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  1. Is It Ethical to Deny Genetic Research Participants Individualised Results?P. Affleck - 2009 - Journal of Medical Ethics 35 (4):209-213.
  • The Symbolic Relevance of Feedback: Return and Disclosure of Genomic Research Results of Breast Cancer Patients in Belgium, Germany and the UK.Imme Petersen Regine Kollek - 2015 - Journal of Clinical Research and Bioethics 6 (4).
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  • Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations.Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Mildred K. Cho, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland, Jordan Paradise, Lisa S. Parker, Sharon F. Terry, Brian Van Ness & Benjamin S. Wilfond - 2008 - Journal of Law, Medicine and Ethics 36 (2):219-248.
    No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...)
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  • Sharing the Knowledge: Sharing Aggregate Genomic Findings with Research Participants in Developing Countries.Angeliki Kerasidou - 2015 - Developing World Bioethics 15 (3):267-274.
    Returning research results to participants is recognised as an obligation that researchers should always try to fulfil. But can we ascribe the same obligation to researchers who conduct genomics research producing only aggregated findings? And what about genomics research conducted in developing countries? This paper considers Beskow's et al. argument that aggregated findings should also be returned to research participants. This recommendation is examined in the context of genomics research conducted in developing countries. The risks and benefits of attempting such (...)
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  • Attitudes of African-American Parents About Biobank Participation and Return of Results for Themselves and Their Children.C. M. E. Halverson & L. F. Ross - 2012 - Journal of Medical Ethics 38 (9):561-566.
    Introduction Biobank-based research is growing in importance. A major controversy exists about the return of aggregate and individual research results. Methods The authors used a mixed-method approach in order to study parents' attitudes towards the return of research results regarding themselves and their children. Participants attended four 2-h, deliberative-engagement sessions held on two consecutive Saturdays. Each session consisted of an educational presentation followed by focus-group discussions with structured questions and prompts. This manuscript examines discussions from the second Saturday which focused (...)
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  • Informing Research Participants of Research Results: Analysis of Canadian University Based Research Ethics Board Policies.S. D. MacNeil - 2006 - Journal of Medical Ethics 32 (1):49-54.
    Background: Despite potential benefits of the return of research results to research participants, the TriCouncil Policy Statement , which reflects Canadian regulatory ethical requirements, does not require this. The policies of Canadian research ethics boards are unknown.Objectives: To examine the policies of Canadian university based REBs regarding returning results to research participants, and to ascertain if the presence/absence of a policy may be influenced by REB member composition.Design: Email survey of the coordinators of Canadian university based REBs to determine the (...)
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  • A Review Of: “Ezekiel J. Emanuel, Robert A. Crouch, John D. Arras, Et Al., Eds. 2004. Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary”: Baltimore, MD: Johns Hopkins University Press. 490 Pp. $39.95, Paperback. [REVIEW]Howard Mann - 2005 - American Journal of Bioethics 5 (3):72-74.
  • Disclosure/Disruption: Considering Why Not to Disclose Genetic Information After Death.Kathleen Galvin & Marla L. Clayman - 2012 - American Journal of Bioethics 12 (10):14-16.
    The American Journal of Bioethics, Volume 12, Issue 10, Page 14-16, October 2012.
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  • Risks to Relatives in Genomic Research: A Duty to Warn?Yvonne Bombard, Kenneth Offit & Mark E. Robson - 2012 - American Journal of Bioethics 12 (10):12-14.
    The American Journal of Bioethics, Volume 12, Issue 10, Page 12-14, October 2012.
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  • Sham Surgery in Randomized Trials: Additional Requirements Should Be Satisfied.Howard Mann - 2003 - American Journal of Bioethics 3 (4):5 – 7.
  • Ethical Considerations in the Communication of Unexpected Information with Clinical Implications.Robert R. Lavieri & Samual A. Garner - 2006 - American Journal of Bioethics 6 (6):46 – 48.
  • Clinical Utility and Full Disclosure of Genetic Results to Research Participants.Richard R. Sharp & Morris W. Foster - 2006 - American Journal of Bioethics 6 (6):42 – 44.
  • Obligations in Offering to Disclose Genetic Research Results.Conrad V. Fernandez & Charles Weijer - 2006 - American Journal of Bioethics 6 (6):44 – 46.
  • Disclosing Individual Genetic Results to Research Participants.Vardit Ravitsky & Benjamin S. Wilfond - 2006 - American Journal of Bioethics 6 (6):8 – 17.
    Investigators and institutional review boards should integrate plans about the appropriate disclosure of individual genetic results when designing research studies. The ethical principles of beneficence, respect, reciprocity, and justice provide justification for routinely offering certain results to research participants. We propose a result-evaluation approach that assesses the expected information and the context of the study in order to decide whether results should be offered. According to this approach, the analytic validity and the clinical utility of a specific result determine whether (...)
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  • Thresholds and Boundaries in the Disclosure of Individual Genetic Research Results.Lynn G. Dressler & Eric T. Juengst - 2006 - American Journal of Bioethics 6 (6):18 – 20.
  • Public Expectations for Return of Results—Time to Stop Being Paternalistic?Conrad Fernandez - 2008 - American Journal of Bioethics 8 (11):46-48.
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  • The Kindness of Strangers: The Donative Contract Between Subjects and Researchers and the Non-Obligation to Return Individual Results of Genetic Research.Michelle N. Meyer - 2008 - American Journal of Bioethics 8 (11):44 – 46.
  • Contextualising the Role of the Gatekeeper in Social Science Research.Shenuka Singh & Douglas Wassenaar - 2016 - South African Journal of Bioethics and Law 9 (1):42-42.
    Accessing research participants within some social institutions for research purposes may involve a simple single administrative event. However, accessing some institutions to conduct research on their data, personnel, clients or service users can be quite complex. Research ethics committee chairpersons frequently field questions from researchers wanting to know when and why gatekeeper permission should be sought. This article examines the role and influence of gatekeepers in formal and organisational settings and explores pragmatic methods to improve understanding and facilitation of this (...)
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  • When Research Seems Like Clinical Care: A Qualitative Study of the Communication of Individual Cancer Genetic Research Results.Fiona A. Miller, Mita Giacomini, Catherine Ahern, Jason S. Robert & Sonya de Laat - 2008 - BMC Medical Ethics 9 (1):4.
    Research ethicists have recently declared a new ethical imperative: that researchers should communicate the results of research to participants. For some analysts, the obligation is restricted to the communication of the general findings or conclusions of the study. However, other analysts extend the obligation to the disclosure of individual research results, especially where these results are perceived to have clinical relevance. Several scholars have advanced cogent critiques of the putative obligation to disclose individual research results. They question whether ethical goals (...)
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  • Attitudes of Research Ethics Board Chairs Towards Disclosure of Research Results to Participants: Results of a National Survey.S. D. MacNeil & C. V. Fernandez - 2007 - Journal of Medical Ethics 33 (9):549-553.
    Background: The offer of aggregate study results to research participants following study completion is increasingly accepted as a means of demonstrating greater respect for participants. The attitudes of research ethics board chairs towards this practice, although integral to policy development, are unknown.Objectives: To determine the attitudes of REB chairs and the practices of REBs with respect to disclosure of results to research participants.Design: A postal questionnaire was distributed to the chairs of English-language university-based REBs in Canada. In total, 88 REB (...)
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  • The Search for Clarity in Communicating Research Results to Study Participants.D. I. Shalowitz & F. G. Miller - 2008 - Journal of Medical Ethics 34 (9):e17-e17.
    Current guidelines on investigators' responsibilities to communicate research results to study participants may differ on whether investigators should proactively re-contact participants, the type of results to be offered, the need for clinical relevance before disclosure, and the stage of research at which results should be offered. Lack of consistency on these issues, however, does not undermine investigators' obligation to offer to disclose research results: an obligation rooted firmly in the principle of respect for research participants.
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  • Ethical Issues Related to Computerised Family Medical Histories in Sickle Cell Disease: Inforare.S. Franrenet, N. Duchange, F. Galacteros, C. Quantin, O. Cohen, R. Nzouakou, S. Sudraud, C. Herve & G. Moutel - 2010 - Journal of Medical Ethics 36 (10):604-607.
    The Inforare project aims to set up a system for the sharing of clinical and familial data, in order to study how genes are related to the severity of sickle cell disease. While the computerisation of clinical records represents a valuable research goal, an ethical framework is necessary to guarantee patients' protection and their rights in this developing field. Issues relating to patient information during the Inforare study were analysed by the steering committee. Several major concerns were discussed by the (...)
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  • Disclosure of Individual Research Results in Clinico-Genomic Trials: Challenges, Classification and Criteria for Decision-Making.Regine Kollek & Imme Petersen - 2011 - Journal of Medical Ethics 37 (5):271-275.
    While an ethical obligation to report findings of clinical research to trial participants is increasingly recognised, the academic debate is often vague about what kinds of data should be fed back and how such a process should be organised. In this article, we present a classification of different actors, processes and data involved in the feedback of research results pertaining to an individual. In a second step, we reflect on circumstances requiring further ethical consideration. In regard to a concrete research (...)
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  • What Does 'Respect for Persons' Require? Attitudes and Reported Practices of Genetics Researchers in Informing Research Participants About Research.F. A. Miller, R. Z. Hayeems, L. Li & J. P. Bytautas - 2012 - Journal of Medical Ethics 38 (1):48-52.
    Background It has been suggested that researchers are obliged to offer summary findings to research participants to demonstrate respect for persons, and that this may increase public trust in, and awareness of, the research enterprise. Yet little research explores researchers' attitudes and practices regarding the range of initiatives that might serve these ends. Methods Results of an international survey of 785 eligible authors of genetics research studies in autism or cystic fibrosis are reported. Results Of 343 researchers who completed the (...)
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  • Ethics of Neuroimaging After Serious Brain Injury.Charles Weijer, Andrew Peterson, Fiona Webster, Mackenzie Graham, Damian Cruse, Davinia Fernández-Espejo, Teneille Gofton, Laura E. Gonzalez-Lara, Andrea Lazosky, Lorina Naci, Loretta Norton, Kathy Speechley, Bryan Young & Adrian M. Owen - 2014 - BMC Medical Ethics 15 (1):41.
    Patient outcome after serious brain injury is highly variable. Following a period of coma, some patients recover while others progress into a vegetative state (unresponsive wakefulness syndrome) or minimally conscious state. In both cases, assessment is difficult and misdiagnosis may be as high as 43%. Recent advances in neuroimaging suggest a solution. Both functional magnetic resonance imaging and electroencephalography have been used to detect residual cognitive function in vegetative and minimally conscious patients. Neuroimaging may improve diagnosis and prognostication. These techniques (...)
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  • Subjects' Views of Obligations to Ensure Post-Trial Access to Drugs, Care and Information: Qualitative Results From the Experiences of Participants in Clinical Trials (EPIC) Study.N. Sofaer, C. Thiessen, S. D. Goold, J. Ballou, K. A. Getz, G. Koski, R. A. Krueger & J. S. Weissman - 2009 - Journal of Medical Ethics 35 (3):183-188.
    Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial drug, (...)
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  • Acknowledging Awareness: Informing Families of Individual Research Results for Patients in the Vegetative State.Mackenzie Graham, Charles Weijer, Andrew Peterson, Lorina Naci, Damian Cruse, Davinia Fernández-Espejo, Laura Gonzalez-Lara & Adrian M. Owen - 2015 - Journal of Medical Ethics 41 (7):534-538.
  • The Informed Consent Aftermath of the Genetic Revolution. An Italian Example of Implementation.Federica Artizzu - 2008 - Medicine, Health Care and Philosophy 11 (2):181-190.
    A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in (...)
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  • Return of Research Results: General Principles and International Perspectives.Emmanuelle Lévesque, Yann Joly & Jacques Simard - 2011 - Journal of Law, Medicine and Ethics 39 (4):583-592.
    Five years ago, an article co-written by two of us (Joly and Simard) presented an emerging trend to disclose certain individual genetic results to research participants. Since then, both technologies and research practices have evolved significantly. Given this rapid evolution, our goal is to provide updated and thorough guidance on this issue. Our paper begins by identifying the ethical principles that support the return of results: justice, beneficence, and respect for persons. Then, it presents the results of an analysis of (...)
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  • Familial Communication of Research Results: A Need to Know?Lee Black & Kelly A. McClellan - 2011 - Journal of Law, Medicine and Ethics 39 (4):605-613.
    Research now provides participants greater indications of genetic risk for disease, even for conditions incidental to the research study. Given this development, should such information also be disclosed to the family of research participants? There has been some indication at the national level that genetic risk information can be disclosed to participants' families; however, limited attention has been given to returning research results to family. Thus, we have also incorporated the discussion surrounding the disclosure of genetic risk discovered in the (...)
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  • Applying Bioethical Principles to Place-Based Communities and Cultural Group Protections: The Case of Biomonitoring Results Communication.Dianne Quigley - 2012 - Journal of Law, Medicine and Ethics 40 (2):348-358.
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  • Return of Research Results: General Principles and International Perspectives.Emmanuelle Lévesque, Yann Joly & Jacques Simard - 2011 - Journal of Law, Medicine and Ethics 39 (4):583-592.
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  • Familial Communication of Research Results: A Need to Know?Lee Black & Kelly A. McClellan - 2011 - Journal of Law, Medicine and Ethics 39 (4):605-613.
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  • Incidental Findings in the Era of Whole Genome Sequencing?Erik Parens, Paul Appelbaum & Wendy Chung - 2013 - Hastings Center Report 43 (4):16-19.