Ethical Benefits and Drawbacks of Digitally Informed Consent

2022 ◽  
pp. 101-123
Author(s):  
Wendy Charles ◽  
Ruth Magtanong
Keyword(s):  
Informed Consent ◽  
Private Information ◽  
Rapid Growth ◽  
Digital Technologies ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Ethical Guidelines ◽  
Data Practices ◽  
User Design ◽  
Digital Methods

As organizations steadily adopt remote and virtual capabilities, informed consent processes are increasingly managed by digital technologies. These digital methods are generating novel opportunities to collect individuals' permissions for use of private information but are blurring traditional boundaries of consent communication and documentation. Therefore, the rapid growth of digital technologies used for informed consent as well as the sheer volume of data resulting from electronic data capture are generating complex questions about individual engagement and data practices. This chapter presents emerging risks, benefits, and ethical principles about digital informed consent methods and technologies. For the areas where digital informed consent creates ethical uncertainties, ethical guidelines and user-design recommendations are provided.

scholarly journals Research Electronic Data Capture (REDCap) electronic Informed Consent Form (eICF) is compliant and feasible in a clinical research setting

2015 ◽  
Vol 2 (3) ◽  
pp. 51 ◽  
Author(s):  
Matthew J. Frelich ◽  
Matthew E. Bosler ◽  
Jon C. Gould
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Data Capture ◽  
Consent Form ◽  
Single Subject ◽  
Electronic Data Capture ◽  
Research Setting ◽  
Electronic Data ◽  
Informed Consent Form ◽  
Nasa Tlx

<p class="abstract"><strong>Background:</strong> Electronic consent for research has shown success in clinical trial models, but has not been rigorously evaluated as an alternative to conventional paper consent.  We sought to design a 21 CFR Part 11 compliant iPad-based electronic Informed Consent Form (eICF) with Research Electronic Data Capture (REDCap). As a secondary aim, we sought to compare subject workload between eICF and paper consent groups.</p><p class="abstract"><strong>Methods:</strong> This is a prospective, randomized study of subjects who completed an iPad-based eICF versus paper consent for research. The eICF was designed with REDCap and presented on an iPad. Subject workload was measured with the NASA Task Load Index (NASA-TLX) and subjective feedback in regards to consent process was collected.</p><p class="abstract"><strong>Results:</strong> A total of 116 subjects were screened for consent. Of which, 51 (44%) subjects provided informed consent and completed all study related procedures. Twenty-five (49%) eICF and 26 (51%) paper consents were completed.  The eICF group rated a significantly greater preference to use the eICF for future research studies (6.4±1.5) compared to the paper consent group (5.0±1.9), p&lt;0.01. There were no significant differences in NASA-TLX Weighted Scale or Total-TLX Scores between groups. One error resulted in the eICF group due to an inadvertent submission by a single subject.</p><p class="abstract"><strong>Conclusion:</strong> In summary, we have demonstrated that an iPad-based eICF designed with REDCap is both 21 CFR Part 11 compliant and feasible in the clinical research setting.  The eICF does not appear to be more technically difficult or demanding than conventional paper consent.</p>

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

scholarly journals 238. Novel Way to Evaluate Antibiotic Use Appropriateness: Moving Towards the “Never Event” Classification by Electronic Algorithm

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S119-S120
Author(s):  
Twisha S Patel ◽  
Lindsay A Petty ◽  
Jiajun Liu ◽  
Marc H Scheetz ◽  
Nicholas Mercuro ◽  
...  
Keyword(s):  
Urine Culture ◽  
Asymptomatic Bacteriuria ◽  
Antibiotic Use ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
False Positivity ◽  
Never Event ◽  
Manual Review

Abstract Background Antibiotic use is commonly tracked electronically by antimicrobial stewardship programs (ASPs). Traditionally, evaluating the appropriateness of antibiotic use requires time- and labor-intensive manual review of each drug order. A drug-specific “appropriateness” algorithm applied electronically would improve the efficiency of ASPs. We thus created an antibiotic “never event” (NE) algorithm to evaluate vancomycin use, and sought to determine the performance characteristics of the electronic data capture strategy. Methods An antibiotic NE algorithm was developed to characterize vancomycin use (Figure) at a large academic institution (1/2016–8/2019). Patients were electronically classified according to the NE algorithm using data abstracted from their electronic health record. Type 1 NEs, defined as continued use of vancomycin after a vancomycin non-susceptible pathogen was identified, were the focus of this analysis. Type 1 NEs identified by automated data capture were reviewed manually for accuracy by either an infectious diseases (ID) physician or an ID pharmacist. The positive predictive value (PPV) of the electronic data capture was determined. Antibiotic Never Event (NE) Algorithm to Characterize Vancomycin Use Results A total of 38,774 unique cases of vancomycin use were available for screening. Of these, 0.6% (n=225) had a vancomycin non-susceptible pathogen identified, and 12.4% (28/225) were classified as a Type 1 NE by automated data capture. All 28 cases included vancomycin-resistant Enterococcus spp (VRE). Upon manual review, 11 cases were determined to be true positives resulting in a PPV of 39.3%. Reasons for the 17 false positives are given in Table 1. Asymptomatic bacteriuria (ASB) due to VRE in scenarios where vancomycin was being appropriately used to treat a concomitant vancomycin-susceptible infection was the most common reason for false positivity, accounting for 64.7% of false positive cases. After removing urine culture source (n=15) from the algorithm, PPV improved to 53.8%. Conclusion An automated vancomycin NE algorithm identified 28 Type 1 NEs with a PPV of 39%. ASB was the most common cause of false positivity and removing urine culture as a source from the algorithm improved PPV. Future directions include evaluating Type 2 NEs (Figure) and prospective, real-time application of the algorithm. Disclosures Marc H. Scheetz, PharmD, MSc, Merck and Co. (Grant/Research Support)

How Did a Multi-Institutional Trial Show Feasibility of Electronic Data Capture in Older Patients With Cancer? Results From a Multi-Institutional Qualitative Study (Alliance A171902)

2021 ◽  
pp. 442-449
Author(s):  
Nichole A. Martin ◽  
Elizabeth S. Harlos ◽  
Kathryn D. Cook ◽  
Jennifer M. O'Connor ◽  
Andrew Dodge ◽  
...  
Keyword(s):  
Older Patients ◽  
Electronic Devices ◽  
Data Entry ◽  
Data Capture ◽  
Data Availability ◽  
Electronic Data Capture ◽  
Wireless Internet ◽  
Electronic Data ◽  
Patients With Cancer ◽  
Patient Reported

PURPOSE New technology might pose problems for older patients with cancer. This study sought to understand how a trial in older patients with cancer (Alliance A171603) was successful in capturing electronic patient-reported data. METHODS Study personnel were invited via e-mail to participate in semistructured phone interviews, which were audio-recorded and qualitatively analyzed. RESULTS Twenty-four study personnel from the 10 sites were interviewed; three themes emerged. The first was that successful patient-reported electronic data capture shifted work toward patients and toward study personnel at the beginning of the study. One interviewee explained, “I mean it kind of lost all advantages…by being extremely laborious.” Study personnel described how they ensured electronic devices were charged, wireless internet access was up and running, and login codes were available. The second theme was related to the first and dealt with data filtering. Study personnel described high involvement in data gathering; for example, one interviewee described, “I answered on the iPad, whatever they said. They didn't even want to use it at all.” A third theme dealt with advantages of electronic data entry, such as prompt data availability at study completion. Surprisingly, some remarks described how electronic devices brought people together, “Some of the patients, you know, it just gave them a chance to kinda talk about, you know, what was going on.” CONCLUSION High rates of capture of patient-reported electronic data were viewed favorably but occurred in exchange for increased effort from patients and study personnel and in exchange for data that were not always patient-reported in the strictest sense.

scholarly journals Assessment of the Appropriateness of the i-CONSENT Guideline Recommendations for Improving Understanding of the Informed Consent Process in Clinical Studies

2021 ◽  
Author(s):  
Jaime Fons-Martínez ◽  
Cristina Ferrer-Albero ◽  
Javier Diez-Domingo
Keyword(s):  
Informed Consent ◽  
Clinical Studies ◽  
Informed Consent Process ◽  
Consent Process ◽  
Ethical Guidelines ◽  
Potential Participant ◽  
Virtual Meeting ◽  
Continuous Interaction ◽  
And Gender ◽  
First Contact

Abstract Background: The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.Methods: An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.Results: Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged appropriate; 19 were judged uncertain; and none was judged inappropriate. After the second round, 9 uncertains changed to appropriate. All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = extremely inappropriate, 5 = uncertain, 9 = extremely appropriate).The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest uncertainty rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.Conclusions: The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged appropriate by all stakeholders involved in the informed consent process.

scholarly journals Web Based Data Capture for Clinical Research

10.28945/3201 ◽  
2008 ◽  
Author(s):  
Stephen Smith ◽  
Samuel Sambasivam
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Device ◽  
Rapid Development ◽  
Research Data ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Proof Of Concept ◽  
Web Based ◽  
Tools And Techniques

Electronic Data Capture (EDC) is increasingly being used in the pharmaceutical, biotech and medical device industries to gather research data worldwide from doctors, hospitals and universities participating in clinical trials. In this highly regulated environment, all systems and software must be thoroughly tested and validated, a task that is burdensome in terms of time and cost. Starting with database structures that are designed to be copied easily, this paper proposes a simple framework that allows for rapid development and minimal testing. The framework includes tools for building modules, for copying modules from one trial to the next, and tools to validate that the modules are the same as modules that have been fully tested previously. A proof-of-concept prototype has been built to demonstrate certain tools and techniques that can be used when designing and building a simplified EDC interface.

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