Rights Of Research Participants Research Articles

BASICS OF SCIENTIFIC RESEARCH AS A MANDATORY COMPONENT IN EDUCATIONAL PROGRAMS IN PHILOLOGY

The article is devoted to an overview of the tasks of the discipline “Fundamentals of scientific research” as a mandatory component of educational programs in philology. The main tasks of the course “Fundamentals of scientific research” in the field of higher education are familiarization with the basic concepts and principles of scientific research. The course aims to familiarize students with the basic concepts and principles of scientific research, such as formulating a research question, developing a hypothesis, choosing research methods, collecting and analyzing data, etc. This will help students understand the process of conducting scientific research and be able to apply it; studying the methodology of scientific research. The course also aims to introduce students to basic methodological approaches to scientific research, such as qualitative and quantitative approaches, experimental and correlational research, and others. This will help students choose the most appropriate methodological approach for their research; development of scientific writing and presentation skills. The course is aimed at developing scientific writing skills, including writing scientific articles, reports and presentations. Students will learn the formatting and design of scientific works, as well as study the current rules of citation and reference to literary sources; study of ethical aspects of scientific research. The course aims to familiarize students with the ethical aspects of scientific research, such as maintaining confidentiality, respecting the rights of research participants, avoiding plagiarism and data fabrication. This will help students understand the importance of ethical standards in scientific activity and adhere to them. Academic integrity is the basis of trust in scientific research and the scientific community as a whole. Studying this topic helps to ensure the quality and reliability of scientific publications, which in turn increases the credibility of science and helps attract funding and support for further research.

Evidence required for ethical social science

The history of science is littered with violations of the human rights of research participants (1, 2). One response has been regulation. In the United States, the Belmont Report lays out ethical principles for human subjects research (3), which form the foundation of modern-day institutional review boards. According to the Belmont Report, ethics committees and investigators need to determine whether the benefits of the research outweigh the costs and whether the costs unevenly burden particular groups. However, the assumptions underlying such assessments can be flawed (4, 5). Without evidence about the causal effects of social science research on participant welfare, researchers risk causing unexpected harms or missing unexpected benefits.

Correspondence article on the research protocol titled ' Towards Health Equity and Transformative Action on tribal health (THETA) study to describe, explain and act on tribal health inequities in India: A health systems research study protocol' published in Wellcome Open Research in December 2019.

Research on indigenous (Tribal) populations is a step towards understanding the various tribal health issues and challenges and paves the way for addressing these issues. However, such populations are categorised as vulnerable and marginalised according to National ethical guidelines by Indian council of medical research. Hence, adequate measures are needed to be ensured by researchers while undertaking any research involving tribal populations to safeguard the rights of research participants. The purpose of this correspondence is to initiate a discussion among the researchers to give due consideration to research ethics especially when the research is being conducted on vulnerable populations and take adequate safeguard measures as suggested by National ethical guidelines to protect the rights of study participants.

Returning raw genomic data: rights of research participants and obligations of health care professionals

Returning raw genomic data: rights of research participants and obligations of health care professionals

Algorithm for the support of non-related (serious) adverse events in an Ebola vaccine trial in the Democratic Republic of the Congo

Implementing an Ebola vaccine trial in a remote area in the Democratic Republic of the Congo (DRC), and being confronted with a dysfunctional health care system and acute unmet health...

Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic.

Research Ethics Committees (RECs)—or Institutional Review Boards (IRBs), as they are known in the US—were created about 50 years ago to independently assess the ethical acceptability of research projects involving human subjects, their fundamental role being the protection of the dignity and rights of research participants. In this paper we develop some critical reflections about the current situation of RECs. Our starting point is the definition of the role they should ideally play, a role that should necessarily include a collaborative approach and the focus on the ethics component of the review. This ideal is unfortunately quite far from reality: inadequacies in the functioning of RECs have been discussed for decades, along with reform proposals. Both in the US and in the European Union (EU), reforms that aim at the centralization of the review process were recently approved. Even though these reforms were needed, they nonetheless raise concerns. We focus on two such concerns, related in particular to Regulation (EU) No 536/2014: the risk of narrowing the scope of the ethics review and that of disregarding the local context. We argue that the COVID‐19 pandemic paved the way for the transition towards the centralized model and that an analysis of its impact on the research review process could provide some interesting insights into possible shortcomings of this new model. We conclude by identifying three objectives that define the role of a REC, objectives that any reform should preserve.

Public awareness of and attitudes towards research biobanks in Latvia.

BackgroundPublic awareness and engagement are among the main prerequisites for protecting the rights of research participants and for successful and sustainable functioning of research biobanks. The aim of our study was to analyse public awareness and attitudes towards research biobanks in Latvia, and to compare these data with the results of the 2010 Eurobarometer study. We also analysed the influence of awareness and attitudes towards biobanks on willingness to participate in biobank studies and on preferred type of informed consent.MethodsWe developed a 12-question survey repeating seven questions about biobanks from the 2010 Eurobarometer questionnaire and adding five others. After describing the study variables, we performed a two-stage analysis of the results. In the first stage we analysed differences between the answers from 2010 and 2019 and conducted univariate analyses of relationships among particular variables, and between those variables and the socio-demographic characteristics of participants. In the second stage we investigated multivariable associations of willingness to participate and type of consent with awareness, trust and the socio-economic characteristics of participants.ResultsAccording to our study, the general public in Latvia is still not well informed about research biobanks. Fewer respondents have heard about research biobanks than in 2010. At the same time, the number of respondents who are willing to donate biological samples and personal data to a biobank has increased, e.g. the number of respondents who would definitely or probably be willing to provide information about themselves has increased from 25.8.% to 40.7 since 2010. Overall, concerns about the donation of different types of biological samples and data to a biobank have slightly decreased.ConclusionsPublic awareness about biobanks is important for their sustainability. It needs to be increased not only by traditional methods of informing the public, but also by more innovative and participatory approaches, e.g. by citizen science projects. There is a need to strengthen the public visibility and trustworthiness of ethics committees in Latvia in the field of biobanking.

On-site monitoring of clinical trials by an Ethics Committee in India: a road less travelled

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We found a large number of shortcomings in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees.

Genomic research and privacy: A response to Staunton et al.

The Protection of Personal Information Act No. 4 of 2013 (POPIA) promises a new dispensation of privacy protection for research participants in South Africa. In a recent article, Staunton et al. proposed that a purposive interpretation of POPIA would allow for the retention of the status quo of broad consent in the context of genomic research. In this response article, we analyse the argument presented by Staunton et al., and conclude that it fails to convince: firstly, because Staunton et al. do not present empirical data for their factual assumption that moving up the consent benchmark is likely to stymie research; secondly, because genomic research does not have a monopoly on the public interest, but shares it with the privacy rights of research participants; and thirdly, because POPIA was designed to promote the protection of privacy, not simply to preserve the status quo as found in existing policy instruments. In contrast to the position advocated by Staunton et al., we suggest that a purposive interpretation of POPIA is aligned with the plain meaning of the statute - namely that specific (not broad) consent is a prerequisite for research on genomic information.This article, which comments on an article by Staunton et al. (Staunton C, Adams R, Botes M, et al.Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013. S Afr Med J 2019;109(7):468-470. https://doi.org/10.7196/SAMJ.2019.v109i7.14148), is followed by a letter by Thaldar and Townsend (Privacy rights of human research participants in South Africa must be taken seriously. S Afr Med J 2020;110(3):175-176. https://doi.org/10.7196/SAMJ.2020.v110i3.14450); and a response to the article and letter by Staunton et al. (S Afr Med J 2020;110(3):175-176. https://doi.org/10.7196/SAMJ.2020.v110i3.14450).

A qualitative study of Institutional Ethics Committees: Members' understanding of research guidelines, privacy, and challenges to privacy protection.

Right to privacy of health-related information is a foundational bioethical principle. In India, the importance of protecting privacy is included in law and ethical guidelines. Institutional Ethics Committees (IECs) are entrusted with the responsibility of protecting fundamental ethical principles, including privacy and confidentiality. The present qualitative study was designed to understand IECs' privacy-related obligations and the members' experience in implementing ethical guidelines and privacy protections in their institutions. An interview guide was prepared regarding knowledge of ethical guidelines. Interviews of nineteen IEC members were recorded, transcribed, and translated. Interviews were analysed using thematic analysis. Themes related to these issues were extracted after analysis: awareness, understanding, and implementation of ethical guidelines; understanding of privacy-related obligations and their implementation; and juridical risks to privacy of patients and research participants. The results suggest that training programmes and awareness workshops should be organised for IEC members to protect the rights of research participants, especially in confidentiality issues.

A conformação protetiva dos direitos fundamentais em pesquisas científicas com seres humanos: Um olhar face aos fundamentos autonomia e vulnerabilidade

Objetivo: Busca-se identificar os direitos fundamentais dos participantes da pesquisa que devem ser resguardados no curso dos experimentos. Pretende-se, ainda, tratar da autonomia e da vulnerabilidade, como pressupostos ínsitos à situação de pesquisa, esclarecendo a sua relevância para a maximização da tutela. Metodologia: A pesquisa tem natureza bibliográfica, em livros e artigos da área jurídica, em legislações ordinárias e resoluções relacionadas, bem como em artigos publicados em periódicos da área de Saúde. Resultados: A realização de pesquisas científicas com pessoas deve ter como pressuposto primordial a observância adequada e eficaz dos seus direitos fundamentais inerentes, considerando que, nesta relação, não se deve afastar o exercício da autonomia, revelada pela obtenção do consentimento, e a condição de vulnerabilidade. Conclusão: A preservação dos direitos fundamentais dos participantes da pesquisa deve pugnar pela captação da exteriorização de uma vontade verdadeiramente esclarecida, considerando, inclusive condições de vulnerabilidade que se concretizam a partir de circunstâncias distintas e de aspectos sociais e econômicos diferentes. Tal garantia depende da coleta de um consentimento adequado e eficaz por parte do pesquisador responsável, resguardando de forma mais ampla a dignidade e os direitos daqueles sujeitos que participam da pesquisa.

A human rights-focused HIV intervention for sex workers in Metro Manila, Philippines: evaluation of effects in a quantitative pilot study

This study evaluated a brief human rights-focused HIV community mobilization intervention for sex workers in the Philippines, a country with one of the fastest rising number of HIV cases worldwide. Five single-session group interventions to reduce sexual risk and increase HIV testing among 86 sex workers in Manila were evaluated with pre-post-test data via Wilcoxon's signed-ranks and Mann-Whitney tests. The 4-h intervention, Kapihan (August-November, 2013), integrated human rights with HIV skill-building. Demographic data, violence/trafficking victimization, human rights knowledge, and intentions to HIV test and treat were collected. Participants were median aged 23; female (69%); had children (55; 22% had 3+children); used drugs (past 3months: 16%); sexually/physically abused by clients (66%); 20% street sex workers ever took an HIV test. Pre-post-test scores significantly improved in knowledge of HIV (z=-8.895, p<0.001), reproductive health (z=-3.850, p<0.001), human rights (z=-4.391, p<0.001), ethical rights of research participants (z=-5.081, p<0.001), and intentions to HIV test (z=-4.868, p<0.001). Integrating human rights into HIV interventions may empower sex workers to address their health and human rights and test for HIV.

The Risks and Benefits of Conducting Sensitive Research to Understand Parental Experiences of Caring for Infants With Hypoxic-Ischemic Encephalopathy.

The aim of this report is to describe the parental experience of the emotional and physical risks and participant burden of participation in sensitive research about caring for an infant with hypoxic-ischemic encephalopathy. Protecting the ethical rights of participants in research is a main focus of investigators. Evaluating the effect of current methods employed to protect participants in sensitive research is necessary to determine if the participants' ethical rights are protected. Little research has addressed the parental perspective of participating in sensitive research. The design of this study is a qualitative, descriptive methodology with structured interviews with parents. Participants were asked to describe their experience of participating in sensitive research. The qualitative data collected were analyzed using content analysis. Interviews were conducted between July 2010 and February 2012. Thirteen parents of infants with hypoxic-ischemic encephalopathy were interviewed. Parents did not report harm or participant burden. Most of these parents found continued participation to be beneficial because they could express intense emotions in a nonjudgmental environment and also reflect on the milestones their child has reached since the traumatic birth experience. This study provides additional evidence to researchers regarding the risks and benefits to participants in sensitive research studies. Individuals are willing to participate in sensitive research, even during stressful times in their lives. The interviews allow participants an outlet to discuss thoughts and feelings and to reflect on past events and gain perspective. Participants do not report experiencing harm when participating in interviews about sensitive research.

Attitudes toward Post-Trial Access to Medical Interventions: A Review of Academic Literature, Legislation, and International Guidelines.

There is currently no international consensus around post-trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post-trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post-trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post-trial access and participants and community members. Given that clinical trials conducted in low-income countries will likely continue, there is an urgent need for consideration of post-trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available.

A cross-sectional survey to investigate community understanding of medical research ethics committees

Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took...

The Institutional Review Board (IRB) and Faculty: Does the IRB Challenge Faculty Professionalism in the Social Sciences?

Institutional Review Boards (IRB) were instituted to protect the rights of research participants and due to past (and at times egregious) practices committed in the name of research. We question whether the IRB is currently overstepping its bounds into the domain of the researcher. We illustrate possible ways in which the IRB subtlety and not so subtlety challenge faculty professionalism and limit faculty research independence, highlighting some instances in which qualitative research topics bump up against boards that mistrust or misunderstand the nature of qualitative research. Using case study vignettes from five universities, our concerns focused on mission creep and potentially legitimating censorship. Areas of mission creep can include institutional reputation, methodological design, and chilling/legal language verses accessible language. In addition we consider multisite studies and when committees focus too much on form rather than content.

Catholic Social Teaching as a Framework for Research Ethics

The importance of having ethical oversight in research that is carried out on humans is well established. Research ethics, which is mainly influenced by a biomedical ethical framework, aims to ensure that the well-being and the rights of research participants are upheld and that any potential risks and harms are reduced. However, research is also considered to be a social activity with social effects. Therefore the principles of Catholic Social Teaching as a framework for research ethics may be significant. This paper outlines those principles and demonstrates how these principles may be used for: (1) reflecting ethically on research (i.e. before the project begins), (2) judging a research ethics proposal (i.e. the ethical review) and (3) providing guidelines for action in research (i.e. the implementation of the research project).

The big Cs of the informed consent form: compliance and comprehension

The informed consent process is a shield which protects subjects from harms that may be caused by a scientific enquiry. Only a competent participant with a complete understanding of the trial can give informed consent. Although the content of a valid informed consent form has been established, the Drugs and Cosmetics (First Amendment) Rules, 2013 have stipulated that ICFs must fulfil the requirements of Appendix V of Schedule Y. We considered 50 ICFs and analysed whether they complied with Appendix V. Our analysis reveals a gloomy picture, with 70% of the ICFs deviating from the requirements of the law. We have identified the elements most commonly overlooked in the ICFs analysed. We recommend certain points which must be incorporated into ICFs to help participants better understand the trial. Our findings indicate that adequate action needs to be taken to ensure the protection of the rights of research participants.

Informed Consent and Patients With Cancer: Role of the Nurse as Advocate

Informed consent is an ongoing process, and oncology nurses are important advocates to identify information gaps and patient concerns during this process. This article discusses the rights of research participants from a regulatory perspective. Two case scenarios are presented and discussed to describe how nurses can ensure that patients are truly informed and understand the clinical trial process.

Theoretical shortcomings of Institutional Review Boards and possible solutions.

Institutional Review Boards (IRBs) have been designed to ensure that ethical considerations are in research projects. Although their role is vital in order to protect the rights of research participants, there are still unmet needs in improving the function and structure of IRBs. These aspects include but are not limited to inconsistency, conflict of interests, unequal sexual distribution, efficacy of non-scientific members, high expenses, unequal regional distribution, high work load, approach to reach a final decision, and the definition of minimal risk research.