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.

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

1980 ◽  
Vol 14 (2) ◽  
pp. 122-125
Author(s):  
Dev S. Pathak ◽  
Thomas S. Foster ◽  
Cynthia L. Raehl
Keyword(s):  
Informed Consent ◽  
Health Education ◽  
Clinical Pharmacy ◽  
Ethical Issues ◽  
Review Committee ◽  
Department Of Health ◽  
Institutional Review ◽  
Consent Document ◽  
Informed Consent Document ◽  
Legal And Ethical Issues

Preparation of an effective informed consent document presents significant problems to those investigators not familiar with federal and institutional requirements. This article examines a detailed format for preparation of an informed consent instrument. Prepared by the authors and supplied to potential clinical investigators by a university institutional review committee, the guidelines incorporate Department of Health, Education, and Welfare regulations. An example consent form is provided.

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.

Commentary 1: Research with Persons Under Involuntary Commitment—Ethical Issues Surrounding Competence and Voluntariness

2019 ◽  
Vol 14 (5) ◽  
pp. 475-478
Author(s):  
Matthé Scholten ◽  
Jochen Vollmann
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Research Participation ◽  
Research Participant ◽  
Involuntary Commitment ◽  
Proxy Consent ◽  
Undue Influence ◽  
Research Participants ◽  
Manic Symptoms ◽  
Prospective Research

In this case commentary, we analyze ethical concerns that were raised in response to an interview with a woman with bipolar disorder who was under involuntary commitment. We focus on competence and voluntariness as two prerequisites for valid informed consent. We recommend that judgments of competence be based on whether prospective research participants sufficiently possess certain decision-making abilities. Based on this functional approach, we argue that manic symptoms need not undermine competence and that, even if we were to assume that the research participant became incompetent during the interview, this would not invalidate her consent retroactively. It would, however, compromise her ability to revoke her consent. We furthermore show that obtaining additional proxy consent for research participation may compromise the autonomy of service users who are competent to consent. Then we turn to the issue of voluntariness. Arguing that neither the great strength nor the external etiology of a desire compromises voluntariness, we propose that the voluntariness of a decision instead depends on whether the decision-maker endorses it on reflection. The researchers disclosed that prospective research participants’ decision about study participation would have no influence on the duration of the commitment or the quality of care. We contend that because of this neither coercion nor undue influence was exerted in the informed consent process. Nevertheless, there is an increased likelihood of perceived coercion and undue influence under conditions of involuntary commitment, and we close by suggesting some safeguards to prevent this.

Legal and ethical issues in informed consent to psychotherapy

1985 ◽  
Vol 13 (2) ◽  
pp. 50-60 ◽  
Author(s):  
James H. Bray ◽  
Juneau N. Shepherd ◽  
J. Ray Hays
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Legal And Ethical Issues

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.

Reflexivity in Research Practice: Informed Consent with Children at School and at Home

2008 ◽  
Vol 13 (4) ◽  
pp. 17-30 ◽  
Author(s):  
Hayley Davies
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Research Process ◽  
Research Practice ◽  
Ethical Practices ◽  
Research Participants ◽  
Ethical Approach ◽  
Ethics Guidelines ◽  
Research Ethics Guidelines

Informed consent is a key consideration in ethical research, particularly research conducted with children. Devising an approach to and obtaining informed consent is a complex task involving multiple considerations. The examples used in this paper are derived from a study investigating how children constitute family members and close relationships. The paper is divided into two sections. The first section suggests that researchers should take a reflexive approach to their professional research practice and addresses how a researcher's professional location determines their particular ethical approach. Consideration is given to how the researcher's particular ethical approach can be achieved in consultation with academic thought and research ethics guidelines, which often offer contradictory advice on important ethical issues. The second section of the paper addresses how researchers negotiate their approach to informed consent in particular research contexts which offer challenges to the researcher's thinking about research participants or chosen procedures for obtaining and maintaining that informed consent is upheld. The paper concludes by arguing that the researcher can incorporate academic thought and aspects of the research ethics guidelines in an approach to informed consent that simultaneously values the research participants and the ethical practices operating in the research setting. Such an approach involves careful negotiation and consideration of the interests of all stakeholders in the research process.

scholarly journals Human Subjects Protections in Biomedical Enhancement Research: Assessing Risk and Benefit and Obtaining Informed Consent

2008 ◽  
Vol 36 (3) ◽  
pp. 546-559 ◽  
Author(s):  
Maxwell J. Mehlman ◽  
Jessica W. Berg
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Significant Risk ◽  
Human Experimentation ◽  
Extensive Literature ◽  
Healthy Children ◽  
Human Capabilities ◽  
Biomedical Enhancement ◽  
Potential Benefits ◽  
Risk And Benefit

There are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects’ informed consent. Although an extensive literature on both of these aspects exists, virtually nothing has been written about human experimentation for which the objective is not to prevent, cure, or mitigate a disease or condition, but to enhance human capabilities. One exception is a 2004 article by Rebecca Dresser on preimplantation genetic modification — one of the most controversial enhancement technologies — in which she states, “Under existing research ethics principles, it would be unethical for investigators to perform modifications exposing embryos expected to develop into healthy children to significant risk in exchange for a possible physical or mental enhancement.” But Dresser does not explain why such an experiment would be unethical under existing principles, and her conclusion is not self-evident.

scholarly journals Informed consent in the field of language and sexuality

2015 ◽  
Vol 4 (1) ◽  
pp. 1-29 ◽  
Author(s):  
Kristine Køhler Mortensen
Keyword(s):  
Informed Consent ◽  
Research Methods ◽  
Empirical Data ◽  
Ethical Issues ◽  
Online Dating ◽  
Symbolic Violence ◽  
Interactional Expertise ◽  
Naturally Occurring ◽  
Spontaneous Interaction ◽  
Interactional Analysis

In order to understand how sexual and romantic relations are established and negotiated in discourse, the field of language and sexuality is dependent upon empirical data from naturally occurring spontaneous interaction. However, detailed discussions of research methods are lacking in the field. In this article, I explore ways of accessing intimate spontaneous data in a heterosexual online dating context. Through interactional analysis of three types of online dating interaction, I examine the multi-faceted context for securing informed consent while at the same time preserving participants’ intimacy. I argue that institutionalized informed consent procedures may undercut participant agency and expose symbolic violence towards their carefully built interactional framework. The analysis demonstrates participants’ ability to negotiate ethical issues and to turn such issues into a contribution to the ongoing flirtatious interaction. As a result, I suggest a method that integrates participants’ interactional expertise in the consent-gaining process.

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