Difference between revisions of "Starting a New Protocol"

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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|]]
 
| 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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| 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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| 3.3 Study contacts - your PI will automatically receive any communication about the study (and will not be in this list). You should add yourself to this list if you are not there already. 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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| Click the Save and Continue to Next Section button at the top right of the screen. ||
 
| Click the Save and Continue to Next Section button at the top right of the screen. ||

Revision as of 11:49, 28 June 2019

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 (and will not be in this list). You should add yourself to this list if you are not there already. 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?

The majority of our studies are Exempt or Expedited. 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.

IMPORTANT: when you are finished with this section, click Save section and NOT Save and Continue unless you are ready to submit your protocol. Save and continue will take you to the last section and run the Validation Check which - if you are not finished will all items - will make your life very difficult as you cannot navigate freely through the protocol sections.

15 IRB of record.png
Click the Save Section button at the top right of the screen.


16.0 Final Items Before Submission
You made it!

Click the radio buttons when you are ready to submit your protocol.

DO NOT save this section until you are ready to submit.

16 final items.png
Click the Save and Continue to Next Section button at the top right of the screen only when you are ready to submit your protocol.


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.