前瞻性生物样本库参与者对获取研究结果的看法。
Prospective biorepository participants' perspectives on access to research results.
作者信息
Beskow Laura M, Smolek Sondra J
机构信息
Duke University, USA.
出版信息
J Empir Res Hum Res Ethics. 2009 Sep;4(3):99-111. doi: 10.1525/jer.2009.4.3.99.
Abstract
DISCLOSURE OF INDIVIDUAL RESEARCH results to research participants has been the subject of professional guidelines as well as scholarly commentary, yet controversy remains. To gather data on participant perspectives, we interviewed 40 individuals from the Durham, North Carolina area about a biorepository consent form and conducted an in-depth analysis of responses to a series of questions concerning access to research results. Cross-cutting themes emerged about (1) the nature of research; (2) the nature of research results; (3) expectations concerning access to research results; and (4) practical issues in providing access to research results. Our findings highlight the importance for sound policy development of soliciting stakeholder input, and exploring the complexities behind their evaluations.
摘要
向研究参与者披露个人研究结果一直是专业指南以及学术评论的主题，但争议仍然存在。为了收集参与者的观点数据，我们采访了北卡罗来纳州达勒姆地区的40个人，了解一份生物样本库知情同意书，并对一系列关于获取研究结果的问题的回答进行了深入分析。出现了一些贯穿各领域的主题，包括：（1）研究的性质；（2）研究结果的性质；（3）关于获取研究结果的期望；以及（4）提供研究结果获取途径方面的实际问题。我们的研究结果强调了征求利益相关者意见以及探索其评估背后复杂性对于制定合理政策的重要性。
相似文献
1
Prospective biorepository participants' perspectives on access to research results.前瞻性生物样本库参与者对获取研究结果的看法。
J Empir Res Hum Res Ethics. 2009 Sep;4(3):99-111. doi: 10.1525/jer.2009.4.3.99.
2
"It's my blood": ethical complexities in the use, storage and export of biological samples: perspectives from South African research participants.“这是我的血液”：生物样本使用、储存及出口中的伦理复杂性：南非研究参与者的观点
BMC Med Ethics. 2014 Jan 22;15:4. doi: 10.1186/1472-6939-15-4.
3
Simplifying informed consent for biorepositories: stakeholder perspectives.简化生物库知情同意书：利益相关者的观点。
Genet Med. 2010 Sep;12(9):567-72. doi: 10.1097/GIM.0b013e3181ead64d.
4
Adolescents with substance use disorder and assent/consent: Empirical data on understanding biobank risks in genomic research.有物质使用障碍且表示同意/同意的青少年：基因组研究中生物银行风险理解的实证数据。
Drug Alcohol Depend. 2016 Feb 1;159:267-71. doi: 10.1016/j.drugalcdep.2015.12.006. Epub 2015 Dec 21.
5
Researcher and study participants' perspectives of consent in clinical studies in four referral hospitals in Vietnam.越南四家转诊医院内临床研究中同意书的研究人员和研究参与者观点。
BMC Med Ethics. 2020 Jan 10;21(1):4. doi: 10.1186/s12910-020-0445-z.
6
Beyond Recommendation: Requiring Returning Findings to Research Participants.超越建议：要求向研究参与者反馈研究结果
Genet Test Mol Biomarkers. 2018 Mar;22(3):141-142. doi: 10.1089/gtmb.2018.0052.
7
Developing model biobanking consent language: what matters to prospective participants?制定适合生物样本库的知情同意书语言：哪些是潜在参与者关注的？
BMC Med Res Methodol. 2020 May 15;20(1):119. doi: 10.1186/s12874-020-01001-2.
8
Informed consent for biorepositories: assessing prospective participants' understanding and opinions.生物样本库的知情同意：评估潜在参与者的理解与意见
Cancer Epidemiol Biomarkers Prev. 2008 Jun;17(6):1440-51. doi: 10.1158/1055-9965.EPI-08-0086.
9
What adolescents enrolled in genomic addiction research want to know about conflicts of interest.参与基因成瘾研究的青少年想了解的利益冲突问题。
Drug Alcohol Depend. 2015 Feb 1;147:272-5. doi: 10.1016/j.drugalcdep.2014.12.004. Epub 2014 Dec 15.
10
The research relationship: participant perspectives on consent in biobanking.研究关系：生物样本库中参与者对知情同意的看法。
BMC Med Ethics. 2025 Apr 12;26(1):47. doi: 10.1186/s12910-025-01199-0.
引用本文的文献
1
How to communicate and what to disclose to participants in a recall-by-genotype research approach: a multistep empirical study.如何在基于基因型的召回研究方法中与参与者进行沟通以及披露哪些信息：一项多步骤实证研究。
J Community Genet. 2024 Dec;15(6):615-630. doi: 10.1007/s12687-024-00733-8. Epub 2024 Sep 26.
2
Return of individual research results from genomic research: A systematic review of stakeholder perspectives.基因组研究中个体研究结果的返还：利益相关者观点的系统评价。
PLoS One. 2021 Nov 8;16(11):e0258646. doi: 10.1371/journal.pone.0258646. eCollection 2021.
3
Taking it to the bank: the ethical management of individual findings arising in secondary research.将其变为现实：二次研究中个体发现的伦理管理。
J Med Ethics. 2021 Oct;47(10):689-696. doi: 10.1136/medethics-2020-106941. Epub 2021 Jan 13.
4
Key Expert Stakeholder Perceptions of the Law of Genomics: Identified Problems and Potential Solutions.关键专家利益攸关方对基因组学法律的看法：已识别的问题和潜在解决方案。
J Law Med Ethics. 2020 Mar;48(1):87-104. doi: 10.1177/1073110520916997.
5
Improving Translation and Cultural Appropriateness of Spanish-Language Consent Materials for Biobanks.提高生物样本库西班牙语同意书的翻译质量及文化适应性
Ethics Hum Res. 2019 Sep;41(5):16-27. doi: 10.1002/eahr.500028.
6
Informed Consent in Translational Genomics: Insufficient Without Trustworthy Governance.转化基因组学中的知情同意：缺乏可靠治理则不足。
J Law Med Ethics. 2018 Mar;46(1):79-86. doi: 10.1177/1073110518766023. Epub 2018 Mar 27.
7
Population-based biobank participants' preferences for receiving genetic test results.基于人群的生物库参与者对接收基因检测结果的偏好。
J Hum Genet. 2017 Dec;62(12):1037-1048. doi: 10.1038/jhg.2017.81. Epub 2017 Aug 10.
8
Views of Cohort Study Participants about Returning Research Results in the Context of Precision Medicine.队列研究参与者对在精准医学背景下反馈研究结果的看法。
Public Health Genomics. 2016;19(5):269-75. doi: 10.1159/000448277. Epub 2016 Aug 24.
9
Lessons from HeLa Cells: The Ethics and Policy of Biospecimens.源自海拉细胞的教训：生物样本的伦理与政策
Annu Rev Genomics Hum Genet. 2016 Aug 31;17:395-417. doi: 10.1146/annurev-genom-083115-022536. Epub 2016 Mar 3.
10
Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families.加拿大研究伦理委员会对向个人及其家庭反馈基因研究结果的领导态度
J Law Med Ethics. 2015 Fall;43(3):514-22. doi: 10.1111/jlme.12293.
本文引用的文献
1
Assessing the understanding of biobank participants.评估生物样本库参与者的理解情况。
Am J Med Genet A. 2009 Feb;149A(2):188-98. doi: 10.1002/ajmg.a.32635.
2
Public expectations for return of results--time to stop being paternalistic?公众对结果反馈的期望——是时候停止家长式作风了吗？
Am J Bioeth. 2008 Nov;8(11):46-8. doi: 10.1080/15265160802513127.
3
Subjects matter: a survey of public opinions about a large genetic cohort study.主题事项：关于一项大型基因队列研究的公众意见调查。
Genet Med. 2008 Nov;10(11):831-9. doi: 10.1097/GIM.0b013e31818bb3ab.
4
Informed consent for biorepositories: assessing prospective participants' understanding and opinions.生物样本库的知情同意：评估潜在参与者的理解与意见
Cancer Epidemiol Biomarkers Prev. 2008 Jun;17(6):1440-51. doi: 10.1158/1055-9965.EPI-08-0086.
5
The impact of sharing results of a randomized breast cancer clinical trial with study participants.与研究参与者分享乳腺癌随机临床试验结果的影响。
Breast Cancer Res Treat. 2009 May;115(1):123-9. doi: 10.1007/s10549-008-0057-7. Epub 2008 Jun 10.
6
Ethical, legal, and social implications of biobanks for genetics research.生物样本库在遗传学研究中的伦理、法律和社会影响。
Adv Genet. 2008;60:505-44. doi: 10.1016/S0065-2660(07)00418-X.
7
Duty to disclose what? Querying the putative obligation to return research results to participants.披露什么的义务？质疑向参与者返还研究结果的假定义务。
J Med Ethics. 2008 Mar;34(3):210-3. doi: 10.1136/jme.2006.020289.
8
Clinical utility and full disclosure of genetic results to research participants.临床效用以及向研究参与者充分披露基因检测结果。
Am J Bioeth. 2006 Nov-Dec;6(6):42-4; author reply W10-2. doi: 10.1080/15265160600938443.
9
Taking our obligations to research participants seriously: disclosing individual results of genetic research.认真对待我们对研究参与者的义务：披露基因研究的个体结果。
Am J Bioeth. 2006 Nov-Dec;6(6):32-4; author reply W10-2. doi: 10.1080/15265160600935993.
10
Undesirable implications of disclosing individual genetic results to research participants.向研究参与者披露个体基因检测结果的不良影响。
Am J Bioeth. 2006 Nov-Dec;6(6):28-30; author reply W10-2. doi: 10.1080/15265160600935811.
Zotero 插件