Problem Statement:

Consent statements in OpenSpecimen are not coded or structured in terms of an ontological standard. Searching for types of consent in OpenSpecimen is problematic and is usually only completed by searching for text terms in the statement itself. A new method for categorizing and editing consent in OpenSpecimen is needed.

Possible Mitigations:

• Usage of a consent ontology
• Integration with IRB systems
• Link consent to an external management system
• Utilize existing consent ontologies where possible, RPMS being a possible choice. Permission concepts for procedures exist in SNOMED-CT and in LOINC however they are procedural based more than for generalized research usage. If none are acceptable a new group of concept types could be proposed and added to OpenSpecimen.

Possible Implementations:

• Integrate with local IRB management systems to insert consent statements into OpenSpecimen at the time of automated patient registration and protocol construction.
• Create a more robust consent management and statement statement editor within OpenSpecimen
• Add consent ontology (RPMS) to permissible values

Functional Use Case:

Consent tier statements are still entered as needed per protocol, but a coded type could be added to the creation form for consent statements. A short list of consent types (currently targeted from RPMS as children of the Consent entity in the RPMS owl file) are used to populate a select list for association to the consent tier text statements. If NCI

A UI change would be needed to allow for adding consent tier statements with consent types and for management of consent tiers associations.

Initial break down of functional requirements:

1. As a OpenSpecimen administrator I need to map consent statements that are not mapped by the researcher.
   1. Create admin UI to add mappings to unmapped consent statements.
2. As a OpenSpecimen administrator I need to add new consent types when required.
   1. Create admin UI to update/add/delete consent categories. (RPMS standards and local categories.)
3. As a researcher, I need to search by types of consent and consent responses.
   
   1. Update database to support linking consent tier statements to RPMS standard categories.
4. As a PI, I need to select standard statements when possible.
   1. Update consent UI to support selection of existing standard terminologies.
5. As a PI, I need to enter consent statements that are not currently in OpenSpecimen.
   1. Continue functionality of entering consent statements, but allow for the PI to map text to the standard ontology.
6. PLEASE ADD MORE REQUIREMENTS AND COMMENT ON THE DOCUMENT IN THE COMMENTS SECTION

Mock-ups and Wireframes:

TDB

Other Documentation:

Information on RPMS:

Health Sciences South Carolina ( http://www.healthsciencessc.org ) has released RPMS as open source. One possible target for consent management could be this product, but certainly other IRB management systems could be supported to pre-populate consent statements/responses.

Source code repo for the RPMS application https://github.com/HSSC/RPMS

The current owl file of the permissions system is stored on the a wiki at Recombinant Data (http://open.recomdata.com/rpms.php) but available to registered users.