scholarly journals Integrating Public Participation, Transparency and Accountability Into Governance of Marketing Authorisation for Genome Editing Products

2021 ◽  
Vol 3 ◽  
Author(s):  
Jane Nielsen ◽  
Lisa Eckstein ◽  
Dianne Nicol ◽  
Cameron Stewart
Keyword(s):  
Gene Therapy ◽  
Public Participation ◽  
Genome Editing ◽  
Policy Development ◽  
Good Governance ◽  
Social Issues ◽  
Marketing Approval ◽  
Regulatory Pathways ◽  
Health Technologies ◽  
Transparency And Accountability

Public participation, transparency and accountability are three of the pillars of good governance. These pillars become particularly important for innovative, personalised health technologies, because of the tendency of these technologies to raise distinct scientific, ethical, legal and social issues. Genome editing is perhaps the most personal of all innovative health technologies, involving precise modifications to an individual’s genome. This article focuses on the adequacy of current requirements for public participation, transparency and accountability in the governance of the market authorisation for genome edited products. Although clinical trials for genome edited products are only just underway, lessons can be drawn from the marketing approvals pathways for related gene therapy products. This article provides a broad overview of the regulatory pathways that have been adopted by the US Food and Drugs Administration, the European Medicines Authority, and the Australian Therapeutic Goods Administration for reviewing gene therapy products for marketing approval. This analysis focuses on the extent to which public participation processes and transparency and accountability of review pathways are incorporated into marketing approval policy and practice. Following this review, the article proposes the application of Sheila Jasanoff’s “technologies of humility” as a foundation for meaningfully incorporating these pillars of good governance into regulatory processes for the review of products of genome editing. We conclude by articulating clear mechanisms for operationalising technologies of humility in the context of public participation, transparency and accountability, providing a blueprint for future policy development.

E-musrenbang: a digital framework for local participatory planning at the community level

2020 ◽  
Vol ahead-of-print (0) ◽  
pp. 1-26
Author(s):  
Dhimas Bayu Anindito ◽  
Saut A. H. Sagala ◽  
Ari Krisna Mawira Tarigan
Keyword(s):  
Public Participation ◽  
City Planning ◽  
Planning Process ◽  
Good Governance ◽  
Participatory Planning ◽  
Community Level ◽  
Digital Version ◽  
Digital Engagement ◽  
Transparency And Accountability

It has been a longstanding mission of policymakers, good governance activists and scholars to encourage greater public participation in formulating legal drafts for better city planning. In recent years, emphasis has been placed upon digital engagement as a process which arguably allows more citizens to voice their needs and desires. In Indonesia, an example of such practices can be seen in the e-musrenbang platform, a digital version of a local public participation mechanism in city planning. This study highlights the case of Bandung City of Indonesia by shedding light on the implemented mechanism of e-musrenbang and the stakeholders involved as well as perceptions from its participants. The findings suggest that e-musrenbang has enhanced the transparency and accountability of the overall planning process, however, it has failed to deliver on promises to channel the voices of citizens and solve existing issues of participation.

scholarly journals TRANSPARANSI ANGGARAN PENDAPATAN DAN BELANJA DAERAH (APBD) MELALUI PENERAPAN E-BUDGETING (Dalam Perspektif Teori Good Governance)

2015 ◽  
Vol 1 (1) ◽  
pp. 72-88
Author(s):  
Hendra Wijayanto
Keyword(s):  
Public Participation ◽  
Public Service ◽  
Management System ◽  
Good Governance ◽  
Government Program ◽  
Finance Management ◽  
District Government ◽  
Bureaucratic Reform ◽  
Transparency And Accountability

Penerapan reformasi birokrasi di bidang anggaran manajemen dianggap tidak memiliki sistem terstruktur. Dalam pemerintah daerah, hal ini ditandai dengan transparansi yang rendah dan akuntabilitas dalam sistem penganggaran lokal. Sistem manajemen keuangan yang mana masih kontradiktif dengan tujuan pemerintahan yang baik membutuhkan transparansi dan akuntabilitas dalam semua bidang pemerintahan. Munculnya e-budgeting secara tidak langsung menjadi bukti pemanfaatan program e-government di Indonesia. Trasnparansi dan partisipasi masyarakat diharapkan mendukung pemerintah untuk melakukan perbaikan dalam kualitas pelayanan publik.Kata Kunci : Reformasi Birokrasi, Good Governance, E-Budgeting, Good GovernanceThe application of bureaucracy reform in the field of management budget is considered not to having structurized systems. In a district government, it is characterized by low transparency and accountability in Local Budgeting system. Finance management system however still is contradictive with the objective of good governance that requires transparency and accountability in all areas of government. The emergence of e-budgeting indirectly becomes a proof of the utilization of e-government program in Indonesia. Transparency and public participation is expected to support government to make improvements in public service quality.Keywords : Bureaucratic Reform, Good Governance, E-Budgeting, Good Governance

Comparing The Principalship of Madrasah and Sekolah in The Decentralization Era

2016 ◽  
Vol 1 ◽  
pp. 24-35
Author(s):  
Saefudin A Safi'i
Keyword(s):  
Public Sector ◽  
School Leadership ◽  
Policy Development ◽  
Central Government ◽  
Good Governance ◽  
Ground Level ◽  
New Order ◽  
The Public ◽  
Centralized Management ◽  
Decentralization Policy

The downfall of the New Order Regime in 1998 brought about significant change to Indonesia’s public sector.  Law number 22 of 1999, further refined by Law 32 of 2004, provide legal bases for district governments to administer the public sector. The central government also introduces the notion of good governance through the promulgation of various regulations. For Madrasah however, decentralization policy failed to provide clear legal bases as to how it relates to district government. Law 32 of 2004 verse 10 article 3 retains the centralized management by the Ministry of Religious Affairs. This however does not exclude Madrasah from public demand of implementing the principle of good governance. This study analyses the dynamics of principal-ship both in the Sekolah and the Madrasah in the era of decentralization. By comparing two research sites, this study sought to create better understanding about the context by which the organization climate of two different schools are shaped, and how principals and teachers perceives the notion of school leadership in the light of most recent policy development. To do this, interviews were undertaken and questionnaire-based data collection was also conducted. The study found that in the ground level implementation of decentralization policy, Sekolah developed more rigorous leadership compared to that in the Madrasah. This research recommends the adoption of stronger regulation regarding principal-ship of Madrasahs in order to create an environment that is more in tune with the spirit of public service reforms.

scholarly journals Progress in Gene Therapy to Prevent Retinal Ganglion Cell Loss in Glaucoma and Leber’s Hereditary Optic Neuropathy

2018 ◽  
Vol 2018 ◽  
pp. 1-11 ◽  
Author(s):  
Sara E. Ratican ◽  
Andrew Osborne ◽  
Keith R. Martin
Keyword(s):  
Gene Therapy ◽  
Clinical Trials ◽  
Optic Nerve ◽  
Genome Editing ◽  
Optic Neuropathy ◽  
Single Gene ◽  
Leber’S Hereditary Optic Neuropathy ◽  
Leber's Hereditary Optic Neuropathy ◽  
Potential Use ◽  
Hereditary Optic Neuropathy

The eye is at the forefront of the application of gene therapy techniques to medicine. In the United States, a gene therapy treatment for Leber’s congenital amaurosis, a rare inherited retinal disease, recently became the first gene therapy to be approved by the FDA for the treatment of disease caused by mutations in a specific gene. Phase III clinical trials of gene therapy for other single-gene defect diseases of the retina and optic nerve are also currently underway. However, for optic nerve diseases not caused by single-gene defects, gene therapy strategies are likely to focus on slowing or preventing neuronal death through the expression of neuroprotective agents. In addition to these strategies, there has also been recent interest in the potential use of precise genome editing techniques to treat ocular disease. This review focuses on recent developments in gene therapy techniques for the treatment of glaucoma and Leber’s hereditary optic neuropathy (LHON). We discuss recent successes in clinical trials for the treatment of LHON using gene supplementation therapy, promising neuroprotective strategies that have been employed in animal models of glaucoma and the potential use of genome editing techniques in treating optic nerve disease.

scholarly journals The Role of Public Participation in Governance towards Achieving Sustainable Development. Part 1

2021 ◽  
Vol 8 (4) ◽  
pp. 395-404
Author(s):  
Maurice S. Nyarangaa ◽  
Chen Hao ◽  
Duncan O. Hongo
Keyword(s):  
Decision Making ◽  
Sustainable Development ◽  
Public Participation ◽  
Good Governance ◽  
Policy Formulation ◽  
Government Officials ◽  
Political Class ◽  
The Public ◽  
Decision Making Processes ◽  
The Government

Public participation aimed at improving the effectiveness of governance by involving citizens in governance policy formulation and decision-making processes. It was designed to promote transparency, accountability and effectiveness of any modern government. Although Kenya has legally adopted public participation in day-to-day government activities, challenges still cripple its effectiveness as documented by several scholars. Instead of reducing conflicts between the government and the public, it has heightened witnessing so many petitions of government missing on priorities in terms of development and government policies. Results show that participation weakly relates with governance hence frictions sustainable development. Theoretically, public participation influences governance efficiency and development, directly and indirectly, thus sustainable development policy and implementation depends on Public participation and good governance. However, an effective public participation in governance is has been fractioned by the government. Instead of being a promoter/sponsor of public participation, the government of Kenya has failed to put structures that would spur participation of citizens in policy making and other days to activities. This has brought about wrong priority setting and misappropriation of public resources; The government officials and political class interference ultimately limit public opinion and input effects on decision-making and policy formulation, which might be an inner factor determining the failure of public participation in Kenya. The study suggests the need for strengthening public participation by establishing an independent institution to preside over public participation processes.

scholarly journals Genome Editing Strategies to Treat Beta-Hemoglobinopathies

Blood ◽  
2017 ◽  
Vol 130 (Suppl_1) ◽  
pp. SCI-16-SCI-16
Author(s):  
Mitchell J Weiss
Keyword(s):  
Gene Therapy ◽  
Genome Editing ◽  
Conflicts Of Interest ◽  
Gene Mutations ◽  
Fetal Hemoglobin ◽  
Beta Thalassemia ◽  
Great Promise ◽  
Globin Genes ◽  
Hematopoietic Stem ◽  
Medical Therapies

Genetic forms of anemia caused by HBB gene mutations that impair beta globin production are extremely common worldwide. The resultant disorders, mainly sickle cell disease (SCD) and beta-thalassemia, cause substantial morbidity and early mortality. Treatments for these diseases include medical therapies and bone marrow transplantation (BMT), which can be curative. However, medical therapies are suboptimal and BMT is associated with serious toxicities, particularly because HLA-matched allogeneic sibling donors are not available for most patients. Thus, new therapies are urgently needed for millions of affected individuals. Gene therapy offers great promise to cure SCD and beta thalassemia and emerging genome editing technologies represent a new form of gene therapy. Approaches to cure SCD and beta-thalassemia via genome editing include: 1) Correction of HBB mutations by homology directed repair (HDR); 2) use of non-homologous end joining (NHEJ) to activate gamma globin production and raise fetal hemoglobin (HbF) levels; 3) NHEJ to disrupt alpha-globin genes (HBA1 or HBA2) and thereby alleviate globin chain imbalance in intermediately severe forms of beta thalassemia. Challenges for these approaches include selection of the most effective genome editing tools, optimizing their delivery to hematopoietic stem cells (HSCs), improving specificity and better understanding potential off target effects, particularly those that are biologically relevant. Technologies for genome editing are advancing rapidly and being tested in preclinical models for HBB-mutated disorders. Ultimately, however, the best strategies can only be identified in clinical trials. This will require close collaborations between basic/translational researchers who study genome editing, clinical hematologists and collaboration between experts in academia and the bio-pharmaceutical industry. Disclosures No relevant conflicts of interest to declare.

scholarly journals PENGELOLAAN DANA DESA BERDASARKAN PERATURAN MENTERI DALAM NEGERI NOMOR 113 TAHUN 2014 (STUDI KASUS PADA NAGORI KAHEAN KECAMATAN DOLOK BATU NANGGAR KABUPATEN SIMALUNGUN

2019 ◽  
Vol 7 (1) ◽  
pp. 79-91
Author(s):  
Helwin Effendi ◽  
Jubi Jubi ◽  
Elly Susanti ◽  
Musa Fernando Silaen
Keyword(s):  
Community Participation ◽  
Sense Of Community ◽  
Good Governance ◽  
Fund Management ◽  
Management Planning ◽  
Village Governance ◽  
Village Government ◽  
The Village ◽  
Transparency And Accountability

The results of this research can be concluaded that: 1. Lack of community participation to participate in village fund management planning, this is due to the lack of motivation of the community to participate in the deliberations. Then there was a delay in submitting a draft village regulation that had been agreed to be evaluated. 2. In the implementation, administration, reporting and accountability of village fund management in accordance with PERMENDAGRI Number 113 of 2014, it shows that the principles of participation in management, orderly and disciplined principles, principles of transparency and accountability principles have been carried out properly.The suggestion from this research is that the village government should develop a participatory concept and foster a sense of community motivation by providing education seminars on managing village funds and leading to the implementation of village governance. Then the village government should pay more attention to the applicable regulations in managing village finances in order to realize Good Governance.

Recent progress in genome editing for gene therapy applications: the French perspective

2021 ◽  
Author(s):  
Mario Amendola ◽  
Aurélie Bedel ◽  
Ana Buj Bello ◽  
Mathieu Carrara ◽  
Jean-paul Concordet ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Genome Editing ◽  
Recent Progress

Cluster Analysis

2014 ◽  
pp. 123-159
Author(s):  
Pankaj Nagar
Keyword(s):  
Cluster Analysis ◽  
Policy Development ◽  
Good Governance ◽  
Unsupervised Classification ◽  
Business Organizations ◽  
Statistical Tools ◽  
Managerial Decisions ◽  
Wide Range ◽  
Spss Software ◽  
Societal Problems

The cluster analysis, also known as grouping, clumping, unsupervised classification, is one of the multivariate analysis techniques. The technique of cluster analysis is highly useful in a wide range of problems related to managerial decisions, psychological solutions, categorization of business organizations on the basis of their performance for constructing separate policies for each clusters, in health sectors, societal problems, etc. For good governance there is a need to apply the proper statistical tools with ICT. Even today, the statistical tools are rarely used in the region of e-governance for better policy development. This chapter discusses the use of cluster analysis in classifying a large amount of data into sub-groups (known as clusters), which are homogeneous in a certain sense, and analyzes each sub-group separately to find solutions for each of them. The method in explained with the help of an illustration, by using the SPSS software.

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