Difference between revisions of "IRB"

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==Getting started==
 
==Getting started==
 
*The submission process is entirely online. You can access the IRB through [https://iris.louisville.edu/ the iRIS website] (right click -> open new tab to open in a new window).  
 
*The submission process is entirely online. You can access the IRB through [https://iris.louisville.edu/ the iRIS website] (right click -> open new tab to open in a new window).  
 +
 
*Online forms are dynamic. That is, options and items change depending on previously selected items. Make sure you complete all necessary items in each section. Not every subsection/sub-item is shown in these tutorials.
 
*Online forms are dynamic. That is, options and items change depending on previously selected items. Make sure you complete all necessary items in each section. Not every subsection/sub-item is shown in these tutorials.
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*For full instructions, see the IRB's documentation. For quick instructions for an exempt or expedited protocol, see below. Your research mentor and the Research Director may have examples of similar protocols that you can modify for your project.
 
*For full instructions, see the IRB's documentation. For quick instructions for an exempt or expedited protocol, see below. Your research mentor and the Research Director may have examples of similar protocols that you can modify for your project.
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*NB: everyone added to your protocol (PI, CoPIs, medical students, nurses, people consenting subjects, etc) must have the following:
 
*NB: everyone added to your protocol (PI, CoPIs, medical students, nurses, people consenting subjects, etc) must have the following:
 
**current CV uploaded into iRIS
 
**current CV uploaded into iRIS
 
**Attestation and Disclosure Form completed in iRIS
 
**Attestation and Disclosure Form completed in iRIS
 
**CITI training completed
 
**CITI training completed
*IRB will return your protocol to you without review if these things are not completed.
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**IRB will return your protocol to you without review if these things are not completed.
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 +
*If you add the Research Director as a CoPI, he/she can view your protocol and provide editing help/protocol suggestions. This also allows for continuity - if someone else takes over your project, or you forget to close it out when you're finished - the RD can facilitate these things. However it is not required.
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*The final step for submitting a protocol is to upload any required documents. These may include:
 +
**written protocol (required for all protocols - you can use the final version of the protocol that you submitted to the Research Working Group)
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**data collection sheet
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**survey
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**any communication you will have with subjects, including texts of emails you will send
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**letter of agreement/support from outside locations
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**consent document (either a consent or HIPAA waiver is required for all studies)
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**HIPAA waiver form
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**certificate of translation
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**UofL Branding Dept approval letter
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**UofL IRB forms are here [https://http://louisville.edu/research/humansubjects/templates/biomedical-forms/ IRB website]
  
 
==How to Write a Protocol -- under construction==
 
==How to Write a Protocol -- under construction==
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*You do not have to suspend work on your project during amendment review. However, you cannot implement the changes in the amendment until it's approved. Eg, the medical student that you're adding to help you with your charts cannot begin work until the amendment is approved, but you and the others on the protocol can continue.
 
*You do not have to suspend work on your project during amendment review. However, you cannot implement the changes in the amendment until it's approved. Eg, the medical student that you're adding to help you with your charts cannot begin work until the amendment is approved, but you and the others on the protocol can continue.
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==Closing your Study==
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When you are finished with your study (which means manuscript written, posters done, no one else is going to continue your study, data is archived appropriately, de-identified data saved if appropriate), contact your PI and confirm it is ok to close out your IRB protocol. If your PI agrees, please go in to Amendments (use above instructions) and submit a request to close the study.

Revision as of 09:36, 20 June 2019

Do I really have to write an IRB protocol? Yes. Nearly every project requires approval, and for the few that do not (some quality improvement projects, use of publicly available de-identified data) you will still need to contact the IRB for an exemption from review.

Basic IRB information

  • There are 3 types of protocols:
    • Exempt: this is the simplest and has the fewest security issues. No PHI (protected health information like MRN, name, dates of procedure or service, ZIP code or address, etc) can be recorded. You can view records but you cannot record any PHI and you cannot access individual records more than once. Examples of Exempt protocols are anonymous surveys, many educational or curriculum improvement projects, and projects using only existing de-identified datasets.
    • Expedited: These are low risk protocols that allow for collection of PHI and for minimal risk studies. Minimal risk studies include chart reviews in which you are recording PHI, studies that require saliva collection or a single blood draw, and some behavioral studies. Most resident chart review projects are Expedited so that student data entry can be checked (which requires recording the MRN or other identifier).
    • Full Board Review: These are the highest risk studies and include randomized controlled trials, drug studies, clinical trials, and any studies that involve more than minimal risk to participants.

Also, there are

  • Protocols exempt from review: These are not the same as Exempt protocols. These are protocols that the IRB has determined do not need to be reviewed and you must obtain this documentation from the IRB prior to starting the project. In general, these are protocols that are internal and do not access or record PHI (like quality improvement studies) or projects using publicly available data. You must submit the study through iRIS (IRB website) and choose the appropriate option to obtain your exempt from review status.

Getting started

  • The submission process is entirely online. You can access the IRB through the iRIS website (right click -> open new tab to open in a new window).
  • Online forms are dynamic. That is, options and items change depending on previously selected items. Make sure you complete all necessary items in each section. Not every subsection/sub-item is shown in these tutorials.
  • For full instructions, see the IRB's documentation. For quick instructions for an exempt or expedited protocol, see below. Your research mentor and the Research Director may have examples of similar protocols that you can modify for your project.
  • NB: everyone added to your protocol (PI, CoPIs, medical students, nurses, people consenting subjects, etc) must have the following:
    • current CV uploaded into iRIS
    • Attestation and Disclosure Form completed in iRIS
    • CITI training completed
    • IRB will return your protocol to you without review if these things are not completed.
  • If you add the Research Director as a CoPI, he/she can view your protocol and provide editing help/protocol suggestions. This also allows for continuity - if someone else takes over your project, or you forget to close it out when you're finished - the RD can facilitate these things. However it is not required.
  • The final step for submitting a protocol is to upload any required documents. These may include:
    • written protocol (required for all protocols - you can use the final version of the protocol that you submitted to the Research Working Group)
    • data collection sheet
    • survey
    • any communication you will have with subjects, including texts of emails you will send
    • letter of agreement/support from outside locations
    • consent document (either a consent or HIPAA waiver is required for all studies)
    • HIPAA waiver form
    • certificate of translation
    • UofL Branding Dept approval letter
    • UofL IRB forms are here IRB website

How to Write a Protocol -- under construction

Starting a New Protocol
To get started, log in to iRIS. Use your normal UofL login credentials. Iris page.png
Then click the Study Assistant tab -> Add New Study or the Add New Study button. Iris main page.png
Select 'IRB Study Application' and click the Start selected Application button. Routing.png


1.0 General Information
Fill in the formal title of your study and the short title you want displayed in your My Studies list. 1.0 gen info.png
Click the Save and Continue to Next Section button at the top right of the screen.


2.0 Setup Department Access
The primary department/division of your PI should be pre-filled. Click to select if it is not. If your PI's primary appointment is in a different institution, please contact the Research Director for guidance. 2.0 depts.png
Click the Save and Continue to Next Section button at the top right of the screen.


3.0 Grant Key Personnel Access to the Study
3.1 should have your PI pre-filled.
3.2 is you and any other Co-PIs, other residents, medical students, other faculty. You should be a CoPI. Add the Research Director as CoPI if you want editing help. Other residents or medical students helping with data collection should be added in (B) Research support staff. Click the green Add User button, search for the person, and click the green check mark next to his/her name to add to your protocol. These folks should be added as a Clinical Research Associate or Participating Clinician. Anyone who is going to view your data, access the medical record, or interact with research participants (including consenting) needs to be added here. People viewing only de-identified data (e.g. statistician) do not need to be in your protocol at all. 3.0 ksp 1.png
3.3 Study contacts - your PI will automatically receive any communication about the study. You should make sure you are there also. You also need to add the contact Research, University Medical Center to this list (search for research and it will come up). 3.0 ksp 2.png
Click the Save and Continue to Next Section button at the top right of the screen.


4.0 Research Nature
Select Biomedical. 4.0 type of research.png
Click the Save and Continue to Next Section button at the top right of the screen.


5.0 Application Types
Select IRB Application.

If you are submitting for an exemption from review, you need to select Non Human Subjects Research (NHSR) and go to this page for further directions.

5.0 app types.png
Click the Save and Continue to Next Section button at the top right of the screen.


6.0 Study Information
6.1 A brief lay description of your study - think Junior High/High School reading level and about 1 paragraph. 6.1 brief explanation.png
6.2 A brief lay description of your intervention. If this is a chart review, then say so and describe what you are going to collect. 6.2 proc explanation.png
6.3 Research methods - Again a brief lay description of your study design and planned analyses. Include a power analysis if appropriate.
6.4 Type of article - Vast majority of our studies will be N/A. If you are doing a drug or device study or you are not sure, contact the Research Director for guidance.
6.9 Select no - unless you are actually charging the subject.
6.11 - Is this study blinded? Select the correct choice for your study.
6.12 - Clinicaltrials.gov - THIS IS IMPORTANT. If you are doing any kind of intervention, you need to register your study. Even if it is low risk. If your study is observational, you do not need to register. 6.12 clinical trials.png
Click the Save and Continue to Next Section button at the top right of the screen.


7.0 Sponsor
You need to identify any sources of funding, even if it's departmental. If your faculty is funding any part of your project with CME/Flex dollars, this counts as Internally Supported. You must also declare if you are getting supplies etc. from any organization. 7.0 sponsor.png
Click the Save and Continue to Next Section button at the top right of the screen.


8.0 Study Sites
This is where you tell the IRB where you are going to be doing your study. If you are doing a chart review, you can just select 'UofL Facilities'. If you are going to be interacting with patients, you need to select where you will be. Importantly, if you are going to be at a private office or outside facility, you need to obtain a letter of agreement/support from that site prior to submitting your protocol. This is in addition to checking the correct box on this list. The Research Director can help you with this. 8.0 study sites.png
Click the Save and Continue to Next Section button at the top right of the screen.


9.0 Review Type
9.1 What type of protocol do you need?

Many of our studies are Expedited. If this is what you need, continue on this page. If you need to submit an Exempt protocol, select Exempt and go here for further directions. If you are submitting a Full Board Study, you need more than this tutorial. The IRB, your PI, and/or the Research Director can help you with further instructions.

Select the appropriate category from 9.2 and provide the justification in 9.3. If you find that your study does not fit into any of the categories, you may need to select a different protocol type.

9.0 review type exped.png
Click the Save and Continue to Next Section button at the top right of the screen.


10.0 Subjects / Data / Specimens
10.1 This section is dynamic. Select what you are going to study and fill in the sections that appear. If you are doing a chart review, you can upload your data collection sheet here. NB even if you select Retrospective Records, 10.2 will not go away. You still need to select who is included in your chart review - even though you are not technically "enrolling" them. 10 subjects and data.png
Click the Save and Continue to Next Section button at the top right of the screen.


11.0 Risk / Benefit
This section is used to state what the risks and benefits (direct and indirect) of your study are. These will differ dramatically depending on what study you are doing. The risk of a chart review is loss of confidentiality. Please talk with your PI or the Research Director if you are unsure how to answer these questions. 11 risk benefit.png
Click the Save and Continue to Next Section button at the top right of the screen.


12.0 Compensation
Are you giving your participants anything for being in your study? This is nearly always gift cards and there is a very specific process for doing this through the University. If you are paying, reimbursing, or giving anything else except prepaid cards, this MUST be approved IN ADVANCE of submitting your study to the IRB. 12 compensation.png
Click the Save and Continue to Next Section button at the top right of the screen.


13.0 Confidentiality and Privacy
Answers for this section vary depending on how you are doing your study. Again talk with your PI and/or the Research Director for guidance. The difference between reviewing/viewing and collecting is just that. Examples would be viewing the medical record but only collecting de-identified information (generally we do not do this) - viewing only - and collecting MRN, DOB, DOS, etc (viewing and collecting).

13.6 In general the answer to this question is no, unless you are in very specific circumstances.

13.7 There is some specific language here that is helpful. Ask the Research Director for copy/paste text for this section.

13 PHI.png
Click the Save and Continue to Next Section button at the top right of the screen.


14.0 Informed Consent
Answers for this section vary depending on how you are doing your study. Again talk with your PI and/or the Research Director for guidance. If you are doing a chart review, you need to paste in each section 'Informed consent will not be obtained, this is a retrospective chart review." If you are consenting, you need to fill in appropriate information. 14 consent.png
In section 14.4, if you are doing a chart review, select the second option (Waiver of Informed Consent) and fill in the bottom sections. If you are consenting, select Consent will be obtained. An example of an unsigned consent (preamble) would be if you are conducting a survey and provide required study information at the beginning of the survey and include a statement like "Continuing to and completing the survey (or clicking the button below to start the survey) implies your consent to participate in this research project". 14 consent 2.png
Click the Save and Continue to Next Section button at the top right of the screen.


15.0 IRB Authorization Agreement (IAA)
In general the answer to this question is no. Situations that would necessitate yes are any that require UofL IRB to be the IRB of record for any activities conducted at a different institution with its own IRB. For example you are conducting a multi-center study at another University with an IRB, but you want UofL's IRB to oversee the entire project (and not just activities at UofL). This does not include, for example, if you have a Norton person on your protocol who is helping you do your study (recruiting from his/her office e.g.) or if you are going to a site off campus but working with a UofL provider (e.g. EMW). Ask if you have questions about this. 15 IRB of record.png
Click the Save and Continue to Next Section button at the top right of the screen.


16.0 Final Items Before Submission
You made it!

Click the radio buttons.

16 final items.png
Click the Save and Continue to Next Section button at the top right of the screen.


Validation Check
iRIS automatically runs a check of any required sections not filled out. You can't submit until these are fixed. Your application is saved so you can go back to other sections to fix/complete or log out to complete later. Validation check.png
Click the Save and Continue to Next Section button at the top right of the screen.


Routing and signatures, documents to upload. File:Placeholder.png
Click the Save and Continue to Next Section button at the top right of the screen.


What Happens Next?

Your protocol will be sent to the IRB staff for a pre-review and you will be notified if there are any omissions, missing documents, or incorrectly explained sections. Once the pre-review is complete, your protocol will be forwarded for review. Exempt protocols generally take a few business days and Expedited a couple of weeks, depending on complexity. Full Board studies are reviewed by the convened IRB and so generally take longer. Full Board studies may require additional information or revision after Board review, so plan accordingly. You will be notified via email both of pre-review requirements and of protocol approval.

Edits and Amendments

  • To edit a protocol that you have saved but not yet submitted:
    • bring up the My Studies list of protocols
    • click the notebook/pencil icon on the far left of the study line
  • To amend an approved protocol, do the same as above to find the protocol.
    • then, in the left hand pane, scroll down until you see the Amendments section.
    • click the appropriate item.
    • click the Add New Form button at the top and fill out the information.
    • submit.
  • You do not have to suspend work on your project during amendment review. However, you cannot implement the changes in the amendment until it's approved. Eg, the medical student that you're adding to help you with your charts cannot begin work until the amendment is approved, but you and the others on the protocol can continue.

Closing your Study

When you are finished with your study (which means manuscript written, posters done, no one else is going to continue your study, data is archived appropriately, de-identified data saved if appropriate), contact your PI and confirm it is ok to close out your IRB protocol. If your PI agrees, please go in to Amendments (use above instructions) and submit a request to close the study.