scholarly journals Tangible and intangible costs of "protecting human subjects": The impact of the National Research Act of 1974 onuniversity research activities

2004 ◽  
Vol 12 ◽  
pp. 65 ◽  
Author(s):  
Frederic Jacobs ◽  
Arina Zonnenberg
Keyword(s):  
Behavioral Treatment ◽  
Human Subjects ◽  
Financial Burden ◽  
The United States ◽  
Research Activities ◽  
Policies And Procedures ◽  
The Social ◽  
Research Oversight ◽  
Protection Of Human Subjects ◽  
The Impact

This article (1) examines the overall structure of regulatory research oversight in the United States; (2) details the origins and evolution of federal legislation pertaining to the protection of human subjects in biomedical and behavioral treatment and research; and (3) describes the expansion of oversight regulation from biomedical and behavioral treatment areas to the social sciences. In addition, the paper describes three areas identified by compliance administrators as susceptible to abuse: (1) informed consent, (2) assessment of risks and benefits, and (3) equitable selection of human subjects. There is a discussion of existing tensions in the implementation of oversight policies and procedures. Finally, the paper identifies four issues for future consideration: (1) scope of the mandate regarding protection of human subjects, (2) impact on the nature of research being undertaken, (3) financial burden of compliance and oversight activities, and (4) ethical standards, constraints, and potential.

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.

RAC Oversight of Gene Transfer Research: A Model Worth Extending?

2002 ◽  
Vol 30 (3) ◽  
pp. 381-389 ◽  
Author(s):  
Nancy M. P. King
Keyword(s):  
Gene Transfer ◽  
Recombinant Dna ◽  
Human Subjects ◽  
The United States ◽  
Layered System ◽  
Institutional Review ◽  
Research Oversight ◽  
Significant Addition ◽  
Protection Of Human Subjects ◽  
Oversight System

Clinical gene transfer research (GTR) has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee (RAC). This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board (IRB) whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration (FDA).

Alcohol Problem Prevention: A “Common Sense” Approach

1987 ◽  
Vol 17 (4) ◽  
pp. 369-393
Author(s):  
Selden D. Bacon
Keyword(s):  
Common Sense ◽  
Direct Methods ◽  
The United States ◽  
Alcohol Problems ◽  
The Social ◽  
The Common ◽  
Definition Of ◽  
The Impact ◽  
Alcohol Related Problems ◽  
Social Science Approach

In view of the low likelihood of the acceptance of the social science approach to alcohol problems proposed several years ago, a “common sense” approach is suggested as an alternative. Several assumptions guide this proposal, the principal one being the absence of any significant progress in the reduction of alcohol problems in the United States over the past 200 years. By the development of a common vocabulary and direct methods of observation and data collection, the “common sense” approach would provide for identifying the strengths of the multitude of past and current efforts in dealing with alcohol problems in terms of both intervention and prevention. The guiding criterion in such an approach would be the impact on alcoholism and alcohol-related problems, the definition of which would be a major task of the research.

Impacts of Liberation Pedagogy: The Case of Workers' Education

1983 ◽  
Vol 165 (1) ◽  
pp. 113-129 ◽  
Author(s):  
David Hakken
Keyword(s):  
United States ◽  
Paulo Freire ◽  
The United States ◽  
Antonio Gramsci ◽  
Social Psychological ◽  
Education Programs ◽  
Worker Education ◽  
The Social ◽  
Liberation Pedagogy ◽  
The Impact

Some perspectives with which to evaluate the impact of the pedagogy of liberation on worker education programs in England and the United States are suggested. The pedagogy of liberation is often associated with the work of Paulo Freire and occasionally with that of the Italian Marxist, Antonio Gramsci. After some initial discussion of the nature of liberation pedagogy, the problems involved in assessing its effectiveness, are discussed in reference to specific worker education programs in England and the United States. The analysis of workers' education involves discussion of the pedagogy which informs particular programs and the social psychological dilemmas which often face the worker/students involved in workers' education. The article concludes with a discussion of the implications of the research on workers' education for liberation pedagogy.

scholarly journals Barriers to symptom management care pathway implementation in pediatric Cancer

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
L. Lee Dupuis ◽  
Allison Grimes ◽  
Emily Vettese ◽  
Lisa M. Klesges ◽  
Lillian Sung
Keyword(s):  
Clinical Research ◽  
Pediatric Oncology ◽  
Pediatric Cancer ◽  
Symptom Management ◽  
Care Pathway ◽  
The United States ◽  
Care Pathways ◽  
Research Activities ◽  
Pediatric Cancer Patients ◽  
The Impact

Abstract Background Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. Results Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P = 0.003). Conclusions The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic may not be a major barrier to clinical research activities in pediatric oncology.

scholarly journals The Need for Shared Nomenclature on Racism and Related Terminology in Psychology

2021 ◽  
Vol 16 (5) ◽  
pp. 886-892
Author(s):  
Angela M. Haeny ◽  
Samantha C. Holmes ◽  
Monnica T. Williams
Keyword(s):  
Clinical Research ◽  
Negative Impact ◽  
Racial Microaggressions ◽  
The United States ◽  
Multiple Forms ◽  
Social Construct ◽  
Racial Hierarchy ◽  
The Social ◽  
The Many ◽  
The Impact

With the increased desire to engage in antiracist clinical research, there is a need for shared nomenclature on racism and related constructs to help move the science forward. This article breaks down the factors that contributed to the development and maintenance of racism (including racial microaggressions), provides examples of the many forms of racism, and describes the impact of racism for all. Specifically, in the United States, racism is based on race, a social construct that has been used to categorize people on the basis of shared physical and social features with the assumption of a racial hierarchy presumed to delineate inherent differences between groups. Racism is a system of beliefs, practices, and policies that operate to advantage those at the top of the racial hierarchy. Individual factors that contribute to racism include racial prejudices and racial discrimination. Racism can be manifested in multiple forms (e.g., cultural, scientific, social) and is both explicit and implicit. Because of the negative impact of racism on health, understanding racism informs effective approaches for eliminating racial health disparities, including a focus on the social determinants of health. Providing shared nomenclature on racism and related terminology will strengthen clinical research and practice and contribute to building a cumulative science.

The Effects of the Westward Movement on California's Growth and Development, 1900–1920

1969 ◽  
Vol 3 (3) ◽  
pp. 20-35
Author(s):  
Frank L. Beach
Keyword(s):  
Social Economic ◽  
The United States ◽  
American Experience ◽  
Present Essay ◽  
United States Population ◽  
Political Implications ◽  
The Social ◽  
Westward Movement ◽  
The One ◽  
The Impact

Internal migration is a growing social phenomenon of today's America: a third of the United States population live in a different state from the one in which they have been born. This, however, has been a constant aspect of the American experience. The author of the present essay analyzes in an historical perspective the growth of California from 1900–1920 under the impact of the westward movement. The social, economic and political implications of the California development are the main features of this paper.

Office for Protection from Research Risks (OPRR)

1994 ◽  
Vol 13 (2) ◽  
pp. 271-273 ◽  
Author(s):  
Gary B. Ellis
Keyword(s):  
Human Services ◽  
Public Health Service ◽  
Human Subjects ◽  
Laboratory Animals ◽  
Department Of Health ◽  
Research Risks ◽  
Policies And Procedures ◽  
Primary Responsibility ◽  
Protection Of Human Subjects ◽  
The U.S

The Office for Protection from Research Risks (OPRR) has primary responsibility within the U.S. Department of Health and Human Services (DHHS) for developing and implementing policies, procedures, and regulations for the protection of human subjects involved in research. It also has primary responsibility within the U.S. Public Health Service for developing and implementing policies and procedures for the care and use of laboratory animals. And, it has responsibility for coordinating the development and implementation of policies, procedures, and regulations for the protection of human subjects involved in research for all U.S. federal departments and agencies that conduct or support such research.

American Labor Unions in the Electoral Arena By Herbert B. Asher, Eric S. Heberlig, Randall B. Ripley, and Karen Snyder. Lanham, MD: Rowman & Littlefield, 2001. 207p. $69.00 cloth, $19.95 paper.

2002 ◽  
Vol 96 (3) ◽  
pp. 630-630
Author(s):  
Glenn Perusek
Keyword(s):  
The United States ◽  
Organized Labor ◽  
Social Scientists ◽  
Race And Gender ◽  
Union Movement ◽  
The Social ◽  
And Gender ◽  
The 1960S ◽  
The Impact ◽  
American Labor

For more than a generation, as the authors rightly point out, the impact of organized labor on electoral politics has been neglected in scholarly literature. Indeed, only a tiny minority of social scientists explicitly focuses on organized labor in the United States. Although the impact of the social movements of the 1960s appeared to heighten awareness of the importance of class, race, and gender, class and its organized expression, the union movement, has received less attention, while studies of race and gender have flourished.

Biobanking Research and Privacy Laws in the United States

2016 ◽  
Vol 44 (1) ◽  
pp. 106-127 ◽  
Author(s):  
Heather L. Harrell ◽  
Mark A. Rothstein
Keyword(s):  
Human Subjects ◽  
The United States ◽  
Common Rule ◽  
State Laws ◽  
Privacy Rule ◽  
Biobank Research ◽  
Privacy Laws ◽  
The Us ◽  
Protection Of Human Subjects ◽  
Hipaa Privacy Rule

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

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