Navigating the ethical world of clinical researchers in China: challenges and pathways for improvement

Abstract

Background

Over the past decade, China has witnessed a sharp increase in clinical trials, exceeding 4,000 in 2023. Yet, this growth has brought emerging ethical challenges and concerning researcher misconduct. Despite growing scholarly attention to clinical trial regulation, a critical knowledge gap remains regarding the ethical world of clinical researchers. This study investigates ethical challenges in clinical research, their contributing factors, and pathways for improvement.

Methods

The research design involved mixed methods, specifically a nationwide questionnaire survey (quantitative) and semi-structured interviews (qualitative). Using stratified random sampling from China’s Clinical Trial Registry (ChiCTR), 1,800 questionnaires were distributed and 287 valid responses analyzed descriptively with SPSS 22 to identify key challenges. Subsequently, 37 clinical researchers were interviewed, and transcripts thematically analyzed with NVivo 11 to explore underlying causes and triangulate the survey findings, thereby identifying potential pathways for improvement.

Results

The descriptive analysis of the questionnaire results, triangulated with interview findings, reveals that general misconduct is common despite the rarity of severe violations; ethical behavior often lags behind ethical cognition and attitude; researchers show blunted moral sensitivity; and most adopt a passive stance toward ethical compliance rather than active engagement. The thematic analysis identifies two core contributors to these challenges: individual factors—including personal traits, dulled moral sensitivity, limited ethical knowledge, and low ethical awareness; and environmental factors—including weak ethical oversight, an inadequate ethical climate, unhealthy research competition, and researcher-subject knowledge asymmetry.

Conclusions

Ethical challenges in China’s clinical research persist due to the interaction of personal ethical limitations and structurally weak oversight systems. To mitigate these challenges, a dual approach is proposed, integrating internal moral cultivation and external oversight. Internally, efforts should focus on creating an ethical space for dialogue, promoting moral consensus, fostering ethical identity and sensitivity, and cultivating a sense of ethical responsibility through moral practice. Externally, improvements are needed in post-approval ethical monitoring, targeted training programs, research climate, and public understanding of clinical trials and ethics.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12910-025-01298-y.

Introduction

Growth of clinical trials and regulatory efforts in China

China has experienced unprecedented growth in clinical research over the past decade. The country’s share of global clinical trials increased from 3% in 2013 to 28% in 2023 [1], with 4,300 newly registered trials in the Chinese Clinical Trials Register (ChiCTR) in 2023 alone [2]. This rapid expansion in ethically complex research areas has been accompanied by concerning misconduct incidents, as evidenced by the 2018 gene-edited babies case [3] and an alarming increase in biomedical publication retractions, particularly after 2019 [4].

In response, China has strengthened ethical governance by establishing comprehensive regulatory frameworks, notably issuing the 2016 Ethical Review Measures for Biomedical Research Involving Humans [5] and the refined 2023 Ethical Review Measures for Life Sciences and Medical Research Involving Humans [6]. These regulations require establishing institutional ethics review committees at secondary or above medical institutions, providing ethics training for research personnel, and implementing formal approval processes.

Existing ethical gaps

Despite these regulatory advances, implementation gaps persist. A 2022 study of 107 Chinese ethics committees found that 21 lacked tracking mechanisms, only 33 conducted public education, and merely 25 obtained ethics accreditation [7]. More concerning, a 2020 nationwide survey by the Chinese Academy of Medical Sciences (CAMS) and Chinese Academy of Science and Technology for Development (CASTED), involving 11,164 medical researchers, revealed that 44.5% had never Heard of the Belmont Report, 27.7% were unaware of the Nuremberg Code, and nearly 20% believed ethical violations were common [8]. These findings give rise to three key questions:

1. What are the current challenges in the ethical world of clinical researchers in China?

2. What factors contribute to their ethical misconduct?

3. What pathways can be identified to address these challenges and enhance ethical practice?

Relevant concepts

Ethical world

The term ethical world was first introduced by Hegel in his Phenomenology of Spirit [9], where he states, “The living ethical world is Spirit in its truth;. an essence which is present and actual through the action of the self.” In recent years, it has been increasingly discussed in academic literature. Fan Hao, for example, proposes an “ethical world outlook” [10], which views the world through an ethical lens. He emphasizes the need to build a spiritual home in China, grounded in ethics as its cultural core and enriched by an ethical spirit. Within this framework, the ethical world of clinical researchers can be understood as the moral and ethical values embedded in their research practices, reflecting a unique dimension of their professional culture.

Moral sensitivity

Moral sensitivity, also known as ethical sensitivity [11], refers to an individual’s awareness of how their actions affect the well-being of others [12]. Over time, this concept has been expanded to encompass the capacity for empathy and role-taking [13, 14], the ability to interpret others’ emotions and reactions [14], the competence to make appropriate moral decisions [15, 16], and the understanding of how one’s behavior impacts others [17]. A lack of sensitivity to others’ needs may lead individuals to act immorally [18]. Moreover, people may hold morally sound intentions yet still behave unethically without recognizing it. In the context of clinical research, diminished moral sensitivity may contribute to researchers’ ethical misconduct during trials.

Research misconduct

The ethical world of clinical researchers faces considerable challenges, many of which originate from research misconduct. Although such misconduct is widespread, there is no universally accepted definition of the term [19]. Definitions vary in scope, ranging from narrow to broad. The narrow definition refers only to gross ethical violations, while the broader definition includes a wide range of practices in clinical research that may infringe upon participants’ rights or pose risks to their safety.

Causal factors to research misconduct

David B. Resnik (2020) proposed two key theories related to ethical behavior: the “bad apple” theory and the “imperfect environment” theory [20]. According to the “bad apple” theory, while most scientists maintain high moral standards, a small number—those who are morally corrupt, financially desperate, or psychologically unstable—are more likely to violate ethical norms. If left unaddressed, these “bad apples” can exert a corrosive influence, undermining the integrity of the research environment. The “imperfect environment” theory, on the other hand, attributes misconduct to institutional factors such as pressures, incentives, and constraints. Ethical misconduct in research is thus generally viewed as the result of interactions between individual and environmental factors.

Existing literature identifies various individual-level contributors to ethical misconduct, including personality traits perceived as character flaws (e.g., impatience, laziness, and irresponsibility) [21], excessive ambition for fame and recognition [22], personal living conditions [23], gender [24], and career stage [25]. Environmental factors include insufficient institutional guidance [26], inadequate research oversight [27], a highly competitive research climate [28], reward and punishment mechanisms related to research ethics [29], negative influences from peers and superiors [30, 31], and sociocultural differences [32].

The three concepts—ethical world, moral sensitivity, and research misconduct—form the theoretical foundation of this study, offering both philosophical and practical dimensions for examining ethical challenges in clinical research. This framework guided our research design, survey development, interview protocols, and data analysis throughout the study.

To date, few studies have examined the ethical world of clinical researchers in China. Existing research is largely limited to descriptive surveys and rarely explores the underlying drivers of ethical misconduct or offers pathways for improvement. This study addresses these gaps by analyzing data from a nationwide questionnaire and semi-structured interviews, aiming to identify key challenges and propose strategies to enhance ethical practices among clinical researchers.

Methods and instruments

Study design

We conducted a mixed methods study that combined both quantitative and qualitative approaches to capitalize on their complementary strengths [33]. The flowchart illustrating the procedures of the convergent mixed methods study is presented in Fig. 1.

Fig. 1.

Flowchart of the mixed methods study process

As shown in Fig. 1, quantitative and qualitative data were collected concurrently. The survey and interviews were conducted from July 2022 to January 2023. Descriptive statistical analysis of the questionnaire data was performed using SPSS 22, while interview transcripts were coded at three levels using NVivo 11.

This study focuses on the medical research community because medical researchers are the primary implementers of clinical trials and are directly subject to clinical research ethics oversight. The nationwide distribution of questionnaires enhanced the representativeness of the study sample, while one-on-one semi-structured interviews facilitated a deeper exploration of the ethical challenges in clinical research in China.

Online survey instrument and participants

In this study, a stratified random sampling method was used to select participants from the ChiCTR. Medical researchers from Secondary Grade A or higher-level hospitals who had participated in at least one human biomedical research project were eligible. Stratification was conducted by province, covering 31 mainland administrative regions. The number of samples drawn from each province was proportionate to the number of medical staff in secondary and higher-level hospitals in that region. A total of 1,800 questionnaires were distributed via email, and 287 responses were returned and all met the inclusion criteria and completed the key items for analysis, resulting in both a response rate and a compliance rate (i.e., valid response rate) of 16%.

As this was an exploratory study with no prior empirical data or effect size estimates available, no formal sample size calculation was performed. The valid response rate was 16%, which may raise concerns about potential non-response bias. The reasons for the relatively low response rate are further discussed in the Limitations section of the paper. To preliminary assess this possibility, we compared basic demographic characteristics between early respondents (those who completed the survey after the initial invitation) and late respondents (those who responded only after reminder emails). No significant differences were observed between the two groups, suggesting minimal observable response bias. This approach is commonly applied in survey research as a proxy for evaluating non-response bias, under the assumption that late respondents may resemble non-respondents more closely.

The questionnaire was developed by the research team, and a pilot study involving 23 medical researchers was conducted under the guidance of two medical ethics experts. Based on feedback from the pilot and expert recommendations, the questionnaire was substantially revised. The final version employed a five-point Likert scale. A reliability test yielded a Cronbach’s alpha of 0.866, indicating high internal consistency.

The questionnaire consisted of eight sections: demographic information, ethical cognition, ethical attitude, ethical behavior, moral sensitivity, regulatory environment, research climate, and ethics education (see Supplementary File).

Table 1 presents the demographic characteristics of the questionnaire respondents. The gender distribution is nearly balanced, with 49.5% male and 50.5% female participants. A majority hold advanced academic degrees: 56.4% hold doctoral degrees and 36.9% hold master’s degrees, totaling 93.3%. Most respondents have senior or intermediate professional titles, with 53.7% holding senior and 28.2% intermediate titles. Additionally, 93.4% of respondents are affiliated with tertiary grade A hospitals. Regarding clinical trial experience, 38.7% have participated in 1–3 projects, 18.1% in 3–5 projects, and 43.2% in more than five projects.

Table 1.

Demographics of questionnaire respondents (N = 287)

Item	Category	N	Percentage (%)	Item	Category	N	Percentage (%)
Gender	Male	142	49.5	Professional title	Junior	52	18.1
	Female	145	50.5		Intermediate	81	28.2
Age (years)	30 and below	39	13.6		Senior	154	53.7
	31–40	124	43.2	Academic degree	Associate’s	1	0.3
	41–50	84	29.3		Bachelor’s	18	6.3
	51–60	37	12.9		Master’s	106	36.9
	Over 60	3	1.0		Doctorate	162	56.4
Trials participated (n)	1–3	111	38.7	Hospital rank	Tertiary Grade A	268	93.4
	3–5	52	18.1		Tertiary Grade B	8	2.8
	5	124	43.2		Tertiary Grade C	1	0.3
					Secondary Grade A	10	3.5

A tertiary hospital is equivalent to a tertiary referral hospital and a secondary hospital is similar to a regional or district hospital in western countries

Semi-structured interview instrument and participants

The semi-structured interviews were conducted following the “case study logic” proposed by Professor Mario Small of the University of Chicago’s Department of Sociology [34]. Under this approach, different respondents may be asked different questions, and subsequent questions are adjusted based on the responses of previous interviewees. Representativeness of interviewees is not required, as each participant’s answers offer valuable insights into the research questions. The interviews continued until the key questions had been sufficiently explored, at which point data collection was concluded.

Respondents who voluntarily provided their contact information at the end of the questionnaire were invited to participate in the semi-structured interviews. The interviews focused on four core areas: medical researchers’ attitudes toward clinical trial ethics, their moral sensitivity, common types of ethical misconduct in clinical trials, and contributing factors to such misconduct (see Supplementary File).

A total of 37 medical researchers participated in the interviews, including 9 early-career researchers with limited clinical trial experience. Ultimately, 28 complete interview transcripts were obtained, with each interview lasting between 20 and 30 min. All interviews were audio-recorded, transcribed verbatim, and de-identified prior to analysis. The transcripts were then thematically analyzed using NVivo 11 by two researchers independently. Discrepancies in coding were resolved through discussion and consensus.

The demographic characteristics of the interviewees are presented in Table 2. Participants were drawn from various provinces across China’s four major regions: eastern, central, western, and northeastern. They ranged in age from 30 to 55 years and Held professional titles spanning junior, intermediate, and senior levels. Their clinical trial experience varied widely, with the number of projects ranging from 1 to 20.

Table 2.

Demographics of interviewees (N = 28)

Item	Category	N	Item	Category	N
Gender	Male	13	Age (years)	31–40	12
	Female	15		41–50	10
				51–55	6
Trials partici- pated (n)	1–3	6	Region	Eastern China	11
	4–5	5		Central China	7
	6–10	8		Western China	6
	> 10	9		Northeast China	4

Interviewees expressed diverse attitudes toward research ethics, with some demonstrating strong support and others showing resistance. The sample included both directors of internationally accredited medical ethics committees and early-career researchers new to clinical studies. Their experience with ethics training also varied considerably—from those who attended the earliest rounds of GCP (Good Clinical Practice) training in China to those who had participated in only a single session.

Data analysis

This section integrates the results of both quantitative and qualitative analyses to examine the ethical world of clinical researchers and the factors contributing to research misconduct. The coding procedure for the qualitative data is outlined as follows:

1. Open coding The tertiary-level codes in the open coding phase were generated from the first-hand interview transcripts. Through the analysis of 28 interviews, 36 tertiary nodes related to causal factors were identified. Examples of the open coding results are presented in Table 3.

2. Axial coding Using NVivo 11, the 36 tertiary-level codes were categorized into 8 secondary-level nodes. These secondary nodes were derived through further induction and integration based on qualitative analysis of the initial codes. Axial coding involved an iterative process of constant comparison and refinement of the tertiary codes. The final results are presented in Table 4.

3. Selective coding To identify the core category, the eight secondary nodes derived from axial coding were further abstracted into two overarching categories: individual factors and environmental factors.

   Individual factors relate to researchers’ personal traits, insufficient ethical knowledge, low ethical awareness, and diminished moral sensitivity. Environmental factors refer to external conditions such as researcher–participant knowledge asymmetry, an inadequate ethical climate, unhealthy competition, and weak oversight mechanisms.

   Among these, four nodes account for 72% of all references: “insufficient ethical knowledge” (individual factor), and “researcher–participant knowledge asymmetry,” “unhealthy competition in research,” and “weak ethical oversight” (environmental factors). These themes exert the greatest influence on ethical misconduct and are therefore identified as the core categories contributing to ethical challenges among clinical researchers. A detailed analysis of these factors is provided in the following section.

4. Coding saturation test No new themes emerged after coding the 24th interview transcript. To ensure saturation, four additional interviews were analyzed, but again, no new categories were identified. This confirmed that the contributing factors to ethical challenges in clinical research had been comprehensively captured. In other words, thematic saturation was reached, and the interview process was concluded accordingly.

Table 3.

Examples of open coding

Excerpts from interview transcriptions	Tertiary node
“Sometimes, a medical researcher infringes on participants’ rights inadvertently—they don’t even realize they’ve done it.”	Inadvertence
“There is a lack of ethical training for researchers. Clinical research is not something that can be simply done by doctors. It must go through rigorous scientific training.”	Lack of ethical training
“After ethical approval, no one really comes to oversee it. How you performed in the clinical trial or whether you obtained informed consent…No one cares.”	Inadequate research oversight
“Some people don’t understand ethics; they think it’s too complicated and unnecessary. But I believe it’s important to raise awareness, so researchers can realize that ethics benefit not only the participants but also themselves—that’s when they’ll take it seriously.”	Insufficient understanding of ethics
“There is a lack of policy and legal norms for some clinical trials, and the ethical requirements for a more specified field of study need to be refined.”	Lack of ethical norms
“Some trials of drugs and medical apparatus often involve interests. They are a bit complex and there is such a thing as transfer of benefits.”	Transfer of benefits
“The research cycle is short and the time is tight … which makes some researchers can’t wait to start clinical studies until ethical approval is obtained.”	Short research cycle
“Favors, such as helping the graduate student of your colleagues to collect blood and pathological specimens without informed consent from subjects…”	Consideration of personal connections
“To reduce the impact of the unethical behavior, some departments or hospitals tend to downplay the wrongdoing. Some hospitals even pay for the misconduct and try to cover it up.”	Hospital cover-up

Table 4.

Examples of axial coding

Secondary node	Tertiary node
Personal traits of researchers	Researcher qualification, sense of responsibility, personal values, obsession with technology
Insufficient ethical knowledge	Researchers’ unfamiliarity with the content of research ethics and ethics-related policies, unfamiliarity with normative ethical practices, lack of basic knowledge of laws and regulations, insufficient understanding of ethics, lack of ethical training
Low ethical awareness	Lack of ethical awareness, researchers’ regarding ethical review as time-wasting, muddle-along attitude towards ethical review, applying for ethical review only to go through the procedure, consideration of personal connections, taking a chance on misconduct
Blunted moral sensitivity	Failing to effectively identify specific ethical issues, inadvertently violating ethical norms
Researcher-subject knowledge asymmetry	Subjects’ noncompliance with the trial protocols, distrust in the researchers, or instinctive resistance to clinical trials; researchers’ exploiting expertise to circumvent ethical review, assuming that the subjects lack understanding, or operating within the inherent medical knowledge gap
Insufficient ethical climate	Transfer of benefits, corporate rent-seeking activities, colleague influence, hospital cover-up, limited status of ethics committees within hospitals, limited hospital support for research ethics work
Unhealthy competition in scientific research	The pressure of research output, promotion pressure, short research cycle, insufficient research funding, inappropriate evaluation system
Weak ethical oversight	Lack of monitoring and supervision, unclear ethical management bodies, deficient ethical norms, inadequate construction of ethics committees, long cycles, one-size-fits-all approach to ethical management, formality in primary hospitals, lack of democratic procedures in meetings, scarce qualifications of committee members

Results

Challenges in the ethical world of clinical researchers

General ethical misconduct is prevalent, while severe violations remain infrequent

In the questionnaire, when asked “In your observation, how common is it for doctors to neglect the protection of subjects’ rights?”, only 21.28% of respondents selected “never occurs”. And to the question “Is it common for doctors around you to neglect the rights (such as decision-making, informed consent, privacy) in clinical trials?”, only 4.26% chose “never occurs”. These results indicate that everyday ethical misconduct is widespread among clinical researchers in China.

Consistent with the survey findings, interviews further revealed the most frequently observed forms of ethical misconduct in clinical research, as summarized in Table 5.

Table 5.

Common ethical misconduct by stage in clinical research in China

Research process	Misconduct
Research design	Research participants (e.g., graduate students) failing to receive proper scientific training; Failing to register the clinical trials in public databases before recruitment;
	Relaxing eligibility criteria to recruit participants (e.g., enrolling subjects who do not meet inclusion or exclusion standards to expedite project completion)
Recruitment	Recruitment materials misleading subjects (e.g., implying that the test drug is healthy, safe, and can cure diseases); Enticing subjects with reimbursement; Conducting clinical trials secretly without recruitment and failing to inform the patients before signing the informed consent.
Informed consent	Failing to inform objectively (e.g., repeatedly emphasizing the free charge of drugs and subsidies while circumventing the key point); Going through informed consent as a formality with the only purpose to obtain the signature; Failing to obtain consent with signature.
Clinical trial	Collecting additional specimens without informing participants with the intention of using them for other research; Simply ignoring minor adverse effects during clinical trials; Failure to document the trial process; Carrying out clinical research without ethical approval.

Although general ethical misconduct is widely perceived to be prevalent among clinical researchers—particularly during the recruitment and informed consent processes—serious violations remain relatively rare.

Few researchers would cross the red line in human trials under regular procedures. The real issue lies not in overt misconduct, but in the multitude of grey zones… (Interviewee 2).

These “grey zones” refer to ethically ambiguous areas in clinical research that are not explicitly prohibited by formal regulations, yet deviate from ideal ethical standards — such as habitual shortcuts, informal norms, or pragmatic compromises made in practice.

Ethical violations mainly occur during the informed consent process. Some physicians lack objectivity when presenting information. They often overemphasize incentives such as free medication and patient subsidies, while failing to clearly explain the nature of the study. (Interviewee 16)

The ethical challenges faced by clinical researchers are often compared to an iceberg: while severe misconduct is highly visible—like the tip above water—everyday violations remain largely hidden beneath the surface. This routine but under-reported actions can accumulate over time and lead to substantial ethical harm.

Ethical behavior lags behind ethical cognition and attitude

To truly uphold research ethics in practice, researchers must align their ethical cognition (what they know), ethical attitude (what they value), and ethical behavior (what they do). In this study, ethical cognition refers to researchers’ awareness of ethics review institutions, ethical norms, and review procedures. Ethical attitude reflects their views on the importance of Institutional Review Boards (IRB), informed consent, and relevant regulations. Ethical behavior involves their actual compliance with ethical guidelines, execution of informed consent procedures, and observations of peer conduct.

The survey data revealed significant disparities across these three dimensions. Researchers scored highest in ethical attitude (mean Likert score = 4.57), followed by ethical cognition (4.16), while ethical behavior received the lowest score (3.79). These results suggest that despite having strong ethical awareness and positive attitudes, many researchers fall short in applying these principles consistently in practice — indicating a behavioral gap in the implementation of research ethics.

Interview data further corroborate this gap between ethical understanding and actual behavior. With regard to ethical attitude, participants generally acknowledged the importance of research ethics:

The hospital has always emphasized it… and we have studied it ourselves. We know research ethics is indeed very important. (Interviewee 7)

In terms of ethical cognition, many researchers demonstrated an awareness of ethical principles, institutional review procedures, and relevant norms:

Overall, researchers are quite confident in their level of understanding of clinical trial ethics… (Interviewee 13).

At the behavioral level, however, deviations from ethical norms were still observed. As one interviewee noted:

Sometimes, they might use discarded blood samples for our research projects without patient consent…(Interview 18).

This disjunction between knowledge, attitude, and practice reveals a critical issue in medical research ethics: even when researchers are aware of ethical standards and express positive attitudes toward them, their actual practices may still fall short. Various contextual pressures or perceived practical considerations may contribute to this inconsistency, underscoring the need to better align ethical awareness with ethical conduct.

Medical researchers exhibit diminished moral sensitivity in clinical research

Findings from the questionnaire reveal concerning trends that suggest a blunting of moral sensitivity among medical researchers. Only 27.9% of respondents reported that they are “always” aware of the ethical issues they may encounter during clinical research. Of particular concern is the limited attention paid to the well-being of research participants: merely 20.9% stated they “always” recognize how their research directly or indirectly impacts others. In addition, only 14.1% consistently express concern about whether participants might feel offended, and 21.4% reported “always” feeling prolonged guilt when participants are not treated appropriately. This reduced emotional responsiveness to ethical lapses further underscores a decline in moral sensitivity within the research environment.

Qualitative interview data further reinforces this pattern. As interviewee 1 observed, “Serious adverse effects tend to attract attention… but when it comes to minor ones, people are more likely to turn a blind eye.”

This suggests a general dulling of moral sensitivity among medical researchers, particularly in recognizing and responding to more subtle or less visible ethical concerns. Such diminished sensitivity may lead to the neglect of ethically significant issues that, while not immediately obvious, are nonetheless critical for upholding research integrity and protecting the rights and well-being of participants.

Most clinical researchers passively accept rather than actively uphold research ethics

Over the past three decades, the ethical review system for clinical trials has been widely implemented in China, contributing to increased awareness of research ethics within the medical research community. However, this awareness remains largely procedural. Researchers often comply with ethical requirements to fulfill institutional expectations, rather than out of genuine ethical commitment. As a result, adherence to ethical norms often reflects passive compliance rather than active ethical engagement.

The survey results show that only 34.1% of medical researchers take active measures to protect research participants beyond merely fulfilling ethical norms and IRB requirements. The majority tend to equate research ethics with procedural obligations—such as submitting review applications and obtaining informed consent—while lacking proactive ethical reflection on the actual protection of participants.

Similarly, over half of the interviewees observed that many clinical researchers approach ethical review as a procedural obligation rather than a reflection of ethical commitment, primarily complying due to institutional mandates. As interviewee 6 put it: “…because without ethical review, research cannot begin… without ethical approval, papers cannot be published.”

Some clinical researchers have begun to recognize the importance of medical ethics; however, their understanding often remains limited to the procedural aspects of ethical review, lacking ethical autonomy and a deeper understanding of research ethics. As interviewee 5 recalled:

In 2010, when I participated in my first medical ethics committee defense as a graduate student, I felt it was just a formality… It wasn’t until 2020, when I started leading my own projects, that I gradually realized the importance of medical ethics. Beyond obtaining hospital ethics approval, I also had to register with the NHC and the ChiCTR.

Given the large number of medical researchers in China and significant regional disparities in clinical trials, adherence to research ethics will remain in a transitional phase for some time—shifting gradually from procedural compliance toward a more substantive commitment to protecting research participants.

Contributing factors to ethical challenges

Based on the coding results and prior analysis, the primary contributing factors to ethical challenges among clinical researchers—which may lead to ethical misconduct—can be classified into two categories: individual and environmental. This classification aligns with David Resnik’s theoretical framework, which attributes misconduct to both “bad apples” (individual failings) and an “imperfect environment” (systemic shortcomings) [20].

Individual factors

Ethical misconduct among medical researchers is influenced by various individual-level factors, including:

1. Personal traits of medical researchers, such as qualifications, sense of responsibility, and personal beliefs, which may predispose individuals to research misconduct and are often difficult to identify and address. As Interviewee 1 put it, “Some people are really passionate about research; they get so obsessed with it that they end up with misconduct, just for the sake of the research.”

2. Blunted moral sensitivity, which is reflected in the inability to clearly identify specific ethical issues or recognize violations of ethical norms. Interviewee 10 confessed, “We know the basics of ethics, but when it comes to real-world situations, we don’t always think too much about it. Sometimes, we see misconduct by our colleagues but just turn a blind eye.”

3. Insufficient ethical knowledge, referring to medical researchers’ lack of understanding about research ethics and unfamiliarity with the specific practices of ethical norms. Interviewee 5 observed, “Especially younger researchers, they care too much on results or their own goals, so they ignore the ethical stuff in medicine.”

4. Low ethical awareness, mainly reflecting researchers’ passive attitude toward research ethics and a tendency to bypass ethical review. Interviewee 3 explained, “Some researchers just don’t get why ethical review matters. They’re so focused on their research that they see the review process as just getting in the way.”

It is worth noting that Chinese clinical researchers in this study rarely attributed ethical misconduct to individual character flaws—a central claim of the “bad apple” theory. Technology-obsessed science enthusiasts and researchers with moral deficiency accounted for only a tiny proportion of reference nodes, suggesting that participants did not view such individuals as representative causes of ethical misconduct.

One possible explanation, as reflected in interview narratives, is that personal misconduct is often perceived as inconsistent with professional and cultural expectations surrounding medical practice. For instance, some interviewees referred to the widely recognized Chinese saying Yizhe Renxin (医者仁心, literally, “a doctor should have a benevolent heart”), which is rooted in traditional Confucian thought. While such phrases are normative—reflecting how medical professionals ought to behave—they may nonetheless shape how researchers perceive their roles and ethical responsibilities. As one participant remarked:

Yizhe Renxin. No one wants to do bad things on purpose…There are very few really bad people. I think the reasons for ethical misconduct among medical researchers are probably these three—lack of attention, lack of understanding, and lack of awareness… (Interviewee 21).

Environmental factors

The environmental contributors to ethical misconduct can be summarized as follows:

1. Weak ethical oversight This study identifies inadequate ethical oversight as the primary environmental contributor to research misconduct. The reference node “inadequate ethical oversight” accounts for the largest proportion among all secondary codes. This issue is primarily reflected in two areas: the absence of ongoing monitoring mechanisms and the over-formalization of initial ethical review processes.

Lack of tracking and oversight provides a hotbed for misconduct to occur…The essential problem with ethical oversight is that…after ethical approval, there is no one watching you. Finally, what you did in clinical studies— whether you signed the consent form with the patients, and how the entire process unfolded—relied on how the researcher and his or her team performed. There may be some risks in this phase. (Interviewee 4)

In China, the responsibilities for ethical oversight remain poorly defined, and many ethical reviews have been reduced to procedural formalities. According to the survey of 287 medical researchers, 37.3% reported that ethical review functions more as a formality than a substantive safeguard, thereby failing to effectively protect research participants.

For example, while medical services are regulated by the National Health Commission (NHC) and drugs by the China Food and Drug Administration (CFDA), ethical governance is often delegated to voluntary or semi-autonomous organizations. In some regions, even secondary or tertiary hospitals have yet to establish functional ethics committees. In addition, limited funding, time pressure, and complex procedures have weakened ethics oversight, making ethical review seem like a bureaucratic requirement and reducing researchers’ willingness to engage with ethical standards.

Unhealthy competition in scientific research Intense competition in clinical research places heavy pressure on medical researchers and is the second most significant external driver of ethical misconduct. In some Chinese hospitals, professional advancement still hinges on a single metric: research output. Academic publications are often treated as the key criterion for promotion, leaving doctors who fail to meet publication targets within tight evaluation cycles at risk of career stagnation. While linking research productivity to promotion has raised awareness of research importance, it also creates incentives for misconduct. Interviewee 5 stated, “If the research cycle is short, sometimes researchers begin the experiments without waiting for approval.”

1. Inadequate ethical climate The ethical climate in medical research is shaped by factors such as conflicts of interest, peer pressure, and institutional protection of researchers involved in misconduct. The relatively weak standing of ethics committees in hospitals, along with limited institutional support, further undermines efforts to uphold ethical standards in clinical research.

In general, national, provincial tertiary, and university-affiliated hospitals place greater emphasis on research ethics. Researchers in these institutions tend to show higher ethical awareness and more standardized conduct. As Interviewee 7 noted: “I believe our hospital is strict about this. We have many doctors from Hong Kong, and their serious approach to research has had a significant impact on me.”

By contrast, most sub-tertiary hospitals have a weaker research ethics climate. As Interviewee 14 observed: “I’ve reviewed many articles that are not in line with ethics. It’s a mess! Some researchers think one official stamp makes everything acceptable—they simply don’ t take ethics seriously.”

• (2)Knowledge asymmetry between researchers and subjects Research subjects often lack sufficient understanding of clinical trials, creating a knowledge gap between them and the researchers. This asymmetry can lead to mistrust or non-cooperation, prompting some researchers to exploit their informational advantage through deceptive or incomplete disclosures. For instance, when participants express concerns about routine tests, researchers may choose to withhold some information and minimize the risks of the clinical trial in order to avoid resistance and keep the trial on track.

If I perform a routine, low-risk test like a complete blood count (CBC) without informing the subject, nothing happens. But once I start the informed consent process, they begin overthinking things, which can lead to unnecessary trouble…. (Interviewee 5)

Discussions

Our findings reveal key differences from similar research in China, such as the CAMS and CASTED survey we cite in the Introduction, which primarily focus on ethical awareness. In contrast, our study places greater emphasis on actual conduct in clinical research. By integrating the theoretical framework developed in the Introduction, we move beyond surface-level descriptions of ethical violations to a deeper understanding of the moral and cultural foundations that shape research behavior.

Based on the above analysis of the challenges to the ethical world of clinical researchers and the individual and environmental factors contributing to them, we propose the following pathways to address ethical challenges and foster improvement.

Internal moral cultivation

1. Create an ethical space for dialogue and promote moral consensus.

   Our findings reveal that clinical researchers often exhibit dulled moral sensitivity and a passive approach to ethical norms, compounded by a significant knowledge asymmetry between researchers and participants. To address this, we propose fostering an ethical space—a conceptual arena where differing perspectives within the research process, such as those of researchers, participants, and oversight bodies, can engage in respectful dialogue. Originally proposed by Ermine [35] in the context of intercultural understanding, ethical space emphasizes mutual recognition across distinct value systems and encourages critical reflection.

   In the context of clinical research, ethical space can be operationalized through regular ethics dialogues, interdisciplinary forums, and case-based discussions embedded into daily research routines. These efforts help researchers reconnect their work with human values, build shared moral understanding, and reinforce collective ethical responsibility.

2. Foster ethical identity and develop moral sensitivity.

   While building a shared ethical space is essential, researchers must also develop an ethical identity [36]—a self-conception grounded in moral commitment and professional responsibility. Our study highlights a gap between ethical cognition and ethical behavior, indicating insufficient moral sensitivity. Moral sensitivity enables researchers to perceive how their actions affect participants and to anticipate potential harm, thereby informing ethical judgment and early recognition of dilemmas.

   To cultivate moral sensitivity, researchers should be encouraged to identify ethical concerns at all stages of the research process. This not only sharpens moral reasoning in specific contexts but also counters moral indifference and strengthens long-term ethical engagement, thus addressing the disconnect between knowing what is right and acting upon it, as seen in our findings.

3. Strengthen ethical responsibility and apply practical wisdom.

   Ethical responsibility in medical research should go beyond avoiding blame or superficial compliance. Researchers should be supported in developing phronesis—a form of moral wisdom rooted in Aristotelian ethics, enabling them to apply ethical principles in concrete, often uncertain situations through sound judgement and experience [37]. This helps them not only to “know responsibility” but to “take responsibility” in the face of uncertainty and long-term consequences.

   Our findings show that many clinical researchers tend to accept ethical norms passively rather than uphold them actively. Given the potential delayed and far-reaching effects of scientific innovation, cultivating phronesis ensures researchers remain accountable to both current and future generations, safeguarding human dignity while advancing medical science.

External oversight

1. Enforce sustainable ethical review and post-approval monitoring.

   This study identifies inadequate ethical oversight as the most significant environmental factor leading to clinical research misconduct, primarily reflected in two areas: formalistic ethical reviews and lack of post-approval monitoring.

   Given China’s vast territory and regional disparities in development, the establishment and functioning of medical ethics committees vary considerably across regions. In some areas, research ethics is often overlooked, and ethical reviews are treated as mere formalities, offering little substantive protection for research participants.

   As the initial step of clinical research, ethical review must be rigorously enforced [38]. Medical institutions at or above secondary hospital level across all regions should strengthen the establishment of medical ethics committees and the operation of ethics review system.

   Currently, ethical oversight in clinical research focuses primarily on initial approval, with little attention paid to post-approval monitoring. Although post-approval review is emphasized in all documents on ethical norms, in practice, it lacks specific monitoring and can rarely carry into effect.

   For a long time, ethical regulation in China has focused more on static approval than dynamic supervision, resulting in limited transparency in clinical research oversight. In the future, efforts should be made to establish an effective mechanism to detect and investigate research misconduct. In particular, it is essential to improve the tracking and oversight mechanism—this includes keeping records of follow-up reviews and building a responsibility system for department directors to take charge of the daily supervision of clinical research.

2. Prioritize ethical training and enhance ethical knowledge.

   Based on our findings, insufficient ethical knowledge is the most critical individual factor contributing to research misconduct. To address this gap, institutions should establish structured and continuous training programs in research ethics. These programs may include mandatory ethics training sessions for all clinical researchers, regular refresher courses, case-based workshops on ethical dilemmas, and standardized modules specifically focused on informed consent procedures. Furthermore, facilitating inter-institutional training rotations and academic exchanges may broaden researchers’ exposure to international ethical standards and best practices.

   Sometimes it’s not that the researchers don’t want to comply with ethical regulations… it’s that they do not know how to do it well. For example, our ethics training doesn’t teach us how to conduct informed consent or how to talk to the subjects. These trainings are available abroad—I learned them when I was studying overseas. (Interviewee 9)

   Particular attention should be given to early-career researchers, who typically have fewer resources and are more vulnerable to research pressure and perverse incentives. A standardized pre-research ethics training program should be implemented, especially for graduate students involved in clinical trials. Currently, ethics training for this group remains limited.

   Graduate students are often the ones actually conducting the research, under their mentors’ guidance, yet they may lack adequate ethical knowledge. This creates a gap that cannot be overlooked. (Interviewee 5)Graduate students are often the ones actually conducting the research, under their mentors’ guidance, yet they may lack adequate ethical knowledge. This creates a gap that cannot be overlooked. (Interviewee 5)

3. Improve the ethical climate and mitigate unhealthy competition.

   Certain features of the research environment can adversely influence ethical behavior. To effectively address ethical misconduct, attention must be directed toward the structural and cultural issues that foster unethical practices. This study found that unhealthy competition has become a major environmental factor contributing to research misconduct among medical researchers.

   Among the 287 surveyed researchers, 50.9% believed that the research environment was overly rushed and impetuous, and 71.8% reported experiencing significant pressure from research evaluation systems. Notably, 25% acknowledged that the impetuous climate and Heavy workload negatively affected their ethical compliance, while 15% were uncertain about its impact. Only 22.7% believed that the external research environment had little influence on their behavior.

   The study reveals that Chinese medical researchers face immense pressure, stemming from a competitive and impatient research culture, an assessment system that prioritizes publication output, heavy clinical workloads, a prevailing utilitarian mindset, low tolerance for failure, and unrealistic expectations for exceptional results. In recent years, the detrimental effects of this high-pressure environment have been significantly underestimated—particularly in the field of biomedical research, where excessive competition can distort the research ecosystem and give rise to various forms of misconduct.

   In 2020, the Wellcome Trust published its report What Researchers Think about the Culture They work in, highlighting how the distribution of research funding fosters a highly competitive environment and reinforces hierarchical power structures. To reduce the negative impact of such competition, policymakers and institutions should recognize the precarious nature of research careers, provide more time and funding to researchers, and ease the intensity of competition in biomedical research. Importantly, a flippant attitude toward research must be corrected, with failure acknowledged as a normal part of scientific progress. The current one-dimensional evaluation system should be replaced with a more holistic framework to reduce perverse incentives. At the same time, mechanisms for monitoring and penalizing research misconduct should be strengthened to promote a healthier research culture.

4. Popularize clinical trial knowledge and promote public ethical awareness.

   A lack of public understanding and trust in clinical trials often leads to non-compliance, instinctive resistance, and delays in trial progress. This gap in awareness can contribute to research misconduct, such as enticement or deception during recruitment, informed consent, and intervention. From a science and technology philosophy perspective, the era of Big Science calls for both the socialization of science and the scientization of society. This means the public should gain a basic understanding of scientific research and its societal implications, helping to reduce the ethical risks arising from human misunderstandings or misuses of science.

   Public perception of science is shaped largely by its dissemination through society. The Vienna Declaration and Programme of Action underscores that it is every scientist’s responsibility to engage in science communication, and that governments and medical researchers should actively educate the public about clinical trials, strengthen public scientific literacy, and encourage participation in research [39].

   Trust between doctors and participants cannot be built instantly or with just a signature…We need to popularize scientific knowledge in clinical research. I believe it not only improves communication between patients and doctors, but also advances clinical research as a whole. (Interviewee 7)

   Enhancing public understanding of clinical trials through science communication can not only foster more informed participation, but also enable low-cost, community-based oversight of research activities.

Limitations

This study has several limitations that should be acknowledged.

First, the survey had a relatively low response rate (16%), which may limit the generalizability of the findings. This can be attributed to two main factors: email-based surveys typically yield lower response rates due to their impersonal format, and the sensitive nature of questions related to ethical misconduct may have led to reluctance among physicians to participate. Consequently, researchers who were more ethically compliant or engaged may have been more inclined to respond, potentially underrepresenting those less aware of or involved in ethical misconduct. This selection bias should be taken into account when interpreting the results. Future research should consider alternative sampling strategies or enhanced incentives to improve response rates and better capture diverse perspectives.

Second, the interview data were limited to medical researchers, without incorporating the voices of other key stakeholders in the research ecosystem—such as policymakers, sponsors, ethics committee members, clinical research coordinators, and research participants. Including these groups in future studies would offer a more comprehensive and nuanced understanding of the ethical challenges in clinical research.

Conclusions

This study explored the ethical environment of clinical researchers in China, examining the challenges they face, the contributing factors to ethical misconduct, and potential pathways for improvement. Our findings suggest that clinical research currently operates under a “consensus of latent risk,” meaning that while such risks are widely recognized, ethical awareness and moral sensitivity have not kept pace with the rapid advances of science and technology. This gap creates vulnerabilities for research integrity and participant protection, underscoring the importance of aligning ethical responsibility with scientific progress.

To address this tension, advancing researchers’ ethical awareness requires a shift from an object-oriented paradigm to a human-centered approach—one that fosters both robust external oversight and the cultivation of internal moral virtues. Only through such an integrated framework can clinical researchers critically assess the rationality, necessity, and ethical implications of their scientific practices in a rapidly evolving biomedical landscape.

Abbreviations

ChiCTR

Chinese Clinical Trials Registry 

CAMS

Chinese Academy of Medical Sciences

CASTED

Chinese Academy of Science and Technology for Development

GCP

Good Clinical Practice

NHC

National Health Commission

CFDA

China Food and Drug Administration

IRB

Institutional Review Boards

Authors’ contributions

ZH, SWS and CJL conceptualized the study and drafted the manuscript. SWS conducted data collection. ZH and CJL contributed to critical revisions of the draft. ZH, SWS and CJL have each approved the final manuscript for publication.

Funding

No financial support was provided in the preparation of this paper.

Data availability

The data that support this study are available from the corresponding author on reasonable request, subject to privacy and confidentiality commitments.

Declarations

Ethics approval and consent to participate

The study was approved by Ethics Committee of Wenzhou Medical University, No. 2021–013. The informed consent was obtained from all participants prior to their involvement in the study. Our study strictly adhered to the Declaration of Helsinki.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.