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Community engagement in the informed consent process in global clinical research
Published in Joseph Tham, Alberto García Gómez, Mirko Daniel Garasic, Cross-Cultural and Religious Critiques of Informed Consent, 2021
The Council for International Organizations of Medical Sciences (CIOMS) guidelines in the revised 2016 version include a brand-new guideline devoted explicitly to community engagement. To this aim, Guideline 7 recommends the inclusion of communities in global collaborative research through a “meaningful participatory process, that involves them in an early and sustained manner in the design, development, implementation, design of the informed consent process and monitoring of the research, and in the dissemination of its results.”32
Cultural variation in informed consent for clinical research participation
Published in Paul M.W. Hackett, Christopher M. Hayre, Handbook of Ethnography in Healthcare Research, 2020
The Council for International Organizations of Medical Sciences (CIOMS), a group established by the World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949, adopted its International Ethical Guidelines for Biomedical Research Involving Human Subjects in 1993. The CIOMS Guidelines were revised in 2016 and renamed the International Ethical Guidelines for Health-related Research Involving Humans (Council for International Organizations of Medical Sciences 2016). The CIOMS Guidelines, like the Nuremberg Code and Helsinki Declaration, include rules for providing and documenting informed consent. The Guidelines also address other relevant consent topics, such as essential information that should be conveyed to the subject, the voluntary nature of consent, freedom of choice, deception, comprehension of information, the capacity to consent, consent by a legally authorized representative, and procedures for modifying or waiving consent (Council for International Organizations of Medical Sciences 2016).
Regulatory and Legislative Policy and Science Considerations in the Era of Patient-Centeredness, Big Data, and Value
Published in Qi Jiang, Weili He, Benefit-Risk Assessment Methods in Medical Product Development, 2017
Tarek A. Hammad, George A. Neyarapally
In 2014, the Council for International Organizations of Medical Sciences (CIOMS) published a guidance document on risk management.104 This guidance emphasizes that the goal of risk management is to improve patient health outcomes and reduce the frequency of harm as much as practicable, although entirely eliminating it is normally not possible.104 The authors emphasize balancing benefits and risks, risk mitigation, and preservation of access to medicines, including considerations of the burden to patients and the health care system. The importance of tailoring risk management tools to be commensurate with the relevant risks over the medical product’s life cycle and obtaining patient perspectives in the development and design of risk management programs is emphasized, consistent with the aforementioned increased patient-focused US initiatives. In contrast to traditional B–R assessment, CIOMS guidance recommends use of the RE-AIM framework for risk management program assessment, including the following dimensions: reach, effectiveness, adoption, implementation, and maintenance.105 The guidance also recommends prior development of an analysis plan, which may enhance risk management program evaluation in the future as there are many limitations in the evaluation of these programs.106 Future modalities for the implementation and evaluation of risk management programs include electronic audit and feedback to rapidly implement and assess health care professional knowledge, web-based physician checklists integrated into workflow via decision support tools, simulations, and web-based strategies.104
A new definition for global bioethics: COVID-19, a case study
Published in Global Bioethics, 2022
Authoritative sources provide guidance in controversies regarding ethics in research with human beings. Two such international documents are in widespread use throughout the world. The first of these is the Declaration of Helsinki (DoH), issued by the World Medical Association (WMA, 2013). The second authoritative source for international research ethics is a set of guidelines prepared by the Council for International Organizations of Medical Sciences (CIOMS), a non-governmental organization based in Geneva, Switzerland (CIOMS, 2016). Both documents contain paragraphs describing the circumstances in which the use of placebo controls in research are unethical. The CIOMS publication cites WHO as a collaborator in drafting its guidelines. The cover and title page say: “Prepared by the Council for International Organizations of Medical sciences (CIOMS) in collaboration with the World Health Organization (WHO).” WHO's website contains this statement regarding the governance of its Ethics Review Committee (ERC): “The ERC is guided in its work by the World Medical Association Declaration of Helsinki (1964) last updated in 2013 as well as the International Ethical Guidelines for Biomedical Research Involving Human Subjects” (WHO REC). These acknowledgments clearly imply that the WHO has an obligation to adhere to the spirit and letter of the DoH and the CIOMS guidelines. The article published in NEJM, under the authorship of a WHO Ad Hoc Expert Group, violates the World Health Organization's own stated ethical commitment to adhere to these two international guidelines for research with human beings.
HIV prevention clinical trials’ community engagement guidelines: inequality, and ethical conflicts
Published in Global Bioethics, 2020
Morenike O. Folayan, Kristin Peterson
The Council for International Organizations of Medical Sciences (CIOMS) guidelines for health related research involving human subjects had alluded in unclear terms, to social contracting model for research-participant engagement when it stated that: “Researchers, sponsors, health authorities and relevant institutions should engage potential participants and communities in a meaningful participatory process that involves them in an early and sustained manner in the design, development, implementation, design of the informed consent process and monitoring of research, and in the dissemination of its results” (CIOMS, 2016). The UNAIDS/WHO and the UNAIDS/AVAC guidelines on community engagement with biomedical HIV prevention research had also promoted consultations between researchers and participants. The documents had however, not been explicit in their request for a contractarian social contract thereby limiting commitments of researcher stakeholders to such obligations.
Influenza vaccine failure: failure to protect or failure to understand?
Published in Expert Review of Vaccines, 2018
The nosology for vaccine failure is incomplete and inadequately developed. The 2012 Council for International Organizations of Medical Sciences (CIOMS) report on “The Definition and Application of Terms for Vaccine Pharmacovigilance: Report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance” [9] is a good start. Further work is needed; ideally, a consensus must emerge on categories, definitions, and examples of vaccine versus nonvaccine failure. This is an important first step toward adequately studying, distinguishing, and cataloging real versus suspected vaccine failure. In turn, such accuracy lends increased credence to reports of true vaccine failure, prevents confusion and misinterpretation of reported vaccine failure, and may serve to either increase confidence in vaccines or suggest and motivate vaccine developers toward areas for further research and/or avenues for new vaccine research and development. For example, validated data demonstrating true vaccine failure and its root cause(s) are important to directing additional research to understand the mechanistic basis of vaccine failure. In turn, the results of such research are highly likely to inform and motivate new directed vaccine-development efforts toward a more highly immunogenic/efficacious vaccine. With the advent of increasingly high-dimensional systems biology and vaccinomics approaches to understanding the development of immunity after vaccination [37,38], as well as the discovery of molecular signatures and biomarkers for vaccine immunogenicity, such research will be enabled.