Date of Award

11-2025

Degree Type

Thesis

Degree Name

Master of Bioethics

First Advisor

Dr. Muhammad Shahid Shamim

Second Advisor

Dr. Anita Anis Allan

Department

Educational Development

Abstract

Background: Potential unethical practices and ethical violations pose a significant responsibility on the Institutional Review Boards (IRBs) and Ethics Review Committees (ERCs), especially in safeguarding already vulnerable research participants. In Pakistan, cultural and socioeconomic disparities further increase these risks, underscoring the need for robust ethical oversight. Herein, ERC|IRB members play a crucial role in ensuring the protection and dignity of vulnerable populations in research.
Objective: This study explored the perceptions of ERC|IRB members in healthcare institutions regarding the inclusion of vulnerable populations in health research. It further examined their experience in safeguarding the rights and welfare of these participants during the review process.
Methods:The study employed an exploratory qualitative research design, utilizing purposive and snowball sampling to recruit participants. In-depth interviews were conducted with ERC/IRB members from healthcare institutions in Karachi, Pakistan, to collect data on their perceptions and experience. Thematic content analysis of the data was carried out to draw inferences.
Results Twelve in-depth interviews were conducted with ERC|IRB members. The analysis yielded five key themes: (i) safeguarding and protection of vulnerable groups, (ii) committee composition, power dynamics and review processes, (iii) Research culture and integrity in Pakistan, (iv) cross- 7 border research and systemic challenges, and (v) Trust and transparency in ERC procedures. The findings revealed gaps in knowledge and policy implementation within ethics review processes. Participants emphasized the need to strengthen collaboration across review boards, enhance monitoring to align practice with policy, and invest in targeted training for ERC members and research ethics for healthcare professionals. Conclusion:This study revealed significant variation in how ERC|IRB members understand the concept of vulnerability in research. Members with greater experience and formal training in bioethics demonstrated a more nuanced grasp of issues related to inclusivity, participant protection and the ethical governance in research. These findings underscore the urgent need to strengthen the capacity of ERC|IRB members in Pakistan, ensuring that vulnerable populations are ethically and meaningfully included in research. Enhancing this capacity is essential not only to safeguard participants but also to maintain the integrity, credibility, and ethical standards of the country’s health research landscape.

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1

Last Page

90

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