Clinical Research Ethics

Africa has a colonial past that renders it a linguistic melting pot, where language is not only important for communication but is inextricably related to cultural identity. In Africa, there are over 2000 languages that are still being used and spoken. Language diversity coupled with cultural diversity may affect the process of obtaining informed consent in data-intensive research. In this review paper, we explore some of the challenges and opportunities of multilingualism in handling informed consent in the context of data-intensive research. In multilingual or highly multilingual countries, as in most African countries, language is exceptionally central, and translation has potential cultural, social, historical, functional, and scientific importance. However, it is recognised that terminological and translation activities may not always be cost-effective or feasible. We consider alternative mechanisms of harmonisation of the lexicon in multilingual contexts, such as iconography, graphic elicitation, and other multimedia formats of information sharing. The inclusion of visual or multimedia explanations in informed consent forms may assist to improve comprehension, enhance information transfer and learning, reduce potential vulnerabilities associated with low literacy levels or the inability to interpret technical language associated with data-intensive research, build trust with participants and their communities, and promote autonomy of potential participants. We recognise that the inclusion of visual or multimedia content to facilitate information transfer is only one component of the informed consent process for data-intensive research. Research ethics committees should be mindful of other key considerations and challenges to informed consent for data science research. We also highlight the importance of a multi-pronged, collaborative approach that builds capacity among research ethics committee members to review data-intensive research, improves data literacy of research communities, and promotes mechanisms to support the harmonisation of terminologies used in data-intensive research in multilingual contexts.
(Abstract: 290 words)

Keywords
Data science, informed consent, multilingualism, harmonisation, iconography

Pharmaceutical Colonialism is the term used to describe the activities of some of the big pharmaceutical companies and their contract research organizations (CROs), that involves exploiting the sickness and poverty of citizens of weak and/or developing states. This is enabled because there is a failure or lack of ethical policies and rules within those states that are implemented and designed to protect against unethical clinical drug trials.

'Right To Try' (RTT) laws originated in the USA to allow terminally ill patients to request access to early stage experimental medical products directly from the producer, removing the oversight and approval of the Food and Drug Administration. These laws have received significant media attention and almost equally unanimous criticism by the bioethics, clinical and scientific communities. They touch indeed on complex issues such as the conflict between individual and public interest, and the public understanding of medical research and its regulation. The increased awareness around RTT laws means that healthcare providers directly involved in the management of patients with lifethreatening conditions such as cancer, infective, or neurologic conditions will deal more frequently with patients' requests of access to experimental medical products. This paper aims to assess the ethical plausibility of the RTT laws, and to suggest some possible ethical tools and considerations to address the main issues they touch.

The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use.

As epigenetic studies become more common and lead to new insights into health and disease, the return of individual epigenetic results to research participants, in particular in large-scale epigenomic studies, will be of growing importance. Members of the International Human Epigenome Consortium (IHEC) Bioethics Workgroup considered the potential ethical, legal, and social issues (ELSI) involved in returning epigenetic research results and incidental findings in order to produce a set of 'Points-to-consider' (P-t-C) for the epigenetics research community. These P-t-C draw on existing guidance on the return of genetic research results, while also integrating the IHEC Bioethics Workgroup's ELSI research on and discussion of the issues associated with epigenetic data as well as the experience of a return of results pilot study by the Personal Genome Project UK (PGP-UK). Major challenges include how to determine the clinical validity and actionability of epigenetic results, and considerations related to environmental exposures and epigenetic marks, including circumstances warranting the sharing of results with family members and third parties. Interdisciplinary collaboration and good public communication regarding epigenetic risk will be important to advance the return of results framework for epigenetic science.

'Right To Try' (RTT) laws originated in the USA to allow terminally ill patients to request access to early stage experimental medical products directly from the producer, removing the oversight and approval of the Food and Drug Administration. These laws have received significant media attention and almost equally unanimous criticism by the bioethics, clinical and scientific communities. They touch indeed on complex issues such as the conflict between individual and public interest, and the public understanding of medical research and its regulation. The increased awareness around RTT laws means that healthcare providers directly involved in the management of patients with lifethreatening conditions such as cancer, infective, or neurologic conditions will deal more frequently with patients' requests of access to experimental medical products. This paper aims to assess the ethical plausibility of the RTT laws, and to suggest some possible ethical tools and considerations to address the main issues they touch.

Bu calismanin amaci, gelecegin tibbi olarak kabul edilen molekuler genomik tibbin baslangici olan HeLa hucresinin kesfedilmesinin hikayesinin, icinde bulundugumuz yillardan geriye dogru giderek izlerini surmek; tip tarihini sekillendiren kose tasi olarak adlandirilabilecek bu olay ile tibbin nasil evrildigini gormek ve halen bu konuda yurutulen etik ve hukuki tartismalari gundeme getirmektir. Bu calismada, Henrietta Lacks’in kanser oldugunu ogrendigi andan baslayarak tedavi olmak uzere gittigi Johns Hopkins hastanesinde neler yasadigindan, hikayesinin arka planinin nasil ogrenildiginden, HeLa isminin kaynagindan ve Henrietta’nin vucudundan alinan ornegin tiptaki hangi gelismeleri nasil sekillendirdiginden soz edilecektir. Calismamizda modern tibbin anasi olarak anilan bir kadinin, tibbi degistirdiginden habersiz, tibbi degistirme sureci icinde kendisinin ve ailesinin yasadiklari ile ilgili hikayesini ortaya cikaran gazeteci-yazar Rebecca Skloot’un calismalari temel alinarak tip tari...

Context In recent years, the continuous improvements in molecular biology techniques have made it possible to detect carriers for several genetic conditions, including cystic fibrosis (CF). In some countries, CF carrier screening is offered to increasing subset of the general population.Offering of carrier screening at a population level should not be decided by local health authorities only, without consulting citizens' preferences. One way to involve citizens in the decision process might be to a Citizens' jury, a method of deliberative democracy. Objective The object of the study is to produce a recommendation statement about CF carrier screening using a Citizens' jury. As this is a new method in the field, the study also provided the opportunity to evaluate its effectiveness. Design The project is designed and managed by an executive committee. The whole process is superintended by a multidisciplinary scientific committee. The 16 members of the jury attend a 1 day meeting, assisted by a non-medical and unbiased facilitator. Informative material was prepared and distributed 15 days before the jury meeting; during the meeting, experts and witnesses interact directly with all the jurors through questions and answers. Results All except one member of the jury felt positively about the Health Service actively providing population carrier screening for CF. The final statement was available to public, clinicians, researchers and decision-makers. Discussion In general, a Citizens' jury is a feasible method for involving citizens in public health decision-making process and in particular for obtaining a community view about CF carrier screening.

At the beginning of 2014 the Ministry of Health prepared a Regulation on Traditional, Complementary and Alternative Medicine Practices Draft and declared that, it’s final shape will be given after asking the opinion of the relevant authorities. Regulation on Traditional and Complementary Medicine Practices was promulgated in the Official Gazette with number 29158, on 27 October 2014. The purpose of this study is to evaluate the scientific and ethical aspects in the context of; purpose, scope, terminology, right to health, secure access to health services and compare of traditional, complementary medicine draft regulations and regulations.

Background: Regulatory and professional bodies issue an ever-increasing number of guidance documents on the ethics and methods of clinical trials, but the quality of clinical trials of invasive therapeutic procedures continues to be a concern. We interviewed aspiring and accomplished surgical trialists to understand how they use guidance documents and other resources in their work. Methods: We performed a qualitative research study involving semistructured interviews of a diverse sample of 15 surgical trialists. Results: Professional development as a surgical trialist was haphazard, inefficient, and marked by avoidable mistakes. Four types of resources played constructive roles: formal education; written materials on clinical trials; experience with actual trials; and interpersonal interactions with peers, experts, collaborators, and mentors. Recommendations for improvement centered on education, mentoring, networking, participating in trials, and facilitation by department chairs. Conclusions: The haphazard and unstructured nature of the current system is adding unnecessarily to the numerous challenges faced by surgical trialists.

One of the unmet challenges for risk-benefit assessment in biomedical research is whether there should be an upper limit of risk in non-beneficial studies involving competent and consenting participants, and if yes, how it should be defined. This paper focuses on this second question. It examines the four dominant regulatory and conceptual approaches to setting a maximal risk threshold in research: no catastrophic harm/risk approach, pure procedural approach, numerical approach, and comparative approach. It then considers the pure procedural approach, which leaves the judgment of risk acceptability to RECs discretion. The approach has significant advantages, but it is not free from certain shortcomings, such as unwarranted diversity and arbitrariness of RECs judgments. The paper concludes by sketching the outlines of what is referred to as the "ELS procedural approach" that provides RECs with procedural recommendations for identifying an ethically, legally and socially acceptable upper limit of risk in non-beneficial research on volunteers. The ELS procedural approach is an improvement over the pure procedural approach. It is more standardized and accountable, but still context-sensitive and flexible.

Background: Nurses engaging in research are held to research ethics standards. Research aim: Examine experiences, behaviors, and perceptions of nurses in Israel regarding research ethics and explore possible related factors. Research design: An original investigator-designed self-administered questionnaire measured five variables: (a) ethics in research, (b) encountered research misconduct during the course of one's studies, (c) the inclination to fabricate data, (d) the inclination to select or omit data, and (e) knowledge of research misconduct in the workplace. Additionally, demographic data were collected. Participants and research context: The questionnaire was completed by 151 Israeli registered nurses. 10.2% hold a PhD, 34 % hold an MA, 42.2% hold a BA, and 13.6% with no academic degree. Ethical considerations: The study was approved by the University's ethics committee; anonymity and consent of the respondents were respected. Findings: Registered nurses' level of studies achieved was significantly associated with a lower inclination to fabricate data, with one exception-PhD nurses were more inclined to fabricate data than nurses with a Master's degree. A trend was found in which a higher level of studies is associated with higher knowledge of research misconduct in the workplace. Discussion: Results indicate that nurses' perceptions of research ethics change throughout their academic studies, indicating a positive influence of level of studies, research experience, and work experience on ethics perceptions. Nevertheless, PhD nurses showed a greater inclination to actually select, omit, or even fabricate data than MA nurses. This may be related to pressure to publish. Conclusion: PhD nursing programs should include ethics training. Academic faculty members should serve as role models regarding research integrity. Research ethics deserves further emphasis on all levels of nurse education in Israel, as well as in the nurses' code of ethics and related documents. This may positively impact ethical research practices.

In this paper, first we recall some paradigmatic ways of implementing carrier screening policies in a community. Then we move on to a proposal concerning a possible bottom-up solution based on deliberative democracy (and thus on real citizens’ participation in decisional processes) that should legitimate libertarian paternalist strategies concerning which genetic screenings should be made and which policies should be adopted by the institutions.

As epigenetic studies become more common and lead to new insights into health and disease, the return of individual epigenetic results to research participants, in particular in large-scale epigenomic studies, will be of growing importance. Members of the International Human Epigenome Consortium (IHEC) Bioethics Workgroup considered the potential ethical, legal, and social issues (ELSI) involved in returning epigenetic research results and incidental findings in order to produce a set of 'Points-to-consider' (P-t-C) for the epigenetics research community. These P-t-C draw on existing guidance on the return of genetic research results, while also integrating the IHEC Bioethics Workgroup's ELSI research on and discussion of the issues associated with epigenetic data as well as the experience of a return of results pilot study by the Personal Genome Project UK (PGP-UK). Major challenges include how to determine the clinical validity and actionability of epigenetic results, and considerations related to environmental exposures and epigenetic marks, including circumstances warranting the sharing of results with family members and third parties. Interdisciplinary collaboration and good public communication regarding epigenetic risk will be important to advance the return of results framework for epigenetic science.

'Right To Try' (RTT) laws originated in the USA to allow terminally ill patients to request access to early stage experimental medical products directly from the producer, removing the oversight and approval of the Food and Drug Administration. These laws have received significant media attention and almost equally unanimous criticism by the bioethics, clinical and scientific communities. They touch indeed on complex issues such as the conflict between individual and public interest, and the public understanding of medical research and its regulation. The increased awareness around RTT laws means that healthcare providers directly involved in the management of patients with life-threatening conditions such as cancer, infective, or neurologic conditions will deal more frequently with patients' requests of access to experimental medical products. This paper aims to assess the ethical plausibility of the RTT laws, and to suggest some possible ethical tools and considerations to address the main issues they touch.

Clinical Research is a branch of medical science that experiments new drug, medical device or biological on human subjects prior to approval. For the study to be credible, unbiased and generally applicable, all ICH-GCP regulations, other international and local regulations governing ethical clinical research studies should strictly be adhered to. The current regulations for clinical research are based on a combination of ethical thoughts and history. Ethics is different from law and regulation, both of which mandate a certain way of acting. The United States regulations for the protection of human subjects and other regulatory agencies from different countries have provided minimum baseline with which everyone must comply in operating an institutional review board (IRB), obtaining informed consent from research subjects and conducting research in an ethical manner.
The challenge, especially in a practical environment such as clinical research, is to translate these regulatory documents, provisions and different ethical principles into action. In clinical research, the consent of the research participants should be received before they are enrolled for trial. Many years after the document governing ethical principles of clinical research was developed and addressing three major areas: respect for persons, beneficence and justice, abuse of informed consent process has been a major ethical problem in most clinical research conducted across the globe and especially those conducted in Africa.
Is informed consent process well administered? Do these patients have a good comprehension of the entire research process? Is informed consent a mere signing of a paper to participate in a trial, or a continuous process?. Is there a better way of administering informed consent to achieve a better research outcome that will benefit all? This review shall focus on recalling history of abuses of informed consent process and ways to correct the unethical practice shall be discussed.

Policies on gift-giving in the medical profession have been—almost uniquely—created and put into place without taking into account recent findings from the social sciences regarding the ways in which human psychology functions. In this paper we intend to fill this gap and approach the question of gift-giving practices from the recent literature on implicit cognition. Our main claim is that proper consideration of implicit social cognition paints a picture of human psychology which is very different from the one assumed by current policy making in medicine, and that in order to draft the most effective policies, we must understand by what mechanism interaction with the pharmaceutical industry biases physicians.

The history of clinical researches on human subjects, which created the opportunity for the current scientific achievements in medicine, has a longstanding past. However, this period of time has witnessed numerous examples that cost human life, such as war crimes and withdrawal of due treatment. In order not to experience those horrible events anymore, and to regain confidence of the society, clinical researches have been structured all over again. The establishment of multidisciplinary ethics committees meant to safeguard the rights of volunteers for granted by necessitating the ethical evaluation of a research project prior to its initiation.
The first legal text in Turkey, ever regulated clinical researches specifically on human volunteers, was the “Regulation on Pharmaceutical Researches” issued in 1993. Yet this  regulation proved to be inadequate to enact the actual needs of clinical researches and it ought to be renewed two times in 2008 and 2011. Nevertheless, the Regulation was amended once again on April 13, 2013, that caused critical debates due to its controversial content.
The reason lies in the fact that the natural stakeholders, such as the representatives of the health professional institutions, medical specialty societies, bioethics institutions are not incorporated enough into the process of preparation and legislation; and it is mostly left to the bureaucratic authorities outside the academy. This ultimately causes lack of due attention requisite to development of ethical awareness of healthcare professionals and all the parties concerned. This paper aims to evaluate the latest Regulation and to emphasize the role of ethics committees as an ideal academic ground by functioning multidisciplinary which is needed for a pluralistic and participatory democratic society guided by the universal values and human rights law .

Key Words: Ethics Committees, Research Ethics, Clinical Research, Volunteer Rights

The fact that the goal of medical research is to improve human well-being on a global-scale only exacerbates the dilemma. The question is whether, and how, such a laudable collective goal can be pursued with full protection of the rights and dignity of individuals. Recently this dilemma has surfaced again, when the US Food and Drug Administration (FDA) announced last month that it will shelve the Helsinki Declaration and, starting in October 2008, it will adopt a new standard for clinical trials called Good Clinical Practice (GCP). Although GPC deals with subject protection (e.g. informed consent, privacy), it is silent on the issue of placebo as controls in cases where proven therapies exist.
Is the FDA decision troubling at all from an ethical point of view? And if so, why?
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The risk we run, if the FDA does not re-think its decision to accept GPC silent on placebo guidelines, is precisely that placebo-controlled trials for severe diseases will be conducted in the developing world, where an effective treatment is not available for economical reasons. This would bring us to the paradoxical conclusion that, while it is unethical to conduct such research in the US, Europe or Japan, it would be ethical to conduct it in Africa, South America or Indonesia.