MyMedR

Fulltext A Competency Framework for Health Research Ethics Educational Programs: Results from a Stakeholder-Driven Mixed-Method Process

Tackett S, Jenn Ng C, Sugarman J, Daniel EGS, Gopalan N, Tivyashinee, et al.

Ethics Hum Res, 2023;45(3):29-39.

PMID: 37167475 DOI: 10.1002/eahr.500166

Educational programs are integral to building health research ethics (HRE) capacity, but no outcomes framework exists to guide them. We empirically developed a competency framework for health research ethics education-the Framework for Research Ethics Studies Competencies and Outcomes (FRESCO)-using mixed methods, including group concept mapping and a survey of international experts. FRESCO includes seven competency domains: (1) Foundational Knowledge; (2) Laws, Regulations, Guidelines, and Policies for Research Oversight; (3) Ethical-Issue Identification, Analysis, and Resolution; (4) Engagement, Communication, and Advocacy; (5) Lifelong Learning, Education, Research, and Scholarship; (6) Coordination, Stewardship, and Responsiveness in HRE Systems; and (7) Impartiality, Honesty, and Responsibility. These domains are detailed in 27 subdomains. Survey respondents rated FRESCO's relevance to HRE highly. FRESCO can be adapted and implemented in educational programs to refine recruitment and selection processes, educational and assessment methods, and performance measures to ensure that HRE educational programs have their intended effects.

Matched MeSH terms: Ethics, Research*

Fulltext Guidelines for Ethical Review of Clinical Research or Research Involving Human Subjects

Citation:
Research Ethics Committee. Guidelines for Ethical Review of Clinical Research or Research Involving Human Subjects. Kuala Lumpur: Universiti Kebangsaan Malaysia; 2014

Matched MeSH terms: Ethics, Research

Fulltext The Malaysian Code of Responsible Conduct in Research

Citation:
The Malaysian Code of Responsible Conduct in Research. Cyberjaya: Malaysian Industry-Government Group for High Technology (MIGHT); 2017

Matched MeSH terms: Ethics, Research

Fulltext Clinical Trials and Biomedical Research

Citation:
MMC Guideline 009/2006: Clinical Trials and Biomedical Research. Kuala Lumpur: Malaysian Medical Council; 2006

Matched MeSH terms: Ethics, Research

Collective danger and individual risk: cultural perspectives on the hazards of medical research

Parker DB, Barrett RJ

Intern Med J, 2003 Sep-Oct;33(9-10):463-4.

PMID: 14511200 DOI: 10.1046/j.1445-5994.2003.00460.x

Changes in medical research ethics in the past two decades have made the communication of risk to potential participants a legal imperative. Using ethnographic data from two different cultures, we examine the hazards associated with medical research in relation to the respective societal contexts that imbue them with meaning. The Iban, a Dayak people indigenous to Borneo, perceive the hazards of participating in research in terms of danger to the collective. In Australia they are construed in terms of risk to individuals. Risk in medical research is one manifestation of a broader notion of 'risk' that is constitutive of the research enterprise itself and, we argue, fundamental to post-industrial society.

Matched MeSH terms: Ethics, Research*

Fulltext Electronic informed consent criteria for research ethics review: a scoping review

Yusof MYPM, Teo CH, Ng CJ

BMC Med Ethics, 2022 Nov 21;23(1):117.

PMID: 36414962 DOI: 10.1186/s12910-022-00849-x

BACKGROUND: The research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject's comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.

METHODS: The search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.

RESULTS: Of 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.

CONCLUSION: The current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.

Matched MeSH terms: Ethics, Research*

Defining Malaysia's health research ethics system through a stakeholder driven approach

Tackett S, Ng CJ, Sugarman J, Daniel EGS, Gopalan N, Tivyashinee T, et al.

Dev World Bioeth, 2024 Jun;24(2):74-83.

PMID: 36861660 DOI: 10.1111/dewb.12396

The need to understand the systems that support ethical health research has long been recognized, but there are limited descriptions of actual health research ethics (HRE) systems. Using participatory network mapping methods, we empirically defined Malaysia's HRE system. 13 Malaysian stakeholders identified 4 overarching and 25 specific HRE system functions and 35 actors internal and 3 external to the Malaysian HRE system responsible for those functions. Functions requiring the most attention were: advising on legislation related to HRE; optimizing research value to society; and defining standards for HRE oversight. Internal actors with the greatest potential for more influence were: the national network of research ethics committees; non-institution-based research ethics committees; and research participants. The World Health Organization, an external actor, had the largest untapped potential for influence overall. In summary, this stakeholder-driven process identified HRE system functions and actors that could be targeted to increase HRE system capacity.

Matched MeSH terms: Ethics, Research*

Fulltext Short review: Implementation of biomedical ethics in Malaysia

Maisarah AS, Nurul Ajilah MK, Siti Amalina MR, Norazuroh MN

Health and the Environment Journal, 2016;7:54-76.

This literature review focuses on the implementation of biomedical ethics in Malaysia based on the government and institutional settings. Insights of the development of biomedical ethics and the responsible entities, particularly the clinical trials that become the emerging field of interest by the government to boost the biomedical research in Malaysia are provided. Some issues and their implications for research and ethical review process in Malaysia are also elucidated. The review indicates the advancement of policies by the government in implementing the biomedical ethics with some affairs that should be a matter to be concerned.
Keywords: Biomedical, ethics, implementation, standards, research ethic committee, good laboratory practice.

Matched MeSH terms: Ethics, Research

Fulltext Malaysian Phase I Clinical Trial Guidelines

Citation:
Malaysian Phase I Clinical Trial Guidelines. Petaling Jaya: Clinical Research Malaysia; 2017

Matched MeSH terms: Ethics, Research

Fulltext Ethical Professional Practice Guidelines

Citation:
Ethical Professional Practice Guidelines. Kuala Lumpur: Academy of Medicine Malaysia; 2016

Matched MeSH terms: Ethics, Research

Fulltext Developing a competency framework for health research ethics education and training

Tackett S, Sugarman J, Ng CJ, Kamarulzaman A, Ali J

J Med Ethics, 2022 Jun;48(6):391-396.

PMID: 33811112 DOI: 10.1136/medethics-2021-107237

Health research ethics (HRE) training programmes are being developed and implemented globally, often with a goal of increasing local capacity to assure ethical conduct in health-related research. Yet what it means for there to be sufficient HRE capacity is not well-defined, and there is currently no consensus on outcomes that HRE training programmes should collectively intend to achieve. Without defining the expected outcomes, meaningful evaluation of individual participants and programmes is challenging. In this article, we briefly describe the evolution of formal education in HRE, articulate the need for a framework to define outcomes for HRE training programmes, and provide guidance for developing HRE competency frameworks that define outcomes suited to their contexts. We detail critical questions for developing HRE competency frameworks using a six-step process: (1) define the purposes, intended uses and scope of the framework; (2) describe the context in which practice occurs; (3) gather data using a variety of methods to inform the competency framework; (4) translate the data into competencies that can be used in educational programmes; (5) report on the competency development process and results and (6) evaluate and update the competency framework. We suggest that competency frameworks should be feasible to develop using this process, and such efforts promise to contribute to programmatic advancement.

Matched MeSH terms: Ethics, Research

Rather than responding to the past, shape the future instead

Kaur S

Am J Bioeth, 2015;15(6):61-3.

PMID: 26030504 DOI: 10.1080/15265161.2015.1028668

Matched MeSH terms: Ethics, Research/history*

Young scientists in Malaysia have made integrity training fun and relevant

Chau DM

Nature, 2020 11;587(7832):9.

PMID: 33144704 DOI: 10.1038/d41586-020-03082-x

Matched MeSH terms: Ethics, Research/education*

Emphasizing the experiences of researchers after RCR instructions: Introduction to Responsible Conduct of Research (RCR) in Malaysia

Olesen AP, Amin L, Mahadi Z, Ibrahim M

Account Res, 2019 04;26(3):157-175.

PMID: 30982340 DOI: 10.1080/08989621.2019.1607312

The purpose of this study is to highlight the experiences of individuals who participate in the Responsible Conduct of Research (RCR) training program held at various universities in Malaysia. In response to a mailing request sent to 40 individuals who had undertaken a RCR training program, 15 participants agreed to be interviewed. The results of the study showed that the three main reasons for participating in the training were as follows: anticipation for knowledge gained; personal experience with research misconduct; and establishing a new network of researchers. In terms of the positive effects gained from undertaking the training, the participants highlighted an increased awareness of the issues and problems related to research misconduct; the need to promote integrity in research conduct; a change in the way they conduct their research; and a change in the way they confront and address misconduct. The findings of this study should be valuable for policy makers and those involved in the management of research programs and ethics, as it demonstrated the importance of RCR training in equipping researchers with the necessary knowledge to conduct research responsibly, and to avoid research misconduct.

Matched MeSH terms: Ethics, Research/education*

Fulltext ISPOR Code of Ethics 2017 (4th Edition)

Santos J, Palumbo F, Molsen-David E, Willke RJ, Binder L, Drummond M, et al.

Value Health, 2017 12;20(10):1227-1242.

PMID: 29241881 DOI: 10.1016/j.jval.2017.10.018

As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results. There are nine chapters: 1 - Introduction; 2 - Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 - Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 - Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 - Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 - Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 - Patient Centricity and Patient Engagement new addition, with explanation and guidance; 8 - Publication and Dissemination; and 9 - Conclusion and Limitations.

Matched MeSH terms: Ethics, Research*

Fulltext Guidelines on health research involving minors

Citation:
Guidelines on health research involving minors. Kuala Lumpur: National Institute of Health, Ministry of Health Malaysia; 2011 [MREC DOC.01-2010]

Matched MeSH terms: Ethics, Research

Fulltext Informed consent in clinical trials with reference to information disclosure to patient-subjects

Yuhanif Yusof, Anisah Che Ngah, Zaki Morad Mohamad Zaher

Int J Public Health Res, 2014;4(1):384-390.

MyJurnal

Introduction 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.
Methods 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 effectiveness of the investigational stent after been diagnosed with coronary artery disease and also in a study to investigate drug for antidepressant. respectively.
Results 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.
Conclusions 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.

Matched MeSH terms: Ethics, Research

How IRBs make decisions: should we worry if they disagree?

Kaur S

J Med Ethics, 2013 Apr;39(4):230.

PMID: 23077337 DOI: 10.1136/medethics-2012-100965

Matched MeSH terms: Ethics, Research*

Research Ethics: Researchers Consider How Best to Prevent Misconduct in Research in Malaysian Higher Learning Institutions Through Ethics Education

Olesen AP, Amin L, Mahadi Z

Sci Eng Ethics, 2019 08;25(4):1111-1124.

PMID: 29717467 DOI: 10.1007/s11948-018-0054-0

The purpose of this study is to encourage and highlight discussion on how to improve the teaching of research ethics in institutions of higher education in Malaysia. Drawing on semi-structured interviews with 21 academics in a research-intensive university in Malaysia, interviewees agreed on the importance of emphasizing the subject of research ethics among students, as well as academics or researchers. This study reveals that participants felt that there is an urgent need to improve the current awareness and knowledge of issues related to misconduct in research among students and academics. The results of this study indicate a need for better teaching on the subject of research ethics in order to prevent misconduct in research. Finally, it concludes with suggestions that there should be a clear definition of research misconduct, to include consequences when engaging in misconduct; a separate research ethics syllabus for pure and social sciences should be conducted; research ethics should be implemented as a core subject, and there should be an early intervention and continuous learning of research ethics, with an emphasis on ethics training.

Matched MeSH terms: Ethics, Research/education*

Promoting Ethics and Integrity in Management Academic Research: Retraction Initiative

Ayodele FO, Yao L, Haron H

Sci Eng Ethics, 2019 04;25(2):357-382.

PMID: 29441445 DOI: 10.1007/s11948-017-9941-z

In the management academic research, academic advancement, job security, and the securing of research funds at one's university are judged mainly by one's output of publications in high impact journals. With bogus resumes filled with published journal articles, universities and other allied institutions are keen to recruit or sustain the appointment of such academics. This often places undue pressure on aspiring academics and on those already recruited to engage in research misconduct which often leads to research integrity. This structured review focuses on the ethics and integrity of management research through an analysis of retracted articles published from 2005 to 2016. The study employs a structured literature review methodology whereby retracted articles published between 2005 and 2016 in the field of management science were found using Crossref and Google Scholar. The searched articles were then streamlined by selecting articles based on their relevance and content in accordance with the inclusion criteria. Based on the analysed retracted articles, the study shows evidence of ethical misconduct among researchers of management science. Such misconduct includes data falsification, the duplication of submitted articles, plagiarism, data irregularity and incomplete citation practices. Interestingly, the analysed results indicate that the field of knowledge management includes the highest number of retracted articles, with plagiarism constituting the most significant ethical issue. Furthermore, the findings of this study show that ethical misconduct is not restricted to a particular geographic location; it occurs in numerous countries. In turn, avenues of further study on research misconduct in management research are proposed.

Matched MeSH terms: Ethics, Research*

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