A Defense of Limited Regulation of Human Genetic Therapies

2018 ◽  
Vol 28 (1) ◽  
pp. 112-120 ◽  
Author(s):  
JAMES J. HUGHES
Keyword(s):  
United States ◽  
Human Subjects ◽  
The United States ◽  
National Institutes Of Health ◽  
Regulatory Agencies ◽  
Cultural Norms ◽  
Regulatory Oversight ◽  
Reproductive Freedom ◽  
Gene Therapies ◽  
Genetic Technologies

Abstract:There is a role for regulatory oversight over new genetic technologies. Research must ensure the rights of human subjects, and all medical products and techniques should be ensured to be safe and effective. In the United States, these forms of regulation are largely the purview of the National Institutes of Health and the Food and Drug Administration. Some have argued, however, that human genetic therapies require new regulatory agencies empowered to enforce cultural norms, protect against hypothetical social harms, or ensure that the human genome remains unchanged. Focusing on the United States, this essay will briefly review these arguments and argue that the current limited regulatory role over human gene therapies is sufficient to protect public health, bodily autonomy, and reproductive freedom.

Towards a redefinition of the role of the court interpreter

Interpreting ◽  
1998 ◽  
Vol 3 (1) ◽  
pp. 21-45 ◽  
Author(s):  
Holly Mikkelson
Keyword(s):  
United States ◽  
Formal Education ◽  
The United States ◽  
Jury Trial ◽  
Cultural Norms ◽  
Anglo Saxon ◽  
New Approach ◽  
Distinctive Features ◽  
State Statutes

Various federal and state statutes in the United States define the role of the court interpreter with clear and unequivocal rules. This definition is based on the underlying principles of the U.S. legal system, which is derived from the Anglo-Saxon common-law tradition. Consequently, the distinctive features of that system, including the jury trial and the concept of adversarial proceedings, make the function of the court interpreter quite different from that of his/her counterparts in other countries. In recent years, the judiciary has made an effort to enhance the public's access to the justice system, but at the same time, the latest wave of immigration comprises individuals from societies in which cultural norms differ greatly from those of the United States. Moreover, many of these immigrants have received little or no formal education. As a result, judiciary interpreters feel somewhat constrained by the rules that govern their profession when they strive to bridge the cultural and linguistic gap. This paper reexamines the function of the court interpreter in light of these circumstances and an analysis of prevailing practices in other countries, and proposes a new approach to the interpreter's role.

scholarly journals Culturally Relevant Human Subjects Protection Training: A Case Study in Community-Engaged Research in the United States

2017 ◽  
Vol 20 (1) ◽  
pp. 107-114 ◽  
Author(s):  
Jennifer Kue ◽  
Laura A. Szalacha ◽  
Mary Beth Happ ◽  
Abigail L. Crisp ◽  
Usha Menon
Keyword(s):  
United States ◽  
Culturally Relevant ◽  
Human Subjects ◽  
The United States ◽  
Community Engaged Research

Savvy Surrogates and Rock Star Parents: Compensation Provisions, Contracting Practices, and the Value of Womb Work

2020 ◽  
Vol 45 (2) ◽  
pp. 398-431
Author(s):  
Hillary L. Berk
Keyword(s):  
United States ◽  
Content Analysis ◽  
Social Process ◽  
The United States ◽  
Symbolic Power ◽  
Cultural Norms ◽  
Structured Interviews ◽  
Selective Abortion ◽  
Medical Risks ◽  
Exchange Relations

Abstract:What is the value of surrogate labor and risks, and how is it negotiated by participants as they contract within an unsettled baby market? This article presents novel data on compensation, fee, and bodily autonomy provisions formalized in surrogacy contracts, and the experiences of actors embedded in exchange relations, as they emerge in a contested reproductive market. It combines content analysis of a sample of thirty surrogacy contracts with 115 semi-structured interviews conducted in twenty states across the United States of parties to these agreements, attorneys who draft them, counselors, and agencies that coordinate matches between intended parents and surrogates. It analyzes the value of services and medical risks, such as loss of a uterus, selective abortion, and “carrier incapacity,” as they are encoded into agreements within an ambiguous field. Surrogacy is presented as an interactive social process involving law, markets, medicine, and a variety of cultural norms surrounding gender, motherhood, and work. Contracts have actual and symbolic power, legitimating transactions despite moral anxieties. Compensation transforms pregnancy into a job while helping participants make sense of the market and their “womb work” given normative flux. Contracts are deployed by professionals without informed policies that could enhance power and reduce potential inequalities.

scholarly journals Nebulizer – In vitro Bioequivalence testing requirements: A review

1970 ◽  
Vol 8 (1) ◽  
pp. 78-81
Author(s):  
Shubham Prajapati ◽  
Sanjay Saha ◽  
B Shambulingappa ◽  
Dilip Kumar Ch. ◽  
Bikash Sahoo
Keyword(s):  
United States ◽  
Size Distribution ◽  
United States Of America ◽  
Droplet Size Distribution ◽  
The United States ◽  
Drug Substance ◽  
Regulatory Agencies ◽  
Metered Dose ◽  
Radiological Health

Generic Nebulized aerosol is often perceived as inferior to their branded counterparts; however, they are safe and effective if they can meet the regulatory requirements. International regulatory agencies have developed recommendations and guidance for bioequivalence approaches of orally inhaled drug products (OIDPs) for local action. The objective of this article is to discuss the approaches can be used for to show bioequivalence requirement for Food and Drug Administration (FDA) in the United States of America (USA) with reference product. This review endorsed that inhalation solutions and suspensions undertaken to determine the drug substance delivery rate, total drug substance delivered and Aerodynamic assessment of nebulized aerosols [aerodynamic particle size distribution (APSD)/droplet size distribution (DSD)].These are the most important parameters in characterization, evaluation and bioequivalence studies of nebulizers. These devices operate continuously; once loaded and require little or no co-ordination on the part of user they proved that these devices suitable for weak, pediatric or geriatric patients. The regulatory agencies declared that; there is no specific requirements testing in case of nebulizers like Metered dose inhalers (MDI) and Dry powder inhalers (DPIs). In United States of America (USA) regulation falls under the auspices of centre for devices and radiological health (CDRH), and new devices require 510(k) premarket notification. This review outlines all the bioequivalence test parameter.  

Research Ethics as Social Policy. Some Lessons from Experiences in Canada and in the United States

2003 ◽  
Vol 24 (2) ◽  
pp. 61-85
Author(s):  
Michael McDonald ◽  
Eric Meslin
Keyword(s):  
United States ◽  
Human Subjects ◽  
Ethics Committees ◽  
The United States ◽  
Prior Review ◽  
Emerging Trends ◽  
Policies And Procedures ◽  
Behavioural Research ◽  
Individual Informed Consent ◽  
Protection Of Human Subjects

For more than tlrree decades, Canada and the United States have used similar mechanisms for ensuring the protection of human subjects involved in biomedical and behavioural research: written guidelines that specify the substantive and procedural requirements of investigators and institutions; individual informed consent, and prior review and approval by interdisciplinary committees. Given the proximity of the countries to one another and the massive amount of trade and commerce that transpires between them, it is not surprising that these countries share a number of values in research. During the past fifteen years, however, both countries have experienced new challenges to their systems. Sorne of the challenges relate to new trends in research, such as genetics studies and massively increased private sector funding for pharmacological research. Other challenges relate to emerging trends in oversight policies and procedures, such as accreditation of ethics committees. Research reflects a country's particular social policies. The responses to emerging trends illustrate how such policies are evolving in sometimes quite different ways in both countries. This reflects the related but distinct political cultures and structures in the two countries. This paper will explore these trends and emerging responses, drawing lessons from each.

Sold—to the Highest Bidder in Japan: Operational Challenges and Culture

2015 ◽  
pp. 1-5
Author(s):  
Gerry Yemen ◽  
Kristin J. Behfar ◽  
Allison Elias
Keyword(s):  
United States ◽  
The United States ◽  
Japanese Firm ◽  
Cultural Norms ◽  
Exit Strategy ◽  
Cross Border ◽  
Start Up ◽  
Financial Benefits ◽  
Operational Issues ◽  
The U.S

Most talented executives can recognize when an acquisition has strategic or financial benefits, and in this case, the decision to be acquired was an appropriate exit strategy for a successful start-up. Peter Street’s start-up had been growing quickly and was building a reputation for reliability in a booming industry when a Japanese firm offered to pay a premium for the U.S. firm. Having done business in Japan (and extensively with the acquiring company) before the sale of his company, Street entered the acquisition with enthusiasm. As part of the deal, Street’s former company would continue to operate in the United States as a division of its parent company and Street would remain as CEO. A few months into the transition, however, Street discovered a huge difference between working with and working for the Japanese firm. Cultural norms for confronting seemingly small problems quickly became bigger operational issues, and Street experienced a growing dichotomy between corporate (in Japan) and his division (in the United States). This case focuses on the challenges of implementing a cross-border acquisition.

Safe until Sorry

2018 ◽  
Author(s):  
Norah MacKendrick
Keyword(s):  
United States ◽  
Precautionary Principle ◽  
Consumer Goods ◽  
Food Production ◽  
Personal Care Products ◽  
The United States ◽  
Policy Framework ◽  
Personal Care ◽  
Regulatory Oversight ◽  
Agriculture And Food

This chapter outlines the United States’ uneven and contradictory relationship with the precautionary principle as a policy ethic, and, more specifically points to how the safe-until-sorry model at the regulatory level helps to explain why precaution has flourished as an individualized, consumer principle. In outlining this relationship, it documents the serious gaps in regulatory oversight in what is a vast, fractured policy framework that oversees chemicals used in agriculture and food production, and in the manufacturing of cosmetics, personal care products and consumer goods.

International expansion of the Accrediting Council on Education in Journalism and Mass Communications (ACEJMC) curricular evaluation program

2020 ◽  
Vol 82 (8) ◽  
pp. 749-763
Author(s):  
Robin Blom ◽  
Brian J Bowe ◽  
Lucinda Davenport
Keyword(s):  
United States ◽  
Curriculum Evaluation ◽  
The United States ◽  
Cultural Imperialism ◽  
Cultural Norms ◽  
Journalism Education ◽  
Mass Communications ◽  
International Expansion ◽  
Curricular Evaluation ◽  
The U.S

Eight journalism educational programs outside the United States are certified by the U.S.-based Accrediting Council on Education in Journalism and Mass Communications. A survey of journalism undergraduate program directors in the United States indicated that many respondents see opportunities for expanding this voluntary curriculum evaluation and endorsement as a way of spreading U.S. values, in particular to countries lacking press freedoms. However, other respondents worry about the cultural imperialism of imposing U.S. cultural norms and practices on those in other countries. And, some directors questioned the ability to apply standards equitably across all programs, in countries with different political and cultural environments. The results indicated a lack of consensus and the need for a thorough discussion about Accrediting Council on Education in Journalism and Mass Communication’s role in promoting journalism education and practice around the globe and what forms that education should take.

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