Understanding Informed Consent: An in Depth Analysis

International Journal of Research and Innovation in Social Science (IJRISS) | Volume VI, Issue V, May 2022 | ISSN 2454–6186

Understanding Informed Consent: An in Depth Analysis

Katwa, Joseph Kigen¹* Joyce Lugulu^2
1Moi University School, College of Health Sciences, Eldoret, Kenya.
²Department of Medical Education, Moi University School of Medicine
*Corresponding Author

Abstract:
Introduction: The history of informed consent started at the same time with the advent of calls for regulation in health related research. This was done in reaction to the Nuremberg trials of 1947 when Nazi physicians conducted abhorrent medical research on prisoners held within concentration camps. Despite the publication of the Nuremberg Code and the trying of Nazi doctors for abuse of human rights, cases of other researchers still subjecting human participants to unethical research continued to emerge. Informed consent evolved in response to failures by researchers to respect the dignity of human subjects. They failed to ensure that participants were given the full power to decide whether or not to participate in their researches.
Objective: This study sought to examine research participants’ views when giving informed consent in the researches they have taken part in.
Methods: This was a qualitative study done using in-depth interviews and Focus Group Discussion (FGD) for data collection. The target population was exclusively people who had participated in health-related research and who resided at Kapseret. Snowball sampling method was used to select 102 participants of both genders. They were divided into 12 focus groups discussion of 8 to 9 members each. To have homogeneous groups, gender, age and educational level were considered when forming the groups. To enable the FGDs to discuss intimate issues freely, participants of the same age group were placed together. Males and females were grouped separately. Collected data was transcribed and FGD-generated themes which were finally analyzed.
Results: Participants showed evidence of having understood and given informed consent before taking part in health related research. However, their consent seems to have been influenced by other factors which they gave more priority. As such, an IRB requirement demand that participants understand consent forms before signing, the reality at the research site is different. Before assenting to take part in a research, participants would want to know the benefits that would accrue to them. An example is that of participants’ valuing money paid as transport refund so much that it seems to be compelling them into joining research.
Conclusion: There is a greater need to educate research participants concerning research and benefits. As much as justice demands that participants should benefit from what they have participated in, it should be made clear to the participants that the said benefit comes if the research yields positive results.

Key Words: Informed Consent; Health research; In depth analysis

I. BACKGROUND

The fact that humanity invented a way of lighting fire and the use of honey as a preservative when storing meat for future use is a pointer that humanity has been conducting informal research ever since the dawn of human history (Middle Ages Food Preservation, 2012). Then came the Greek era when medical research was part of learning and treatment guided by the Hippocratic Oath which required physicians to benefit their patients to the best of their knowledge (Middle Ages Food Preservation, 2012). But it was not until the 1900s; the era of modern science which was accelerated by research in medical field (Medicine 1900-1949, 2012).

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