Belmont Report
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Knowing what constitutes ethical research is important for those who conduct research and the researcher should be familiar with the basic ethical principles and policies designed to ensure the safety of the research subjects. Research... more
Knowing what constitutes ethical research is important for those who conduct research and the researcher should be familiar with the basic ethical principles and policies designed to ensure the safety of the research subjects. Research must be ethically conducted, trustworthy, and socially responsible for the results to be valuable. Ignorance of policies designed to protect research subjects is not considered a viable excuse and the researcher needs to fully understand the ethical code and guidelines to guarantee upstanding research practices. In the last decade medical research in India saw emergence of difficult ethical issues and intervention from the Supreme Court of India. The different socio-cultural ethos and the varying standards of health care in India pose unique challenges to the application of the universally prevailing ethical principles and guidelines. This necessitated the Indian Council of Medical Research (ICMR) to revise their 2006 ethical guidelines for biomedical research as ‘National Ethical Guidelines for Biomedical and Health Research on Human Participants 2016’. These guidelines are applicable to all biomedical, socio-behavioral and health research conducted in India which involves human subjects. This article gives an overview of the evolution and principles of research bioethics, and helps to understand and disseminate the general principles of the Declaration of Helsinki 2013 of World Medical Association and the National Ethical Guidelines 2016 of ICMR.
Background: This paper offers practical insights for researchers who conduct studies with vulnerable populations, including those using secondary data sources from government entities. Methods/Design: The paper is based on the approval... more
Background: This paper offers practical insights for researchers who conduct studies with vulnerable populations,
including those using secondary data sources from government entities.
Methods/Design: The paper is based on the approval process to secure secondary government data from a
Midwestern county juvenile probation department and the state courts for the author’s dissertation study.
Discussion: This paper proposes general considerations and ten lessons learned to successfully conduct research
with vulnerable populations and/or their information.
including those using secondary data sources from government entities.
Methods/Design: The paper is based on the approval process to secure secondary government data from a
Midwestern county juvenile probation department and the state courts for the author’s dissertation study.
Discussion: This paper proposes general considerations and ten lessons learned to successfully conduct research
with vulnerable populations and/or their information.
This chapter analyses and develops the concept as well as the ethics of “clinical innovation” in the context of the emerging field of individualized approaches in medicine. We argue for clinical innovation as an alternative approach to... more
This chapter analyses and develops the concept as well as the ethics of “clinical innovation” in the context of the emerging field of individualized approaches in medicine. We argue for clinical innovation as an alternative approach to clinical research in the context of the application of new and yet untested interventions. Even though clinical innovation applies to reasonable, but yet unproven novel health interventions, it does not aim to generate generalizable knowledge under a sound research design. We will characterize clinical innovation as “new and insufficiently validated practice” because it resembles medical practice in terms of the aim to directly benefit individual patients. However, clinical innovation departs in a significant way from validated medical practice because innovative medical procedures go along with unknown safety and efficacy features. We will argue that innovation understood as new and non-validated practice is ethically justified as an acceptable medical option when no reasonable alternatives can be provided to an individual patient. Thus, we show that clinical innovation is an ethically required category that falls under the category of clinical practice, which should be distinguished from clinical research.