Making the case for completion bonuses in clinical trials

2018 ◽  
Vol 16 (2) ◽  
pp. 176-182 ◽  
Author(s):  
Emily A Largent ◽  
Holly Fernandez Lynch
Keyword(s):  
Clinical Trials ◽  
Financial Incentives ◽  
Institutional Review Board ◽  
Study Endpoint ◽  
Ethical Problems ◽  
Research Participants ◽  
Institutional Review ◽  
The Right ◽  
Incentive Payments

Attrition is a serious problem in many clinical trials. The practice of offering completion bonuses—financial incentives offered to participants on the condition that they remain in a trial until they reach a prespecified study endpoint—is one means of addressing attrition. Despite their practical appeal, however, completion bonuses remain ethically controversial due to concern that they will coerce or unduly influence participants to not exercise their right to withdraw from a trial. Although this interaction with the right to withdraw does render completion bonuses conceptually distinct from other incentive payments offered to research participants, we argue here that completion bonuses are never coercive and, in the context of effective institutional review board oversight, are unlikely to be unduly influential. Nonetheless, because completion bonuses may in some cases still encourage unreasonable continued participation in a study, additional safeguards are appropriate. Rejecting completion bonuses entirely is, however, unnecessary and would problematically fail to address the significant ethical problems associated with participant attrition.

scholarly journals The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

2018 ◽  
Vol 16 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Michael P Diamond ◽  
Esther Eisenberg ◽  
Hao Huang ◽  
Christos Coutifaris ◽  
Richard S Legro ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Child Health ◽  
Clinical Research ◽  
Human Development ◽  
Reproductive Medicine ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
The Impact ◽  
Review Boards

Background/aims: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. Methods: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. Results: While time required for actual institutional review board submission’s review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7–24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. Conclusion: A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health’s goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.

scholarly journals Could providing financial incentives to research participants be ultimately self-defeating?

2016 ◽  
Vol 12 (3) ◽  
pp. 137-148 ◽  
Author(s):  
TL Zutlevics
Keyword(s):  
Intrinsic Motivation ◽  
Research Ethics ◽  
Financial Incentives ◽  
Financial Incentive ◽  
Ethics Committees ◽  
Ethical Guidelines ◽  
Research Participants ◽  
Human Research Ethics ◽  
Institutional Review ◽  
The Individual

Controversy over providing financial incentives to research participants has a long history and remains an issue of contention in both current discussions about research ethics and for institutional review bodies/human research ethics committees which are charged with the responsibility of deciding whether such incentives fall within ethical guidelines. The arguments both for and against financial incentives have been well aired in the literature. A point of agreement for many is that inducement in the form of financial incentive is permissible when the risk of harm to the individual is negligible in terms of degree and probability of occurrence. In the absence of harm to the individual, encouraging more people to participate in research would appear to be a good thing in so far as it will lead to statistically more robust research outcomes, which can then be translated into better healthcare and other practice. Whilst, on the face of it, this position seems highly defensible, I will explore the possibility that it is counterproductive – that is, providing individuals with financial incentives to become research participants may have the unintended outcome of reducing participation rates in some areas of research. In exploring this idea I will draw on empirical findings from the literature on crowding-out – the hypothesis that providing monetary incentives to people can backfire by overall reducing intrinsic motivation, in this instance intrinsic motivation to behave altruistically or undertake civic duties.

scholarly journals The Association for the Accreditation of Human Research Protection Programs: 15 years of emphasizing research safety, ethics, and quality

2016 ◽  
Vol 2 (1) ◽  
pp. 38 ◽  
Author(s):  
Elyse I. Summers
Keyword(s):  
Institutional Review Board ◽  
Research Staff ◽  
Human Research ◽  
Research Participants ◽  
High Profile ◽  
Institutional Review ◽  
Policies And Procedures ◽  
15Th Anniversary ◽  
Research Protections ◽  
Human Research Protection

This year marks the 15th anniversary of the founding of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), an organization that has been instrumental in strengthening protections for research participants. AAHRPP was established by seven Founding Members in response to a series of high-profile incidents that shook the foundation of the U.S. research enterprise. The Founding Members viewed voluntary accreditation as one way to strengthen research protections and restore and preserve public trust. Today, AAHRPP accreditation is widely regarded as the gold standard for research protections. To attain accreditation, organizations must demonstrate that they adhere to rigorous standards covering three domains: The Organization, The Institutional Review Board or Ethics Committee, and Researcher and Research Staff. The emphasis is on system-wide policies and procedures that strengthen an organization’s commitment to participants and help ensure a more consistent, more effective approach to protecting them. Because AARHPP accreditation is considered an objective indicator of quality, the benefits to accredited organizations can be considerable. Their accreditation status sends a signal — to potential research partners, to sponsors and other funders, and to research participants — that the organization has the systems in place to conduct research in a scientifically and ethically sound manner.

scholarly journals When are clinical trials beneficial for study patients and future patients? A factorial vignette-based survey of institutional review board members

BMJ Open ◽  
2016 ◽  
Vol 6 (9) ◽  
pp. e011150
Author(s):  
Rahul Mhaskar ◽  
Branko Miladinovic ◽  
Thomas M Guterbock ◽  
Benjamin Djulbegovic
Keyword(s):  
Clinical Trials ◽  
Institutional Review Board ◽  
Board Members ◽  
Institutional Review

scholarly journals Modified Orbitozygomatic Craniotomy for Previously Coiled Giant Basilar Apex Aneurysm: 2-Dimensional Operative Video

2019 ◽  
Vol 17 (5) ◽  
pp. E199-E199
Author(s):  
Benjamin K Hendricks ◽  
Robert F Spetzler
Keyword(s):  
Video Recording ◽  
Institutional Review Board ◽  
Anterior Circulation ◽  
Institutional Review Board Approval ◽  
Institutional Review ◽  
Orbitozygomatic Approach ◽  
Clip Application ◽  
Complicating Factors ◽  
The Right ◽  
Significant Size

Abstract Basilar apex aneurysms are generally preferentially managed with endovascular intervention; however, these lesions can demonstrate refractory persistence despite this treatment and, in such cases, must be managed microsurgically. Successful navigation to and manipulation of the basilar apex through the orbitozygomatic approach requires an intricate understanding of the cerebrovascular microanatomy and arachnoid planes within interpeduncular fossa and comfort with use of the operating microscope for the long surgical trajectory to the basilar apex. This patient had a multiply recurrent basilar apex aneurysm; 3 previous coil embolization attempts had been made without successful aneurysm obliteration. This case presented multiple complicating factors, including the presence of a large coil mass and the significant size of the basilar apex lesion. An Allcock test was performed to determine the collateralization across the posterior communicating arteries, and no posterior communicating arteries were visualized, which suggested isolation of the posterior and anterior circulation. A fenestrated clip was utilized from the right side to occlude the base of the aneurysm. Single-clip application was not impeded by the coil mass. Postoperative angiography demonstrated complete occlusion of the aneurysm. The patient gave informed consent for surgery and video recording. Institutional review board approval was deemed unnecessary. Used with permission from Barrow Neurological Institute, Phoenix, Arizona.

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