Breast Cancer Registry of Greater Cincinnati (BCRGC) APPLICATION for ACCESS to INFORMATION/DATA

Transcription

1 Breast Cancer Registry of Greater Cincinnati (BCRGC) APPLICATION for ACCESS to INFORMATION/DATA Application Date: / / 20 Applicant's Name: LAST FIRST MIDDLE INITIAL Study Title: Institutional Affiliation(s) of Applicant: Title(s) of Applicant: Address of Applicant: Phone Number: ( ) - address: 1. Are you requesting access to Registry data for: Recruitment of enrollees for a research study? Please answer questions 2, 3, 4, 5, 8, 9, 10 and 11 Statistical analyses of Registry data? Please answer questions 2,, 6, 7, 8, 9, 10 and Describe the specific research questions and/or hypotheses for which you intend to use the Breast Cancer Registry data (attach additional pages if necessary). Attach an abstract of your proposal and the Specific Aims. P:\Registry\actodata.doc 1 3/20/06

2 If you are requesting access to Registry data for recruitment of enrollees for a research study, provide answers to 3, 4 and 5: 3. What are the eligibility requirements for your study? 4. How do you plan to conduct your recruitment? Be specific in describing your recruitment plan. How many times do you plan to contact a potential subject? By what type of communication? Attach copies of your recruitment letter, brochure or flyer, and your study consent form with this application. 5. How many study subjects will you need? (When you submit your application, please attach your sample size estimation.) In most situations, the Registry will provide a researcher with contact information for approximately two times the number of study subjects he or she wishes to recruit from the Registry population. How do you propose that we select from the entire Registry the number of enrollees necessary for your study recruitment? (In other words, describe the sampling strategy that you would like us to use.) If you are requesting access to Registry data for obtaining de-identified data files for statistical analyse, provide answers to 6 and 7: 6. What data elements will you need? On a copy of the enrollment form (questionnaire), please mark which data elements you are requesting for your analysis. 7. Do you have eligibility requirements for the persons from the Registry that you will use in your data analyses? If YES, what are they? NO YES Eligibility requirements are: P:\Registry\actodata.doc 2 3/20/06

3 All applicants should answer questions 8 through Have you received applied for IRB approval for your study? YES NO At what institution? What was the outcome of the review? Exempt from review (Attach IRB exempt status memo) Expedited review (Attach IRB approval memo and your study consent form with the IRB stamp.) Full review (Attach IRB approval memo and your study consent form with the IRB stamp.) IRB approval expires on / / 20 The Registry requires that IRB approval or exempt status be obtained before the application for Access to Data is submitted. Approval must be current at the time of providing any data or information to the approved researcher. The following questions are asked to ascertain if you have adequate resources to perform your study. 9. What resources do you need to perform your study? What is the cost of performing your study? Have you obtained funding for your study? YES NO If Yes: Funding source: Funding period: Direct costs funding amount over entire funding period: Name of PI on funding: Project title: If you currently have funding from more than one source, please list the other sources on a separate page. Are you applying for additional funding? If YES, please provide the name of the organization, and the submission deadline, and the amount of funding you are requesting: P:\Registry\actodata.doc 3 3/20/06

4 10. Describe how your proposed study will benefit the general public or persons with breast cancer. 11. Please list the names, roles and institutional affiliations of all persons working on the research study who will have access to the data provided by the Breast Cancer Registry of Greater Cincinnati. This list should include research associates, student assistants and database managers as well as the primary scientists. Use an additional page(s) if necessary. Please note that each of these individuals must sign the Agreement for Use of Information from the Breast Cancer Registry of Greater Cincinnati. Please submit a copy of the curriculum vita of the primary applicant with this request. If IRB approval has been obtained, please also submit a copy of the IRB protocol approval memo, and IRB stamped consent form. P:\Registry\actodata.doc 4 3/20/06

5 AGREEMENT FOR USE OF INFORMATION/DATA FROM THE BREAST CANCER REGISTRY OF GREATER CINCINNATI Principal Investigator 1. I attest that my use of the information from the Breast Cancer Registry of Greater Cincinnati database will be limited to the research questions posed in this application. I further attest that I have no affiliations with individuals, attorneys, or companies who would use the information in preparation for litigation, in risk management, or in medical insurance claim review. 2. I attest that: I have received IRB approval for my study from the IRB, protocol number OR I have received exempt status for my study from the IRB, protocol number. 3. I agree to maintain strict confidentiality of the data (including names and addresses) that I receive from the Breast Cancer Registry of Greater Cincinnati. Paper copies of the data will be stored in a locked file cabinet. Electronic data files will be password protected, and stored on a secure computer system. 4. I agree that no one other than persons named in the application(s) and myself will be permitted to have access to data (including names and addresses) from the Breast Cancer Registry of Greater Cincinnati. Check either #5 or #6. 5. I am receiving information for the purpose of recruiting individuals for a research study. I agree to use the information only for recruitment to the study described in my application, using the stated recruitment methods. I understand that I am responsible for the costs of preparation and mailing of a letter to eligible Registry enrollees, as stated in the cost statement, which is attached. I agree to provide the Registry with a report of the number of Registry enrollees contacted, and the number and descriptive demographic statistics of Registry members who eventually participate in my study. I understand that I must submit a brief progress report every six moths and that my access to the data will be reviewed on a yearly basis. I agree to return this information (names and addresses) and any copies of the information to the Registry at the end of recruitment, or the end of my approved interval for access whichever comes first. 6. I am receiving de-identified data files for statistical analyses. I agree to conduct only those analyses that are outlined in my application. I understand that the Breast Cancer Registry of Greater Cincinnati is not responsible for costs incurred in downloading and analyzing the data. I agree to be responsible for expenses as detailed in the attached statement. I understand that I must submit a brief progress report every six months and that my access to the data will be reviewed on a yearly basis. I agree to return the original data and any copies of the P:\Registry\actodata.doc 5 3/20/06

6 original data to the Registry at the conclusion of the analyses or at the end of my approved interval of access, whichever comes first. 7. I agree to provide the Registry with a copy of all manuscripts and abstracts resulting from this research, prior to their publication. I agree that all published manuscripts will acknowledge the support of the Breast Cancer Registry of Greater Cincinnati in conducting the research study. 8. I agree that all manuscripts and presentations of results from my analysis will be written so that no identification of individuals is possible. Signature: Date: P:\Registry\actodata.doc 6 3/20/06