Literature DB >> 20090675

Payment to healthy volunteers in clinical research: the research subject's perspective.

M J Czarny1, N E Kass, C Flexner, K A Carson, R K Myers, E J Fuchs.   

Abstract

Although there is much discussion regarding the ethics of making payments to healthy volunteers for participating in clinical research, little data are available from the point of view of the volunteers as to what they would consider to be fair payment. The objectives of this study were to determine healthy volunteers' estimates of appropriate payments for participation in hypothetical clinical trials in order to explore the reasoning behind these estimates and to examine the association between volunteer demographics and payment expectations. Sixty participants with previous experience as healthy volunteers in research studies were presented with four hypothetical studies and interviewed about their impressions of burden and risks involved in the studies. They were also asked to estimate an appropriate payment to the volunteers for each of the studies. For each of the studies, the payment estimates made by the participants varied over a wide range. However, each individual tended to be consistent in estimate placement within this range. No demographic factor was significantly associated with the estimated study payment. Subjects frequently mentioned risk and logistical burden as factors that should determine payment levels. Healthy volunteer subjects appear to have individualized yet consistent methods of arriving at estimates of payments for participating in clinical studies. These estimates are based on each subject's perception of study burden and associated risk.

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Year:  2010        PMID: 20090675      PMCID: PMC2946170          DOI: 10.1038/clpt.2009.222

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


  14 in total

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Authors:  J Latterman; J F Merz
Journal:  Am J Bioeth       Date:  2001       Impact factor: 11.229

2.  On paying money to research subjects: 'due' and 'undue' inducements.

Authors:  Ruth Macklin
Journal:  IRB       Date:  1981-05

3.  An ethical framework for the practice of paying research subjects.

Authors:  Terrence F Ackerman
Journal:  IRB       Date:  1989 Jul-Aug

4.  Guinea pigs on the payroll: the ethics of paying research subjects.

Authors:  Trudo Lemmens; Carl Elliott
Journal:  Account Res       Date:  1999       Impact factor: 2.622

5.  Adverse events in phase-I studies: a report in 1015 healthy volunteers.

Authors:  M Sibille; N Deigat; A Janin; S Kirkesseli; D V Durand
Journal:  Eur J Clin Pharmacol       Date:  1998-03       Impact factor: 2.953

6.  Motives and perception of healthy volunteers who participate in experiments.

Authors:  C E van Gelderen; T J Savelkoul; W van Dokkum; J Meulenbelt
Journal:  Eur J Clin Pharmacol       Date:  1993       Impact factor: 2.953

7.  Clinically significant adverse effects in a Phase 1 testing program.

Authors:  C J Zarafonetis; P A Riley; P W Willis; L H Power; J Werbelow; L Farhat; W Beckwith; B H Marks
Journal:  Clin Pharmacol Ther       Date:  1978-08       Impact factor: 6.875

8.  Paying people to participate in research: why not? A response to Wilkinson and Moore.

Authors:  Paul McNeill
Journal:  Bioethics       Date:  1997-10       Impact factor: 1.898

9.  Participation in clinical drug studies: motivations and barriers.

Authors:  K A Cunny; H W Miller
Journal:  Clin Ther       Date:  1994 Mar-Apr       Impact factor: 3.393

10.  Balancing justice and autonomy in clinical research with healthy volunteers.

Authors:  N E Kass; R Myers; E J Fuchs; K A Carson; C Flexner
Journal:  Clin Pharmacol Ther       Date:  2007-04-04       Impact factor: 6.875

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  11 in total

1.  Research participation by low-income and racial/ethnic minority groups: how payment may change the balance.

Authors:  Jennifer K Walter; James F Burke; Matthew M Davis
Journal:  Clin Transl Sci       Date:  2013-07-29       Impact factor: 4.689

2.  Why do we pay? A national survey of investigators and IRB chairpersons.

Authors:  Elizabeth Ripley; Francis Macrina; Monika Markowitz; Chris Gennings
Journal:  J Empir Res Hum Res Ethics       Date:  2010-09       Impact factor: 1.742

3.  Payment expectations for research participation among subjects who tell the truth, subjects who conceal information, and subjects who fabricate information.

Authors:  Eric G Devine; Clifford M Knapp; Ofra Sarid-Segal; Sean M O'Keefe; Cale Wardell; Morgan Baskett; Ashley Pecchia; Katie Ferrell; Domenic A Ciraulo
Journal:  Contemp Clin Trials       Date:  2014-12-18       Impact factor: 2.226

4.  Incentives to participate in clinical trials: practical and ethical considerations.

Authors:  Steven L Bernstein; James Feldman
Journal:  Am J Emerg Med       Date:  2015-05-29       Impact factor: 2.469

5.  Bioethical Issues in Providing Financial Incentives to Research Participants.

Authors:  David B Resnik
Journal:  Medicoleg Bioeth       Date:  2015-06-24

6.  To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials.

Authors:  Lisa McManus; Jill A Fisher
Journal:  AJOB Empir Bioeth       Date:  2018 Apr-Jun

7.  Phase 1 healthy volunteer willingness to participate and enrollment preferences.

Authors:  Stephanie C Chen; Ninet Sinaii; Gabriella Bedarida; Mark A Gregorio; Ezekiel Emanuel; Christine Grady
Journal:  Clin Trials       Date:  2017-08-02       Impact factor: 2.486

8.  Strategy for recruitment and factors associated with motivation and satisfaction in a randomized trial with 210 healthy volunteers without financial compensation.

Authors:  Quentin Luzurier; Cédric Damm; Fabien Lion; Carine Daniel; Lucille Pellerin; Marie-Pierre Tavolacci
Journal:  BMC Med Res Methodol       Date:  2015-01-05       Impact factor: 4.615

9.  When money talks: Judging risk and coercion in high-paying clinical trials.

Authors:  Christina Leuker; Lasare Samartzidis; Ralph Hertwig; Timothy J Pleskac
Journal:  PLoS One       Date:  2020-01-31       Impact factor: 3.240

10.  The Association between Emergency Department Super-Utilizer Status and Willingness to Participate in Research.

Authors:  Henry W Young; Emmett T Martin; Evan Kwiatkowski; J Adrian Tyndall; Linda B Cottler
Journal:  Emerg Med Int       Date:  2020-06-29       Impact factor: 1.112

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