Informed consent procedures with cognitively impaired patients: A review of ethics and best practices

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.

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Teach an I-O To Fish: Integrating Data Science Into I-O Graduate Education

Industrial and Organizational Psychology ◽

10.1017/iop.2015.80 ◽

2015 ◽

Vol 8 (4) ◽

pp. 539-544 ◽

Cited By ~ 3

Author(s):

Juliet R. Aiken ◽

Paul J. Hanges

Keyword(s):

Big Data ◽

Informed Consent ◽

Consumer Behavior ◽

Best Practices ◽

National Security ◽

Graduate Education ◽

Data Science ◽

National Security Agency ◽

Internet Searches ◽

Corporate Language

Big data is becoming a buzzword in today's corporate language and lay discussions. From individually targeting advertising based on previous consumer behavior or Internet searches to debates by Congress concerning National Security Agency (NSA) access to phone metadata, the era of big data has arrived. Thus, the Guzzo, Fink, King, Tonidandel, and Landis (2015) discussion of the challenges (e.g., confidentiality, informed consent) that big data projects present to industrial and organizational (I-O) psychologists is timely. If the hype associated with these techniques is warranted, then our field has a clear imperative to debate the ethics and best practices surrounding use of these techniques. We believe that Guzzo et al. have done our field a service by starting this discussion.

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The Participation of Cognitively Impaired Elderly in Research

Care Management Journals ◽

10.1891/cmaj.2004.5.4.245 ◽

2004 ◽

Vol 5 (4) ◽

pp. 245-257 ◽

Cited By ~ 2

Author(s):

Sana Loue

Keyword(s):

Informed Consent ◽

Mental Capacity ◽

Legal Issues ◽

Cognitively Impaired ◽

Limited Capacity ◽

Information Uncertainty ◽

Underlying Causes ◽

Ethical And Legal Issues ◽

Study Participants

It is critical that cognitively impaired adults be permitted to participate in research in order to develop a greater understanding of the underlying causes of the impairments and strategies to prevent or ameliorate their impact. Significant ethical and legal issues may arise in the recruitment and enrollment of these persons as study participants, due to difficulties in understanding information, uncertainty regarding the existence of sufficient mental capacity to provide informed consent to participate, and the potential for coercion to participate as a function of limited capacity and dependence on others for care. This article explores these issues and suggests mechanisms to maximize the understanding of information and facilitate the cognitively impaired elders’ expression of choice during incapacity.

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Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices

Journal of Neural Engineering ◽

10.1088/1741-2560/13/4/043001 ◽

2016 ◽

Vol 13 (4) ◽

pp. 043001 ◽

Cited By ~ 9

Author(s):

Eran Klein ◽

Jeffrey Ojemann

Keyword(s):

Informed Consent ◽

Best Practices ◽

Research Risks

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Evidence-Based Nudging: Best Practices in Informed Consent

The American Journal of Bioethics ◽

10.1080/15265161.2015.1074311 ◽

2015 ◽

Vol 15 (10) ◽

pp. 43-45 ◽

Cited By ~ 8

Author(s):

Ricky Munoz ◽

Mark Fox ◽

Michael Gomez ◽

Scott Gelfand

Keyword(s):

Informed Consent ◽

Best Practices ◽

Evidence Based

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Data Collection

Evaluations of Police Suitability and Fitness for Duty ◽

10.1093/med-psych/9780190873158.003.0005 ◽

2020 ◽

pp. 129-192

Author(s):

David M. Corey ◽

Mark Zelig

Keyword(s):

Executive Function ◽

Informed Consent ◽

Data Collection ◽

Best Practices ◽

Psychological Tests ◽

Assessment Instruments ◽

Negative Outcomes

This chapter describes the procedures commonly followed in suitability and fitness evaluations, with a particular focus on the collection of data from three sources routinely required for these assessments. The authors discuss best practices for providing examinees with the necessary elements of disclosure about the evaluation, including its probable uses and potential negative outcomes, and for obtaining the examinee’s informed consent. The chapter includes detailed guidance for selecting assessment instruments, brief descriptions of the psychological tests most commonly used in suitability and fitness evaluations, and discussion of the emerging use of executive function measures in suitability evaluations.

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