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.

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.

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.

Steps to add consent data

1. Navigate to participant and click on the 'Consents'

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2. Click 'Edit Responses' to add the participant's response

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3. Enter the details in the field and click on 'Update'

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4. You can also upload a signed consent form by clicking the ‘Upload form’ button beside the 'Edit Responses' option

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5. Select the required file and click 'Upload'

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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 multiple participants.

Refer 'Upload Consents' to add/update consent responses or consent form in bulk.

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.