Human participation is the basis of health research, and guaranteeing the security and privacy of participants is essential. The first step for researchers in health studies is obtaining informed consent, usually in the shape of consent forms signed by study subjects. Despite its importance, the process of consent management is fallible and subjected to many possible misconducts.
The main deficiencies related to consent, according to the FDA, are: the failure to obtain informed consent; use of expired, incomplete or non-validated forms; failure to provide copies of the forms to study subjects; missing documents; and changes made to documents by hand and without the approval of ethics review boards. These problems become more complex considering that consent is not a static process and re-consent has to be sought in several cases. For example, when new risks are discovered or there is a worsening of the medical condition of a participant, which can impair his cognitive ability to give proper consent. In addition, there are situations where consent needs to be obtained not only for participants but also for co-habitants, caregivers or legal guardians.
Introducing blockchain into the consent process can improve the safety, security and privacy of research stakeholders in healthcare studies. Blockchain can provide an immutable and timestamped log of consent, making the process more transparent for everyone involved. Participants will be able to monitor, manage, and revoke their consent at any time. Through the use of cryptographic techniques, participants will also be able to ensure the safety of the study by making sure that they are reviewing the latest version of the consent forms approved by ethics boards. This would also make obtaining, tracking and updating patient consent easier for the researchers.