence, Characteristics, and Publication of Discontinued Randomized Trials

    Abstract Full Text
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    JAMA. 2014; 311(10):1045-1052. doi: 10.1001/jama.2014.1361
  • JAMA September 11, 2013

    Figure 1: Participant Enrollment

    IRB indicates institutional review board; PC, primary care; PCP, primary care practitioners; PI, principal investigator; R&D, research and development.aNonphysician participants included 7 registered nurses, 4 nurse practitioners, 4 registered nurse case managers, 1 physician assistant, and 1 pharmacist.bNonphysician participants included 10 licensed practical nurses, 9 registered nurses, 3 medical support assistants, 2 registered nurse care coordinators, and 1 pharmacist.cNonphysician participant.dTwo additional nonphysicians left the practice-level incentives group during the intervention. One new nonphysician was enrolled.eSeven nonphysicians left the physician- and practice-level incentives group during the intervention. Two new nonphysicians were enrolled.fOnly data from physicians were used to assess both physician-level and practice-level performances; each physician participant received ≥2 instances of the intervention.
  • JAMA May 22, 2013

    Figure: Study Flow for REMIT Trial

    LVEF indicates left ventricular ejection fraction; MSIMI, mental stress−induced myocardial ischemia; REMIT, Responses of Mental Stress Induced Myocardial Ischemia to Escitalopram Treatment. aLack of interest (n = 529); living too far away (n = 75); lack of approval of primary care clinician or study principal investigator because of medical comorbid conditions (n = 457); other (incorrect contact information, use of coumadin) (n = 127); awaiting telephone screening (n = 239); currently taking antidepressants that could not be discontinued (n = 91); would be contacted later because of recent procedures or patient preference (n = 127); awaiting approval of primary care clinicians (n = 322); attempted but failed to contact (eg, left message, no answer, or both) (n = 327). bInitial exclusion criterion that was eliminated rapidly via institutional review board approval.
  • Community Research Partnerships: Underappreciated Challenges, Unrealized Opportunities

    Abstract Full Text
    JAMA. 2013; 309(6):555-556. doi: 10.1001/jama.2012.108937
  • Protecting Research Participants While Reducing Regulatory Burdens

    Abstract Full Text
    JAMA. 2011; 306(20):2260-2261. doi: 10.1001/jama.2011.1727
  • How to Enroll Participants in Research Ethically

    Abstract Full Text
    JAMA. 2011; 305(15):1587-1588. doi: 10.1001/jama.2011.421
  • Do IRBs Protect Human Research Participants?

    Abstract Full Text
    JAMA. 2010; 304(10):1122-1123. doi: 10.1001/jama.2010.1304
  • Strengthening Institutional Review Board Review of Highly Innovative Interventions in Clinical Trials

    Abstract Full Text
    JAMA. 2009; 302(24):2697-2698. doi: 10.1001/jama.2009.1917
  • Parent-Investigators: A Dilemma

    Abstract Full Text
    JAMA. 2009; 301(20):2159-2161. doi: 10.1001/jama.2009.728
  • IRB Oversight Questioned

    Abstract Full Text
    JAMA. 2009; 301(18):1868-1868. doi: 10.1001/jama.2009.604
  • Companies’ Use of Web to Recruit Patients for Studies Brings Opportunities, Risks

    Abstract Full Text
    JAMA. 2008; 299(23):2733-2734. doi: 10.1001/jama.299.23.2733
  • Responses of Medical Schools to Institutional Conflicts of Interest

    Abstract Full Text
    free access
    JAMA. 2008; 299(6):665-671. doi: 10.1001/jama.299.6.665
  • JAMA November 28, 2007

    Figure 2: Patient Flow Diagram

    Percutaneous coronary intervention (PCI) hospital patient population derived from National Registry of Myocardial Infarction database of all patients with ST-segment elevation myocardial infarction during 3-month time frames preintervention and postintervention. Non-PCI hospital population is overlapping but distinct and is derived from a separate nonlinked database using abbreviated consistent forms and definitions including approximately 10 consecutive patients per hospital preintervention and postintervention. A stipulation of the institutional review board for collecting data was removal of identifiers that would allow linkage.
  • JAMA November 14, 2007

    Figure: Percentage of Respondents Indicating the Proportion of Institutional Review Board Applications on Which the Privacy Rule Had a Positive or Negative Influence on Human Subjects Protection

    Six hundred three (53%) respondents thought that in 0% of institutional review board (IRB) applications the implementation of Health Insurance Portability and Accountability Act (HIPAA) would have a positive effect on protection of human subjects. In comparison, 438 (39%) thought that in 0% of IRB applications HIPAA implementation would have a negative effect on protection of human subjects. One hundred nineteen (11%) respondents thought that in at least 75% of IRB applications HIPAA implementation would have a positive effect on protection of human subjects. In comparison, 185 (17%) thought that in at least 75% of IRB applications HIPAA implementation would have a negative effect on protection of human subjects. A total of 346 respondents answered “don't know.”