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

Background and objective: 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. The aim of this study was to explore the EA/IC reporting standards, as well as their implementation, of the Association of Southeastern Asian Nation (ASEAN) member journals.Methods: A literature search was performed in PubMed for articles that were published in journals from ASEAN member states in 2016. The articles were then reviewed, categorized into study types, and given two scores-one for their EA statement and one for their IC statement-ranging from 0-4. A list of journals was compiled from the articles retrieved and their instructions to authors regarding EA/IC statements were scored on a scale of 0-2. The data was statistically analyzed using Chi-square test (2-sided) with SPSS (version 21) with p-value < .05 being considered statistically significant.Results: While a high proportion of articles adequately reported EA, many failed to report IC. Journals with better EA and IC instruction scores had a higher percentage of articles that adequately reported EA/IC. There were significant relationships between EA/IC statement scores and journals' instructions scores (EA: p = .002; IC: p = .019).Conclusions: There may be a need for journals to play key roles in advocating the importance of reporting EA and IC by strictly enforcing high EA/IC reporting standards and refusing the publication of articles that fail to comply.

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. Furthermore, novel therapies in the current decade, such as molecular-targeted, gene transfer, and pluripotent stem cells therapies, have led to numerous emerging ethical challenges or different ethical assessment and justification frameworks for FIH research. This article presents, discusses, and interlinks ethical considerations and challenges in FIH research through a review of related ethical principles and their application to each ethical issue with given examples. Possible solutions to address each ethical challenge are presented. The scope of this article focuses on 4 major ethical issues in FIH research: risk-benefit assessment and justification for the conduct of research, selection of a suitable target population, informed consent, and conflict of interest.

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. The three principles underlying the SIDCER ICF were: (i) an ICF contains all the required regulatory elements; (ii) an ICF provides only such information as is relevant for the subject's decision-making; and (iii) an ICF presents information in a simple format that conveys relevant information to the target population. The SIDCER ICF template, with its instructions, was then structured to assist an investigator in developing an enhanced ICF according to the three principles. The applicability of the SIDCER ICF was tested using a phase I study protocol, and a variety of experts with a special interest in ethics and clinical research were invited to evaluate the comprehensiveness of the three-page ICF for the phase I study. The SIDCER ICF template was refined and finalised in accordance with the results and comments from the experts.

Improved participants' understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study.

PURPOSE: This study aimed to evaluate the applicability of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in a clinical pharmacokinetic study by comparing the volunteers' understanding of the enhanced ICF (developed based on the SIDCER methodology) and the conventional ICF (which was previously approved by local Ethics Committee and used in the clinical study). METHODS: A total of 550 volunteers were randomly assigned to read either the enhanced ICF or the conventional ICF (1:1) in a mock informed consent approach and subsequently performed the post-test questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥ 80 %; the secondary endpoints were the total score of the post-test, the score of the categorized ICF elements, and time spent for participation. RESULTS: The proportion of the participants in the enhanced ICF group who achieved the primary endpoint was significantly higher than the conventional ICF group (82.2 % vs. 60.4 %, p < 0.001). The participants in the enhanced ICF group obtained higher scores and spent less time in reading the given ICF and answering the post-test than those in the conventional ICF group (total score 19/21 vs. 18/21, p < 0.001; time spent 20 min vs. 25 min, p < 0.001). CONCLUSION: The enhanced ICF improved the understanding of the participants in this study. This demonstrates the applicability of the SIDCER ICF principles and its template in the development of an enhanced ICF for improving the quality of ICFs and subjects' understanding in clinical research. TRIAL REGISTRATION: TCTR20140727001.

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. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants' understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.