The non-admissibility of the principle of therapeutic privilege in clinical trials

• Main Authors: Yusof, Yuhanif, C. N., Anisah, Md Desa, Md Rejab
• Format: Article
• Language: English
• Published: Universiti Putra Malaysia Press 2015
• Subjects: K Law (General); R Medicine (General)
• Online Access: http://repo.uum.edu.my/16838/1/2.pdf; http://repo.uum.edu.my/16838/; http://www.pertanika.upm.edu.my/regular_issues.php?jtype=3&journal=JSSH-23-S-8
• Institution: Universiti Utara Malaysia

The objective of this paper is to examine the issue of non-admissibility of the principle of therapeutic privilege in clinical trials.In medical treatment, doctors could decide not to disclose information for the best interest of the patients by adopting the principle of therapeutic privilege.This principle exempts doctors from disclosing risky information at his discretion especially if by doing so will cause harm or trauma to patients.However, this principle is not recognised in clinical trials. Instead, the need to obtain patient’s consent by way of informed consent has been mandatorily imposed as a way to protect the patients.The doctor-investigator must disclose full information pertaining to the trial to the patient.This paper is a library based collating literature review data. Qualitative methodology and analysis were used in this paper. This paper revealed that despite the fact that the principle of therapeutic privilege has not been recognised in clinical trials, the attitude of patients that placed high hopes on doctor-investigator has indirectly encouraged the latter not to disclose information by adopting this principle.This paper implies that the doctor investigator practices the principle of therapeutic privilege, an act of paternalism that has been brought into the process of consent taking in clinical trials.In conclusion, the Good Clinical Practice Training Curriculum by the Ministry of Heath Malaysia is suggested to be improvised and further enhanced.