C. Consent for Clinical Trial Use Sequence

For applications such as clinical trials, the distribution of composite instances in Studies, whether containing identifying information or partially or completely de-identified, may need to be controlled. Permission for distribution is usually granted under the control of the patient (through informed consent), the ethics committee or institutional review board responsible for the study, and the sponsor of the study through contractual means. The Consent for Clinical Trial Use Sequence (0012,0083) is intended to encode the result of the consent process to allow appropriate subsequent handling of the instances.

The defined terms for Distribution Type (0012,0084) mean that consent has been issued to distribute for the purpose of:

NAMED_PROTOCOL - conducting the protocol named in Clinical Trial Protocol ID (0012,0020)

RESTRICTED_REUSE - re-use for restricted purposes (not specified here) other than those for which the instances were originally created

PUBLIC_RELEASE - release to the general public for re-use without restriction

Notes: 1. There is no intent to convey in this sequence further details of the often complex consent and approval process. Further information about the protocol and ethics committee may be found in the Clinical Trials modules, if present.

2. There is no identification of an individual responsible for the approval or granting consent, since in the case of a clinical trial subject granting informed consent, the presence of this information would breach de-identification requirements.

3. Multiple sequence items may be present; for example a Study may be approved for distribution for conducting multiple explicitly named protocols.

4. Whether or not the instances have been adequately de-identified for any particular purpose of distribution is not defined by the Attributes in the Consent for Clinical Trial Use Sequence (0012,0083). Other Attributes address this, such as Patient Identity Removed (0012,0062), De-identification Method (0012,0063), De-identification Method Code Sequence (0012,0064) and Burned In Annotation (0028,0301). See also PS 3.15 Application Level Confidentiality Profiles.

5. It is possible that the list of Defined Terms for Distribution Type (0012,0084) may be extended in future for other purposes, not necessarily related to the conduct of clinical trials.