Every clinical trial or biobank collection protocol needs to obtain 'informed consent' of the participants. It consists of multiple consent statements depending upon the nature of study. The biobank/hospital needs to capture the response of the participants to these statements and track them from time to time.

OpenSpecimen allows the user to track consents for participants at the protocol level. Consents can be set as statements for which responses can be captured for every participant. The user can also upload a signed consent form.

Create consent statements

Coded consent statements have to be created at the system level by a Super admin or an Institute admin first to set them at the protocol level. These coded statements are standardized and can be used in multiple collection protocols across Openspecimen for a particular institute.

Refer ‘Coded Consents‘ to create new consent statements.

Set Consent statements to the protocol

The newly created or already existing consent statements can be set to a collection protocol. This will help in directly adding the response of the participants involved in that collection protocol.

 Refer to the 'Setting up consents' section of the wiki page.

Add consent responses or upload signed consent form

After the consent statements are set to a collection protocol, the user can add the responses of the participants. Also, the user can upload the signed consent form of the participant registered under that protocol.

Refer ‘Enter consent responses’ section of the ‘Registering Participants’ page to add responses or upload consent form.

Save/Update consents in bulk

There are cases where many participants can be involved in the protocol. In such cases, instead of adding/updating responses for each participant one by one, the user can add/update the consent responses or signed consent forms in bulk for a multiple participants.

Refer ‘Save/Update consents’ to add/update consent responses or consent form in bulk.

Consent tracking in specimen distribution

It is important for a biobank to ensure that the specimen distributed to a researcher is not used for any purpose for which the donor of the specimen had not given his/her consent.

You can set consent statements at the distribution protocol level. The system will verify these consents against the consents of the specimens being distributed. The specimen's distribution is restricted if the consents are not matching. 

Refer 'Adding Consent Statements' in 'Distribution Protocol' page for more information.