Broad-scale informed consent: A survey of the CTSA landscape

Broad-scale informed consent: A survey of the CTSA landscape
Redonna Chandler, Kathleen T. Brady, Rebecca N. Jerome, Milton Eder, Erin Rothwell, Kimberly A. Brownley, Paul A. Harri
Journal of Clinical and Translational Science, 27 June 2019
Open Access
Abstract
Introduction
Research opportunities associated with the proliferation of the electronic health record (EHR), big data initiatives, and innovative approaches to trial design can present challenges for obtaining and documenting informed consent. Broad-scale informed consent (a term used herein to describe institutional models, rather than the Common Rule’s strict regulatory definition for “broad consent”) may facilitate the use of existing data and samples and speed the pace of research by minimizing barriers to consent. We explored the use of broadscale informed consent within the Clinical Translational Science Award (CTSA) Program Network.
Methods
We surveyed CTSA Hubs concerning policies, practices, experiences, and needs within three domains of broad-scale informed consent: (1) participant recontact; (2) biospecimens; and (3) clinical data sharing.
Results
Of 61 CTSA Hubs surveyed, 37 (61%) indicated ongoing work related to at least 1 domain of broad-scale informed consent; 18 Hubs (30%) reported work in all 3 domains. The EHR predominated as the implementation system across all three domains. Research and IT leadership and the Institutional Review Board were most commonly endorsed as institutional drivers, while systems/technical issues and impact on clinical workflow were the most commonly reported barriers.
Conclusions
While survey results indicate considerable variability in the implementation of broad-scale informed consent across the CTSA consortium, it is clear that all CTSA Hubs are actively considering policy and process related to these concepts. Next steps cluster within three areas: training and workforce development, streamlined policies and templates, and implementation strategies that facilitate integration into clinical workflow.

From Individual to Collective Consent: The Case of Indigenous Peoples and UNDRIP

From Individual to Collective Consent: The Case of Indigenous Peoples and UNDRIP
Research Article
Richard Healey
International Journal on Minority and Group Rights, 13 September 2019
Abstract
Much of the debate around requirements for the free, prior, and informed consent of indigenous peoples has focused on enabling indigenous communities to participate in various forms of democratic decision-making alongside the state and other actors. Against this backdrop, this article sets out to defend three claims. The first two of these claims are conceptual in nature: (i) Giving (collective) consent and participating in the making of (collective) decisions are distinct activities; (ii) Despite some scepticism, there is a coherent conception of collective consent available to us, continuous with the notion of individual consent familiar from discussions in medical and sexual ethics. The third claim is normative: (iii) Participants in debates about free, prior, and informed consent must keep this distinction in view. That is because a group’s ability to give or withhold consent, and not only participate in making decisions, will play an important role in realising that collectives’ right to self-determination.

Editor’s note: The UNDRIP is the United Nations Declaration of the Rights of Indigenous Peoples

The Transformative Potential of Indigenous-Driven Approaches to Implementing Free, Prior and Informed Consent: Lessons from Two Canadian Cases

The Transformative Potential of Indigenous-Driven Approaches to Implementing Free, Prior and Informed Consent: Lessons from Two Canadian Cases
Research Article
Martin Papillon, Thierry Rodon
International Journal on Minority and Group Rights, 13 September 2019
Abstract
While it is increasingly recognised as a core element of the emerging international Indigenous rights regime, the implementation of the principle of free, prior and informed consent (FPIC) remains contested. As the comparative literature shows, if and how fpic is implemented depend both on the institutional context and on the agency of actors involved. Faced with deep power asymmetries and strong institutional resistance to their understanding of fpic as a decision-making right, a number of Indigenous groups in Canada have taken advantage of the uncertain legal context to unilaterally operationalise fpicthrough the development of their own decision-making mechanisms. Building on two case studies, a mining policy adopted by the Cree Nation of James Bay and a community-driven impact assessment process established by the Squamish Nation, this article argues Indigenous-driven mechanisms can be powerful instruments to shape how fpic is defined and translated in practice.

Mobilising Free, Prior and Informed Consent (FPIC) from Below: A Typology of Indigenous Peoples’ Agency

Mobilising Free, Prior and Informed Consent (FPIC) from Below: A Typology of Indigenous Peoples’ Agency
Research Article
Almut Schilling-Vacaflor, Riccarda Flemmer
International Journal on Minority and Group Rights, 30 Aug 2019
Abstract
Based on rich empirical data from Bolivia, Colombia, and Peru – the three Latin American countries where the implementation of prior consultation processes is most advanced – we present a typology of indigenous peoples’ agency surrounding prior consultation processes and the principle of free, prior and informed consent (FPIC). The typology distinguishes between indigenous actors (1) mobilising for a strong legal interpretation of FPIC, (2) mobilising for meaningful and influential FPIC processes, (3) mobilising against prior consultation processes, and (4) blockading prior consultation processes for discussing broader grievances. We identify the most prominent indigenous strategies related to those four types, based on emblematic cases. Finally, we critically discuss the inherent shortcomings of the consultation approach as a model for indigenous participation in public decision-making and discuss the broader implications of our findings with regard to indigenous rights and natural resource governance.

The Politics of Free, Prior and Informed Consent: Indigenous Rights and Resource Governance in Ecuador and Yukon, Canada

The Politics of Free, Prior and Informed Consent: Indigenous Rights and Resource Governance in Ecuador and Yukon, Canada
Research Article
Roberta Rice
International Journal on Minority and Group Rights, 30 Aug 2019
Abstract
What are the institutional arrangements required to implement a genuine process of free, prior and informed consent (fpic)? This article provides a comparative perspective on the politics of consent in the context of relations between Indigenous peoples, states and extractive industries in Canada and Latin America. The case of Ecuador is presented as an emblematic example of a hybrid regime in which Indigenous communities have the right to free, prior and informed consultation, not consent, concerning planned measures affecting them, such as mineral, oil and gas exploitation. In the case of Yukon, Canada, the settlement of a comprehensive land claim with sub-surface mineral rights has provided the institutional basis for the implementation of a genuine fpic process, one that includes participatory decision-making power over natural resource development projects. The article concludes with a discussion on the necessary conditions for moving governments from a consultation to a consent regime.

Sustainable exploitation of natural resources in Kenya : a case for communities’ free, prior and informed consent in oil and gas projects

Sustainable exploitation of natural resources in Kenya : a case for communities’ free, prior and informed consent in oil and gas projects
Rodgers Otieno Odhiambo
Africa Nazarene University Law Journal, 2019; 7(1) pp 1 – 23
Abstract
This article attempts to analyse the development of free, prior and informed consent (FPIC) as an international law principle, its nature and its essence. Further, the article seeks to illustrate the advantages of the principle in natural resource development. Indeed, the principal aim of this article is to bring the development of an international law principle useful in the exploitation of natural resources to the attention of Kenyan legal scholars and policymakers. This is crucial in the context of Kenya which has no experience in the exploration and exploitation of oil and gas, and in view of the fact that the country has embarked on various legal and policy reforms within the extractive sector. Being a frontier market, Kenya needs to learn the nuances within the oil and gas sector. It would therefore be imperative to examine the jurisprudence of international bodies and the activities of other international actors with regard to communities’ participatory rights, while recognising that a new standard of international law has developed which recognises that there is a duty to obtain the FPIC of local and indigenous communities when undertaking extraction of natural resources activities within their locality. Thus, the paper seeks to explore the development of the duty to obtain FPIC in international instruments such as declarations, treaties and Acts by international bodies. The article concludes by making a strong case for the entrenchment of FPIC within the policy and legal framework governing the extractive sector in Kenya.

Indigenous Peoples, Consent and Rights; Troubling Subjects [Book]

Indigenous Peoples, Consent and Rights; Troubling Subjects [Book]
Stephen Young
Routledge, 19 December 2019; 272 pages
Summary
Analysing how Indigenous Peoples come to be identifiable as bearers of human rights, this book considers how individuals and communities claim the right of free, prior and informed consent (FPIC) as Indigenous peoples.

The basic notion of FPIC is that states should seek Indigenous peoples’ consent before taking actions that will have an impact on them, their territories or their livelihoods. FPIC is an important development for Indigenous peoples, their advocates and supporters because one might assume that, where states recognise it, Indigenous peoples will have the ability to control how non-Indigenous laws and actions will affect them. But who exactly are the Indigenous peoples that are the subjects of this discourse? This book argues that the subject status of Indigenous peoples emerged out of international law in the late 1970s and early 1980s. Then, through a series of case studies, it considers how self-identifying Indigenous peoples, scholars, UN institutions and NGOs dispersed that subject-status and associated rights discourse through international and national legal contexts. It shows that those who claim international human rights as Indigenous peoples performatively become identifiable subjects of international law – but further demonstrates that this does not, however, provide them with control over, or emancipation from, a state-based legal system. Maintaining that the discourse on Indigenous peoples and international law itself needs to be theoretically and critically re-appraised, this book problematises the subject-status of those who claim Indigenous peoples’ rights and the role of scholars, institutions, NGOs and others in producing that subject-status. Squarely addressing the limitations of international human rights law, it nevertheless goes on to provide a conceptual framework for rethinking the promise and power of Indigenous peoples’ rights…

To Consent, or Not to Consent, That Is the Question; Ethical Issues of Informed Consent for the Use of Donor Human Milk in the NICU Setting

To Consent, or Not to Consent, That Is the Question; Ethical Issues of Informed Consent for the Use of Donor Human Milk in the NICU Setting
Kelly McGlothen-Bell, Lisa Cleveland, Britt Frisk Pados
Advances in Neonatal Care, October 2019; 19 (5) pp 371–375
Abstract
Background
Evidence supports the superiority of mother’s own milk (MOM) in reducing the comorbidities common to prematurity and very low birth weight. In situations where an insufficient amount of MOM is available or maternal contraindications prevent its use, pasteurized donor human milk (DHM) is a viable substitution. When DHM is deemed best, a common practice in many neonatal intensive care units (NICUs) is for parents to provide their consent. However, no universal mandate for informed consent exists. Often, healthcare providers present and obtain the consent for DHM use prior to delivery or shortly after birth and this consent may be “bundled” along with other standardized NICU treatment consents. This approach is likely less than ideal since it provides insufficient time for decision making and often precedes the mother’s ability to initiate the expression of her own milk.
Purpose
To review the history of DHM use and the ethics surrounding the consenting process including the ethical principles involved in infant feeding decision making. We argue for the standardization and consistent use of informed consent for DHM in the NICU and offer clinical practice implications.
Findings/Results/Implications for Practice and Research
Providers face several challenges in the consenting process for the use of DHM in the NICU setting. These include limited time to support parents and educate them appropriately during the decision-making process. Standardized and consistent use of informed consent is essential to address the ethical concerns surrounding the use of DHM in the NICU setting.

Transplant candidates’ perceptions of informed consent for accepting deceased donor organs subjected to intervention research and for participating in post‐transplant research

Transplant candidates’ perceptions of informed consent for accepting deceased donor organs subjected to intervention research and for participating in post‐transplant research
Original Article
Elisa J. Gordon, Elizabeth Knopf, Caitlin Phillips, Adam Mussell, Jungwha Lee, Robert M. Veatch, Peter Abt, Sue Dunn, Peter P. Reese
American Journal of Transplantation, 24 September 2019
Abstract
Deceased donor organ intervention research holds promise for increasing the quantity and quality of organs for transplantation by minimizing organ injury and optimizing function. Such research will not progress until ethical, regulatory, and legal issues are resolved regarding whether and how to obtain informed consent from transplant candidates offered intervention organs given time constraints intrinsic to distribution. This multi‐center, mixed‐methods study involved semi‐structured interviews using open‐ and closed‐ended questions to assess wait‐listed candidates’ preferences for informed consent processes if offered an organ after undergoing intervention. Data were analyzed thematically. Sixty‐one candidates participated (47% participation rate). Most were male (57%), white (61%), with a mean age of 56 years. Most candidates (79%) desired being informed that the organ offered was an intervention organ before accepting it, and were likely to accept an intervention organ if organ quality was good (defined as donor age 30) (81%), but fewer candidates would accept an intervention organ if quality was moderate (i.e., donor age 50) (26%). Most perceived informed consent important for decision‐making, while others considered it unnecessary given medical necessity to accept an organ and trust in their physician. Our findings suggest that most candidates desire an informed consent process before accepting an intervention organ and post‐transplant data collection.

Informed consent guidelines for ionising radiation examinations: A Delphi study

Informed consent guidelines for ionising radiation examinations: A Delphi study
C. W. E. Younger, C. Douglas, H. Warren-Forward
Radiography, 16 September 2019
Abstract
Introduction
Informed consent for ionising radiation medical imaging examinations is currently undertaken inconsistently in Australian radiographic practice. There is no uniform informed consent process, and opinions vary about how it should be undertaken, and by whom, if indeed it needs to be undertaken at all. To ensure that patients’ rights are maintained, the informed consent process must be consistent, proactive in the provision of information, and must empower the patient to formulate and ask questions about their care, and to make voluntary decisions.
Methods
The Delphi technique utilises a group of experts whose individual responses are used to create a collective consensus on a process. This ten-expert (five radiographer, five radiologist) Delphi study examined a basic modelling of the process of informed consent for ionising radiation medical imaging examinations and made recommendations for an ideal process.
Results
A series of consensus statements were developed, seeking to rectify areas of the process that were inconsistent, unclear, or ethically unsound. These statements were then considered alongside current codes of professional practice, and Australian law on the duty of disclosure. A model of the ideal process was then developed using these consensus statements and adhering to codes of practice.
Conclusion
The final process model has a continuity of care and a continuity of information provision. The model eliminates the radiographer as a delegatee, and emphasises physician involvement. The referrer and the radiologist have a shared responsibility of providing risk disclosure information.
Implications for Practice
For a non-pregnant adult, the ionising radiation dose from conventional radiography is considered insignificant, and does not require risk disclosure, ameliorating the time commitment needed for the process.