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:*Facilitate contact with an investigator or obtain their written authorization to share their interest in study participation with the investigators and to be contacted by them. The Honest Broker would not directly contact the patient. | :*Facilitate contact with an investigator or obtain their written authorization to share their interest in study participation with the investigators and to be contacted by them. The Honest Broker would not directly contact the patient. | ||
:*After secondary review by the Associate Vice Chancellor for Clinical Research, an Honest Broker may provide the research investigator with a list of potentially eligible patients who have agreed to be contacted for research studies they are eligible for based on their election on the Conditions of Treatment form or consistent with the Human Research Protection Program Policy #3.4 “Use of Protected Health Information in Research and Registries” for further information. | :*After secondary review by the Associate Vice Chancellor for Clinical Research, an Honest Broker may provide the research investigator with a list of potentially eligible patients who have agreed to be contacted for research studies they are eligible for based on their election on the Conditions of Treatment form or consistent with the Human Research Protection Program Policy #3.4 “Use of Protected Health Information in Research and Registries” for further information. | ||
*Honest Broker Data Requests: Individuals requesting PHI or de-identified data shall complete the UNMC/Nebraska Medicine EHR Service Request | *Honest Broker Data Requests: Individuals requesting PHI or de-identified data shall complete the [https://unmcredcap.unmc.edu/redcap/surveys/?s=9TsTE2UGsM UNMC/Nebraska Medicine EHR Service Request Form] (research), the [http://newintranet.nebraskamed.com/AnalyticsRequest/Login.aspx?ReturnUrl=%2fanalyticsrequest%2f Analytics Request Form] (performance improvement) or another similar form. | ||
The | ===Honest Broker Certification Criteria=== | ||
*Appointment: Honest Brokers shall not be a part of the research team for which they are performing honest broker services, unless approved by the ACE Privacy Officer, the Associate Vice Chancellor for Clinical Research and the Chief, Quality/Outcomes Officer. | |||
Nebraska Medicine | *Education and Training: The proposed Honest Brokers responsible for a research data source must complete education and training, currently mandated by the IRB for all research investigators, prior to submitting an application. | ||
*The individual or the organization or team must submit an [http://www.unmc.edu/hipaa/_documents/application-for-honest-broker-certification.pdf Application for Honest Broker Certification Form] to become part of the UNMC Honest Broker System. | |||
:*The Honest Broker Certification applications are available at http://www.unmc.edu/hipaa/forms/index.html. | |||
"*Applications should be submitted to the Privacy Officer for the ACE. | |||
*Attestation of Agreement: All Honest Brokers must sign a written agreement that they will abide by all relevant ACE policies including continuing adherence to the ACE Honest Broker certification criteria section of this policy. | |||
*Certification, Approval, and Maintenance | |||
:*Initial Review and Approval: The ACE Privacy Officer, the Associate Vice Chancellor for Clinical Research and the Chief, Quality/Outcomes Officer will review and approve Honest Broker applications and related documentation to determine that satisfactory evidence has been presented to meet or exceed the following certification criteria: | |||
::*Written documentation of the processes and/or systems to be used to develop both fully de-identified health information data sets and limited data sets, for both electronic and paper-based records; | |||
::*Written documentation of policies, procedures and controls necessary for: | |||
:::*Compliance with HIPAA, and regulations for human subject protections (45 CFR 46), if applicable. | |||
:::*Security and management of all PHI in the Honest Broker’s possession during the performance of Honest Broker functions; | |||
:::*Audits and/or quality checks related to determining the efficacy of de-identification mechanisms; | |||
:::*Security and management of re-identification keys; and | |||
:::*Maintenance and retention of work-product documentation for all work performed (for whom, what was provided, IRB approval info, etc.). | |||
:::*Requests for data shall be retained for six (6) years. | |||
*Ongoing Review and Maintenance: Each certified Honest Broker’s individual status will be reviewed at least annually by the Privacy Office. Changes in an Honest Broker’s status should be reported immediately by the sponsoring investigator or team leader. | |||
*Adding and/or Removing Brokers | |||
:*Adding Brokers: | |||
::*New brokers must first complete the education/certification modules as noted in the Honest Broker certification section above. | |||
::*In accordance with UNMC/Nebraska Medicine policy, applicants who are not UNMC/Nebraska Medicine employees must complete and sign a business associate agreement (BAA). | |||
::*A complete revision of the each unit’s application must be submitted to the Privacy Office with any brokers to be added reflected in the revision. A copy of any relevant BAAs must accompany the revision documents. | |||
:*Removing Brokers: A complete revision of the application must be submitted to the Privacy Office with any brokers to be removed and the reason for the removal reflected in the revision. | |||
*Duties and Other Requirements of the Honest Broker: In order for a certified Honest Broker to work on behalf of investigators to de-identify PHI that is owned/held by UNMC, the Honest Broker must perform the following UNMC/Nebraska Medicine-defined duties and adhere to the following -defined requirements: | |||
:*Non-UNMC/Nebraska Medicine Honest Brokers must execute a Business Associate Agreement (BAA) with UNMC: | |||
::*The terms of the BAA will specify continuing confidentiality requirements, duties and other expectations UNMC/Nebraska Medicine has of an Honest Broker service. The UNMC/Nebraska Medicine BAA can be viewed at [http://www.unmc.edu/hipaa/forms/index.html http://www.unmc.edu/hipaa/forms/index.html]. | |||
:*All certified Honest Brokers must ensure that approval of the IRB of record has been obtained for a research study before the Honest Broker acts on a request for PHI (from an investigator that is served by the IRB of record). | |||
:*All certified Honest Brokers must adhere to any and all terms and conditions specified by the IRB of record for any research study for which the Honest Broker will perform services. | |||
:*If an investigator requests a Limited Data Set, rather than a fully/completely de-identified data set: | |||
::*The IRB of record may require evidence of a completed Data Use Agreement for a Limited Data Set as part of its application process for approval of the proposed research involving the use of a Limited Data Set. | |||
::*An individual Honest Broker for the investigator must obtain (and retain) evidence of an appropriately executed Data Use Agreement in order to be granted access to the UNMC/Nebraska Medicine-held PHI. | |||
==Additional Information== | ==Additional Information== | ||
*Contact the [mailto:tscrogin@unmc.edu Compliance Officer] | *Contact the [mailto:tscrogin@unmc.edu Compliance Officer] | ||
*Contact the Privacy Officer | |||
*[http://www.unmc.edu/hipaa/_documents/application-for-honest-broker-certification.pdf Application for Honest Broker Certification Form] | *[http://www.unmc.edu/hipaa/_documents/application-for-honest-broker-certification.pdf Application for Honest Broker Certification Form] | ||
*[http://www.unmc.edu/hipaa/_documents/attestation-of-honest-brokers-responsibilites.pdf Attestation of Honest Brokers Responsibilities Form] | *[http://www.unmc.edu/hipaa/_documents/attestation-of-honest-brokers-responsibilites.pdf Attestation of Honest Brokers Responsibilities Form] | ||
This page maintained by [mailto:dpanowic@unmc.ed dkp] | This page maintained by [mailto:dpanowic@unmc.ed dkp] | ||