Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary

被引：3

作者：

Beskow, Laura M. ^{[1
]}

Hammack-Aviran, Catherine M. ^{[2
]}

Brelsford, Kathleen M. ^{[3
]}

O'Rourke, P. Pearl ^{[4
,5
]}

机构：

[1] Vanderbilt Univ, Med Ctr, Ctr Biomed Eth & Soc, Med Eth, 221 Kirkland Hall, Nashville, TN 37235 USA

[2] Vanderbilt Univ, Med Ctr, Ctr Biomed Eth & Soc, Hlth Policy, 221 Kirkland Hall, Nashville, TN 37235 USA

[3] Vanderbilt Univ, Med Ctr, Ctr Biomed Eth & Soc, 221 Kirkland Hall, Nashville, TN 37235 USA

[4] Partners HealthCare Syst, Human Res Affairs, Boston, MA USA

[5] Harvard Med Sch, Pediat, Somerville, MA USA

来源：

JOURNAL OF LAW MEDICINE & ETHICS | 2020年 / 48卷 / 1_SUPPL期

关键词：

CLINICAL-RESEARCH; ETHICS; IRBS;

D O I：

10.1177/1073110520917039

中图分类号：

B82 [伦理学（道德学）];

学科分类号：

摘要：

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.

引用

页码：138 / 146

页数：9

共 33 条

[1] A SYSTEMATIC REVIEW OF THE EMPIRICAL LITERATURE EVALUATING IRBs: WHAT WE KNOW AND WHAT WE STILL NEED TO LEARN [J].

Abbott, Lura ;

Grady, Christine .

JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS, 2011, 6 (01) :3-19

[2]

[Anonymous], 2018, Declaration of Helsinki: ethical principles for medical research involving human subjects

[3] ETHICS AND CLINICAL RESEARCH [J].

BEECHER, HK .

NEW ENGLAND JOURNAL OF MEDICINE, 1966, 274 (24) :1354-&

[4] Reimagining Human Research Protections for 21st Century Science [J].

Bloss, Cinnamon ;

Nebeker, Camille ;

Bietz, Matthew ;

Bae, Deborah ;

Bigby, Barbara ;

Devereaux, Mary ;

Fowler, James ;

Waldo, Ann ;

Weibel, Nadir ;

Patrick, Kevin ;

Klemmer, Scott ;

Melichar, Lori .

JOURNAL OF MEDICAL INTERNET RESEARCH, 2016, 18 (12)

[5]

Cobb W M, 1973, J Natl Med Assoc, V65, P345

[6] FDA Regulation of Mobile Health Technologies [J].

Cortez, Nathan G. ;

Cohen, I. Glenn ;

Kesselheim, Aaron S. .

NEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (04) :372-379

[7] Ethics review of social, behavioral, and economic research: Where should we go from here? [J].

De Vries, R ;

DeBruin, DA ;

Goodgame, A .

ETHICS & BEHAVIOR, 2004, 14 (04) :351-368

[8]

Department of Homeland Security, 2017, Fed Regist, V82, P7149

[9] What makes clinical research ethical? [J].

Emanuel, EJ ;

Wendler, D ;

Grady, C .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2000, 283 (20) :2701-2711

[10] Oversight of human participants research: Identifying problems to evaluate reform proposals [J].

Emanuel, EJ ;

Wood, A ;

Fleischman, A ;

Bowen, A ;

Getz, KA ;

Grady, C ;

Levine, C ;

Hammerschmidt, DE ;

Faden, R ;

Eckenwiler, L ;

Muse, CT ;

Sugarman, J .

ANNALS OF INTERNAL MEDICINE, 2004, 141 (04) :282-291

← 1 2 3 4 →