Academic journal article IRB: Ethics & Human Research

Motivated by Money? the Impact of Financial Incentive for the Research Team on Study Recruitment

Academic journal article IRB: Ethics & Human Research

Motivated by Money? the Impact of Financial Incentive for the Research Team on Study Recruitment

Article excerpt

Biomedical research is a very competitive arena. Investigators not only compete for internal and external funding for their clinical trials, but also for healthy people or patients to enroll in their studies. Indeed, one of the largest obstacles investigators face is getting people to enroll in their trials. (1) Thus, budgets for conducting clinical trials increasingly include financial remuneration to research participants; they might also include financial remuneration to the research team.

Although studies have been conducted to determine whether payment to participate in research influences a person's decision to enroll in a study, (2) little is known about what motivates researchers to conduct and complete studies. One explanation is that researchers have the desire to contribute to medical knowledge with the hope that such knowledge will benefit future generations of patients. Other factors might include answering a specific research question, publishing the results of research in peer-reviewed journals, professional enhancement, and financial remuneration.

With the growth in industry sponsored clinical trials, there has been increasing concern about the ethics of financial remuneration for research-related activities. Although the impact of financial incentive on the research team has been perceived as important by industry and the public, the significance of this impact is unknown. (3) Media reports about industry payments to investigators with the headlines "Drug Trials Hide Conflicts for Doctors" (4) and "Bounty-Hunting Doctors Recruit Human Guinea Pigs" (5) reflect a negative view of such payment practices and suggest that researchers' financial ties to industry sponsors might compromise their obligations to trial participants. This was one of the issues that emerged from the investigation of the death of a young man involved in a gene transfer trial. (6)

Due to a fortuitous set of circumstances at our institution, we had the opportunity to explore the issue of financial remuneration to the research team for research-related activities. We examined whether financial remuneration to the research team in a neonatal intensive care unit (NICU) impacted either the rate at which the research team approached parents about research participation or the rate at which parents provided consent to participate.

Neonatology is an area of medicine with an intense amount of clinical research focusing on the extremely low birth weight infant. Clinical trials within NICUs often vie for the same population of patients, making trial recruitment a challenging activity. (7) Moreover, because parents or guardians are asked to enroll their newborn in a clinical trial at a time when they are experiencing great stress and anxiety as a result of the preterm birth, (8) they find decisions about trial participation difficult. Thus, one tactic to increase the number of patients enrolled in trials would be for the trial sponsor to provide financial remuneration to members of the research team for time spent in the recruitment process. The remuneration might only be provided if a patient or surrogate provides consent to participate.

Study Methods

We examined the recruitment and informed consent rates for two separate clinical trials with nearly identical inclusion criteria that were conducted concurrently in the NICU of a tertiary institution in Canada. Infants born at less than 1,250 grams (approximately 2.75 pounds) birth weight were eligible for entry into one of two randomized controlled trials. The trials--both of which were initiated by investigators--examined commonplace therapies designed to provide respiratory support for preterm newborns when they were close to being extubated. At the time the studies were conducted, the NICU had a policy that parents could be asked to enroll their newborn in only one interventional study during the infant's first week of life.

Study A was a multicentered, federally funded, placebo-controlled trial involving a medication that was the standard of care for treatment of newborns nearing extubation in order to prevent apnea of prematurity, an immature and irregular breathing pattern in preterm babies. …

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