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

2015 ◽  
Vol 69 (8) ◽  
pp. 462-471 ◽  
Author(s):  
Lindy Marie Fields ◽  
James Douglas Calvert
Keyword(s):  
Informed Consent ◽  
Best Practices ◽  
Cognitively Impaired

Cyber-Situational Awarenss in Clinical Trials Using Wearable Device Technology

2021 ◽  
Vol 10 (1) ◽  
pp. 33-36
Author(s):  
Elizabeth A. Johnson ◽  
Jane M. Carrington
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Best Practices ◽  
Situational Awareness ◽  
Implantable Devices ◽  
Wearable Device ◽  
Sleep Habits ◽  
Privacy Issues ◽  
Trial Participants ◽  
Device Technology

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.

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

2015 ◽  
Vol 8 (4) ◽  
pp. 539-544 ◽  
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.

The Participation of Cognitively Impaired Elderly in Research

2004 ◽  
Vol 5 (4) ◽  
pp. 245-257 ◽  
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.

Evidence-Based Nudging: Best Practices in Informed Consent

2015 ◽  
Vol 15 (10) ◽  
pp. 43-45 ◽  
Author(s):  
Ricky Munoz ◽  
Mark Fox ◽  
Michael Gomez ◽  
Scott Gelfand
Keyword(s):  
Informed Consent ◽  
Best Practices ◽  
Evidence Based

Data Collection

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.

Experimenter Characteristics and Word Choice: Best Practices When Administering an Informed Consent

2014 ◽  
Vol 24 (5) ◽  
pp. 397-407 ◽  
Author(s):  
John E. Edlund ◽  
Jessica L. Hartnett ◽  
Jeremy D. Heider ◽  
Emmanuel J. Perez ◽  
Jessica Lusk
Keyword(s):  
Informed Consent ◽  
Best Practices ◽  
Word Choice

Enhancing informed consent best practices: gaining patient, family and provider perspectives using reverse simulation

2012 ◽  
Vol 38 (9) ◽  
pp. 546-551 ◽  
Author(s):  
Elizabeth Goldfarb ◽  
John A Fromson ◽  
Tristan Gorrindo ◽  
Robert J Birnbaum
Keyword(s):  
Informed Consent ◽  
Best Practices ◽  
Provider Perspectives ◽  
Reverse Simulation
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