Nursing research in the United States: The protection of human subjects

1990 ◽  
Vol 27 (1) ◽  
pp. 21-33 ◽  
Author(s):  
Lorys F. Oddi ◽  
Virginia R. Cassidy
2003 ◽  
Vol 24 (2) ◽  
pp. 61-85
Author(s):  
Michael McDonald ◽  
Eric Meslin

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.


2011 ◽  
Vol 39 (3) ◽  
pp. 488-501 ◽  
Author(s):  
Ana S. Iltis

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services (whose regulations appear at 45CFR46), to require that investigators follow the same rules for conducting human research. (The Food and Drug Administration [FDA] has its own rules (at 21CFR50 and 21CFR56), though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter the National Commission). The National Commission was appointed in 1974 as part of the National Research Act (P.L. 93-348) in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study.


2018 ◽  
Vol 34 (5) ◽  
pp. 597-618 ◽  
Author(s):  
Karen E. Johnson ◽  
Christopher P. Salas-Wright ◽  
David Córdova ◽  
Jenny Ugalde ◽  
Jelena Todic ◽  
...  

In this study, we explored Latinx adolescents’ knowledge and perceptions of biobehavioral research and their willingness to participate in such studies. We conducted four focus groups in the summer of 2014 with Latinx adolescents in Texas between the ages of 12 and 17 years ( n = 17; 53% male; M age = 14.6 years [ SD = 1.66]) who were recruited from a community-based clinic. Five themes emerged from our content analysis: (a) protection of human subjects is important to participants, (b) comfort with providing different types of biological data varies depending on different factors, (c) engagement in biobehavioral research should be grounded in a cultural lens, (d) providing bilingual research staff is essential, and (e) adolescents have various motivations for participating. Findings highlighted how various factors could serve as both barriers and facilitators to participation. Our study provides insight into strategies for conducting biobehavioral research with Latinxs, who are the fastest growing group of adolescents in the United States and experience disparities in health-risk behaviors that can be better understood through research approaches that integrate biological and psychological measures. Without considering the perspectives of historically marginalized or understudied populations, we jeopardize the quality and validity of research findings, and risk harming participants.


2017 ◽  
Vol 20 (1) ◽  
pp. 107-114 ◽  
Author(s):  
Jennifer Kue ◽  
Laura A. Szalacha ◽  
Mary Beth Happ ◽  
Abigail L. Crisp ◽  
Usha Menon

Curationis ◽  
1991 ◽  
Vol 14 (3) ◽  
Author(s):  
M. Poggenpoel

In addressing nursing research education in the United States of America a short overview of the development of nursing research will be given and then one specific approach to nursing research education will be discussed fully.


2016 ◽  
Vol 44 (1) ◽  
pp. 106-127 ◽  
Author(s):  
Heather L. Harrell ◽  
Mark A. Rothstein

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.


2020 ◽  
Vol 52 (6) ◽  
pp. 671-679 ◽  
Author(s):  
Eun‐Ok Im ◽  
Reiko Sakashita ◽  
Chia‐Chin Lin ◽  
Tae‐Hwa Lee ◽  
Hsiu‐Min Tsai ◽  
...  

2002 ◽  
Vol 20 (1) ◽  
pp. 369-395 ◽  
Author(s):  
TERRY FULMER

Elder mistreatment (EM) is a serious and prevalent syndrome that is estimated to affect between 500,000 to 1.2 million older adults in the United States annually (Pillemer & Finkelhor, 1988). This chapter reviews both the state of the published science and limitations in the knowledge base on the topic. The literature for this review was obtained through computer-assisted searches of PubMed (878 citations), the Cumulative Index of Nursing Research (CINAHL) (593 citations) and Psych-Info databases (443 citations). The search terms used were elder mistreatment, elder neglect, elder abuse, or domestic abuse of the elderly. No limit was placed on the age of publications because of the relative scarcity of research on the subject. Nonnursing articles were included because there are so few nurse researchers addressing this topic. The age limit for subjects in these studies was 65 years and older. Studies were limited to those conducted in the United States, and descriptive studies were included as they form the majority of the research to date. Findings indicate that frail, very old (over 75 years), older adults who have a diagnosis of depression or dementia are more likely to be mistreated (Dyer, Pavlik, Murphy, & Hyman, 2000; Coyne, Reichman, & Berbig, 1993; Fulmer & Gurland, 1996; Lachs & Pillemer, 1995; Lachs et al., 1997; Lachs, Williams, O’Brien, Pillemer, & Charlson, 1998; Lachs & Fulmer, 1993; Lachs, Berkman, Fulmer, & Horwitz, 1994). Those older adults who required assistance with activities of daily living had poor social networks and were at higher risk for EM (Lachs & Pillemer, 1995; Lachs et al., 1997; Lachs et al., 1998; Lachs & Fulmer, 1993; Lachs et al., 1994). Neglect, as a subcategory of EM, accounts for the majority of cases (Fulmer, Paveza, Abraham, & Fairchild, 2000; Pavlik, Hyman, Festa, & Bitondo Dyer, 2001; Fulmer & Gurland, 1996). There is still debate regarding the role of minority status, abuse in childhood, and the persons most likely to mistreat older adults. There is a critical need for replication studies and new research on this important topic. Problems with measurement, funding challenges, and the paucity of investigators conducting research on EM have left the field with several unanswered questions and some conflicting findings. This chapter summarizes the interdisciplinary literature and makes recommendations for future nursing research programs.


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