Remote Consent Clinical Research

Authors

  • Preethi Sriram

DOI:

https://doi.org/10.17140/CTPOJ-2-109

Keywords:

e-consent, Remote consent, Clinical trials, Rare disease, Time-sensitive

Abstract

Recruitment in clinical research trials can be challenging in trials that are time-sensitive and/or are rare disease and critical care
trials. One of the hurdles for recruitment in these types of clinical trials is due to the consent process, and the need to have
consent of the patient within a certain timeframe, or the patient unable to consent for themselves. This paper will discuss the
usage of the utilization of remote consent options for these trials.

References

Welch BM, Marshall E, Qanungo S, et al. Teleconsent: A nov-el approach to obtain informed consent for research. Contempo-rary Clinical Trials Communications. 2016; 3: 74-79. doi: 10.1016/j. conctc.2016.03.002

Crow RA, Hart KA, McDermott MP, et al. A checklist for clini-cal trials in rare disease: Obstacles and anticipatory actions-lessons learned from the FOR-DMD trial. Trials. 2018; 19(1): 291. doi: 10.1186/s13063-018-2645-0

Chamberlain JM, Lillis K, Vance C, et al. Perceived challenges to obtaining informed consent for a time-sensitive emergency de-partment study of pediatric status epilepticus: Results of two focus groups. Acad Emerg Med. 2009; 16(8): 763-770. doi: 10.1111/j.1553- 2712.2009.00455.x

Khairat S, Ottmar P, Sleath B. Facilitating the informed consent process using teleconsent: Protocol for a feasibility and efficacy study. JMIR Res Protoc. 2018; 7(10): e11239. doi: 10.2196/11239b Submit your article to this journal | https://openventio.org/submit-manuscript/ Commentary | Volume 2 | Number 1 | Sriram P

University of Wisconsin-Madison. Budget in brief budget re-port 2017-2018. Web site. https://chancellor.wisc.edu/content/ uploads/2018/02/Budget-in-Brief-2017-18-pdf.pdf. Accessed September 28, 2019.

U.S. Department of Health and Human Services, Office for Hu-man Research Protections (OHRP), Food and Drug Administra-tion (FDA), et al. Use of electronic informed consent in clinical investigations-questions and answers: Guidance for institutional review boards, investigators, and sponsors 2016. Web site. https:// www.fda.gov/media/116850/download. Accessed at September 28, 2019.

Smith A, U.S. Pew Research Center: Internet, Science & Tech-nology. Smartphone Use in 2015. Web site. http://www.pewin-ternet.org/2015/04/01/us-smartphone-use-in-2015/. Accessed September 28, 2019.

Wilbanks J. Design issues in e-consent. J Law Med Ethics. 2018; 46(1): 110-118. doi: 10.1177/1073110518766025

Pandotra T. Electronic Informed Consent - Benefits & Chal-lenges. Web site. https://www.linkedin.com/pulse/electonic-in-formed-consent-benefits-challenges-tarun-pandotra/. Accessed September 28, 2019.

Downloads

Published

2019-10-30

How to Cite

Preethi Sriram. (2019). Remote Consent Clinical Research. Clinical Trials and Practice – Open Journal, 2(1), 22–24. https://doi.org/10.17140/CTPOJ-2-109