Without Informed Consent

2012 ◽  
pp. 291-305
Author(s):  
Sara Belfrage
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
New Technology

The requirement of always obtaining participants’ informed consent in research with human subjects cannot always be met, for a variety of reasons. This paper describes and categorises research situations where informed consent is unobtainable. Some of these kinds of situations, common in biomedicine and psychology, have been previously discussed, whereas others, for example, those more prevalent in infrastructure research, introduce new perspectives. The advancement of new technology may lead to an increase in research of these kinds. The paper also provides a review of methods intended to compensate for lack of consent, and their applicability and usefulness for the different categories of situations are discussed. The aim of this is to provide insights into one important aspect of the question of permitting research without informed consent, namely, how well that which informed consent is meant to safeguard can be achieved by other means.

Without Informed Consent

2011 ◽  
Vol 2 (3) ◽  
pp. 48-61 ◽  
Author(s):  
Sara Belfrage
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
New Technology

The requirement of always obtaining participants’ informed consent in research with human subjects cannot always be met, for a variety of reasons. This paper describes and categorises research situations where informed consent is unobtainable. Some of these kinds of situations, common in biomedicine and psychology, have been previously discussed, whereas others, for example, those more prevalent in infrastructure research, introduce new perspectives. The advancement of new technology may lead to an increase in research of these kinds. The paper also provides a review of methods intended to compensate for lack of consent, and their applicability and usefulness for the different categories of situations are discussed. The aim of this is to provide insights into one important aspect of the question of permitting research without informed consent, namely, how well that which informed consent is meant to safeguard can be achieved by other means.

scholarly journals Informed Consent in the U.S. Indigenous Peoples Context: A Systematic Literature Review 

2021 ◽  
Author(s):  
Tasha Gross ◽  
Clarita Lefthand-Begay
Keyword(s):  
Informed Consent ◽  
Literature Review ◽  
Cultural Values ◽  
Systematic Literature Review ◽  
Human Subjects ◽  
The United States ◽  
Inclusion Criteria ◽  
Research Practices ◽  
The Individual ◽  
The U.S

Abstract BACKGROUND: Tribal communities in the United States (U.S.) have a long history of subjection to unethical and exploitive medical and research practices. Today, many Tribal nations are establishing procedures in order to protect themselves from further harm and to advance culturally informed research practices. These procedures are also meant to ensure that their communities benefit from research conducted within their communities. Informed consent is a key element in protecting human subjects, but it may not be sufficient in the tribal context, as its conception is rooted in Western understandings of protection. Specifically, the informed consent emphasizes the individual, rather than the community as a whole, which is just as important in the context of conducting research with Native communities.METHODS: We conduct a systematic literature review to answer two related questions: How is informed consent being conceived of by U.S. tribes? And how is informed consent being required by U.S. tribes? Our inclusion criteria include articles focusing on informed consent within the U.S. tribal context, written in English in 2010-2020. Articles that did not fit our inclusion criteria were excluded. Two reviewers independently reviewed and coded 30 peer-reviewed articles by using content analysis and, in an iterative process, agreed on emerging codes and themes. RESULTS: A number of themes arise in the selected literature, including the conception of informed consent as a process, its operation at various levels (individual, collective, and government-to-government), possible alternatives to informed consent, and the need for specificity about ownership of samples and data, benefits and/or risks, and the methods and procedures that researchers use in the course of study.CONCLUSIONS: Our key results point to a need for clear and transparent information for prospective research participants and for consent forms and processes to include the collective, as well as the individual. This will better align with the cultural values and political standing of sovereign tribes in the U.S.

Informed Consent in Healthcare

2020 ◽  
pp. 1222-1253
Author(s):  
Bo Yu ◽  
Duminda Wijesekera ◽  
Paulo Cesar G. Costa
Keyword(s):  
Informed Consent ◽  
Open Source ◽  
Human Subjects ◽  
Sensitive Information ◽  
Electronic Documents ◽  
Implementation Challenges ◽  
Patient Participant ◽  
New Challenges ◽  
Participant Information

Informed consents, either for treatment or sensitive information use/disclosure, that protect the privacy of patient/participant information subject to law that in certain circumstances may override patient wishes, are mandatory practice in healthcare. Similarly, for protecting and respecting research participants, informed consents are also prerequisite for human subjects research. Although the healthcare industry has widely adopted Electronic Medical Record (EMR) systems, consents are still obtained and stored primarily on paper or scanned electronic documents. Integrating a consent management system for different purposes into an EMR system involves various implementation challenges. A case study, informed consent for genetic services, is used to show how genetic informed consents placed new challenges on the traditional ethical standards of informed consent, and how appropriate consents can be electronically obtained and automatically enforced using a system that combines medical workflows and hierarchically, ontologically motivated rule enforcement. Finally, this chapter describes an implementation that uses the open-source software-based addition of these components to an open-source EMR system, so that existing systems do not need to be scrapped or otherwise rendered obsolete.

scholarly journals Characterizing Current Attitudes and Practices for Human Subject Safety in Studies Involving Pupil Dilation

2020 ◽  
pp. 155626462096898
Author(s):  
Jacob Szpernal ◽  
Joseph Carroll ◽  
Ryan Spellecy ◽  
Jane A. Bachman Groth
Keyword(s):  
Informed Consent ◽  
Adverse Effects ◽  
Vision Research ◽  
Human Subject ◽  
Human Subjects ◽  
Pupil Dilation ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Attitudes And Practices ◽  
Institutional Review

Standards in pupil dilation practices regarding the safety of human subjects are not present in vision research despite the potential for significant adverse effects. We developed two surveys to examine current practices around pupil dilation among vision researchers and individuals associated with oversight of human subjects research. While both groups note an absence of adverse events associated with pupil dilation, vision researcher practices differed with informed consent use and measures taken to minimize complications. For Institutional Review Boards, general risk assumption associated with dilation was not unanimous and there was a lack of specific guidance available to researchers for minimizing risk. These results uncover the need for standardized practices regarding pupil dilation in human subjects research.

scholarly journals Dynamic assessment of the tear film muco-aqueous and lipid layers using a novel tear film imager (TFI)

2019 ◽  
Vol 104 (1) ◽  
pp. 136-141 ◽  
Author(s):  
Fani Segev ◽  
Noa Geffen ◽  
Anat Galor ◽  
Yoel Cohen ◽  
Raanan Gefen ◽  
...  
Keyword(s):  
Human Subjects ◽  
New Technology ◽  
Dynamic Assessment ◽  
Case Series ◽  
Tear Film ◽  
Control Group ◽  
Aqueous Layer ◽  
Break Up ◽  
Sequential Images ◽  
Lipid Layers

PurposeThe objective of the study was to assess a new technology, the tear film imager (TFI), which can dynamically image the muco-aqueous and lipid layers.MethodsProspective pilot case series of individuals with and without dry eye (DE). Two sequential images were obtained with the TFI. Measurements were assessed for reproducibility and compared with clinically derived DE metrics. Individuals were grouped into DE categories based on signs of DE.Results49 patients participated in the study with a mean age of 58.8 years (SD 15.9) and a female majority (69%). Reproducibility of the muco-aqueous layer thickness (MALT) was excellent (r=0.88). MALT measurements significantly correlated with the Schirmer score (r=0.31). Lipid break up time (LBUT) as measured by the TFI significantly correlated with the clinical measure of tear break up time (TBUT) (r=0.73). MALT and LBUT were significantly thinner and shorter, respectively, in the DE groups (mild–moderate and severe) compared with the control group. When comparing TFI parameters to clinically assessed signs, sensitivity of the device was 87% and specificity was 88%.ConclusionThe TFI is the first machine capable of reproducibly measuring muco-aqueous thickness in human subjects which correlates with Schirmer score. In parallel, it assesses other important aspects of tear film function which correlate with clinician assessed DE metrics.

Nanomedicine First-in-Human Research: Challenges for Informed Consent

2012 ◽  
Vol 40 (4) ◽  
pp. 823-830 ◽  
Author(s):  
Nancy M. P. King
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Clinical Research ◽  
Human Subjects ◽  
Consent Form ◽  
Human Research ◽  
Research Challenges ◽  
Starting Point ◽  
Human Subjects Protections

First-in-human (FIH) research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent form and process are by no means the primary protectors of human subjects (although they are sometimes so regarded). Instead, consideration of the form and content of informed consent becomes relevant only after a clinical trial has been reviewed and deemed scientifically and ethically acceptable.Two convergent types of challenges to informed consent are posed by nanomedicine FIH research. First, some issues appear generally applicable to FIH research, but have specific nanomedicine implications.

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