Informacja

Drogi użytkowniku, aplikacja do prawidłowego działania wymaga obsługi JavaScript. Proszę włącz obsługę JavaScript w Twojej przeglądarce.

Tytuł pozycji:

Points of contention: Qualitative research identifying where researchers and research ethics committees disagree about consent waivers for secondary research with tissue and data.

Tytuł:
Points of contention: Qualitative research identifying where researchers and research ethics committees disagree about consent waivers for secondary research with tissue and data.
Autorzy:
Ballantyne A; Department of Primary Health Care and General Practice and the Bioethics Centre, University of Otago, Wellington, New Zealand.
Moore A; Philosophy, University of Otago, Dunedin, New Zealand.
Bartholomew K; Waitematā and Auckland District Health Boards, Auckland, New Zealand.
Aagaard N; Ethics, Health System Improvement and Innovation, Ministry of Health, Wellington, New Zealand.
Źródło:
PloS one [PLoS One] 2020 Aug 05; Vol. 15 (8), pp. e0235618. Date of Electronic Publication: 2020 Aug 05 (Print Publication: 2020).
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
Język:
English
Imprint Name(s):
Original Publication: San Francisco, CA : Public Library of Science
MeSH Terms:
Ethics Committees, Research*/ethics
Informed Consent/*ethics
Ethics, Research ; Focus Groups ; Humans ; Qualitative Research ; Research Design ; Research Personnel/ethics ; Tissue Banks/ethics
References:
Bioethics. 2019 May;33(4):502-510. (PMID: 30657596)
Dev World Bioeth. 2019 Mar;19(1):9-17. (PMID: 29063669)
HEC Forum. 2016 Sep;28(3):245-59. (PMID: 26613717)
JAMA. 1982 Jul 9;248(2):197-202. (PMID: 7045428)
BMC Med Ethics. 2017 Nov 28;18(1):65. (PMID: 29179709)
N Z Med J. 2000 Jun 9;113(1111):210-4. (PMID: 10909934)
Eur J Hum Genet. 2019 Jun;27(6):841-847. (PMID: 30683927)
Dev World Bioeth. 2019 Mar;19(1):25-35. (PMID: 29578658)
Adv Exp Med Biol. 2015;864:11-27. (PMID: 26420610)
J Empir Res Hum Res Ethics. 2020 Feb-Apr;15(1-2):28-39. (PMID: 31826689)
J Med Ethics. 2018 Jul;44(7):481-487. (PMID: 26566944)
Hastings Cent Rep. 2013 Jan-Feb;Spec No:S16-27. (PMID: 23315888)
Biotechnol Genet Eng Rev. 2008;25:429-52. (PMID: 21412365)
Dev World Bioeth. 2012 Aug;12(2):63-73. (PMID: 22515423)
Genet Med. 2017 Mar;19(3):345-351. (PMID: 27632687)
Int J Environ Res Public Health. 2019 Nov 22;16(23):. (PMID: 31766594)
Kennedy Inst Ethics J. 2014 Dec;24(4):385-411. (PMID: 25638948)
Ir J Med Sci. 2004 Apr-Jun;173(2):72-4. (PMID: 15540705)
BMC Med Ethics. 2015 Aug 19;16:54. (PMID: 26286519)
Nat Rev Genet. 2020 Jun;21(6):377-384. (PMID: 32251390)
Eur J Hum Genet. 2016 Jul;24(7):956-60. (PMID: 26554881)
J Law Med Ethics. 2005 Spring;33(1):154-9. (PMID: 15934672)
AJOB Empir Bioeth. 2018 Jul-Sep;9(3):143-153. (PMID: 30407144)
J Law Med. 2018 Oct;26(1):188-203. (PMID: 30302981)
J Med Ethics. 2013 Apr;39(4):224-9. (PMID: 22982492)
Minerva. 2019 Sep;57(3):317-343. (PMID: 31501635)
JAMA. 2013 Nov 27;310(20):2191-4. (PMID: 24141714)
Sociol Health Illn. 2003 Nov;25(7):768-92. (PMID: 19780205)
N Z Med J. 2017 Oct 27;130(1464):64-71. (PMID: 29073658)
EMBO Rep. 2015 May;16(5):557-62. (PMID: 25851645)
Qual Quant. 2018;52(4):1893-1907. (PMID: 29937585)
Rand Health Q. 2018 Jan 29;7(2):3. (PMID: 29416943)
J Med Ethics. 2007 May;33(5):302-7. (PMID: 17470509)
J Med Ethics. 2018 Jul;44(7):494-495. (PMID: 27174807)
Int J Med Inform. 2017 Jan;97:43-51. (PMID: 27919394)
Biopreserv Biobank. 2016 Jun;14(3):207-16. (PMID: 27192126)
J Comp Eff Res. 2016 Mar;5(2):123-8. (PMID: 26930026)
J Am Coll Dent. 2014 Summer;81(3):4-13. (PMID: 25951677)
Entry Date(s):
Date Created: 20200807 Date Completed: 20200929 Latest Revision: 20200929
Update Code:
20240105
PubMed Central ID:
PMC7406047
DOI:
10.1371/journal.pone.0235618
PMID:
32756563
Czasopismo naukowe
Background: This is a multi-method, in-depth, three part qualitative study exploring the regulation and practice of secondary research with tissue and data in a high-income country. We explore and compare the perspectives of researchers, research ethics committees (RECs) and other relevant professionals (e.g. pathologists and clinicians). We focus on points of contention because they demonstrate misalignment between the expectations, values and assumptions of these stakeholders.
Methods: This is a multi-method study using observational research, focus groups and interviews with 42 participants (conducted 2016-2017) and analyzed using thematic analysis.
Results: Results are arranged under the following themes: consent; balancing the social value of the research with consent requirements; and harm. Our findings demonstrate different perspectives on the review process, styles of ethical reasoning and issues of concern. First, researchers and RECs disagreed about whether the cost of re-consenting patients satisfied the criterion of impracticability for consent waivers. Second, most researchers were skeptical that secondary research with already collected tissue and data could harm patients. Researchers often pointed to the harm arising from a failure to use existing material for research. RECs were concerned about the potential for secondary research to stigmatize communities. Third, researchers adopted a more consequentialist approach to decision-making, including some willingness to trade off the benefit of the research against the cost of getting consent; whereas RECs were more deontological and typically considered research benefit only after it had been established that re-consent was impractical.
Conclusion: This research highlights ways in which RECs and researchers may be talking past each other, resulting in confusion and frustration. These finding provide a platform for realignment of the expectations of RECs and researchers, which could contribute to making research ethics review more effective.
Competing Interests: The authors have read the journal's policy and the authors of this manuscript have the following competing interests: Andrew Moore was a lead author of the current National Ethics Advisory Committee Guidelines for research ethics. Angela Ballantyne was a member of a Health and Disability Ethics Committee from 2010-2018; Karen Bartholomew is a current member of a Health and Disability Ethics Committee. Nic Aagaard and Karen Bartholomew have been involved with drafting the revised New Zealand research ethics guidelines (released Dec 2019). This does not alter our adherence to PLOS ONE policies on sharing data and materials.
Zaloguj się, aby uzyskać dostęp do pełnego tekstu.

Ta witryna wykorzystuje pliki cookies do przechowywania informacji na Twoim komputerze. Pliki cookies stosujemy w celu świadczenia usług na najwyższym poziomie, w tym w sposób dostosowany do indywidualnych potrzeb. Korzystanie z witryny bez zmiany ustawień dotyczących cookies oznacza, że będą one zamieszczane w Twoim komputerze. W każdym momencie możesz dokonać zmiany ustawień dotyczących cookies