The aim of this study was to examine the aspect of information disclosure by doctor-investigator during the process of obtaining informed consent in clinical trials. This research employed a mixed-method data collection that is library research and interview. A qualitative methodology and analysis were used in an open-ended, face-to-face interviews with 17 patient-subjects. The interview questions were based on information that needed to be disclosed to patient-subjects during the process of obtaining informed consent. Each interview took place in Kajang Hospital and National Heart Institute and lasted 25-30 minutes. Interviews were conducted in Bahasa Melayu and English. The interviews were tape-recorded, and the main points from the interviews were jotted down to ensure that all information was adequately gathered. Interviewed occurred in Kajang Hospital and National Heart Institute. The participants were patients who had been referred to the Kajang Hospital and National Heart Institute. They were recruited (8 from Kajang Hospital and 9 from National Heart Institute) by their own doctors to participate in a study to evaluate the safety and effectivenes of the investigational stent after been diagnosed with coronary artery disease and also in a study to investigate drug for antidepressant. respectively. The study revealed that doctor-investigators fail to disclose full information to patient-subjects. Instead, doctor-investigators only disclosed information which they thought were necessary for the patient-subjects to know. The study also showed that there were doctor-investigators who did not disclose information at all to the patient-subjects. This study implies that the aspect of information disclosure in the process of obtaining informed consent in clinical trials is rather poor and did not fulfill the criterion of good medical practice. A random monitoring task to be conducted by the research ethics commitees during the informed consent process is suggested.

Introduction Women as patients is a normal situation. However, women patients of the obstetric and gynaecology category are of a different category. This is because obstetric and gynaecology patients will be warded in the maternity ward and labour room according to the needs of their care and treatment. The care and treatments in the maternity ward and labour room involving the care and treatments by a special team of trained medical doctors, midwives and nurses in obstetrics and gynaecology areas of expertise. Hence, the importance of scutinising the relevant laws and legislations pertaining to the protection of female patients’ rights when they are utilising the maternity ward and labour room are fundamental in determining whether such rights existing in our healthcare services pertaining to pregnant women. Healthcare laws relating to women’s healthcare and government health policy on pregnant women are scrutinised to ascertained whether the laws and policy give impact or effect to the healthcare services rendered, including scrutinising the qualification, capability and the quantity of obstetric and gynaecology doctors on whether it fulfils the requirement of the government hospitals’ maternity ward and labour room. Methods Doctrinal research method is adopted with applying the empirical approach whereby interviews and a focus group discussion were held with the O&G specialist doctors and selected medical officer and staff nurses of Maternity Hospital Kuala Lumpur. Results The finding shows that there are already in placed a policy of the Ministry of Health Malaysia outlining the women patients’ rights in maternity ward and labour room. However, there are deficiencies from the aspect of law and government policy wherein there is no specific laws in relation to pregnant patient rights nor is there a clear policy on women health. Conclusions The writing concludes that there is a need for a new policy to re-establish governance in maternity ward and to further enhance health care quality for women patients hence, to appropriately define the position of women patients’ rights in the government hospital’s maternity ward.