Journal of Clinical Trials
Open Access

Department of Pharmaceutical Regulatory Affairs, A.U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, India

Publications

• Research Article   
  Ensuring Rights and Dignity in Ethical Practices of Clinical Studies with Vulnerable Group and Safeguarding Vulnerable Group Act (2006)
  Author(s): Pashikanti Shailaja and Gonugunta Divya*
  
  Vulnerability in research refers to participants who cannot protect their interests, leading to an increased risk of harm. This manuscript explores the conditions making a group vulnerable, tools to reduce ethical violations, and the importance of ethical safeguards in research. Vulnerability may arise from inability to understand informed consent or from unequal power dynamics. Excluding vulnerable groups from research solely based on their status is unethical and can skew results. Special protection is needed for vulnerable populations, such as children, the elderly, or those with mental health issues, to ensure their rights and dignity are upheld in clinical trials. Ethical principles like informed consent, beneficence, and justice, as well as regulatory frameworks like the Declaration of Helsinki and Good Clinical Practice (GCP), ensure participant safety and research integrity. I.. View More»
  

  Abstract PDF