Broad Consent for Research With Biological Samples: Workshop Conclusions

被引：214

作者：

Grady, Christine ^{[1
]}

Eckstein, Lisa ^{[2
]}

Berkman, Ben ^{[3
]}

Brock, Dan ^{[4
]}

Cook-Deegan, Robert ^{[5
]}

Fullerton, Stephanie M. ^{[6
]}

Greely, Hank ^{[7
]}

Hansson, Mats G. ^{[8
]}

Hull, Sara ^{[1
,9
]}

Kim, Scott ^{[1
]}

Lo, Bernie ^{[10
]}

Pentz, Rebecca ^{[11
]}

Rodriguez, Laura ^{[12
]}

Weil, Carol ^{[13
]}

Wilfond, Benjamin S. ^{[14
]}

Wendler, David ^{[1
]}

机构：

[1] NIH, Ctr Clin, Dept Bioeth, Bethesda, MD 20892 USA

[2] Univ Tasmania, Fac Law, Hobart, Tas 7001, Australia

[3] NHGRI, Bethesda, MD USA

[4] Harvard Univ, Sch Med, Dept Social Med, Div Med Eth, Cambridge, MA 02138 USA

[5] Duke Inst Genome Sci & Policy, Durham, NC USA

[6] Univ Washington, Sch Med, Genome Eth Law & Policy, Seattle, WA 98195 USA

[7] Stanford Law Sch, Crown Quadrangle, Stanford, CA USA

[8] Uppsala Univ, Uppsala, Sweden

[9] NHGRI, Bioeth Core, Bethesda, MD USA

[10] Greenwall Fdn, New York, NY USA

[11] Emory Univ, Ctr Eth, Winship Canc Inst, Atlanta, GA 30322 USA

[12] NHGRI, Div Policy Commun & Educ, Bethesda, MD USA

[13] NCI, Canc Diag Program, Bethesda, MD 20892 USA

[14] Seattle Childrens Hosp, Seattle, WA USA

来源：

AMERICAN JOURNAL OF BIOETHICS | 2015年 / 15卷 / 09期

关键词：

biomedical research; informed consent; regulatory issues; research ethics; GENETIC RESEARCH; RESEARCH PARTICIPANTS; INFORMED-CONSENT; PUBLIC-ATTITUDES; BIOBANK RESEARCH; OPT-OUT; POPULATION; DONORS; PERSPECTIVES; HEPATITIS;

D O I：

10.1080/15265161.2015.1062162

中图分类号：

B82 [伦理学（道德学）];

学科分类号：

摘要：

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.

引用

页码：34 / 42

页数：9

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