# Teleconsent: Enabling informed consent for remote care and research

> **NIH NIH R42** · DOXY.ME, LLC · 2022 · $863,404

## Abstract

PROJECT SUMMARY .
Informed consent is legal and ethical requirement in health care and research that assures that individuals
have the autonomy to make informed care and research decisions at their own volition, under no coercion or
undue influence, and with reasonable understanding of the risks, benefits, and responsibilities of their
decisions as they would in-person. Obtaining informed consent is a required yet challenging requirement that
can impede participation in health care and clinical research. As a result of the COVID-19 pandemic,
telemedicine has proven to be an effective way to deliver health and research services to patients remotely.
Yet, providers and researchers (“consenters”) are still required to obtain and document informed consent
from patients and research participants (“consentees”). Conventional informed consent approaches are not
compatible with telemedicine presenting logistical, technical and security barriers such as travel and cost
burdens, low comprehension, confusion and dissatisfaction, alterations in clinical workflows, compliance
challenges, and concern over clinical equipoise. Teleconsent is an innovative and proven solution for
obtaining remote informed consent developed by Doxy.me, Inc and Medical University of South Carolina.
Teleconsent allows consenters to (1) meet and discuss the informed consent by video with consentees over a
telemedicine platform, (2) share and collaboratively complete the consent document in real-time, and (3)
generate electronically signed copies of the consent for immediate download by both parties. Our Phase I
STTR research identified enhancements such as an improved mobile interface, interface for consenters to
build and manage consent forms, and the ability for consentees to read consent forms in advance. Optimizing
teleconsent to meet the demands of its users is critical, especially during these unprecedented times of the
COVID-19 pandemic when most individuals engage in remote care and research. The objective of this Phase
II proposal is to refine and expand teleconsent features and deploy them on a large-scale via doxy.me. To
achieve this objective, we will refine prototype teleconsent enhancements via iterative user experience assets
design and evaluate them employing formal usability methods (Aim 1); build an enhanced, scalable
teleconsent interface using Large-Scale Scrum principles and test the new teleconsent features via a formal
user acceptance testing program (Aim 2); and implement teleconsent at a large scale with doxy.me providers
and researchers to determine performance and measure impact using quantitative metrics for success (Aim
3). Achieving these aims to expand teleconsent features and conduct a large-scale implementation will
increase the capacity of consenters to improve the efficiency of the remote informed consent, which will
improve recruitment, simplify consent workflows, and enhance telemedicine engagement.

## Key facts

- **NIH application ID:** 10325737
- **Project number:** 2R42TR004277-02
- **Recipient organization:** DOXY.ME, LLC
- **Principal Investigator:** Brandon M Welch
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $863,404
- **Award type:** 2
- **Project period:** 2022-07-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325737

## Citation

> US National Institutes of Health, RePORTER application 10325737, Teleconsent: Enabling informed consent for remote care and research (2R42TR004277-02). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10325737. Licensed CC0.

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