Data Access Application TERMS OF THIS APPLICATION: 1. All applications for access to data in the custody of the New Brunswick Institute for Research, Data and Training (NB-IRDT), and all projects for which applications are made, must comply with the requirements of the NB Personal Health Information Privacy and Access Act, SNB 2009, c P-7.05 (PHIPAA), the NB Right to Information and Protection of Privacy Act, SNB 2009, c R-10.6 (RTIPPA) and other provincial and federal legislation pertaining to the protection of Personal Information and Personal Health Information as well as NB-IRDT policies and procedures. 2. The Applicant understands and agrees that, by signing and submitting this application to NB-IRDT, the Applicant warrants the truth and accuracy of the information contained herein and, further, acknowledges that NB-IRDT will be relying on the information contained herein in assessing the application. 3. The Applicant understands and agrees that all requests for access to data from NB-IRDT shall be reviewed carefully with regard to compliance with the PHIPAA, RTIPPA, other relevant provincial and federal legislation and NB-IRDT policies and procedures, and that the application may be denied by NB-IRDT for any reason. 4. The Applicant undertakes to advise NB-IRDT of any significant change to the information contained herein should any such change take place while the application is being considered by NB-IRDT or, if the application is granted, during the life of the project. 5. The Applicant understands and agrees that the information provided herein shall form the basis for a data sharing agreement and a confidentiality agreement between the Applicant and NB-IRDT that must be signed by the appropriate parties should this application be granted. 6. The Applicant understands and agrees that, if this application is granted, the Applicant and all members of his or her research team who seek access to the data will be required to participate in a privacy and confidentiality training session prior to data being made available to the researcher. All members of the research team will be required to sign a confidentiality agreement with NB-IRDT and agree to abide by all relevant rules and regulations of NB-IRDT and UNB. 7. The Applicant and all members of his or her research team who seek access to the data must pass a criminal record check. 8. The Applicant understands and agrees that NB-IRDT reserves the right to require further information from the Applicant in considering the application or to specify further conditions on the provision of the data requested herein. 9. The Applicant acknowledges that, if provided, NB-IRDT data is to be used solely for the purpose identified in this application. 10. The Applicant acknowledges that linking data sets is limited only to what has been outlined in the application, approved by NB-IRDT for access, and covered in the data sharing agreement signed between the parties. Any additional linkage requests will need additional Effective date: Month xxxx Review date: Month xxxx Page 1 of 10 Data Access Application review by NB-IRDT and may require a full review if it constitutes a major revision to the original approved application. 11. The applicant agrees that in the event that data linking is intended, this process will be controlled entirely by NB-IRDT staff. Individuals will not be permitted to link their own data under any circumstances. 12. The Applicant acknowledges that, if any further uses or disclosures are contemplated, such uses or disclosures must be identified to NB-IRDT either in this application or in a future communication and NB-IRDT’s written consent to such uses or disclosures must be obtained before such uses or disclosures occur. Depending on the nature of the request the Applicant may need to submit a revised application to REB. NB-IRDT reserves the right to withhold its approval of any such request for any reason. By signing below, we covenant that we have read and understood the terms of this agreement as set out above and we agree to be bound by such terms. Signature of Applicant Signature of Research Lead (if different from Applicant) Name: Click here to enter name. Name: Click here to enter name. Date: Click here to enter a date. Date: Click here to enter a date. Effective date: Month xxxx Review date: Month xxxx Page 2 of 10 Data Access Application Provide the following requested information. You may include any additional information that you feel may be helpful in our review and consideration of your application. If you are unsure how to respond to any question, please contact our Project Coordinator at NBIRDTprojects@unb.ca or 506-447-3320. The term “Personal Information” includes “Personal Health Information”; these terms are used as defined under RTIPPA and PHIPAA respectively. For greater certainty, Personal Health Information is understood to include personal behavioural information (e.g., use of or addiction to a drug, sexual activity, experiences of physical or emotional violence, etc.). 1. APPLICANT INFORMATION Full name: Email address: Telephone: (xxx) xxx-xxxx Mailing address: Affiliation: Choose one Name of affiliation: If other, describe: Position: All applicants must include a CV. If the applicant does not have a CV, a letter of support from a supervisor must be provided. Include these documents as Appendix A to the NB-IRDT Data Access Application. 2. PROJECT DETAILS Full project title: Project Duration: Start date: (yyyy-mm-dd) End date: (yyyy-mm-dd) ☐ New Application - No prior application for information on this project. ☐ Extension - Extension of deadline only. No changes in data sets. Effective date: Month xxxx Review date: Month xxxx Page 3 of 10 Data Access Application ☐ Minor Amendment - Inclusion of more years, variables, adding a researcher or linking aggregate data such as publicly available regional level data. ☐ Major Amendment - Inclusion of additional data sets, linkages between data sets, especially sensitive variables or substantial change in direction of research. NOTE: Minor amendments can be deemed major at the discretion of the NB-IRDT Director. PROJECT SUMMARY: In 500 words or less, provide a brief overview for your project, including the following information: Sample universe Information on funding and other support Literature review, if applicable Is this project considered to be a government administrative request? Will this project include linking to applicant-provided data? If so, complete Schedule A. Project Summary STAKEHOLDERS: Identify all Stakeholders (e.g. Funders, Collaborators) involved in this project, their affiliation, and their role in the project. Name Effective date: Month xxxx Review date: Month xxxx Affiliation Role in Project Page 4 of 10 Data Access Application OTHERS WHO WILL HAVE ACCESS TO THE DATA: Identify all persons who will have access to the data, their affiliation, role in the project, and the purpose for their access. Name Affiliation Role in Project Purpose for Access 3. ACCOUNTABILITY PRINCIPAL INVESTIGATOR: Identify the Principal Investigator for this project and their contact information. Requests for any modifications to the approved project must be made by the Principal Investigator. PI Full Name: Email: Telephone: (xxx) xxx-xxxx LEAD RESEARCHER OR PRINCIPAL APPLICANT: Identify the name and contact information for the person (Lead Researcher, Principal Applicant or Principal Investigator) mandated to oversee the data analysis in the research project and to ensure that the Personal Information or Personal Health Information disclosed to his or her research team will be protected as required by NB legislation and NB-IRDT policies and procedures. Full Name: Email: Effective date: Month xxxx Review date: Month xxxx Telephone: (xxx) xxx-xxxx Page 5 of 10 Data Access Application 4. PURPOSE Using 250 words or less, describe your research question in plain language including: the overall objectives of the project the purpose for which NB-IRDT Data is being requested Purpose 5. CONSENT Has the project been reviewed by the UNB Research Ethics Board? A review and subsequent approval by another Research Ethics Board, acting according to the Tri-Council Policy Statement on Research Ethics, may be taken into account by the UNB Research Ethics Board in its deliberations. Attach copies of both the research ethics application document and the approval(s), if applicable, as Appendix B. 6. REQUESTED DATA SETS Provide a list of the requested data sets as found on the NB-IRDT website, go.unb.ca/fr-nbirdt. NOTE: Proposals requesting applicant-provided data will provide these details in Schedule A. Data Sets 7. LIMITING COLLECTION Use Schedule B to provide all the required details for each requested data set outlined in Section 6. In order to comply with PHIPAA, you will only be granted access to the minimum amount of information necessary to complete this project. 8. ADEQUACY Answer the following questions to identify how you will ensure that the requested data are sufficient for your stated purpose: Effective date: Month xxxx Review date: Month xxxx Page 6 of 10 Data Access Application Does this project have clear research goals? What are they? How does the design of this project make it possible to meet these goals? How will this project contribute to the advancement of knowledge? Adequacy 9. METHODOLOGY In 500 words or less, explain the methodology for the proposed project and include the following: Data sets required: The proposal should clearly state the data sets from NB-IRDT and non-NB-IRDT databases required to conduct the proposed research. For each data set, specify data set names and years and how the data will be used. Type of study: Specify, for example, if the study is cross-sectional, or if cohort development is needed. If it is longitudinal, changes in data values occurring over time need to be taken into account (e.g., residential moves, coding changes <e.g., ICD-9-CM change to ICD-10 April 1, 2004>, family structure alterations). Type of analysis: Specify methods that will be used and indicate whether original data fields can be used or whether they must be derived. Also, indicate whether analytic methods need to be developed or if existing methods may be used. You may reduce your study costs by checking to see if you can find the necessary programming from existing resources such as the Concept Dictionary and Glossary (and specifying the URL in your proposal). If methodological/analytical techniques are novel, references to the work should be included. Disease/Drug/Procedure Classification codes: Specify classification codes you are using in the study (e.g., ICD-10-CA/CCI) and tariff codes for diagnoses, tests, and procedures and Drug Identification Numbers (DINs) for drugs. Multiple codes within various time frames (as opposed to a code at one point in time) will require extra programming. Methodology 10. RESOURCE REQUIREMENTS AND TIMELINES Effective date: Month xxxx Review date: Month xxxx Page 7 of 10 Data Access Application NB-IRDT provides the following kinds of support on a cost-recovery basis, with timelines dependent on availability of NB-IRDT resources. The support needed to complete the project should be included, indicating the role of NB-IRDT in providing that support, and noting where conceptual definitions and/or code already exist for various methodological needs. NB-IRDT will provide a quote based on the following: Data extraction: Is it necessary to build and test an analytical data set? Data processing: Is it new database that requires additional work, e.g. installation, transferring and understanding of the data? Data analysis including code development: Are basic descriptives, like frequencies and means, sufficient for completion of analyses or are more complex analyses like hierarchical linear modeling, exploration of interaction effects necessary? It should be clearly stated what outcomes/dependent variables are being examined. Physical/computer workspace: Does the project have its own programmer requiring the use of NB-IRDT facilities? NB-IRDT should be contacted for availability of resources and for the data access fee that will need to be included in the budget. Support: Does the project have support from MSSU or other funding providers? Is this a government priority request? Resource Requirements and Timelines Effective date: Month xxxx Review date: Month xxxx Page 8 of 10 Data Access Application Schedule A A. DATA SET INFORMATION Data Set Name: Data Custodian’s Full Name: Email: Telephone: (xxx) xxx-xxxx Data Set Description: general content (e.g., injury occurrence reports) Start Date: (yyyy-mm-dd) End date: ☐ Individual Data ☐ Aggregate data ☐ Personal Information ☐ Personal Health Information (yyyy-mm-dd) ☐ Both B. APPROVAL Do you have approval to access and use these data? ☐Yes ☐No If approved, please include copy of approval documentation. Approval provided by: (full name) Email: Telephone: (xxx) xxx-xxxx C. REQUIREMENTS FOR THE TRANSFER AND USE OF PROJECT-SPECIFIC DATA ☐ A Data Sharing Agreement is in place for the ongoing transfer of data to NB-IRDT. NOTE: Use of the data will require separate approvals for each project from the identified organization(s). ☐ Data will only be used for this specific project. NOTE: Copies of all supporting documentation must be provided to NB-IRDT for using and transferring the data to NB-IRDT. Effective date: Month xxxx Review date: Month xxxx Page 9 of 10 Data Access Application Schedule B For each data set outlined in Section 6, complete a separate table, providing details in each column. Use the following example to display your information. Example: Data Set Title & Requested Years: DAD1999-2002 Requested Level of ID Definition Variable(s) Birth date Year Year of birth Readmission code Denotes a readmission to the same level of care within the reporting facility Rationale To calculate age and age adjusted incidence rates To calculate post-surgery complications over time Data Set Title & Requested Years: Requested Variable(s) Level of ID Effective date: Month xxxx Review date: Month xxxx Definition Rationale Page 10 of 10