Ethical issues in neonatal research involving human subjects

被引：10

作者：

Fleischman, Alan R. ^{[1
,2
]}

机构：

[1] Albert Einstein Coll Med, Bronx, NY 10467 USA

[2] Childrens Hosp Montefiore, Div Neonatol, Dept Pediat, Bronx, NY USA

来源：

SEMINARS IN PERINATOLOGY | 2016年 / 40卷 / 04期

关键词：

research ethics; neonatology; federal regulations;

D O I：

10.1053/j.semperi.2015.12.014

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

Research involving critically ill neonates creates many ethical challenges. Neonatal clinical research has always been hard to perform, is very expensive, and may generate some unique ethical concerns. This article describes some examples of historical and modem controversies in neonatal research, discusses the justification for research involving such vulnerable and fragile patients, clarifies current federal regulations that govern research involving neonates, and suggests ways that clinical investigators can develop and implement ethically grounded human subjects research. (C) 2016 Elsevier Inc. All rights reserved.

引用

页码：247 / 253

页数：7

共 13 条

[1]

[Anonymous], 1978, THE BELM REP

[2]

[Anonymous], 1970, PATIENT PERSON EXPLO

[3] Target Ranges of Oxygen Saturation in Extremely Preterm Infants. [J].

Carlo, Waldemar A. ;

Finer, Neil N. ;

Walsh, Michele C. ;

Rich, Wade ;

Gantz, Marie G. ;

Laptook, Abbot R. ;

Yoder, Bradley A. ;

Faix, Roger G. ;

Das, Abhik ;

Poole, W. Kenneth ;

Schibler, Kurt ;

Newman, Nancy S. ;

Ambalavanan, Namasivayam ;

Frantz, Ivan D., III ;

Piazza, Anthony J. ;

Sanchez, Pablo J. ;

Morris, Brenda H. ;

Laroia, Nirupama ;

Phelps, Dale L. ;

Poindexter, Brenda B. ;

Cotten, C. Michael ;

Van Meurs, Krisa P. ;

Duara, Shahnaz ;

Narendran, Vivek ;

Sood, Beena G. ;

O'Shea, T. Michael ;

Bell, Edward F. ;

Ehrenkranz, Richard A. ;

Watterberg, Kristi L. ;

Higgins, Rosemary D. ;

Jobe, A. H. ;

Caplan, M. S. ;

Oh, W. ;

Hensman, A. M. ;

Gingras, D. ;

Barnett, S. ;

Lillie, S. ;

Francis, K. ;

Andrews, D. ;

Angela, K. ;

Fanaroff, A. A. ;

Siner, B. S. ;

Zadell, A. ;

DiFiore, J. ;

Donovan, E. F. ;

Bridges, K. ;

Alexander, B. ;

Grisby, C. ;

Mersmann, M. W. ;

Mincey, H. L. .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (21) :1959-1969

[4] Resolving our uncertainty about oxygen therapy [J].

Cole, CH ;

Wright, KW ;

Tarnow-Mordi, W ;

Phelps, DL .

PEDIATRICS, 2003, 112 (06) :1415-1419

[5] LAW-MEDICINE NOTES - TUSKEGEE SYPHILIS STUDY [J].

CURRAN, WJ .

NEW ENGLAND JOURNAL OF MEDICINE, 1973, 289 (14) :730-731

[6]

Fleischman, 2008, The Oxford Textbook of Clinical Research Ethics, P446

[7] Comparative Effectiveness Research Ethical and Regulatory Guidance [J].

Fleischman, Alan R. ;

Solomon, Mildred Z. .

JAMA PEDIATRICS, 2014, 168 (12) :1089-1090

[8]

Institute of Medicine, 2004, ETH COND RES INV CHI

[9]

KRUGMAN S, 1971, LANCET, V1, P966

[10] EXTRACORPOREAL MEMBRANE-OXYGENATION AND THE ETHICS OF CLINICAL RESEARCH IN PEDIATRICS [J].

LANTOS, JD ;

FRADER, J .

NEW ENGLAND JOURNAL OF MEDICINE, 1990, 323 (06) :409-413

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