Nanomedicine First-in-Human Research: Challenges for Informed Consent

2012 ◽  
Vol 40 (4) ◽  
pp. 823-830 ◽  
Author(s):  
Nancy M. P. King
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Clinical Research ◽  
Human Subjects ◽  
Consent Form ◽  
Human Research ◽  
Research Challenges ◽  
Starting Point ◽  
Human Subjects Protections

First-in-human (FIH) research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent form and process are by no means the primary protectors of human subjects (although they are sometimes so regarded). Instead, consideration of the form and content of informed consent becomes relevant only after a clinical trial has been reviewed and deemed scientifically and ethically acceptable.Two convergent types of challenges to informed consent are posed by nanomedicine FIH research. First, some issues appear generally applicable to FIH research, but have specific nanomedicine implications.

scholarly journals Informed consent of human subjects: a review

2014 ◽  
Vol 5 (1) ◽  
pp. 20-35
Author(s):  
Mohammad Rashedul Islam
Keyword(s):  
Developing Countries ◽  
Informed Consent ◽  
Human Subjects ◽  
Research Process ◽  
Informed Decision ◽  
Consent Form ◽  
Clear Understanding ◽  
Human Research ◽  
Vital Part

Informed consent is a vital part of the research process, and as such entails more than obtaining a signature on the consent form. Researchers or investigators must educate potential subjects to ensure that they can reach a truly informed decision about whether or not to participate in the research. Their consent must be given freely, without coercion, and must be based on a clear understanding of what participation involves. Only then it can be regarded as ‘informed consent’. Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18444 Bangladesh Journal of Bioethics 2014 Vol.5(1): 20-35

scholarly journals Regulation of professional clinical trial volunteers in New Zealand

2021 ◽  
Author(s):  
◽  
Malisa Mulholland
Keyword(s):  
Clinical Trial ◽  
Human Rights ◽  
New Zealand ◽  
Clinical Research ◽  
Disability Services ◽  
Bill Of Rights ◽  
Financial Compensation ◽  
Starting Point ◽  
Research Volunteers ◽  
Professional Volunteers

<p>This paper aims to form a starting point for a discussion of the regulation of paid clinical research volunteers (professional volunteers) in New Zealand. It will argue that professional volunteers, who are currently unregulated as a class of research participants, present unique issues which are not addressed by existing regulation. The major arguments will be that: by restricting the value of financial compensation that can be provided for volunteering in a clinical trial, existing regulation allows professional volunteers to be exploited; professional volunteers are exposed to unregulated compounded risks and it is unlikely that they are properly informed of these risks; and in failing to recognise the existence of professional volunteers, current regulation fails to address their commodification and dehumanisation. Proposals to address these issues will be evaluated through a human rights lens for consistency with the New Zealand Bill of Rights Act 1990 and the Code of Health and Disability Services Consumers’ Rights 1996. Recommendations for reform will be put forward on the basis of this analysis.</p>

Informed Consent in Research Involving Human Subjects

2019 ◽  
pp. 171-191 ◽  
Author(s):  
Antonio Sandu ◽  
Ana Frunza
Keyword(s):  
Informed Consent ◽  
Dynamic Process ◽  
Medical Condition ◽  
Human Subjects ◽  
Consent Form ◽  
Ethical Reflection ◽  
Administrative Procedure ◽  
The Subject ◽  
A Minor ◽  
Ethical Character

Informed consent (IC) in research is a key element in ensuring the ethical character of any research involving human subjects, either bio-medical or psychosocial. IC involves three elements: validity, communication of information, and deliberation. Obtaining IC is a dynamic process of ethical reflection in order to facilitate the expression of autonomy of the subject involved in research. The process of obtaining the IC must be accompanied by the administrative procedure for completing a consent form signed by both the participant and the researcher. If the participant cannot sign—either because he is a minor or because of the medical condition—a delegated consent signed by the legal representatives of the subject is required.

Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines

2012 ◽  
Vol 40 (4) ◽  
pp. 841-847 ◽  
Author(s):  
Jonathan Kimmelman
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Clinical Development ◽  
Nuremberg Code ◽  
Human Research ◽  
Clinical Investigator ◽  
Nazi Doctors ◽  
Personal Interests

Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect a sphere of protection around the latter.As a consequence of this history, all major policies start with a well-rehearsed model of human investigations. Clinical research is viewed as an encounter between investigators and volunteers. The clinical investigator is given certain duties. The human volunteer has certain moral entitlements. What is ethically at stake in human investigations inheres in the nature and quality of the interactions between investigators and volunteers. These interactions involve an asymmetry because the investigator has privileged knowledge and influence.

scholarly journals Responsible research for the construction of maximally humanlike automata: the paradox of unattainable informed consent

2017 ◽  
Vol 22 (4) ◽  
pp. 297-305 ◽  
Author(s):  
Lantz Fleming Miller
Keyword(s):  
Informed Consent ◽  
Research And Development ◽  
Human Subjects ◽  
Moral Rights ◽  
Human Beings ◽  
Research Subjects ◽  
Nuremberg Code ◽  
Human Research ◽  
Ethical Codes ◽  
Responsible Research

Abstract Since the Nuremberg Code and the first Declaration of Helsinki, globally there has been increasing adoption and adherence to procedures for ensuring that human subjects in research are as well informed as possible of the study’s reasons and risks and voluntarily consent to serving as subject. To do otherwise is essentially viewed as violation of the human research subject’s legal and moral rights. However, with the recent philosophical concerns about responsible robotics, the limits and ambiguities of research-subjects ethical codes become apparent on the matter of constructing automata that maximally resemble human beings (as defined hereunder). In this case, the automata themselves, as products of research and development, are in the very process of their construction subjects of research and development. However, such research faces a paradox: The subjects cannot give their informed consent to this research for their own development, although their consent would be needed for the research. According to ethical codes, this research would be unethical. The article then explores whether the background concepts giving rise to this paradox could be reframed in order to allow such research to proceed ethically.

scholarly journals What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis

2021 ◽  
Vol 6 (5) ◽  
pp. e004729
Author(s):  
Sangeetha Paramasivan ◽  
Philippa Davies ◽  
Alison Richards ◽  
Julia Wade ◽  
Leila Rooshenas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Clinical Research ◽  
Empirical Research ◽  
Scoping Review ◽  
Narrative Synthesis ◽  
Research Gaps ◽  
Evidence Map ◽  
Starting Point ◽  
Wide Range

IntroductionThe post-2005 rise in clinical trials and clinical research conducted in India was accompanied by frequent reports of unethical practices, leading to a series of regulatory changes. We conducted a systematic scoping review to obtain an overview of empirical research pertaining to the ethics of clinical trials/research in India.MethodsOur search strategy combined terms related to ethics/bioethics, informed consent, clinical trials/research and India, across nine databases, up to November 2019. Peer-reviewed research exploring ethical aspects of clinical trials/research in India with any stakeholder groups was included. We developed an evidence map, undertook a narrative synthesis and identified research gaps. A consultation exercise with stakeholders in India helped contextualise the review and identify additional research priorities.ResultsTitles/Abstracts of 9699 articles were screened, full text of 282 obtained and 80 were included. Research on the ethics of clinical trials/research covered a wide range of topics, often conducted with little to no funding. Studies predominantly examined what lay (patients/public) and professional participants (eg, healthcare staff/students/faculty) know about topics such as research ethics or understand from the information given to obtain their consent for research participation. Easily accessible groups, namely ethics committee members and healthcare students were frequently researched. Research gaps included developing a better understanding of the recruitment-informed consent process, including the doctor-patient interaction, in multiple contexts and exploring issues of equity and justice in clinical trials/research.ConclusionThe review demonstrates that while a wide range of topics have been studied in India, the focus is largely on assessing knowledge levels across different population groups. This is a useful starting point, but fundamental questions remain unanswered about informed consent processes and broader issues of inequity that pervade the clinical trials/research landscape. A priority-setting exercise and appropriate funding mechanisms to support researchers in India would help improve the clinical trials/research ecosystem.

Medical Research Ethics: What We Need to Comply When Obtaining Informed Consent from Human Subjects?

2009 ◽  
Vol 16 (4) ◽  
pp. 271-276
Author(s):  
CSK Tay
Keyword(s):  
Patient Safety ◽  
Informed Consent ◽  
Medical Ethics ◽  
Clinical Research ◽  
Medical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Well Being ◽  
Research Subjects ◽  
Medical Research Ethics

Patient safety and well-being are very important to safeguard in medical research. A subject's life cannot be sacrificed for the benefits of future mankind, as medical ethics of autonomy dictate the respect of an individual. By reference to the Declaration of Helsinki, this article discusses the ethical principles and processes in obtaining a valid and proper informed consent from the research subjects who should freely consent and voluntarily participate in the clinical research, including the ‘contents’ of the informed consent and the ‘skills’ of obtaining informed consent.

scholarly journals The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection

2002 ◽  
Vol 30 (3) ◽  
pp. 411-419 ◽  
Author(s):  
Arlene M. Davis ◽  
Sara Chandros Hull ◽  
Christine Grady ◽  
Benjamin S. Wilfond ◽  
Gail E. Henderson
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Human Subjects ◽  
Critical Role ◽  
Invisible Hand ◽  
Community Settings ◽  
Institutional Review ◽  
Research Organizations ◽  
Study Staff ◽  
Protection Of Human Subjects

Over the past decade, the number of clinical trials registered with the Food and Drug Administration (FDA) has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board (IRB) review, data monitoring, and informed consent forms. However, the protection of human subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research.

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