Research Ethics Course Research Articles

An Evaluation of Research Ethics in Undergraduate Health Science Research Methodology Programs at a South African University.

The amended research ethics policy at a South African University required the ethics review of undergraduate research projects, prompting the need to explore the content and teaching approach of research ethics education in health science undergraduate programs. Two qualitative data collection strategies were used: document analysis (syllabi and study guides) and semi-structured interviews with research methodology coordinators. Five main themes emerged: (a) timing of research ethics courses, (b) research ethics course content, (c) sub-optimal use of creative classroom activities to facilitate research ethics lectures, (d) understanding the need for undergraduate project research ethics review, and (e) research ethics capacity training for research methodology lecturers and undergraduate project supervisors.

Opportunities and barriers to enhance research capacity and outputs among academic family physicians in the Arab world.

To explore the current status of academic primary care research in Arab countries and investigate the barriers to its adequate implementation. Research is an essential building block that ensures the advancement of the discipline of Family Medicine (FM). FM research thus ought to be contributed to by all family physicians; nevertheless, its development is being hindered worldwide by several challenges. The amount of research conducted by academic academic family physicians and general practitioners is scant. This phenomenon is more pronounced in the Arab countries. An online questionnaire was emailed to all academic family physicians practicing in member Arab countries of the World Organization of Family Doctors WONCA-East Mediterranean Region. Seventy-six out of 139 academic family physicians from eight Arab countries completed the questionnaire. Around 75% reported that they are required to conduct research studies, yet only 46% contributed to at least one publication. While 75% and 52.6% disclosed their interest in participating in a research team and in leading a research team respectively, 64.5% reported being currently involved in research activities. Of all, 56% have attended a research ethics course. Lack of training in research, the unavailability of a healthcare system that is supportive of research, insufficient financial resources, and the unavailability of electronic health records were perceived as major barriers in conducting FM research. Although many physicians in Arab academic institutions expressed enthusiasm to conduct research projects, FM research infrastructure remains to be weak. This demonstrates the need for immense efforts from different parties particularly governments and academic institutions.

Development and Pilot Testing of a Human Subjects Protection Training Course Unique to Registered Dietitian Nutritionists

Development and Pilot Testing of a Human Subjects Protection Training Course Unique to Registered Dietitian Nutritionists

Building research capacity with members of underserved American Indian/Alaskan Native communities: training in research ethics and the protection of human subjects.

To develop a research ethics training course for American Indian/Alaskan Native health clinic staff and community researchers who would be conducting human subjects research. Community-based participatory research methods were used in facilitated discussions of research ethics centered around topics included in the Collaborative Institutional Training Initiative research ethics course. The community-based participatory research approach allowed all partners to jointly develop a research ethics training program that was relevant for American Indian/Alaskan Native communities. All community and clinic partners were able to pass the Collaborative Institutional Training Initiative course they were required to pass so that they could be certified to conduct research with human subjects on federally funded projects. In addition, the training sessions provided a foundation for increased community oversight of research. By using a collaborative process to engage community partners in research ethics discussions, rather than either an asynchronous online or a lecture/presentation format, resulted in significant mutual learning about research ethics and community concerns about research. This approach requires university researchers to invest time in learning about the communities in which they will be working prior to the training.

An Analysis of Online Courses in Research Ethics in the Fogarty-Sponsored Bioethics Training Programs

Several training programs sponsored by the NIH/Fogarty International Center's International Research Ethics Education and Curriculum Development Program offer online graduate-level courses in research ethics to participants in lowand middle-income countries. This paper describes the evaluation of four of these online courses and recommendations for improvements to achieve the highest-quality design and delivery. We used an evaluation matrix consisting of 95 criteria based on recommended best practices in eLearning. Our results showed that these courses are developing or meeting nearly 73% of the criteria, while they are not meeting approximately 21% of the criteria. Together, one or more of the courses are developing or meeting 89 of the 95 criteria. These results suggest that the necessary skills and expertise exist in these programs to bring all of the eLearning courses close to 100% proficiency by sharing a common set of best practices. This paper is part of a collection of articles analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development Program.

Building Research Ethics Capacity in Post-Communist Countries: Experience of Two Fogarty Training Programs

The post-Communist countries of Central and Eastern Europe and Central Asia are at various stages of development with respect to their capacity to protect human research participants. We examined the impact of two Fogarty-funded programs in this region, the Union Graduate College-Vilnius University Advanced Certificate Program and the Case Western Reserve University Master's Degree Program, by surveying these programs' graduates and by examining alumni activities. Alumni have served in leadership roles on research ethics committees, developed and taught new courses in research ethics, and contributed to scholarship. However, political, social, and economic challenges impede the ability of graduates to maximize their effectiveness. Additional curricular attention is needed in research methodology, policy development and implementation, and the interplay between research ethics and human rights.

Consensus standards for introductory e-learning courses in human participants research ethics

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants...

간호학 전공 대학원생들의 연구윤리에 대한 인식, 자기효능감 및 지식수준*

This study aimed to identify the level of awareness, self-efficacy, and knowledge of research ethics among nursing graduate students. A descriptive survey design was used. A total of 102 nursing graduate students were recruited from one nursing school in Korea. Data collection instruments were developed based on the core instructional areas of Responsible Conduct of Research (RCR) from the Office of Research Integrity at the research team’s institution. Participants completed a self-reported questionnaire consisting of questions on research ethics. The data were analyzed with descriptive statistics using PASW Statistics 18.0 Window program. Participants (mean age=31 years) consisted of master’s (77.5%) and doctoral (22.5%) level students. Only 25.5% of participants had taken a course in research ethics, and 26.5% of participants had experience conducting research as principle investigators. The level of awareness (mean score 2.91 out of 5) and self-efficacy for good research practice (3.15 out of 5) were moderate. The level of knowledge regarding research ethics was low (10.59 out of 16). The area of lowest awareness was ‘protection of intellectual property and patents,’ followed by ‘justifying authorship’;the area of least knowledge was ‘writing research articles,’ followed by ‘criteria for authorship.’ Statistically significant correlations were found between awareness, self-efficacy, and knowledge of research ethics (all p<0.05). These results support the conclusion that educational programs for enhancing awareness, self-efficacy, and knowledge of research ethics for graduate nursing students are needed in order to help students conduct ethically sound research.

간호학 전공 대학원생들을 위한 연구윤리 과목 개발, 운영 및 효과평가

Purpose: This study was conducted to develop and evaluate a research ethics course in a graduatelevel educational program in nursing. Methods: This study consisted of three major parts. First, an initial course was developed based on a review of the existing literature regarding research protocols and the ethical issues involved in research. Second, this initial course was delivered to the graduate students in one nursing program and a quasiexperimental study was applied to evaluate the course. Third, based on an analysis of quantitative responses from the participating nursing students, as well as input from a panel of experts, a final research ethics course was developed for this graduate program in nursing. Results: The initial course involved the following six content areas: the concept of research ethics,bioethics and research ethics, research ethics for the protection of human subjects, statistical analyses in research ethics, ethical issues in publishing and intellectual property, and research ethics in nursing. The quantitative research reports showed a significant increase in the nursing students’ perception, self-efficacy, and knowledge regarding research ethics. Further analyses show that graduate nursing students still need structured course work in order to increase their ability to carry out good research. Additionally, a course in research ethics in nursing was designed as a 1-credit, pass/fail official course consisting of the following five content areas: the concept of research ethics, the protection of human subjects in nursing, data management and research ethics, statistical management and research ethics, and publication and research ethics. Conclusion: This study was carried out to develop and evaluate a course in research ethics for a graduate-level educational program for nursing students.

A Comparison of Online versus On-site Training in Health Research Methodology: A Randomized Study

BackgroundDistance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses.MethodsSubjects: Volunteer Indian scientists were randomly assigned to one of two arms.Intervention: Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical.Main Outcome Measures: Improvement in knowledge immediately and 3-months after course completion, compared to baseline.ResultsBaseline characteristics were similar in both arms (n = 29 each). Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p < 0.001) 3 months after the on-site course, and from 48% to 63% (p = 0.009) after the on-line course. For the on-site Research Ethics course, median score increased from 69% to 83% (p = 0.005), and for the on-line Research Ethics course from 62% to 80% (p < 0.001). Three months after the course, median gains in knowledge scores remained similar for the on-site and on-line platforms for both Biostatistics (16% vs. 12%; p = 0.59) and Research Ethics (17% vs. 13%; p = 0.14).ConclusionOn-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly useful for expanding health research capacity in resource-limited settings.

Scientific dishonesty—questionnaire to doctoral students in Sweden

‘Scientific dishonesty’ implies the fabrication, falsification or plagiarism in proposing, performing or reviewing research or in reporting research results. A questionnaire was given to postgraduate students at the medical faculties...

Web-Based Research Ethics Training for Gerontologists

As part of a Canadian Institutes for Health Research (CIHR)-funded Strategic Training Grant, we have developed and delivered a brief course in research ethics directed toward postgraduate students in experimental gerontology. In this paper, we report on the initial offering, its content and delivery, and student reactions to the course. We conclude with some thoughts for others who wish to develop and evaluate similar courses in the future.

Using Creative Writing Techniques to Enhance the Case Study Method in Research Integrity and Ethics Courses

The following article explores the use of creative writing techniques to teach research ethics, breathe life into case study preparation, and train students to think of their settings as complex organizational environments with multiple actors and stakeholders.

Field Notes

field notes Karen J. Maschke, Associate for Ethics and Science Policy Editor Optimism. "You have to be an optimist here, despite all the odds. Otherwise, pack your bags and leave." That's what Dr. Jean Pape, the founder and director of the first HIV voluntary counseling and testing center in Port-au-Prince, Haiti, told Science magazine last year. Known as GHESKIO (Groupe Haitien d'Etudes du Sarcome de Kaposi et des Infections Opportunistes), the center conducts nearly twenty thousand HIV tests a year and provides free antiretroviral drugs to approximately eight thousand individuals. Its nurses and physicians also treat patients for active tuberculosis, syphilis, chlamydia, and gonorrhea, and its psychologists offer HIV/AIDS and rape counseling. In addition, GHESKIO is one of several global trial sites for three HIV vaccine trials. Haiti has the unfortunate distinction of being the poorest country in the Western hemisphere. Most Haitians do not have formal jobs. Only about half of the population over fifteen years old can read and write, and less than 30 percent of primary school children will reach the sixth grade. Yet every morning and afternoon in Port-au-Prince—where a large percentage of the population live in extreme poverty with no electricity, sanitation, or portable water—children can be seen walking to and from privately run schools wearing their distinctive uniforms and backpacks. A few of those children may grow up to become doctors, nurses, or pharmacists like those in the research ethics course I taught last fall for public health students at the Quisqueya University Medical School. Meeting for nearly ten days in a small windowless classroom at GHESKIO, we examined the ethical issues related to research with humans. After the first day or so—when the students and teacher typically don't know what to make of each other—we settled into a rhythm of lectures punctuated by candid, engaging discussions in English, French, and Creole about informed consent, vulnerable populations, and the ethical challenges of conducting clinical trials in resource-poor settings. Several of the students were GHESKIO physicians involved with the HIV vaccine trials. They provided the rest of us with firsthand accounts of the ethical challenges involved in recruiting vulnerable populations to participate in the trials and in determining whether antiretroviral treatment should be provided during and after trial participation. When the course was over, I realized that I had probably learned more from the students than they did from me: that humans persevere in the midst of chaos and crisis, and that hope for a better future sustains dedicated health professionals in providing services to some of the world's poorest and most neglected people. I look forward to learning more from the students who will be in this year's course, and from the GHESKIO professionals who work day in and day out to prevent disease and improve the health of their patients. Karen J. Maschke, Associate for Ethics and Science Policy Editor IRB: Ethics & Human Research Copyright © 2007 The Hastings Center

생명과학 전공 대학원생을 위한 「연구윤리」강의사례 보고*

A research ethics course for students majoring in biology was developed and offered as an optional course for graduate students in the Department of Biology at Chonnam National University in the fall semester of 2005. The course was intended to serve as a pilot program for a larger research project to develop a research ethics course for students in the biomedical sciences. Among eleven students enrolled in the course, six were in the Master’s program and five were pursuing their doctoral degrees. Topics covered in the course included the following: being a biologist, career development, what to do in a graduate school, the lab community, mentor-mentee relationship, record keeping, data mining, scientific writing, authorship, scientific misconduct, conflicts of interests, research involving animals, human subjects, and the ethics of stem-cell research. For each topic, a general introduction was followed by problem-based discussions among students. All reading materials and cases to be discussed were posted on a web site prior to class. Students were required to read the material and express their opinions at an on-line forum before coming to each class. In the classroom, a pre-designated student would introduce and analyze the cases in order to facilitate discussion. Students actively participated in both the on-line and off-line discussions, especially when the topics were related to their first-hand experiences. The evaluation of the answers to the pre- and the post-course questionnaires showed that the students’ perception of research ethics had changed in such a way that they paid greater attention to the issues of integrity in scientific research. While students were aware of the dominant ethical issues concerning research in biomedical science, before completing the course they were relatively unaware that ethical issues are raised by such things as mentor-mentee relationships and authorship criteria. The problem-based discussion process and the supplementary web-material were regarded positively by the students. In conclusion, as long as enough teaching materials and discussion cases are made available to teachers, a case-based discussion course with on-line supplements can help graduate students increase their ethical sensitivity toward issues of scientific integrity.

Student perceptions of the effectiveness of education in the responsible conduct of research

Responsible conduct of research (RCR) courses are widely taught, but little is known about the purposes or effectiveness of such courses. As one way to assess the purposes of these courses, students were surveyed about their perspectives after recent completion of one of eleven different research ethics courses at ten different institutions. Participants (undergraduate and graduate students, post-doctoral fellows and faculty, staff and researchers) enrolled in RCR courses in spring and fall of 2003 received a voluntary, anonymous survey from their instructors at the completion of the course. Responses were received from 268 participants. Seventy-seven percent of open-ended responses listed specific kinds of information learned; only a few respondents talked about changes in skills or attitudes. The perception that courses did more to provide information than to foster skills or attitudes was verified in quantitative responses (P<0.0001). Over 75% of the respondents specifically noted that courses were useful in preparing them to recognize, avoid, and respond to research misconduct. The two principal findings of this multi-institutional study are that respondents reported: (1) a wide variety of positive outcomes for research ethics courses, but that (2) the impact on knowledge was greater than that for changes in skills or attitudes.

Policy Needs Regarding the Duty to Protect in Epidemiological Research with High-Risk Populations

The paper presents an analysis of policy directives needed to respond to threats of harm (e.g., violence against third parties) that may arise in the course of conducting descriptive epidemiological research with high-risk populations. It identifies two key areas where new policies must be developed to guide researchers conducting such investigations. The paper recommends that: (1) an NIH consensus panel be convened to set standards, analogous to Common Toxicity Criteria (CTC) criteria, to classify the severity of different types of indirect, non-research-related risk; and (2) case-based training modules be developed and incorporated into public health research ethics courses and training programs, to enhance researcher judgments in determining the likelihood of harm in different situations. In addition, researchers, Institutional Review Boards (IRBs) and community advisory groups must consider the issue of staff safety and the effectiveness of available responses to reduce the threat of harm. The author reviews and discusses implications for informed consent and IRB review.

Ethics in exercise science research.

Ethical evaluation is a vital but sometimes neglected component of research policy in the exercise sciences. This article reviews some issues in human research, with particular reference to studies undertaken by the exercise scientist. The typical composition and functions of the research review committee are examined in the context of individual and institutional ethical norms. In multicentre trials, there are often problems in coordinating ethical approval between institutions. On-going monitoring of research may have value in the detection of fraud. A reduction in the secrecy of committee proceedings would allow a closer auditing of the research review process. Authors need to give more thought to developing appropriate research questions. Scarce resources may be wasted because of inappropriate study design or an inadequate statistical analysis of the results. The costs of any proposed investigation must be weighed carefully against possible benefits. Confidentiality is particularly important when collecting data at the worksite or over the internet. Informed consent should be based on a full disclosure of risks; the participant should be competent to understand the nature and magnitude of these risks, and undue pressure to participate in an experiment must be avoided. The opposition to placebo trials expressed in the Declaration of Helsinki requires careful consideration of the use of control groups, since regular exercise is known to benefit health. If research is conducted in under-developed societies, the standards of treatment of the participants should match those expected in developed societies. The publication of findings must be fair and well balanced; examples of fraud and misconduct continue to be reported. Some journals apparently still publish papers, even if they have not received an initial institutional review. Editors should restore meaning to the word 'author', avoid the bias to a publication of 'positive' results, limit the impact of commercial sponsorship on reporting and curtail the current trend to redundant presentations and publications. Development of academic courses in research ethics may help to avoid some of these abuses.

Ethical Values in the Education of Biomedical Researchers

Research is relatively new activity for physicians--scientific medicine and the culture of research that supports it date from only the beginning of this century. Whereas Western physicians have discussed ethical values in patient care for over 2,000 years, true discourse on the ethics of biomedical research has developed only in the last few decades. Instruction in the ethics of biomedical research has become part of the professional development of young doctors even more recently. While the history of ethical reflection on biomedical research has been short, scholarly and professional activity in the field has been intense. Unfortunately, contemporary attention to the ethics of research and the integrity of biomedical science has been prompted not by idealism but by public scandals over abuse of human and animal subjects, reports of scientific fraud, and public concern over an apparent lack of general ethical standards among biomedical scientists.[1] Professional discussion of the ethics of biomedical research has resulted largely from the need to identify, punish, and prevent wrongdoing among researchers. In most instances, this discussion has not meant the creation of new ethical norms, but rather the articulation of previously unwritten ethical standards that became evident only as they were violated. Integrity and ethical responsibility in biomedical research have received particularly serious attention in U.S. universities and medical institutions since 1989. That year the National Institutes of Health (NIH) issued formal requirement that a program in the principles of scientific integrity be an integral part of the proposed research training of any institution that applies for National Research Service Award training grant, funds that support graduate students and postdoctoral fellows in biomedical research.[2] In the years since, administrators and faculty in medical universities have spent significant time and effort developing educational programs in research ethics for physicians in training and graduate students in the biomedical sciences. NIH's order was issued amid profound concern among senior medical researchers, science policy experts, and high-ranking members of government that the informal transmission of ethical norms from teacher to student was not enough in today's complex world of biomedical research. The growing emphasis on formal instruction in ethics is intended as corrective to the past generation's more exclusive concentration on trainees' technical skills and research productivity. By requiring young researchers to study ethics as an essential tool of their work--just as they might study statistics--NIH called for the ethical standards of biomedical science to be formalized, analyzed, and taught deliberately. In seeking to meet NIH's requirement, many schools have struggled to define essential professional values in research and determine what core curriculum expressing these values should contain. The ethic, al issues facing physician researchers are widely recognized: the humane and respectful use of human and animal subjects in research; the proper maintenance of data and records; conflicts of interest; self-deception and fraud; the definition of intellectual property in authorship, publishing, and patenting; and the scientist's relationship with peers, students, teachers, funders, and society at large. However, there is still work to be done in articulating the ground on which to address specific ethical problems in biomedical research as well as in devising effective methods for ethics instruction. The Source of Ethics in Scientific Research The first intellectual challenge in designing an educational program in the ethics of biomedical research is to define what is meant by ethics. Many courses in medical and research ethics begin with an overview of the fundamental theories and methods of philosophical ethics, which they later apply to the specific problems of the field. …

A Course in Research Ethics for Graduate Students

An important goal of graduate education is for the students to develop an internal set of ethical standards that will guide them throughout their professional careers. Several recent examples of apparent ethical misconduct within the academic community have raised questions about our ethical stan dards in general. There have been allega tions that dissertations, books, or journal articles have been based on falsified or plagiarized materials, that individuals have inappropriately manipulated or overstated the significance of research data, and that unsubstantiated informa tion has been presented prematurely to the public. These cases have involved graduate students, postdoctoral fellows, and nationally recognized scientists and scholars. Although most instances of mis conduct have been in biom?dical research, others have occurred in fields such as history and religion. These apparent lapses in ethical behav ior have been extensively reported in Sci ence, Nature, and The Chronicle of High er Education, as well as in major newspapers and newsmagazines. The resulting pressure from the media and the Congress on the academic community for public accountability has led to an intense