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  1. Country Reports.Ma'N. H. Zawati, Don Chalmers, Sueli G. Dallari, Marina de Neiva Borba, Miriam Pinkesz, Yann Joly, Haidan Chen, Mette Hartlev, Liis Leitsalu, Sirpa Soini, Emmanuelle Rial-Sebbag, Nils Hoppe, Tina Garani-Papadatos, Panagiotis Vidalis, Krishna Ravi Srinivas, Gil Siegal, Stefania Negri, Ryoko Hatanaka, Maysa Al-Hussaini, Amal Al-Tabba', Lourdes Motta-Murgía, Laura Estela Torres Moran, Aart Hendriks, Obiajulu Nnamuchi, Rosario Isasi, Dorota Krekora-Zajac, Eman Sadoun, Calvin Ho, Pamela Andanda, Won Bok Lee, Pilar Nicolás, Titti Mattsson, Vladislava Talanova, Alexandre Dosch, Dominique Sprumont, Chien-Te Fan, Tzu-Hsun Hung, Jane Kaye, Andelka Phillips, Heather Gowans, Nisha Shah & James W. Hazel - 2019 - Journal of Law, Medicine and Ethics 47 (4):582-704.
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  • Should the gold rule? Assessing "equivalent protections" for research participants across international borders.Jeremy Sugarman - 2005 - Hastings Center Report 35 (5):12-13.
  • Regulation of International Direct-to-Participant Genomic Research: Symposium Introduction.Mark A. Rothstein & Bartha Maria Knoppers - 2019 - Journal of Law, Medicine and Ethics 47 (4):579-580.
  • International Health Research after Schrems v. Data Protection Commissioner.Mark A. Rothstein - 2015 - Hastings Center Report 46 (2):5-6.
    On October 6, 2015, in Schrems v. Data Protection Commissioner, the European Court of Justice, the European Union's highest court, held that the fifteen-year-old Safe Harbor Framework Agreement with the United States was invalid. Under the agreement, about forty-five hundred American companies each year self-certified to the U.S. Department of Commerce that they were in compliance with the essential privacy protections of the European Union, and therefore it was permissible for entities in the European Union to send personal data to (...)
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  • California Takes the Lead on Data Privacy Law.Mark A. Rothstein & Stacey A. Tovino - 2019 - Hastings Center Report 49 (5):4-5.
    In the early 1970s, Congress considered enacting comprehensive privacy legislation, but it was unable to do so. In 1974, it passed the Privacy Act, applicable only to information in the possession of the federal government. In the intervening years, other information privacy laws enacted by Congress, such as the Health Insurance Portability and Accountability Act, have been weak and sector specific. With the explosion of information technology and the growing concerns about an absence of effective federal privacy laws, the legal (...)
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  • Research ethics committee audit: differences between committees.M. E. Redshaw, A. Harris & J. D. Baum - 1996 - Journal of Medical Ethics 22 (2):78-82.
    The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and decision-making. The (...)
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  • Model consent clauses for rare disease research.Minh Thu Nguyen, Jack Goldblatt, Rosario Isasi, Marlene Jagut, Anneliene Hechtelt Jonker, Petra Kaufmann, Laetitia Ouillade, Fruszina Molnar-Gabor, Mahsa Shabani, Eric Sid, Anne Marie Tassé, Durhane Wong-Rieger & Bartha Maria Knoppers - 2019 - BMC Medical Ethics 20 (1):1-7.
    Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants’ overall protection. A global Task Force (...)
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  • Informed Consent: Some Challenges to the Universal Validity of the Western Model.Robert J. Levine - 1991 - Journal of Law, Medicine and Ethics 19 (3-4):207-213.
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  • Informed Consent: Some Challenges to the Universal Validity of the Western Model.Robert J. Levine - 1991 - Journal of Law, Medicine and Ethics 19 (3-4):207-213.
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  • Demystifying Central Review Boards: Current Options and Future Directions: A Summary Report of Outcomes from "Central IRB Review of Multi-Site Trials," 27-28 October 1998. [REVIEW]Robert J. Levine & Louis Lasagna - 2000 - IRB: Ethics & Human Research 22 (6):1.
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  • How local IRBs view central IRBs in the US.Robert Klitzman - 2011 - BMC Medical Ethics 12 (1):13.
    Background: Centralization of IRB reviews have been increasing in the US and elsewhere, but many questions about it remain. In the US, a few centralized IRBs (CIRBs) have been established, but how they do and could operate remain unclear. Methods: I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. Results: These interviewees had often interacted with (...)
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  • Ethical considerations in forensic genetics research on tissue samples collected post-mortem in Cape Town, South Africa.Laura J. Heathfield, Sairita Maistry, Lorna J. Martin, Raj Ramesar & Jantina de Vries - 2017 - BMC Medical Ethics 18 (1):1-8.
    Background The use of tissue collected at a forensic post-mortem for forensic genetics research purposes remains of ethical concern as the process involves obtaining informed consent from grieving family members. Two forensic genetics research studies using tissue collected from a forensic post-mortem were recently initiated at our institution and were the first of their kind to be conducted in Cape Town, South Africa. Main body This article discusses some of the ethical challenges that were encountered in these research projects. Among (...)
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  • International variation in ethics committee requirements: comparisons across five Westernised nations. [REVIEW]Felicity Goodyear-Smith, Brenda Lobb, Graham Davies, Israel Nachson & Sheila Seelau - 2002 - BMC Medical Ethics 3 (1):1-8.
    Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable (...)
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  • Considerations for Returning Research Results to Culturally Diverse Participants and Families of Decedents.Nanibaa' A. Garrison - 2015 - Journal of Law, Medicine and Ethics 43 (3):569-575.
    There has been considerable debate on which genomic research results to return to participants and when those results should be returned, but little attention to how those results should be returned, especially to minority and culturally diverse participants. This paper explores the cultural and ethical considerations around returning research results to participants and families of culturally diverse backgrounds, with a special focus on considerations when the research participant is deceased, and raises points for further discussion.
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  • Requiring a Single IRB for Cooperative Research in the Revised Common Rule: What Lessons Can Be Learned from the UK and Elsewhere?Edward S. Dove - 2019 - Journal of Law, Medicine and Ethics 47 (2):264-282.
    This article argues in general support of the sIRB rule, but also draws on recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggests ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule.
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  • Expert perspectives on ethics review of international data-intensive research: Working towards mutual recognition.Edward S. Dove & Chiara Garattini - 2018 - Research Ethics 14 (1):1-25.
    Life sciences research is increasingly international and data-intensive. Researchers work in multi-jurisdictional teams or formally established research consortia to exchange data and conduct research using computation of multiple sources and volumes of data at multiple sites and through multiple pathways. Despite the internationalization and data intensification of research, the same ethics review process as applies to single-site studies in one country tends to apply to multi-site studies in multiple countries. Because of the standard requirement for multi-jurisdictional or multi-site ethics review, (...)
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  • Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries.Jantina de Vries, Syntia Nchangwi Munung, Alice Matimba, Sheryl McCurdy, Odile Ouwe Missi Oukem-Boyer, Ciara Staunton, Aminu Yakubu & Paulina Tindana - 2017 - BMC Medical Ethics 18 (1):1-9.
    The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate research (...)
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  • A perpetual source of DNA or something really different: ethical issues in the creation of cell lines for African genomics research.Jantina de Vries, Akin Abayomi, James Brandful, Katherine Littler, Ebony Madden, Patricia Marshall, Odile Ouwe Oukem-Boyer & Janet Seeley - 2014 - BMC Medical Ethics 15 (1):60.
    The rise of genomic studies in Africa – not least due to projects funded under H3Africa – is associated with the development of a small number of biorepositories across Africa. For the ultimate success of these biorepositories, the creation of cell lines including those from selected H3Africa samples would be beneficial. In this paper, we map ethical challenges in the creation of cell lines.
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  • A Belmont Reboot: Building a Normative Foundation for Human Research in the 21st Century.Kyle B. Brothers, Suzanne M. Rivera, R. Jean Cadigan, Richard R. Sharp & Aaron J. Goldenberg - 2019 - Journal of Law, Medicine and Ethics 47 (1):165-172.
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  • Delays and diversity in the practice of local research ethics committees.A. H. Ahmed & K. G. Nicholson - 1996 - Journal of Medical Ethics 22 (5):263-266.
    OBJECTIVES: To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study. DESIGN: A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees. SETTING: Thirty-six local research ethics committees covering 38 district health authorities in England. MAIN MEASURES: Response of chairmen and women, the time required to obtain approval, and questions asked in application forms. RESULTS: We received replies from all 36 chairmen contacted: (...)
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  • Broad Data Sharing in Genetic Research: Views of Institutional Review Board Professionals.Amy Lemke, Maureen Smith, Wendy Wolf & Susan Trinidad - 2011 - IRB: Ethics & Human Research 33 (3):1-5.
    Genome-wide association studies raise important ethical and regulatory issues. This is particularly true of the current move toward broad sharing of genomic and phenotypic data. Our survey study examined the opinions of professionals involved in human subjects protection regarding genetic research review. The majority indicated that it is important for their institutional review board to offer guidance about developing and using a data repository or biobank that includes genetic data, and also about sharing this data with other investigators. Only one-third (...)
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