We’ve recently had some questions with regard to REDCap and electronic consent. Specifically “does REDCap provide a mechanism that is adequate for providing consent electronically?”.

The answer is that it depends on what the study participant is consenting to.  The REB may approve an electronic consent process however, if you are collecting identifiable healthcare information, you will need to comply with any conditions imposed by the Custodian and meet the Health Information Act’s requirement for a “validated” electronic consent.

The following notes give guidance on this, but it should be noted that these are ethical and legal matters and will depend on study specific procedures. If the research team is unsure they should seek advice from the appropriate University of Alberta or Alberta Health Services departments. At the University of Alberta this may include the Health Research Ethics board (HREB), the Research Ethics Office (REO) and the Information and Privacy Office (IPO).

Participation in Research

Health Canada Regulated Clinical Trial

Division 5 of Canada’s Food and Drug Regulations requires a signed consent document.

Other Research

Consent for research involving human subjects is governed by Chapter 3 of the TCPS2.

TCPS2 states that evidence of consent shall be contained in either a signed consent form or in documentation by the researcher of another appropriate means of consent.  Ultimately, the REB will, using TCPS2 and relevant privacy legislation, make the determination with regard to the form of consent that is appropriate.  Depending on the nature of this research, this may include implied or electronic consent delivered through REDCap. 

Consent for Disclosure of Identifiable Healthcare Information.

Alberta's Health Information Act (HIA) requires that before a custodian (for example Alberta Health or Alberta Health Services) can disclose identifiable health information to a researcher, the individual who is the subject of the information must have consented to this disclosure in accordance with the consent requirements in the HIA (i.e. HIA section 34) unless consent is waived by the Research Ethics Board (HIA section 50 (1)(b)(iv)).  This consent “must be provided in writing or electronically”. Alberta’s Health Information Regulations state that electronic consent is valid only if “the level of authentication is sufficient to identify the individual who is granting the consent”. 

Currently we cannot guarantee that REDCap provides adequate capabilities to comply with this section of the regulations and therefore an electronic consent process may not be approved by the REB or access granted by the data custodian if consent is obtained in this way. However this is to some extent dependent on study processes and should be considered on a case by case basis. 

Consent for Disclosure of Non-Identifiable Health Information.

Disclosure of non-identifiable information by a custodian is authorized under HIA section 32.  In a situation where a custodian (for example AHS or Alberta Health) is matching study data with an administrative data set and then delivering non-identifiable  data to the researcher, section 34 of the Health Information Act does not apply. The study’s informed consent procedure should document the intended use of study data, including any data matching or sharing.

Note: HIA sections 49-55 will apply to custodians disclosing health information or performing data matching to facilitate research.  HIA sections 52 and 54 requires an agreement between the custodian and the researcher and consent may be required by the REB.  Also note that in HIA section 53, the custodian may impose other conditions on the researcher.

The REB should make the determination with regard to the form of consent that is appropriate and this may include implied or electronic consent delivered through REDCap. The researchers must also comply with any conditions that may imposed by the custodian of the data.

References and Relevant Legal Documents

Food and Drug Regulations

Note: Covers informed consent in Health Canada regulated clinical trials.

C.03.311. A sponsor shall ensure that each study is conducted in accordance with good clinical practices and that…

(g) before a study subject participates in the study, a copy of their signed consent form is included in the records for the study;

TCPS2 Chapter 3 – Consent

Note: This document covers consent to participate in a research study.

D. Consent Shall Be Documented

ARTICLE 3.12

Evidence of consent shall be contained either in a signed consent form or in documentation by the researcher of another appropriate means of consent.

APPLICATION

Written consent in a signed statement from the participant is a common means of demonstrating consent, and in some instances, is mandatory (e.g., Health Canada regulations under the Food and Drugs Act, the Civil Code of Québec). However, there are other means of providing consent that are equally ethically acceptable. In some types of research, and for some groups or individuals, written signed consent may be perceived as an attempt to legalize or formalize the consent process and therefore may be interpreted by the participant as a lack of trust on the part of the researcher. In these cases, oral consent, a verbal agreement or a handshake may be required, rather than signing a consent form. In some cultures, the giving and receiving of gifts symbolizes the establishment of a relationship comparable to consent.

Alberta’s Health Information Act Section 34

Note: This document covers consent for disclosure of personally identifying healthcare information.

1. Subject to sections 35 to 40, a custodian may disclose individually identifying health information to a person other than the individual who is the subject of the information if the individual has consented to the disclosure.

2. A consent referred to in subsection (1) must be provided in writing or electronically and must include

   1. an authorization for the custodian to disclose the health information specified in the consent,

   2. the purpose for which the health information may be disclosed,

   3. the identity of the person to whom the health information may be disclosed,

   4. an acknowledgment that the individual providing the consent has been made aware of the reasons why the health information is needed and the risks and benefits to the individual of consenting or refusing to consent,

   5. the date the consent is effective and the date, if any, on which the consent expires, and(f) a statement that the consent may be revoked at any time by the individual providing it.

3. A disclosure of health information pursuant to this section must be carried out in accordance with the terms of the consent.

4. A revocation of a consent must be provided in writing or electronically.

5. A consent or revocation of a consent that is provided in writing must be signed by the person providing it.

6. A consent or revocation of a consent that is provided electronically is valid only if it complies with the requirements set out in the regulations.

Alberta’s Health Information Regulation – Section 6

Note: This document provides specific details relevant to the Health Information Act and therefor only refers to consent required for disclosure of identifiable healthcare information.

1. In this section, “electronic consent” means a consent provided electronically.

2. For the purposes of sections 34 and 59 of the Act, an electronic consent or a revocation of an electronic consent is valid only if the level of authentication is sufficient to identify the individual who is granting the consent or revoking the consent, as the case may be.

REDCap Features for eConsents

Enhanced support for electronic consents was introduced in REDCap version 8.3.0. Additional information can be found in the 8.3.0 release notes and on REDCap's Survey Settings page. There is also a discussion of these features here.