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AJOB Empirical Bioethics

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https://www.readbyqxmd.com/read/30285561/reliance-agreements-and-single-irb-review-of-multisite-research-concerns-of-irb-members-and-staff
#1
Charles W Lidz, Ekaterina Pivovarova, Paul Appelbaum, Deborah F Stiles, Alexandra Murray, Robert L Klitzman
The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs...
October 4, 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/30248000/conflicts-of-interest-policies-for-authors-peer-reviewers-and-editors-of-bioethics-journals
#2
Zubin Master, Kelly Werner, Elise Smith, David B Resnik, Bryn Williams-Jones
BACKGROUND: In biomedical research, there have been numerous scandals highlighting conflicts of interest (COIs) leading to significant bias in judgment and questionable practices. Academic institutions, journals, and funding agencies have developed and enforced policies to mitigate issues related to COI, especially surrounding financial interests. After a case of editorial COI in a prominent bioethics journal, there is concern that the same level of oversight regarding COIs in the biomedical sciences may not apply to the field of bioethics...
September 24, 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/30240342/parents-attitudes-toward-consent-and-data-sharing-in-biobanks-a-multisite-experimental-survey
#3
Armand H Matheny Antommaria, Kyle B Brothers, John A Myers, Yana B Feygin, Sharon A Aufox, Murray H Brilliant, Pat Conway, Stephanie M Fullerton, Nanibaa' A Garrison, Carol R Horowitz, Gail P Jarvik, Rongling Li, Evette J Ludman, Catherine A McCarty, Jennifer B McCormick, Nathaniel D Mercaldo, Melanie F Myers, Saskia C Sanderson, Martha J Shrubsole, Jonathan S Schildcrout, Janet L Williams, Maureen E Smith, Ellen Wright Clayton, Ingrid A Holm
BACKGROUND: The factors influencing parents' willingness to enroll their children in biobanks are poorly understood. This study sought to assess parents' willingness to enroll their children, and their perceived benefits, concerns, and information needs under different consent and data-sharing scenarios, and to identify factors associated with willingness. METHODS: This large, experimental survey of patients at the 11 eMERGE Network sites used a disproportionate stratified sampling scheme to enrich the sample with historically underrepresented groups...
September 21, 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/30235076/freezing-fertility-or-freezing-false-hope-a-content-analysis-of-social-egg-freezing-in-u-s-print-media
#4
Lisa Campo-Engelstein, Rohia Aziz, Shilpa Darivemula, Jennifer Raffaele, Rajani Bhatia, Wendy M Parker
In 2012, the American Society for Reproductive Medicine (ASRM) lifted the experimental label on oocyte preservation, but cautioned against women using it to avoid age-related infertility, known as social egg freezing (SEF). In 2014, Facebook and Apple announced that they would offer SEF as a workplace benefit. Within the context of a rapidly growing market for SEF, we were interested in how these two decisions affected media discussions, given that such discourse can strongly influence public perceptions and behaviors...
September 20, 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/30160616/taking-societal-cost-into-clinical-consideration-u-s-physicians-views
#5
Alissa R Stavig, Hyo Jung Tak, John D Yoon, Farr A Curlin
BACKGROUND: Recent campaigns (e.g., the American Board of Internal Medicine Foundation's Choosing Wisely) reflect the increasing role that physicians are expected to have in stewarding health care resources. We examine whether physicians believe they should pay attention to societal costs or refuse requests for costly interventions with little chance of patient benefit. METHODS: We conducted a secondary analysis of data from a 2010 national survey of 2016 U.S...
August 30, 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29727598/moving-beyond-the-theoretical-medical-students-desire-for-practical-role-specific-ethics-training
#6
Shana D Stites, Justin Clapp, Stefanie Gallagher, Autumn Fiester
BACKGROUND: It has been widely reported that medical trainees experience situations with profound ethical implications during their clinical rotations. To address this, most U.S. medical schools include ethics curricula in their undergraduate programs. However, the contents of these curricula vary substantially. Our pilot study aimed to discover, from the students' perspective, how ethics pedagogy prepares medical students for clerkship and what gaps might remain. METHODS: This qualitative study organized focus groups of third- and fourth-year medical students...
May 4, 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29722609/-i-didn-t-have-anything-to-decide-i-wanted-to-help-my-kids-an-interview-based-study-of-consent-procedures-for-sampling-human-biological-material-for-genetic-research-in-rural-pakistan
#7
Nana Cecilie Halmsted Kongsholm, Jesper Lassen, Peter Sandøe
BACKGROUND: Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures, complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values underlying informed consent...
May 3, 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29847254/cross-cultural-perspectives-on-decision-making-regarding-noninvasive-prenatal-testing-a-comparative-study-of-lebanon-and-quebec
#8
Hazar Haidar, Meredith Vanstone, Anne-Marie Laberge, Gilles Bibeau, Labib Ghulmiyyah, Vardit Ravitsky
Noninvasive prenatal testing (NIPT), based on the detection of cell-free fetal DNA in maternal blood, has transformed the landscape of prenatal care by offering clinical benefits (noninvasive, high specificity and sensitivity, early detection of abnormalities) compared to existing prenatal screening tests. NIPT has expanded rapidly and is currently commercially available in most of the world. As NIPT spreads globally, culturally sensitive and ethically sound implementation will require policies that take into consideration the social and cultural context of prenatal testing decisions...
April 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29693508/to-report-or-not-to-report-exploring-healthy-volunteers-rationales-for-disclosing-adverse-events-in-phase-i-drug-trials
#9
Lisa McManus, Jill A Fisher
BACKGROUND: Phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants. Adverse events (AEs) are collected in part through participants' self-reports of any symptoms they experience during the trial. In some cases, experiencing AEs can result in trial participation being terminated. Because of the economic incentives underlying their motivation to participate, there is concern that healthy volunteers routinely fail to report AEs and thereby jeopardize the validity of the trial results...
April 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29630457/how-acceptable-is-paternalism-a-survey-based-study-of-clinician-and-nonclinician-opinions-on-paternalistic-decision-making
#10
Kunal Bailoor, Thomas Valley, Chithra Perumalswami, Andrew G Shuman, Raymond DeVries, Darin B Zahuranec
We conducted an empirical study to explore clinician and lay opinions on the acceptability of physician paternalism. Respondents read a vignette describing a patient with brain hemorrhage facing urgent surgery that would be lifesaving but would result in long-term severe disability. Cases were randomized to show either low or high surrogate distress and certain or uncertain prognosis, with respondents rating the acceptability of not offering brain surgery. Clinicians (N = 169) were more likely than nonclinicians (N = 649) to find the doctor withholding surgery acceptable (30...
April 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29611768/patient-perspectives-on-compensation-for-biospecimen-donation
#11
Samuel C Allen, Minisha Lohani, Kristopher A Hendershot, Travis R Deal, Taylor White, Margie D Dixon, Rebecca D Pentz
BACKGROUND: The purpose of this study was to determine whether biospecimen donors believe they should receive compensation. This is the first study to report biospecimen donors' views on compensation and can potentially improve informed consent and recruitment practices. METHODS: Researchers asked patients undergoing surgical removal of tissue to donate biological materials to a biobank; the request was made at their presurgical appointment or in the preoperative clinic of the Emory University Hospital...
April 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29513089/an-empirical-assessment-of-the-short-term-impacts-of-a-reading-of-deborah-zoe-laufer-s-drama-informed-consent-on-attitudes-and-intentions-to-participate-in-genetic-research
#12
Erin Rothwell, Jeffrey R Botkin, Sydney Cheek-O'Donnell, Bob Wong, Gretchen A Case, Erin Johnson, Trent Matheson, Alena Wilson, Nicole R Robinson, Jared Rawlings, Brooke Horejsi, Ana Maria Lopez, Carrie L Byington
OBJECTIVE: This study assessed the short-term impact of the play "Informed Consent" by Deborah Zoe Laufer (a fictionalized look at the controversy over specimens collected from the Havasupai Tribe for diabetes research in 1989) on perceptions of trust, willingness to donate biospecimens, and attitudes toward harm and privacy among the medical and undergraduate students, faculty, and the public in the Intermountain West. METHODS: Surveys were administered before and after a staged reading of the play by professional actors...
April 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29400625/undisclosed-conflicts-of-interest-among-biomedical-textbook-authors
#13
Brian J Piper, Drew A Lambert, Ryan C Keefe, Phoebe U Smukler, Nicolas A Selemon, Zachary R Duperry
BACKGROUND: Textbooks are a formative resource for health care providers during their education and are also an enduring reference for pathophysiology and treatment. Unlike the primary literature and clinical guidelines, biomedical textbook authors do not typically disclose potential financial conflicts of interest (pCoIs). The objective of this study was to evaluate whether the authors of textbooks used in the training of physicians, pharmacists, and dentists had appreciable undisclosed pCoIs in the form of patents or compensation received from pharmaceutical or biotechnology companies...
April 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29369013/children-s-perspectives-on-the-benefits-and-burdens-of-research-participation
#14
Claudia Barned, Jennifer Dobson, Alain Stintzi, David Mack, Kieran C O'Doherty
BACKGROUND: Participation in research is associated with benefits and burdens for individual research participants. Children living with a chronic illness are considered particularly vulnerable as they are already burdened with symptoms of their illness. In particular contexts, such as learning health care systems (LHS), where research and clinical care are integrated, children with chronic illnesses may be asked to participate in research related to their illness. A growing body of literature has focused on children's perspectives as research subjects; however, a relatively understudied aspect concerns children's experiences of research in clinics where they are also patients...
January 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29368998/a-paradigm-for-understanding-trust-and-mistrust-in-medical-research-the-community-voices-study
#15
M Smirnoff, I Wilets, D F Ragin, R Adams, J Holohan, R Rhodes, G Winkel, E M Ricci, C Clesca, L D Richardson
BACKGROUND: To promote justice in research practice and rectify health disparities, greater diversity in research participation is needed. Lack of trust in medical research is one of the most significant obstacles to research participation. Multiple variables have been identified as factors associated with research participant trust/mistrust. A conceptual model that provides meaningful insight into the interplay of factors impacting trust may promote more ethical research practice and provide an enhanced, actionable understanding of participant mistrust...
January 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29338674/would-you-be-willing-to-zap-your-child-s-brain-public-perspectives-on-parental-responsibilities-and-the-ethics-of-enhancing-children-with-transcranial-direct-current-stimulation
#16
Katy Wagner, Hannah Maslen, Justin Oakley, Julian Savulescu
BACKGROUND: Transcranial direct current stimulation (tDCS) is an experimental brain stimulation technology that may one day be used to enhance the cognitive capacities of children. Discussion about the ethical issues that this would raise has rarely moved beyond expert circles. However, the opinions of the wider public can lead to more democratic policy decisions and broaden academic discussion of this issue. METHODS: We performed a quantitative survey of members of the U...
January 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29267141/-god-is-the-giver-and-taker-of-life-muslim-beliefs-and-attitudes-regarding-assisted-suicide-and-euthanasia
#17
Chaïma Ahaddour, Stef Van den Branden, Bert Broeckaert
In the context of the Belgian debates on end-of-life care, the views of Muslims remain understudied. The aim of this article is twofold. First, we seek to document the relation between contemporary normative Muslim ideas on assisted suicide and voluntary euthanasia on the one hand and real-world views and attitudes of Muslims living in Belgium on the other hand. Second, we aim to identify whether a shift is observable in the views and attitudes regarding active termination of life between first- and second-generation Muslims...
January 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29131714/understanding-variations-in-secondary-findings-reporting-practices-across-u-s-genome-sequencing-laboratories
#18
Sara L Ackerman, Barbara A Koenig
BACKGROUND: Increasingly used for clinical purposes, genome and exome sequencing can generate clinically relevant information that is not directly related to the reason for testing (incidental or secondary findings). Debates about the ethical implications of secondary findings were sparked by the American College of Medical Genetics (ACMG) 2013 policy statement, which recommended that laboratories report pathogenic alterations in 56 genes. Although wide variation in laboratories' secondary findings policies has been reported, little is known about its causes...
January 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/28985136/same-behavior-different-provider-american-medical-students-attitudes-toward-reporting-risky-behaviors-committed-by-doctors-nurses-and-classmates
#19
Sahil Aggarwal, Aaron Kheriaty
The bioethics literature lacks findings about medical students' attitudes toward reporting risky behaviors that can cause error or reduce the perceived quality of health care. A survey was administered to 159 medical students to assess their likelihood to directly approach and to report various providers-a physician, nurse, or medical student-for three behaviors (poor hand hygiene, intoxication, or disrespect of patients). For the same behavior, medical students were significantly more likely to approach a classmate, followed by a nurse and then a doctor (p < ...
January 2018: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/29125425/ethical-and-regulatory-challenges-of-research-using-pervasive-sensing-and-other-emerging-technologies-irb-perspectives
#20
Camille Nebeker, John Harlow, Rebeca Espinoza Giacinto, Rubi Orozco-Linares, Cinnamon S Bloss, Nadir Weibel
Vast quantities of personal health information and private identifiable information are being created through mobile apps, wearable sensors, and social networks. While new strategies and tools for obtaining health data have expanded researchers' abilities to design and test personalized and adaptive health interventions, the deployment of pervasive sensing and computational techniques to gather research data is raising ethical challenges for Institutional Review Boards (IRBs) charged with protecting research participants...
October 2017: AJOB Empirical Bioethics
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