Teleconsent: A novel approach to obtain informed consent for research

Welch, Brandon M.; Marshall, Elizabeth; Qanungo, Suparna; Aziz, Ayesha; Laken, Marilyn; Lenert, Leslie; Obeid, Jihad S.

doi:10.1016/j.conctc.2016.03.002

Cited by 82 publications

(88 citation statements)

References 28 publications

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“…Other options to consent research participants have become available since this study began, and these may have reduced study burden on clinic staff while also facilitating more efficient clinic enrollment. For example, video consent via a HIPAA-compliant service such as doxy.me [47] or electronic consent via REDCap paired with a phone call would allow each participant to be connected in real time to an offsite member of the research team to complete consent. This procedure likely would decrease burden on inclinic staff.…”

Section: Discussionmentioning

confidence: 99%

Nicotine replacement therapy sampling via primary care: Methods from a pragmatic cluster randomized clinical trial

Dahne

Wahlquist

Boatright

et al. 2018

Contemporary Clinical Trials

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Background: Primary care is the most important point of healthcare contact for smokers. Brief physician advice to quit, based on the 5As/AAR model, offers some efficacy but is inconsistently administered and has limited population impact. Nicotine replacement therapy (NRT) sampling, defined as provision of a brief NRT starter kit, when added to the 5As/AAR, is well-suited to primary care because it is simple, brief, and can be provided to all smokers. This article describes the design and methods of an ongoing comparative effectiveness trial testing standard care vs. standard care + NRT sampling within primary care. Methods: Smokers were recruited directly from primary care practices between July 2014 and December 2017 within an established network of South Carolina clinics. Interventions were delivered randomly by clinic personnel, and phone-based follow-ups were centrally coordinated by research staff to track outcomes through six months post-intervention. Primary study aims are to examine the impact of NRT sampling on smoking, inclusive of cessation, quit attempts, and uptake of evidence-based treatment. Results: Twenty-two clinics were recruited. Across clinics, patient census ranged from 985 to 10,957 and number of providers ranged from 1 to 63. Average patient age across clinics was 52.9 years and smoking prevalence across ranged from 10.6% to 28.5%. Conclusion: Improving the effectiveness and reach of brief interventions within primary care could have a considerable impact on population quit rates. We consider the advantages and disadvantages of key methodological decisions relevant to the design of future primary care-based cessation trials.

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Section: Discussionmentioning

confidence: 99%

Nicotine replacement therapy sampling via primary care: Methods from a pragmatic cluster randomized clinical trial

Dahne

Wahlquist

Boatright

et al. 2018

Contemporary Clinical Trials

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“…An online questionnaire can test the participants' understanding of the informed consent. In addition to the online information the participants have the opportunity to ask questions and discuss relevant topics with the investigator through a phone or online call before giving the consent [11,12]. Furthermore, a limited number of study sites are involved in VCT.…”

Section: Virtual Clinical Trialsmentioning

confidence: 99%

Virtual Clinical Trials: Perspectives in Dermatology

Ali

Zibert²,

Thomsen

2020

Dermatology

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Background: The cost of developing a new drug is approximately USD 2.6 billion, and over two-thirds of the total cost is embedded in the clinical-testing phase. Patient recruitment is the single biggest cause of clinical trial delays, and these delays can result in up to USD 8 million per day in lost revenue for pharmaceutical companies. Further, clinical trials struggle to keep participants engaged in the study and as many as 40% drop out. To overcome these challenges pharmaceutical companies and research institutions (e.g., universities) increasingly use an emerging concept: virtual clinical trials (VCT) based on a remote approach. Summary: VCT (site-less) are a relatively new method of conducting a clinical trial, taking full advantage of technology (apps, monitoring devices, etc.) and inclusion of web platforms (recruitment, informed consent, counselling, measurement of endpoints, and any adverse reactions) to allow the patient to be home-based at every stage of the clinical trial. Studies have shown that VCT are not only operationally feasible, but also successful. They have higher recruitment rates, better compliance, lower drop-out rates, and are conducted faster than traditional clinical trials. The visual nature of dermatological conditions, the relative ease in evaluating skin diseases virtually, and the fact that skin diseases often are not life-threatening and rarely require complex examinations make VCT very attractive for dermatological research. Further, making correct diagnoses based on photographs and patient symptomatology has always been part of the dermatologist’s routine. Thus, VCT are in many ways made for dermatology. Herein we describe VCT and their implications in dermatological research.

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“…Teleconsent was found to be most well received at hospitals that already have telemed services integrated into their current standard of care. 8 Paperless enrollment is recommended, but when not possible, the recommendation to use disposable pens, sterilize clipboards, and minimize entrances into the patient room were cited as strategies that could aid in infection control. Where appropriate, instead of leaving to make a photo copy of a signed consent form, consider holding the document up to the window and having a colleague taking a photo using a HIPAA-compliant device to document consent.…”

Section: Covid-19mentioning

confidence: 99%