IRB Frequently Asked Questions for Vital Event Data

Contents

1. What are the limitations around release of vital events data?
2. If identifiable data cannot be released, how do I receive vital events data? 
3. How do I know if I quality for an IRB/DUA/MOU/etc?
4. I don’t understand the “applicable federal or state regulations” question.
5. I was asked to submit a complete CORPD/IRB package. What should a complete application include?
6. I was told to start the IRB renewal, amendment, or renewal with amendment process. What should a renewal or amendment include?
7. My project involves linking these vital events data to another data source. What additional documentation might be required of me?
8. I was asked to submit a complete CORPD/IRB package and have it ready. Where do I submit it?
9. I have not heard back for a couple of weeks, where is my application?
10. What is the IRB process from start to finish?
11. How often does the IRB meet? What are the deadlines for submission?
12. I submitted an application to the IRB Administrator and was turned away.
13. I am working on the IRB forms. What are some tips and common issues found when reviewing applications?
14. I was asked to include more detail on the program form. What does this mean?
15. Does the program include anything other than my paperwork to the IRB?
16. My question wasn’t answered here. Who do I talk to?
    

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1. What are the limitations around release of vital events data?
   Per Texas Government Code §552.115 and Texas Health and Safety Code §192.002(b), the entire birth, death, and fetal certificate are considered potentially identifiable and confidential. These data cannot be released in a manner that identifies a person or facility. 
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2. If identifiable data cannot be released, how do I receive vital events data? 
   If you can work with aggregated, non-identifiable statistics, this may be a much faster way to receive what you need. Send an email to vstat@dshs.texas.gov with the details of your statistics request. Requests of Texas vital events data may be approved for release if they satisfy a couple of requirements:
   
   • To members of local, state and federal law enforcement or governmental agencies, if they can demonstrate a need for these data to fulfill statutory requirements.
   • To researchers or other requesters who qualify to receive these data through an approved request made to the Committee on Requests for Personal Data (CORPD), per 25 Texas Administrative Code §181.11. This CORPD is fulfilled via our DSHS Institutional Review Board #1 (IRB).
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3. How do I know if I qualify for an IRB/DUA/MOU/etc?
   To help determine the correct process for your request, complete our data item checklist(s), answer the following questions and include these in an email to HIRBRequests@dshs.texas.gov :
   • Which specific data elements are requested and for which year(s),
   • From which data source,
   • The level of individual identification associated with the requested data,
   • Who is requesting those specific data,
   • The purpose or intended use of those specific data,
   • Applicable federal or state regulations.
   • Does your request involve linkage to another data source? If so, describe.

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4. I don’t understand the “applicable federal or state regulations” question.
   Some agencies and programs fall under specific statutory authority to receive vital events data from DSHS. If you have statutory authority for these data, a DUA/MOU/Contract process may be more appropriate for your request. If you are unsure whether your statutory authority allows you to receive vital events data, consult your program’s attorney. If you are unaware of any statutory authority, this question can be left blank and will be discussed with the program contact if needed.
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5. I was asked to submit a complete CORPD/IRB package. What should a complete application include?
   IRB Forms
   CHS Program Forms
   The HRP-410 on the IRB Forms page is a checklist for new studies. To submit a complete application to CHS, the packet must include:
   
   • 301 - Application
   • 302 - New submission detail
   • 306 - Research team log
   • Informed Consent Documentation

     • 305 - Informed consent document checklist and informed consent documents (if applicable)

       OR

     • 304 - Waiver or alteration of informed consent
   • Program form
   • Data item checklist(s) with justification provided
   • Copy of study protocol
   • Copy of other IRB approvals, if applicable
   • If funded by a federal agency/grant, a copy of proposal
   • Human subjects training certificates required (CITI, NIH, etc.) for PI and all project partners who will have access to these identifiable data
     • Please refer to the DSHS IRB Page for more information: http://www.dshs.texas.gov/irb/  
       
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7. I was told to start the IRB renewal, amendment, or renewal with amendment process.  What should a renewal or amendment include?
             
   If you would like to renew your study and there are no changes to it, the  HRP-411 is a checklist for renewals. If you would like to amend your study (e.g.principle investigators, study protocol), the  HRP-412 is a checklist for amendments. If you need to do both, submit components from both  HRP-411 and HRP-412 together for a renewal with an amendment.

   To summarize the  HRP-411 and  HRP-412, a renewal with amendment typically includes the following documents:

   • 201 – Application
   • 203 – Renewal Submission Status report
   • 207 – Amendment request form (if applicable)
   • 206 – Waiver of informed consent (for most requesters you'd be checking part 1B, be sure to include justification for all 4 statements listed). OR a copy informed consent document.
   • Program Form.
   • Data item checklist(s) with justification provided
   • Human subjects training certificates (CITI, NIH, etc) for PI and all project partners
   • Other documents as necessary, such as:
     • The study protocol with revisions, in track change format as well as a clean copy
     • The  HRP-202 with revisions, in track change format as well as a clean copy
     • Copy of other IRB approvals, if applicable
     • If funded by a federal agency/grant, any documentation as necessary to indicate.
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8. My project involves linking these vital events data to another data source. What additional documentation might be required of me?
   
   • When you submit this application to us, please describe the data sources and linkage procedure you would like to use.
   • If you want to link these data to any other HHS Enterprise data source, please also discuss with that program and make sure your IRB application satisfies all of their requirements as well. You may have additional requirements and program forms to complete.
   • If you want to link these data to any other data that you do not own, please obtain any necessary agreements for this use before the application is approved. 
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9. I was asked to submit a complete CORPD/IRB package and have it ready. Where do I submit it?
   Email an electronic copy of all forms to HIRBRequests@dshs.texas.gov . CHS will review the application to make sure it’s feasible for release.
   Completed IRB applications will be placed in queue for CHS program review. Once reviewed, the program contact will write back with any questions or comments regarding the application. If the program contact requests revisions, the edited application will be placed back in the queue for review.
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10. I have not heard back for a couple of weeks, where is my application?
    While our team places IRB reviews as a top priority, there are times when there are multiple competing high level processes going on as well. We make every effort to complete all projects as efficiently as possible. Though, there may be times where it takes a couple of weeks to review a new application.
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11. What is the IRB process from start to finish?
    1. Submit a complete application to CHS, which will be reviewed by the program contact. If edits are needed, work with CHS program contact until program signs off on application.
    2. The program approved application is sent to the CHS attorney for legal review.
    3. The legally approved application is sent to the DSHS Assistant Deputy Commissioner or designee for review.
    4. The final application signed by all required parties is submitted to the IRB Administrator.
    5. If approved by the IRB, the application is sent to the DSHS Executive Steering Committee (ESC) for review.
    6. If approved by the ESC, an IRB approval letter will be sent to you via email.
    7. Send the approval letter and a request for data to HIRBRequests@dshs.texas.gov with your preferred data format (CSV, SAS, SPSS, etc).
    8. CHS will process the data release and contact you when ready for download. 
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12. How often does the IRB meet? What are the deadlines for submission?
    The IRB meets once a month following this deadline schedule.
    Please note these are the deadlines to submit the final application signed by all required parties (Step 4 from Question 10above). The application will need to be approved by the CHS program, our attorney, and Assistant Deputy Commissioner before submission to the IRB.
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13. I submitted an application to the IRB Administrator and was turned away.
    The IRB only accepts completed applications from the CHS program contact. Submissions that bypass the program contact will not be accepted.
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14. I am working on the IRB forms. What are some tips and common issues found when reviewing applications?
    Confidentiality
    Record-level birth, death, and fetal death data are confidential in Texas. These data cannot, per statute, be “de-identified” unless aggregated with suppression for small counts. When describing data management and security, treat all record-level data as sensitive.
    Variable Justification
    The IRB requires clear justification for all requested variables. We suggest adding a sentence next to each variable as needed. Some can be as simple as “potential confounder” or “outcome of interest,” so long as the IRB understands their purpose.
    Project Partners
    All study collaborators, project partners, co-investigators, etc. who will have any access to study data must be listed as a “Project Partner” on the 201 form with Human Subjects Training attached to the application.
    Data Management section of the HRP-202
    The IRB and CHS take data security very seriously. The data management section of the 202 should include all of the following:
    
    • How and where data will be stored, and who will have access to it
    • What steps will be taken to avoid identifying individuals in publications? Will data be aggregated?
    • What suppression criteria will be applied to small counts?
    • Clarify that only those listed on the 201 will have access to study data
    • List the date of destruction along with destruction method. If you wish to hold on to data past the study end date, provide justification for the delay.
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15. I was asked to include more detail on the program form. What does this mean?
    The program form is used by our analysts to produce your dataset. Please list all relevant selection criteria on the program form so there is no confusion as to what should be produced. For example, only births to teenage moms, only deaths with underlying cause of death as suicide, only residents of Tarrant County, etc.
    When in doubt, imagine handing the program form to a complete stranger who has no idea about your protocol, and asking for a dataset. Would they be able to produce your dataset based on what you’ve written?
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16. Does the program include anything other than my paperwork to the IRB?
    A completed application will include all documents submitted by you as well as hard copies of attorney approval and approvals or documents from any other needed program/agency based on the request.
    In addition, please note that any email communication between the requester and program can be included as part of the IRB review, if needed.
    If you would like a copy of the final submission that is given to the IRB Administrator, the program contact can send you a scanned PDF of the entire submission. 
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17. My question wasn’t answered here. Who do I talk to?
    Requests for data
    DSHS HIRB Requests
    HIRBRequests@dshs.texas.gov