Protection Of Research Subjects Research Articles

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.

Data Safety Monitoring Boards: Overview of Structure and Role in Spinal Cord Injury Studies

This paper provides an overview of the history, composition, organization, responsibilities, and regulatory requirements of Data Safety Monitoring Boards (DSMB), with particular reference to the context of clinical trials in spinal cord injury. It is intended to help potential members of such boards and those undertaking the design of new clinical trials to understand the important role of the DSMB in safeguarding the integrity of complex trials, promoting safety, and countering potential bias. An independent DSMB helps to protect research subjects by providing study oversight and serves as an additional step to assure that clinical trials are performed to existing and appropriate standards. The DSMB must meet on a regular schedule, diligently evaluate all the information it receives, and report in a timely and decisive manner. Members must be free of significant conflicts of interest throughout the study and be adequately trained and experienced to serve their roles within the group. DSMB service can be a valuable learning experience and a gratifying opportunity to participate in advancing medicine and helping to maintain and improve the standards of research.

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).

Ethical Planning in Conducting a Research Project

Countries that still do not have a national normative document on research ethics, like most African and Latin American countries, have taken the Declaration of Helsinki as a reference for ethical guidance to researchers and members of ethics committees. However, the literature has shown that the latest revisions of this declaration have tended to favor the interests of central countries and their industries, mainly through the more flexible acceptance of greater risks and smaller benefits. Even when there are norms adequate to the reality of each country, the ethical planning of a research goes far beyond the simple bureaucratic fulfillment of the norms that guide the presentation of a protocol and a consent term to a research ethics committee. It presupposes an in-depth reflection on the methodological procedures themselves that will involve the participants and on the ways in which they interact with the socioeconomic and cultural contexts of these participants' daily lives. In developing countries, consideration of social vulnerability, especially with regard to poverty and low levels of education, is a central element in this planning. I intend to discuss this planning taking the three classic axes of research subject protection: obtaining consent, minimizing risks and maximizing benefits in their relationship with contexts of social vulnerability in three modalities of health research: those that handle information from identifiable subjects, such as clinical protocols; those using interviews and questionnaires; and clinical trials for new drugs.

Contextual Vulnerability Should Guide Fair Subject Selection in Xenotransplantation Clinical Trials

Contextual Vulnerability Should Guide Fair Subject Selection in Xenotransplantation Clinical Trials

인간대상연구를 수행하는 초보 연구자의 연구진실성 증진을 위한 고찰

Research ethics is a desirable way of conducting responsible research, which means maintaining the integrity and complying with ethical norms in a particular field of research. Research integrity means keeping the values and standards required by researchers in the research process. Despite educational institutions' efforts to improve research ethics, the judgment of research cheating is on the rise. In addition, there were unclear regulations related to self-plagiarism, duplicate publication, and the scope of research ethics. If you are a researcher of human research, planning and conducting ethical research is the first step for research integrity. Researchers need to understand protecting research subjects conducting research, and educational institutions should review and improve the current curriculum to provide research ethics education more effectively. Before strengthening legal sanctions on research cheating centered on results, the government should seek solutions through fundamental cause analysis to prevent researchers from committing research cheating. Given the current status of research ethics educational institutions and the progress of policies so far, we hope that if everyone tries at the individual, educational institution, and government levels, we will move in a more positive direction.

Ethics Committees: Structure, Roles, and Issues.

An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It's pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study.

Understanding the research-care demarcation and why it must be revised

BackgroundA clean-cut separation between research and care was artificially created at the time of the Belmont report more than 40 years ago. The demarcation was initially controversial but eventually was implemented for political reasons. We examine why it must be revised. MethodsWe review historical research scandals as well as the theoretical basis for the Belmont demarcation. We then discuss consequences on medical practice and propose an alternative. DiscussionMost research scandals involved abusing human beings supposedly for the sake of science. Belmont commissioners were aware the research/care problem was double-headed. While research subjects should be protected from abuse in the research context, patients need to be protected from unvalidated medical and surgical interventions in the care context. For political reasons the Commission recommended the regulation of research but to leave medical practice untouched. Thus the Commission had to distinguish research from care. The notion of ‘generalizable knowledge’ was introduced to define and regulate research, but the inadvertent result was that by trying to protect research subjects, the regulation has not only failed to protect all other patients, but also encouraged the widespread practice of unvalidated interventions within the care context. The notion of validated care should be re-introduced into a proper analysis of the care-research demarcation, for care research is an integral ingredient of a good medical practice. ConclusionThe research-care demarcation should be revised to leave room for the validated/unvalidated care distinction. Care research, essential to guide medical practice, should be facilitated at all levels.

International Research and Philanthropy

International Research and Philanthropy

Using public data to measure diversity in computer science research communities: A critical data governance perspective

Encouraging and supporting diversity and inclusion in computer science research communities is a critical issue for many reasons, including the ethical and robust design, delivery and publication of research that addresses real-world situations ranging from the use of digital tools in health to predictive policing to workplace hiring practices, just to name a few. One way to measure diversity is to apply analytical research methods to data sourced from the public domain for use in research. However, attempts to measure diversity using public data may themselves raise legal and ethical questions about the provenance of the data, research methods adopted, and treatment of diversity in the publication of results. This article interrogates the challenges of measuring diversity using public data, examining an illustrative case study framed around an academic research project at an Australian university using a public data set to identify gender representation in computer science communities. Employing a critical data governance perspective, we point to a range of ethical and legal concerns and recommend greater regulatory guardrails to better balance public interests in research and the privacy, data protection and other ethical interests of research subjects.

Open Access and Sensitive Social Sciences Data in Different Legislative Contexts: The Case of Strategic Selection “Elite” Interviewing in Sweden

Open access has moved from the periphery to the mainstream in the last few years, and most recently there have been calls to make research data “accessible, useable and reusable”. While there are many good arguments for this development, including that it makes the research process more transparent and enables others to re-use the data collected, it also has negative implications for social science research in certain contexts. The case addressed here is “elite” interviewing in the context of conducting research in Sweden. In this case there is already a strong legislative focus on openness with implications for research ethics. This suggests that open data access implementation, particularly in the context of specific legislative frameworks, needs to be reviewed to ascertain ethically correct interviewee and research subject protection in the social sciences.

Student Subjects in Research

Student Subjects in Research

Implications of the Revised Common Rule for Qualitative Health Research: Opportunities, Concerns, and Recommendations.

In January 2019, revisions to federal regulations that outline requirements for ethical oversight of human subjects research (The Revised Common Rule) went into effect. These revisions reflect major changes in thinking about risk and protection of research subjects. The Revised Common Rule (RCR) considerably curtails federal oversight of social and behavioral science, with most non-interventional research and "benign" behavioral interventions becoming exempt from mandated Institutional Review Board (IRB) approval, although determination of exemption remains with IRBs. As two qualitative health researchers serving on IRBs, we consider how this contraction of federal oversight dovetails with longstanding criticisms of IRB oversight of qualitative research. We explore the passage of the RCR as a point of potentially important change in procedure and principle in relation to ethical oversight of qualitative health research. We identify challenges and opportunities with these changes at the institutional, professional, and individual levels for ethical and impactful qualitative research.

QOLP-13. RETROSPECTIVE REVIEW OF HOSPICE CARE UTILIZATION IN GLIOBLASTOMA PATIENTS IN A TERTIARY CARE CENTER

Abstract BACKGROUND Glioblastoma is a highly aggressive grade IV tumor of the brain. Standard of care is maximal safe resection followed by radiation therapy and chemotherapy. Despite optimal management, majority recur, and the median survival is 2-3 years. Hospice is a philosophy of care to alleviate end-of-life suffering, and it can also relieve caregiver fatigue. METHODS This is a retrospective chart review in a tertiary care center. IRB approval was obtained from the Office for the Protection of Research Subjects. ICD-10 code for malignant gliomas C71.9 was used to query EMR at UIC from 2015-2020. Patients with primary glioblastoma that had their entire neuro-oncologic care at UIC were included in the data analysis. Patient’s age < 18 years, unknown date of death, or those who transitioned to a different facility were excluded. Data included were demographic (including marital status as a proxy for social support), insurance, ethnicity, tumor characteristics, and treatments provided. End-of life quality measure assessed were (1)no chemotherapy < 2w, (2)hospice status < 7 days, (3)no hospital admission > 30 days (4)no ICU admission < 14 days. RESULTS 48 patients with primary glioblastoma were identified and out of those, a total of 35 patients received entirety of neurooncological care at our center. Date of death was available for 13 patients. 9 patients had been referred to hospice and 4 were not. Demographic variables were similar except social support – patients referred to hospice were more likely to be married. End-of-life quality measures were met in all patients in hospice group (9/9) but only in half of those not referred to hospice (2/4). DISCUSSION Social support has an impact on enrollment of hospice care. Including goals of care discussion earlier in the treatment would require a multi-disciplinary team with additional involvement of supportive care, nurses, and social workers.

Investigating the process of ethical approval in citizen science research: the case of Public Health

Undertaking citizen science research in Public Health involving human subjects poses significant challenges concerning the traditional process of ethical approval. It requires an extension of the ethics of protection of research subjects in order to include the empowerment of citizens as citizen scientists. This paper investigates these challenges and illustrates the ethical framework and the strategies developed within the CitieS-Health project. It also proposes first recommendations generated from the experiences of five citizen science pilot studies in environmental epidemiology within this project.

Taking the principle of the primacy of the human being seriously

This paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion about the meaning and role of the principle. Several authors note that the principle is vogue, ambiguous and apparently conflicting with the accepted practice of conducting non-beneficial research on individuals unable to give consent. There are opinions that it is just “a vacuous figure of speech” and should be abandoned. This paper argues that the primacy principle is far from being “a vacuous figure of speech”, rather it should be seen as a threefold concept: a fundamental interpretative rule, a procedural rule, and a substantive rule aimed at protecting research subjects from instrumental treatment and unacceptable risks. This interpretation tracks back to the principle regulatory and normative origins in the Declaration of Helsinki of 1975, but also acknowledges changes in research ethics and practice, which took place at the turn on the twentieth and twenty-first centuries. Thus, the proposed reading of the principle is not only original, but also historically grounded and normatively fruitful. It provides a fresh and ethically rich perspective on extensively debated, but still controversial problem of an upper limit of permissible risks in non-beneficial studies.

Normative framework of informed consent in clinical research in Germany, Poland, and Russia

BackgroundBiomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki.MethodsFor this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed.ResultsThe normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible.ConclusionsThe identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements.Trial registration: Not applicable.

Online Extremism and Terrorism Research Ethics: Researcher Safety, Informed Consent, and the Need for Tailored Guidelines

ABSTRACT This article reflects on two core issues of human subjects’ research ethics and how they play out for online extremism and terrorism researchers. Medical research ethics, on which social science research ethics are based, centers the protection of research subjects, but what of the protection of researchers? Greater attention to researcher safety, including online security and privacy and mental and emotional wellbeing, is called for herein. Researching hostile or dangerous communities does not, on the other hand, exempt us from our responsibilities to protect our research subjects, which is generally ensured via informed consent. This is complicated in data-intensive research settings, especially with the former type of communities, however. Also grappled with in this article therefore are the pros and cons of waived consent and deception and the allied issue of prevention of harm to subjects in online extremism and terrorism research. The best path forward it is argued—besides talking through the diversity of ethical issues arising in online extremism and terrorism research and committing our thinking and decision-making around them to paper to a much greater extent than we have done to-date—may be development of ethics guidelines tailored to our sub-field.

Protecting Research Subjects During a Pandemic.

This commentary discusses twelve stories in which people who are involved in institutional review board (IRB) administration or serve as IRB members tell the stories of how the COVID-19 pandemic affected their work and lives. Among the aspects of these stories it highlights are the need to focus on the well-being of the institution's employees, and how issues involving protecting vulnerable subjects might relate to current policy debates about underserved communities. The final portion of this commentary focuses in particular on how one might measure success for a program in protecting its research subjects during a pandemic.

IRB Reform in North America: Challenges and Opportunities

Clinical research is necessary to advance medical knowledge and to test new drugs or devices. It is therefore vital to society, and ethically imperative, that clinical studies be performed if patients are to have access to safe and effective treatments. However, clinical research by its very nature involves risk. Subjects who volunteer in clinical studies may receive no benefit; in fact, they may be seriously harmed or even die as a result of their participation. Indeed, research-related injuries and deaths, though relatively few in number (1), have become the subject of much controversy in recent years (2). Thus, the protection of human research subjects must be given the highest priority by researchers, their institutions, and the government and regulatory bodies charged with overseeing the clinical research process. Central to this process is the institutional review board (IRB) in the United States (U.S.), or research ethics board as it is known in Canada. (For the purpose of this paper, the term "IRB" will be used to refer to both American and Canadian boards.) The IRB has frequently been referred to as the "first line of defense" in research subject protection (3), yet the specific roles and responsibilities of this board and its members are not clear (4). Defining these roles and responsibilities is more important now than ever before, for several reasons.