What Is Human Subjects Research?

2020 ◽  
Author(s):  
Kirstin Borgerson
Keyword(s):  
Stem Cells ◽  
Ethical Issues ◽  
Human Subjects ◽  
General Question ◽  
Human Subjects Research ◽  
Research Participants ◽  
Is Research ◽  
Social Scientific ◽  
The Way

This chapter provides an overview of the nature, scope, and practice of human subjects research. It begins by tackling the general question, “What is research?” Attempts to answer this question typically define research by its methods and/or goals, and the chapter surveys the limits of these definitions through discussion of tough boundary cases. Along the way, the chapter describes various methods (quantitative, qualitative) and types of human subjects research (clinical, social scientific, etc.). The second section of the chapter investigates who is referred to by the language of “human subjects”: which humans tend to be selected as research participants, where human subjects are located globally, and how these locations are changing. The chapter also raises questions about which subjects are considered human in this context, for instance, whether definitions include embryos, cadavers, or stem cells. Throughout, the chapter highlights the ethical issues raised by the various types of activities and subjects described.

scholarly journals Intergenerational monitoring in clinical trials of germline gene editing

2019 ◽  
Vol 46 (3) ◽  
pp. 183-187 ◽  
Author(s):  
Bryan Cwik
Keyword(s):  
Clinical Trials ◽  
Gene Editing ◽  
Ethical Issues ◽  
Human Subjects ◽  
Germline Gene ◽  
Ethical Challenges ◽  
Human Subjects Research ◽  
Follow Up Study

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.

Remedies for Human Subjects of Cold War Research: Recommendations of the Advisory Committee

1996 ◽  
Vol 24 (2) ◽  
pp. 118-126 ◽  
Author(s):  
Anna Mastroianni ◽  
Jeffrey Kahn
Keyword(s):  
Cold War ◽  
Advisory Committee ◽  
Ethical Issues ◽  
Human Subjects ◽  
Executive Branch ◽  
Bill Clinton ◽  
Final Report ◽  
Human Subjects Research ◽  
White House ◽  
Research Recommendations

At a White House ceremony in October 1995, the Advisory Committee on Human Radiation Experiments presented its Final Report to President Bill Clinton. The 925-page report and the over 2,000 pages of supplemental volumes summarized eighteen months of investigative research, debate, and deliberation on historical and contemporary issues in human subjects research. The Advisory Committee's efforts were aided by unprecedented support from the highest levels of the executive branch, including the heads of eight cabinet-level agencies and their departments' resources. The presidentially appointed committee and its staff delved into long-forgotten Cold Warera government archives, listened to hours of public testimony, interviewed key players in the development of medical therapies and nuclear weapons, and studied ethical issues arising in today's research.In this article we focus on a critical, but narrowly defined, part of the Advisory Committee's Final Report: remedying harms or wrongs to subjects of human radiation experiments conducted or sponsored by the U.S. government between 1944 and 1974.

Cognitive Research in Information Systems

2011 ◽  
pp. 572-577
Author(s):  
Felix B. Tan ◽  
M. Gordon Hunter
Keyword(s):  
Information Systems ◽  
Human Subjects ◽  
Organizational Outcomes ◽  
Personal Construct ◽  
Personal Construct Theory ◽  
Research Participants ◽  
Is Research ◽  
Making Sense ◽  
Construct Theory ◽  
P 351

The existence and significance of cognition in organizations and its influence on patterns of behaviour in organizations and organizational outcomes are increasingly accepted in information systems (IS) research (Barley, 1986; DeSanctis & Poole, 1994; Griffith, 1999; Griffith & Northcraft, 1996; Orlikowski, 1992, 1994 #208). However, assessing the commonality and individuality in cognition and eliciting the subjective understanding of research participants either as individuals or as groups of individuals remain a challenge to IS researchers (Orlikowski & Gash, 1994). Various methods for studying cognition in organizations have been offered - for example, clinical interviewing (Schein, 1987), focus groups (Krueger, 1988), discourse-based interviewing (Odell, Goswami & Herrington, 1983). This article proposes that cognition applied to making sense of IT in organizations can also be explored using Kelly’s (1955) Personal Construct Theory and its methodological extension, the Repertory Grid (RepGrid). The RepGrid can be used in IS research for uncovering the constructs research participants use to structure and interpret events relating to the development, implementation, use and management of IS in organizations. In the context of this article, cognition is considered to be synonymous with subjective understanding: “the everyday common sense and everyday meanings with which the observed human subjects see themselves and which gives rise to the behaviour that they manifest in socially constructed settings” (Lee, 1991, p. 351). Research into cognition in organizations investigates the subjective understanding of individual members within the organization and the similarities and differences in the understandings among groups of individuals (Jelinek & Litterer, 1994; Porac & Thomas, 1989). In IS research, it is the personal constructs managers, users and IS professionals use to interpret and make sense of information technology (IT) and its role in organizations. The discussion here outlines the myriad of ways the RepGrid can be employed to address specific research objectives relating to subjective understanding and cognition in organizations. It illustrates, from a variety of published studies in IS (see Table 1), the flexibility of the RepGrid to support both qualitative and/or quantitative analyses of the subjective understandings of research participants.

Legal and Ethical Issues in Clinical Pharmacy Research — Informed Consent, Part I

1980 ◽  
Vol 14 (1) ◽  
pp. 40-43
Author(s):  
Dev S. Pathak ◽  
Thomas S. Foster ◽  
Cynthia L. Raehl
Keyword(s):  
Informed Consent ◽  
Research Methods ◽  
Clinical Pharmacy ◽  
Health Professionals ◽  
Ethical Issues ◽  
Human Subjects ◽  
Human Experimentation ◽  
Regulatory Agencies ◽  
Research Participants ◽  
Legal And Ethical Issues

The continued growth of hospital and clinical pharmacy should be paralleled by the development of sound research methods justifying innovative practices. Such research will, on occasion, require experimentation involving human subjects. The principal means of assuring that the welfare of research participants is not compromised is through the procurement of effective informed consent. Pharmacists, like many other health professionals, have had relatively little exposure to methodology involved in the writing of an informed consent instrument. A comprehensive document must not only conform to the requirements of federal regulatory agencies, but must also satisfy various institutional guidelines. Past instances of unethical human experimentation are discussed, and a format for preparation of an informed consent instrument is examined. Circumstances requiring informed consent and identification of the basic elements of consent are also explained.

Ethics in Research with Teen Mothers

2015 ◽  
pp. 79-106 ◽  
Author(s):  
Devi Akella
Keyword(s):  
United States ◽  
Teenage Pregnancy ◽  
Qualitative Methodology ◽  
Ethical Issues ◽  
Human Subjects ◽  
Teen Mothers ◽  
Human Subjects Research ◽  
Industrialized Nations ◽  
Ethics In Research ◽  
Shed Light

United States has the highest level of teenage pregnancy amongst industrialized nations. However, research on teenage pregnancy involves research participants who are young girls undergoing the life-altering process of motherhood. Given the topic of research, where the girls themselves would need to shed light on factors responsible for early pregnancy, qualitative methodology would be an appropriate choice. It would allow the participants to voice their own stories to bring alive their experiences, lifestyles, and problems. Further, all participants, being minors, would be emotionally and psychologically stressed out and in a highly vulnerable condition. This raises numerous ethical issues when examining teenage mothers before, during, and after the fieldwork. This chapter provides insights on ethical issues involving human subjects' research in the context of teenage pregnancies.

The Apomediated World: Regulating Research When Social Media Has Changed Research

2013 ◽  
Vol 41 (2) ◽  
pp. 470-483 ◽  
Author(s):  
Dan O’Connor
Keyword(s):  
Social Networks ◽  
Social Media ◽  
Human Subjects ◽  
Smart Phone ◽  
Digital Technologies ◽  
Human Subjects Research ◽  
Broadband Internet ◽  
Internet Connection ◽  
The Way

Social media, meaning digital technologies and platforms such as blogs, wikis, forums, content aggregators, sharing sites, and social networks like Facebook and Twitter, have profoundly changed the way that information can be shared online. Now, almost anyone with a broadband internet connection or a smart phone can share ideas, data, and opinions with just about anyone else on the planet. This change has serious implications for the way in which human subjects research can be conducted and, concomitantly, for the ways in which such research may be regulated. This article explores some of these issues.

scholarly journals Incidental findings in human subjects research: Is ignorance really bliss?

2021 ◽  
Author(s):  
◽  
Hannah Brown
Keyword(s):  
Informed Consent ◽  
Incidental Findings ◽  
Research Study ◽  
Human Subjects ◽  
Informed Choice ◽  
Research Participant ◽  
Informed Consent Process ◽  
Human Subjects Research ◽  
Research Participants ◽  
Minimum Standards

<p>Human subjects research has the potential to produce information beyond the aims of the research study. This information may, nevertheless, have health or reproductive significance for the research participant. With the development of sophisticated technologies, these occurrences, known as incidental findings (IFs), are becoming increasingly common. As yet, however, there is no consensus on how IFs in human subjects research should be managed. This paper examines the current law and guidelines relating to human subjects research, and in doing so determines that research participants are inadequately informed about IFs. Consequently, their ability to make an informed choice about and provide informed consent to research procedures is compromised. After addressing the ethical and practical issues most salient to IFs, a framework for their management is developed. The framework sets out the information that should be discussed with research participants during the informed consent process. Recommendations for how this framework should be implemented are then made. The paper concludes that guidelines establishing minimum standards for communicating the possibility and presence of IFs are urgently required so that the rights of research participants are sufficiently protected.</p>

scholarly journals Informed consent in field trials of gene-drive mosquitoes

2017 ◽  
Vol 1 ◽  
pp. 14 ◽  
Author(s):  
Pamela A. Kolopack ◽  
James V. Lavery
Keyword(s):  
Informed Consent ◽  
Private Information ◽  
Ethical Issues ◽  
Population Control ◽  
Human Subjects ◽  
Field Trials ◽  
Institutional Review Boards ◽  
Gene Drive ◽  
Research Participants ◽  
Gene Drives

The US National Academies’ (NAS) recent report ‘Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values’ examines the requirements of responsible conduct in research involving gene drives in non-human organisms. Many of the complex ethical issues raised by the introduction of gene drive technologies for mosquito population control have been anticipated during the development and field-testing of earlier-generation genetic engineering approaches with mosquitoes. One issue—the requirement for informed consent in field trials—is not addressed explicitly in the NAS’ report. Some commentators have presumed that informed consent should play a role as a protection for research participants in studies of genetically modified mosquitoes. Others have argued that there are no human subjects of field trials, so the informed consent requirement does not apply. It is both ethically and practically important that these presumptions are adequately scrutinized to ensure that any applications of informed consent in these trials are properly justified. We argue that informed consent from individual research participants in gene drive trials may be required: (1) when blood and other forms of clinical data are collected from them, as will likely be the case in some studies involving epidemiological endpoints, such as the incidence of new infections with dengue and malaria; (2) when they participate in social science and/or behavioral research involving the completion of surveys and questionnaires; or (3) when their home or property is accessed and the location recorded as a spatial variable for the release or collection of mosquitoes because the precise location of the household is important for entomological reasons and these data constitute identifiable private information at the household level. Importantly, most regulations and guidelines allow these requirements to be waived or modified, to various degrees, according to the judgment of Institutional Review Boards.

scholarly journals Incidental findings in human subjects research: Is ignorance really bliss?

2021 ◽  
Author(s):  
◽  
Hannah Brown
Keyword(s):  
Informed Consent ◽  
Incidental Findings ◽  
Research Study ◽  
Human Subjects ◽  
Informed Choice ◽  
Research Participant ◽  
Informed Consent Process ◽  
Human Subjects Research ◽  
Research Participants ◽  
Minimum Standards

<p>Human subjects research has the potential to produce information beyond the aims of the research study. This information may, nevertheless, have health or reproductive significance for the research participant. With the development of sophisticated technologies, these occurrences, known as incidental findings (IFs), are becoming increasingly common. As yet, however, there is no consensus on how IFs in human subjects research should be managed. This paper examines the current law and guidelines relating to human subjects research, and in doing so determines that research participants are inadequately informed about IFs. Consequently, their ability to make an informed choice about and provide informed consent to research procedures is compromised. After addressing the ethical and practical issues most salient to IFs, a framework for their management is developed. The framework sets out the information that should be discussed with research participants during the informed consent process. Recommendations for how this framework should be implemented are then made. The paper concludes that guidelines establishing minimum standards for communicating the possibility and presence of IFs are urgently required so that the rights of research participants are sufficiently protected.</p>

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