Biobanking

2010 ◽  
pp. 216-232
Author(s):  
Robert J. Barnet
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Scientific Research ◽  
Research Subjects ◽  
Social Consensus ◽  
Related Research ◽  
Material Benefits ◽  
Past Experiences ◽  
Power Position

It is important to recognize that the four “p”s - power, position, prestige and profit - too frequently drive science, business, academia, and the professions. This chapter is concerned with the importance of appropriate consent, the just distribution of the material benefits of scientific research, and the possible exploitation of research subjects. Informed consent and social consensus may not adequately address the related ethical issues involved in biobanking and other related research. Past experiences internationally, especially among the marginalized, are reviewed. The chapter explores whether benefits that accrue to those involved in research, and even the larger community, can rely on the concept of social consensus. Is there sufficient attention to transparency and adequate consideration of present and future harms and benefits to research subjects, their descendants and the broader community? Are conflicts of interest, real and potential, adequately acknowledged and addressed?

scholarly journals Becoming and being a biobank donor: The role of relationships and ethics

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0242828
Author(s):  
Signe Mezinska ◽  
Jekaterina Kaleja ◽  
Ilze Mileiko
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Family Members ◽  
Research Subjects ◽  
Structured Interviews ◽  
Research Results ◽  
General Data Protection Regulation ◽  
Related Data ◽  
Research Findings

Relational aspects, such as involvement of donor’s relatives or friends in the decision-making on participation in a research biobank, providing relatives’ health data to researchers, or sharing research findings with relatives should be considered when reflecting on ethical aspects of research biobanks. The aim of this paper is to explore what the role of donor’s relatives and friends is in the process of becoming and being a biobank donor and which ethical issues arise in this context. We performed qualitative analysis of 40 qualitative semi-structured interviews with biobank donors and researchers. The results show that relatedness to relatives or other types of close relationships played a significant role in the donors’ motivation to be involved in a biobank, risk-benefit assessment, and decisions on sharing information on research and its results. Interviewees mentioned ethical issues in the context of sharing relatives’ health-related data for research purposes and returning research findings that may affect their relatives. We conclude that the question of what information on family members may be shared with a biobank by research participants without informed consent of those relatives, and when family members become research subjects, lacks a clear answer and detailed guidelines, especially in the context of the introduction of the European Union’s (EU) General Data Protection Regulation. Researchers in Latvia and EU face ethical questions and dilemmas about returning research results and incidental findings to donors’ relatives, and donors need more information on sharing research results with relatives in the informed consent process.

Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest

2019 ◽  
pp. 545-548
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Ethical Conduct ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Essential Components ◽  
Financial Conflicts Of Interest

Describe the essential components of the ethical conduct of research, the role of the institutional review board, the process of informed consent, the potential areas of conflict of interest for clinicians participating in research, and other ethical issues related to research in HIV medicine.

Controlled Donation After Circulatory Determination of Death

2016 ◽  
Vol 32 (3) ◽  
pp. 179-186 ◽  
Author(s):  
Anne L. Dalle Ave ◽  
David M. Shaw
Keyword(s):  
Informed Consent ◽  
End Of Life ◽  
Conflict Of Interest ◽  
End Of Life Care ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Life Care ◽  
Determination Of Death ◽  
The Family

Controlled donation after circulatory determination of death (cDCDD) concerns donation after withdrawal of life-sustaining therapy (W-LST). We examine the ethical issues raised by W-LST in the cDCDD context in the light of a review of cDCDD protocols and the ethical literature. Our analysis confirms that W-LST procedures vary considerably among cDCDD centers and that despite existing recommendations, the conflict of interest in the W-LST decision and process might be difficult to avoid, the process of W-LST might interfere with usual end-of-life care, and there is a risk of hastening death. In order to ensure that the practice of W-LST meets already well-established ethical recommendations, we suggest that W-LST should be managed in the ICU by an ICU physician who has been part of the W-LST decision. Recommending extubation for W-LST, when this is not necessarily the preferred procedure, is inconsistent with the recommendation to follow usual W-LST protocol. As the risk of conflicts of interest in the decision of W-LST and in the process of W-LST exists, this should be acknowledged and disclosed. Finally, when cDCDD programs interfere with W-LST and end-of-life care, this should be transparently disclosed to the family, and specific informed consent is necessary.

Warfighter Enhancement: Research and Technology

2021 ◽  
pp. 181-203
Author(s):  
Michael L. Gross
Keyword(s):  
Informed Consent ◽  
Medical Science ◽  
Scientific Research ◽  
Organizational Efficiency ◽  
Research Subjects ◽  
Surgical Interventions ◽  
Pain And Suffering ◽  
Therapeutic Research ◽  
Modern Warfare ◽  
Cultural Skills

To improve warfighter performance, medical science seeks pharmacological, surgical, genetic, and neurological technologies to make soldiers smarter, faster, stronger, and more alert. The sought after soldier is a gladiator or Jedi knight. Scientific research, however, is unwarranted if superfluous, and there are grave doubts about the usefulness of super soldiers in modern warfare where warfighters need language and cultural skills rather than strength and endurance. Beneficial enhancement research, therefore, focuses on learning, information analysis, and organizational efficiency that do not require invasive, irreversible, or surgical interventions. Utilizing noninvasive technologies such as wearables or neuroplasticity training carry few risks and enable research subjects to give fully informed consent. Nevertheless, medical scientists are not conducting therapeutic research to ameliorate pain and suffering. They are building weapons of war. As a result, enhancement researchers and providers jeopardize their immunity on the battlefield and leave themselves liable to defensive killing in war.

Balancing Risk and Benefit

2014 ◽  
pp. 366-401
Author(s):  
Rachel Glennerster ◽  
Shawn Powers
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Ethical Framework ◽  
Respect For Persons ◽  
Ethical Challenges ◽  
Research Subjects ◽  
Data Confidentiality ◽  
Ethical Guidelines ◽  
Antipoverty Programs ◽  
Risk And Benefit

The increasing use of randomized evaluations in economics has brought an increase in discussion about ethical issues. We argue that while there are ethical issues specific to randomization, most important ethical challenges are not unique to this methodology. The rise in direct researcher involvement with antipoverty programs that has accompanied the rise in randomized evaluations has made ethics issues more salient and raised complex regulatory questions. Though the principles of respect for persons, justice, and beneficence outlined by the 1978 Belmont Report continue to provide a useful ethical framework, we note a number of challenging tradeoffs in applying them including those around data confidentiality, informed consent, and misleading research subjects. We conclude by discussing how ethical guidelines are applied in practice, noting a number of gaps, ambiguities, and areas where we believe practice is diverging from the underlying principles. These issues apply with equal force to all empirical methodologies.

scholarly journals Ethical Characteristics of Research Proposals Related of COVID-19 Pandemic in Nepal: A Retrospective Review

2021 ◽  
Vol 19 (1) ◽  
pp. 148-153
Author(s):  
Namita Ghimire ◽  
Pawan Kumar Hamal ◽  
Asmita Panthee ◽  
Anju Vaidya ◽  
Mira Khadka ◽  
...  
Keyword(s):  
Informed Consent ◽  
Health Research ◽  
Ethical Issues ◽  
Critical Time ◽  
Standard Operating Procedure ◽  
Ethics Committees ◽  
World Health ◽  
Ethical Review ◽  
Ethical Guidelines ◽  
Related Research

Background: Public health emergency is vulnerable time where maintaining ethical principles is obligatory while doing research, on the other hand, it is the same time when breach in ethics is much likely whenever a researcher is unaware, unprepared or hastens to do research. The aim of this study was to assess ethical issues of the coronavirus disease 2019 (COVID-19) related research proposals submitted during the early stages of pandemic in Nepal.Methods: Retrospective analysis of COVID-19 related research proposals and their informed consent document submitted to the ethical review board at Nepal Health Research Council was done for the study. The analysis was done as per the National Ethical Guidelines, Standard Operating Procedure for Health Research in Nepal and World Health Organization guidelines for infectious disease outbreak, 2016 under ethically relevant headings. Descriptive data were analyzed in SPSS v24.Results: The major issues were observed in the informed consent documents where 55% were lacking principal investigator’s contact information, 68% not having participant selection criteria, 70% without clear informed consent taking process, 57% without explanation of possible risks. Similarly, 68% of the interventional studies’ consent form didn’t mention possible adverse events and mitigation mechanisms.Conclusions: Most of the research proposals related to COVID-19 were devoid of major ethical elements which took longer time for receiving approval and eventually delayed the opportunity for evidence generation in critical time. More attention is needed to increase awareness and to develop capacity of researchers, reviewers, ethics committees and relevant stakeholders at the time of health emergencies.Keywords: COVID-19; ethics pandemic; research proposals

scholarly journals Ethical issues in genomics research on neurodevelopmental disorders: a critical interpretive review

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
S. Mezinska ◽  
L. Gallagher ◽  
M. Verbrugge ◽  
E.M. Bunnik
Keyword(s):  
Informed Consent ◽  
Neurodevelopmental Disorders ◽  
Cognitive Abilities ◽  
Social Impact ◽  
Mental Health Problems ◽  
Ethical Issues ◽  
Family Members ◽  
Genetic Diagnosis ◽  
Research Participation ◽  
Genomic Research

Abstract Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research participants, and communication of research results. Ethical issues known to be associated with genomic research in general, such as privacy risks and informed consent/assent, seem especially pressing for NDD participants because of their potentially decreased cognitive abilities, increased vulnerability, and stigma associated with mental health problems. Additionally, there are informational risks: learning genetic information about NDD may have psychological and social impact, not only for the research participant but also for family members. However, there are potential benefits associated with research participation, too: by enrolling in research, the participants may access genetic testing and thus increase their chances of receiving a (genetic) diagnosis for their neurodevelopmental symptoms, prognostic or predictive information about disease progression or the risk of concurrent future disorders. Based on the results of our review, we developed an ethics checklist for genomic research involving children affected by NDDs. Conclusions In setting up and designing genomic research efforts in NDD, researchers should partner with communities of persons with NDDs. Particular attention should be paid to preventing disproportional burdens of research participation of children with NDDs and their siblings, parents and other family members. Researchers should carefully tailor the information and informed consent procedures to avoid therapeutic and diagnostic misconception in NDD research. To better anticipate and address ethical issues in specific NDD studies, we suggest researchers to use the ethics checklist for genomic research involving children affected by NDDs presented in this paper.

Death, taxes and uncertainty: Economic motivations in end-of-life decision making

2021 ◽  
pp. 147775092110114
Author(s):  
George Slade Mellgard ◽  
Jacob M Appel
Keyword(s):  
End Of Life ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Clinical Care ◽  
Third Party ◽  
Ethical Conflicts ◽  
Financial Interests ◽  
End Of Life Decision ◽  
Death Taxes

Economic motivations are key drivers of human behavior. Unfortunately, they are largely overlooked in literature related to medical decisionmaking, particularly with regard to end-of-life care. It is widely understood that the directions of a proxy acting in bad faith can be overridden. But what of cases in which the proxy or surrogate appears to be acting in good faith to effectuate the patient’s values, yet doing so directly serves the decision-maker’s financial interests? Such situations are not uncommon. Many patients care as deeply about economic wellbeing of their families as they do for their own lives and health. This brief work examines three scenarios that raise ethical issues regarding the role of pecuniary motives in making critical medical decisions. Each scenario presents a potential financial conflict of interest between an incapacitated patient and a third-party decision-maker and offers a framework for integrating ethical and legal concerns into clinical care. It is our hope that this work prepares physicians for unexpected ethical conflicts of interest and enables them to further the interests of his or her patients.

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