Research Design, Biostatistics, and Literature Evaluation
Introduction
Angus DC, Barnato AE, Linde-Zwirble WT, et al. Use
of intensive care at the end of life in the United States: an
https://doi.org/10.1097/01.ccm.0000114816.62331.08
Coopersmith CM, Wunsch H, Fink MP, et al. A compar-
ison of critical care research funding and the financial
Med.
2012;40(4):1072-1079.
https://doi.org/10.1097/
ccm.0b013e31823c8d03
Bioethics
DeRenzo EG, Moss J, Singer EA. Implications of the
revised common rule for human participant research.
Chest.
2019;155(2):272-278.
https://doi.org/10.1016/j.
chest.2018.09.022
Emanuel EJ, Wendler D, Grady C. What makes clinical
doi.org/10.1001/jama.283.20.2701
Freedman B. Equipoise and the ethics of clinical
research. N Engl J Med. 1987;317(3):141-145. https://doi.
org/10.1056/nejm198707163170304
Hodge JG Jr, Gostin LO. Revamping the US federal
common rule: modernizing human participant research
org/10.1001/jama.2017.1633
Koski G. Ethics, science, and oversight of critical care
research: the Office for Human Research Protections.
https://doi.org/10.1164/rccm.2402022
National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research. The
Belmont Report: Ethical Principles and Guidelines for
the Protection of Human Subjects i n R e s e a rc h . US
G ove r n m e n t P r i n t i n g O f f i c e; 19 79.
Vitti JN, Vitti R, Chu K, Mellis S. The ethics of clini-
cal research in the era of COVID-19. Front Public
Health.
2024;12:1359654.
https://doi.org/10.3389/
fpubh.2024.1359654
Practical Challenges to Critical Care Research
Clark D 3rd, Woods J, Patki D, et al. Digital informed
Cardiol.
2020;5(7):845-847.
https://doi.org/10.1001/
jamacardio.2020.0984
Coppolino M, Ackerson L. Do surrogate decision mak-
ers provide accurate consent for intensive care research?
Chest.
2001;119(2):603-612.
https://doi.org/10.1378/
chest.119.2.603
Gaille M, Horn R. Solidarity and autonomy: two con-
flicting values in English and French health care and
bioethics debates? Theor Med Bioeth. 2016;37(6):441-
446. https://doi.org/10.1007/s11017-016-9391-7
Gaudry S, Hajage D, Schortgen F, et al. Initiation strate-
gies for renal-replacement therapy in the intensive care
unit. N Engl J Med. 2016;375(2):122-133. https://doi.
org/10.1056/nejmoa1603017
Goligher EC, DouflΓ© G, Fan E. Update in mechanical
org/10.1164/rccm.201502-0346up
Grady C. Enduring and emerging challenges of informed
consent. N Engl J Med. 2015;372(9):855-862. https://doi.
org/10.1056/nejmra1411250
Harhay MO, Wagner J, Ratcliffe SJ, et al. Outcomes and
statistical power in adult critical care randomized trials.
https://doi.org/10.1164/rccm.201401-0056cp
Ho JD, Cole JB, Klein LR, et al. The Hennepin
Ketamine Study Investigatorsβ reply. Prehosp Disaster
Med.
2019;34(2):111-113.
https://doi.org/10.1017/
s1049023x19000219
Jeste DV, Palmer BW, Appelbaum PS, et al. A new brief
instrument for assessing decisional capacity for clini-
cal research. Arch Gen Psychiatry. 2007;64(8):966-974.
https://doi.org/10.1001/archpsyc.64.8.966
Jose R, Rooney R, Nagisetty N, Davis R, Hains D.
Biorepository and integrative genomics initiative:
designing and implementing a preliminary platform for
predictive, preventive and personalized medicine at a
pediatric hospital in a historically disadvantaged com-
munity in the USA. EPMA J. 2018;9(3):225-234. https://
doi.org/10.1007/s13167-018-0141-y
Kass N, Pronovost PJ, Sugarman J, Goeschel CA,
Lubomski LH, Faden R. Controversy and qual-
ity improvement: lingering questions about ethics,