Establishment of ethical oversight of human research in El Salvador: lessons learned

Human research is necessary for establishing the best approaches to health care, and should be overseen by a functional research ethics committee. However, in most low-income countries these committees are inadequate in providing the guidelines needed to ensure that ethics remain a prominent feature of human research. We developed a model of interaction with key institutions in low-income countries that had an interest in improving the infrastructure of human participant research. As a result, a research ethics committee was established at three hospitals in El Salvador. The skills gained from developing these committees and the interest shown by the Salvadoran government in rigorous ethical oversight of research involving human participants has allowed the creation of a national ethics committee, which serves as an entity to establish norms and guidelines for further development of research ethics committees in El Salvador. This model of interaction can also be used by institutions in high-income countries to create and strengthen the capacity for ethics in human research in low-income countries.     

Cancer: de l’engagement éthique à la responsabilité politique

Today, ethical awareness is not able to comply with general considerations or academic resolutions. It must meet a commitment requirement, even sometimes leaning towards dissent and supporting certain necessary resistances. The cancer story is not particularly meaningful from an ethical values point of view that it could move on from. This, in a context where representations of the disease and its tragic realities trigger positions and practices that are questionable in many respects. In the 1980s, AIDS patients were able to promote other principles and impose the image of a person who was clearly ill, but recognized for their words, their own knowledge, their rights and their choices. With this outlook, the up until then little known aspects of medical and care ethics could be identified. These aspects concern the follow-up the person receives along the course of the disease, but are just as much about access to innovative care and treatments, new research practices and the daily issues in life during and after the disease. It is certainly not ethics specific to cancer, although this disease which penetrates our collective consciousness with such intensity is likely to trigger a more global thinking, that now specifically applies to chronic disease, its human and societal issues.     

Ethical Conduct of Research in the Clinical Environment

Clinical research has a long history of questionable ethical practice. Abuse of subjects and neglectful research practices have harmed individuals, groups, and the reputation of the scientific community. Policies, codes, and guidelines have been implemented and enforced as a result. To ensure ethical research practice, clinical trials and studies need to be assessed at various stages to ensure ethical design, just recruitment practices, voluntary informed consent, safe and ethical conduct, and appropriate dissemination of results. This paper identifies and explains ethical principles that apply to research. The purpose and focus of the four fundamental policy documents that inform current research practice are outlined. Ethical challenges that a researcher may face are also discussed. The requirements related to the humane use of animals for research purposes will be considered. Lastly, controversies and challenges with exporting research to developing countries will be briefly discussed.     

Démocratie sanitaire : le patient partenaire de sa prise en charge

In 2019, the scientific committee of the French society of radiation oncology (SFRO) created an ethics committee. Its mission is to provide our professional community with food for thought on ethical issues, and to identify its specificities within the radiation oncology departments. For the 2020 annual conference, the commission looked into the evolution of the patient-carer relationship, and more particularly to the strong idea of patient partnership. Indeed, the writing of the White Book of Cancer gave voice to sick people and stressed the need for new devices, such as the Caregiving Time. Patients can no longer be considered as objects of care but as people whose dignity and autonomy must be imperatively respected. The acquisition of knowledge allows a bilateral exchange, prerequisite of a dynamic collaboration. Patients can be partners in their own care, partners in training and research (expert patient), but also partners in health institutions and policies. It is this notion of partnership and involvement of the person in their path of care in radiation oncology that we will analyse here. It will be about defining it, by developing the concept of autonomy, and bringing out its complexity and ambivalence through two examples from our clinical practice: the shared decision-making process for patients with localized prostate cancer and the patient's involvement in the success of his radiotherapy.     

Governance and measures for the ethical and social aspects of biobanks

This paper provides an overview of measures regarding the ethical and social aspects of biobanks from the perspective of governance. A Biobanks is a system that manages samples taken from humans along with data of the sample donor(genetic information, information on medical records, information on lifestyle habits, etc.)in a centralized manner according to a set quality standard. In recent years, biobanks have become an essential research infrastructure, especiallyin the field of genome medical research and research concerning common diseases such as cancer and diabetes. Simultaneously, this indicates that biobanks are strongly linked to the realization of benefits that are highly public. For this reason, biobanks need to consider not only the promotion of medical research, but must also practice consideration for the ethical, social, and public aspects. In other words, biobanks need to be subject to governance. In this paper, three specific issues concerning the ethical and social aspects of biobank have been discussed: (i)issues regarding boroad or future consent, (ii)risks related to the handling of samples and data, and (iii) feedback on incidental findings. These are issues that accompany rapid advances in genome medicine and involve complex elements that cannot be completely resolved by the existing principles of life ethics and rules. For this reason, the parties managing biobanks are required to make an effort toward realizing an ethically and socially feasible operation of the biobank, with consideration paid not only to compliance but also to the reaction of research participants and society. Furthermore, there is an urgent need to establish a system of governance that enables organizational management with the wide perspective discussed here.     

Perceptions of the ethical conduct of cancer trials by oncology nurses

Informed consent and subject protection are internationally mandated requirements for the ethical conduct of research; however, the monitoring of the day-to-day conduct of research may be insufficient for ensuring consistent compliance with required ethical ideals. Oncology nurses were surveyed about their perceptions of ethical issues relevant to cancer trials research. Utilising an investigator-developed instrument, multi-item scales assessed six ethical domains. Of 192 respondents, 95% or more held definite views in 12 of 15 items about patient understanding of cancer trials, informed consent and the welfare of participants. Approximately 95% perceived that patients consented freely and knew how to withdraw from a trial, and 81% perceived better monitoring of trial than non-trial patients. However, more than 80% of respondents perceived that at times patients had unrealistic expectations of participation, and more than 50% perceived that participants sometimes did not understand the nature and risk of cancer trials. Although the conative attributes of patients place limits on the goals of bioethics, the results of this study show first that oncology nurses have opinions about ethical constructs directly linked to the daily conduct of cancer clinical trials, and second that this link warrants further investigation in order to benchmark trial conduct against the ideals of ethical research.     

Fight Against Cancer in Countries with Limited Resources: The Post-genomic Era Scenario

The enormous advances in science and technology in the 20th century have facilitated the process of globalization ‍with the aim of a better quality of life for all. Paradoxically, the gap between the rich and the poor, for both nations ‍and people, is constantly widening. The actual trends in human genome research are leading towards promising ‍genomic medicine, but it will be expensive and inaccessible for many. Also, it may not offer a quick fix ‘cure’ for ‍various types of cancers. The biggest challenge before the clinicians now is the management of the rising incidence of ‍cancer in developing countries, with little prospect of more resources becoming available to fight the disease. The ‍death rate from cancer in the developing countries is set to rise at least 3-fold by the year 2025 largely due to the ‍increased life expectancy, containment of infectious diseases and changing lifestyles. It is estimated that about 50% ‍of cancers are curable if they are detected early and treated appropriately. Screening has a major role in early ‍diagnosis. However, in the developing world around 80% of cancer patients have late stage incurable disease when ‍they are diagnosed. Moreover, in a developing country like India, about 70% of the population obtain medical help ‍from private practitioners. Nearly half of those who seek medical help utilize alternative and traditional systems of ‍medicine. Appalling poverty, poor hygiene and complex social dynamics, pose major hurdles in this regard. Many in ‍the private sector who call themselves doctors have no medical degree. By 2030 tobacco is expected to kill 10 million ‍people worldwide, out of which 70% of the deaths will occur in the developing countries. Control of usage of tobacco ‍has still not achieved a conducive atmosphere. It is now realized that the research information and knowledge ‍generated in the west may neither be relevant nor applicable to developing countries, due to differences in social and ‍cultural attitudes, lifestyles and lack of sophisticated technologies. Though the sequencing of the human genome will ‍have a major impact on the prevention, diagnosis, treatment, monitoring, and outcome of cancer, the cancer scenario ‍in the developing countries for the next 20 years is likely to be more or less the same, rather than presenting a ‍radically different picture. Cancer awareness and screening programs for early detection thus should be continue to ‍be given utmost attention .     

Priorités éthiques des services d’oncologie pédiatrique africains

The Nuremberg Code, the Helsinki Declaration, the Manila Declaration, and all other legal texts, drawn up by major bodies like the World Medical Association, put forward the so-called international concepts of medical ethics. While at the same time globalization is becoming irreversible and the gap between “developed”; countries and countries of the “South” is increasing, the article questions the impact of these concepts in the African environment. Taking into account an extremely diverse cultural and socioeconomic context, it was thought as useful to examine whether the ethical issues have been addressed in the African continent the same way Western medical ethics have addressed them. In other words, the article questions whether it is relevant, in Africa, to impose the concepts judged as necessary in the industrialized countries or, alternatively, to admit that other ethical priorities should be addressed. Some of the proposed answers come out of a long survey in African pediatric oncological departments on behalf of the French non governmental organization Franco-African Group for Oncological Paediatrics (GFAOP). This article, centered on a disease as particular as the pediatric cancer, aims at delivering thoughts resulting from an immersion into African health reality.     

Éthique de la recherche : réglementations françaises et applications en oncologie radiothérapie

French regulations about research ethics are based on the so-called Jardé law, which defines researches involving human beings. Researches involving human beings require the submission of research protocols to a committee for protection of persons with a precise list of documents to submit for a favourable opinion. This law describes different categories of researches and determines the ethical procedures to apply before setting up a research protocol. This issue of categorisation is central and must be taken into account by researchers from the beginning of the research process. Researches considered as not involving human beings also require a set of ethical precautions focused on patients’ information and the collection of their non-opposition (due to the application of the General Data Protection Regulation adopted by the European Parliament). Thus, many regulations exist and they require a real work for researchers to meet these requirements in research ethics. This article aims to summarise French regulations. Selected examples are specifically taken into the field of radiation oncology research.     

Cancer control research 2001

Objectives: Major societal changes, including the changing demographics of US society and the genetics and communications revolutions, are providing new opportunities to control cancer both in the United States and around the world. This article examines the implications of these trends and other issues in the context of cancer control research. A seven-item strategy for cancer control research is proposed. Results: Epidemiology, statistics, genetics, and bio-behavioral research are central disciplines for cancer control research. The identification of particular at-risk populations is increasingly possible. Cancer control research must focus on increasing fundamental knowledge in order to accelerate improvements in cancer prevention and early detection. Cancer control research also must be used to conduct trials of new cancer detection methods, overcome differential participation in cancer screening, develop evidence-based strategies to improve decision-making, and develop evidence-based cancer communications. A comprehensive cancer surveillance system is the foundation for cancer control research. Cancer control research must aim to reduce cancer risk, incidence, and mortality, and improve quality of life. These are important challenges for the new millennium.     

Ethical issues in psychosocial research among patients with cancer

The ethical implications of psychosocial research among patients with cancer are discussed. Two key issues were identified: obtaining informed consent and the impact of participating in research. Barriers to obtaining genuinely informed consent are described, as well as the costs and benefits of participation in research. Recommendations are made for the conduct of future research, relating to the removal of barriers to informed consent and monitoring the impact of the research process on its subjects.     

Ethical aspects of molecular epidemiology of cancer

In molecular epidemiology of cancer where many studies are genetic in nature and they are done among healthy people, ethical issues require special consideration. Genetic information differs from other health care information in that it is predictive in nature, and it always involves at least family members, but in some genetically very homogeneous populations even a wider group. General discussion of the potential good and harm should be encouraged more, so that it would be possible for lay people to make informed decisions. Personal involvement of scientists in education of public, general discussion and considering their own studies from the point of view of the study subject and their family is in the end the only way to ensure that the spirit of international regulations of ethics are realized in practise.     

Medicolegal and ethical issues in genetic cancer syndromes

Physicians whose patients may be affected by genetic cancer syndromes must be sensitive to a range of legal and ethical concerns. We provide an overview of the major issues, focusing on developments in the United States. The first section examines the physician's legal and ethical duties to the patient. A number of general rules are advanced, including: 1) genetic counseling should be offered to those considering genetic testing; 2) a genetic test should not be performed without the patient's informed consent; and 3) genetic information should not be disclosed to third parties without the patient's written authorization. Laws addressing genetic testing and disclosure of information are reviewed, as well as laws addressing genetic discrimination. Physicians must be aware that the availability of legal protections may affect a patient's willingness to undergo testing. Next, we examine the physician's duty to the patient's family. Where a conflict exists between the interests of the patient and the interests of family members, ethics and current law favor the interests of the patient, absent unusual circumstances. Further, we provide guidance on the scope of the physician's duty to inform, e.g., whether the physician must inform the patient of all medically reasonable treatment options, including those with which the physician disagrees. Finally, we discuss the special ethical and legal issues that prophylactic surgery raises. Areas covered include informed consent and insurance coverage. Several recent cases involving these issues are reviewed.     

Multinational clinical trials in oncology and post-trial benefits for host countries: where do we stand?

International collaboration has undoubtedly played a key role in the extraordinary progress we have witnessed in some areas of oncology in recent years. It has allowed us, for instance, to design trials large enough to depict very small benefits, as well as high-quality trials in less incident types of cancer. For different reasons, developing countries have also shown growing interest in this international effort and have been participating in many international trials. However, the ever-growing costs of novel anti-cancer treatments and technologies have created unprecedented difficulties for health economies in developing countries. Although the issue of individual benefit for patients must also be taken into account, the actual benefit for their society may be minimal. This paper discusses the ethics of including patients from non-developed countries in clinical trials evaluating the role of treatments that are unlikely to be made available to them after the trial because of prohibitive costs. Upfront arrangements ensuring post-trial access to interventions that have been proven successful might be the best alternative to exclusion from the research.     

An overview of the situation in radiotherapy with emphasis on the developing countries

Radiotherapy services are closely linked to the level of medical care which, in turn, is an important component of the overall health care program, with its development related to social, economic, and educational factors. As a basis for understanding the situation regarding adequate coverage of the population by radiotherapy services, general information about the world population (currently 5 billion), age distribution, frequency of cancer occurrence, and causes of death is presented. For an appreciation of the obstacles that must be overcome, the situation with regard to Gross National Product (GNP), transfer of economic resources, and per capita expenditures for health services is shown. For example, in the developing world, most countries spend less than 5% of their GNP for health, and on a macro scale at least 20 billion U.S. dollars per year are being transferred from the poor nations of the southern hemisphere to the northern hemisphere. Information about the wide range of population coverage with radiotherapy resources and the trend regarding high-energy radiotherapy machines is presented. For example, in North America (USA) there are six high-energy machines for each one million persons, and each machine is used to treat about 230 new patients per year. In other parts of the world, such as large areas of Africa and South-East Asia, there may only be one high-energy radiotherapy machine for 20 to 40 million people, and one machine may be used to treat more than 600 new patients per year. Many cancer patients have no access to radiotherapy services. When estimates of the need for radiotherapy services in the developing world as a consequence of cancer incidence are compared with the current health expenditures, it is concluded that a combined effort of national authorities, donor and financial institutions, professional and scientific societies, and international organizations is required. The knowledge, skills, and technology are available in many excellent radiotherapy centers throughout the world. The key issues are priority and the commitment of sufficient resources.     

Capacity building for the clinical investigation of AIDS malignancy in East Africa

PURPOSE: To build capacity in the resource-poor setting to support the clinical investigation and treatment of AIDS-related malignancies in a region of the world hardest hit by the AIDS pandemic. METHODS: An initial MEDLINE database search for international collaborative partnerships dedicated to AIDS malignancies in developing countries failed to identify any leads. This search prompted us to report progress on our collaboration in this aspect of the epidemic. Building on the formal Uganda-Case Western Reserve University (Case) Research Collaboration dating back to 1987, established NIH-supported centers of research excellence at Case, and expanding activities in Kenya, scientific and training initiatives, research capital amongst our institutions are emerging to sustain a international research enterprise focused on AIDS and other viral-related malignancies. RESULTS: A platform of clinical research trials with pragmatic design has been developed to further enhance clinical care and sustain training initiatives with partners in East Africa and the United States. An oral chemotherapy feasibility trial in AIDS lymphoma is near completion; a second lymphoma trial of byrostatin and vincristine is anticipated and a feasibility trial of indinavir for endemic Kaposi's sarcoma is planned. CONCLUSIONS: In the absence of published reports of evolving international partnerships dedicated to AIDS malignancy in resource constrained settings, we feel it important for such progress on similar or related international collaborative pursuits to be published. The success of this effort is realized by the long-term international commitment of the collaborating investigators and institutions to sustain this effort in keeping with ethical and NIH standards for the conduct of research; the provision of formal training of investigators and research personnel on clinical problems our East African partners are faced with in practice and the development of pragmatic clinical trials and therapeutic intervention to facilitate technology transfer and enhance clinical practice.     

Challenges of cancer control in developing countries: current status and future perspective

Cancer is a global problem accounting for almost 13% of all deaths worldwide. This equates to over 7 million people a year, more than is caused by HIV/AIDS, TB and malaria combined. Now is the time to strengthen the health systems of developing countries to deal with cancer, to avoid a future crisis similar to the HIV/AIDS pandemic. In this article we discuss the current state of cancer in the developing world, how we need to advocate for a change in cancer control policy with the governments of developing nations/transnational governmental bodies (e.g., the UN and WHO etc) and how we think cancer care could be improved in developing countries. We feel the only way to overcome the growing burden of cancer in the developing world is working in partnership with, nongovernmental organizations, international nongovernmental organizations, transnational governmental bodies and governmental bodies.     

Estimates of the worldwide incidence of eighteen major cancers in 1985

The annual incidence rates (crude and age-standardized) and numbers of new cases of 18 different cancers have been estimated for the year 1985 in 24 areas of the world. The total number of new cancer cases (excluding non-melanoma skin cancer) was 7.6 million, 52% of which occur in developing countries. The most common cancer in the world today is lung cancer, accounting for 17.6% of cancers of men worldwide, and 22% of cancers in men in the developed countries. Stomach cancer is now second in frequency (it was slightly more common than lung cancer in 1980) and breast cancer—by far the most important cancer of women (19.1% of the total)—is third. There are very large differences in the relative importance of the different cancers by world area. The major cancers of developed countries (other than the 3 already named) are cancers of the colon-rectum and prostate, and, in developing countries, cancers of the cervix uteri, mouth and pharynx, liver and oesophagus. The implications of these patterns for cancer control, and specifically prevention, are discussed. Tobacco smoking and chewing are almost certainly the major prevent able causes of cancer today.     

Recherche et multiplicité des conflits d’intérêts

Researches are no longer an individual activity but are now “plural,” and therefore involve conflicts of interest. Many examples can be imagined (or observed): the patient versus patients leading to the paradigmatic case of sacrifice. Is it allowed to sacrifice one human being on purpose to increase the benefit of many? Researcher (the agent of science) versus physician (the agent of the patient). Patients versus patients (struggling for funding). Industrial versus academic that is the most emblematic (Manichean) case with both “shady” capitalism versus “immaculate” research and Goliath versus David. There is, however, some truth within that case but the point here argued is that it is not (or it should not be) an ethical concern but an organizational issue. To deal with conflicts of interest is a necessity since they won’t disappear. Modern tools of crisis management such as participation of all at stake groups and debating and transparency of argued decision are required. If no real improvement is carried out, loss of confidence in science will occur. Therefore, conflicts of interest are traps for physicians/researchers and are a threat to the society.