ETHICAL AND LEGAL DIMENSIONS OF CLINICAL TRIALS IN PAKISTAN: PROTECTING VULNERABLE POPULATIONS

Abstract

The environment of Pakistan in terms of clinical trials has complicated ethical and legal issues that have a great impact on the vulnerable groups. Medical research has been increasing at a very high rate; therefore, there is a need to take more decisive actions, especially in societies that are not well-informed about their rights. Ethical problems with informed consent, community participation and even exploitation are ethical problems in poor and poorly-regulated areas. Some other issues that affect legal matters are implementation problems, lack of institutional capacity, and a lack of alignment between international and domestic ethical standards. While the regulatory framework in place in Pakistan is improved as compared to the previous one, its application is still lagging behind, with gaps in the guidance and ethics review system which makes it difficult to ensure equal protection. The weak populations (women, children, low-income patients, remote areas) continue to be more prone to being pressured or ill-informed in undertaking research. To ensure equality, trust and accountability in the clinical trial system in Pakistan, it is essential to strengthen the ethical governance, transparency and meaningful engagement.