Exploring the research participants' perceptions and experiences of the informal consent process in clinical trials and observational studies at Karachi, Pakistan

Date of Award


Document Type


Degree Name

Master of Science in Nursing (MScN)


School of Nursing and Midwifery, Pakistan


Ethical and legal dogmas mandated obtaining informed consent from the research participants and their legal representatives before enrolling them in any clinical research. National and international research guidelines emphasize that research participants should have adequate information and understanding about the research and informed consent should be an ongoing process rather than an event. There is a debate that the quality of informed consent is poor in developing countries, as compared to the developed ones. With the notion of improving the quality of informed consent in our setting, this qualitative study was conducted at one of the tertiary care hospital in Pakistan. Aim: The purpose of this study was to explore the research participants' perceptions on the informed consent process in clinical trials and observational studies. The study also intended to assess the participants' understanding about the basic elements of informed consent, i.e. purpose, risks and benefits, voluntary participation, alternative treatment or procedures, confidentiality, indemnity or compensation for harm or injury, and whom to contact in case of injury. Methodology : A qualitative exploratory-descriptive design was used using in-depth one to one semi-structured interviews. Participants were recruited in the study from three ongoing clinical trials and two observational studies, and a total of twenty participantsere recruited, using the purposive sampling technique. Participants' recruitment was stopped when data saturation was achieved. Findings Data was categorized into themes, categories, and subcategories. Five major themes emerged from the results of the study, which includes: (I) information disclosure, (2) comprehension or understanding, and (3) voluntariness, (4) competence, (5) and decision making. The categories were information content, information delivery, education level and understanding, clarity on standard treatment versus new treatment, motivation for participation treatment, communal and shared decision making clinical. The subcategories were time and amount if information, clinical equipoise, therapeutic misconception, new information, altruism, incentives, and researchers' client relationships. The results showed that information about research studies was partially disclosed. Research participants with higher level of education have better understanding of the informed consent as compared to those who have less education. All participants shared that they have voluntary participated in the studies and most of them showed altruism as motivating factor for participation. Research participants preferred to discuss informed consent with family and then take a shared decision with the research investigators after getting all the information. Recommendations: Research investigators need to give proper training to the research team on research consent administration and monitor the process frequently. National and institutional regulatory bodies need to be Stringent in protocol reviews and should have infrastructure (SOPs and guidelines) for monitoring and audits; monitor the compliance and take appropriate action on noncompliance. Future longitudinal studies are also suggested to assess the phenomena on a broader level.

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