Assessing safety and ethical issues among participants in a herbal medicine phase І clinical trial: conducted in Addis Ababa Ethiopia: A Mixed Methods Research
No Thumbnail Available
Date
2024-06
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Addis Ababa University
Abstract
Background: Ethics in the conduct of clinical research is mandatory to protect research
participants. The goal of phase І clinical trial is to determine the maximum dose of the new
medication that may be administered without the risk of serious side effects. Participants in most
of phase І clinical trial have no direct benefit in participating in the trial but the amount of money
provided for compensation can cause the participants to participate without being concerned to
the risks the new drug may bring.
Objective: To investigate the safety and ethical issues among healthy volunteers in phases І
clinical Study in Addis Ababa, Ethiopia in 2024.
Methods: An institutional-based cross-sectional study design mixed with a qualitative
description approach was employed. The study was conducted at Armauer Hansen Research
Institute; semi-structured interviews were conducted face-to-face. Data was entered into the
Kobo toolbox and exported to SPSS version 24; a descriptive analysis was done; and the socio-
demographic characteristics of the study participants were described. For qualitative method,
twelve interviewees were purposefully selected and interviewed. An open-ended question was
developed to facilitate in-depth interviews with respondents. Interviews were audio-recorded
with consent. Transcriptions were entered into ATLAS.ti and coded. The data was analyzed
using a thematic analysis approach.
Result: The major motivation of participants (54.4%) was financial benefit. The majority of the
participants (52.6%) had a low monthly income of less than 2000 birr per month, followed by
(42.1%) agreed to the need to help in the development of new drugs. When deciding to join a
trial, the majority of them (40.4%), strongly agreed with giving consideration to the type of drug
under investigation and the level of risk that can be caused. Altruism and medical care provided
by the trial site were also the other major decision factors mentioned.
Conclusion: The findings of this study indicate that the motivations and enrollment decisions of
healthy participants to engage in a phase І clinical trial are diverse, extending beyond financial
incentives. By taking these factors into account, researchers can develop more effective
approaches to engage and protect the healthy volunteers in the trial.
Description
Keywords
Healthy volunteers, Motivation and decision factors, phase І trials.