Process factors influencing informed consent for participation in clinical research

Nwali, Nwanyieze (2021) Process factors influencing informed consent for participation in clinical research. Doctoral thesis, Northumbria University.

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Abstract

Background:
Nationally and internationally, evidence indicates that the process of informed consent for clinical research is not fulfilling the purpose for which it was intended, despite efforts by Research Ethics Committees (REC). The reason for this is unknown. Many studies have looked at the views of healthcare professionals on the process of informed consent for participation in clinical research but few focus on the views and overall experiences of real-life clinical research participants. There is a need therefore to gain more insight, particularly from service users’ perspectives.

Methods & Analysis:
Nineteen (19) clinical research participants were interviewed after having taken part in the process of informed consent for participation in clinical research studies. The interviews were conducted face-to-face individually in natural settings and were audio recorded with informed consent. Following verbatim transcription, constructive thematic analysis was conducted, and transcripts were coded to develop categories and themes. Themes were applied to discover theoretical concepts.

Findings:
Four themes emerged from the data, namely: Trusting Interpersonal Relationships; Researcher Attributes; Study Information; and Personhood. The factors that influenced participants’ decision making concerned the involvement of a trusted clinician and the timing of such involvement. The interpersonal attributes of the person seeking consent and how the participants perceived the relevance of the information being shared also influenced engagement and decision making. Other factors that encouraged research participation related to personal interests, the desire to do good and/or the hope for a cure. Perceived barriers to participation included intellectual limitations, lack of research awareness, social, physical, and demographic challenges, transportation, burden of illness, and interference with family life.

Conclusion:
The findings suggest that the decision to sign up for research was influenced by a range of factors other than the content, size, or layout of written study information. There appears to be a conflict between the perspectives of real-life patients and those of policy makers in relation to the factors influencing decision making for clinical research.

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