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Ethical and Practical Issues Associated With the Possibility of Using Controlled Human Infection Trials in Developing a Hepatitis C Virus Vaccine.

ABSTRACT: Despite the existence of established treatments for hepatitis C virus (HCV), more effective means of preventing infection, such as a vaccine, are arguably needed to help reduce substantial global morbidity and mortality. Given the expected challenges of developing such a vaccine among those at heightened risk of infection, controlled human infection studies seem to be a promising potential approach to HCV vaccine development, but they raise substantial ethical and practical concerns. In this article, we describe some of the challenges related to the possibility of using controlled human infection studies to accelerate HCV vaccine development. The related ethical and practical concerns require further deliberation before such studies are planned and implemented.

SUBMITTER: Cox A

PROVIDER: S-EPMC7778335 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Ethical and Practical Issues Associated With the Possibility of Using Controlled Human Infection Trials in Developing a Hepatitis C Virus Vaccine.

Cox Andrea A Sulkowski Mark M Sugarman Jeremy J

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20201201 11

Despite the existence of established treatments for hepatitis C virus (HCV), more effective means of preventing infection, such as a vaccine, are arguably needed to help reduce substantial global morbidity and mortality. Given the expected challenges of developing such a vaccine among those at heightened risk of infection, controlled human infection studies seem to be a promising potential approach to HCV vaccine development, but they raise substantial ethical and practical concerns. In this art ...[more]

PMID: 32442262

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Project description:BackgroundImmunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy.AimsTo determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women.MethodWe conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories.ResultsSeventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs.ConclusionThis review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women - offering new and valuable insights for programs developed to prevent disease in newborn children in low- and middle-income countries.

Project description:BackgroundPeople who are at elevated risk of suicide stand to benefit from internet-based interventions; however, research in this area is likely impacted by a range of ethical and practical challenges. The aim of this study was to examine the ethical issues and practical barriers associated with clinical studies of internet-based interventions for suicide prevention.MethodThis was a mixed-methods study involving two phases. First, a systematic search was conducted to identify studies evaluating internet-based interventions for people at risk of suicide, and information pertaining to safety protocols and exclusion criteria was extracted. Second, investigators on the included studies were invited to complete an online survey comprising open-ended and forced-choice responses. Quantitative and qualitative methods were used to analyse the data.ResultsThe literature search identified 18 eligible studies, of which three excluded participants based on severity of suicide risk. Half of the 15 suicide researchers who participated in the survey had experienced problems obtaining ethics approval, and none had encountered adverse events attributed to their intervention. Survey respondents noted the difficulty of managing risk in online environments and the limitations associated with implementing safety protocols, although some also reported increased confidence resulting from the ethical review process. Respondents recommended researchers pursue a collaborative relationship with their research ethics committees.ConclusionThere is a balance to be achieved between the need to minimise the risk of adverse events whilst also ensuring interventions are being validated on populations who may be most likely to use and benefit from them (i.e., those who prefer anonymity). Further research is required to obtain the views of research ethics committees and research participants on these issues. Dialogue between researchers and ethics committees is necessary to address the need to ensure safety while also advancing the timely development of effective interventions in this critical area.

Project description:The field of public health includes a wide scope of activities and professional disciplines, ranging from sanitation, health protection, epidemiology, environmental health, financing, health promotion, including supervision, or the provision of clinical care. Each of these disciplines works in systems that face ethical dilemmas, making it important that public health workers have motivation to understand and practice within the ethical guidelines of their profession, thus making ethics an important component of training and practice. The dangers of ethical lapses are overwhelmingly apparent in the case of the Eugenics movement of the early 20th century which metamorphosed from forced sterilizations in many liberal democratic countries into mass murder of physically and mentally handicapped children and adults in Nazi Germany. Between 1939 and 1941, 180 thousand psychiatric patients along with an equivalent number of handicapped children and adults were killed in an organized extermination program in Germany by lethal gassing. This method was then applied to the industrialized murder or Holocaust of six million Jews and millions of other “untermenschen” (sub human) in the greatest genocide in human history. Shortly after World War II ended the Nuremberg Trials of Nazi war criminals were conducted including medical doctors, and some were executed for crimes against humanity. This was followed by the 1948 United Nations Declaration on Human Rights and by the World Medical Association’s Helsinki Declaration. Both are widely accepted as cornerstone documents—the latter specifically governing ethical standards related to human experimentation—and are revised regularly since being issued in 1964. But genocide has not disappeared, nor has unscrupulous experimentation such as the Tuskegee experiment on black Americans infected with syphilis and left untreated even after the availability of a cure, penicillin. Ethical standards are now required by “Helsinki Committees”—ethical review boards—in most medical facilities worldwide. Ethical frameworks have evolved in part due to bitter experience of ethical failures later recognized and affecting public health standards of practice. Future generations of public health leaders and staff will face many ethical issues such as mandatory immunization of health workers and school children, and assisted death of terminally ill patients.

Dataset Information

Ethical and Practical Issues Associated With the Possibility of Using Controlled Human Infection Trials in Developing a Hepatitis C Virus Vaccine.

Publications

Ethical and Practical Issues Associated With the Possibility of Using Controlled Human Infection Trials in Developing a Hepatitis C Virus Vaccine.

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