SECONDARY USE OF DATA IN HEALTH RESEARCH: ETHICS AND PRIVACY CONSIDERATIONS. Donna Roche & Sandra Veenstra
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1 1 SECONDARY USE OF DATA IN HEALTH RESEARCH: ETHICS AND PRIVACY CONSIDERATIONS Donna Roche & Sandra Veenstra
2 Outline 2 Landscape oversight Privacy best practices Ethics considerations Chicken and egg problem And that s not all! Where to from here?
3 Secondary Use of Data 3 Secondary use refers to the use of data originally collected for a purpose other than the current purpose. Accessing data that has already been collected for a different purpose to answer a research question (e.g. research using medical charts) Re-analyzing an existing research data set to answer a different research question
4 Landscape legislation 4 Provincial health-specific privacy legislation (NL PHIA) Establish rules for the collection, use and disclosure of personal health information (PHI) Balances an individuals right to privacy with the practical requirements of the health care system to collect, use and disclose PHI
5 Landscape - approvals 5 Typically access to data for secondary use research requires two approvals: Research Ethics Board (REB) approval; and Approval from the data custodian (i.e. organizational approval/data access committees). Ethics = ethical acceptability of the study (principles based review) with the aim of protecting research participant s rights Data access committees = permitted under legislation, privacy considerations, operational impact, feasibility
6 REB and Data Access 6 REB application: Identify data sources Data custodians Variables Identifiable? Data flow Front end access or disclosure? Linking? Code? Who has access? Privacy Organizational safeguards Technical safeguards Physical safeguards
7 Ethics - consent 7 Privacy legislation permits the disclosure of PHI without consent for research purposes when REB approval is obtained (NL) Most lax standard compared to other provinces TCPS2, Chapter 3: consent Waiver of consent considerations
8 Consent - principles 8 TCPS2 PHIA Free Informed Ongoing Not obtained through deception and coercion Knowledgeable Of the individual
9 Consent - elements 9 TCPS2 (informed) PHIA (knowledgeable) Assurance that participants are under no obligation to participate, are free to withdraw, information that is relevant to decision to continue or withdraw consent, including limitations of withdrawal of data Individual may give or hold consent An indication of what info will be collected and for what purposes, who can access the information, anticipated uses, duty to disclose and how confidentiality will be maintained Information on use and disclosure Statement of research purpose, identity of researcher, identity of the funder, the duration and nature of participation, description of research procedures, explanation of the responsibilities of the participant The purpose of the collection
10 Ethics privacy 10 TCPS2, Chapter 5: privacy and confidentiality Privacy: Minimal data used Limit use of personal identifiers Confidentiality: Limit access to personal identifiers Limit access to analytic data files Release of aggregate results Security: Secure transmission of files Files on secure server (analysis & storage)
11 Request Process - NLCHI 11 Intake and Assessment Central Intake (Information Request Coordinator) Consultation meeting Gather requirements/determine feasibility Study information: study design, study sample, objectives, groups of interest, outcomes, time period Identify data sources Identify data elements Type of data (de-identified vs. identifiable) Data flow Cost estimate and Agreement Initiated Resource planning (extraction/linkage)
12 Request Process - NLCHI 12 Application Review Key considerations: Permitted under legislation Type of data (de-identified vs. identifiable) Minimum amount of PHI requested Data accuracy Ethics approval obtained and information in application corresponds to ethics application Consent requirements Data flow, data management, data storage, retention, and disposal, etc.
13 Request Process - NLCHI 13 Approval Agreement/Letter of Approval Future uses and/or disclosures require additional approval Do not attempt to re-identify information Do not publish cell counts <5 Data must be stored on an organization asset Research team must comply with their organization s policies and procedures Data retention disposal Notify NLCHI of changes with the research study or research team Secure transfer Data Preparation and Data Review Compare prepared dataset against what was approved Cell count/re-identification risk assessment
14 REB Review vs. Custodian Privacy Review 14 Conceptually parallel processes that require similar content Review elements Data sources Data elements Data flow Identifiability/re-identifiability Data storage and disposal Data retention Limits of use Privacy safeguards Where does one mandate end and the other begin? And are there any gaps? NS research plan, how is this managed?
15 15 Classic and problem 1. All custodians in NL require REB review and approval prior to consideration of access request. 2. NS Emergency Health Services (EHS) steering committee requires the protocol and REB application be submitted to them PRIOR to sending to the REB. 3. Health Data NS(HDNS) application to the HDNS committee can occur prior to, at the same time, or after applying to the REB. 4. NS Department of Health and Wellness Data Access Committee conducts preliminary review and issues feasibility review letter to support application to REB, once approved by ethics return for final review.
16 Pros and Cons 16 PROS CONS 1. REB approval first? REB heavy lifting/poor quality submissions Amendments Time consuming No other approvals required 2. Data access review first Better quality applications to REB Institutions that are not well resourced carry the review load Out of order? Time consuming 3. Either/or Flexibility for researchers Inconsistent process Difficult to regulate 4. Preliminary data access review prior to REB approval, then finalize?happy medium for REB and custodian Back and forth for researchers/administrative burden
17 But that s not all! 17 Several initiatives in 2017 shed light on some other issues we seem to be having with secondary use of data: PHIA review Provincial Secondary Use Working Group OIPC Guidance piece
18 Common Misconceptions 18 Privacy legislation is a barrier to research. Approvals not required if using de-identified data. If ethics approval is obtained, no other approvals are required.
19 Challenges 19 Custodians Lack of resources required to process research requests Inconsistent processes between organizations Researchers Find it difficult to identify data custodians Custodians individuals or organizations who have custody or control of PHI to perform their power or duties
20 Where to from here? 20 Next steps: Listserv? Source document for Maritimes? Risks? Privacy breaches in research context?
21 Contact 21 Donna Roche, Manager, Health Analytics, NLCHI Sandra Veenstra, Ethics Director, HREA THANK YOU!
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