Indigenous agency through normative contestation: Defining the scope of free, prior and informed consent in the Russian North [BOOK CHAPTER]
Marina Peeters Goloviznina
Indigenous Peoples, Natural Resources and Governance, 2021 [Routledge]
Abstract
This chapter explores how obshchiny, the most numerous grassroots Indigenous peoples’ organizations in contemporary Russia, deal with the challenge of exercising their right to free, prior and informed consent (FPIC). The study nuances our understanding of the agency of obshchiny, drawing much-needed attention to their practices of making a difference in the governance of extractive activities at the local level through FPIC. The analysis explores normative contestation practices of a family-based obshchina in the Sakha Republic (Yakutia), focusing on their members’ efforts to enhance their rights to FPIC in relations with a gold mining company. Despite the obshchina’s inferior position in asymmetrical power relations with the mining company, the study shows that assistance from the Ombudsman for Indigenous Peoples’ Rights can increase the obshchina’s chances of maximizing the benefits of negotiations with the company.
Month: December 2021
Can free, prior and informed consent support reconciliation between indigienous peoples and the state in multicultural societies [THESIS]
Can free, prior and informed consent support reconciliation between indigienous peoples and the state in multicultural societies [THESIS]
A Beales
City University of London Doctoral Thesis, 2021
Abstract
The United Nations Declaration on the Rights of Indigenous Peoples has been hailed as a ‘framework for reconciliation’ on which states and indigenous peoples can build harmonious relationships. However, during the negotiations of UNDRIP’s text, some argued that its impact would be constrained by the adoption of a cultural rights framework over an unambiguous recognition of the right to self-determination.
This thesis investigates the implementation of a key provision of UNDRIP: the requirement on states to consult with indigenous peoples in order to obtain their consent before approving measures or policies that would impact on indigenous rights, asking whether weak interpretations of indigenous self-determination under a multicultural model of rights are constraining the reconciliatory potential of prior consultation. It provides a theoretical analysis of prior consultation, drawing from indigenous critiques of human rights based multiculturalism and western theories of dispute resolution, and applying a decolonial theoretical framework. The theoretical analysis is grounded in case studies that illustrate how prior consultation is being implemented in Peru and Canada.
This thesis concludes that two different conceptualisations of FPIC have emerged: the ‘general rule’ approach, which is based on the right to self-determination and generally favoured by indigenous peoples; and the ‘multiculturalist approach’, which views FPIC as a facet of multicultural democracy. This latter approach is generally favoured by states, whose practice in this regard will shape the future development of FPIC as an international legal norm. However, this ‘multiculturalist approach’ is unlikely to lead to reconciliation because it constrains indigenous self-determination within a colonial imbalance of epistemic, political and economic power that overwhelmingly benefits the state.
In contrast, this thesis puts forward a dispute resolution approach which reimagines prior consultation as a duty to forge consensus. Such an approach, based on mutual respect and collaboration between peoples, may be more likely to contribute to reconciliation because it sidesteps commonly-held concerns that indigenous consent will be wielded as a unilateral right of veto, and recognises indigenous self-determination more fully. Viewing prior consultation through the lens of dispute resolution also suggests that mediation may offer a range of tools to counterbalance structural disadvantages that indigenous peoples face within the prior consultation process and encourage a more genuine intercultural dialogue.
Cross-Cultural and Religious Critiques of Informed Consent [BOOK]
Cross-Cultural and Religious Critiques of Informed Consent [BOOK]
Joseph Tham, Alberto García Gómez, Mirko Daniel Garasic
Routledge, 29 November 2021
Open Access
Summary
This book explores the challenges of informed consent in medical intervention and research ethics, considering the global reality of multiculturalism and religious diversity. Even though informed consent is a gold standard in research ethics, its theoretical foundation is based on the conception of individual subjects making autonomous decisions. There is a need to reconsider autonomy as relational—where family members, community and religious leaders can play an important part in the consent process. The volume re-evaluates informed consent in multicultural contexts and features perspectives from Buddhism, Confucianism, Hinduism, Christianity, Judaism and Islam. It is valuable reading for scholars interested in bioethics, healthcare ethics, research ethics, comparative religions, theology, human rights, law and sociology.
Exception from Informed Consent for Biomedical Research in Emergency Settings: A Study from Jordan
Exception from Informed Consent for Biomedical Research in Emergency Settings: A Study from Jordan
Samah F. Al-Shatnawi, Karem H. Alzoubi, Rawand A. Khasawneh, Omar F. Khabour, Basima A. Almomani
Heliyon, 23 November 2021
Open Access
Abstract
Background
Research conduction in emergency settings is of paramount importance to promote knowledge and experiences related to treating acutely ill patients. However, the complexity of situations creates a considerable ethical challenge facing researchers who basically deal with emergent cases. This study aimed to determine attitudes of healthcare providers (HCPs) towards exception from informed consent (EFIC) and enrollment willingness in emergency research in Jordan.
Methods
A quantitative research with face-to-face questionnaire was conducted by an interviewer during 6-month period in 2019. Survey measures included items related to EFIC policy and overall willingness of HCPs to participate or support their family members’ participation in emergency research.
Results
A total of 151 HCPs in the emergency departments (EDs) in Jordan was recruited. Positive attitude toward emergency research dominated among participants; about 21.9% of participants reported previous experience in the conduction of emergency research and 12.3% had related publications. Regarding EFIC policy, there was a general consensus of disagreement to most of the examined items. There was a trend to lower support of EFIC policy when questioned about the enrollment of family members or public in emergency research, however, the application of EFIC was accepted for self-enrollment of respondents in emergency research. No significant differences (P = 0.37), among participants from different disciplines, were reported regarding the attitudes towards EFIC items or willingness to enroll in emergency research.
Conclusions
Generally, HCPs reported an overall positive support to emergency research despite a consensus of disagreement related to EFIC terms. Therefore, it is recommended to pursue future studies to compare well informed subjects; recruited from well-developed institutions in regard to emergency research potentials; with the present basic attitudinal surveillance in order to dissipate the effect of such confounder and to get better insight of the actual attitudes related to emergency research and EFIC. In addition, efficient multidisciplinary communication channels between researchers and policy makers can lather the way to collaborative research with simultaneous innovative delivery of quality emergency care.
An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB
An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB
Ann R. Johnson, Lisa M. Rigtrup, John VanBuren, Erin Rothwell, J. Michael Dean
Ethics & Human Research, 9 November 2021
Abstract
In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site’s community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site-specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four-site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution’s human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site’s community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB.
Consent to minimally invasive tissue sampling procedures in children in Mozambique: A mixed-methods study
Consent to minimally invasive tissue sampling procedures in children in Mozambique: A mixed-methods study
Research Article
Khátia Munguambe, Maria Maixenchs, Rui Anselmo, John Blevins, Jaume Ordi, Inácio Mandomando, Robert F. Breiman, Quique Bassat, Clara Menéndez
PLoS One, 8 November 2021
Open Access
Abstract
Background
Minimally invasive tissue sampling (MITS), also named minimally invasive autopsy is a post-mortem method shown to be an acceptable proxy of the complete diagnostic autopsy. MITS improves the knowledge of causes of death (CoD) in resource-limited settings. Its implementation requires understanding the components of acceptability, including facilitators and barriers in real-case scenarios.
Methods
We undertook a mixed-methods analysis comparing anticipated (hypothetical scenario) and experienced (real-case scenario) acceptability of MITS among relatives of deceased children in Mozambique. Anticipated acceptability information was obtained from 15 interviews with relatives of deceased children. The interview focus was on whether and why they would allow the procedure on their dead child in a hypothetical scenario. Experienced acceptability data were obtained from outcomes of consent requested to relatives of 114 deceased children during MITS implementation, recorded through observations, clinical records abstraction and follow-up informal conversations with health care professionals and semi-structured interviews with relatives.
Results
Ninety-three percent of relatives indicated that they would hypothetically accept MITS on their deceased child. A key reason was knowing the CoD to take preventive actions; whereas the need to conform with the norm of immediate child burial, the secrecy of perinatal deaths, the decision-making complexity, the misalignment between MITS’ purpose and traditional values, lack of a credible reason to investigate CoD, and the impotency to resuscitate the deceased were identified as potential points of hesitancy for acceptance. The only refusing respondent linked MITS to a perception that sharing results would constitute a breach of confidentiality and the lack of value attached to CoD determination. Experienced acceptability revealed four different components: actual acceptance, health professionals’ hesitancy, relatives’ hesitancy and actual refusal, which resulted in 82% of approached relatives to agree with MITS and 79% of cases to undergo MITS. Barriers to acceptability included, among others, health professionals’ and facilities’ unpreparedness to perform MITS, the threat of not burying the child immediately, financial burden of delays, decision-making complexities and misalignment of MITS’ objectives with family values.
Conclusions
MITS showed high anticipated and experienced acceptability driven by the opportunity to prevent further deaths. Anticipated acceptability identified secrecy, confidentiality and complex decision-making processes as barriers, while experienced acceptability revealed family- and health facility-level logistics and practical aspects as barriers. Health-system and logistical impediments must also be considered before MITS implementation. Additionally, the multiple components of acceptability must be taken into account to make it more consistent and transferrable.
Perceptions of Singaporeans towards informed consent: a cross-sectional survey
Perceptions of Singaporeans towards informed consent: a cross-sectional survey
Mehek Gupta, Sudharsan Madhavan, Felicia Siok Ying Teo, Jee Keem Low, Vishal G Shelat
Singapore Medical Journal, 31 October 2021
Abstract
Introduction
In a patient-centric health system, it is essential to know patients’ views about informed consent. The objective of this study was to understand the perceptions of the local population regarding informed consent.
Methods
Spanning across six weeks from January 2016 to March 2016, a cross-sectional survey of adults attending General Surgery outpatient clinics at Tan Tock Seng Hospital was performed. Sociodemographic data, lifestyle and health-related information, perception and purpose of consent forms, and decision-making preferences were studied.
Results
445 adults participated in the survey. Most participants were below 40 years old (n = 265, 60.1%), female (n = 309, 70.1%) and degree holders (n = 196, 44.4%). 56.9% of participants wanted to know every possible risk, while 28.3% wanted to know common and serious risks. On multivariate analysis, age (age 61-74 years: odds ratio [OR] 11.1, 95% confidence interval [CI] 2.2-56.1, p = 0.004; age > 75 years: OR 22.2, 95% CI 1.8-279.1, p = 0.017) was a predictor of not wanting to know any risks. Age also predicted risk of disclosure for death (age 61-74 years: OR 13.4, 95% CI 4.2-42.6, p < 0.001; age > 75 years: OR 32.0, 95% CI 4.5-228.0, p = 0.001). Most participants (48.1%) preferred making shared decisions with doctors, and an important predictor was employment status (OR = 4.8, 95% CI 1.9-12.2, p = 0.001).
Conclusion
Sociodemographic factors and educational level influence decision-making, and therefore, the informed consent process should be tailored for each patient.
Compliance with the Informed Consent to Blood Transfusion: Constraints and Physic for the Developing Africa
Compliance with the Informed Consent to Blood Transfusion: Constraints and Physic for the Developing Africa
Joseph Aondowase Orkuma, George N. Ayia, Mernan Roselynda Ikwue, Joseph Ojobi, Gomerep Samuel Simji
Asian Journal of Medicine and Health, 9 July 2021; 19(7) pp 78-91
Abstract
The informed consent to blood transfusion is a patient centered care where the health care provider is ethically obliged and legally compelled to disclose the details, alternatives and consequences of a procedure such as blood donation or transfusion and obtain from the patient a prior consent before it is carried out. However, this newly evolving practice is largely constrained in many developing countries of Africa and this study sought to identify constraints and advance remedies. Literature search on PubMed, PubMed Central, Google Scholar, and African Journal on Line (AJOL) as well as print material literatures where applicable was used to retrieve 66 publications whose contents met the criteria for inclusion into the study. Constraints range from nondisclosure or defective disclosure, knowledge gaps of health care providers and non-comprehension of consent-based information by patients, illiteracy, religious and cultural practices, poor funding and administrative bottlenecks like non provision of consent forms or consent-based information materials as well as weak structures of effective oversight for compliance of health institutions by governmental regulating agencies. Physic like deployment of contentious professional development (CPD) activities for different professionals, focused training on consent-related guidelines, public awareness and education on prevailing social, religious and cultural impediments, research and localization of institution specific challenges. Additionally, proactive economic policies like the deployment of insurance indemnity covers for healthcare workers with negligent liabilities in order to dissuade health care providers from practicing defensive medicine which is inimical to quality health care delivery. There is a need for more researches on constraints prevalent in each developing country in Africa for a more appreciable advancement of the practice.
Editor’s note: We recognize some of the variable sentence structure in the abstract above.
The Urine Drug Screen in the Emergency Department: Overuse, Technical Pitfalls, and a Call for Informed Consent
The Urine Drug Screen in the Emergency Department: Overuse, Technical Pitfalls, and a Call for Informed Consent
Megan Yu, Charles Desmond Donohoe
International Journal of Health Systems and Translational Medicine, 2022
Abstract
Urine drug screens (UDSs) are often performed in the emergency department (ED) as part of a standard ED order set in patients with significant altered mental status, trauma, or seizures usually without the patient’s knowledge or specified informed consent. In the ED the UDS has been included in the standard consent to treatment for routine testing along with blood studies, EKG, urinalysis and radiology. Many technical factors are known to effect UDS results.There is a lack of education among physicians regarding the clinical pitfalls of UDS interpretation. This article discusses the current state and issues associated with the UDS, and presents three clinical vignettes that illustrate the impact of false-positive UDS results on patient care and the potential for a patient becoming unknowingly and unfairly stigmatized. The article also offers suggestions including a requirement for either formal informed consent or an “opt out” screening process, as recommended by the CDC in HIV testing, designed to protect patient autonomy and confidentiality.
Problems between the theory and practice of informed consent in Dentistry in South America
Problems between the theory and practice of informed consent in Dentistry in South America
Investigation Article
Paola Luciani Reynoso, Aldo Calzolari
Vital Dentistry, December 2021
Summary
Introduction
Ethical and legal aspects play a preponderant role in the dentist-patient relationship.
Aim
Analyze the relevant criteria necessary for informed consent in dentistry and evaluate its incorporation into models in use by professionals.
Methods
81 theoretical documents and informed consent models from South American countries were analyzed, extracted from the Internet, in a selection for convenience. The theoretical data were contrasted with the models applied in professional practice. After cleaning the 81 materials found to eliminate theoretical documents with very similar texts, 17 theoretical documents and 12 models of informed consent remained.
Results
The 17 documents coincide in pointing to 10 criteria as the most relevant. On the contrary, none of the 12 models contemplate these 10 criteria. Seven of the informed consent models contained 6 or fewer relevant criteria, while some only contemplated 4, those referring to basic patient identification data, treatment, and understanding of what they were signing.
Conclusion
There is a lack of relationship between the relevant theoretical criteria accepted as important for informed consent in Dentistry and the models in use by professionals.
Center for Informed Consent Integrity 