Proposal Design and Statistical Analysis - Frequently Asked Questions

  1. Why does it take so long to get IRB approval?
  2. Is there anything I can do to make sure my request is as timely as possible?
  3. I understand that IRB reviews all protocols involving human participants.  I just received something about a methodological review. Is IRB separate?
  4. I have revised my protocol based on methodological review.  Do I go back to Movaris/Trintech to resubmit?
  5. Protocol? What do you mean “protocol”? What do I need to write?
  6. I had to provide a materials and methods section as part of the Human Studies Form on the Movaris/Trintech application. Isn’t that the same thing as a protocol?
  7. How much will it cost? How much does your department charge?
  8. Am I required to use your services?
  9. What resources are available to me for funding?
  10. Can I check my department’s database, or medical records, to see how many cases we have before getting started with my research?
  11. I understand that the Research Program can help me with analyses and writing; what if I need help with tables/figures/graphs?
  12. Where do I go for help with submitting my application in Movaris/Trintech?

Why does it take so long to get IRB approval?
The application and attachments (e.g., protocol, budget, etc.) must each be reviewed by different sections within Research Administration. Sometimes revisions need to be made or other material needs to be provided. Once the IRB review type (exempt, expedited, or full board) has been determined, there is generally a 2-3 week turnaround for expedited applications and 6-8 weeks for full board reviews, because the IRB meets once per month.
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Is there anything I can do to make sure my request is as timely as possible?
Yes. Please make sure that your application is complete, that all attachments are included, that you have passed the required one-time combined HIPAA/research training course, and completed financial disclosures, if applicable. If you are submitting an investigator-initiated proposal, it is generally helpful to consult with the senior scientist assigned to your department first (prior to submitting your application). Additionally, if you are submitting a proposal that you know will require a full board review, please check here for monthly submission deadlines or check with IRB.
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I understand that IRB reviews all protocols involving human participants.  I just received something about a methodological review. Is IRB separate?
Yes. All protocols are reviewed for design and methodology before going to IRB to . Once the scientific component is acceptable, the IRB can review the study for ethical considerations; namely, that measures to assure patient safety and benefit-to-risk ratios are appropriate.
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How do I reply to a methodological review.  Do I need to go back to Movaris/Trintech and resubmit protocol?
No, this is not necessary. Depending on the extent of the changes, a revised protocol might be appropriate.  If so, please send this as an e-mail attachment to the senior scientist with whom you corresponded.  You may also be able to submit just an addendum or explanation.
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Protocol? What do you mean “protocol”? What do I need to write?
This is a document attached to the application which describes the design, method and rationale for the study.  It is written much as a paper being submitted for publication would appear. The Research Program offers a template called “Elements of a Protocol” that we suggest you consult. It is available on this site by clicking here.
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I had to provide a materials and methods section as part of the Human Studies Form on the Movaris/Trintech application. Isn’t that the same thing as a protocol?
No. The protocol and the Human Studies Form are reviewed by different sections within Research Administration. The protocol is more comprehensive and is separate from the application. Parts of the protocol might be used for the Human Studies Form.
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How much will it cost? How much does your department charge?
Consultations to design a study and power analyses/sample size calculations are done at no charge. There is a fee, however, for the time for analysis.  Please consult with the senior scientist assigned to your area to learn how long, and much, your project will need for analysis.  Click here to see current analysis costs.
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Am I required to use your analysis services?
No. Some investigators or departments have resources to do their own analysis.  If you choose to seek analytical assistance from outside HH, please be aware that certain paperwork (e.g., subcontracts, confidentiality agreements, etc.) may be required.  Additionally, working with any analyst you will be required to de-identify (remove all protected health information, PHI, from) all of your data if you will be sending it via any e-mail other than of GroupWise (de-identified preferred for all internal correspondence).
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What resources are available to me for funding?
Hartford Hospital is able to offer some assistance through the Research Endowment and/or funds provided by the Medical Staff (click here) You may wish to check with your department, as small amounts may be available.  Where appropriate, the Research Program encourages applications for externally funded grants (e.g., NIH and its branches) and foundation awards (e.g., Donaghue, Robert Wood Johnson). Please contact your senior scientist for additional information and help with external grant funding.
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Can I check my department’s database, or medical records, to see how many cases we have before getting started with my research?
No. If there is a need to learn how many cases/records are available in a database prior to beginning your work, please obtain and complete a “verification of use” form, available by clicking here.
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I understand that the Research Program can help me with analyses and writing; what if I need help with tables/figures/graphs?
We’ll be happy to do those things, too. We can assist you with tables and figures for publication and/or presentation.
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Where do I go for help with submitting my application in Movaris/Trintech?
The whole Department can help with different parts of the Movaris/Trintech application:
Need technical help? – the Movaris/Trintech help line - click here
A clinical trial? – if you are working with the CRC, your coordinator can help you - click here
Need help with design, statistical power or protocol writingclick here
Question on IRB approval or procedure – e-mail IRB@hhchealth.org or click here
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