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The Effectiveness and Ethics of Incentives for Research Participation: Two Embedded Randomized Recruitment Trials

30 Pages Posted: 27 Oct 2020

See all articles by Scott D. Halpern

Scott D. Halpern

University of Pennsylvania - Perelman School of Medicine, Department of Medicine

Marzana Chowdhury

University of Pennsylvania - Perelman School of Medicine, Palliative and Advanced Illness Research Center

Brian Bayes

University of Pennsylvania - Perelman School of Medicine, Palliative and Advanced Illness Research Center

Elizabeth Cooney

University of Pennsylvania - Perelman School of Medicine, Palliative and Advanced Illness Research Center

Brian L. Hitsman

Northwestern University - Feinberg School of Medicine, Department of Preventive Medicine

Robert A. Schnoll

University of Pennsylvania - Perelman School of Medicine, Department of Psychiatry

Su Fen Lubitz

University of Pennsylvania - Perelman School of Medicine, Department of Psychiatry

Celine Reyes

Northwestern University - Feinberg School of Medicine, Department of Preventive Medicine

Mitesh S. Patel

University of Pennsylvania - Perelman School of Medicine, Department of Medicine

S. Ryan Greysen

University of Pennsylvania - Perelman School of Medicine, Department of Medicine

Ashley Mercede

University of Pennsylvania - Perelman School of Medicine, Department of Medicine

Catherine Reale

University of Pennsylvania - Perelman School of Medicine, Department of Medicine

Frances K. Barg

University of Pennsylvania - Perelman School of Medicine, Palliative and Advanced Illness Research Center

Kevin Volpp

University of Pennsylvania - Perelman School of Medicine, Department of Medicine

Jason Karlawish

University of Pennsylvania - Perelman School of Medicine, Department of Medical Ethics and Health Policy

Alisa J. Stephens-Shields

University of Pennsylvania - Perelman School of Medicine, Palliative and Advanced Illness Research Center

More...

Abstract

Background: Using financial incentives to improve research participation is controversial and variably regulated due to uncertainty regarding whether incentives serve as undue inducements by blunting peoples’ sensitivity to research risks, or unjust inducements by preferentially increasing enrollment among disadvantaged persons.

Methods: Patients were randomly assigned to incentives of $0, $200, or $500 for participating in a trial comparing smoking cessation interventions, and to $0, $100, or $300 for participating in a trial evaluating an ambulation intervention. Each incentive trial was powered to rule out interactions between incentive size and perceived research risk (undue inducement), and between incentive size and income (unjust inducement), on the primary outcome of consenting to the parent trial.

Findings: Incentives significantly increased enrollment among 654 patients in the smoking cessation trial (adjusted odds ratio (OR) for each increase in incentive = 1.70, 95% confidence interval (CI) = 1.34 – 2.17; p < 0.001), but not among 642 patients in the ambulation trial (adjusted OR = 0.88, 95% CI = 0.64 – 1.22; p = 0.45). In both trials, undue and unjust inducement were ruled out (upper confidence limits of ORs for undue inducement = 1.15 and 0.99, both p < 0.001; upper confidence limits of ORs for unjust inducement = 1.21 and 1.26, p = 0.011 and p < 0.001, respectively). In both trials, larger incentives were associated with more time spent reviewing consent forms (both p < 0.005). Incentives were not associated with perceived research risks, trial understanding, perceptions of coercion, or therapeutic misconceptions in either trial.

Interpretation: Financial incentives increased trial enrollment in one of two trials, and did not produce undue or unjust inducement or other unintended consequences in either trial.

Trial Registration: ClinicalTrials.gov number, NCT02697799.

Funding Statement: National Cancer Institute.

Declaration of Interests: We declare no competing interests.

Ethics Approval Statement: Approved by IRBs at the University of Pennsylvania and Northwestern University, using a waiver of the requirement for informed consent. The trials were also guided by an Ethics Advisory Board and overseen by a Data and Safety Monitoring Board (DSMB).

Keywords: Financial incentives, randomized trials, research ethics, embedded recruitment trials

Suggested Citation

Halpern, Scott D. and Chowdhury, Marzana and Bayes, Brian and Cooney, Elizabeth and Hitsman, Brian L. and Schnoll, Robert A. and Lubitz, Su Fen and Reyes, Celine and Patel, Mitesh S. and Greysen, S. Ryan and Mercede, Ashley and Reale, Catherine and Barg, Frances K. and Volpp, Kevin and Karlawish, Jason and Stephens-Shields, Alisa J., The Effectiveness and Ethics of Incentives for Research Participation: Two Embedded Randomized Recruitment Trials. Available at SSRN: https://ssrn.com/abstract=3690899 or http://dx.doi.org/10.2139/ssrn.3690899

Scott D. Halpern (Contact Author)

University of Pennsylvania - Perelman School of Medicine, Department of Medicine ( email )

Philadelphia, PA 19104
United States

Marzana Chowdhury

University of Pennsylvania - Perelman School of Medicine, Palliative and Advanced Illness Research Center ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

Brian Bayes

University of Pennsylvania - Perelman School of Medicine, Palliative and Advanced Illness Research Center ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

Elizabeth Cooney

University of Pennsylvania - Perelman School of Medicine, Palliative and Advanced Illness Research Center ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

Brian L. Hitsman

Northwestern University - Feinberg School of Medicine, Department of Preventive Medicine ( email )

Chicago, IL
United States

Robert A. Schnoll

University of Pennsylvania - Perelman School of Medicine, Department of Psychiatry ( email )

Philadelphia, PA
United States

Su Fen Lubitz

University of Pennsylvania - Perelman School of Medicine, Department of Psychiatry ( email )

Philadelphia, PA
United States

Celine Reyes

Northwestern University - Feinberg School of Medicine, Department of Preventive Medicine ( email )

Chicago, IL
United States

Mitesh S. Patel

University of Pennsylvania - Perelman School of Medicine, Department of Medicine

Philadelphia, PA 19104
United States

S. Ryan Greysen

University of Pennsylvania - Perelman School of Medicine, Department of Medicine ( email )

Philadelphia, PA 19104
United States

Ashley Mercede

University of Pennsylvania - Perelman School of Medicine, Department of Medicine ( email )

Philadelphia, PA 19104
United States

Catherine Reale

University of Pennsylvania - Perelman School of Medicine, Department of Medicine ( email )

Philadelphia, PA 19104
United States

Frances K. Barg

University of Pennsylvania - Perelman School of Medicine, Palliative and Advanced Illness Research Center ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

Kevin Volpp

University of Pennsylvania - Perelman School of Medicine, Department of Medicine ( email )

Philadelphia, PA 19104
United States

Jason Karlawish

University of Pennsylvania - Perelman School of Medicine, Department of Medical Ethics and Health Policy ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

Alisa J. Stephens-Shields

University of Pennsylvania - Perelman School of Medicine, Palliative and Advanced Illness Research Center ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

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