Difference between revisions of "Expedited"

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(Created page with "{| border="1" | 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...")
 
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Latest revision as of 10:13, 20 June 2019

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
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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
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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
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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.

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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
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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
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16.0 Final Items Before Submission
You made it!

Click the radio buttons.

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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
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Routing and signatures, documents to upload. File:Placeholder.png
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