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. 2021 Jul 28;22(1):104.
doi: 10.1186/s12910-021-00672-w.

Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda

Dan Kabonge Kaye  1   2
Affiliations

Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda

Dan Kabonge Kaye. BMC Med Ethics. .

Abstract

Background: Informed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits, may be impossible or impractical in emergency research. In low resource settings, there is limited information on the experiences of the informed consent process for randomized clinical trials in the emergency care context. The objective of this study was to explore the experiences of the informed consent process and factors that motivated participation in two obstetrics and newborn care randomized clinical trials (RCTs).

Methods: This was a qualitative study conducted among former participants of RCTs in the emergency obstetric care context, conducted at Kawempe National Referral Hospital, Uganda. It employed 30 in-depth interviews conducted from June 1, 2019 to August 30, 2019. Issues explored included attitudes about research, the purpose of the research in which they participated, motivations to take part in the study, factors that influenced enrolment decisions, and experiences of the informed consent process.

Results: Respondents felt that research was necessary to investigate the cause, prevention or complications of illness. The decisions to participate were influenced by hope for material or therapeutic benefit, trust in the healthcare system and influence of friends and family members. Many were satisfied with the informed consent process, though they did not understand some aspects of the research.

Conclusion: Respondents valued participation in RCTs in emergency obstetric and newborn care. Hope for benefit, altruism, desire to further scientific knowledge and trust in the investigators featured prominently in the motivation to participate. Both intrinsic and extrinsic factors were motivators for RCT participation.

Keywords: Emergency obstetric care; Motivation for research participation; Perceptions and experiences of informed consent; Randomized clinical trials.

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Conflict of interest statement

The author declares that he has no competing interests.

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References

    1. Aluisio AR, Waheed S, Cameron P, Hess J, Jacob ST, Kissoon N, et al. Clinical emergency care research in low-income and middle-income countries: opportunities and challenges. BMJ Glob Health. 2019;4(Suppl 6):e001289. doi: 10.1136/bmjgh-2018-001289. - DOI - PMC - PubMed
    1. Dickert NW, Brown J, Cairns CB, et al. Confronting ethical and regulatory challenges of emergency care research with conscious patients. Ann Emerg Med. 2016;67:538–545. doi: 10.1016/j.annemergmed.2015.10.026. - DOI - PMC - PubMed
    1. Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA. 1995;273(16):1283–1287. doi: 10.1001/jama.1995.03520400053044. - DOI - PubMed
    1. Rincon F, Lee K. Ethical considerations in consenting critically ill patients for bedside clinical care and research. J Intensive Care Med. 2015;30(3):141–150. doi: 10.1177/0885066613503279. - DOI - PubMed
    1. Vanpee D, Gillet JB, Dupuis M. Clinical trials in an emergency setting: implications from the fifth version of the Declaration of Helsinki. J Emerg Med. 2004;26(1):127–131. doi: 10.1016/j.jemermed.2003.04.007. - DOI - PubMed

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