Protection Of Subjects Research Articles

How Well Are We Protecting Human Research Subjects?

Protecting human research subjects is an ethical mandate for all contemporary research involving human subjects. From 1974 to 1999, we had the institutional review board (IRB) system and the Common Rule, but realized that in addition to IRBs, investigators, institutions, sponsors of research, research participants, and the government, all share responsibilities in protecting human research subjects. Starting 2000, institutions established human research protection programs to ensure the rights and welfare of research participants and to meet human research ethical and regulatory requirements. Some institutions had their human research protection programs further accredited to ensure rigorous standards for quality and protection. In 2018, the Common Rule was extensively revised to modernize the regulations by enhancing protections and reducing burden for researchers. However, throughout these periods, we did not know how well we were protecting human research subjects, because we did not know how to measure human research subject protections. With the publication of human research subject protections performance metrics in 2023, it becomes possible for the first time to assess quantitatively how well we are protecting human research subjects. Research institutions can now monitor the effectiveness of their human research protection programs and identify areas of vulnerability for quality improvement. We should also be able to determine how well human research protection programs are doing in protecting human research subjects; determine whether external accreditation improves human research subject protections and whether the revised Common Rule in fact leads to enhanced protections; and identify prospectively which procedures or interventions can enhance human research subject protections.

Methodological approaches in developing and implementing digital health interventions amongst underserved women.

Minority populations are utilizing mobile health applications more frequently to access health information. One group that may benefit from using mHealth technology is underserved women, specifically those on community supervision. Discuss methodological approaches for navigating digital health strategies to address underserved women's health disparities. Using an intersectional lens, we identified strategies for conducting research using digital health technology and artificial intelligence amongst the underserved, particularly those with community supervision. We explore (1) methodological approaches that combine traditional research methods with precision medicine, digital phenotyping, and ecological momentary assessment; (2) implications for artificial intelligence; and (3) ethical considerations with data collection, storage, and engagement. Researchers must address gendered differences related to health, social, and economic disparities concurrently with an unwavering focus on the protection of human subjects when addressing the unique needs of underserved women while utilizing digital health methodologies. Women on community supervision in South Central Texas helped inform the design of JUN, the mHealth app we reported in the case exemplar. JUN is named after the Junonia shell, a native shell to South Texas, which means strength, power, and self-sufficiency, like the participants in our preliminary studies.

Protocol for a discrete choice experiment: understanding preferences for seeking health services for survivors of sexual violence in Uganda

IntroductionSexual violence is a significant public health concern with severe physical, social and psychological consequences, which can be mitigated by health service utilisation. However, in Uganda and much of sub-Saharan...

Mobility of older people in public spaces from agender perspective

For older people, asufficient mobility offer is an essential prerequisite for participation in social life and abetter quality of life. The goal should be self-determined everyday mobility that enables asatisfying and healthy life. Mobility depends on diverse individual abilities and needs. On the other hand, social structures as well as regulatory and spatial framework conditions limit the realisation of mobility services and their transport infrastructure. These framework conditions are characterised by the perception of social roles, the availability of resources and gender-specific attributions. For example, care and caring work is predominantly the responsibility of women in the age group of 50years plus. The availability of transport infrastructure is geared towards goals that are characterised by the needs of gainful employment and not the goals of care work. Conversely, the availability of flexible means of transport, such as cars, also decreases for women in old age for economic reasons. For this reason, mobility planning should take greater account of specific needs, such as orientation towards care objectives, counselling, and health services and place agreater focus on the local area. For elderly people, especially women, security needs are often an important factor in the decision to become mobile or to forego mobility. This includes perceived subjective safety, accessibility and protection from weather conditions such as slippery surfaces or exposure to excessive heat. If these basic principles are taken into account, more people can be guaranteed self-determined participation in social life.

Privacy’s Sky-High Battle: The Use of Unmanned Aircraft Systems for Law Enforcement in the European Union

Benefiting from the rapid advancements in Unmanned Aircraft Systems (UAS) technology with enhanced tracking and data collection capabilities, law enforcement authorities re-discovered air as a dimension where state power can be exercised in a more affordable, accessible, and compact way. On the other hand, during law enforcement operations, UAS can collect various types of data that can be personal or sensitive, threatening the right to privacy and data protection of the data subjects. Risks include challenges related to data security, bulk data collection, the diminished transparency and fairness resulting from the inconspicuous nature of UAS, as well as ethical concerns intertwined with privacy and data protection. Upon examination of the legal framework including the General Data Protection Regulation the Law Enforcement Directive, various Aviation rules, and the new proposal for the Artificial Intelligence Act, it becomes apparent that the EU legal framework’s adequacy in safeguarding privacy and data protection against law enforcement use of UAS is context-dependent, varying across use cases. The current framework lacks clarity, leading to arbitrary application and limited protection for data subjects. Enforcement of safeguards is insufficient, and the Aviation Regulations, applicable to law enforcement UAS, require member states' opt-in, which has not occurred as of the authors’ knowledge. The Artificial Intelligence Act addresses UAS operations but focuses on market risks rather than obligations imposed on law enforcement authorities. Consequently, the existing framework is rendered inadequate for medium to high-risk law enforcement operations, leaving individuals vulnerable and insufficiently protected against intrusive UAS surveillance. Rectifying this involves addressing the enforcement gap and making the necessary amendments to relevant regulatory aspects. Additionally, the implementation of specific technical measures and steps to foster effective cooperation among stakeholders in UAS deployment for law enforcement is imperative.

Comparative study of the effects of custom-made insole and ordinary insole in adults with flexible flatfoot on different slopes.

Flatfoot (pes planus) is a common foot deformity, and its causes are mainly related to age, gender, weight, and genetics. Previous studies have shown that custom-made insoles could have a positive effect in improving plantar pressure and symptoms in individuals with flexible flatfeet, but it remains to be explored whether they can still show benefits in daily walking on different slopes. This study aims to investigate a custom-made insole based on plantar pressure redistribution and to verify its effectiveness by gait analysis on different slopes. We recruited 10 subjects and compared the peak pressure and impulse in each area between custom-made insole (CI) and ordinary insole (OI) groups. The results illustrate that CI raises the pressure in T area, improves the ability of the subjects to move forward in the slope walking, which was beneficial to gait stability. The redistribution of pressure in MF and MH area is promoted to provide active protection for subjects. Meanwhile, CI could decrease the impulse in MF area during uphill and level walking, which effectively reduces the accumulation of fatigue during gait. Moreover, avoiding downhill walking could be able to protect foot from injury in daily life.

WEAKNESS AS A PHILOSOPHICAL CONCEPT AND LEGAL CATEGORY

The article is devoted to the most complex, little-studied in jurisprudence and the theory of civil law, deep-seated issues of protecting the weakness in delicate and other legal relations. The authors proceed from the fact that the effectiveness of the protection of the weakness is based on its holistic understanding of both legal and philosophical categories. Based on this, the authors draw a philosophical-semantic and lexical-legal analogy between this category and the category of a weak subject, its semantic conditionality from such philosophical categories as personality, self-worth of a person. It is proposed to consider the category of the weakness from the standpoint of its static and dynamic states, the conditionality of the effectiveness of its protection in the post-Soviet society from the development and state of effectiveness of formal institutions, as well as the ideological and value attitude of Kazakhstan society to the fundamental principles of the rule of law, formal equality and social justice The authors separately highlight the dependence of legal protection of a weak subject on the extent to which Kazakhstan's socio-legal reality realizes: a) the conditionality of a person from society, on the one hand; and b) his natural-biological and cognitive self-sufficiency, on the other. In this context, the authors make some retrospective analysis of the state of natural human rights in Kazakhstan of the Soviet period, reveal the nature and essence of the category "I". According to the authors, the category "I" in post-classical reality is a key element of such self-sufficiency. It is on the basis of their unity that reflection, comprehension and concepts of self-awareness and self-knowledge, self-identity, respect for self and other, society and the state should be built.

Research on the Balance Mechanism of Rights Conflict in the Cross-border Flow of Personal Financial Data

The cross-border flow of personal financial data is inevitable due to the needs of cross-border business or overseas supervision such as anti-money laundering. The conflict between national financial security and financial efficiency results in a series of unbalanced situations under cross-border financial data. The state takes measures to regulate in order to balance different demands, promote economic development, and seek economic globalization. In an unbalanced state, the lack of systematic rights protection will lead to a lack of confidence in the degree of protection of personal financial data subjects, which may hinder the construction of global economic integration. This paper first analyzes the causes of imbalance from the perspective of value orientation and makes suggestions for institutional improvement. Secondly, from the perspective of the contradictions between the subjects of personal financial data rights and processors, as well as the contradictions between regulators, it studies the feasibility methods to check and balance and resolve the conflicts, so as to achieve the goal of clarifying the basic value and coordinating the conflict relationship. It should also focus on the development of national independent artificial intelligence, science and technology to help development cooperation, and the goal of international economic integration.

PERLINDUNGAN HUKUM BAGI SUBJEK PENELITIAN KESEHATAN DITINJAU DARI ETIKA DAN TANGGUNG JAWAB

Legal protection is everyone's right, including legal protection for research subjects. This research includes observational and experimental research. In these two types of research, students need to involve research subjects, both experimental animals and humans. In its implementation, it is necessary to obtain permission to be involved as a research subject in health research. This relates to fulfilling the rights and legal protection of health research subjects, especially in the field of dental education. This research is sociological juridical research, with analytical descriptive research specifications. This research uses sources from primary data and secondary data with data collection methods through field studies and literature studies to obtain the required data. The analysis method uses qualitative data analysis. Legal protection, both preventive and repressive, for health research subjects has not been realized even though there are legal provisions that regulate it, so firmness is needed in the implementation process.

An observational study protocol to capture, validate and characterise lucid episodes in people living with advanced dementia receiving hospice care

IntroductionLucid episodes (LEs) in advanced neurodegenerative disease, characterised by a transient recovery of abilities, have been reported across neurological conditions, including Alzheimer’s disease and related dementias. Evidence on LEs in...

A Brief Review on Good Clinical Practice and its Training Methods

Abstract The field of clinical research continues to advance, and for ethical conduct of research, researchers need to have a strong foundation in good clinical practice (GCP). GCP guidelines are internationally recognized standards that govern the conduct of clinical trials, ensuring the protection of human subjects and the generation of reliable data. However, novice researchers or postgraduate medical students who would delve into research activities may face difficulty getting avenues for GCP training. Hence, in this brief review article, we discuss the significance of GCP in the field of clinical research with a glimpse of its history, development, and key principles. We provide a list of online courses, benefits, and disadvantages of those courses, and a list of organizations that conduct GCP workshops or continued medical education programs in India.

Peripheral Arterial Disease in Diabetes and its Relation to Cardiovascular Risk Factors in Women

Objectives: Peripheral arterial disease (PAD) is characterized by occlusive disease in the abdominal aorta, iliac, and femoral arteries, leading to reduced blood flow and complications. Diabetes mellitus (DM) is known to contribute to the development and progression of PAD due to factors such as hyperglycemia, dyslipidemia, endothelial dysfunction, and inflammation. However, PAD may be underdiagnosed in women with DM, leading to adverse cardiovascular outcomes. The present study aimed to investigate the prevalence of PAD in women with type 2 DM (T2DM) and its relationship with cardiovascular risk factors. Materials and Methods: This hospital-based, cross-sectional, and observational study was conducted for a period of 3 months from June 10, 2023, to September 10, 2023, in the outpatient department of general medicine. After obtaining the approval from the Institutional Ethical Committee, the study was performed according to the Declarations of Helsinki and Good Clinical Practice requirements for human subject protection. Non-probability purposive sampling technique was used to enroll participants. Participants underwent face-to-face interviews and clinical examinations. Sociodemographic data, medical history, and pharmacotherapy details were collected. Laboratory investigations were conducted, including blood glucose, lipid profile, and glycosylated hemoglobin (HbA1C) tests. The ankle-brachial index (ABI) was measured. Results: The results showed that the majority of the participants were between 50 and 70 years of age, married, and had a high school education. Participants had an average body mass index (BMI) indicating overweight, and the average duration of diabetes was 6.571 years. Hypertension was the most prevalent comorbidity. Overweight, obesity I, and obesity II were present in 15.25% (n = 19), 33.6% (n = 42), and 8.8% (n = 11), respectively. Average values for HbA1C, fasting blood glucose (FBG), and postprandial blood glucose (PPBG) were within the diabetic range. ABI was normal in the right side, left side, and bilateral in 43.2%, 56%, and 14.4% of participants, respectively. ABI was borderline on the right side, left side, and bilateral in 40.8%, 36.8%, and 22.4% of participants, respectively. PAD was observed on the right side, left side, and bilateral in 16%, 7.2%, and 4% of participants, respectively. BMI, duration of DM, glycosylated hemoglobin, FBG, and PPBG showed significant negative correlations with ABI. Age, triglycerides, high-density lipoprotein, and low-density lipoprotein did not show any statistically significant correlation with ABI. Conclusion: The study highlighted the importance of screening for PAD in women with T2DM to improve cardiovascular outcomes. The findings shed light on the prevalence of risk factors for PAD and their association with the disease. These insights can contribute to the development of targeted interventions to reduce adverse clinical outcomes in this population.

Ethics Review of Biomedical Research in Uzbekistan: Policy and Program Gaps.

We describe the national health research ethics review system of Uzbekistan and identify policy and program gaps that impede the protection of human research subjects. We find that the National Ethic Committee (NEC), functioning at the national level, is solely responsible for conducting research ethics review. There is little evidence that regional ethics committees work as intended, and there is no research ethics review at medical institutes and research centers even though they conduct CDTs (clinical drug trials). There is no national policy for the ethical review of non-clinical trials. We recommend the establishment of institutional review boards (IRBs) at medical institutes and research centers while at the same time building capacity at the national level to oversee and support the research ethics review system of the entire country.

Equitable Representation of Pregnant and Lactating Women in Clinical Research: A Historical Review and Critical Analysis of Proposed Legislation.

A long history of policymaking and regulation constructed for the purpose of ensuring adequate fetal and infant protections has inadvertently sanctioned the widespread exclusion of pregnant and lactating patients from biomedical research, leaving a paucity of high quality data necessary for clinical decision-making. Although well-intended, the regulatory classification of pregnant women as "vulnerable", in conjunction with burdensome enrollment criteria and other factors weighing against broad inclusion, have ultimately placed the health and safety of these women and their babies in jeopardy. Robust measures are urgently needed to overcome patient and physician reluctance, address substantial evidence gaps and rectify longstanding disparities which precipitate disproportionately poor health outcomes among this population. In February 2023, the Advancing Safe Medications for Moms and Babies Act of 2023 (the Act) was introduced in the United States House of Representatives with the overarching goal of enabling pregnant and lactating women to achieve equitable participation in clinical research and contribute to developing important biomedical knowledge to guide and improve healthcare delivered to these patients. This review discusses the historical influence of federal human subject protection regulations on the health and clinical treatment of pregnant and lactating women, outlines and critically analyzes the provisions incorporated into the Act, and reflects on the potential long-term impact the Act would have should it be successful in becoming law.

Focus group interviews as part of a clinical research immersion experience

Background Research is an essential component of the dental profession and should be integrated into dental education and training curricula. Opportunities to participate in clinical research studies can enrich the learning experience of those involved. Methods This paper reports a new educational method utilized to enhance the experiences of novice members of a research study team in conducting Focus Group Interviews (FGIs) as part of a double-blind clinical trial exploring an oral probiotic intervention. Study team members participated in a series of in-person FGIs conducted at the beginning and toward the end of a University-based clinical trial, which took place from October 2021 to October 2022. Results Study team members consisting of faculty, staff, and pre-doctoral dental students help plan and conduct interviews, curate, and qualitatively analyze the data. Study team members acquired experience with regard to interpersonal communication skills, organization, research subject communication, the application of human subject protection, FGI methodology, data analysis, developing presentations, and preparing scientific data presentation and publications. Conclusion Exposing dental faculty and students to clinical research studies in university settings can offer opportunities for experiential, multidimensional learning and the development of new research knowledge and skills.

Self-Perception of Risk for HIV Acquisition and Calculated Risk for HIV Acquisition Among Active Duty Air Force Members With Newly Diagnosed HIV Infection.

There have been nearly 1,600 new diagnoses of Human Immunodeficiency Virus (HIV) across the US Armed Forces between 2017 and 2022. While treatment has improved overall survival, self-perception of acquiring HIV may not align with actual risk of acquiring HIV, thus slowing diagnosis and treatment. We aim to evaluate self-perceived risk (SPR) versus calculated risk (CR) of HIV infection in US Air Force (USAF) members with incident HIV diagnosis. All USAF members with new HIV diagnosis evaluated at a specialty care military medical center between January 2015 and March 2020 with case report forms were included (n = 142). SPR was compared to CR using the Denver HIV Risk Score (DHRS). The study was approved by the Army Public Health Center's Public Health Review Board (#14-311) and the Walter Reed Army Institute of Research Human Subjects Protection Branch (#1861E). Patients were predominantly male (98%), with a median age of 26 (IQR 22-30) years, and the majority (85%) reported same-sex partners. Most patients reported a low SPR (n = 78; 55%). A higher proportion of low SPR patients were married or partnered than high SPR patients (29% versus 14%; P = 0.04). Both groups had median DHRS scores in the highest risk category with similar results by reason for HIV screening. The majority of USAF members with incident HIV infection reported a low SPR despite risk factors and CRs identical to high SPR patients. In order to inform HIV prevention strategies in the military, further efforts are needed to educate the military population and providers about HIV risk perception.

Bioethics-CSR Divide

Bioethics-CSR Divide

Does surgical volume correlate with outcomes in TMJ replacement surgery?

ObjectivesTo survey oral and maxillofacial surgeons (OMS) who perform temporomandibular joint replacement (TMJR) to determine whether length of surgery, specific TMJR protocols, or the incidence of complications are related to experience and case volume. Study DesignAn anonymous electronic survey was emailed to 407 surgeon members of the American Association of Oral and Maxillofacial Surgeons, American Society of Temporomandibular Joint Surgeons, and European Society of Temporomandibular Joint Surgeons known to have TMJR experience via publications or reputation. The descriptive survey contained multiple choice and open-ended questions. Descriptive statistics were computed for each variable for data analysis. Results49 surgeons completed the survey. The average stock TMJR cases included 54.6% unilateral and 50.5% bilateral cases. The average custom TMJR cases included 50.5% unilateral and 49.5% bilateral cases. Average procedure time for stock TMJR was 2.86 hours for unilateral, and 5.30 hours for bilateral cases. The average procedure time for a custom TMJR was 2.75 hours for unilateral, and 4.87 hours for bilateral cases. Average duration of hospital stay for stock and custom TMJR cases was 1.49 and 1.41 days (unilateral), and 1.98 and 1.95 days (bilateral). ConclusionThis study provides some pilot data that demonstrates that the length of surgery, specific TMJR surgical protocols, and the incidence of complications may be related to surgeon TMJR experience and case volume. IntroductionAlloplastic temporomandibular joint replacement (TMJR) is indicated for patients with end-stage temporomandibular joint pathology.1 As with any surgery, complications may occur, however, to date the relationship between the incidence of adverse events and surgeon experience has been unreported for TMJR surgery. The orthopedic literature demonstrates that the risk of complications decreases with more surgeon experience with alloplastic joint replacements.2,3 The aim of this study was to survey OMS who perform TMJR to determine whether length of surgery, specific TMJR protocols, and the incidence of complications could be related to their TMJR experience and case volume. It is hypothesized that with more TMJR surgical experience and case volume there will be fewer complications. Materials and MethodsThe study received Institutional Review Board approval (IRB #2023-0095) by the University of Illinois Chicago Research Office of Protection of Research Subjects. The study complies with the Helsinki Declaration and Health Insurance Portability and Accountability Act of 1996 (HIPAA). An invitation to participate in an anonymous electronic survey, via Survey Monkey (http://www.surveymonkey.com), was emailed to 407 surgeon members of the American Association of Oral and Maxillofacial Surgeons (AAOMS), American Society of Temporomandibular Joint Surgeons (ASTMJS), and European Society of Temporomandibular Joint Surgeons (ESTMJS) list serves. Two weeks after the initial recruitment email was sent, a reminder email was sent to the surgeons. All potential participants were provided with 4 weeks to sign a detailed informed consent form and complete the survey.The descriptive survey contained multiple choice and open-ended questions including: practice type, years in practice, if alloplastic TMJR is preformed, if TMJR Fellowship was completed, years of TMJR practice, average number of annual unilateral and bilateral TMJR cases, number considered an annual “high volume number” of TMJR procedures, average procedure time in hours for unilateral, bilateral, stock, and custom TMJR cases, average duration of hospital stay in days, and any complications and management. Descriptive statistics were computed for each variable for data analysis. ResultsThe survey was successfully sent to 394 emails, with a response rate of 12.9%. 13 emails were returned from the original 407 emails. 49 surgeons completed the survey, and 2 surgeons replied that they did not complete the survey because they are retired. 63.27% of the responding surgeons identified as academic, 53.06% as private practice, 22.45% as both academia and private practice, and 2.04% as military (Figure 1A). 93.88% reported they perform alloplastic TMJR (Figure 1B). 79.17% had not completed a TMJR fellowship (Figure 1C). 27.08% employed TMJR surgery in their practices >26 years (Figure 2).

The Belmont Report doesn’t need reform, our moral imagination does

In 1974, the United States Congress asked a question prompting a national conversation about ethics: which ethical principles should govern research involving human participants? To embark on an answer, Congress passed the National Research Act, and charged this task to the newly established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission’s mandate was modest however, the results were anything but. The outcome was The Belmont Report: a trio of principles - respect for persons, beneficence, and justice - serving as an ethical compass for scientists, researchers, and institutional review boards (IRBs). Almost 50 years later, the utility, legacy, and ingenuity of The Belmont Report continues to be both admired and challenged. Critics argue that Belmont is not fit for the 21st century, while supporters praise Belmont for its enduring wisdom. The goal of this paper is to equip IRB practitioners with the tools necessary to maximally interpret The Belmont Report and meaningfully engage in ethical analysis that reconsiders outmoded legacy thinking and fixed decision-making. Through historical and contextual reflection, this paper describes how IRB practitioners can contemporize review of ethical human research using their moral imagination – a skill found at the intersection of creativity, deliberation, and empathy.

Whistleblower’s Rights in a Legal Investigation: Exploring the Challenges and Opportunities in Albania

Background: This article examines the issues, possibilities, and methods associated with whistleblowing in Albania. Transparency and accountability became increasingly important as the country moved from communist rule to democracy. The passage of the Whistleblower Protection Law in 2016 laid the groundwork for recognising and protecting whistleblowers. This article discusses the legal framework of Law No. 60/2016, as well as other legal initiatives, in the light of the rights and protection provided for whistleblowers, following up with an administrative investigation and criminal proceeding. However, despite these legal strides, whistleblowing is hindered by several issues, including a lack of public awareness, a continuing fear of retaliation, limited legislative safeguards, and resource restrictions among whistleblower-handling organisations. As Albania continues to grapple with these challenges and seize the opportunities at hand, the challenge stands in strengthening the culture of integrity, transparency, and accountability. Commitment to this critical part of governance not only strengthens whistleblower practices but also adds to the fight against corruption and the rule of law. This article concludes with recommendations on turning challenges into opportunities and strengths through the right governance and tools, aligning with the best international practices. Methods: The methodology applied for exploring whistleblowing practices in Albania included a thorough assessment of relevant legal texts, legislative frameworks, and academic literature. Primary sources included a careful review of Albanian whistleblower legislation, emphasising clauses covering rights, safeguards, and processes. This legal research offered a solid grasp of the statutory systems in place to facilitate whistleblowing practices in the nation. Furthermore, a thorough assessment of academic papers, reports from international organisations, and case studies was carried out to capture the practical consequences and obstacles faced by whistleblowers in Albania. This multidimensional approach enabled a full analysis of the theoretical underpinnings as well as real-world uses of whistleblower mechanisms in the Albanian setting. Results and conclusions: The whistleblower practice in Albania has encountered many challenges, but improvements have been made to guarantee access to justice. The main problem that the whistleblower faces is retaliation, which creates such a fear that most will choose to stay silent in the face of injustice or illegal acts. Another issue is certainly job insecurity because many can’t afford to switch jobs or find jobs that meet their criteria. Some recommendations for improving whistleblowing practices and guaranteeing more protection for vulnerable subjects include whistleblower training, strengthening the whistleblower network, evaluating results often and putting financial safeguards in place.