Implementing Honest Broker System(s) in Academic Medical Centers: The Pittsburgh Experience
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1 Implementing Honest Broker System(s) in Academic Medical Centers: The Pittsburgh Experience Christopher Ryan, Ph.D., CIP IRB Director Professor of Psychiatry University of Pittsburgh
2 The Researcher s Dilemma: How can I study patient medical information when I m not providing care to them? Whatever I shall see or hear in the course of my dealings with patients I will never divulge, holding such things to be holy secrets Hippocratic Oath Before releasing medical records, HIPAA requires written authorization from the patient, where the authorization specifies how PHI will be used, and who will access it No authorization is needed when information is de-identified
3 The Clinical Institution s Dilemma: How do we de-identify PHI and share these with outside researchers Hospitals and their affiliated Universities are usually legally separate entities Most large hospital systems have records and specimens stored in multiple places, with paper charts and multiple electronic MR systems May have little incentive to invest in an expensive infrastructure to support research, when their mission is patient care
4 Honest Broker Someone who speaks to both sides involved in an argument or disagreement and tries to help them agree Cambridge Dictionary Tissue/data bank trustee that acts as a well defined barrier between the clinical environment (in which fully identified, confidential patient information is exchanged routinely as part of medical care) and the general research community (in which all information must be de-identified completely). Dhir, 2008, Cancer 113:
5 Honest Brokers as Trustees Individual(s) serving as HBs are not part of the research team Must be members of the clinical facility workforce (or Business Associate) Only entity that can link research data and clinical identifiers Retains code so that information can be updated over time; superior to anonymization Protects confidentiality of patient data and ensures honest research
6 UPMC Certified Honest Broker Systems More than 80 Honest Broker Systems at UPMC Set up for department/division/clinic/lab/bank Vary in size and design; may be intrinsic to, or embedded in, a repository IRB protocol Written to cover specific records, databases, samples Supports retrospective and prospective research Requires approval by Pitt IRB and by UPMC Privacy Officer
7 Establishing a Certified HB System Group or Department or Program identifies need and meets with designated IRB staff Staff examines other alteratives / existing system; discourage establishment of new HB system Reviews need; types of info to be accessed and shared; who will serve as HBs; planned training and oversight; infrastructure / support Application for Certification of Honest Broker Systems/Processes is submitted to IRB first Reviewed and approved by IRB, and then by UPMC Privacy Officer
8 Key Elements of Application (1) Identify individual responsible for oversight* Name all individuals performing HB services* *Must be part of UPMC workforce Identify medical records systems to be accessed other materials? (specimens; radiographic images) Address how materials will be de-identified to comply with HIPAA (Safe Harbor/Limited Data Sets) How will system ensure that LDS are consistent with data elements described in IRB protocol?
9 Key Elements (2): Policies & Procedures Assigning linkage codes to de-identified info Managing codes to prevent researcher from accessing identifiers Ensuring IRB approval prior to release of info Documenting each HB transaction Routine monitoring of released data to ensure compliance with HIPAA de-identification rules Maintaining security of identifiable PHI by HB system Certification of Honest Broker Responsibilities
10 Institutional Oversight Challenges Shared governance Who takes responsibility? HB applications have not been integrated into IRB electronic review system Obtaining timely (annual?) updates of activities Absence of a formal renewal process Lack of resources for efficient institutional monitoring of listed procedures via research compliance audits Limited training provided by IRB of HBs Variability in infrastructure and support
11 Investigator Use of HB System Investigators contact the honest broker in their department/division and request services Informal call: to establish what materials are available Investigator prepares IRB protocol HB signs study-specific Honest Broker Assurance Form ; uploaded into IRB application Investigator completes whatever application is required by the HB system to access records / specimens 11
12 Study-Specific Honest Broker Assurance
13 - Large collection of frozen specimens & paraffin blocks - Includes excess clinical tissue and specimens collected with consent - Can be linked to medical record information by honest brokers, and to other institutional research / clinical repositories - Requests are reviewed by tissue utilization committee
14 Health Sciences Tissue Bank: HB 15 Activities covered by HSTB IRB Protocol Specimens stored in 4 hospitals, and off-site IRB protocol describes operation of HB 15 Supported by 6 Departments / Divisions Pathology / HSTB Cancer Registry (Registry Information Services) Otolaryngology (Head/neck cancer) Gynecologic Oncology Oncology Informatics (Pathology) Department of BioMedical Informatics Continuity of leadership
15 HSTB: Honest Broker Request Form
16 Honest Broker A Identifies T2DM cases PT Name linked to code (HBA-12345) and sent to HB B Honest Broker B Obtains info on Prostate CA Provides T2DM info Linked to code (HBA-12345) Request: Samples/Data from 200 Patients with T2DM and Prostate CA Investigator Provides Prostate CA Linked only by code (HBA-12345)
17 CARe: Center for Assistance in Research Using erecord Medical Record HB System (HB 98) supported through UPMC and the Pitt CTSI (Regulatory Core)
18 Challenges with this System Patient IDs are not consistent across different clinical systems, affecting ability to merge data Investigators often start with 1 data source and then find other sources are needed. Requires reidentification of initial set can be cumbersome Investigators often start with 1 set of variables and then desire additional; if data have been subsequently archived, may be difficult to retrieve Most HBs have clinical responsibilities which trump research requests Investigators must pay for report writers & programmers time
19 Honest Broker Systems Are Everywhere! Medical School, University of Michigan: HBO University of Arkansas for Medical Sciences Translational Research Institute Honest Broker University of Florida: Privacy Office HB System National Jewish Health Research Database and Biobank Children s Hospital of Philadelphia Center for Biomedical Informatics U. Chicago Human Imaging Research Office
20 Getting Started Dhir et al., A multidisciplinary approach to honest broker services for tissue banks and clinical data, Cancer 2008; 113: Boyd et al., The University of Michigan Honest Broker, J Am Med Inform Assoc 2009; 16: Gupta et al., Evaluation of a deidentification (De- ID) software engine to share pathology reports and clinical documents for research, Am J Clin Pathol 2004; 121: Meystre et al., Automatic de-identification of textual documents in the electronic health record: A review, BMC Med Res Methodol, 2010; 10:70
21 Questions?
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