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. Documentation may be as simple as an email from an IRB staff but you must obtain this prior to starting the study. Usually you must submit the study through iRIS (IRB website) and choose the appropriate option to obtain your exempt from review status.
- The submission process is entirely online. You can access the IRB through the iRIS website.
- For full instructions, see the IRB's documentation. For quick instructions for an exempt or expedited protocol, see below. Your research mentor 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 IU OneStart. Use your normal IU login credentials. Click the Kuali Coeus (KC) link in the left hand menu.||File:IRB example find IRB.png|
|Then click the Access KC IRB Live System link in the middle of the page.||File:IRB example find IRB 2.png|
|To start a new protocol, click the + symbol under Create IRB Protocol.||File:IRB example start protocol.png|
|Start filling out the tabs. You have to complete most of the Protocol tab before you can save the protocol. Choose the correct type of protocol from the drop down menu and enter a title for your project. This does not have to be anything fancy or formal. Your faculty mentor should be added as the Principal Investigator and the Lead Unit will be filled in automatically. To add your PI, click the magnifying glass icon and search by name. Click the 'return selected' link next to the correct person's name.||File:IRB example title.png|
|You do not need to fill out the Additional Information tab.|
|Organizations are the places where you are performing your study. Click the magnifying glass icon to add organizations.||File:IRB example protocol orgs.png|
|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|
|Here's an example of the three hospitals added to a protocol.||File:IRB example protocol sites.png|
|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|
|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|
|Click the Save button at the bottom of the screen.|
|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|
|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|
|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|
|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|
|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.|
|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.||600px|
|Notes and Attachments Tab|
|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.||600px|
|Protocol Actions Tab|
|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.||600px|
|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.||600px|
|Custom Data and Medusa Tabs|
|You do not need to use these tabs. They are both for IRB Office use only.||600px|
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.