Developing a Training Program for Healthcare Data Professionals in South Korea: A Needs Analysis.

Research ethics education is critical to developing a culture of responsible conduct of research. Many countries in sub-Saharan Africa (SSA) have a high burden of infectious diseases like HIV and malaria; some, like Uganda, have recurring outbreaks. Coupled with the increase in non-communicable diseases, researchers have access to large populations to test new medications and vaccines. The need to develop multi-level capacity in research ethics in Uganda is still huge, being compounded by the high burden of disease and challenging public health issues. Only a few institutions in the SSA offer graduate training in research ethics, implying that the proposed ideal of each high-volume research ethics committee having at least one member with in-depth training in ethics is far from reality. Finding best practices for comparable situations and training requirements is challenging because there is currently no “gold standard” for teaching research ethics and little published information on curriculum and implementation strategies. The purpose of this paper is to describe a model of research ethics (RE) education as a track in an existing 2-year Master of Public Health (MPH) to provide training for developing specific applied learning skills to address contemporary and emerging needs for biomedical and public health research in a highly disease-burdened country. We describe our five-year experience in successful implementation of the MPH-RE program by the Mbarara University Research Ethics Education Program at Mbarara University of Science and Technology in southwestern Uganda. We used curriculum materials, applications to the program, post-training and external evaluations, and annual reports for this work. This model can be adapted and used elsewhere in developing countries with similar contexts. Establishing an interface between public health and research ethics requires integration of the two early in the delivery of the MPH-RE program to prevent a disconnect in knowledge between research methods provided by the MPH component of the MPH-RE program and for research in ethics that MPH-RE students are expected to perform for their dissertation. Promoting bioethics education, which is multi-disciplinary, in institutions where it is still “foreign” is challenging and necessitates supportive leadership at all institutional levels.

The importance of research ethics (RE) training has led academic and funding institutions to require that students, trainees, and faculty obtain such training at various stages of their careers. Despite the increasing awareness of the value RE education offers, this training requirement is absent in Jordan. We aimed to assess RE education offerings of pharmacy master programs in Jordan and compare with the top-ranked pharmacy graduate programs globally. Therefore, a list of universities that offer research-based pharmacy master programs was created. Each program was evaluated for the inclusion of RE education. A qualitative content analysis approach based on inductive reasoning and latent analysis was followed to analyze the data. Results of the study showed a lack of appropriate RE education for graduate-level pharmacy programs in Jordan with only 40% of the programs partially discuss selected topics related to RE. Regarding pharmacy graduate programs globally, 10% offer a standalone RE course, 40% offer some discussions related to RE, another 10% do not offer RE education in any form, and the remaining 40% of the programs were difficult to assess due to lack of sufficient information available online. Based on the findings of this study, training in RE is tends to be lacking in pharmacy graduate programs in Jordan and globally, with a greater lack in Jordan than globally. There is a need to incorporate formal RE education into programs that do not offer this type of instruction. Programs that formally touch on some aspects of RE need to expand the scope of topics to include more RE-related themes. Integrating a standalone RE course into pharmacy graduate programs is highly encouraged.

Promoting the circulation and sharing of health care data is not only a practical necessity for the advancement of the digital economy, but also a key to achieving the strategic goals of China's health care development. However, the sharing and utilization of China's health care data still face a series of challenges, including unclear allocation of rights and interests of data, breaches of personal privacy, misuse of personal information, and an underdeveloped collaborative mechanism. To overcome these barriers in the era of big data, firstly it is necessary to clarify the rights and interests’ allocation of health care data. Health care data involves three categories of stakeholders: patients, medical institutions, and the public. It is essential to appropriately allocate the rights and interests to health care data among patients, medical institutions, and public health management agencies. From the perspective of effectively utilizing health care data, the rights and interests of patients to their personal health care data are merely an extension of their individual rights and do not include the right to use the data in terms of resource utilization. The rights and interests to use health care data for resource utilization should be granted to medical institutions that actually own or control the health care data. For public health management agencies serving the public interest, only necessary rights and interests should be granted when meeting the needs of the public interest. Secondly, it is necessary to balance the inherent contradiction between sharing and privacy. This requires improving the means by which patients can exercise control over their personal information, establishing a tiered protection mechanism based on the type and sensitivity of health care data, and enhancing the enforcement of health care data regulations to ensure the protection of personal privacy and data security. Ensuring efficient sharing of health data, while respecting individual privacy. Lastly, strengthening the collaborative mechanism for health care data, accelerating the compilation of a health care data resource catalog, and developing universal standards for health care data. From both technical and institutional perspectives, this lays the foundation for the orderly and secure sharing of health care data.
 
 促进健康医疗数据的流通、共享，既是推动数字经济发展的现实需要，也是实现中国健康医疗发展战略目标的关键。然而，中国健康医疗数据共享利用仍然面临数据权益配置不明、个人隐私泄露、个人信息被滥用、协作机制不健全等一系列问题。为了破解大数据时代健康医疗数据共享利用的现实壁垒，首先是要明晰健康医疗数据的权益配置。健康医疗数据涉及患者个人、医疗机构、社会公众三类利益主体，需要妥当配置患者个人、医疗机构和公共卫生管理机构对健康医疗数据的权益。从有效利用健康医疗数据的角度来看，患者对其个人健康医疗数据的权益只是个人权利的延伸，并不包括健康医疗数据资源化利用意义上的使用权。健康医疗数据资源化利用的使用权，应该赋予实际上拥有或控制健康医疗数据的医疗机构。而对服务于公共利益的公共卫生管理机构而言，只应赋予其必要的权益以满足公共利益的需要。其次，还需平衡共享与隐私的内在矛盾，需完善患者个人信息自决的行使途径，健全基于医疗健康数据类型及其敏感性的分级保护机制，并且通过加强健康医疗数据的执法进一步让个人隐私、数据安全得到保证。确保医疗健康数据高效共享的同时，又让个人隐私得到应有的尊重。最后，强化医疗健康数据的协作机制，加快编制医疗健康数据资源目录，制定医疗健康数据通用标准。从技术、制度层面，进一步奠定医疗健�

This study attempted to determine the status of Ph.D. communication education in research ethics. Four areas were examined: coursework offered in research ethics, research issues addressed in the cousework, reading material used in the cousework, and how course instructors acquired their knowledge of research ethics. Results indicate that no Ph.D. communication program surveyed currently devotes an entire course to communication research ethics. Seventy percent of the programs surveyed offered a course partly dealing with research ethics. In these courses, research ethics tended to be discussed 15 percent or less of total course time. Course issues that were and were not discussed in these courses are also examined. In addition, an ethics reading list used in Ph.D. courses is included. Current graduate instruction in communication research ethics is seemingly not extensive. The discussion examines the implications of these findings.

BackgroundThere has been significant effort in attempting to use health care data. However, laws that protect patients’ privacy have restricted data use because health care data contain sensitive information. Thus, discussions on privacy laws now focus on the active use of health care data beyond protection. However, current literature does not clarify the obstacles that make data usage and deidentification processes difficult or elaborate on users’ needs for data linking from practical perspectives.ObjectiveThe objective of this study is to investigate (1) the current status of data use in each medical area, (2) institutional efforts and difficulties in deidentification processes, and (3) users’ data linking needs.MethodsWe conducted a cross-sectional online survey. To recruit people who have used health care data, we publicized the promotion campaign and sent official documents to an academic society encouraging participation in the online survey.ResultsIn total, 128 participants responded to the online survey; 10 participants were excluded for either inconsistent responses or lack of demand for health care data. Finally, 118 participants’ responses were analyzed. The majority of participants worked in general hospitals or universities (62/118, 52.5% and 51/118, 43.2%, respectively, multiple-choice answers). More than half of participants responded that they have a need for clinical data (82/118, 69.5%) and public data (76/118, 64.4%). Furthermore, 85.6% (101/118) of respondents conducted deidentification measures when using data, and they considered rigid social culture as an obstacle for deidentification (28/101, 27.7%). In addition, they required data linking (98/118, 83.1%), and they noted deregulation and data standardization to allow access to health care data linking (33/98, 33.7% and 38/98, 38.8%, respectively). There were no significant differences in the proportion of responded data needs and linking in groups that used health care data for either public purposes or commercial purposes.ConclusionsThis study provides a cross-sectional view from a practical, user-oriented perspective on the kinds of data users want to utilize, efforts and difficulties in deidentification processes, and the needs for data linking. Most users want to use clinical and public data, and most participants conduct deidentification processes and express a desire to conduct data linking. Our study confirmed that they noted regulation as a primary obstacle whether their purpose is commercial or public. A legal system based on both data utilization and data protection needs is required.

Background Regulations on research ethics in France have evolved considerably over the past four years: the implementation of the Jardé law and of the General Data Protection Regulations have changed the landscape of research ethics for research involving or not involving human persons. In a context of creation of an Institutional Review Board at the University of Bordeaux, France, we sought to explore research ethics practices and perceptions in the medical community of our University Hospital. Methods A short questionnaire was sent to all physicians of the University Hospital of Bordeaux. The questionnaire included closed questions and main topics were: physicians’ education in research ethics, ethics practices concerning researches non implying human persons, and physicians’ perceptions about current regulations. Results 86 questionnaires were sent back (response rate: 24.2%). If a majority of physicians have validated Good Clinical Practices (GCPs) trainings (76%), there was a low rate of specific training on fundamental references in research ethics and a high proportion of responders do not consider themselves as educated in research ethics after completion of GCPs (56%). Regulations on research ethics have many implications on medical research, especially by inducing changes in protocols in order to alleviate ethical requirements (57%). Malpractices were acknowledged like false mention of positive opinion from an ethics committee (21%). If If a majority of responders considers regulations as a positive answer to research ethics, a large majority considers it as a constraint and a complexification of research process. For 58%, regulations in research ethics are perceived as a hindrance for research initiatives. Conclusion Because of their impact on research process, regulations seem to constitute a scarecrow for physicians. Lack of training, bad representations and questionable practices (or even malpractices) highlight the need to improve education and to propose concrete guidance for medical researchers.

This study was designed to examine the attitudes of biological scientists concerning research ethics education and the role of government agencies in promoting research ethics. An explanatory letter was sent via e-mail to the members of the Korean Society for Molecular and Cell Biology requesting participants to respond to an on-line questionnaire. Although most respondents claimed to be aware of the main issues in research ethics and the importance of research ethics education, 121 (or 69.1%) of the 175 participants experienced no formal training in research ethics education. The preferred formats for research ethics education among respondents included seminars at research institutes (98 respondents, 56.0%) or college courses at the undergraduate or graduate level (50, 28.6%) for less than 8 hours (117, 66.9%). Data processing and recording (122, 69.7%), authorship (109, 62.3%), and the management of research funds (105, 60.0%) were regarded as the most appropriate topics for education. Sixty-eight respondents (38.9%) reported some experiences with ethical dilemmas in conducting research and 135 (77.1%) showed interest in consulting an ombudsman if available. Chi-square analysis detected significant differences between principal investigators and other researchers concerning specific views on how research ethics education should be implemented in research institutes. To promote research integrity, respondents recommended that government agencies support research ethics education and construct an equitable, reliable, and transparent funding system for research. Jurisdiction and regulatory bodies to investigate research misconduct were also recommended.

In their role as care provider, clinical nurses are involved in research protocols. Although clinical nurses seldom serve as principal investigators, nursing care often is delivered to patients involved in study protocols. This article explores the need for continuing education in research ethics for clinical nurses and offers recommendations for core research ethics education. Professional nursing statements, federal policy, and federal recommendations for improving protection of human participants in research were reviewed to identify areas pertinent to the role of nurses. Continuing education in research ethics is an important component in ensuring protection of human participants in research. Essential research ethics education topics for clinical nurses, including three case studies, are presented. Continuing education that enhances clinical nurses' awareness of the ethical issues involved in research assures nurses have the knowledge and ethical sensitivity needed to act as patient advocates and improves the protection of human rights.

Kazakhstan, Kyrgyzstan, and Uzbekistan are Central Asian, post-Soviet republics in which research ethics education is an underdeveloped field. Broad academic integrity issues are becoming a focus in Central Asia; however, knowledge of human participant research ethics remains scant. This paper explores the availability and understandings of research ethics education in the social sciences in three Central Asian countries. The mixed methods design collected data from internet searches of government and higher education websites, a quantitative online survey, and qualitative interviews. The findings show that research ethics education is not stipulated in national policies. A small number of mainly private higher education institutions provide research ethics education, mainly to students. Education has most frequently occurred within postgraduate research methods, especially in international contexts. The findings suggest that educating researchers about ethical research in these countries is not systematic, despite policies from the state emphasising the importance of research development. The development of a broader, systematic approach to research ethics education is recommended.

Despite the potential value of graduate-level research ethics training, most Middle East countries, including Jordan, do not routinely offer formal research ethics training. In students enrolled in Jordanian master’s level graduate program in pharmacy, the current study assessed: 1- differences in pre- and post-enrollment exposure to research ethics core themes, 2- whether this exposure was through a formal course or in an informal setting, and 3- student attitudes towards research ethics education and the need for integrating a dedicated research ethics course into pharmacy graduate programs. A 12-item on-line survey was developed by the authors and disseminated to a convenience sample of current and former master-level pharmacy students in Jordan. A total of 61 eligible respondents completed the survey. A minority of respondents (38%) acknowledged receiving research ethics training prior to enrollment into a postgraduate pharmacy program with nearly half (16%) describing this training as informal. In comparison, a larger percentage of the total respondents (56%) had received research ethics training during their postgraduate program enrollment, with nearly half of those (25%) indicating that this training was informal. A majority of respondents reported a strong need for integrating a formal research ethics course into postgraduate pharmacy curriculum (90%) to support their research training and thesis writing (89%). Overall, the study revealed a notable lack of research ethics education for graduate-level pharmacy students in Jordan.

IntroductionThe Radiography Research Ethics Standards for Europe (RRESFE) project aimed to provide a cross-sectional view of the current state of radiography research ethics across Europe. This included investigating education and training in research ethics, and identifying the key challenges and potential improvements associated with using existing research ethics frameworks. MethodsThis cross-sectional online survey targeting radiography researchers in Europe was conducted between April 26 and July 12, 2021. Descriptive and analytical statistics were used to identify research ethics education and training trends. Content analysis of qualitative responses was employed to identify significant challenges and proposed improvements in research ethics frameworks of practice. ResultsThere were 232 responses received across 33 European countries. Most (n = 132; 57%) respondents had received some research ethics training; however, fewer participants had received training on safeguarding vulnerable patients (n = 72; 38%), diversity and inclusivity (n = 62; 33%), or research with healthy volunteers (n = 60; 32%). Training was associated with a greater perceived importance of the need for research ethics review (p = 0.031) and with the establishment of EQF Level 6 training (p = 0.038). The proportion of formally trained researchers also varied by region (p = <0.001). Time-to-ethics-approval was noted as the biggest challenge for professionals making research ethics applications. ConclusionEarly and universal integration of research-oriented teaching within the radiography education framework which emphasises research ethics is recommended. Additionally, study findings suggest research ethics committee application and approval processes could be further simplified and streamlined. Implications for practiceThe survey contributes to a growing body of knowledge surrounding the importance of education and training in research ethics for assuring a high standard of research outputs in Radiography and has identified hurdles to obtaining research ethics approval for further investigation and address.

Objectives : The purpose of this study was to examine the professors, who teach the dental hygiene program in Korea, on the awareness of the research ethics education check. And attempt to provide and promote a basic foundation for future research ethics education Methods : Questionnaire survey was carried out targeting 119, who teach the dental hygiene program. The collected data was performed frequency & percentage, independent t-test and one-way ANOVA, Pearson's correlation coefficient and multiple regression. Results : 1. As recognition about research ethics education needs, they expressed the biggest recognition that research ethics education is required(<TEX>$3.66{\pm}0.57$</TEX>) 2. Regarding the correlation between students needs research ethics education and interested research ethics education had a statistically significant correlation of r=0.381 which was the highest correlation factor. 3. Research ethics education taking institutions, 39.4% respondents experienced the biggest national research institutes. 4. Between general characteristics and research ethics education recognition level, they were statistically significantly different with age and major course(p<0.05). 5. The affecting factors on the research ethics education were teaching career and number of articles published as the first author, explained 12.8%(p<0.001). Conclusions : Research ethics education is desperately needed. Therefore I will insist the case based approach in the research ethics education program with the format of a stand course.

BackgroundResearch ethics provides the ethical standards for conducting sound and safe research. The field of medical research in China is rapidly growing and facing various ethical challenges. However, in China, little empirical research has been conducted on the knowledge and attitudes of medical postgraduates toward research ethics and RECs. It is critical for medical postgraduates to develop a proper knowledge of research ethics at the beginning of their careers. The purpose of this study was to assess the knowledge and attitudes of medical postgraduates toward research ethics and RECs.MethodsThis cross-sectional study was conducted from May to July 2021 at a medical school and two affiliated hospitals in south-central China. The instrument of the study was an online survey that was distributed via WeChat.ResultsWe found that only 46.7% were familiar with the ethical guidelines for research with human subjects. In addition, 63.2% of participants were familiar with the RECs that reviewed their research, and 90.7% perceived RECs as helpful. However, only 36.8% were fully aware of the functions of RECs. In the meantime, 30.7% believed that review by an REC would delay research and make it more difficult for researchers. Furthermore, most participants (94.9%) believed that a course on research ethics should be mandatory for medical postgraduates. Finally, 27.4% of the respondents considered the fabrication of some data or results to be acceptable.ConclusionThis paper serves to suggest that research ethics education should be prioritized in medical ethics curriculum, and course syllabi or teaching methods should be revised to provide medical postgraduates with a deeper understanding of the principles, regulations, and specifics of research ethics. We also recommend that RECs provide diverse approaches in their review procedure to facilitate the understanding of medical postgraduates of the functions and processes of RECs and to enhance their awareness of research integrity.

Routinely recorded data from everyday ambulatory medical care are urgently needed for health services and systems research, but this faces major limitations in Germany. In 2018, European General Data Protection Regulation (GDPR) and new German Federal Data Protection Act (FDPA) become effective. Via simulated real-life scenarios it may be possible to find out if access to and utilization of routine data for research becomes easier or faces additional obstacles. General practitioners, information scientists, data trustees and privacy protection experts create concepts, processes and standards for lawful handling of routinely recorded data for secondary research and study their feasibility in 2 scenarios (anonymous and pseudonymous data utilization). From the point of view of technical assessment and privacy protection, technical and organizational obstacles are presented as well as the legal framework. Outdated software interface, insufficient maintenance by software vendors, burdens associated with organization and cost as well as poor IT standards place obstacles to systematic and longitudinal use of healthcare routine data. Future pan-European law for privacy protection will allow research utilization of ambulatory data in principle. However, there are persisting conflicts between individual (fundamental right of privacy protection) and public interests (research for quality and efficiency of public spending; European market's free exchange of goods and services). This becomes evident especially when using routine data via pseudonymization. Neither insurmountable hurdles by privacy protecting law nor a threat from Big Data are currently the major obstacles to secondary utilization of routine data but real-life problems at the technology and operational level. GDPR and FDPA that have become into effect in May 2018 have improved European legal unity and transparency of patients' interests. Tension between privacy protection of data on an identified or identifiable person and scientific utilization and exchange of such data in public interest necessitates additional legal clarification. One possible solution, an advanced and ready-to-use software interface, awaits implementation.

Health-Care Data Collecting, Sharing, and Using in Thailand, China Mainland, South Korea, Taiwan, Japan, and Malaysia