Introduction

As a result of COVID restrictions, more and more medical research that would normally be conducted in a clinic, is being moved online. This raises questions about how the consent process can be conducted remotely and how remote or electronic consents can be supported by REDCap.

Disclaimer: Please note that REDCap support staff are not experts in research ethics, regulatory affairs or privacy legislation. This document discusses some options for conducting eConsent which may or may not be appropriate for any given study. Questions regarding the viability of your consent process should be addressed, in the first instance, to your REB.

Risk Based Approach

When deciding on a consent process for a study, investigators should use a risk based approach. It is important to understand what the patient is consenting to and to consider the risks to the individual. Some important considerations might be:

• Are you collecting identifiable health information or other potentially sensitive information from the participant?

• Are you recruiting participants from an ‘at-risk’, handicapped or sensitive population?

• Are you requesting access to the participant’s healthcare records?

• Are you modifying aspects of the participant’s healthcare or treatment as a result of their participation in the study?

• Will the participants be undergoing an experimental procedure or taking an unapproved medication?

• Will you be performing any invasive study procedures?

Elements of Informed Consent

• Regardless of the approach by which informed consent is obtained, all the normal required elements of the consent should be present and documented. These will be dependent on the type of study but may include:

• A description and purpose of the study

• Duration

• Costs to the participant

• Risks associated with participation

• Alternatives to study participation (for example other treatments)

• Payments or compensation for time spent participating in the study

• Discussion of voluntary participation and the right to withdraw at any time

• Consequences of participation or withdrawal, if any.

• Investigator’s contact information and procedure for asking questions about the study.

• Confidentiality of study data

• Authorization to disclose identifiable healthcare information

• Statement of agreement to be completed by the participant

• The participant’s signature (or equivalent) if (required)

• Signature or attestation of the study coordinator or other witness (if required).

Types of Electronic Informed Consent

Implied Consent

Implied consent may be appropriate for simple, low risk studies such as online surveys where the study participant is voluntarily entering data that relates to their health or some other subject matter.

In implied consent the study participant is simply asked to acknowledge a statement that contains the required elements of consent before they complete the study questionnaire. Implied consents are usually anonymous.

Simple Remote Consent

Simple remote consent may be appropriate for more complex but still low risk studies, where the participant is required to identify themselves or supply contact information as part of the consent procedure. Remote consent is not usually anonymous.

In a simple remote consent process the study information presented to the participant may be more detailed than that in an implied consent. So too will be the statement acknowledged by the participant. The contact information may be used to send study questionnaires to the participant over the course of the study. It may also be used to login to the data collection system. An example could be a low risk longitudinal study where participants are required to answer a baseline questionnaire and follow-up questionnaires.

Guided Remote Consent

Guided Remote consent may be suitable for more complex studies such as clinical trials, in which a member of the study team maintains contact with the participant throughout the study. Contact may be through telephone, email or a teleconferencing service such as Google Meet or Zoom.

Guided remote consent is a more complex process in which informed consent is facilitated by a member of the study team. It may be appropriate for higher risk studies or studies where a signed informed consent might normally be required.

Wet or Digital Signature?

Some studies may require a legally binding signature for some aspects of consent. For example:

• Health Canada regulated clinical trials require a “written informed consent”

• In Alberta, consent to access a patient’s medical records also requires a binding signature.

There is some debate as to what constitutes a legally binding signature and although the Government of Canada and the Province of Alberta may allow electronic signatures this is still a grey area and open to interpretation.

In some circumstances a formal process for identifying the participant, applying an electronic signature and enforcing participant login may be appropriate. At the University of Alberta the Health Research Ethics Board (HREB), the Faculty of Medicine and Dentistry’s (FOMD) Privacy Advisor and the Quality Management in Clinical Research group (QMCR) may be able to help with this determination.

Must the Consent be Witnessed?

Once again this appears to be open to some interpretation. For some types of study, such as Health Canada clinical trials, the consent process should be witnessed, but this is not necessary for all types of study and once again you should seek guidance from your REB. Even for regulated clinical trials a witness may not be required if informed consent is achieved electronically. A 2016 guidance document from the US Food and Drug Administration states:

...If any or all of the consent process takes place remotely and is not personally witnessed by study personnel, the electronic system must include a method to ensure that the person electronically signing the informed consent is the subject who will be participating in the research study. 

(FDA - Use of Electronic Informed Consent, Guidance for Institutional Review Boards, Investigators, and Sponsors. December 2016)

Electronic Consent in REDCap

REDCap has a number of features that may be combined to facilitate online consents.

Online Surveys

REDCap has two distinct user interfaces. The “standard” interface, which is used for study setup and data entry by the study team, and surveys which are used to collect data directly from the study participants. Electronic consent documents would normally be delivered to participants using one or more surveys.

Survey setup and administration is a complex topic in REDCap with many features that are outside the scope of this document. We recommend that users wishing to use surveys attend one of our training sessions or email redcap@ualberta.ca for advice.

Public Survey Links

Under some circumstances, REDCap surveys may be configured with a public survey link. This could, for example, be used to recruit study participants. A survey used in this way would either include an appropriate form of consent or would lead to a subsequent consent process.

Automated Survey Invitations

Automated Survey Invitations (ASI) allow REDCap to automatically schedule and send survey invitations to study participants. These are particularly useful in longitudinal projects. In the context of electronic consents, they allow participants to be registered in REDCap by a member of the study team and then be automatically sent consent documents as a REDCap survey.

Survey Login

Once enabled, survey logins force a study participant to authenticate each time they complete a REDCap survey. Depending on the study, identification and ongoing authentication are two important elements of electronic consent and these can be facilitated by survey logins.

eConsent Framework

REDCap’s eConsent Framework adds a feature to a REDCap survey that:

1. Adds a certification page to the end of the survey

2. Saves a ‘frozen’ PDF copy of the completed and certified survey in the study’s file repository

3. Optionally emails a copy of the certified consent to the participant

4. The eConsent Framework does not directly provide for a study coordinator or other third-party to witness the consent. If this is required by your REB then it may be appropriate to add an additional survey or have the study coordinator electronically sign an attestation on a separate form using REDCap’s eSignature feature.

Please note that the language used by the certification stage of REDCap's eConsent is fixed and cannot be changed. If you are preparing new materials for REB approval then these should match the wording used by REDCap.

This is the language used by REDCap as the participant electronically signs using the eConsent framework:

•  I certify that all the information in the document above is correct. I understand that clicking 'Submit' will electronically sign the form and that signing this form electronically is the equivalent of signing a physical document.

Separate Project

For most studies the eConsent process is easier to manage in a separate project. This is particularly important If the electronic consent will contain identifiers, such as the name of the participant, or if the project involves multiple study sites.

Example eConsent Process

The process outlined below is intended to illustrate how electronic consent may be achieved using REDCap. Please confer with your REB when considering an appropriate consent process for your study. (Note that this is an example to illustrate the use of a password. For studies where ongoing data collection is not being performed in REDCap and where consent is being facilitated by a study coordinator, a password may not be required.)

1. The study coordinator contacts a potential participant by telephone, formally identifies the participant and obtains their email address. Optionally, and depending on the study, the coordinator also provides the participant with a unique 4-digit password.

2. The study coordinator registers the participant in the study database, as a result of this, a link to the online electronic consent document is automatically emailed to the participant. This link contains a token which is unique to the study participant.

3. The participant logs into REDCap using the link contained in the email. If required by the study, they must also enter the password provided by the coordinator. They review the consent documents and complete the consent form.

4. The participant applies their electronic signature to the consent form and certifies that the information displayed on the form is accurate. A ‘frozen’ copy of this form is emailed to the participant and stored in REDCap’s file repository.

5. As a result of the participant completing the consent form REDCap emails additional study questionnaires. If required by the study the participant must login to REDCap using their 4-digit code before they can complete these subsequent questionnaires.

For an example of this process in operation try this link.

Example Text for Ethics Applications

The following text may be appropriate to include in your ethics application. It should describe how you plan on identifying the participant AND how you know that it is the participant that is actually completing the form.

Participants are contacted by telephone using the contact telephone number contained in their electronic medical record. During the call, the participant is identified by asking them to provide their date of birth and provincial healthcare number. These are verified by comparing them with the data in the participant's electronic medical record. Once the participant has been identified they are registered in REDCap and REDCap emails them a link to the eConsent form. The link in this email contains a token, which is unique to that study participant. The participant clicks the link and completes the eConsent form while still on the phone with the study coordinator.

If you are using a password then this text is more appropriate...

Participants are contacted by telephone using the contact telephone number contained in their electronic medical record. During the call, the participant is identified by asking them to provide their date of birth and provincial healthcare number. These are verified by comparing them with the data in the participant's electronic medical record. Once the participant has been identified they are registered in REDCap. REDCap generates a unique password and emails the participant a link to the eConsent form. The link in this email contains a token, which is unique to that study participant. The participant clicks the link, logs into REDCap using the password provided by the coordinator, and completes the eConsent form while still on the phone with the study coordinator.

Project Template

The University of Alberta has a template that can be used as the basis for eConsent projects. If you would like to use this template please let us know in the comments section of the project request form.