Electronic Consent to Improve Access to Research Opportunities
The Provincial Health Services Authority (PHSA) delivers province-wide specialized health services through its services and programs. PHSA’s research community provides opportunities for patients to access important studies across a wide range of health domains but participation is often limited to those who can attend a face-to-face meeting and sign a paper-based consent form. In the past, researchers have attempted to overcome this participation barrier by asking participants to email, scan, mail, or fax signed consent forms but these methods are cumbersome and less than ideal from a privacy and security perspective. To resolve this issue, the BC Children’s Hospital (BCCH) Research Data Management Team is now offering electronic-consent (e-consent) to researchers across the PHSA.
E-consent is a platform for consenting research participants either on site or at home using a computer-based consent form rather than traditional paper documentation. Consent forms can be implemented in a REDCap survey via computer, mobile phone, or tablet. The REDCap platform at BCCH is a pre-approved tool that is available to all PHSA researchers and has undergone extensive security and privacy review. When using the BCCH instance of REDCap, the consent form data are stored on a private, relational MySQL database at the data centre which is located on-site at BC Children’s Hospital in Vancouver, BC. Research studies that use this tool are captured under the current privacy impact assessment and security review and are not required to undergo any additional reviews after Research Ethics Board (REB) review and approval is secured.
The BCCH Research Data Management Team has already published
E-Consent Tips and Tricks
on its website to educate the community and both PHSA REBs have been consulted throughout the process to ensure that the new offering is both privacy and ethics compliant. It is important to note that we have not investigated if e-consent would be acceptable for sponsored clinical trials and/or FDA regulated studies. This use is yet to be determined and will be initiated at the request of interested REB partners.
PHSA Research Services supports advancing the use of e-consent as an alternative method of consent for patients across the PHSA. It will help to foster equity in recruitment since it is capable of reaching participants from across the province or with limited mobility with ease. It will also empower patients and their families by encouraging a better understanding of the risks and benefits of research participation by facilitating the production of multimedia patient-centered consent processes. We hope you will investigate this new tool and how it might work for your research studies.