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Textbook Getting To Good Arthur L Caplan Ebook All Chapter PDF
Textbook Getting To Good Arthur L Caplan Ebook All Chapter PDF
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Arthur L. Caplan
Barbara K. Redman
Editors
Getting to Good
Research Integrity in
the Biomedical Sciences
123
Getting to Good
Arthur L. Caplan • Barbara K. Redman
Editors
Getting to Good
Research Integrity in the Biomedical Sciences
Editors
Arthur L. Caplan Barbara K. Redman
New York University Langone Medical Center New York Langone Medical Center
William F. and Virginia Connolly Mitty New York, NY, USA
New York, NY, USA
This Springer imprint is published by the registered company Springer International Publishing AG part of Springer
Nature.
The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Preface
Reference
v
Contents
1 Methodology.............................................................................................................. 1
Arthur L. Caplan and Barbara K. Redman
1.1 Why Most Published Research Findings Are False................................... 2
John P. A. Ioannidis
1.2 The Controversy Surrounding Bone Morphogenetic Proteins
in the Spine: A Review of Current Research............................................. 9
Joshua W. Hustedt and Daniel J. Blizzard
1.3 Research Integrity and Everyday Practice of Science.............................. 23
Frederick Grinnell
1.4 Lessons from the Infuse Trials: Do We Need a Classification
of Bias in Scientific Publications and Editorials?...................................... 41
Sohaib Hashmi, Mohamed Noureldin, and Safdar N. Khan
2 Policy.......................................................................................................................... 51
Arthur L. Caplan and Barbara K. Redman
2.1 In Retrospect: Science—The Endless Frontier.......................................... 52
Roger Pielke Jr.
2.2 Publish or Perish Culture Encourages Scientists to Cut Corners........... 55
Virginia Barbour
2.3 “Something of an Adventure”: Postwar NIH Research Ethos
and the Guatemala STD Experiments........................................................ 59
Kayte Spector-Bagdady and Paul A. Lombardo
2.4 Perverse Incentives....................................................................................... 74
Paula Stephen
2.5 Flint Water Crisis Yields Hard Lessons in Science and Ethics................ 78
Katie L. Burke
3 Reproducibility.......................................................................................................... 95
Arthur L. Caplan and Barbara K. Redman
3.1 What Does Research Reproducibility Mean?............................................ 96
Steven N. Goodman, Daniele Fanelli, and John P. A. Ioannidis
3.2 Limited Reproducibility of Research Findings: Implications
for the Welfare of Research Participants and Considerations
for Institutional Review Boards.................................................................. 103
Barbara K. Redman and Arthur L. Caplan
3.3 Quality Time................................................................................................. 107
Monya Baker
vii
viii Contents
Index................................................................................................................................... 581
Methodology
1
Arthur L. Caplan and Barbara K. Redman
Research integrity is now being redefined to require a higher areas of inquiry, integrating qualitative with quantitative
level of methodological quality than has historically been the findings is becoming standard.
case. Innovations to reach this new standard fall into several Clinical trial endpoints and surrogates are important for
categories: increased use of alternative trial designs with the rapid, accurate accumulation of evidence. Outcomes such
questions about how subject protection can be applied; need as survival, health status, and disease progression may not be
to move away from ‘P’ values and toward effect sizes in sta- evident for a long time. Surrogate endpoints may represent
tistical analysis and full reporting of research methods part of the causal chain of disease progression; they must
including methods of analysis and modified endpoints. have been validated to be predictive of true endpoints and be
Driven by the recognition that the historically dominant stan- sensitive to various ongoing clinical interventions. Surrogate
dard of the randomized placebo-controlled trial (RCT) is not data are now beginning to be accepted by many regulatory
economically, politically, or scientifically always useful, new agencies for the approval of new drugs and vaccines.
trial designs recognize the heterogeneity of disease, the need Beyond these methodological innovations, perhaps the
for timely answers in humanitarian emergencies or for the most important message for research integrity is that the tra-
seriously ill, improvement in trial recruitment and receipt of ditional model of science describes it as a linear process
appropriate treatment, and recognition of the need to synthe- based on logic that is carried out by objective researchers.
size information across trials (Berry 2016). For example, Grinnell (2013) notes that in reality the scientific practice is
pragmatic trials occur in usual practice settings and raise much more nuanced, requiring judgments about how to
questions about whether and how patients can opt out and interpret findings or how to diagnose the source of “failed
who should review them; basket trials test whether different experiments” so as to move forward.
diseases or subtypes respond to a particular therapy; plat- Advice: Read a scientific memoir to get a flavor for how
form trials test multiple therapies made by different sponsors the science was really practiced. Be sure your institution pro-
simultaneously for a particular disease; adaptive trials adjust vides full instruction in the methods for your field of research.
enrollment during the trial based on accumulating evidence If you feel it doesn’t, ask for more, take relevant courses in
of superiority or inferiority of various arms; cross over an allied discipline, or do an internship with a scientist who
designs afford all subjects a chance to experience the active is on the cutting edge of innovative methodology. Inadequate
agent in a trial; and cluster randomized trials enroll naturally methods are a common problem for research integrity; meth-
occurring groups of patients permitting comparisons other- ods well fitted to the research problem support integrity and
wise not possible in standard trial recruitment. And in many build your career.
John P. A. Ioannidis
Ioannidis, J. Why most published research findings are
false. PLoS Medicine 2(8)e124, 0696–0701 (2005)
1 Methodology 3
4 A. L. Caplan and B. K. Redman
1 Methodology 5
6 A. L. Caplan and B. K. Redman
1 Methodology 7
8 A. L. Caplan and B. K. Redman
1 Methodology 9
Kaukaa voi hän jo kuulla, miten niitä nyt ajettiin takaisin talleihin,
mutta hän ei halunnut kysyä, montako niistä tuli ja savu olivat
tappaneet. Kaiken tuon sai hän kyllä tietää tarpeeksi pian — jo
huomenna. Tänään ei hän luullut kaipaavansa enää muuta kuin
lepoa. Hän totesi, että useimmat talonpojat olivat poislähdössä
palatakseen jälleen Arokszállakseen. Tuo taivaanrannalta näkyvä
ruusunpunainen juova alkoi levetä ja kirkastua, ja savunkin läpi voi
hän nähdä, miten tähdet himmenivät auringonnousun lähestyessä.
Isä Ambrosius sanoi hänelle monta lohduttavaa sanaa, ja jokainen
talonpoika nosti kunnioittavasti lakkiaan mennessään vararikkoon
joutuneen kreivin sivu.
TOINEN OSA
XVI
PÄÄSIÄISAAMU.
»Mistä?»
»Mutta sitä kai et voine kieltää», sanoi vanha Berczi, »että juuri
tuona tulipaloyönä muuttui András tuollaiseksi omituiseksi ja
vakavaksi»?
»Pauhu oli hirmuinen viime yönä. Eilen kävin aivan kreivin talleilla
asti ja minusta näytti, että koko Bideskuty on veden vallassa».
Jokaisen asunnon ovesta tuli nyt tielle kauniita tyttöjä, jotka olivat
pukeutuneet koko sunnuntaikoreuteensa. Leveät silitetyt pellavahihat
kiilsivät ja kansallisväriset, punaiset, valkoiset ja viheriät nauhat
liehuivat tuulessa. Kaunis huntu, joka oli sidottu niskaan suurella
nauharuusulla, täydensi kuningatarmaisen pienen pään kauneutta.
Tukka oli kammattu sileäksi ja letitetty kahdeksi paksuksi palmikoksi,
pusero oli edestä kauniisti koruompeluin kirjailtu ja hoikan vartalon
ympärille oli napitettu ahtaat liivit. Lukemattomat hameet heiluivat
iloisesti tyttöjen kävellessä omituisesti lanteitaan heiluttaen, suuret
kultaiset korvarenkaat, useat helminauhat ja liivien kirkkaat soljet
loistivat auringossa yhtä kirkkaasti kuin kauniit silmät ja lumivalkoiset
hampaat. Vanhemmilla naisilla oli hieman tummemmat puvut ja
pitemmät hunnut, kirkkaanväriset huivit peittivät heidän hartioitaan ja
kaikilla oli käsissään suurilla joko messinki- tahi hopeahakasilla
varustetut raskaat rukouskirjat.
»Hän tuli kyllä tänne viime vuonna, mutta en tiedä, tuleeko hän
tänään», sanoi eräs nuori Bideskuty’n paimen. »Kun sivuutin
päärakennuksen, odottivat vaunut ja hevoset portaitten edustalla,
joten on varma, että kreivitär ja nuori neiti saapuvat».
»Auta minut ylös, Rezsö, äläkä puhu tyhmyyksiä. Olen varma, että
jalo
Ilonka on aivan alttarilla olevan pyhän neitsyen näköinen».