Ethical approval and informed consent reporting in ASEAN journals: a systematic review.

Scientific publication is a way to disseminate knowledge to the scientific community. However, an article usually has very little information on how and why ethical approval (EA) and informed consent (IC) was obtained, which can make it very difficult for a reader to evaluate the ethical validity of the study. While many internationally recognized journals and publishers have already adopted a high EA/IC reporting standard, many journals still fail to do so.

Ethical considerations and challenges in first-in-human research.

First-in-human (FIH) research is a translational process to move a new potential therapy from bench to bedside. Major ethical challenges of an FIH trial arise because of the indeterminate nature of the risks involved and the controversial risk-benefit justification. Severe adverse events and death of subjects who participated in FIH research in the past have led to an increased attention on ethical considerations in the design and conduct of such research.

SIDCER informed consent form: principles and a developmental guideline.

The quality of informed consent forms (ICFs) remains an issue in clinical research. The lengthy and complicated ICFs currently being used lower research participants' ability to read and understand the information provided therein. In collaboration with the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), we have developed the SIDCER ICF, which could be of value in improving the quality of the ICFs.

Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members.

The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions.