Biomedical Research Ethics Research Articles

What should be measured and reported in clinical trials for the treatment of patients with acute pancreatitis? A study protocol for establishing a core outcome set

IntroductionAcute pancreatitis (AP) is characterised by inflammation of the exocrine pancreas, which potentially leads to local complications and organ failure resulting in significant morbidity and mortality. A long-term follow-up by...

Self-reported emotional and behavioural problems among adolescents with migrant parents in Lithuania

Abstract Background The mental health effects of parental emigration on adolescents who stayed behind in Eastern European countries are not fully understood. This study examines the emotional and behavioural difficulties of stay-behind adolescents in Lithuania. Methods The data collection took place January 2022-April 2023 from adolescents between the ages of 12 and 17 who attended 25 schools from 15 regions in Lithuania. This cross-sectional study was approved by the Biomedical Research Ethics Committee, No. 2021/11-1378-861. Parents and adolescents provided informed consent to participate in the study. Self-reported Strengths and Difficulties Questionnaire (Goodman, 2005) and a questionnaire on demographics and health status, were collected. Descriptive statistics and t-tests were calculated by using Stata (version 15.1). Results The sample consisted of 728 adolescents (response rate 52,6%), with a mean age of 14.5 years (SD 1.63), 43.4% males and 54.7% females. Of the total sample, 35,7% lived in rural areas, 84,8% had siblings and, 15.7% had at least one migrant parent. Most staying behind adolescents had migrant fathers (83.3%), and (90,6%) maintained regular online communication with their emigrated parents. Compared to peers living with parents, staying behind adolescents obtained significantly higher emotional and behavioural problems total score (12.3, SD 5.5 vs 10.7, SD 5.5, respectively), with a p-value of 0.006. In addition, adolescents with migrant parents had significantly higher scores than their peers living with parents on the emotional subscale (3.2, SD 2.5 vs 2.5, SD 2.4) and problems subscale (2.9, SD 1.7 vs 2.5, SD 1.7), with a p-value of 0.02 for both subscales. Conclusions This study found higher emotional and behavioural problems among stay-behind adolescents compared to those living with parents in their home country. The findings emphasize the need to implement supportive interventions and increase awareness of these issues in society. Key messages • Stay-behind adolescents in Lithuania experience higher emotional and behavioural problems than their peers living with parents in home country. • Greater focus should be given to the emotional health of stay-behind children and adolescents in migrant-sending countries.

Reticulocyte hemoglobin content as a marker of iron deficiency in premature newborns with very low birth weight. A simple tool for diagnosing iron deficiency

Reticulocyte hemoglobin content (RET-He) is a promising marker of iron deficiency (ID) in newborns. Objective: to determine the diagnostic value of RET-He as a marker of ID in premature newborns with very low birth weight (VLBW). We conducted a single-center retrospective cohort study, which included 66 premature infants admitted to the National Medical Research Center for Obstetrics, Gynecology and Perinatology named the Academician V.I. Kulakov of the Ministry of Healthcare of the Russian Federation. Data were obtained from January 2016 to December 2018. The gestational age ranged from 29 to 32 weeks. Laboratory examination included blood tests on the 1st and 3rd day of life, then every 10–14 days until the day of life, then every 10–14 days the Institute of Neonatology and Pediatrics; discharge from hospital, and the measurements of serum iron, ferritin, transferrin on the 7th until the discharge from hospital. This clinical study was approved by the Biomedical Research Ethics Committee (Minutes No.12 of 17 November 2016) and the Scientific Council (Minutes No.19 of 29 November 2016) of the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after the Academician V.I. Kulakov of Ministry of Healthcare of the Russian Federation. RET-He was the highest at birth and declined gradually thereafter in premature newborns reaching the lowest values after 3 weeks of life (median (interquartile range) 28.4 (25.8–34.8) pg (on the 1st day of life – 40.0 (35.7–41.9) pg and 33.5 (29.2–36.6) pg at the time of discharge). A low RET-He level was associated with low reticulocytes, with no changes in hemoglobin. There was a positive correlation between RET-He and MCH. D-He decreased from 1 to 42 days of life as a marker of increasing anemia. There was a negative correlation between RET-He and Hypo-He (p < 0.005). Starting from 42 days of life, or by the time of discharge, 32% of premature infants (n = 21) had a low ferritin level and 77% (n = 51) of premature infants had a low RET-He level, of which 21 infants developed ID (a positive correlation between RET-He and ferritin after 42 days of life (r = 0.34, p = 0.046)). There was no correlation between RET-He and ferritin in newborns without ID. Also, there were no correlations between RET-He and iron and RET-He and transferrin. After 42 days of life, RET-He less than 28.4 pg was a marker of ID (sensitivity 83.3% and specificity 93.7%). Low RET-He, D-He, RBC-Hе and high microR, Hypo-He were the earliest markers of ID in premature infants which predicted a decrease in serum iron and ferritin levels. RET-He, D-Не and Hypo-He are biomarkers with accurate diagnostic value of ID in premature infants with VLBW.

Diagnostic significance of serum erythropoietin as a marker of perinatal brain damage in premature newborns with very low birth weight

The search for promising markers of brain damage in premature newborns is important for the development and optimization of individual diagnostic and therapeutic approaches to neuroprotection in neonatology. Objective: to evaluate the diagnostic significance of serum erythropoietin (sEPO) on the 1st day of life as a marker of perinatal brain damage in premature infants with very low birth weight (VLBW). The study protocol was approved by the Biomedical Research Ethics Committee (Minutes No.12 of 17 November 2016) and the Scientific Council (Minutes No.19 of 29 November 2016) of the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after the Academician V.I. Kulakov of Ministry of Healthcare of the Russian Federation. Written informed consent to the patients' participation in the study was obtained from their parents. The study included 47 premature infants with VLBW born in 2018 at the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Healthcare of the Russian Federation. In these patients, sEPO was determined on the 1st day of life. Depending on the level of sEPO, infants were divided into 3 groups: group 1 – premature infants with VLBW with a low sEPO level on the 1st day of life (< 20 IU/L, n = 24); group 2 – premature infants with VLBW with an average sEPO level of 20–39 IU/L (reference values) (n = 14) – control group; group 3 – premature infants with VLBW with an elevated sEPO level (≥ 40 IU/L, n = 9). We determined the frequency of brain damage, including intraventricular hemorrhages (IVH) and periventricular leukomalacia. sEPO was not correlated with gestational age. In group 1, IVH ≤ Grade II was observed in 4/24 (16.7%) infants; in group 2, IVH ≤ Grade II was observed in 3/14 (21.4%) infants, and 1/14 (7.1%) infant had IVH Grade III; in group 3, IVH ≤ Grade II was noted in 1/9 (11.1%) infant, and IVH Grade III – in 1/9 (11.1%) infant, p > 0.05. There were no cases of periventricular leukomalacia. A high sEPO level on the 1st day of life in premature infants with VLBW was not associated with an increased risk of perinatal brain damage. The clinical value and practical significance of the determination of sEPO on the 1st day of life as a marker of perinatal brain damage in premature infants with VLBW did not demonstrate any benefits. Further studies are required to assess the role of sEPO in predicting neonatal outcomes.

End-of-Life Narratives of Patients who Request Medical Assistance in Dying: A Qualitative Study Protocol

Many groups (healthcare professionals, lawyers, philosophers, non-governmental organisations, bioethics committees, journalists, religious groups, etc.) participate in the bioethical debate about medical assistance in dying (MAiD). Bioethics literature on the topic involve different approaches (analytic, empirical, policy oriented, activist) and various normative perspectives (discourses based on deontological premises as the sanctity of life and human dignity, or on utilitarianism, libertarianism, etc.), some of which are at times irreconcilable. Regarding empirical studies, some voices (e.g., healthcare professionals) have been widely considered but the voice of people who request MAiD has been neglected. Understanding the personal and medical circumstances that lead to MAiD, which can only be achieved by listening to the phenomenological discourse of those involved, is key. This study aims to provide knowledge from the testimonies and experiences of patients who have initiated a MAiD request. We believe this research protocol can increase our understanding of a social and academic controversy that lacks important information to be complete. By doing so, this type of research could inform and improve end-of-life public policies, and particularly the health care of individuals who request a MAiD. We propose a qualitative phenomenological study using semi-structured interviews of people in the process of requesting MAiD, as outlined in the Ley Orgánica 3/2021, de regulación de la eutanasia (LORE), the Spanish Law on the Regulation of Euthanasia. The study is conducted nationally using a convenience sampling. The number of interviews is determined sequentially and cumulatively, depending on the richness of the narratives and the saturation of the information that has been collected. For the purposes of analysis, the interviews are transcribed verbatim and pseudonymised afterwards. Data analysis is conducted at the same time as data collection. The proposed study has received a favourable report from the Coordinating Committee on Biomedical Research Ethics of Andalusia (CCEIBA).

Stepping into small shoes: Gaining user perspective on appropriate administration devices for paediatric medication in India

A cross sectional pan-India study about use of administration devices for paediatric oral and inhalation medicines was conducted with a diverse pool of participants of various age groups. Via 634 respondents from more than 15 states in India, this study has identified the administration devices commonly used by parents/caregivers for children 0 to 18 years and by children over 10 years. It has provided insights on device ease of use, challenges faced and recommendations to facilitate the correct use of administration devices for paediatric oral and inhalation medicines. Ethics approval (DPSRU-BREC/2020/A/008)) was obtained from the Biomedical Research Ethics Committee of Delhi Pharmaceutical Sciences and Research University.The survey was completed by parents only (n = 514) and jointly by both parents and children (n = 120). The mean age of the child was 7.2 ± 4.96 years. 72% of the respondents reported that an oral medicine had been taken recently, 6.3% reported that an inhaled medicine had been taken and the remaining 21.9% reported that both an oral and inhaled medicine had been taken. The use of measuring cup was most prevalent followed by household spoons. The mean of the score for ease of use was found to be highest 4.6 ± 0.50 for oral syringe and lowest (3.8 ± 0.76) for measuring cups. The majority of them found the oral device easy to use. Difficulties were reported mostly for measuring cups and household spoons and were related to a lack of user instructions and measuring difficulties. The respondents who found the device easy to use had mostly received clear instructions from healthcare professionals.Compared to oral devices, there were very limited responses for inhalation devices (n = 175/634). Nebulisers with facemasks were most frequently used followed by manually actuated Metered dose inhalers with and without spacer. The mean of the ease-of-use score for dry powder inhalers was found to be highest (4.2 ± 0.37) followed by mist inhalers (4.0 ± 0) and manually actuated pressurised metered dose inhalers (4.0 ± 0.71). The nebulisers with facemask were reported to be difficult to use by most of the respondents despite receiving clear instructions from healthcare professionals.The study findings add evidence to the understudied area of user experiences and perspectives on administration devices for oral and inhalation medicines in India. It highlights a need for initiatives to improve the usability, availability, and affordability of administration devices for children in India. Awareness on the importance of proper use of devices needs to be raised and sustained about the existence of affordable administration devices.

Awareness and Perception About Research Ethics and Misconduct Among the Teaching Staff of Health Colleges, Jazan University, Saudi Arabia.

Despite adopting biomedical research ethics rules, regulations, and statements, unethical behavior is pervasive and frequently reported. This study assessed the perception and awareness of research Ethics and Misconduct among the Teaching Staff of Health Colleges at Jazan University, southwest Saudi Arabia. This research aimed to assess the awareness and perception of research ethics and misconduct among the teaching staff of the health colleges at Jazan University in southwest Saudi Arabia. Observational cross-sectional study targeted 424 faculty members randomly chosen from health-related colleges at Jazan University. A structured questionnaire was used to collect data using a web-based survey. The overall level of knowledge about medical ethics indicated that more than half of respondents (57.8%) had a good level of knowledge, 23.4% had a fair level of knowledge, and only 18.4% had poor knowledge. The Saudi National Committee on Bioethics was only known by 49.5% of the study participants. In addition, just 48.3% of respondents knew Saudi Arabia's national standards of ethics and principles for conducting scientific research. The knowledge of research ethics was found to be significantly (P<0.05) higher in participants with higher academic positions, such as professors, MD degree holders, and participants with more extensive work experience. About 48.2% reported that the severity of penalties for scientific misconduct would highly affect scientific integrity, and 74.3% found that their understanding of rules and procedures related to scientific misconduct has a very high effect on scientific integrity. Poor knowledge of research ethics is typically associated with an individual's academic job title, as "lecturer" showed a lower level of knowledge in comparison to other job titles. Even though about 50% of participants in the study had a good understanding of research ethics, it's crucial to ensure that all faculty members have a universal understanding. Therefore, it's essential to implement an appropriate research ethics training program.

Extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV-negative women: study protocol for the randomised, placebo-controlled double-blinded, phase 2 CAPRISA 012C trial

IntroductionWomen-controlled HIV prevention technologies that overcome adherence challenges of available daily oral pre-exposure prophylaxis and give women a choice of options are urgently needed. Broadly neutralising monoclonal antibodies (bnAbs) administered...

An analysis of referrals to a level 3 intensive care unit in a resource-limited setting in South Africa.

With a shortage of intensive care unit (ICU) beds and rising healthcare costs in resource-limited settings, clinicians need to appropriately triage admissions into ICU to avoid wasteful expenditure and unnecessary bed utilisation. To assess the nature, appropriateness and outcome of referrals to a tertiary centre ICU. A retrospective review of ICU consults from September 2016 to February 2017 at King Edward VIII Hospital was performed. The study was approved by the University of KwaZulu-Natal Biomedical Research Ethics Committee (BE291/17). Data pertaining to patients' demographics, referring doctor, diagnosis, comorbidities as well as biochemical and haemodynamic parameters were extracted. This information was then cross-referenced to the outcome of the ICU consultation. Data were descriptively analysed. Five hundred consultations were reviewed over a 6-month period; 52.2% of patients were male and the mean age was 44 years. Junior medical officers referred 164 (32.8%) of the consultations. Although specialist supervision was available in 459 cases, it was only utilised in 339 (73.9%) of these cases. Most referrals were from tertiary (46.8%) or regional (30.4%) hospitals; however, direct referrals from district hospitals and clinics accounted for 20.4% and 1.4% of consultations, respectively. The appropriate referral pathway was not followed in 81 (16.2%) consultations. Forty-five percent of consults were accepted; however, 9.3% of these patients died before arrival in ICU. A total of 151 (30.2%) patients were refused ICU admission, with the majority (57%) of these owing to futility. Patients were unstable at the time of consult in 53.2% of referrals and 34.4% of consults had missing data. Critically ill patients are often referred by junior doctors without senior consultation, and directly from low-level healthcare facilities. A large proportion of ICU referrals are deemed futile and, of the patients accepted for admission, almost 1 in 10 dies prior to ICU admission. More emphasis needs to be placed on the training of doctors to appropriately triage and manage critically ill patients and ensure appropriate ICU referral and optimising of patient outcomes. There is a paucity of information related to ICU referrals in South Africa. The nature, appropriateness and outcomes of referrals to a tertiary ICU is discussed in this study.

Application of the whole-course care model (IWF/C Care) for postintensive care syndrome based on an early warning system in critically ill patients: a randomised controlled trial study protocol

IntroductionCritically ill patients are at risk of developing postintensive care syndrome (PICS), which is manifested by physical, psychological and cognitive impairment. Currently, there are no programmes that combine early warning...

Ethics of research

Ethics of research

Moving out of the Human Vivarium

Homes are increasingly being built as sensor-laden living environments to test the performance of novel technologies in interaction with real people. When people’s homes are turned into the site of experiments, the inhabitants become research subjects. This paper employs findings from biomedical research ethics to evaluate live-in laboratories and argues that when live-in laboratories function as a participant’s main residence, they constrain an individual’s so-called ‘right to withdraw’. Withdrawing from the live-in laboratory as a participant’s main residence means losing one’s home, which creates negative financial and psychological consequences for participants. I will argue that such costs conflict with a participants’ right to withdraw on two counts. First, that the exit costs from the live-in laboratory constitute a penalty, and second, that the costs of withdrawing from the live-in laboratory function as a constraint on a participant’s liberty. The paper concludes that (i) the right to withdraw is a necessary condition for the ethical permissibility of modern live in lab experiments and conclude (ii) the practice of making an experimental home as a participant’s main residence is ethically problematic.

#3197 A NOVEL INVESTIGATION OF AVF WITH A SECOND HARMONIC GENERATION MICROSCOPY IN PATIENTS WITH END STAGE RENAL DISEASE

Abstract Background and Aims The population of patients with end-stage renal disease is rapidly growing and hemodialysis (HD) remains the most common treatment option. In clinical practice, the formation of arteriovenous fistulas (AVFs) is considered a priority in order to ensure optimal vascular access for HD patients. One of the complications in the formation of AVF is the hyperplasia of the neointimal layer of the vein, which leads to the failure of the fistula. The impact of the arrangement of collagen fibers in the veins of AVFs is little studied and opens wide opportunities for investigations. The structural tissue can be imaged with polarimetric nonlinear microscopy. Collagen fibers have a non-centrosymmetric structure, so they can be effectively imaged by second harmonic generation (SHG) microscopy [1]. The polarimetric nonlinear microscopy, exploiting the multidimentional tensor nature of light-matter interactions, is emerging as a valuable research tool in biomedical investigations and applications to digital pathology, and is only now becoming technically feasible for potential clinical translation [2,3]. This proposal represents a novel application of multimodal polarimetric nonlinear microscopy in histopathology, and biomedical imaging. The aim of this study is to determine the influence of the arrangement of collagen fibers in veins on the formation efficiency of AVFs by using the innovative method of nonlinear SHG microscopy. Method In this prospective study, we first used a novel SHG microscopy method to investigate AVFs venous intima hyperplasia. V. Cephalica segment is being obtained during arteriovenous fistula formation surgery from patients with end stage renal disease and after the removal of aneurysmatic or fibrotic AVF. Cross-sections of venous specimens are being fixed in 10% buffered formalin and stained with hematoxylin and eosin (H&amp;E). Further, sample investigation is being performed in Laser Research Centre, Vilnius University using a home-built multiphoton laser-scanning microscope. The investigation is being performed with the permission of Lithuanian Biomedical Research Ethics Committee. Results We determined the arrangement of collagen fibers in veins before AVF formation and after the removal of aneurysmatic AVFs. It was observed that tunica intima of V. Cephalica is dominated both by endothelial cells and connective tissue made up of high-density collagen fibers. Whereas tunica adventitia consists mainly of collagen fibers. Collagen in tunica intima and adventitia are found to be highly noncentrosymmetric. Thus a strong SHG signal, resulting in high-contrast structural visualization of the V. Cephalica segment is generated. Conclusion Our initial investigations of AVF show clearly visible collagen fibers. The future work will focus on the structural changes of collagen fibers in the vein intimal hyperplasia. Further investigations need to be done to create artificial intelligence-based identification of new predictive collagen markers.

Development of an Effective Neutralizing Antibody Assay for SARS-CoV-2 Diagnosis.

Neutralizing antibodies (NAbs) are essential for preventing reinfection with SARS-CoV-2 and the recurrence of COVID-19; nonetheless, the formation of NAbs following vaccination and infection remains enigmatic due to the lack of a practical and effective NAb assay in routine laboratory settings. In this study, we developed a convenient lateral flow assay for the rapid and precise measurement of serum NAb levels within 20 minutes. Receptor-binding domain-fragment crystallizable (RBD-Fc) and angiotensin-converting enzyme 2-histidine tag (ACE2-His) were expressed by the eukaryotic expression systems of Spodoptera frugiperda clone 9 and human embryonic kidney 293T, respectively. Then, colloidal gold was synthesized and conjugated with ACE2. After optimizing various operating parameters, an NAb lateral flow assay was constructed. Subsequently, its detection limit, specificity, and stability were systematically evaluated, and clinical samples were analyzed to validate its clinical feasibility. RBD-Fc and ACE2-His were obtained with 94.01% and 90.05% purity, respectively. The synthesized colloidal gold had a uniform distribution with an average diameter of 24.15 ± 2.56 nm. With a detection limit of 2 μg/mL, the proposed assay demonstrated a sensitivity of 97.80% and a specificity of 100% in 684 uninfected clinical samples. By evaluating 356 specimens from infected individuals, we observed that the overall concordance rate between the proposed assay and conventional enzyme-linked immunosorbent assay was 95.22%, and we noticed that 16.57% (59/356) of individuals still did not produce NAbs after infection (both by ELISA and the proposed assay). All the above tests by this assay can obtain results within 20 minutes by the naked eye without any additional instruments or equipment. The proposed assay can expediently and reliably detect anti-SARS-CoV-2 NAbs after infection, and the results provide valuable data to facilitate effective prevention and control of SARS-CoV-2. Serum and blood samples were used under approval from the Biomedical Research Ethics Subcommittee of Henan University, and the clinical trial registration number was HUSOM-2022-052. We confirm that this study complies with the Declaration of Helsinki.

Investigating the sustainability of self-help programmes in the context of leprosy and the work of leprosy missions in Nigeria, Nepal and India: a qualitative study protocol

IntroductionLeprosy occurs among very poor people who may be stigmatised and pushed further to the margins of society. Programmes to improve social integration and stimulate economic development have been implemented...

Evidence for feasibility of implementing online brief cognitive‐behavioral therapy for eating disorder pathology in the workplace

CBT-T is a brief (10-week) cognitive-behavioral therapy for non-underweight eating disorders. This report describes the findings from a single center, single group, feasibility trial of online CBT-T in the workplace as an alternative to health service settings. This trial was approved by the Biomedical and Scientific Research Ethics committee, University of Warwick, UK (reference 125/20-21) and was registered with ISRCTN (reference number: ISRCTN45943700). Recruitment was based on self-reported eating and weight concerns rather than diagnosis, potentially enabling access to treatment for employees who have not previously sought help and for those with sub-threshold eating disorder symptoms. Assessments took place at baseline, mid-treatment (week 4), post-treatment (week 10), and follow-up (1 and 3 months post-treatment). Participant experiences following treatment were assessed using quantitative and qualitative approaches. For the primary outcomes, pre-determined benchmarks of high feasibility and acceptability were met, based on recruiting >40 participants (N = 47), low attrition (38%), and a high attendance rate (98%) over the course of the therapy. Participant experiences revealed low previous help-seeking for eating disorder concerns (21%). Qualitative findings indicated a wide range of positive impacts of the therapy and the workplace as the therapeutic setting. Analysis of secondary outcomes for participants with clinical and sub-threshold eating disorder symptoms showed strong effect sizes for eating pathology, anxiety and depression, and moderate effect sizes for work outcomes. These pilot findings provide a strong rationale for a fully powered randomized controlled trial to determine the effectiveness of CBT-T in the workplace. This study demonstrates the feasibility of implementing an eating disorders intervention (online CBT-T) in the workplace as an alternative to traditional healthcare settings. Recruitment was based on self-reported eating and weight concerns rather than diagnosis, potentially enabling access to treatment for employees who had not previously sought help. The data also provide insights into recruitment, acceptability, effectiveness, and future viability of CBT-T in the workplace.

Double standard in clinical research

In the development of clinical research, the social conditions of the societies involved must be taken into account, such as vulnerability and social vulnerability. The contexts of conflicts of interest, whether economic or academic, must also be considered. Another highlight is related to the so-called moral imperialism, a condition in which societies impose their moral standards on others, not considering cultural differences, geographical conditions and social development. Thus, the “double ethical standard” in research imposes a form of imperialism of principles, values, moral relativism and na exclusively economic vision above all. The principles of ethics in biomedical research promulgated by international consensus statements are not sufficient to protect the most vulnerable societies, especially the poorest countries. The ethical principles that govern clinical research need to be translated into procedures and practices that take into account the different cultural aspects and socioeconomic resources of societies. Research participants cannot just bear the risks and not reap the benefits. There are arguments that propose the double standard as a violation of human rights, especially for not taking into account the principles of the Universal Declaration of Bioethics and Human Rights of UNESCO, approved by consensus by the countries in 2005. The existence of a “strong” system ethical evaluation of research projects, with social participation, especially in local ethics committees in the most vulnerable societies, is a minimum condition for the protection of people and societies.

Scoping review protocol exploring the relationship between food insecurity, mental health and diet intake among adolescents across the globe

IntroductionStudies, exploring the effect of food insecurity on physical and mental health, have shown that food insecurity is associated with lower self-reports of physical and mental health. With the COVID-19...

Contemporary Understanding of Ethics in clinical Research and Publication in India

Ethics, in principle, is what distinguishes the acceptable from unacceptable. The role of ethics in biomedical research and publication has a new found growing importance in the recent times. Its initial role was merely in safeguarding the participant’s interests. The role of ethics in biomedical research has now expanded by encompassing not only the safety and integrity of subjects, but also in curbing the unlawful practices in the publication of the study material. Violation of the rules laid by the various regulatory bodies is now considered an offence. This article aims to give a crisp and concise picture of the role of ethics, various misconducts and its repercussions, in clinical study and publication in today’s time.

Hodgkin lymphoma in the bone marrow aspirate of a young patient with human immunodeficiency virus.

Hodgkin lymphoma in the bone marrow aspirate of a young patient with human immunodeficiency virus.