Perceived Benefits and Risks of Research Involving Terminally Ill Patients: Physicians’ Perspective

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Onyeka, Onyinye Hope Chime, Ngozi Idemili Aronu This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7585889/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Terminally ill patients are a particularly vulnerable group in healthcare research. Their participation raises ethical concerns about informed consent, therapeutic misconception, and potential exploitation, yet their exclusion limits evidence generation for improved end-of-life care. Few studies in low- and middle-income countries have examined physicians’ perspectives on this issue. Methods We conducted a qualitative study using descriptive phenomenology to explore physicians’ views on the benefits and risks of involving terminally ill patients in research. In-depth interviews were held with 24 physicians across two tertiary hospitals in Enugu State, Nigeria. Interviews were audio-recorded, transcribed verbatim, and analyzed thematically with NVivo software. Results Most physicians (75%) supported including terminally ill patients in research, citing opportunities to improve symptom control, enhance clinical management, and expand the knowledge base for future care. Reported benefits included stronger physician–patient relationships, deeper understanding of disease progression, and altruistic contributions by patients. However, concerns were raised about patient vulnerability, risk of emotional distress, unrealistic expectations, and ethical dilemmas in balancing protection with inclusion. Key barriers included inadequate funding, limited time, lack of research training, and constrained infrastructure for palliative care research. Conclusions Physicians in this study recognized both the value and the ethical complexities of research with terminally ill patients. Their insights highlight the urgent need for context-specific guidelines that respect cultural norms, safeguard patient dignity, and support ethically sound research in resource-limited settings. Strengthening these frameworks will enable equitable participation of terminally ill patients while advancing palliative and end-of-life care. Oncology Terminally ill patients research ethics physicians’ perspectives informed consent Nigeria palliative care Background A terminal illness, also known as an end-stage disease or fatal illness, refers to a medical condition that is unresponsive to curative treatment and is expected to deteriorate, ultimately resulting in death 1 . End-of-life care is a sensitive and controversial topic for researchers, as dying patients, ranging from those on life support to those with metastatic cancers, severe trauma, or progressive illnesses, often face a heavy symptom burden that complicates their participation in studies 2 , 3 . One major concern in research involving terminally ill patients is to enhance understanding of restoring health, minimizing discomfort, reducing organ-related distress, extending survival, and improving overall quality of life 4 . These priorities mirror the central goals of palliative care, which seeks to relieve suffering and improve the quality of life for patients and their families facing life-limiting illnesses 5 . Globally, palliative care has become recognized as an essential component of healthcare, yet major disparities in access persist, particularly in low- and middle-income countries 5 . Globally, disparities in end-of-life communication and care remain, particularly in low- and middle-income countries. For instance, a study from South Africa showed that many patients with advanced cancer had limited understanding of their illness and inadequate communication about end-of-life care preferences 6 . In Nigeria, palliative care services remain limited and underdeveloped, with challenges including inadequate training, scarce resources, and uneven integration of palliative care into health services 7 , 8 , 9 . Against this backdrop, the involvement of terminally ill patients in research is especially complex, as physicians must weigh ethical concerns about vulnerability, consent, and patient dignity against the urgent need to build context-specific evidence that can strengthen care delivery. There are divergent views regarding the inclusion of terminally ill patients in research studies. Some researchers argue that the terminally ill patients should not participate in research. Some proponents advocate for their participation, suggesting that the participation of terminally ill patients in research can provide them with opportunities to share their narratives, reflect on their experiences, contribute to the welfare of others, enhance future medical care, and augment the body of knowledge 10 . Research involving terminally ill patients helps them feel connected to the world and recognized as individuals beyond their medical conditions. Engaging terminally ill patients in research can help them feel valued and restore a sense of control 5 . Some school of thought posit that knowledge gained from research informs treatment for patients and future care 11 . In addition to enriching medical knowledge, it may offer insights for future management of the disease 12 . While research can be said to be beneficial and encouraged among the terminally ill, researchers advocate that specific guideline be established to regulate their involvement 13 . Conversely, certain researchers question the appropriateness of such restrictive guidelines, positing that terminally ill patients possess the autonomy to make their own decisions 11 . These critics view restrictions on participation as paternalistic, potentially undermining the dignity and right to self-determination of these individuals. Furthermore, excluding terminally ill patients from research not only impedes advancements in medical science but may also adversely affect the well-being of future patients 11 . Research involving vulnerable individuals, such as the terminally ill, can be quite challenging. Physicians sometimes perceive participation as burdensome or even ethically questionable, especially given patients’ vulnerability 14 . Several factors are perceived by physicians as barriers to conducting research involving terminally ill patients. One major challenge is time constraints, as physicians often struggle to balance their clinical responsibilities with research activities in a busy clinical environment. Additionally, a lack of education and training in research can hinder their involvement 15 . Physicians who also serve as researchers often struggle to balance their dual roles as caregivers and investigators, raising important ethical concerns 6 . This difficulty can impact how researchers communicate the study's purpose to patients, leading to a phenomenon known as therapeutic misconception, where patients mistakenly believe that the primary goal of the research is to provide therapeutic benefits rather than to generate scientific knowledge 16 . Bias in funding can greatly influence both the design and communication of a study, often creating the misleading impression that research participation guarantees therapeutic benefits, rather than accurately presenting it as an experimental scientific process. This distortion can mislead audiences and undermine the integrity of the findings. Funding presents a significant challenge in research involving the terminally ill 17 . Clinicians report that this type of research is time-consuming and resource-intensive, with funding shortfalls creating major barriers to sustaining ethically sound palliative care research 10 . Empirical work shows that patients, caregivers, and clinicians often hold differing views on risks and benefits of research participation at the end of life, which can affect consent quality and trial conduct 18 , 19 . Despite the clear ethical stakes, there is limited empirical evidence from Nigeria on clinicians’ attitudes, perceived barriers, and decision-making practices regarding research involving terminally ill patients. Understanding Nigerian physicians’ perspectives is therefore essential to design ethically appropriate research protocols, informed-consent procedures, and locally relevant safeguards, thus ensuring that research in this patient cohort is both scientifically valid and respectful of patient rights. This study will fill that gap and inform policy and practice for safe, equitable research involving patients with life-limiting illnesses in Nigeria. Methods Study Area Two sites, the University of Nigeria Teaching Hospital (UNTH) and the Enugu State University Teaching Hospital (ESUTH), both in Enugu State, South East Nigeria, were chosen for the study Both of these tertiary health institutions provide oncology services through their departments of pediatrics, general surgery, obstetrics and gynecology, and medicine. It is important to note that UNTH has a dedicated oncology unit and a dedicated palliative care unit, whereas ESUTH does not. Study Design This study utilized a phenomenological design, specifically descriptive phenomenology, which is a qualitative research approach aimed at understanding and describing the universal essence of a phenomenon. Study Population The study population consisted of physicians working in selected tertiary health institutions. Participants included those who manage both pediatric and adult terminally ill patients, as well as physicians who have been involved in or have knowledge of research activities related to terminally ill patients. Physicians who have not managed terminally ill patients were excluded from the study. Data Collection : Participants were recruited until data saturation was achieved, defined as the point at which no new insights emerged from additional interviews. Two trained researchers conducted interviews using a semi-structured interview guide across wards and outpatient clinics in two tertiary health institutions. A total of 24 physicians participated: 2 consultants, 17 senior residents, and 5 junior residents. Interviews were scheduled at times convenient for participants and conducted face-to-face. With prior consent, all interviews were audio recorded. Recordings were transcribed verbatim and cross-checked against field notes to ensure accuracy, completeness, and quality of data. Data Analysis The collected data were coded and analyzed thematically using NVivo (version 12; QSR International, Melbourne, Australia), a software tool designed for qualitative research and analysis. A thematic analysis was conducted to identify the main themes and subthemes that emerged from the coded data. The codes were organized to reflect the relationships between themes and subthemes, and sociodemographic attributes of the respondents were assigned to the coded data. Ethical Considerations Ethical approval was obtained from the Health Research Ethics Committee (HREC) of the University of Nigeria Teaching Hospital Ituku/Ozalla, Enugu, under reference number NHREC/05/01/2008B-FWA00002458-1RB00002323. Written informed consent was obtained from the participants at both sites after explaining the study's objectives, procedures, risks, and benefits. Anonymity and confidentiality of the information were assured and maintained throughout the study. Results A total of 24 in-depth interviews (IDIs) were conducted, with equal participation from 12 males and 12 females. The participants' ages ranged from 30 to 70 years, with a median age of 50. Among the 24 physicians interviewed, 17 (72.7%) had been practicing for 10 years or more, while 7 physicians (27.3%) had less than 10 years of experience in the medical field. From this study, five key themes emerged: Viewpoint on research participation by the terminally ill; factors to consider before including terminally ill patients in studies; reasons for excluding terminally ill patients from research; perceived benefits of including terminally ill patients in research; and barriers associated with involving terminally ill patients in research. Viewpoint on research participation by the terminally ill A majority of the participants (75%) expressed the opinion that terminally ill patients should participate in research. The reasons for this viewpoint were varied, including the pursuit of optimal care for individual patients, a desire to enhance understanding of their conditions, and the potential benefits of improving management and care for those facing terminal illnesses. Some participants shared their thoughts through the following quotes: “Terminally ill patients should be involved in research because if we don’t study their conditions, we won’t make any progress in understanding them better. Such findings can improve their management,” said a participant (Male, E/S/IDI/C1). “It’s very important to understand more about their care and identify their problems. I witnessed research conducted at UNTH with terminally ill patients. I believe involving them in research is crucial because it helps identify their issues and manage them effectively,” stated another participant. (Male, E/S/IDI/S8) One participant emphasized the importance of including terminally ill patients in research to ensure its validity. “Involving these patients is crucial for understanding their unique issues and management needs. Their participation can significantly benefit society, as their insights can help improve treatments and enhance prognoses. In short, engaging terminally ill patients in research is essential for achieving meaningful and applicable results.” (Male, E/O/IDI/S7) Factors to be considered before involving terminally ill patients in research Most participants identified funding as a key factor necessary for involving terminally ill patients in research. They explained that without adequate funding, research involving terminally ill patients may risk ethical breaches, participant distress, low data quality, or outright failure. They saw funding not just as a logistical necessity, but a moral obligation to ensure that sensitive research is conducted with the highest standards of care, dignity, and scientific integrity. One participant remarked, “While obtaining funding for research is undeniably vital, it is essential to recognize that the allocation of these funds can be influenced by biases. These biases not only affect the fairness of distribution but also have the potential to hinder groundbreaking discoveries and limit the diversity of perspectives in such research. Addressing this issue is crucial if we want a more equitable and innovative research environment.” (Male, U/P/IDI/S2) With regards to conducting research involving a drug trial or a novel therapy, a pediatrician highlighted the importance of gathering comprehensive information, particularly when it concerns children. He emphasized, “in a drug trial or when introducing a novel therapy, it is essential to understand the drug itself, ensure proper monitoring of the child, and be aware of the most effective treatment options.” (Male, U/P/IDI/S2) One participant emphasized the importance of time in research considerations: “Research involving terminal patients requires ample time. If we want our research to truly make a difference, we must invest that time to improve the quality of life for other patients. I believe prioritizing time for such impactful research is essential.” (Female, E/I/IDI/S5) Excluding terminally ill patients from research Some participants believed that terminally ill patients should not be involved in research. One participant voiced concern about the emotional and psychological stress that these patients face, "They should not be involved because most of them are psychologically down, and their parents and relatives are also affected." (Male, E/P/IDI/S1) Some participants noted that involving terminally ill patients in research could create unrealistic expectations, leading to a false sense of hope for treatment outcomes. “If researchers come to conduct studies, it might not feel like they are merely seeking information, even if the participants understand that the researchers cannot truly help them. I don't think it will feel like genuine assistance or kindness; it could even heighten their emotional distress, and I wouldn’t want to contribute to what they are already experiencing.” (Female, E/P/IDI/S1) Some participants emphasized that if the research serves only as an academic exercise without providing any benefit to the patients, then involvement of the latter was unnecessary. They believe that efforts should focus on minimizing the burden on patients. Perceived benefits of including terminally ill patients in research The study highlighted the participants’ several perceived benefits of involving terminally ill patients in research. These benefits mentioned included a better understanding of disease conditions, an expanded knowledge base regarding the management of terminally ill patients, improved patient management, strengthened patient-physician relationships, and the provision of valuable statistics. "Conducting research with terminally ill patients enhances our understanding of how to manage their care, which ultimately improves the quality of care for both current and future patients. Therefore, it is vital to include them in research. We can never predict who the next patient will be, making it essential to continually improve our training and remain prepared for any situation."(Male, E/O/IDI/S6) Barriers associated with involving terminally ill patients in research Participants highlighted several barriers to involving terminally ill patients in research. Key challenges include time constraints, limited funding, difficulties in obtaining information from patients, and the need for a conducive environment for research. One participant noted, “Since research involving terminally ill patients is time-sensitive, the choice of data collection method must consider the limited time available. A questionnaire may be the most appropriate option for studies with a short time frame, as it allows for quick and efficient data gathering. However, if the study is expected to be prolonged, there is a risk that some terminally ill participants may no longer be available due to the progression of their condition. It is also important to note that many terminally ill patients often present late, emphasizing the need for timely and efficient data collection. For a prospective study, success is more challenging, whereas a retrospective study is likely to be more successful. Follow-up is also necessary.” (Female, E/P/IDI/S2) Another participant expressed that while researchers might be eager to conduct studies with terminally ill patients, financial constraints can be a significant limitation due to high ethical, logistical, medical, and operational costs, coupled with limited funding opportunities and the need for extensive support systems.. “The funding available to involve terminally ill patients in research may be limited due to a lack of funding sources and the complexities of the grant application process,” said a participant (Male, E/I/IDI/S3). Additionally, another participant stated that, "In some cases, the financial burden associated with involving terminally ill patients in research is considerable. This encompasses not only the direct medical expenses related to their care but also the costs associated with palliative and hospice services. Such financial implications can represent a serious barrier for researchers.” (Female, U/I/IDI/S5) Discussion The study explored the perceptions of physicians regarding research involving terminally ill patients at two tertiary institutions in Enugu, southeastern Nigeria, and revealed diverse perspectives among participants. While most of the participants supported the involvement of terminally ill patients in research, some held opposing views. The results indicated that many participants believed it was important for terminally ill patients to take part in research to pursue optimal care. They expressed a desire to enhance the understanding of terminal illnesses and acknowledged the potential benefits of improving management and care for individuals facing terminal ailments in the future, even if such research may not directly benefit the patients involved. This finding aligns with previous research conducted in Australia, which examined the perspectives and experiences of dying individuals who participated in research 15 . The Australian study underscored that involving terminally ill patients in research contributes to the body of evidence that can improve future care for other terminally ill patients, regardless of whether it benefits the current participants. Additionally, a study from the United Kingdom on patient and caregiver involvement in palliative care research emphasized that patients and caregivers often wish to contribute to research and should not be excluded solely due to their prognosis 20 . Participants emphasized the benefits of including terminally ill patients in research, noting that their involvement enhances understanding of management strategies, validates the research, benefits society, and improves the quality of care for both current and future patients. This participation can provide essential data for physicians, inform solutions for effectively managing terminally ill patients, support new drug trials, and aid in the development of new treatment approaches. These findings align with a Canadian study, where health professionals reported that involving terminally ill patients in non-therapeutic oncology research expanded the knowledge base and provided deeper insights into patient care 17 . They also described participation as an altruistic act that benefits society as a whole, helping family members avoid similar circumstances and improving health outcomes for future generations 17 . Some participants expressed opposing views regarding the involvement of terminally ill patients in research. They raised concerns that these patients might experience emotional or psychological stress. This perspective aligns with a study conducted in India, 21 where physicians observed that many terminally ill patients undergo emotional challenges such as fear and anxiety and often require time to process their feelings. Therefore, these patients often need reassurance and proper counseling during the recruitment process 22 . All participants agreed that elderly terminally ill patients should not participate in research due to their increased vulnerability. The physicians believed that if research benefits are primarily academic with no direct advantage to the patient, then the patient should be exempt from participation. They emphasized the importance of minimizing patients' burdens rather than adding to them. A study conducted in the United States also reported that physicians view involving terminally ill patients in research as potentially burdensome patients approach the end of life, their goals tend to focus on comfort 23 . Participants identified several barriers that should be considered when determining the involvement of terminally ill patients in research studies. These barriers include: patient's perception that the research will improve his or her health conditions or enhance their quality of life; the nature and prognosis of the disease; the burden of the disease; time constraints (most researches are time bound and time-consuming); and the availability of funds. They also noted that the environment in which the research is conducted can influence a terminally ill patient's willingness to engage in research activities. A study in the United States highlighted that physician frequently encounter challenges related to time and funding when conducting research involving terminally ill patients. This difficulty often stems from the need to balance their responsibilities as clinicians with their roles as researchers 24 . Strengths and Limitations This study addresses an important gap in the literature by exploring physicians’ perspectives on the involvement of terminally ill patients in research, an area that has not previously been examined within the African context. While several studies from Nigeria and other African countries have described healthcare providers’ attitudes toward truth-telling, communication, and care of the terminally ill 24 none have specifically focused on physicians’ views regarding research participation. This makes the present study, to the best of our knowledge, the first of its kind on the continent, contributing novel insights to the discourse on ethics and research in palliative care and oncology. The study also benefits from the inclusion of physicians across different levels of training and involvement in oncology and palliative care, enhancing the diversity of perspectives and capturing a spectrum of experiences. However, certain limitations must be acknowledged. The study was conducted in only two institutions, which may limit the generalizability of the findings to other regions or healthcare settings in Nigeria and Africa. In addition, social desirability bias cannot be entirely excluded, as physicians may have shaped their responses in line with perceived professional or ethical expectations. Finally, while qualitative interviews allowed for an in-depth exploration of views, the findings may not capture the full range of opinions across the broader physician community. Conclusion This study provides novel insights into Nigerian physicians’ perspectives on the inclusion of terminally ill patients in research. While most physicians supported their participation, citing opportunities to improve care and expand medical knowledge, others raised ethical and practical concerns, particularly regarding patient vulnerability, limited resources, and potential psychological distress. These findings highlight the complex balance between protecting patient dignity and advancing evidence-based care. Our results point to the need for context-specific ethical guidelines that are sensitive to cultural norms, physician concerns, and patient rights. Developing a culturally competent ethical framework that enshrines both Western and African ethical values for medical research 3 hcould facilitate ethically sound and practically feasible research, while also promoting equitable participation of terminally ill patients in studies that may ultimately benefit future patients. It will also ensure that the cultural needs of the terminally ill in Africa are respected and maintained throughout the research process 3 . This work contributes to the broader discourse on research ethics in low- and middle-income countries and emphasizes the importance of incorporating local perspectives into global conversations on palliative care and end-of-life research. Declarations Institution and ethics approval and informed consent Ethical clearance was obtained from the Health Research and Ethics Committee of University of Nigeria Teaching Hospital (UNTH), Enugu with reference number NHREC/05/01/2008B-FWA00002458-1RB00002323.A written informed consent was obtained from the participants. Acknowledgement The authors acknowledge the physicians who participated in this research. Financial support and sponsorship NIL Conflicts of Interest There are no conflicts of interest. - Ethics Approval: Approved by Health Research Ethics Committee of University of Nigeria Teaching Hospital (UNTH), Enugu (Ref: NHREC/05/01/2008B-FWA00002458-1RB00002323) - Consent for Publication: All participants provided consent for the use of anonymized quotes. - Data Availability: Transcripts and anonymized data are available upon reasonable request from the corresponding author. - Competing Interests: The authors declare no competing interests. - Funding: NIL - Consent to Participate: Written informed consent was obtained from all participants. References Taylor P, Dowding D, Johnson M. Clinical decision making in the recognition of dying: a qualitative interview study. BMC Palliat Care. 2017;16(1):11. doi:10.1186/s12904-017-0186-1 Nwosu AC, Mayland CR, Mason S, Cox TF, Varro A, Ellershaw J. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7585889","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":513295568,"identity":"1ca65c51-1c59-4ae6-ba60-0f31eae05266","order_by":0,"name":"Ebere Juliet Achi","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA4UlEQVRIiWNgGAWjYBACxgYeCMOAmfkAkJKQIUULWwJICw8R9sC0MPAYIHHxAOb23oOPKyrs5M3ZeT6/ulFjwcPAfvjoBrwO6zmXbHjmTLLhzmbebdY5x4AO40lLu4FXy4wcM8nGNuYEg8O824xz2IBaJHjM8GuZ/8b8Z+O/eqAWnmfGOf+I0TKDx4yxseEwSAvz49w2YrT05CVLNhw7brjhMJsZc26fBA8bIb8Ytp89+LGhplre4Pzhx59zvtXJ8bMfPoZfSwOCzSYBJvEpBwF5JDbzB0KqR8EoGAWjYGQCAEnXRXNnbfp2AAAAAElFTkSuQmCC","orcid":"https://orcid.org/0009-0004-9696-0838","institution":"Department of Community Medicine, Enugu State University Teaching Hospital","correspondingAuthor":true,"prefix":"","firstName":"Ebere","middleName":"Juliet","lastName":"Achi","suffix":""},{"id":513295569,"identity":"80e1739d-9095-4b4b-a9fe-524b8859b2f9","order_by":1,"name":"Tonia C. Onyeka","email":"","orcid":"https://orcid.org/0000-0001-8138-3100","institution":"Department of Anesthesia/Pain and Palliative Care Unit, University of Nigeria Teaching Hospital/IVAN Research Institute, Nigeria.","correspondingAuthor":false,"prefix":"","firstName":"Tonia","middleName":"C.","lastName":"Onyeka","suffix":""},{"id":513295570,"identity":"562294d7-bb2e-4c92-bfb6-b5c646578ce5","order_by":2,"name":"Onyinye Hope Chime","email":"","orcid":"https://orcid.org/0000-0002-1055-9903","institution":"Department of Community Medicine and PHC, Enugu State University Teaching Hospital.","correspondingAuthor":false,"prefix":"","firstName":"Onyinye","middleName":"Hope","lastName":"Chime","suffix":""},{"id":513295571,"identity":"567b0cd9-ed1b-40da-904d-4d1be44f7e8e","order_by":3,"name":"Ngozi Idemili Aronu","email":"","orcid":"https://orcid.org/0000-0001-9719-8153","institution":"Department of Sociology/Anthropology and Community Medicine University of Nigeria, Nsukka.","correspondingAuthor":false,"prefix":"","firstName":"Ngozi","middleName":"Idemili","lastName":"Aronu","suffix":""}],"badges":[],"createdAt":"2025-09-10 20:16:36","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":true,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-7585889/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7585889/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":91147578,"identity":"e7d5f13c-c288-46fb-84bd-ba58270d0512","added_by":"auto","created_at":"2025-09-12 06:36:57","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":557797,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7585889/v1/a05fc168-5f49-45ad-a65f-e8fa49b47f33.pdf"},{"id":91146326,"identity":"4e8dba91-7ada-423c-8755-063ff653f7ab","added_by":"auto","created_at":"2025-09-12 06:20:57","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":15489,"visible":true,"origin":"","legend":"","description":"","filename":"COREQChecklistPerceivedBenefitsandRisks.docx.docx","url":"https://assets-eu.researchsquare.com/files/rs-7585889/v1/67b63bf974361c22cc256297.docx"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003ePerceived Benefits and Risks of Research Involving Terminally Ill Patients: Physicians’ Perspective\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Background","content":"\u003cp\u003eA terminal illness, also known as an end-stage disease or fatal illness, refers to a medical condition that is unresponsive to curative treatment and is expected to deteriorate, ultimately resulting in death\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e. End-of-life care is a sensitive and controversial topic for researchers, as dying patients, ranging from those on life support to those with metastatic cancers, severe trauma, or progressive illnesses, often face a heavy symptom burden that complicates their participation in studies\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e. One major concern in research involving terminally ill patients is to enhance understanding of restoring health, minimizing discomfort, reducing organ-related distress, extending survival, and improving overall quality of life\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. These priorities mirror the central goals of palliative care, which seeks to relieve suffering and improve the quality of life for patients and their families facing life-limiting illnesses\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e. Globally, palliative care has become recognized as an essential component of healthcare, yet major disparities in access persist, particularly in low- and middle-income countries\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e. Globally, disparities in end-of-life communication and care remain, particularly in low- and middle-income countries. For instance, a study from South Africa showed that many patients with advanced cancer had limited understanding of their illness and inadequate communication about end-of-life care preferences\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e. In Nigeria, palliative care services remain limited and underdeveloped, with challenges including inadequate training, scarce resources, and uneven integration of palliative care into health services\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e,\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e,\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e. Against this backdrop, the involvement of terminally ill patients in research is especially complex, as physicians must weigh ethical concerns about vulnerability, consent, and patient dignity against the urgent need to build context-specific evidence that can strengthen care delivery.\u003c/p\u003e\u003cp\u003eThere are divergent views regarding the inclusion of terminally ill patients in research studies. Some researchers argue that the terminally ill patients should not participate in research. Some proponents advocate for their participation, suggesting that the participation of terminally ill patients in research can provide them with opportunities to share their narratives, reflect on their experiences, contribute to the welfare of others, enhance future medical care, and augment the body of knowledge\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e. Research involving terminally ill patients helps them feel connected to the world and recognized as individuals beyond their medical conditions. Engaging terminally ill patients in research can help them feel valued and restore a sense of control\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e. Some school of thought posit that knowledge gained from research informs treatment for patients and future care\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e. In addition to enriching medical knowledge, it may offer insights for future management of the disease\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. While research can be said to be beneficial and encouraged among the terminally ill, researchers advocate that specific guideline be established to regulate their involvement\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. Conversely, certain researchers question the appropriateness of such restrictive guidelines, positing that terminally ill patients possess the autonomy to make their own decisions\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e. These critics view restrictions on participation as paternalistic, potentially undermining the dignity and right to self-determination of these individuals. Furthermore, excluding terminally ill patients from research not only impedes advancements in medical science but may also adversely affect the well-being of future patients\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eResearch involving vulnerable individuals, such as the terminally ill, can be quite challenging. Physicians sometimes perceive participation as burdensome or even ethically questionable, especially given patients\u0026rsquo; vulnerability\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e. Several factors are perceived by physicians as barriers to conducting research involving terminally ill patients. One major challenge is time constraints, as physicians often struggle to balance their clinical responsibilities with research activities in a busy clinical environment. Additionally, a lack of education and training in research can hinder their involvement\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. Physicians who also serve as researchers often struggle to balance their dual roles as caregivers and investigators, raising important ethical concerns\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e. This difficulty can impact how researchers communicate the study's purpose to patients, leading to a phenomenon known as therapeutic misconception, where patients mistakenly believe that the primary goal of the research is to provide therapeutic benefits rather than to generate scientific knowledge\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e. Bias in funding can greatly influence both the design and communication of a study, often creating the misleading impression that research participation guarantees therapeutic benefits, rather than accurately presenting it as an experimental scientific process. This distortion can mislead audiences and undermine the integrity of the findings. Funding presents a significant challenge in research involving the terminally ill\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eClinicians report that this type of research is time-consuming and resource-intensive, with funding shortfalls creating major barriers to sustaining ethically sound palliative care research\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eEmpirical work shows that patients, caregivers, and clinicians often hold differing views on risks and benefits of research participation at the end of life, which can affect consent quality and trial conduct\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e,\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. Despite the clear ethical stakes, there is limited empirical evidence from Nigeria on clinicians\u0026rsquo; attitudes, perceived barriers, and decision-making practices regarding research involving terminally ill patients. Understanding Nigerian physicians\u0026rsquo; perspectives is therefore essential to design ethically appropriate research protocols, informed-consent procedures, and locally relevant safeguards, thus ensuring that research in this patient cohort is both scientifically valid and respectful of patient rights. This study will fill that gap and inform policy and practice for safe, equitable research involving patients with life-limiting illnesses in Nigeria.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy Area\u003c/strong\u003e\u003cp\u003eTwo sites, the University of Nigeria Teaching Hospital (UNTH) and the Enugu State University Teaching Hospital (ESUTH), both in Enugu State, South East Nigeria, were chosen for the study Both of these tertiary health institutions provide oncology services through their departments of pediatrics, general surgery, obstetrics and gynecology, and medicine. It is important to note that UNTH has a dedicated oncology unit and a dedicated palliative care unit, whereas ESUTH does not.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eStudy Design\u003c/strong\u003e\u003cp\u003eThis study utilized a phenomenological design, specifically descriptive phenomenology, which is a qualitative research approach aimed at understanding and describing the universal essence of a phenomenon.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eStudy Population\u003c/strong\u003e\u003cp\u003eThe study population consisted of physicians working in selected tertiary health institutions. Participants included those who manage both pediatric and adult terminally ill patients, as well as physicians who have been involved in or have knowledge of research activities related to terminally ill patients. Physicians who have not managed terminally ill patients were excluded from the study.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eData Collection\u003c/b\u003e: Participants were recruited until data saturation was achieved, defined as the point at which no new insights emerged from additional interviews. Two trained researchers conducted interviews using a semi-structured interview guide across wards and outpatient clinics in two tertiary health institutions. A total of 24 physicians participated: 2 consultants, 17 senior residents, and 5 junior residents. Interviews were scheduled at times convenient for participants and conducted face-to-face. With prior consent, all interviews were audio recorded. Recordings were transcribed verbatim and cross-checked against field notes to ensure accuracy, completeness, and quality of data.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eData Analysis\u003c/strong\u003e\u003cp\u003eThe collected data were coded and analyzed thematically using NVivo (version 12; QSR International, Melbourne, Australia), a software tool designed for qualitative research and analysis. A thematic analysis was conducted to identify the main themes and subthemes that emerged from the coded data. The codes were organized to reflect the relationships between themes and subthemes, and sociodemographic attributes of the respondents were assigned to the coded data.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eEthical Considerations\u003c/strong\u003e\u003cp\u003e Ethical approval was obtained from the Health Research Ethics Committee (HREC) of the University of Nigeria Teaching Hospital Ituku/Ozalla, Enugu, under reference number NHREC/05/01/2008B-FWA00002458-1RB00002323. Written informed consent was obtained from the participants at both sites after explaining the study's objectives, procedures, risks, and benefits. Anonymity and confidentiality of the information were assured and maintained throughout the study.\u003c/p\u003e\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 24 in-depth interviews (IDIs) were conducted, with equal participation from 12 males and 12 females. The participants' ages ranged from 30 to 70 years, with a median age of 50. Among the 24 physicians interviewed, 17 (72.7%) had been practicing for 10 years or more, while 7 physicians (27.3%) had less than 10 years of experience in the medical field.\u003c/p\u003e\u003cp\u003eFrom this study, five key themes emerged: Viewpoint on research participation by the terminally ill; factors to consider before including terminally ill patients in studies; reasons for excluding terminally ill patients from research; perceived benefits of including terminally ill patients in research; and barriers associated with involving terminally ill patients in research.\u003c/p\u003e\n\u003ch3\u003eViewpoint on research participation by the terminally ill\u003c/h3\u003e\n\u003cp\u003eA majority of the participants (75%) expressed the opinion that terminally ill patients should participate in research. The reasons for this viewpoint were varied, including the pursuit of optimal care for individual patients, a desire to enhance understanding of their conditions, and the potential benefits of improving management and care for those facing terminal illnesses. Some participants shared their thoughts through the following quotes: \u003cem\u003e\u0026ldquo;Terminally ill patients should be involved in research because if we don\u0026rsquo;t study their conditions, we won\u0026rsquo;t make any progress in understanding them better. Such findings can improve their management,\u0026rdquo; said a participant (Male, E/S/IDI/C1).\u003c/em\u003e\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;It\u0026rsquo;s very important to understand more about their care and identify their problems. I witnessed research conducted at UNTH with terminally ill patients. I believe involving them in research is crucial because it helps identify their issues and manage them effectively,\u0026rdquo; stated another participant. (Male, E/S/IDI/S8)\u003c/em\u003e\u003c/p\u003e\u003cp\u003eOne participant emphasized the importance of including terminally ill patients in research to ensure its validity. \u003cem\u003e\u0026ldquo;Involving these patients is crucial for understanding their unique issues and management needs. Their participation can significantly benefit society, as their insights can help improve treatments and enhance prognoses. In short, engaging terminally ill patients in research is essential for achieving meaningful and applicable results.\u0026rdquo; (Male, E/O/IDI/S7)\u003c/em\u003e\u003c/p\u003e\n\u003ch3\u003eFactors to be considered before involving terminally ill patients in research\u003c/h3\u003e\n\u003cp\u003eMost participants identified funding as a key factor necessary for involving terminally ill patients in research. They explained that without adequate funding, research involving terminally ill patients may risk ethical breaches, participant distress, low data quality, or outright failure. They saw funding not just as a logistical necessity, but a moral obligation to ensure that sensitive research is conducted with the highest standards of care, dignity, and scientific integrity. One participant remarked, \u003cem\u003e\u0026ldquo;While obtaining funding for research is undeniably vital, it is essential to recognize that the allocation of these funds can be influenced by biases. These biases not only affect the fairness of distribution but also have the potential to hinder groundbreaking discoveries and limit the diversity of perspectives in such research. Addressing this issue is crucial if we want a more equitable and innovative research environment.\u0026rdquo; (Male, U/P/IDI/S2)\u003c/em\u003e\u003c/p\u003e\u003cp\u003eWith regards to conducting research involving a drug trial or a novel therapy, a pediatrician highlighted the importance of gathering comprehensive information, particularly when it concerns children. He emphasized, \u003cem\u003e\u0026ldquo;in a drug trial or when introducing a novel therapy, it is essential to understand the drug itself, ensure proper monitoring of the child, and be aware of the most effective treatment options.\u0026rdquo; (Male, U/P/IDI/S2)\u003c/em\u003e\u003c/p\u003e\u003cp\u003eOne participant emphasized the importance of time in research considerations: \u003cem\u003e\u0026ldquo;Research involving terminal patients requires ample time. If we want our research to truly make a difference, we must invest that time to improve the quality of life for other patients. I believe prioritizing time for such impactful research is essential.\u0026rdquo; (Female, E/I/IDI/S5)\u003c/em\u003e\u003c/p\u003e\n\u003ch3\u003eExcluding terminally ill patients from research\u003c/h3\u003e\n\u003cp\u003eSome participants believed that terminally ill patients should not be involved in research. One participant voiced concern about the emotional and psychological stress that these patients face, \u003cem\u003e\"They should not be involved because most of them are psychologically down, and their parents and relatives are also affected.\" (Male, E/P/IDI/S1)\u003c/em\u003e\u003c/p\u003e\u003cp\u003eSome participants noted that involving terminally ill patients in research could create unrealistic expectations, leading to a false sense of hope for treatment outcomes. \u003cem\u003e\u0026ldquo;If researchers come to conduct studies, it might not feel like they are merely seeking information, even if the participants understand that the researchers cannot truly help them. I don't think it will feel like genuine assistance or kindness; it could even heighten their emotional distress, and I wouldn\u0026rsquo;t want to contribute to what they are already experiencing.\u0026rdquo; (Female, E/P/IDI/S1)\u003c/em\u003e\u003c/p\u003e\u003cp\u003eSome participants emphasized that if the research serves only as an academic exercise without providing any benefit to the patients, then involvement of the latter was unnecessary. They believe that efforts should focus on minimizing the burden on patients.\u003c/p\u003e\n\u003ch3\u003ePerceived benefits of including terminally ill patients in research\u003c/h3\u003e\n\u003cp\u003eThe study highlighted the participants\u0026rsquo; several perceived benefits of involving terminally ill patients in research. These benefits mentioned included a better understanding of disease conditions, an expanded knowledge base regarding the management of terminally ill patients, improved patient management, strengthened patient-physician relationships, and the provision of valuable statistics.\u003c/p\u003e\u003cp\u003e\u003cem\u003e\"Conducting research with terminally ill patients enhances our understanding of how to manage their care, which ultimately improves the quality of care for both current and future patients. Therefore, it is vital to include them in research. We can never predict who the next patient will be, making it essential to continually improve our training and remain prepared for any situation.\"(Male, E/O/IDI/S6)\u003c/em\u003e\u003c/p\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eBarriers associated with involving terminally ill patients in research\u003c/h2\u003e\u003cp\u003eParticipants highlighted several barriers to involving terminally ill patients in research. Key challenges include time constraints, limited funding, difficulties in obtaining information from patients, and the need for a conducive environment for research.\u003c/p\u003e\u003cp\u003eOne participant noted, \u003cem\u003e\u0026ldquo;Since research involving terminally ill patients is time-sensitive, the choice of data collection method must consider the limited time available. A questionnaire may be the most appropriate option for studies with a short time frame, as it allows for quick and efficient data gathering. However, if the study is expected to be prolonged, there is a risk that some terminally ill participants may no longer be available due to the progression of their condition. It is also important to note that many terminally ill patients often present late, emphasizing the need for timely and efficient data collection. For a prospective study, success is more challenging, whereas a retrospective study is likely to be more successful. Follow-up is also necessary.\u0026rdquo; (Female, E/P/IDI/S2)\u003c/em\u003e\u003c/p\u003e\u003cp\u003eAnother participant expressed that while researchers might be eager to conduct studies with terminally ill patients, financial constraints can be a significant limitation due to high ethical, logistical, medical, and operational costs, coupled with limited funding opportunities and the need for extensive support systems.. \u003cem\u003e\u0026ldquo;The funding available to involve terminally ill patients in research may be limited due to a lack of funding sources and the complexities of the grant application process,\u0026rdquo; said a participant (Male, E/I/IDI/S3).\u003c/em\u003e\u003c/p\u003e\u003cp\u003eAdditionally, another participant stated that, \u003cem\u003e\"In some cases, the financial burden associated with involving terminally ill patients in research is considerable. This encompasses not only the direct medical expenses related to their care but also the costs associated with palliative and hospice services. Such financial implications can represent a serious barrier for researchers.\u0026rdquo; (Female, U/I/IDI/S5)\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003e The study explored the perceptions of physicians regarding research involving terminally ill patients at two tertiary institutions in Enugu, southeastern Nigeria, and revealed diverse perspectives among participants. While most of the participants supported the involvement of terminally ill patients in research, some held opposing views. The results indicated that many participants believed it was important for terminally ill patients to take part in research to pursue optimal care. They expressed a desire to enhance the understanding of terminal illnesses and acknowledged the potential benefits of improving management and care for individuals facing terminal ailments in the future, even if such research may not directly benefit the patients involved. This finding aligns with previous research conducted in Australia, which examined the perspectives and experiences of dying individuals who participated in research \u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. The Australian study underscored that involving terminally ill patients in research contributes to the body of evidence that can improve future care for other terminally ill patients, regardless of whether it benefits the current participants. Additionally, a study from the United Kingdom on patient and caregiver involvement in palliative care research emphasized that patients and caregivers often wish to contribute to research and should not be excluded solely due to their prognosis\u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eParticipants emphasized the benefits of including terminally ill patients in research, noting that their involvement enhances understanding of management strategies, validates the research, benefits society, and improves the quality of care for both current and future patients. This participation can provide essential data for physicians, inform solutions for effectively managing terminally ill patients, support new drug trials, and aid in the development of new treatment approaches. These findings align with a Canadian study, where health professionals reported that involving terminally ill patients in non-therapeutic oncology research expanded the knowledge base and provided deeper insights into patient care\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. They also described participation as an altruistic act that benefits society as a whole, helping family members avoid similar circumstances and improving health outcomes for future generations\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eSome participants expressed opposing views regarding the involvement of terminally ill patients in research. They raised concerns that these patients might experience emotional or psychological stress. This perspective aligns with a study conducted in India,\u003csup\u003e21\u003c/sup\u003e where physicians observed that many terminally ill patients undergo emotional challenges such as fear and anxiety and often require time to process their feelings. Therefore, these patients often need reassurance and proper counseling during the recruitment process\u003csup\u003e\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eAll participants agreed that elderly terminally ill patients should not participate in research due to their increased vulnerability. The physicians believed that if research benefits are primarily academic with no direct advantage to the patient, then the patient should be exempt from participation. They emphasized the importance of minimizing patients' burdens rather than adding to them. A study conducted in the United States also reported that physicians view involving terminally ill patients in research as potentially burdensome patients approach the end of life, their goals tend to focus on comfort \u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eParticipants identified several barriers that should be considered when determining the involvement of terminally ill patients in research studies. These barriers include: patient's perception that the research will improve his or her health conditions or enhance their quality of life; the nature and prognosis of the disease; the burden of the disease; time constraints (most researches are time bound and time-consuming); and the availability of funds. They also noted that the environment in which the research is conducted can influence a terminally ill patient's willingness to engage in research activities. A study in the United States highlighted that physician frequently encounter challenges related to time and funding when conducting research involving terminally ill patients. This difficulty often stems from the need to balance their responsibilities as clinicians with their roles as researchers \u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003ch3\u003eStrengths and Limitations\u003c/h3\u003e\n\u003cp\u003eThis study addresses an important gap in the literature by exploring physicians\u0026rsquo; perspectives on the involvement of terminally ill patients in research, an area that has not previously been examined within the African context. While several studies from Nigeria and other African countries have described healthcare providers\u0026rsquo; attitudes toward truth-telling, communication, and care of the terminally ill \u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e none have specifically focused on physicians\u0026rsquo; views regarding research participation. This makes the present study, to the best of our knowledge, the first of its kind on the continent, contributing novel insights to the discourse on ethics and research in palliative care and oncology. The study also benefits from the inclusion of physicians across different levels of training and involvement in oncology and palliative care, enhancing the diversity of perspectives and capturing a spectrum of experiences.\u003c/p\u003e\u003cp\u003eHowever, certain limitations must be acknowledged. The study was conducted in only two institutions, which may limit the generalizability of the findings to other regions or healthcare settings in Nigeria and Africa. In addition, social desirability bias cannot be entirely excluded, as physicians may have shaped their responses in line with perceived professional or ethical expectations. Finally, while qualitative interviews allowed for an in-depth exploration of views, the findings may not capture the full range of opinions across the broader physician community.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study provides novel insights into Nigerian physicians’ perspectives on the inclusion of terminally ill patients in research. While most physicians supported their participation, citing opportunities to improve care and expand medical knowledge, others raised ethical and practical concerns, particularly regarding patient vulnerability, limited resources, and potential psychological distress. These findings highlight the complex balance between protecting patient dignity and advancing evidence-based care.\u003c/p\u003e\n\u003cp\u003eOur results point to the need for context-specific ethical guidelines that are sensitive to cultural norms, physician concerns, and patient rights. Developing a culturally competent ethical framework that enshrines both Western and African ethical values for medical research\u003csup\u003e3\u003c/sup\u003e hcould facilitate ethically sound and practically feasible research, while also promoting equitable participation of terminally ill patients in studies that may ultimately benefit future patients. It will also ensure that the cultural needs of the terminally ill in Africa are respected and maintained throughout the research process\u003csup\u003e3\u003c/sup\u003e. This work contributes to the broader discourse on research ethics in low- and middle-income countries and emphasizes the importance of incorporating local perspectives into global conversations on palliative care and end-of-life research.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eInstitution and ethics approval and informed consent\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical clearance was obtained from the Health Research and Ethics Committee of University of Nigeria Teaching Hospital (UNTH), Enugu with reference number NHREC/05/01/2008B-FWA00002458-1RB00002323.A written informed consent was obtained from the participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors acknowledge the physicians who participated in this research.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFinancial support and sponsorship\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNIL\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflicts of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere are no conflicts of interest.\u003cbr\u003e\u0026nbsp;- Ethics Approval: Approved by Health Research Ethics Committee of University of Nigeria Teaching Hospital (UNTH), Enugu (Ref: NHREC/05/01/2008B-FWA00002458-1RB00002323)\u003c/p\u003e\n\u003cp\u003e- Consent for Publication: All participants provided consent for the use of anonymized quotes.\u003c/p\u003e\n\u003cp\u003e- Data Availability: Transcripts and anonymized data are available upon reasonable request from the corresponding author.\u003c/p\u003e\n\u003cp\u003e- Competing Interests: The authors declare no competing interests.\u003c/p\u003e\n\u003cp\u003e- Funding: NIL\u003cbr\u003e\u0026nbsp;- Consent to Participate: Written informed consent was obtained from all participants.\u003cbr\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eTaylor P, Dowding D, Johnson M. Clinical decision making in the recognition of dying: a qualitative interview study. BMC Palliat Care. 2017;16(1):11. doi:10.1186/s12904-017-0186-1\u003c/li\u003e\n \u003cli\u003eNwosu AC, Mayland CR, Mason S, Cox TF, Varro A, Ellershaw J. The association of hydration status with physical signs, symptoms and survival in advanced cancer: the use of bioelectrical impedance vector analysis (BIVA). PLoS One. 2016;11(9):e0163114. doi:10.1371/journal.pone.0163114\u003c/li\u003e\n \u003cli\u003eIyioke I, Uwanduoma Maduabuchi JM, Onyeka T, O\u0026rsquo;Rourke M. An African Research Ethics Reader. Leiden: Brill; 2024.\u003c/li\u003e\n \u003cli\u003eWorld Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191\u0026ndash;4. doi:10.1001/jama.2013.281053\u003c/li\u003e\n \u003cli\u003eWorld Health Organization. Quality health services and palliative care: practical approaches and resources to support policy, strategy and practice. Geneva: WHO; 2021.\u003c/li\u003e\n \u003cli\u003eShen MJ, Prigerson HG, Ratshikana-Moloko M, Mmoledi K, Ruff P, Jacobson JS, et al. Illness understanding and end-of-life care communication among patients with advanced cancer in South Africa. J Glob Oncol. 2018;4:1\u0026ndash;9. doi:10.1200/JGO.17.00160\u003c/li\u003e\n \u003cli\u003eOnyeka TC. Palliative care in Enugu, Nigeria: challenges to a new practice. Indian J Palliat Care. 2011;17(2):131\u0026ndash;6. doi:10.4103/0973-1075.84533\u003c/li\u003e\n \u003cli\u003eNwosu DC. Palliative care: the Nigerian perspective. In: Palliative Care. London: IntechOpen; 2019. doi:10.5772/intechopen.84220\u003c/li\u003e\n \u003cli\u003eArias-Casais N, Garralda E, S\u0026aacute;nchez-C\u0026aacute;rdenas MA, Rhee JY, Centeno C. Evaluating the integration of palliative care in national health systems: an indicator rating process. BMC Palliat Care. 2021;20(1):142. doi:10.1186/s12904-021-00836-0\u003c/li\u003e\n \u003cli\u003eFischer DJ, Burgener SC, Kavanaugh K, Ryan C, Keenan G. Conducting research with end-of-life populations: overcoming recruitment challenges. Appl Nurs Res. 2012;25(4):258\u0026ndash;63. doi:10.1016/j.apnr.2011.02.004\u003c/li\u003e\n \u003cli\u003eBellamy G, Gott M, Frey R. \u0026ldquo;It\u0026rsquo;s my pleasure?\u0026rdquo;: the views of palliative care patients about being asked to participate in research. Prog Palliat Care. 2011;19(4):159\u0026ndash;64. doi:10.1179/1743291X11Y.0000000019\u003c/li\u003e\n \u003cli\u003eTerry W, Olson LG, Ravenscroft P, Wilss L, Boulton-Lewis G. Hospice patients\u0026rsquo; views on research in palliative care. Intern Med J. 2006;36(7):406\u0026ndash;13. doi:10.1111/j.1445-5994.2006.01100.x\u003c/li\u003e\n \u003cli\u003eChatland LE, Harvey C, Kelly K, Paradine S, Bhagat M, Hudson BF. Research participation in palliative medicine\u0026mdash;benefits and barriers for patients and families: a rapid review. BMJ Support Palliat Care. 2023;13(1):35\u0026ndash;44. doi:10.1136/bmjspcare-2021-003378\u003c/li\u003e\n \u003cli\u003eGysels M, Shipman C, Higginson IJ. \u0026ldquo;I will do it if it will help others\u0026rdquo;: motivations among patients taking part in qualitative studies in palliative care. J Pain Symptom Manage. 2008;35(4):347\u0026ndash;55. doi:10.1016/j.jpainsymman.2007.05.012\u003c/li\u003e\n \u003cli\u003eKleiderman E, Avard D, Black L, Diaz Z, Rousseau C, Knoppers BM. Recruiting terminally ill patients into non-therapeutic oncology studies: views of health professionals. BMC Med Ethics. 2012;13:33. doi:10.1186/1472-6939-13-33\u003c/li\u003e\n \u003cli\u003eLidz CW, Albert K, Appelbaum P, Dunn LB, Overton E, Pivovarova E. Why is therapeutic misconception so prevalent? Camb Q Healthc Ethics. 2015;24(2):231\u0026ndash;41. doi:10.1017/S0963180114000532\u003c/li\u003e\n \u003cli\u003eHigginson IJ, Koffman J. Funding for palliative care research: the evidence base and ethical priorities. BMJ Support Palliat Care. 2015;5(2):125\u0026ndash;7. doi:10.1136/bmjspcare-2014-000784\u003c/li\u003e\n \u003cli\u003eCardenas V, Rahman A, Giulioni J, Coulourides Kogan A, Enguidanos S. Patient and physician perspectives on engaging in palliative and healthcare trials: a qualitative descriptive study. BMC Palliat Care. 2021;20(1):129. doi:10.1186/s12904-021-00830-6\u003c/li\u003e\n \u003cli\u003eBloomer MJ, Hutchinson AM, Brooks L, Botti M. Dying persons\u0026rsquo; perspectives on participating in research: an integrative review. Palliat Med. 2018;32(4):851\u0026ndash;60. doi:10.1177/0269216317745090\u003c/li\u003e\n \u003cli\u003eAbernethy AP, Capell WH, Aziz NM, Ritchie C, Prince-Paul M, Bennett RE, et al. Ethical conduct of palliative care research: enhancing communication between investigators and IRBs. J Pain Symptom Manage. 2014;48(6):1211\u0026ndash;21. doi:10.1016/j.jpainsymman.2014.03.009\u003c/li\u003e\n \u003cli\u003eRameshkumar K. Ethics in medical curriculum: ethics by the teachers for students and society. Indian J Urol. 2009;25(3):337\u0026ndash;9. doi:10.4103/0970-1591.56205\u003c/li\u003e\n \u003cli\u003eTulsky JA, Arnold RM, Alexander SC, Olsen MK, Jeffreys AS, Rodriguez KL, et al. Enhancing communication between oncologists and patients: a computer-based training program. Ann Oncol. 2011;22(9):2136\u0026ndash;43. doi:10.1093/annonc/mdq722\u003c/li\u003e\n \u003cli\u003eHurst DJ. Does the distinctiveness of palliative care research require distinct ethical guidelines? Am J Hosp Palliat Med. 2017;34(7):635\u0026ndash;7. doi:10.1177/1049909116641744\u003c/li\u003e\n \u003cli\u003eAyanore M, Asampong R, Akazili J, Awoonor-Williams JK, Akweongo P. Sub-national variations in general service readiness of PHC facilities in Ghana: equity implications for UHC. PLoS One. 2022;17(6):e0268962. doi:10.1371/journal.pone.0268962\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"University of Nigeria Teaching Hospital","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Terminally ill patients, research ethics, physicians’ perspectives, informed consent, Nigeria, palliative care","lastPublishedDoi":"10.21203/rs.3.rs-7585889/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7585889/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003cbr\u003e\nTerminally ill patients are a particularly vulnerable group in healthcare research. Their participation raises ethical concerns about informed consent, therapeutic misconception, and potential exploitation, yet their exclusion limits evidence generation for improved end-of-life care. Few studies in low- and middle-income countries have examined physicians’ perspectives on this issue.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003cbr\u003e\nWe conducted a qualitative study using descriptive phenomenology to explore physicians’ views on the benefits and risks of involving terminally ill patients in research. In-depth interviews were held with 24 physicians across two tertiary hospitals in Enugu State, Nigeria. Interviews were audio-recorded, transcribed verbatim, and analyzed thematically with NVivo software.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003cbr\u003e\nMost physicians (75%) supported including terminally ill patients in research, citing opportunities to improve symptom control, enhance clinical management, and expand the knowledge base for future care. Reported benefits included stronger physician–patient relationships, deeper understanding of disease progression, and altruistic contributions by patients. However, concerns were raised about patient vulnerability, risk of emotional distress, unrealistic expectations, and ethical dilemmas in balancing protection with inclusion. Key barriers included inadequate funding, limited time, lack of research training, and constrained infrastructure for palliative care research.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e\u003cbr\u003e\nPhysicians in this study recognized both the value and the ethical complexities of research with terminally ill patients. Their insights highlight the urgent need for context-specific guidelines that respect cultural norms, safeguard patient dignity, and support ethically sound research in resource-limited settings. Strengthening these frameworks will enable equitable participation of terminally ill patients while advancing palliative and end-of-life care.\u003c/p\u003e","manuscriptTitle":"Perceived Benefits and Risks of Research Involving Terminally Ill Patients: Physicians’ Perspective","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-12 06:20:53","doi":"10.21203/rs.3.rs-7585889/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"a3088975-4545-4f25-bdb7-2e5cbe7c4284","owner":[],"postedDate":"September 12th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":54531475,"name":"Oncology"}],"tags":[],"updatedAt":"2025-09-12T06:20:53+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-12 06:20:53","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7585889","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7585889","identity":"rs-7585889","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}