Solidarity and equity: new ethical frameworks for genetic databases

Chadwick, Ruth; Berg, K.

doi:10.1038/35066094

Cited by 214 publications

(118 citation statements)

References 10 publications

Supporting

Mentioning

112

Contrasting

Unclassified

Order By: Relevance

“…As informed consent procedures are one of the essential aspects of clinical trials, discussing and disclosing aforementioned concerns to individuals seem crucial (Howard et al 2011). However, many scholars claim that these wide-ranging concerns cannot be simply integrated into individualistic informed consent in postgenomic era (Chadwick and Berg 2001;Manson and O'Neill 2007;O'Neill 2001). By the same token, but specifically in pharmacogenetics context, Corrigan and Williams-Jones (2006) maintain that the rights of patients could not be addressed sufficiently by individually based informed consent.…”

Section: Introductionmentioning

confidence: 99%

Within and beyond the communal turn to informed consent in industry-sponsored pharmacogenetics research: merits and challenges of community advisory boards

Soofi

Leeuwen²

2016

J Community Genet

View full text Add to dashboard Cite

The one-size-fits-all paradigm of drug development fails to address inter-individual variability in drug response. Pharmacogenetics research aims at studying the role of genotypic differences in drug response. Recently, the pharmaceutical industry has shown interest to embed pharmacogenetics studies in the process of drug development. Nevertheless, population-based and commercial aspects of such futureoriented studies pose challenges for individually based informed consent (IC). As an exemplar of the communal turn to IC procedures, community advisory boards (CABs) have been integrated into different types of medical research. CABs hold the promise of organizing the relationship between participants and researchers in a more reciprocal and participatory way, offering possible means of overcoming the lapses of individualistic IC. However, the involvement of CABs with pharmacogenetics research might be rife with difficulties, uncertainties, and challenges. The current study first reviews the existing literature to discuss added values and challenges of relying on CABs as a supplement to individually based IC. Then, the particular moral and regulatory landscape of pharmacogenetics research will be delineated to argue that community engagement is both necessary and promising beyond the communal turn to IC processes. Three main features of the landscape include (1) new supportive stances that some regulatory bodies have adopted toward pharmacogenetics research, (2) the motivation of the industry to draw reception and trust from the subpopulations, and (3) the important role of the society in generating and embedding pharmacogenetics knowledge. Finally, some points to consider will be discussed to contextualize relying on CABs within this landscape.

show abstract

Section: Introductionmentioning

confidence: 99%

Within and beyond the communal turn to informed consent in industry-sponsored pharmacogenetics research: merits and challenges of community advisory boards

Soofi

Leeuwen²

2016

J Community Genet

View full text Add to dashboard Cite

show abstract

“…Proposals for automatic or prompted sharing can be justified by moral obligations between patients and medicine as a practice: a non-binding "duty to participate" has, for example, been previously advanced in medical ethics [10][11][12]. Without taking a position on the validity of such a duty, respect for user autonomy suggests options should be provided for users to easily share their data with researchers according to personal preference.…”

Section: Facilitate Public Health Actions and User Engagement With Rementioning

confidence: 99%

Designing the Health-related Internet of Things: Ethical Principles and Guidelines

Mittelstadt

2017

Information

View full text Add to dashboard Cite

Abstract:The conjunction of wireless computing, ubiquitous Internet access, and the miniaturisation of sensors have opened the door for technological applications that can monitor health and well-being outside of formal healthcare systems. The health-related Internet of Things (H-IoT) increasingly plays a key role in health management by providing real-time tele-monitoring of patients, testing of treatments, actuation of medical devices, and fitness and well-being monitoring. Given its numerous applications and proposed benefits, adoption by medical and social care institutions and consumers may be rapid. However, a host of ethical concerns are also raised that must be addressed. The inherent sensitivity of health-related data being generated and latent risks of Internet-enabled devices pose serious challenges. Users, already in a vulnerable position as patients, face a seemingly impossible task to retain control over their data due to the scale, scope and complexity of systems that create, aggregate, and analyse personal health data. In response, the H-IoT must be designed to be technologically robust and scientifically reliable, while also remaining ethically responsible, trustworthy, and respectful of user rights and interests. To assist developers of the H-IoT, this paper describes nine principles and nine guidelines for ethical design of H-IoT devices and data protocols.

show abstract

“…Accurate information about the potential financial gains and transparency about who will benefit is essential to create realistic expectations. 3,11,24,34,35 Many studies show that participants are generally interested in knowing this information; however, this would not necessarily make a difference to their decision to participate. 36,37 The MICROS information leaflet states that although no commercial benefits are anticipated, any that are forthcoming will be reinvested in research and health facilities in the region but that there will be no individual benefits to participants.…”

Section: Benefit Sharingmentioning

confidence: 99%

“…Now, family-based study designs are also being used on a much larger scale to investigate genetic predisposition to diseases that have hitherto not been recognised as running in families. As this approach is not as widely used at present as large population-based studies, discussion of the ethical issues inherent in genetic epidemiological research has largely focused on genomics and biobanks [3][4][5][6][7][8] and specifically on the tension between the promise of important advances in biomedical research 6,9 and the requirement for robust ethical standards. 7,[10][11][12] New research techniques raise important ethical issues relating to consent [13][14][15][16] ownership, governance, access to information, benefit sharing and community participation.…”

Section: Introductionmentioning

confidence: 99%

Comparison of participant information and informed consent forms of five European studies in genetic isolated populations

et al. 2009

View full text Add to dashboard Cite

on behalf of the EUROSPAN consortiumFamily-based research in genetically isolated populations is an effective approach for identifying loci influencing variation in disease traits. In common with all studies in humans, those in genetically isolated populations need ethical approval; however, existing ethical frameworks may be inadequate to protect participant privacy and confidentiality and to address participants' information needs in such populations. Using the ethical-legal guidelines of the Council for International Organizations of Medical Sciences (CIOMS) as a template, we compared the participant information leaflets and consent forms of studies in five European genetically isolated populations to identify additional information that should be incorporated into information leaflets and consent forms to guarantee satisfactorily informed consent. We highlight the additional information that participants require on the research purpose and the reasons why their population was chosen; on the potential risks and benefits of participation; on the opportunities for benefit sharing; on privacy; on the withdrawal of consent and on the disclosure of genetic data. This research raises some important issues that should be addressed properly and identifies relevant types of information that should be incorporated into information leaflets for this type of study.

show abstract

Solidarity and equity: new ethical frameworks for genetic databases

Cited by 214 publications

References 10 publications

Within and beyond the communal turn to informed consent in industry-sponsored pharmacogenetics research: merits and challenges of community advisory boards

Within and beyond the communal turn to informed consent in industry-sponsored pharmacogenetics research: merits and challenges of community advisory boards

Designing the Health-related Internet of Things: Ethical Principles and Guidelines

Comparison of participant information and informed consent forms of five European studies in genetic isolated populations

Contact Info

Product

Resources

About