Difference between revisions of "IRB"

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(How to Write a Protocol -- under construction)
(How to Write a Protocol -- under construction)
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| 1.0 General Information
 
| 1.0 General Information
 
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| Fill in the formal title of your study and the short title you want displayed in your My Studies list.|| [[File:gen_info.png|600px|]]
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| Fill in the formal title of your study and the short title you want displayed in your My Studies list.|| [[File:1.0_gen_info.png|600px|]]
 
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| You do not need to fill out the Additional Information tab. ||
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| Click the Save and Continue to Next Section button at the top right of the screen. ||
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| Organizations are the places where you are performing your study. Click the magnifying glass icon to add organizations. || [[File:IRB_example_protocol_orgs.png|600px|]]
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{| border="1"
| Scroll down the list of sites and click the checkboxes next to the appropriate ones. Then click the 'return selected' link to add them to your protocol. For example, if you are reviewing charts from patients in the EZ, MH, and IU systems, you will need to select all those sites. If you are working with an outside site or clinic, there will be an opportunity to enter those later. (IU is 900011, MH is 000054, and EZ is 0017232.)|| [[File:IRB_example_org_lookup.png|600px|]]
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| 2.0 Setup Department Access
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| Here's an example of the three hospitals added to a protocol. || [[File:IRB_example_protocol_sites.png|600px|]]
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| In the funding tab, indicate how your project is funded. Many resident projects are unfunded, but if you have formal support choose the correct option from the dropdown menu. (Do not include Departmental Research Funds.) Click the 'add' button on the right to add your choice. || [[File:IRB_example_protocol_funding.png|600px|]]
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| 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.|| [[File:2.0_depts.png|600px|]]
 
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| You must include the number of study participants or charts that you will review. Include the maximum number, eg the total number of participants you will recruit or the total number of charts that you will review for eligibility - not the final number who participate after drop out or the final number of charts included in the analysis. Choose 'Total' from the dropdown menu and then enter your total number. Then click 'add'. If you are including any special populations in your study (pregnant women, children, fetuses, prisoners, students, etc), choose the appropriate group from the dropdown and click 'add' - you do not have to enter a specific number - just indicate that you are including members of this population in your study. || [[File:IRB_example_protocol_particip_2.png|600px|]]
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| Click the Save and Continue to Next Section button at the top right of the screen. ||
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| Click the Save button at the bottom of the screen. ||
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<br>
 
<br>
 
{| border="1"
 
{| border="1"
| Personnel Tab
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| 3.0 Grant Key Personnel Access to the Study
 
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| In this tab you specify all the people who will be working on your project. You need to include your faculty mentor as the Principal Investigator, yourself as the CoPI/Resident/Fellow, and any medical students or other residents helping you as Key Personnel. You only need to include the person doing your statistics if he/she will have access to your database or will be seeing identified data. If you are only sending that person your de-identified data for analysis at the end of the project, you do not need to include that person here. To add people to your protocol, click the magnifying glass icon next to IU User ID Search. || [[File:IRB_example_adding_people_1.png|600px|]]
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| 3.1 should have your PI pre-filled.
 
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| Type in the first and last name (or just last name if it is uncommon, or the IU username if you know it) and click the 'search' button. A list of people will show up at the bottom of the screen. Click the 'return value' link next to the name of the appropriate person. || [[File:IRB_example_adding_people_2a.png|600px|]]
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| 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. ||[[File:3.0_ksp_1.png|600px|]]
 
|-
 
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|Then choose the appropriate role from the dropdown menu and click 'add person'. If the person's name appears in the list in green with a checkmark, then that person has a current Conflict of Interest form on file and has completed the required CITI training modules. Folks in red with an x have not; the system will not allow submission of a protocol with any personnel in red. Repeat for all the people involved in your study.|| [[File:IRB_example_adding_people_2.png|600px|]]
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| 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). || [[File:3.0_ksp_2.png|600px|]]
 
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| Answer the 3 Conflict of Interest questions below the list of personnel, then click 'update' and then the 'save' button at the bottom of the screen. || [[File:IRB_example_COI_questions.png|600px|]]
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| Click the Save and Continue to Next Section button at the top right of the screen. ||
 
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{| border="1"
 
{| border="1"
| Permissions Tab
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| 4.0 Research Nature
 
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|You do not need to fill out the Permissions Tab, unless you want someone else (other than the faculty PI) to be able to edit and submit your protocol. If that is the case, assign this person as the Study Manager / Correspondent.
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| Select Biomedical.|| [[File:4.0_type_of_research.png|600px|]]
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{| border="1"
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| Questionnaire Tab
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| The questionnaire tab is where you will explain your project, identify risks, and explain what steps you will take to reduce risk to participants. The answers to these questions are protocol specific and you should ask your mentors for help and examples. You must complete each section; the system will help you keep track by changing the fonts to green as in this image. Be sure to click 'save' at the bottom. || [[File:IRB_example_questions.png|600px]]
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| Click the Save and Continue to Next Section button at the top right of the screen. ||
 
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{| border="1"
 
{| border="1"
| Notes and Attachments Tab
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| 5.0 Application Types
 
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| This tab is where you upload your consents, information sheets, recruitment flyers or letters, data collection sheets, and any information that participants will see. Select the correct document type from the dropdown menu and leave the status as Complete. Click the 'Choose File' button to select your file and then click the 'add' button. Repeat for all your documents. You do not need to upload a separate written protocol for Exempt and Expedited protocols but you can if you desire. Full Board protocols require a formal, written protocol document. Click the 'save' button at the bottom of the screen when you are finished. (Notes are not required.) Click 'save' at the bottom after you have uploaded documents. If you need to replace a document with a new version or delete it, click 'show' next to the uploaded document and use the 'replace' or delete' button below it. || [[File:IRB_example_attachmentst.png|600px]]
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| Select IRB Application. <p>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.</p>|| [[File:5.0_app_types.png|600px|]]
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| Click the Save and Continue to Next Section button at the top right of the screen. ||
 
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<br>
 
{| border="1"
 
{| border="1"
| Protocol Actions Tab
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| 6.0 Study Information
 
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| When you are ready to submit your protocol for review, go to the Protocol Actions tab. First click the 'Data Validation' tab and click the 'turn on validation' button. This will perform an automated review of your protocol and notify you of any incomplete requirements or contradicting information. Fix any identified errors. || [[File:IRB_example_data_validation.png|600px]]
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| 6.1 A brief lay description of your study - think Junior High/High School reading level and about 1 paragraph. || [[File:6.1_brief_explanation.png|600px|]]
 
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| Finally, click the 'Request an Action' tab, then click the 'show' button next to Submit for Review. The Submission Type and the Submission Review Type will be automatically entered based on information you have previously entered. Make sure they are correct and then check the box next to the appropriate Checklist category - this should be the same category that you selected in the Questionnaire tab. When you are ready, click the 'submit' button and you will get a confirmation that it has been routed for review. || [[File:IRB_example_submit.png|600px]]
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| 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. ||[[File:6.2_proc_explanation.png|600px|]]
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{| border="1"
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| Custom Data and Medusa Tabs
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| You do not need to use these tabs. They are both for IRB Office use only. || [[File:IRB_example_custom_data.png|600px]]
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| 6.3 Research methods - Again a brief lay description of your study design and planned analyses. Include a power analysis if appropriate. ||
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| 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. ||
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| 6.9 Select no - unless you are actually charging the subject. ||
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| 6.11 - Is this study blinded? Select the correct choice for your study. ||
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| 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. ||
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| Click the Save and Continue to Next Section button at the top right of the screen. ||
 
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<br>
  
 
==What Happens Next?==
 
==What Happens Next?==

Revision as of 08:03, 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).
  • 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.

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.
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, click the magnifying glass button next to All My Protocols on the main KC IRB page. Scroll down to see a list of all the protocols. Find the correct one, then click the 'edit' link next to it.
  • To amend an approved protocol, do the same as above to find the protocol (go to All My Protocols, find yours, and then click edit). Go to the Protocol Actions tab and click the Request an Action tab. Then click 'show' next to Create Amendment. Enter a brief summary of why you are amending the protocol (eg, adding key personnel to assist with chart review) and then click the boxes next to the sections that you will need to edit. (Ask for help with this if you are not sure!). Click the 'create' button at the bottom of the section. An amendment will be created and you will be able to edit the sections you indicated. When you are finished, click submit for review in the Protocol Actions tab.
    • 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.