The Concept of Vulnerability and the Protection of Human Subjects of Research

2007 ◽  
Vol 21 (3) ◽  
pp. 156-173 ◽  
Author(s):  
Elizabeth R. A. Beattie ◽  
Terry M. VandenBosch
Keyword(s):  
Vulnerable Populations ◽  
Human Subject ◽  
Human Subjects ◽  
Vulnerable Groups ◽  
Federal Regulations ◽  
Current Controversy ◽  
Vulnerable Subjects ◽  
Protection Of Human Subjects ◽  
The U.S

This article provides an overview of the concept of vulnerability through the lens of the U.S. federal regulations for the protection of human subjects of research. General issues that emerge for nurse researchers working with regulated vulnerable populations are identified. Points of current controversy in the application of the regulations and current discourse about vulnerable groups are highlighted. Suggestions for negotiating the tension between federally regulated human subject requirements and the realities of research with vulnerable subjects are given. The limitations of the designation of vulnerable as a protection for human subjects will also be discussed.

Ethical Issues Related to the Use of Humans in Human Factors and Ergonomics

1994 ◽  
Vol 38 (6) ◽  
pp. 404-408
Author(s):  
William F. Moroney
Keyword(s):  
Human Subject ◽  
Ethical Issues ◽  
Human Subjects ◽  
Federal Regulations ◽  
Critical Area ◽  
Human Factors And Ergonomics ◽  
Research Material ◽  
Protection Of Human Subjects ◽  
Changing Role

As professionals, we must be aware of our ethical responsibilities when engaged in research and testing. The purpose of this paper is threefold: 1) to increase the reader's awareness of some of the issues specific to our discipline, 2) to provide some guidelines and references regarding the use of human subjects, and 3) to increase the dialog in this critical area. The material discussed focuses on Federal Regulations related to the protection of human subjects. The changing role of the human subject from “research material” to “participant partners” is also discussed.

scholarly journals Social and Behavioral Research with Undocumented Immigrants: Navigating an IRB Committee

2020 ◽  
Vol 42 (1) ◽  
pp. 3-17
Author(s):  
Elizabeth Jach ◽  
Gene Gloeckner ◽  
Colleen Kohashi
Keyword(s):  
Vulnerable Populations ◽  
Human Subjects ◽  
Undocumented Students ◽  
Institutional Review Board ◽  
Federal Regulations ◽  
Political Climate ◽  
Human Subjects Research ◽  
Institutional Review ◽  
The U.S

When conducting human subjects research, social and behavioral researchers seeking to study current issues involving immigrants, refugees, and undocumented students must submit their research to an institutional review board (IRB). Research applications proposing to enroll these populations lie outside the scope of vulnerable populations named in the U.S. Code for Federal Regulations (45 CFR 46). Through a consideration of privacy, confidentiality, flexibility in providing protections, and case study examples, this article examines how researchers and IRBs can negotiate protecting participants who may be undocumented while supporting the advancement of research in the midst of the current, and uncertain, political climate.

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.

When Scientists Deceive: Applying the Federal Regulations

2009 ◽  
Vol 37 (2) ◽  
pp. 344-350 ◽  
Author(s):  
Collin C. O'Neil ◽  
Franklin G. Miller
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Federal Regulations ◽  
Human Subjects Research ◽  
Legal Requirement ◽  
Research On Human Subjects ◽  
Material Information ◽  
The U.S

Informed consent is a basic ethical and legal requirement for human subjects research. The U.S. federal regulations governing research on human subjects stipulate general requirements for informed consent. Investigators are required to disclose to prospective subjects material information about the purpose, procedures, and likely consequences of the study, among other things. However, investigators sometimes employ deception for methodological reasons. In order to keep subjects’ responses unbiased, investigators deceive subjects about such things as the fact that they are taking part in research, the purpose of the research, the research interventions or interactions, or the likely consequences of those interventions or interactions. When investigators deceive subjects about such aspects of a study, the study fails to meet these general requirements for informed consent.

The Invisible Vulnerable: The Economically and Educationally Disadvantaged Subjects of Clinical Research

2003 ◽  
Vol 31 (1) ◽  
pp. 149-153 ◽  
Author(s):  
T. Howard Stone
Keyword(s):  
Human Subjects ◽  
Disabled Persons ◽  
Federal Regulations ◽  
Research Subjects ◽  
Undue Influence ◽  
Common Rule ◽  
Educationally Disadvantaged ◽  
Mentally Disabled ◽  
The Common ◽  
Protection Of Human Subjects

U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.

Revolution or Reform in Human Subjects Research Oversight

2012 ◽  
Vol 40 (4) ◽  
pp. 922-929 ◽  
Author(s):  
Steven Joffe
Keyword(s):  
New England ◽  
Human Subjects ◽  
The United States ◽  
National Commission ◽  
Human Subjects Research ◽  
Prior Review ◽  
Independent Review ◽  
Protection Of Human Subjects ◽  
Oversight System ◽  
The U.S

Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal of Medicine. The oversight system is based on a foundation, first implemented by the U.S. Public Health Service (PHS) in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report.

A Living Wage for Research Subjects

2011 ◽  
Vol 39 (2) ◽  
pp. 243-253 ◽  
Author(s):  
Trisha B. Phillips
Keyword(s):  
Human Subjects ◽  
Crowding Out ◽  
Living Wage ◽  
Research Subject ◽  
Federal Regulations ◽  
Research Subjects ◽  
Wage Payment ◽  
Study Results ◽  
Undue Inducement ◽  
Protection Of Human Subjects

Offering cash payments to research subjects is a common recruiting method, but this practice continues to be controversial because of its potential to compromise the protection of human subjects. Some critics question whether researchers should be allowed to offer money at all, citing concerns about commodification of the research subject, invalidation of study results, and increased risks to subjects. Other critics are comfortable with the idea of monetary payments but question how much researchers can pay their subjects, citing concerns about undue inducement, crowding out, and monetary exploitation. Focusing only on the amount researchers can pay their subjects, this paper argues that the federal regulations and guidelines should implement a standard payment formula. It argues for a wage payment model, and critically examines three candidates for a base wage: the nonfarm production wage, the FLSA minimum wage, and a living wage.

scholarly journals Improved zinc and iron absorption from breakfast meals containing malted oats with reduced phytate content

1996 ◽  
Vol 76 (5) ◽  
pp. 677-688 ◽  
Author(s):  
Marie Larsson ◽  
Lena Rossander-Hulthén ◽  
Brittmarie Sandström ◽  
Ann-Sofie Sandberg
Keyword(s):  
Iron Absorption ◽  
Human Subjects ◽  
Vulnerable Groups ◽  
Whole Body ◽  
Absolute Amount ◽  
Average Increase ◽  
Mineral Deficiency ◽  
Breakfast Meal ◽  
Body Retention ◽  
Phytate Content

The absorption of Zn or Fe from breakfast meals containing oat porridge prepared from malted and soaked oats and a control porridge made from untreated oats was measured in human subjects. The effect on Zn and Fe absorption of reducing the phytate content of oat-porridge meals was examined in each subject by extrinsic labelling of porridge with 65Zn and of bread rolls with 55Fe and 59Fe, and measuring whole-body retention and the erythrocyte uptake of isotopes. Each experiment comprised nine to ten subjects. The absorption of Zn from malted-oat porridge with a phytate (inositol hexaphosphate) content of 107 μmol was 18·3%, and significantly higher (P < 0·05) than from the control porridge containing 432 μmol phytate (11·8%). Fe absorption from the meal containing malted-oat porridge with 107 μmol phytate (Expt 2) was also significantly improved (P < 0·05) compared with that from the meal containing control porridge with 437 μmol phytate. The average increase in Fe absorption was 47%, or from 4·4 to 6·0%. In the breakfast meal containing malted porridge with 198 μmol phytate (Expt 3) the increase in Fe absorption was not significantly improved. Even though the phytate content was reduced to a greater extent in Expt 3 than Expt 2, the average increase in Fe absorption in Expt 3 was only 25% more than that from the meal containing control porridge (with 599 μmol phytate), depending on the higher absolute amount of phytate. In conclusion, an improvement in Zn and Fe absorption from oat products can be achieved by practising malting and soaking in the processing of oats. This may be of importance in the prevention of mineral deficiency in vulnerable groups.

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