Abstract
Background:
In China, research ethics is a subject of increasingly formal regulation. However, little is known about how nursing researchers understand the concept of research ethics and the ways in which they can maintain ethical standards in their work.
Aim:
The aim of this study is to examine nursing researchers’ perspectives on research ethics in China.
Research design:
We conducted a descriptive qualitative study. Qualitative research methods enabled us to gain an in-depth understanding of nursing researchers’ views on research ethics.
Participants and research context:
We carefully selected and extensively interviewed 28 nursing researchers, nursing faculty, and clinical nurses who had been involved in research or who may undertake research in the future. We collected data between October 2014 and March 2015.
Ethical considerations:
This study was approved by the institutional review boards of Yale University and Central South University.
Findings:
We grouped the data into five categories based on the interviewees’ responses: (1) perceptions of ethics, bioethics, and research ethics; (2) perception of the ethics review process; (3) perception of the function of institutional review boards; (4) the need for comprehensive ethical guidelines for future studies; and (5) ethical challenges faced by the interviewees.
Discussion and conclusion:
This study contributes new insights into nursing researchers’ views on research ethics in China and finds considerable shortcomings in researchers’ understanding and implementation of ethical principles. Intensive educational efforts are needed to provide nursing researchers, institutional review board members, and even study subjects with accurate and up-to-date information and guidance on research ethics. In addition, while Western research ethics theoretically have guided Chinese clinical research for several years, the ways in which nursing researchers have implemented these ethical standards highlight the differences between the Eastern and Western ethical paradigms. This finding suggests the need for ethical standards that are more tailored to the Chinese context.
Introduction
Our study examines the views of nursing researchers located in south central China, on research ethics. This section provides general context for the importance of research ethics as applied to nursing research before turning to nursing research ethics considerations specific to China.
Nursing research contributes to the development of nursing science. 1 Through their research, nurses can disseminate new theories, concepts, and standards of nursing practice. Such research can lead to improved patient care. Because nursing research often involves vulnerable individuals or societal groups—and because most participants in nursing research obtain little or no direct benefit from their participation 2,3 —it is particularly important that nursing research adheres to the principles of research ethics.
Medical and nursing journals are perhaps the most important way that nursing researchers disseminate their ideas. These journals can play an important role in pushing researchers to adhere to ethical principles. 4,5 Increasing numbers of medical and nursing journals require that the studies they publish have addressed ethical considerations and received approval from an institutional review board (IRB) or IRB equivalent. 2,6 –8 However, this requirement is far from universal, 4 and some recent studies highlight failures of medical and nursing research to explicitly address ethical considerations. 2,9,10 In their online review of 1780 articles from five major medical journals, Finlay and Fernandez 11 found that 5.5% of these articles lacked descriptions of measures that were taken to protect participants’ rights, such as whether and how researchers obtained participants’ informed consent. These omissions were not otherwise explained or accounted for in the articles.
A study by Kjellström and Fridlund 2 provides an additional example of inadequate attention to research ethics specifically in nursing research. It analyzed 64 Swedish nurses’ PhD dissertations and found that only 39% of these dissertations claimed the use of ethical principles and regulations, 20% reported the rationale for the study, and 14% reported having a fair participant selection method. Such findings in Western nursing research suggest the potential to fall short of ensuring adequate protection of human subjects through ethics committee oversight and consent processes. Given that Chinese nursing researchers play an increasingly prominent role in nursing science internationally, we believe that it is important to ascertain how this problem is similar or different in China.
In China, nursing research has flourished rapidly over the past decades, as is demonstrated by the increase in new national or regional journals and publications in both Chinese and English. 12 For example, Peng and Hui’s 13 analysis of scientific papers revealed that the number of nursing articles from China increased fourfold between 1999 (50) and 2008 (207), as measured by papers included in the Science Citation Index Expanded that were published by Chinese authors in nursing journals.
The increase in nursing research in China has brought new focus to the question of whether researchers’ work sufficiently addresses ethical considerations. 14,15 Peng and Hui’s 13 research also suggests that articles published by nursing researchers from mainland China were of low quality, as represented by their impact factors and citation reports. One possible reason for these articles’ limited influence is their inadequate attention to ethical considerations in the research process. 16,17 Although a large proportion of nursing publications in China claim that their studies have been reviewed and approved by research ethics committees, the questions of how nursing researchers perceive research ethics concepts and whether they understand how to implement research ethics in their work have not yet been investigated.
Objectives of the study
The objective of this study is to examine the views and experiences of nursing researchers in China with regard to (1) research ethics, (2) the ethics review process for nursing studies, (3) the role and function of IRBs, (4) the need for comprehensive ethical guidelines for future studies, and (5) ethical issues that have arisen in their own studies and how these issues have been addressed.
Methodology and methods
Research design
We conducted a descriptive qualitative study, as qualitative research methods enable us to gain an in-depth understanding of nursing researchers’ perspectives on research ethics. 18 We used semi-structured interviews, a predominant method of data collection in qualitative studies. 18 The research team developed the interview guide, and the project advisor critically examined the interview questions to identify poorly worded, offensive, or biased questions. 19 Interview topics were arranged in accordance with our research purposes.
Sample and settings
The study was conducted at a comprehensive university in the city of Changsha in central south China. The school of nursing at this university is one of the first Chinese institutions to offer a doctoral program in nursing.
The sampling strategies followed two principles of qualitative sampling: appropriateness and adequacy. We maintained appropriateness by selecting our sample from different groups of nursing researchers, which enabled us to explore the topic from different perspectives. Adequacy refers to the sufficiency and quality of the data. 20 Information adequacy was ensured by the completeness and the amount of information collected rather than by the number of participants. Because firmly established criteria for sample size in qualitative studies has not yet been developed, we determined the sample size for our study on the basis of informational needs. 21 For a study that uses qualitative interviews to generate extensive data, Safman and Sobal 22 recommend a sample size between 20 and 30 participants. Using this range as a guideline, we continued data collection to the point of data saturation, at which no new information about the participants’ experiences in or perspectives on research ethics could be collected. 23
We used purposeful sampling to select nursing researchers, nursing faculty, and clinical nurses at the study setting who had been involved in research or may engage in research in the future. We interviewed 28 participants for 20–46 min each, and their answers provided rich and extensive data. The participants in this study included senior nursing researchers who had published academic papers or obtained research grants (n = 15), and junior nursing researchers who had undertaken or may undertake research in the future, including young nursing faculty who were pursuing postgraduate studies (n = 13). We tried to recruit nursing researchers who were involved in ethics review committees (n = 5) and researchers who were working in one of the five affiliated hospitals of this university at the time of our research (n = 6).
Data collection
Before they conducted the interviews, the interviewers were trained in how to build rapport, gain trust, and establish a free flow of information. All interviews were conducted in Mandarin. Two interviews were conducted via Skype, and all others were conducted face-to-face. Most of the interviews (n = 16) were conducted in Changsha, nine interviews were conducted in Beijing during a research training program, and three interviews were conducted in the United States during a research conference. All face-to-face interviews were conducted in a private room. The interview guide served only as a starting point to stimulate the conversation between the participants and the researcher. The interviews began with some general questions about ethics and bioethics, which allowed the participants to talk about their experiences freely and to describe their views as completely as possible. Interviewers used probing questions to encourage participants to elaborate as needed. All of the interviews were recorded using a portable audio recorder.
Data analysis
First, the audio recordings of the 28 interviews were transcribed verbatim in Chinese. Two investigators used content analysis to select, streamline, simplify, and transform the raw data. 23 Through this process, the investigators conceptualized the data and identified patterns and categories, in order to subsequently draw valid and reliable inferences. 19
As shown in Appendix 1, there were three basic steps involved in the data analysis: developing meaningful units, developing a set of categories for those units, and developing the rationale and illustration to guide the coding of data into categories. The data were coded manually, labeling sentences from the interviews in order to identify common themes and various dimensions of the participants’ perspectives on research ethics. 24 The main category was labeled in each paragraph by writing the code in the margin. The labeled paragraphs were cut and pasted onto a large sheet of paper for manual sorting. Relevant phrases or sentences were highlighted to group text portions with corresponding extracts for the final stages of data analysis.
Ethical considerations
Ethical approval was obtained from the Yale University–based IRB and from the Ethics Review Committee of the School of Nursing of the Chinese university. All participants were asked to provide their verbal consent before they participated in the study. The researchers explained the purpose and nature of the study to the participants, who were informed of their right to withdraw from the study at any time and to refuse to answer any question. Confidentiality was pledged, and all participants were assured that privacy would be maintained throughout the study by the use of a coding system rather than the use of their names. All interview data were kept in a locked cabinet, and data were accessible only to the main researchers.
Findings
Five categories emerged from the data: (1) perceptions of ethics, bioethics, and research ethics; (2) perception of the ethics review process; (3) perception of the function of IRBs; (4) the need for comprehensive ethical guidelines for future studies; and (5) ethical challenges faced by the interviewees.
Perceptions of ethics, bioethics, and research ethics
Most of the participants noted that they had not received any professional training in ethics, bioethics, or research ethics. Their thoughts on these issues stemmed from their individual beliefs and personal knowledge. Participants broadly described ethics as encompassing humane conduct, honesty, and societal norms. Some participants also cited respect for the individual and the equality of all people as the core concepts of ethics. A few participants described ethics as obedience to the law and codes of conduct as well as adherence to traditional Chinese values, such as prioritizing social harmony over individual interests. A senior nursing researcher described her understanding of ethics, bioethics, and/or research ethics by saying, Ethics relates to human beings. We have a personal connection with ethics when we are conducting research. You know that the research subjects are human beings, which brings up issues like privacy, harm, and so on. However, in terms of the specific definition of ethics and bioethics, I really have no idea about that. (P(22)48)
Although all participants are active nursing researchers or may engage in research in the future, a few participants demonstrated difficulties in defining and understanding basic issues in research ethics. One participant believed that research ethics is a social science research domain that does not apply to nursing research. This junior researcher described her beliefs in the following way: Actually, I have no experience [with research ethics]. It seems that research ethics has more to do with social science research. Nursing has nothing to do with it. At least, I have no experience in research ethics. (P(06)48)
Perception of the ethics review process
Most of the participants were aware of the ethics review process. They described different practices at their respective institutions, and a few of them described the ethics review process very clearly. As for the institutional differences that the participants reported, an interesting finding was that one nursing school had its own review process that preceded the university-wide IRB process. Researchers would complete an application and the nursing school’s review board would review it before it was submitted to the university review board. In addition, at this institution, participants also were required to present their proposals at a university-wide ethics review meeting.
Other participants described simpler processes of ethics review at their institutions. At these institutions, nursing researchers only were required to submit their proposals to the medical IRB committee, and they obtained notification of their approval at once or in a few days. One participant incorrectly believed that ethical approval was not required for research that only involved students enrolled in the school. She said that she would have to obtain ethics approval when a study involved hospital patients, hospital employees, or community members, but even in these cases, ethics approval from her university was not always required if an external institution approved of the research. She commented on the relationship between ethics approval from her university and ethics approval from an external institution: If your study involves a setting outside of our school—for example, a hospital or a community health center—you need to get approval from the hospital or the community center. If the IRB committee of our university approves the research, but the hospital or the community center does not approve it, you cannot carry out the study. You definitely cannot conduct the study. However, if your research is not approved by our university but approved by the community center or the hospital, you could carry out your study. (P(07)18)
Perception of the function of IRBs
Participants frequently described the purpose of the IRB as providing constraints and supervision. In many institutions, obtaining IRB approval is a compulsory requirement for grant applications and for conducting studies. By applying for IRB approval, researchers are forced to consider seriously the ethical issues involved in their studies. A junior researcher described the function of IRB by saying, I believe that the role of the IRB is to provide constraints. The purpose of the IRB committee is to make all researchers consider the ethical issues before they conduct research. Actually, IRB approval is compulsory. You cannot carry out a study until you receive ethical approval…The IRB forces the researchers to consider ethics. I suppose this practice has helped me to do good research. It benefits both researchers and study participants. (P(1)32) On the one hand, the IRB process protects study participants; on the other hand, it also protects the researcher. Sometimes the purpose of your study is to discover something that was previously unknown, and it is possible that you have not anticipated all the ethical issues that may arise. For example, you may not be able to foresee some unknown side effects of a drug, but through the IRB review process, experts can point out these potential side effects. Thus, I think the IRB plays a protective role in the research process. (P(05)76) Actually, we do not have a very sound system for ethics review. There is only the IRB committee, which is an independent organization. We do not have a very sound system, and there is nobody to review the decisions of the IRB committee. It is possible that the IRB could make mistakes, and sometimes they seem to approve any proposal quite easily. Nevertheless, the IRB review process could also sometimes become a site for workplace politics [i.e., where the IRB members’ personal views about or relationships with the researchers affect their decision-making]. It is a process controlled by people, and thus, it is possible that something [undesirable] will happen. (P(2)14, 104, 108)
Need for comprehensive ethical guidelines for future studies
Data from the 28 interviews indicated nursing researchers’ need for comprehensive guidelines for the research that they may undertake in the future. Participants expressed a desire for comprehensive and updated ethical training to deal with new ethical issues that may emerge in the course of their work. Emerging issues with potential ethical implications included researchers’ need to recruit more study participants, researchers’ need to revise the data collection schedule at the site, researchers’ knowledge of the correct actions to take after failing to protect subjects’ privacy, and researchers’ understanding of the implications of reusing study data without notifying participants. Participants often perceived existing ethics training as extremely inadequate, and they suggested that research ethics training in China should be modeled after the training conducted at top international universities. One junior researcher stated, The ethics course at the university only taught us some basic knowledge about medical ethics. The professors simply introduced us to this area and informed us of some basic professional norms…Well, the relationships between the physician and patient as well as between the nurse and patient are actually very complex. The ethics course did not cover all of these issues and did not apprise us of new advances in ethics and new best practices. For example, it would have been helpful to learn how to identify ethical issues in different scenarios and apply relevant coping strategies as these issues arise. (P(1)12)
Ethical challenges faced by the interviewees
Participants shared that they had encountered many ethical challenges in the course of their work, most of which were associated with China’s social and cultural context. Although some participants were aware of the theoretical need to adhere to ethical guidelines and regulations, they seldom did so because of China’s limited resources and insufficient facilities. This state of affairs is currently accepted as the norm. A junior researcher described the situation by saying, Perhaps because China has a huge population, it is quite difficult to do everything perfectly. Consequently, many researchers do not do very well in terms of adhering to the ethical value of respect for humanity, for instance. But somehow everybody thinks it is okay; even the patients who are mistreated think it is okay. They just get used to being treated in this way, so only patients who have higher levels of education may understand that their treatment is supposed to be different…(P(2)22, 24, 26) For example, every undergraduate student in our nursing school is required to complete a graduation paper. Most of the time, they need to do a pilot study with about 30 study participants. When they carry out this study at the affiliated hospital, they are required to follow a procedure to obtain ethics approval. But sometimes the students believe that following the procedure is too troublesome, and they stealthily do their research at night. In other words, they collect data from patients at night. Some ethics rules are not strictly implemented in China…I found that it is okay if the hospital does not find out the misconduct of the student. The patient does not talk about what happened. The education that we provide on ethical issues is comparatively weak. Although we offer ethics courses, the ethics is not practiced in real-world research. (P(3)56, 58) It is difficult to practice informed consent fully within the current medical environment in China. For example, it is tough to recruit participants if you communicate independently with the study subject…It may be easier to recruit participants with the help of other members of the medical staff. In fact, if you are not already working with the study participants, it may be difficult for you to persuade them to participate. However, this reality also raises the issue of coercion. It is really difficult to balance the need to recruit study participants with concerns over coercion. If you don’t have medical staff working in the hospital to help you approach potential patient participants, the patients may not trust you, and some may even consider you a liar. (P(05)88; 94)
Discussion
This study examined shortcomings in research ethics in the context of the rapid growth of nursing research in mainland China. We found that the nursing researchers in this study only had limited knowledge and understanding of ethics, bioethics, and research ethics; it is worth noting that most nursing researchers in our study do not receive formal ethics training in the course of their higher education.
Our results suggest that the nursing researchers in our study lacked careful consideration of the ethical challenges of their research. For instance, some nursing researchers expressed doubt about the value of research ethics because they considered their research minimally harmful or lacking the potential to cause harm. Nursing researchers also may neglect the interests of research subjects in response to a variety of factors beyond their lack of formal training, including their personal ambitions or career goals and their desire to expedite scientific progress. 25 Although national, regional, and institutional guidelines on ethics, bioethics, and research ethics are available, nursing researchers do not receive sufficient instruction about how to apply ethical principles to actual situations.
Findings from this study showed that nursing researchers’ understanding of ethics is often limited to the need to gain ethical approval from IRBs and the need to complete consent forms. Researchers rarely contacted IRBs for follow-up support on ethical issues that arose in the course of research. These findings echo the concerns that other scholars have raised about the reality that some researchers perceive research ethics as constituting a series of tasks (e.g. completing the required ethics paperwork). 2 This attitude may divert researchers’ attention from salient ethical issues that arise in the research process. We believe that nursing researchers’ knowledge of research ethics should not be limited to rote interactions with the IRBs. Practicing research ethics is essential to nursing research; it is a way to protect the rights and well-being of participants and researchers alike. 2
However, IRBs themselves may sometimes exacerbate rather than alleviate nursing researchers’ lack of knowledge of research ethics. IRBs in China have not always provided sound advice about nursing research, primarily as a result of their limited experience in handling relevant ethical questions. 16 Some IRBs do not have members with substantial experience in nursing research; as a result, nursing researchers do not receive the benefits of a comprehensive discussion of the ethical implications of their studies. 16 As most of the nursing researchers in our sample demonstrated insufficient understanding of the ethical principles related to their work, there is a particularly strong case to be made for establishing IRBs that can provide researchers with more robust guidance.
An additional factor that complicates Chinese nursing researchers’ adherence to ethics guidelines is cultural tradition. China is deeply influenced by Confucian culture, which emphasizes the importance and rights of the community but does not hold individual rights as a core concern. With this Confucian background in mind, Chinese nursing researchers’ practices that deviate from Western ethical paradigms may not be “wrong” or “deficient” in the context of Chinese culture. Most of the concepts, methods, and techniques used to ensure ethical research conduct in China were adapted from Western countries. Currently in China, nursing researchers may not be familiar with or willing to implement these Western principles—for instance, the requirement of informed consent and the right to privacy—in the precise way that these principles are supposed to be implemented. 26
Previous literature has documented the gap between Western guidelines on research ethics and Chinese nursing researchers’ actual practices, which can include activities that would not pass muster under Western ethics guidelines. Examples of such activities are direct participant recruitment from medical records without explicit permission and consultation with the participant’s family to obtain consent. 15,27 However, there are often deep-seated cultural reasons for such behaviors. For example, the Western informed consent standard—which seeks to obtain informed consent from individuals—is arguably ill-suited to the context of Chinese society. On the contrary, a family-oriented decision-making model may be more appropriate as it promotes family harmony, which is the aim of a Confucian society. 25 In a similar vein, some studies have suggested that—in contrast to the individual-centered decision-making process in Western culture—patients in China show great deference to their physician when it comes to medical decisions, a phenomenon that is known as the physician-centered medical paternalism model. 25,28,29 As a consequence, patients are more likely to agree to participate in medical research if their doctor recommends that they do so. 30 In light of this socio-cultural context, most Chinese nursing researchers prefer having physicians and nurses communicate first with the patient participants in the clinical setting. Commenting on bioethics in China, Hennig 16 said, “Although national guidelines are in place, their implementation remains difficult.” We believe that the development of research ethics in China should emphasize current Chinese realities and conditions and combine international concepts with traditional Chinese doctrines. 16
The nursing researchers in our study noted a number of additional influences on the practice of research ethics in China, including relational, community, and societal factors. 31 One participant in our study noted that, even though some researchers understand the ethical requirements for conducting research, they may use as pretext the role of guanxi, or personal relationship in the decision-making process in Chinese society, for the omission of some parts of the ethical requirements. The profit-driven atmosphere of China’s economy arguably has resulted in outcome-oriented practices in nursing research; these practices may engender unethical and irresponsible research behavior. However, current departures from standard research ethics may also indicate that Chinese nursing researchers do not completely agree with Western ethical norms. 32
We would like to note a few caveats to our results. Most of the nursing researchers in our study were trained and are working at the study university. Further research may be required to explore the views of participants with more diverse professional backgrounds. Participants may have felt the need to protect their institution, which may have influenced their openness and truthfulness; participants also might have felt obliged to emphasize how well they adhere to research ethics.
Conclusion
This study contributes new insights into nursing researchers’ perspectives on research ethics in China and reveals that intensive educational efforts are needed to provide nursing researchers, IRB members, and to some extent, study subjects with accurate and up-to-date information and guidance on research ethics. Our study has highlighted some of the possible reasons for this state of affairs, including the lack of comprehensive formal training and continuing education on research ethics, the lack of well-trained nursing researchers and IRB members, and insufficient guidance and support from the IRB throughout the research process. Another major possible reason is the difference between Eastern and Western ethical paradigms. This finding suggests that considerable work is needed to bridge this gap and to develop ethics protocols that are more compatible with the Chinese cultural context.
Footnotes
Acknowledgements
The authors would like to thank the nursing researchers who spent time participating in the study and special thanks to Miss Jessica Hahne for her assistance in reviewing and editing the paper.
Conflict of interest
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Fogarty International Center, National Institutes of Health under Grant No. R25 TW007700 (International Research Ethics Education and Curriculum Development Award (Bioethics) “Research Ethics Training and Curriculum Development Program with China”).
Appendix 1
An example of the analytic procedure.