Can StudyTRAX Be Used For Electonic Informed Consent?

Overview

It should be noted that a gold standard EIC policy applicable across studies and universities/organizations has NOT emerged. Thus, it will be important to include in your IRB submission your plans and rationale for EIC.

StudyTRAX has been used for electronic informed consent (EIC) in a number of studies. In general, the IRB is NOT likely to allow only EIC for experimental treatment studies and/or studies with planned variation from standard of care. In such cases, EIC can be helpful for delivering standardize, engaging electronic content (e.g., videos, educational materials), but is not considered to be in-lieu of a face-to-face conversation with the subject to ensure adequate possession of information, understanding, decision-making capacity and choice. In this case, a full-signature is required (i.e., not a check-box). Conversely, the IRB does allow EIC for studies that do not involve significant risk or changes in standard of care (e.g., survey research, patient registries).

Setup Options

Electronic consent can take several forms, depending on what is appropriate. For example, participants could check a check box, enter initials, etc. Other electronic multi-media could be used:

video of investigator with diagrams, charts and demonstration of procedures;
text with audio links (to listen to text or further explanation);
interactive website containing a walkthrough of the procedures, multi-media, etc.

Example

Note: Only showing bottom part of form.

Waiver of Documentation of Informed Consent

According to Department of Health and Human Services (DHHS), a study can qualify for a waiver of documentation of consent according to two criteria.

45 CFR 46.117(c)(1) – 1) the only record linking the subject and the research is the consent document and 2) the principal risk of the research is the potential harm from a
breach of confidentiality

45 CFR 46.117(c)(2) – 1) the research presents no more than minimal risk of harm to subjects and 2) involves no procedures for which written consent is normally required outside of the research context
The applicable FDA regulations are slightly different than those of DHHS.

The FDA uses only 45 CFR 46.117(c)(2)

Example of Organization Policy (Partners HealthCare)

Informed_Consent_in_Online_Research_110411.pdf

Informed Consent Components

For Consent to be informed the process must address at a minimum 5 basic elements:

A description of the proposed treatment
A description of the diagnosis for which it is being done
The purpose
Benefits
Risks and alternative therapies

References