An Honest Broker for Research is an individual acting on behalf of the researcher or study team to collect and provide data to the research team. This can consist of protected health information including de-identified data, limited data sets, and identified patient data. The Honest Broker for Research is a neutral intermediary, who is not part of the research project in any way, is not one of the investigators or study coordinators, and cannot be listed as an author on any publication resulting from the research. An Honest Broker for Research must have normal access, as part of their primary job responsibilities, to the data that they will be accessing, transforming, and providing to researchers. Utilizing Honest Brokers for Research helps protect the confidentiality of subjects' data while enabling research. The Honest Brokers for Research are responsible for provisioning data while ensuring researchers only receive the necessary information for their study. They can also maintain linkages, allowing researchers to re-identify individuals with proper authorization if needed.
Key reasons for using an honest broker:
- Protection of Patient Privacy: By de-identifying data, the honest broker ensures that sensitive patient information remains protected.
- Compliance with Ethical and Legal Regulations: Using an honest broker can help research teams comply with regulations like HIPAA (Health Insurance Portability and Accountability Act) and IRB (Institutional Review Board) requirements.
- Improved Data Security: The honest broker maintains a separate system for tracking the data point linked to identifiable information, adding an extra layer of security.
- Focus on Research Purposes: The broker ensures that researchers only receive the data needed for their specific research project, preventing the use of identifiable information for other purposes.
- Facilitates Secure Data Sharing: The honest broker enables the safe and secure linking of clinical data for research purposes.
Certification of Honest Brokers for Research
Advocate Health has a certification process for individuals wishing to become Honest Brokers for Research. Responsibilities of and process for becoming an Honest Broker for research are found in the Advocate Health policy Honest Broker Certification for Enterprise Research and are listed below. Honest Brokers for research must complete the requirements and be approved by Advocate Health’s Honest Broker Approval Committee before serving in this role. Certification is maintained with education and attestation required annually.
An individual seeking an Honest Broker certification must complete the required education within their respective operational region.
Midwest Divisions Required Education
- CITI Training: Basic Human Subject Protection training course and,
- CITI Training: Biomedical Investigators
- Honest Broker for Enterprise Research Training
- Annual Regulatory Training: Compliance and Integrity
Southeast Division Required Education
- CITI Training: Basic Human Subject Protection training course and,
- CITI Training: Biomedical Investigators
- Honest Broker for Enterprise Research Training
- Annual Regulatory Training: Compliance and Integrity
- Initial I2B2 Self-Service or appropriate database training
An individual seeking an Honest Broker certification must complete an application form which will, at a minimum, include:
- Attestation of meeting Honest Broker certification requirements
- Attestation of completing the required education
- Attestation of completing the required review of the policies
- Attestation that the Honest Broker will abide by all relevant Advocate Health guidelines, policies, including this policy, and required education
- Submit written documentation of the processes and/or systems used to develop de-identified and Limited Data Sets for both paper and electronic records
- Submit written documentation of the operational policies and procedures (i.e., auditing, retention, or transfer of data) for handling data
- Submit a signed letter of support from department chair or another appropriate supervisor or administrative leader
Advocate Health’s Honest Broker for Research review committee includes representation from all Advocate Health divisions from four key areas:
- Advocate Health Compliance and Integrity department
- Advocate Aurora Research Institute (AARI)
- Research Administration: Institutional Review Board (IRB)
- Wake Forest CTSI: Informatics Program (Office of Informatics)
Please email ctsidata@wakehealth.edu with any questions.