Hasil untuk "Public law"

Stephen Morse

Yale’s Environmental Performance Index (EPI) has emerged as the premier framework of national-scale metrics for global environmental policy analysis. Data and indicators from 180 countries gauge progress on 20+ environmental public health and ecosystem vitality goals. The framework offers a policy-relevant scorecard that highlights leaders and laggards in environmental performance, gives insight on best practices, and provides guidance for countries that aspire to be leaders in sustainability. The Yale Center for Environmental Law & Policy (YCELP) is looking for research assistants to contribute to the 2018 release of the next EPI report. For more information, visit epi.yale.edu.

Daniel Kaufmann, Aart C. Kraay, Massimo Mastruzzi

This paper reports on the 2009 update of the Worldwide Governance Indicators (WGI) research project, covering 212 countries and territories and measuring six dimensions of governance between 1996 and 2008: Voice and Accountability, Political Stability and Absence of Violence/Terrorism, Government Effectiveness, Regulatory Quality, Rule of Law, and Control of Corruption. These aggregate indicators are based on hundreds of specific and disaggregated individual variables measuring various dimensions of governance, taken from 35 data sources provided by 33 different organizations. The data reflect the views on governance of public sector, private sector and NGO experts, as well as thousands of citizen and firm survey respondents worldwide. The authors also explicitly report the margins of error accompanying each country estimate. These reflect the inherent difficulties in measuring governance using any kind of data. They find that even after taking margins of error into account, the WGI permit meaningful cross-country comparisons as well as monitoring progress over time. The aggregate indicators, together with the disaggregated underlying indicators, are available at www.govindicators.org.

P. Carter

Zsófia Zádor, Gergő Pintér, Máté Mizsák et al.

The 15-minute city is a powerful planning concept to counter car-dependence by promoting active mobility to amenities and fostering inclusive urban environments. However, this policy has challenges in amenity-poor urban peripheries. Public transport remains underexplored in this discourse despite its role in distant access. Here, we propose a framework that incorporates public transport into the 15-minute city model using openly available data. By comparing Helsinki, Madrid, and Budapest, we demonstrate that multimodal mobility substantially increases access to amenities and enhances socio-spatial integration within a 15-minute reach. Although urban periphery benefit significantly from radial or high-speed public transport lines in their social mixing potential, such lines alone do not improve their access to amenities. These findings underscore the need to optimize polycentric public transport networks that can improve inclusive urban accessibility and complement active mobility in polycentric cities.

Machiko Kanetake

The decentralized international legal order arguably creates structural incentives for states to utilize INTERPOL—an entity of virtually universal membership—to reduce gaps in transnational police cooperation. One of INTERPOL’s iconic actions is the release of a Red Notice. It is the publication of decentralized requests by a member country or approved international entities such as the International Criminal Court (ICC),1 asking police worldwide to locate and, if applicable domestic law and treaties permit, provisionally arrest wanted persons or restrict their movement, pending extradition or surrender.2 Although INTERPOL does not have legal authority to oblige members to arrest persons in question, a Red Notice regularly leads to border stops or arrest pending extradition, travel or visa denials, and knock-on effects such as banking and employment difficulties. The fragmented international legal order may have paradoxically generated structural incentives to support a level of centrality represented by INTERPOL.

Joshua Tan, Nicholas Vincent, Katherine Elkins et al.

Open source projects have made incredible progress in producing transparent and widely usable machine learning models and systems, but open source alone will face challenges in fully democratizing access to AI. Unlike software, AI models require substantial resources for activation -- compute, post-training, deployment, and oversight -- which only a few actors can currently provide. This paper argues that open source AI must be complemented by public AI: infrastructure and institutions that ensure models are accessible, sustainable, and governed in the public interest. To achieve the full promise of AI models as prosocial public goods, we need to build public infrastructure to power and deliver open source software and models.

Georgy Lukyanov, Samuel Safaryan

We study public persuasion when a sender communicates with a large audience that can fact-check at heterogeneous costs. The sender commits to a public information policy before the state is realized, but any verifiable claim she makes after observing the state must be truthful (an ex-post implementability constraint). Receivers observe the public message and then decide whether to verify; this selective verification feeds back into the sender's objective and turns the design problem into a constrained version of Bayesian persuasion. Our main result is a reverse comparative static: when fact-checking becomes cheaper in the population, the sender optimally supplies a strictly less informative public signal. Intuitively, cheaper verification makes bold claims invite scrutiny, so the sender coarsens information to dampen the incentive to verify. We also endogenize two ex-post instruments - continuous falsification and fixed-cost repression - and characterize threshold substitutions from persuasion to manipulation and, ultimately, to repression as monitoring improves. The framework provides testable predictions for how transparency, manipulation, and repression co-move with changes in verification technology.

Fanjun Bu, Alexandra Bremers, Mark Colley et al.

Human-robot interaction requires to be studied in the wild. In the summers of 2022 and 2023, we deployed two trash barrel service robots through the wizard-of-oz protocol in public spaces to study human-robot interactions in urban settings. We deployed the robots at two different public plazas in downtown Manhattan and Brooklyn for a collective of 20 hours of field time. To date, relatively few long-term human-robot interaction studies have been conducted in shared public spaces. To support researchers aiming to fill this gap, we would like to share some of our insights and learned lessons that would benefit both researchers and practitioners on how to deploy robots in public spaces. We share best practices and lessons learned with the HRI research community to encourage more in-the-wild research of robots in public spaces and call for the community to share their lessons learned to a GitHub repository.

Beth Goldberg, Diana Acosta-Navas, Michiel Bakker et al.

Two substantial technological advances have reshaped the public square in recent decades: first with the advent of the internet and second with the recent introduction of large language models (LLMs). LLMs offer opportunities for a paradigm shift towards more decentralized, participatory online spaces that can be used to facilitate deliberative dialogues at scale, but also create risks of exacerbating societal schisms. Here, we explore four applications of LLMs to improve digital public squares: collective dialogue systems, bridging systems, community moderation, and proof-of-humanity systems. Building on the input from over 70 civil society experts and technologists, we argue that LLMs both afford promising opportunities to shift the paradigm for conversations at scale and pose distinct risks for digital public squares. We lay out an agenda for future research and investments in AI that will strengthen digital public squares and safeguard against potential misuses of AI.

Kamila Ćwik, Tomasz Wołowiec, Artur Grzesiak et al.

On the surface, it would seem that the operation of a health resort commune does not differ from the majority of local authorities in Poland that do not have health resorts in their area and its activities can be subordinated to the market law of supply and demand. It would seem that it is the health resort gminas that are particularly privileged entities, endowed by nature with unique therapeutic raw materials, unique landscape, clean air and high forest cover, and being the proverbial apple of the sovereign's (the State's) eye, they have versatile development opportunities. A health resort municipality is a municipality whose area or part thereof has been granted the status of a health resort in accordance with the procedure set out in the Act on Health Resort Treatment, Health Resorts and Areas of Health Resort Protection and on Health Resort Municipalities of 28 July 2005. A health resort is an area where spa treatment is carried out, separated for the purpose of utilising and protecting the natural medicinal resources located in its area, which has been granted the status of a health resort. It follows from these definitions that a health resort is a limited area of the territory of a municipality, carrying out a specific activity such as spa treatment.

Anna Paluch

The purpose of the article is to answer the question, whether Article 934 of the Polish Civil Code outlines the subjective boundaries of statutory inheritance correctly and adequately to contemporary social realities, and whether there are reasons for limiting the degree of kinship between the deceased’s ascendants or their descendants and the deceased. The draft amendment of the Civil Code and certain other acts (Parliamentary Document no. 2977) became an impulse to take up this discussion. The draft is analysed within the scope of the proposed amendment to Article 934 of the Polish Civil Code. The analysis leads to the conclusion that the statutory inheritance of grandparents has been rightly introduced into the civil code, while the current wording of Article 934(2) of the Civil Code outlines the circle of persons called to statutory inheritance too broadly, without providing for any limitation of grandparents’ descendants in terms of the degree of kinship with the deceased. Such a solution means that persons completely alien to the deceased, but only formally related to them, may be appointed to inherit, which is not approval-worthy. For this reason, the proposed change of the Civil Code, providing for the inheritance of the descendants of grandparents up to the fourth degree of kinship with the deceased, should be considered justified.

Naohiro Takanashi, Masaaki Hiramatsu, Shio Kawagoe et al.

We report on the results of a survey we conducted on the Japanese public's attitudes toward astronomy. This survey was conducted via an online questionnaire, with 2,000 responses received. Based on this data, we present what kind of interest the general public in Japan has in astronomy. We also conducted a questionnaire survey of those involved in astronomy communication to examine how they differ from the general public. The results suggest that while there are clear differences between them in terms of their engagement in astronomy, there is also continuity between them by looking at their attributes in more detail. The data presented in this paper could help us to promote communicating astronomy to the public.

Revista Digital de Derecho Administrativo

أنجى فاروق أحمد مراد

هدف البحث إلى تحليل تأثير جائحة كورونا على كفاءة النشاط الاكتتابي للقطاعات التأمينية التشغيلية بشركات التأمين السعودية، ولتحقيق هذا الهدف تم الاعتماد على نموذج التأثيرات الثابتة كأحد نماذج البيانات المقطعية. وتوصلت النتائج إلى أن هناك تأثير معنوي متباين لجائحة كورونا على كفاءة النشاط الاكتتابي للقطاعات التشغيلية، تبعًا لاختلاف طبيعة كل قطاع. كما أن نموذج التأثيرات الثابتة قد نجح في تفسير 69.5% من التغير في معدلات كفاءة النشاط الاكتتابي للقطاعات التشغيلية مقارنة بنموذج الانحدار التجميعي كأحد نماذج البيانات المقطعية، والذي فسر 51.5% من التغير في معدلات كفاءة النشاط للقطاعات، بالإضافة إلى أن هناك علاقة طردية بين كفاءة النشاط الاكتتابي للقطاعات التشغيلية وكل من: (معدل الاحتفاظ ـ جائحة كورونا)، وعلاقة عكسية مع كلا من (معدل المصروفات ـ معدل النمو ـ معدل الخسارة). وبشكل عام فإن هناك اتجاه ايجابي للجائحة وكفاءة النشاط الاكتتابي لكل من قطاعات (الممتلكات والحوادث ـ الصحي ـ الحماية والادخارـ الهندسي) على الترتيب. بينما نجد أن التأثير السلبي للجائحة على كفاءة النشاط الاكتتابي ينعكس على قطاع تأمين المركبات.

Naomi Moy, Marcello Antonini, Mattias Kyhlstedt et al.

Abstract Background The initial policy response to the COVID-19 pandemic has differed widely across countries. Such variability in government interventions has made it difficult for policymakers and health research systems to compare what has happened and the effectiveness of interventions across nations. Timely information and analysis are crucial to addressing the lag between the pandemic and government responses to implement targeted interventions to alleviate the impact of the pandemic. Methods To examine the effect government interventions and technological responses have on epidemiological and economic outcomes, this policy paper proposes a conceptual framework that provides a qualitative taxonomy of government policy directives implemented in the immediate aftermath of a pandemic announcement and before vaccines are implementable. This framework assigns a gradient indicating the intensity and extent of the policy measures and applies the gradient to four countries that share similar institutional features but different COVID-19 experiences: Italy, New Zealand, the United Kingdom and the United States of America. Results Using the categorisation framework allows qualitative information to be presented, and more specifically the gradient can show the dynamic impact of policy interventions on specific outcomes. We have observed that the policy categorisation described here can be used by decision-makers to examine the impacts of major viral outbreaks such as SARS-CoV-2 on health and economic outcomes over time. The framework allows for a visualisation of the frequency and comparison of dominant policies and provides a conceptual tool to assess how dominant interventions (and innovations) affect different sets of health and non-health related outcomes during the response phase to the pandemic. Conclusions Policymakers and health researchers should converge toward an optimal set of policy interventions to minimize the costs of the pandemic (i.e., health and economic), and facilitate coordination across governance levels before effective vaccines are produced. The proposed framework provides a useful tool to direct health research system resources and build a policy benchmark for future viral outbreaks where vaccines are not readily available.

Mahdy Mortazavi, Hosein Mohammadidoost, Raziyeh Dashti

IntroductionGovernance refers to focusing on processes through which collective groups can be managed. In this regard, non-public institutional mechanisms such as civil society have been increasingly expanded in governance processes (Bozzini and Enjolras 2011; Rhodes, 1997). In other words, the administration of affairs in a framework of non-hierarchical, systematic, and collaborative relationships and interactions that includes the real cooperation and interaction of all actors and stakeholders in a field, including government, private and civil society institutions, is referred to as governance.Due to the excessive expansion of the public sector in Iran, the third sector has not been able to have a proper position in responding to the needs of citizens as it deserves (Research Center Parliament, 2008); on the other hand, the public sector itself has not had sufficient efficiency and effectiveness due to its numerous administrative and economic problems, large size and high costs (Danai Fard and Abbasi, 2007). The endowment system is no exception to this rule. Endowment is an institution through which a significant part of the problems and bottlenecks of society can be recognized and the property and assets of good people can be used voluntarily to solve them. But so far, the impact of endowments on the growth and development of the country's economy, reducing economic inequalities and using the endowment capacity in difficult economic conditions has not been tangible (Khaksar Astana et al., 2014). Therefore, the main goal of this research is to formulate the governance model of the Endowment system in Iran, and the research question is, what is the governance model of the Endowment system in Iran? Research MethodologyThis research has been conducted with a qualitative approach, qualitative content analysis was used to analyze the data, and structural-interpretive modeling was used to validate the components of the model. Philosophically, this research has an interpretive approach and is developmental in terms of orientation.In this research, we use qualitative content analysis with a thematic analysis unit (Sandelowski, 1995). In this regard, we have used the method of Braun and Clark (2006):Stage 1: Familiarizing yourself with your data "repeatedly reading the data" and actively reading the data (looking for meanings and patterns).Stage 2: Creating initial conceptual identifiers from the dataStage 3: Categorizing different identifiers in the form of selective identifiers and sorting the identified data summary.Stage 4: Reviewing the primary themes createdStage 6: Defining and naming sub-themesStage 6: Review, comparison, and participation of experts, and final analysis and report writing (Hajipour et al., 2015).The structural-interpretive modeling strategy is a suitable method for identifying and designing the model of complex relationships between the components of a phenomenon (Attri et al, 2013). This method was first proposed and introduced by Warfield (1974).The data collection tool in the qualitative section was semi-structured documents and interviews, and in this stage, 22 experts were selected using non-probability sampling and snowball methods. In the stage of structural-interpretive modeling, the number of samples was 14 experts. Also, to measure the reliability and validity of the research findings, it was indicated that the coefficient of Cohen's kappa is 0.7544, and since it is more than 0.7, it indicates the appropriate reliability of the findings. Research FindingsThe governance model of the endowment system with 3 main themes of strategic factors, infrastructural factors, and consequences and effects, as well as 11 sub-themes of data and information management, spatial oriented strategic plan, structure and model of the endowment administration, coherence and integration, rule of law, accountability, transparency, participation, independence, outcomes, and effects and 46 components were compiled, and the dimensions of the model were organized in four levels Discussion and ConclusionThe three key axes and bottlenecks of endowment governance are explained below:Management of data and information instead of the management of endowments:To implement the trustee-based governance of endowments, information on endowments and real and legal trustees (charities), including the intentions, geography, qualifications of trustees, and the like, should be collected in the territorial arena (Charities Regulator, 2018).The structure and model of endowment administration:In the trustee-centered governance model, each endowment is considered a self-sufficient unit with a legal personality, and a board of trustees, a trustee, and a supervisor can be considered for its management. Therefore, in contrast to state-oriented governance, which has a simple approach, in trustee-oriented governance, a complex, non-hierarchical approach based on the endowment is dominant.The spatial-oriented strategic plan:Having a program based on local requirements, needs and capacities can provide further development and progress. It is obvious that endowments also have specific and special intentions in the field of land in different regions, and the spatial-oriented strategic plan should be formulated and implemented in accordance with this issue, and each region and sometimes each endowment (large endowment) has its own special plan (Chew, 2009). References:Attri, R., Devi, N. & Sharma, V. (2013). Interpretive structural modeling (ISM) approach: An overview. Research Journal of Management Sciences, 2(2), 3-8.Bozzini, E. & Enjolras, B. (Eds.). (2011). Governing ambiguities. Baden-Baden: Nomos Verlag.Braun, V. & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-10.Charities Regulator. (2018(. Charities Governance Code, Dublin.Chew, C. (2009). Strategic Positioning in Voluntary and Charitable Organizations. Publishing RoutledgeDanai Fard, H. & Abbasi, T. (2007). Administrative reforms in Iran: An analysis of government downsizing. Daneshvar Raftar, 15(29), 102-121.Hajipour, B., Moutamani, A. & Tayyebi Abolhasani, A.H. (2015). The combination of success factors for the commercialization of advanced technology products. Innovation Management, 5(4), 54-19.Khaksar Astane, H., Rahnama, Ali. & Ibrahim, H. (2014). Pathology of the position of the endowment institution in strengthening the country's economy. The first knowledge-based conference on resistance economy.Research Center Parliament. (2008). Pathology of non-governmental organizations in Iran. Rhodes, R. (1997). Understanding governance: Policy networks, governance, reflexivity, and accountability. Buckingham, PA: Open University Press.Sandelowski, M. (1995). Sample size in qualitative research. Res Nurs Health, 18(2), 179- 83.Warfield, J.N. (1974). Developing interconnection matrices in structural modeling. IEEE Transactions on Systems, Man, and Cybernetic, 4(1), 81-87.

Ikechukwu P. Ugwu

The aim of the article is to examine the theories that underpin the ownership and management of oil rights in Nigeria and the need for a new ownership model. The economy of Nigeria is majorly supported by revenues from natural resources, especially crude oil. With the downturn in the country’s economy, the Nigerian Federal Government recently embarked on a series of crude oil discoveries to increase revenue despite the unresolved violations of human rights of the indigenous peoples and environmental abuses committed during oil exploration in the Niger Delta region of the country. The Nigerian government finds justification for this uncontrolled exploration of natural resources in the doctrine of discovery and the rule of capture. The author argues that basing the right of the Nigerian Federal Government to explore natural resources on the two doctrines has negative implications on the rights of indigenous peoples in Nigeria and environmental protection, and is a continuation of the philosophies behind colonialism. Therefore, the article examines the doctrine of discovery, the rule of capture, the colonial philosophies of property rights, and the legal regime regarding ownership of natural resources in Nigeria. It suggests a hybrid ownership model where ownership is shared between indigenous groups and the government.

Suzanne Mistretta

Photo by Amador Loureiro on Unsplash ABSTRACT As English is the predominant language of research protocols in the United States, non-English speaking subjects face language barriers during clinical trial enrollment. Federal regulation 45 C.F.R. 46 requires that a research subject receive information about a clinical trial “in language understandable to the subject or the legally authorized representative." A researcher may enroll a subject using short-form consent when a long-form translation in the subject’s native language is not available. However, the abbreviated short form does not adequately inform the subject of the study’s purpose and potential risks. United States Department of Health and Human Services (HHS) leaders should amend federal guidance to provide specific details on obtaining proper informed consent when there is a language barrier. The code of federal regulations should also establish a standard for quality translation services and interpreters. This paper will review current federal regulations and draft policy, analyze literature describing hospital experiences, and discuss non-compliance areas. This author recommends an amendment to federal policy, which is important because it helps ensure the rights of study participants under the principle of justice. INTRODUCTION As English is the predominant language of research protocols in the United States, non-English speaking subjects face language barriers during clinical trial enrollment. Law requires that a research subject should receive information about a clinical trial “inlanguage understandable to the subject or the legally authorized representative.”[1]This law states that a researcher may enroll a subject using a “short-form” consent when a “long-form” translation in the subject’s native language is not available.[2]However, the abbreviated short form does not adequately inform the subject of the study’s purpose and potential risks. Furthermore, the law does not outline a standard for quality translators. United States Department of Health and Human Services (HHS) leaders should amend federal guidance to provide specific details on obtaining proper informed consent when there is a language barrier.[3]The Code of Federal Regulations should also establish a standard for quality translation services and interpreters. This paper will review current federal regulations and draft policy, analyze literature describing hospital experiences, and discuss non-compliance areas. I. Draft Guidance In 1995, HHS issued a policy memo clarifying the informed consent process for individuals who do not speak English.[4]The policy states that the witness required for the signing of consent documents should be fluent in both languages and that the study team should issue a translated short form.[5]The guidance still does not require an official translator in the short-form process. However, if used, the translator may serve as witness as well.[6]The policy does not mention the translator’s language proficiency requirements or whether the institution must provide the translator.[7] In 2014, HHS issued draft guidance to expand upon the requirements for informed consent. Per its disclaimer, the guidance is non-binding and not intended for implementation.[8]First, the guidance attempts to clarify the phrase “language understandable”, by adding “the information presented to potential subjects is in a language, and at a level they can comprehend, including an explanation of scientific and medical terms.”[9]The draft guidance also notes that all potential research subjects needing translation might have a low level of health literacy and education. Suppose the research subjects expect a non-English speaking group of participants for enrollment. In that case, the guidance suggests that the researchers provide a long-form translation of study materials before an institutional review board (IRB) initial review of the “appropriately translated consent documents (i.e., either a long form or a short  form with written summary).”[10]To satisfy the guidance, researchers would need to provide multiple translations of the same document as the study progresses and the IRB proposes edits to the long-form English document. Because translating the informed consent forms is costly and time-consuming, having a long form available is not always feasible or practical. Foreseeing this problem, HHS outlined three steps for what to do when a subject’s language is not expected or planned for in the population. First, the guidance suggests that the investigator “determine that there is Sufficient Justification to Enroll the Subject Without Using a Translated Long-form to Document the Subject’s Informed Consent.”[11]Although this provision protects non-English-speaking subjects from uninformed consent, it adds a barrier to enrollment. The investigator must justify the registration of the individual based on the individual’s language. The justification process may delay enrollment, placing individuals at a disadvantage based on their language. If the researcher can adequately justify and use the short-form consent process, the investigator must then translate the long-form consent. After the subject starts participating in research, the investigator then provides the long-form translated document. II. Short Form and Noncompliance Vagueness in the federal regulations has caused disparate interpretation among institutions, leading to noncompliance.[12]Each institution has its own interpretation of 45 CFR 46, also known as the Common Rule, which protects vulnerable research subjects and provides research teams with a short-form template.[13]As noted above, the regulations do not require a translator, nor do they specify the translator’s specific role or qualifications.[14]HHS has not made it clear whether the witness may be a member of the study team or related to the patient, or whether the witness providing interpretation must be independent. Furthermore, it is not clear if the witness is overseeing merely the signing of the document or serving as a witness to the informed consent process.[15]In review of noncompliance areas, the institution should clarify the use of short-form consent, the witness’s role, and impose qualification requirements for translators.[16]Each institution will have its own resources and interpretations. Therefore, non-English speakers will find different translation quality across many research institutions. An individual may receive a different research experience and quality of language resources based on location and the degree to which their language was expected by the research team. This barrier is an implicit form of discrimination and violates the principle of justice. III. Equitable Selection of Subjects Minority populations are underrepresented in research due to a lack of cultural competence and language barriers to subject recruitment.[17]Paradoxically, minority populations are most impacted by many of the diseases for which there are clinical trials.[18]In 2015, researchers surveyed 10,000 studies registered on clinicaltrials.gov.[19]The authors found, “English fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010.”[20]Researchers who often exclude non-English speaking ethnic minorities claim that diversity may impact whether the studied intervention’s effect is noticed.[21]This manipulation of the subject population goes against the principle of justice outlined in the Belmont Report. Of 14,367 clinical research studies registered on clinicaltrials.gov between 2010 and 2020, 18.98 percent required subjects to be fluent in English.[22]Regulations and institutions do not compel researchers to include non-English speaking subjects; the researcher is not breaking any federal regulations by excluding them. From an ethical standpoint, the deliberate exclusion based on an inability to read/write in English is inequitable and unjust. In 2018, researchers reviewed enrollment rates and staff competency for subject enrollment.[23]Researchers found low levels of cultural competency among research staff and a misunderstanding of the federal regulations.[24]In 2005, researchers reviewed the importance of cultural competency training for healthcare providers.[25]Authors synthesized data based on 34 programs and found that competency programs improved provider “knowledge, attitudes, and skills, and patients’ ratings of care.”[26]However, cultural competency programs did not improve or impact patient compliance and health outcomes.[27]Authors requested more research to evaluate cultural training’s impact on researcher bias and attitudes toward subject inclusion.[28] IV. Institutional Barriers In 2018, researchers conducted a review of approximately 1,500 clinical trials at Boston Children’s Hospital and its Anesthesia Research Unit to identify enrollment barriers for non-English-speaking subjects.[29]The researchers discovered that the number of potential non-English speaking subjects increased, while the number of studies approved to enroll non-English speaking subjects did not grow at the same rate.[30]Of 1,492 studies that were open to enrollment between 2011 and 2016, 714 did not allow non-English speaking subjects.[31]The institution cited six barriers to enrollment that precluded these minority-language populations (Table 1).[32] The barriers described in Categories 1, 3, and 5 are due to a lack of translators, funding, or validated translated material. Categories 2, 4, and 6 may reflect an implicit bias on the institution’s part and suggest a lack of cultural understanding. Some researchers[33]called on the institution to increase cultural awareness and to provide resources to address the effects of the language barrier on enrollment.[34]However, with no set standard on the institutional level, it is up to the researchers to address this discrepancy and uphold the principle of justice. The uneven distribution of resources requires the research subjects to counteract their own language barrier. In many clinical cases, as time is of the essence, a person may need to seek several research options before participating in their desired study. Until each institution discloses its barriers and noncompliance, we have no way of knowing the full extent of this problem. V. Policy Recommendations The current HHS regulations and draft guidance are not sufficient to resolve implicit bias and logistical problems that arise when enrolling non-English speaking subjects. HHS should take the following actions. First, HHS should translate short-form consent forms for the most common languages in the US. HHS should then publish the translated documents for use as a template on its website for centers that lack adequate translation resources. Second, HHS should create a federal database of qualified translators who meet language proficiency benchmarks established by HHS. Individuals listed on this database should provide written translation of study materials and verbal translations during the consent process. The database should contain individuals affiliated and unaffiliated with an institution to track credentials and verify language proficiency. Third, HHS should create a federal fund for institutions to draw from when they need resources for long-form translations or translators. HHS should amend the Common Rule to add specificity. It should define the role of the witness in the short-form consent process to eliminate unequal interpretations across study sites. Second, it should mandate that the IRB obtain strong justification for the exclusion of subjects based on English-fluency criteria. Third, it should recommend cultural competency programs for investigators at the institutional level. VI. Limitations The proposed actions and policy may face objections from the federal government and industry. At the federal level, the government may not have the resources or funding needed to establish a nationwide registry of translators or quality check for fluency. HHS may need to develop a separate office to track these credentials and select a proficiency baseline. Perhaps an independent organization should be contracted by the government to perform these quality checks on a regional basis and call on the states to help fund the project. Also, the federal government may not have adequate resources to create a national fund for institutional-level translation services. One solution may be to include a flat rate of translation in the site budget during start-up activities. The government would be responsible for translations for government-sponsored research when the institution cannot feasibly provide a translation. Research centers can pull from the translator database for institutional studies if they cannot translate in-house. For pharmaceutical corporation-led protocols, industry sponsors may not appreciate the added cost of translation. However, by mandating the fee, the government would eliminate systemic discrimination based on English fluency. VII. Support Researchers should show support for more specific guidance on the institutional level, granted they receive adequate resources to meet the regulations. By clarifying the use of a translator and the role of a witness, and establishing common resources, every institution will benefit. Furthermore, it is crucial to hold institutions accountable for supporting cultural competency initiatives. These programs do not need to be intensive or expensive; there are many resources available to the public on websites such as YouTube. Institutions should make cultural competency programming a mandatory requirement for staff training during the orientation and continuing education. Encouraging cultural competency programs will improve provider attitudes and subject treatment. CONCLUSION Federal regulations do not require the use of resources when enrolling a subject who is non-English speaking, nor do they mandate the inclusion of “unexpected” populations based on language. Lack of clarity and specificity on the federal level places the onus of responsibility on the institution to mitigate language barriers. The lack of universal policy leads to an unequal research experience among institutions and locations. Furthermore, clinical trial sponsors may manipulate data based on limiting the study population and engaging in studies that overly represent homogeneous populations. Influencing the study population will skew results and will not lead to generalizable knowledge. To uphold the principle of justice, the research community must gather its resources to support non-English speaking subjects who wish to participate in research. [1]“45 C.F.R. 46 FAQs,” 45 C.F.R. §46.116 (a)(3), Office for Human Research Protections, last modified 2018, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/45-cfr-46/index.html#:~:text=Basic%20regulations%20governing%20the%20protection,were%20first%20published%20in%201974. [2]Office for Human Research Protections, “45 C.F.R. 46 FAQs.” [3]“Protection of Human Subjects, 45 C.F.R.§ 46,” United States Department of Health and Human Services, last modified 2018, https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML. [4]Office for Human Research Protections, 45 C.F.R. §46.117(b)(2), “45 C.F.R. 46 FAQs.”  [5]The researcher can orally present the information to the subject or LAR, with a witness present, and provide a short-form of consent with a brief written summary of the research. [6]“Informed Consent of Subjects Who Do Not Speak English,” Office for Human Research Protections, last modified February 25, 2016, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/obtaining-and-documenting-infomed-consent-non-english-speakers/index.html. [7]Lad, Pramod M., and Rebecca Dahl. "Overcoming Language Barriers in the Informed Consent Process: Regulatory and Compliance Issues With the use of the ‘Short Form.’” Accountability in Research 21, no. 5 (2014): 315-320. https://doi.org/10.1080/08989621.2013.848801. [8]“Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors Draft Guidance,” Office of the Commissioner, last modified 2014, https://www.fda.gov/media/88915/download. [9]Office of the Commissioner, “Informed Consent Information Sheet Guidance.” [10]Office of the Commissioner, “Informed Consent Information Sheet Guidance.” [11]Office of the Commissioner, “Informed Consent Information Sheet Guidance.” [12]Lad and Dahl, “Regulatory and Compliance Issues.” [13]Lad and Dahl, “Regulatory and Compliance Issues.” [14]Lad and Dahl, “Regulatory and Compliance Issues.” [15]Lad and Dahl, “Regulatory and Compliance Issues.” [16]Lad and Dahl, “Regulatory and Compliance Issues.” [17]Staples, Jeanine N. et al., "Language as a Barrier to Cancer Clinical Trial Accrual: Assessing Consenting Team Knowledge and Practices for Cancer Clinical Trial Consent Among Low English Fluency Patients." Applied Cancer Research 38, no. 1 (2018): 1-7.https://doi.org/10.1186/s41241-018-0065-9. [18]Staples et al., “Language as a Barrier.” [19]Egleston, Brian L. et al., "Characteristics of Clinical Trials That Require Participants to be Fluent in English." Clinical Trials 12, no. 6 (2015): 618-626.https://doi.org/10.1177/1740774515592881. [20]Egleston et al., “Characteristics of Clinical Trials.” [21]Egleston et al., “Characteristics of Clinical Trials.” [22]Muthukumar AV, Morrell W, Bierer BE (2021) Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov. PLoS Med 18(9): e1003758. https://doi.org/10.1371/journal.pmed.1003758 https://doi.org/10.1080/08989620600654043. [23]Staples et al., “Language as a Barrier.” [24]Staples et al., “Language as a Barrier.” [25]Beach, Mary Catherine et al., "Cultural Competency: A Systematic Review of Health Care Provider Educational Interventions." Medical Care 43, no. 4 (2005): 356. https://doi.org/10.1097/01.mlr.0000156861.58905.96. [26]Beach et al., “Cultural Competence,” 8. [27]Beach et al., “Cultural Competence,” 8. [28]Beach et al., “Cultural Competence,” 8. [29]Bernier, Rachel et al., "Inclusion of Non‐English‐Speaking Patients in Research: A Single Institution Experience." Pediatric Anesthesia 28, no. 5 (2018): 415-420. https://doi.org/10.1111/pan.13363. [30]Bernier et al., “Inclusion of Non-English-Speaking Patients.” [31]Bernier et al., “Inclusion of Non-English-Speaking Patients.” [32]Bernier et al., “Inclusion of Non-English-Speaking Patients.” [33]Lad and Dahl, “Regulatory and Compliance Issues.” [34]Bernier et al., “Inclusion of Non-English-Speaking Patients.”

Indah Kencanawati, Lia Angela

This study aims to reconstruct the community's original knowledge in the process of making potato dodol into scientific knowledge according to the halal criteria of a product determined by the halal product guarantee system. The research method used is descriptive qualitative based on ethnoscience with the scope of examination including document analysis, interviews and documentation. Data collection is done directly to respondents (business actors) by purposive sampling. The data obtained were analyzed according to the criteria for the halal product assurance system which includes: commitment and responsibility, materials, halal product processes, products and monitoring and evaluation. Data analysis is carried out with traceability according to the halal document of a product. The results showed that the process of making potato dodol according to community knowledge  can be transformed into scientific knowledge was acquired and developed from generation to generation. The stage of start from preparing ingredients, boiling, milling, mixing the dought with other ingredients, kneading, printing and cutting, drying, packaging and labeling. It can be concluded that the procedure for making potato dodol  developed through generations is comply with Islamic law, star from use of tools, production facilities, packaging systems, storage, distribution that are free of non-halal materials which meet standards and can be consumed by the public.

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