Well-being Of Participants Research Articles

Systematic review of ethical/methodological issues in transgender youth participative research

Abstract Background Understanding the experiences of transgender and gender-diverse (TGD) youth is essential for developing appropriate support services. However, studies focusing on TGD youth under 18 outside clinical settings are scarce, limiting effective support development. The requirement for parental consent in participatory research poses ethical and logistical challenges, impacting the safety, well-being, and privacy of adolescent participants. This dynamic complicates the balance between adolescents’ rights to autonomy and privacy and parental duties to protect their children. This review aims to illuminate the ethical and methodological challenges in participatory research with TGD youth. Methods A systematic review of bibliometric databases from 2006 to 2022 was conducted, focusing on transgender and gender non-conforming identities, adolescence, qualitative and participatory research methods, and consent issues. This review was registered with PROSPERO in November 2022 (CRD42022368360). Results Of 3,794 articles initially identified, 291 met the inclusion criteria, and 48 were extensively reviewed. Research with TGD youth commonly faces ethical tensions including parental inclusion in the consent process, safeguarding participant safety and privacy, ensuring confidentiality, and creating environments that allow TGD youth to express themselves and feel empowered. Methodological challenges include engaging public and stakeholders, recruiting participants, data collection, and maintaining research integrity. Conclusion & Implications The literature on participatory research with young transgender and gender-diverse individuals reveals intricate and often conflicting issues related to consent procedures, power dynamics, and the researcher’s role. These findings are applicable in various legal and geographical contexts, providing insights that can guide practices globally. Key messages • Research reveals ethical dilemmas in participatory research with transgender young people, highlighting difficulties around consent and the need for tailored support. • Understanding the complexities of research ethics enables better support for transgender and gender-diverse young people during research.

Trauma-informed Financial Empowerment Programming Associated with Improved Financial Well-being

AbstractFinancial well-being and overall health are significantly linked, especially among those in poverty who have been exposed to violence and suffer from unaddressed trauma. Yet existing public assistance programs fail to address the presence or impact of trauma and adversity. Built specifically for families living in poverty who experience adversity, the Building Wealth and Health Network (the Network) provides a space for families to heal from the effects of trauma while also building social networks and economic security. The sample for this study was primarily Black (91%) women (92%) in Philadelphia with at least one child. A repeated measures linear regression model was performed via a Difference-in-Differences approach to test differences in financial well-being scores between two groups (full participation vs. low/no participation) at two time points (baseline vs 3 months, and baseline vs 6 months). We use this program as a field study to better understand the financial well-being of program participants who took part in fewer or more program sessions. Those who participated in more sessions reported greater increases in two measures of financial well-being at three months and six months post baseline, when compared to those with low or no participation.

Comusichiamo. First Language, Life-Soundtracks and Storytelling to Support the Cultural Wellbeing of Migrants Living with Dementia

ABSTRACT This study, located at the intersection of anthropology, ageing, music therapy and dementia, explores the value of music, life-storytelling and first language, to support the cultural identity and wellbeing of people from culturally and linguistically diverse backgrounds living with dementia in Australia. It uses participant observation, the collection of oral histories and ‘life soundtracks’ to co-create a song with older Italian migrants and their families. This paper presents the first case study which informed the development of the music engagement program we call Comusichiamo (let’s make music together). The case study shows that the co-creation of a culturally tailored song, composed and sung in first language, can enhance physical and social engagement, and contribute to the general wellbeing of participants living with dementia, and their carers. Central to the program is the sharing of life history, comprising autobiographic memory, the use of ipsissima verba, the precise words participants employ repeatedly, and ipsissima fabula, the particularistic stories participants narrate frequently. This music engagement program supports a relationship-centred approach to dementia care, drawing on narrative theory and anthropological notions of personhood, and Benenzon’s notion of ‘sound identity’, to support cultural safety, protect personhood, and guard against ‘social death’.

The long-term effect of the coronavirus pandemic on parkrun participation: an interrupted time series analysis

BackgroundThe growth of parkrun between 2004 and 2019 has been heralded as a success story for public health as a result of its physical activity and wellbeing benefits for participants. However, parkrun was not immune from the COVID-19 pandemic - with events in mainland England cancelled from March 2020 to July 2021. This study explores the lasting impact of the pandemic on parkrun participation to February 2023, and its implications across the socioeconomic spectrum.MethodsThe study combines aggregated parkrun weekly finisher data from 32,470 Lower Layer Super Output Areas (LSOA) in England from January 2015 to February 2023 with Office of National Statistics (ONS) data on population and deprivation. Interrupted time series analysis using segmented Poisson regression models was used to estimate the immediate change in parkrun participation and the change in the rate of growth following the pandemic. Models were fitted for each Index of Multiple Deprivation (IMD) quintile separately to assess whether this effect differed by socioeconomic deprivation.ResultsVisualisation and interrupted time series analysis showed a significant and long-term decrease in parkrun participation following the reopening of parkrun events. This was consistent across all IMD quintiles, indicating that the inequalities in parkrun participation according to IMD observed prior to the pandemic remained after the pandemic. Between March 2020 and February 2023, almost 13 million fewer parkrun finishes are estimated to have occurred relative to what would have occurred in the absence of the pandemic.ConclusionThe reduction in parkrun participation during the pandemic and following the reopening of events is likely to have negatively impacted wellbeing in would-be participants. Going forwards, policymakers must make the difficult trade-off between the long-term health and social implications of restricting outdoor physical activity events against the benefits associated with a reduction in infectious disease transmission.

Functional Principal Component Analysis for Continuous Non-Gaussian, Truncated, and Discrete Functional Data.

Mobile health studies often collect multiple within-day self-reported assessments of participants' behavior and well-being on different scales such as physical activity (continuous scale), pain levels (truncated scale), mood states (ordinal scale), and the occurrence of daily life events (binary scale). These assessments, when indexed by time of day, can be treated and analyzed as functional data corresponding to their respective types: continuous, truncated, ordinal, and binary. Motivated by these examples, we develop a functional principal component analysis that deals with all four types of functional data in a unified manner. It employs a semiparametric Gaussian copula model, assuming a generalized latent non-paranormal process as the underlying generating mechanism for these four types of functional data. We specify latent temporal dependence using a covariance estimated through Kendall's bridging method, incorporating smoothness in the bridging process. The approach is then extended with methods for handling both dense and sparse sampling designs, calculating subject-specific latent representations of observed data, latent principal components and principal component scores. Simulation studies demonstrate the method's competitive performance under both dense and sparse sampling designs. The method is applied to data from 497 participants in the National Institute of Mental Health Family Study of Mood Spectrum Disorders to characterize differences in within-day temporal patterns of mood in individuals with the major mood disorder subtypes, including Major Depressive Disorder and Type 1 and 2 Bipolar Disorder. Software implementation of the proposed method is provided in an R-package.

“Too Much Trouble”: Transgender and Nonbinary People's Experiences of Stigmatization and Stigma Avoidance in the Workplace

Transgender and nonbinary (TNB) people in the U.S. navigate significant employment and economic inequities. Gaps in knowledge about their workplace experiences limit our broader understanding of how social inequality is interactionally constructed through employment contexts. We conducted and analyzed interviews with 26 TNB young adults. Routine hiring processes and structural constraints made participants vulnerable to interactional stigmatization and subsequent discrimination, with deleterious consequences for employment as well as mental health. Participants deployed a variety of strategies to avoid or resist anticipated stigma, including exiting the workforce or changing careers. One's ability to avoid stigmatization at work was partially shaped by structural and managerial support, organizational form, and one's gender and gender conformity. Beyond contributing to economic inequality by limiting job and career options, our findings suggest that these social processes comprise minority stressors that diminish the well-being of TNB participants and exacerbate their economic marginalization. In contributing empirical insight into the experiences of TNB people, we demonstrate the salience of stigmatization and stigma avoidance strategies for social closure within organizations and thereby advance sociological understanding of the relational generation of inequality at work.

Self-reported mental health effects of changing migration policies on immigrant health and allied care professionals in the UK

This study explores the impact of changing migration policies on the mental health of immigrant health professionals in the UK and their access to mental health services. A cross-sectional online survey was conducted among ninety-six immigrant health professionals and allied health and care workers in the UK’s health and social care sector. The mental well-being of study participants was measured using the Warwick-Edinburgh Well-being Scale (WEMWBS). Mood changes post-migration, use of mental health services and perceived effectiveness of these services were assessed using direct survey questions. The majority of respondents reported average levels of mental well-being. A significant portion of the study participants experienced a decline in mental health post-migration. The study found a strong association between ethnicity and mental well-being, with certain ethnic groups reporting worse outcomes (p=0.003, p<0.05). Despite reported mental health concerns, only a few sought professional help from mental health services or support groups, and even fewer found these effective. This study shows significant mental health challenges and poor service access faced by immigrant health professionals in the UK, exacerbated by changing migration policies. Addressing these challenges is vital for the affected individuals and ensuring a thriving, diverse UK healthcare workforce.

Empowering voices, shaping futures: digital storytelling for sustainable transformation

Digital storytelling has emerged as a powerful tool for advocating sustainability and driving social change, particularly in the diverse and rapidly developing context of Asia. This paper explores the transformative potential of digital storytelling in promoting sustainable practices across the region. By analyzing successful campaigns and case studies, the research examines how various storytelling formats and platforms effectively engage audiences, raise awareness of critical sustainability issues—such as climate change, pollution, and biodiversity loss—and inspire action towards positive change. The study delves into the capacity of digital storytelling to amplify marginalized voices, foster empathy, and mobilize collective action. It investigates the crafting of narratives that resonate with diverse Asian cultures, effectively communicate complex issues, and motivate behavior change. The role of local communities and indigenous knowledge in shaping authentic and relevant narratives is also explored, emphasizing the importance of inclusivity and cultural sensitivity. Additionally, the paper addresses ethical considerations and challenges associated with digital storytelling for advocacy. It emphasizes responsible and inclusive storytelling practices that empower communities while safeguarding participants' rights and well-being. By providing insights into effective strategies and ethical guidelines, this research equips communicators and changemakers with the tools to harness the power of digital storytelling for a more sustainable future in Asia.

Community Connector Pilot – Review Of A Non-Clinical Programme Within An Integrated Care Programme For Older Persons Team

Abstract Background A Community Connector is a specialist Social Prescriber for older individuals who often present with complex medical needs and are referred directly by an Integrated Care team. The programme is a collaborative model between this team and a respective community host organisation. Integrated Care, as part of the Sláintecare Programme, places a stronger emphasis on social supports and person-centredness as key elements in healthcare (Goodwin, 2013). Methods Referrals are received approximately two to three weeks prior to discharge from the Integrated Care team which allows for relevant feedback from the Community Connector to this team. A coaching approach is utilised as a way of exploring each participant’s individual priorities and their expressed interests and goals in order to enhance their awareness of resources and supports in their own community and their subsequent readiness to engage. This process involves co-creating a personalised wellbeing plan with each individual which can act as the basis for a joint learning journey together. Results On referrals received to the programme, ongoing data is recorded regarding the number of individuals participating, the activities undertaken and the outcomes affecting the wellbeing of participants. Social isolation is a key reason for referral among this cohort in addition to cognitive stimulation, reengagement in social outlets and carer stress. Programme participants continue to be referred to a range of community activities, programmes and supports. Preliminary findings show an increase in community connectedness in regard to individuals’ increased knowledge and subsequent participation in local activities. Conclusion Key qualitative and quantitative data are the basis for initial and ongoing evaluation of the programme. These include recording any reflections and challenges which then act as key learning tools in delivering a unique person-centred programme for older individuals.

Dance for Parkinson, multifaceted experiences of persons living with Parkinson’s Disease

Background Dance classes for people with Parkinson’s Disease (PD) are offered worldwide; however, further studies are needed to explore patients’ experiences of how dance affects well-being. Purpose To explore how Dance for Parkinson (Dance for PD) is experienced, and how it contributes to the well-being and health of participants in Sweden. Methods This qualitative study collected data from four focus groups. Participants were asked how dance classes impacted their well-being, and their ability to perform activities of daily life. The focus groups were recorded and transcribed. Data were analysed using content analysis, meaning units were coded, and codes were coalesced into categories from which themes were abstracted. Results Dance for PD provided a multifaceted experience related to social relationships, aesthetic context, feelings of wellbeing and the physical experience of dancing. The main theme contained four sub-themes: Connectedness, Pleasure and glamour, Well-being in mind and body and Customized movements. Conclusion The present study highlights that health and well-being are improved by Dance for PD. It is an enjoyable activity that meets the specific needs of persons living with the consequences of PD and should therefore be promoted by occupational therapists.

Psychotherapeutic Playback Theatre, Well-Being, and Psychological Distress: An Impact Study.

Psychotherapeutic Playback Theatre (PPT) is a new psychotherapeutic format inspired by Playback Theatre and several therapies. The research presented here aims to study the impact of PPT on the Well-being and Psychological Distress of participants in this expressive-based group psychotherapy. To achieve this, after training 30 psychotherapists and creating an implementation handbook for their use, the research team assisted 20 of them (individually or in groups of two or three) in implementing therapeutic groups that offered 12 weekly sessions, each lasting two to three hours. Nine groups were formed, including a total of 50 participants, who were assessed before and after the PPT program using questionnaires evaluating Psychological Distress and Well-being. The latter consisted of six subscales: Autonomy, Environmental Mastery, Personal Growth, Positive Relations with Others, Purpose in Life, and Self-Acceptance. A control group of 50 participants was assessed using the same variables. No significant differences were found between pre- and post-tests in the control group. However, significant differences were observed in the PPT group, with Psychological Distress decreasing and Well-being improving, both on the total scale and across all subscales except for Self-Acceptance. This set of results allows us to establish connections between participation in the PPT sessions and the positive psycho-emotional effects on participants.

Well-Being and Cardiovascular Health: Insights From the UK Biobank Study.

Cardiovascular diseases (CVDs) are a leading global health concern. Emerging evidence suggests a potential protective role of well-being in reducing CVD risk. We conducted a cohort analysis using the UK Biobank data set, encompassing 121 317 participants. We assessed the well-being of participants using a well-being index derived from baseline questionnaires. Well-being categories were derived by latent class analysis using general happiness and satisfaction with family, friendships, health, and finance situations. The relationship between well-being and 4 major CVDs was analyzed using Cox proportional hazards models and Mendelian randomization. The study also examined the impacts of well-being on lifestyle factors and inflammatory markers, and its mediating role in the well-being-CVD relationship. Higher well-being was associated with a significantly reduced risk of various CVDs. Latent class analysis identified 4 distinct well-being groups (low, variable, moderate-to-high, and high satisfaction), with higher satisfaction levels generally associated with lower risk of CVDs. Mendelian randomization suggested potential causal relationships between well-being and reduced risk of CVDs. Participants with greater well-being demonstrated healthier behaviors and lower levels of inflammatory markers. Mediation analysis indicated that lifestyle and inflammatory markers partially mediated the relationship between well-being and CVDs. This study demonstrates a robust inverse association between well-being and the risks of CVDs, suggesting that enhancing well-being may be a viable strategy for CVD prevention. The role of lifestyle factors and inflammation as a mediator provides insight into possible biological pathways linking psychological states and cardiovascular health.

Co-administration of midazolam and psilocybin: differential effects on subjective quality versus memory of the psychedelic experience

Aspects of the acute experience induced by the serotonergic psychedelic psilocybin predict symptomatic relief in multiple psychiatric disorders and improved well-being in healthy participants, but whether these therapeutic effects are immediate or are based on memories of the experience is unclear. To examine this, we co-administered psilocybin (25 mg) with the amnestic benzodiazepine midazolam in 8 healthy participants and assayed the subjective quality of, and memory for, the dosing-day experience. We identified a midazolam dose that allowed a conscious psychedelic experience to occur while partially impairing memory for the experience. Furthermore, midazolam dose and memory impairment tended to associate inversely with salience, insight, and well-being induced by psilocybin. These data suggest a role for memory in therapeutically relevant behavioral effects occasioned by psilocybin. Because midazolam blocks memory by blocking cortical neural plasticity, it may also be useful for evaluating the contribution of the pro-neuroplastic properties of psychedelics to their therapeutic activity.

Private Mediation as a Means of Achieving Public Goals

The development and strengthening of private mediation significantly determine the possibilities of overcoming the challenges in the process of the institutionalization of mediation. Establishes an effective system of dispute resolution at the state level. The legal or practical regulation of the abovementioned should be considered a prerequisite for implementing the interests of the subjects of law and forming legal awareness. In addition, the perfect functioning of the justice system, which should ensure the implementation of the legal interests of the subjects of law, is an expression of public and private interests. The well-being and satisfaction of the civil turnover participants are significantly determined by the existence of flexible dispute resolution systems and mechanisms, the correct implementation of which creates guarantees for the stability of civil turnover. In addition, it’s in the public interest that the chain of the means of dispute resolution should be flexible and diverse and allow the interested parties to choose an acceptable method in each case. Regardless of its importance, providing fast and affordable forms of dispute resolution remains a challenge. In addition, it’s important to strengthen cooperation between the public and private sectors in this process, which will be considered an innovation in Georgia. Accordingly, following legislative changes, it is important to raise public awareness, improve legal culture, and strengthen the court’s role in implementing state policy regarding dispute resolution.

Pickleball Participation and the Health and Well-Being of Adults-A Scoping Review.

Pickleball has grown tremendously in recent years, yet little evidence exists regarding pickleball-related injuries. This scoping review extends current work on pickleball participation by identifying positive and negative health effects associated with the sport. We summarize how pickleball impacts the health and well-being of adult participants. Searches were conducted on MEDLINE, CINAHL, ProQuest Nursing, ERIC, SPORTDiscus, PsycINFO, Scopus, CBCA Complete, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and ProQuest Dissertations and Theses. Selected studies considered aspects of health and/or well-being of adult pickleball participants. Using the population/concept/context framework, participants were healthy, able-bodied adults 18years of age or over, who had played pickleball at least once. The positive and negative outcomes of pickleball on participants' health and well-being (concept) within the context of pickleball participation were examined. Full-text articles written in English since 2013 were included. Extracted data were tabulated, and a descriptive summary with thematic analysis was completed. This scoping review comprised 27 articles that met the inclusion criteria. Pickleball is promising as an exercise intervention for all adults, and there is evidence of positive social and psychological effects, and health and fitness benefits to participating in pickleball by older adults. Although we are still in the early stages of studying pickleball, there have been some documented health benefits of using the sport as a physical exercise intervention for adults. More research is needed on the types, prevalence, and severity of pickleball injuries and the sport's impact on younger players.

An out-of-court community-based programme to improve the health and well-being of young adult offenders: the Gateway RCT.

Young adults represent a third of the United Kingdom prison population and are at risk of poor health outcomes, including drug and alcohol misuse, self-harm and suicide. Court diversion interventions aim to reduce the negative consequences of criminal sanctions and address the root causes of offending. However, evidence of their effectiveness has not yet been established. The Gateway programme, issued as a conditional caution, aimed to improve the life chances of young adults committing low-level offences. Participants agreed not to reoffend during the 16-week caution and, following a needs assessment, received individual support from a Gateway navigator and attended two workshops encouraging analysis of own behaviour and its consequences. To evaluate the effectiveness and cost-effectiveness of Gateway in relation to health and well-being of participants compared to usual process (court summons or a different conditional caution). Pragmatic, multisite, parallel-group, superiority randomised controlled trial with two 6-month internal pilots and a target sample size of 334. Randomisation between Gateway and usual process was on a 1 : 1 basis. Four Hampshire Constabulary sites recruited 18- to 24-year-old residents of Hampshire and Isle of Wight who were questioned for an eligible low-level offence. Semistructured interviews were also held with a sample of Gateway programme participants, staff and police study recruiters. Primary outcome was the Warwick-Edinburgh Mental Wellbeing Scale score at 12 months. Secondary outcomes included health status, alcohol and drug use, recidivism and resource use. Recruitment commenced in October 2019 and the trial stopped in April 2021. A total of 191 participants were recruited, with 109 randomised to Gateway and 82 to usual process. Due to an initial overestimation of potentially eligible young people and low retention rates, recruitment targets were adjusted, and a range of mitigating measures introduced. Although recruitment broadly met study progression criteria [35/50 (70%) Pilot 1: 64/74 (86%) Pilot 2], retention was low throughout (overall: data collected at week 4 was 50%: at week 16 it was 50%: 1-year 37%). Low retention was multifactorial, with one of the main barriers being difficulties contacting participants. It was therefore not possible to complete the randomised controlled trial or the health economics analyses. Qualitative interviews held with 58 individuals yielded rare insights into the benefits and limitations of this type of intervention, as well as barriers and facilitators in relation to recruitment in this setting. Despite close collaboration with the police to address recruitment and consent issues, expansion of the inclusion criteria and recruitment area and introducing other measures, the researchers were unable to collect sufficient data within an acceptable timeframe. The Gateway study was a unique endeavour to gather evidence for a potentially life-changing intervention for an underserved population. The experience gained indicates that randomised controlled trials of interventions, with a health-related outcome, are possible in this setting but point towards the need for conservative recruitment and retention estimates in this target population. Other study designs should be considered. The qualitative evaluation provided a range of valuable lessons for those seeking to design similar interventions or conduct research in similar settings. This study is registered as ISRCTN11888938. This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 16/122/20) and is published in full in Public Health Research; Vol. 12, No. 7. See the NIHR Funding and Awards website for further award information.

Innovation of Tri Hita Karana Yoga Model in Improving Mental Well-being of Independent Student Exchange Program Participants

Innovation of Tri Hita Karana Yoga Model in Improving Mental Well-being of Independent Student Exchange Program Participants

“Hope is the Indispensable Life Force”: A Qualitative Study of the Meaning of Hope in the Life Experiences of Lymphoma Patients

Aim Although hope is considered to be of vital importance for cancer patients, it remains uncertain in lymphoma patients. This study aimed to examine the life experiences of patients with lymphoma and reveal the meaning of hope. Method A hermeneutic-phenomenological design was used in this study. 19 lympho¬ma patients who were receiving chemotherapy participated in interviews. Participants were selected through the purposive sampling method, and the interviews were audio-recorded. A phenomenological-hermeneutic approach was used to analyze the data. Results Three themes and 12 sub-themes emerged that summarized the life experiences of patients and the meaning of hope. These themes were as follows: ‘Being in existence’, ‘Hope is the indispensable life force’, and ‘There is always hope, but it varies’. Within the scope of the sub-themes, this study showed that there were changes in the physical and emotional well-being of participants and the importance of discovering the moment. This study, which reveals the meaning of hope as a “desire to return to routine, a bridge from now to the future”, emphasized that both the patients affect hope and the factors related to the disease. Conclusion This study revealed the changes in the physical and emotional well-being of lymphoma patients, the meaning of hope in their life experiences, and the factors affecting hope. It is thought that the findings obtained will contribute to the provision of psychosocial support and care planning by healthcare professionals to strengthen hope in lymphoma patients and may guide future studies.

Use and impact of virtual resources for peer support by young adults living with cancer: A systematic review

Background: Young adults (YA) with cancer often have unmet psychosocial needs. The impact of peer support delivered in an online format to fulfil these needs in the populations of YA with cancer has not been thoroughly examined. Methods: We searched Cochrane Central Register of Controlled Trials, CINAHL, Embase, and Medline databases. We included articles about online peer support interventions for YA cancer survivors between the ages of 18 to 40 years old. Results: Our literature search yielded n = 2,773 articles and we obtained consensus on 12 articles for inclusion. We qualitatively synthesized these articles using data abstraction based on the Template for Intervention and Replication (TIDierR) checklist. Overall, six studies demonstrated correlation between online peer support and improved wellbeing of participants. Thus, online peer support may be useful for young cancer patients. Conclusion: This systematic review summarizes the current state of knowledge regarding the availability and evaluation of online YA peer support programs and reveals the need for further research in this field. Keywords: young adult, social support, cancer survivor, social survivorship, social media, internet-based intervention

Деятельность локального этического комитета по повышению качества биомедицинских исследований молодых сотрудников университета

The article is devoted to the issues of clinical research: their ethical and legal regulation at the present time, the history of ethical expertise in the Russian Federation and at Kazan State Medical University. The role of ethical committees as a structure responsible for quality of scientific research and a guarantor of compliance with the principles of ethics, protection of the rights, safety and well-being of research participants is considered. The article presents the working experience of the local ethics committee of Kazan State Medical University on ethical examination of research projects with human participation and analysis of the most common mistakes in preparation of research documentation made by young scientists of clinical departments. The digital information showing typical errors and inaccuracies in the formation of a package of documents for ethical examination, based on the analysis of 284 initiative papers of PhD candidates from clinical departments: every fifth protocol required revision in accordance with the ethical and legal framework adopted in the Russian Federation, in 1.5% of cases the documentation was submitted for already conducted studies (i.e. ost factum), when no changes to its design are possible anymore. Typical mistakes were the following: inability to form research and control groups, calculate a representative number of participants, write an information sheet for a participant in a clinical trial and a sheet of informed consent, going beyond the specialty, desire to prescribe drugs beyond the scope of registered indications, etc. The ways of increasing both the awareness of young researchers and quality of ethical expertise by specialists of the ethics committee are proposed.