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Effect of a Multimedia Patient Decision Aid to Supplement the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Pre-Post Quasi-Experimental Study

Effect of a Multimedia Patient Decision Aid to Supplement the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Pre-Post Quasi-Experimental Study

Informed consent is a complex process that aims to discuss with patients complete, clear, and easy-to-understand information about a medical procedure, its treatment indications, associated risks and benefits, and other treatment alternatives using a two-way communication with a teach-back mechanism. Signing the consent form by the patient does not always indicate the process was informed and does not cover the health care team members from liability or protect them against lawsuits.

Azizeh K Sowan, Arlienita R Beraya, Adrian Carrola, Charles Reed

JMIR Med Inform 2018;6(4):e11056


Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

These search strings consisted of keywords such as electronic (informed) consent, dynamic (informed) consent, e-consent, digital (informed) consent, interactive (informed) consent, online (informed) consent, multimedia, and telemedicine. The search was restricted to studies published in English after January 1, 2010. This timeframe was justified by the fact that electronic informed consent in biomedical research gained popularity only in the last decade and that technology has evolved quite rapidly.

Evelien De Sutter, Drieda Zaçe, Stefania Boccia, Maria Luisa Di Pietro, David Geerts, Pascal Borry, Isabelle Huys

J Med Internet Res 2020;22(10):e19129


A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial

A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial

As shown in Table 1, both groups will be exposed to the same informed consent content but delivered through different channels—a digital informed consent app (experimental) or paper informed consent or usual practice (control). The content of both versions of the informed consent describes the requirements for participating in a hypothetical clinical trial for a fake prescription drug for FXS. Both versions include IRB-required information (eg, study procedures, study duration, and compensation).

Robert D Furberg, Melissa Raspa, Anne C Wheeler, Lauren A McCormack, Donald B Bailey

JMIR Res Protoc 2018;7(11):e10360


Foundations for Meaningful Consent in Canada’s Digital Health Ecosystem: Retrospective Study

Foundations for Meaningful Consent in Canada’s Digital Health Ecosystem: Retrospective Study

Implementing a consent management system would empower users to exercise their data-sharing preferences [8,9]. Canadian legislation also requires consent for the collection, use, and disclosure of personal information and PHI; however, consent is seldom transparent or informed, leaving patients unaware of how their data are used and with minimal control over their data [10].

Nelson Shen, Iman Kassam, Haoyu Zhao, Sheng Chen, Wei Wang, Sarah Wickham, Gillian Strudwick, Abigail Carter-Langford

JMIR Med Inform 2022;10(3):e30986


Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial

Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial

Previous Web-based research with MSM has also shown that brief consent summaries may improve consent information comprehension over a standard consent process, but this research was done before Web-based interactions became more photo- or video-focused and therefore we did not examine this alternative [19,25]. The objective of our study was to assess if comprehension of key informed consent facts improved through the use of these new techniques versus a standard text-based informed consent form.

Eric William Hall, Travis H Sanchez, Aryeh D Stein, Rob Stephenson, Maria Zlotorzynska, Robert Craig Sineath, Patrick S Sullivan

J Med Internet Res 2017;19(3):e64


The Art of Surgery: Balancing Compassionate With Virtual Care

The Art of Surgery: Balancing Compassionate With Virtual Care

Consent for email communication needs to be obtained, and the patient informed that personal health information will be protected. This information will not be collected, disclosed, or utilized more than reasonably necessary and will be obtained securely and privately [9]. Care provided through virtual means does not replace the need for physical examination or an in-person visit for certain disorders or urgent problems.

Elisheva Tamar Anne Nemetz, David Robert Urbach, Karen Michelle Devon

J Med Internet Res 2020;22(8):e22417


Connected Medical Technology and Cybersecurity Informed Consent: A New Paradigm

Connected Medical Technology and Cybersecurity Informed Consent: A New Paradigm

The practice of medicine is built on the foundation of clinician-patient engagement, and consent is a key pillar supporting this essential relationship [1]. As medicine has shifted from a paternalistic, subordinating art to a collaborative effort of shared goal setting and decision making between parties, so too has the understanding of the ethics and acquisition of consent evolved. It is widely acknowledged that consent must be informed.

Jeffrey Tully, Andrea Coravos, Megan Doerr, Christian Dameff

J Med Internet Res 2020;22(3):e17612


Facilitating the Informed Consent Process Using Teleconsent: Protocol for a Feasibility and Efficacy Study

Facilitating the Informed Consent Process Using Teleconsent: Protocol for a Feasibility and Efficacy Study

Informed consent readability and comprehension continue to be a major issue; a participant’s understanding during the consent process cannot easily be assessed by telephone or obtaining consent through an Web-based form [15,16].

Saif Khairat, Paige Ottmar, Betsy Sleath, Brandon Welch, Suparna Qanungo, Michelle Nichols, Jihad S. Obeid

JMIR Res Protoc 2018;7(10):e11239


Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior

Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior

The reduced barrier to entry for participation in online biomedical research and the sensitivity of the resultant data highlight the importance of informed online consent processes and require us to reevaluate their effectiveness and potential to enhance the consent deliberation process in this new context. Electronic consent poses new challenges when contrasted to traditional consent processes.

Martina Balestra, Orit Shaer, Johanna Okerlund, Lauren Westendorf, Madeleine Ball, Oded Nov

J Med Internet Res 2016;18(7):e197


Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study

Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study

Informed consent of participants is fundamental to the ethical practice of clinical research. Disclosure, voluntariness, and decisional capacity make up the core of valid informed consent processes [1-3]. Since the adoption of the Declaration of Helsinki in 1964, regulatory authorities in countries around the world have further codified the elements of informed consent, for example the 8 requirements described in the US Code of Federal Regulations, title 45, section 46.116 [4].

Megan Doerr, Amy Maguire Truong, Brian M Bot, John Wilbanks, Christine Suver, Lara M Mangravite

JMIR Mhealth Uhealth 2017;5(2):e14