alexa Amnestic MCI Patients’ Perspectives on Volunteer Participation in a Research Context
ISSN: 2155-9627

Journal of Clinical Research & Bioethics
Open Access

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Research Article

Amnestic MCI Patients’ Perspectives on Volunteer Participation in a Research Context

Gwendolien Vanderschaeghe1*, Jolien Schaeverbeke2,3, Rik Vandenberghe2,3,4 and Kris Dierickx1

1Department of Public Health and Primary Care, Centre for Biomedical Ethics and Law, KU Leuven, Belgium

2Department of Neurosciences, Laboratory for Cognitive Neurology, KU Leuven, Belgium

3Alzheimer Research Centre KU Leuven, Leuven Research Institute for Neurodegenerative Disorders, Belgium

4Department of Neurology, University Hospitals Leuven, Belgium

*Corresponding Author:
Gwendolien Vanderschaeghe
Department of Public Health and Primary Care, Centre for Biomedical Ethics and Law
KU Leuven, Kapucijnenvoer 35 Blok D Box 7001
3000 Leuven, Belgium
Tel: +3216 377629
E-mail: [email protected]

Received date: May 03, 2017; Accepted date: May 22, 2017; Published date: May 25, 2017

Citation: Vanderschaeghe G, SchaeverbekeJ, Vandenberghe R, Dierickx K (2017) Amnestic MCI Patients’ Perspectives on Volunteer Participation in a Research Context. J Clin Res Bioeth 8:305. doi:10.4172/2155-9627.1000305

Copyright: © 2017 Vanderschaeghe G, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



Background: Inclusion of patients in research studies is immensely important when evaluating new biomarkers for Alzheimer’s disease (AD) and when the efficacy of possible treatment options is under trial investigation. If medical treatment is to advance in slowing the progression of AD, or even preventing it, voluntary participation of patients is not only important but also their reliable participation is key. To get closer in achieving this goal, researchers need to understand better what motivates research participants to enroll in a clinical trial and get insight into participants’ expectations about their participation. Furthermore, what researchers perceive as benefits and risks of a study can differ from participants’ view. This difference could lead to a situation in which researchers recruit fewer subjects than they expected or result in unreliable research subject participation.

Method: We conducted semi-structured in-depth interviews in 38 patients with amnestic mild cognitive impairment (aMCI) as part of a clinical trial (EUDRACT no. 2013-004671-12) on the predictive value of biomarkers for AD. Patients had the option of receiving their Individual Research Results (IRR; visual binary read amyloid PET results). In this study, the motivations and perceived advantages and disadvantages of trial participation were investigated from the patients’ perspective. Before deciding to participate, patients received an information brochure describing the possible benefits and risks of participation.

Results: The two most frequently mentioned reasons for volunteering for the trial were to contribute to scientific progress and to receive their IRRs. Participating to ameliorate scientific progress was not solely motivated by altruistic reasons; it was mostly mentioned along with the possibility of receiving a valuable result about their health condition, suggesting that self-interest also motivated patients to participate. The two most frequently mentioned disadvantages were the possible risks related to being subjected to invasive medical procedures and that volunteering was considered to be time consuming. Most patients felt that their partner and children supported their decision to enroll in the biomarker study.

Conclusion: aMCI patients have several reasons for wanting to volunteer in a clinical trial, with the option of IRR disclosure being the primary motivation for enrolling. Most of our patients felt that family members supported their decision to volunteer. However, researchers need to be cautious when recruiting subjects for clinical trials by ensuring that they truly desire to participate in the study and those family members are not coercing them into doing so. In addition, what the information brochure mentions as possible benefits and risks of trial participation was not always perceived similarly by patients.


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