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- Templates, Forms & Procedures: [HRPP Research Protocol Templates](https://research.rutgers.edu/researcher-support/research-compliance/human-research-protection-program/toolkit)
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-[**(HRP-103) Investigator Manual: A Guide To Human Subjects’ Protection In Research](https://research.rutgers.edu/sites/default/files/2022-02/hrp-103_-_sop_-_investigator_manual_a_guide_to_hspp_1.21.22.pdf)**
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-[(HRP-103) Investigator Manual: A Guide To Human Subjects’ Protection In Research](https://research.rutgers.edu/sites/default/files/2022-02/hrp-103_-_sop_-_investigator_manual_a_guide_to_hspp_1.21.22.pdf)
- Submit *at least* 2 months before wanting to start the study
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## Tutorial: Creating an IRB Application in eIRB
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**Rutgers (Internal) IRB Manuals**
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[eIRB Quick Reference Guide for Investigators](https://research.rutgers.edu/sites/default/files/2021-04/eirb_quick_reference_guide_for_investigators_11.8.16_v2.pdf) (PDF)
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[eIRB User Manual For Research Staff](https://research.rutgers.edu/sites/default/files/2021-08/eIRB User Manual for Research Staff v2 10.2016.pdf) (PDF)
[**sIRB 101: An Introduction to Relying on an External IRB**](https://info.advarra.com/sirb101-wbnr-od.html)
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> Tips on Protocol
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>
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-[eIRB Quick Reference Guide for Investigators](https://research.rutgers.edu/sites/default/files/2021-04/eirb_quick_reference_guide_for_investigators_11.8.16_v2.pdf)
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-[eIRB User Manual For Research Staff](https://holmeslab.github.io/holmeslab/docs/Admin/irb-submission/irb/eirb_quick_reference_guide_for_investigators_11.8.16_v2)
-[sIRB 101: An Introduction to Relying on an External IRB](https://info.advarra.com/sirb101-wbnr-od.html)
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## Tips on Submissions
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- All documents submitted in ‘clean’ and ‘tracked’ forms
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- Clean version of each document and tracked version showing the changes from the last approved version of this document
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- Save as <name>_clean.docx and <name>_tracked.docx
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- Easiest to copy the clean version of the approved document, select Review > “Track Changes” on Word, then make your edits for that amendment. Once you’re ready to submit, duplicate the tracked version and then select Review > “Accept All Changes” to create a clean version with all your updates
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- If you have a clean version of the updated file, create a tracked version of this by going to Review > Compare > Compare Documents. Upload the original version and then the new version, and it will create a new document for you.
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- Use lay-person language- IRB staff are not experts in your field
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- Don’t use undefined acronyms or jargon
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- Don’t use Google docs / excel - not approved for research purposes
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- If you’re using Rutgers-sponsored application, like MS Office, Box etc, reference that they’re Rutgers
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-if you’re using not Rutgers-sponsored, you must include the app privacy information
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- Don’t use Google docs / excel for data storage or study documents storage - not approved for research purposes
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- If you’re using Rutgers-sponsored application for data storage/software, like MS Office, Box etc, reference that they’re Rutgers
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-If you’re using not Rutgers-sponsored, you must include the app privacy information
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### Tips on filling out IRB Application in [eIRB](https://eirb.rutgers.edu/) (Holmes-Lab)
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## How to Add People to eIRB
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1. Sign into with your NetID
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1. Make sure your profile lists the correct affiliation
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2. Make sure you’ve completed your necessary CITI courses (Aka Basic course: social-behavioral research OR Basic Course: biomedical study)
@@ -66,29 +58,17 @@ Single IRB review / multi site IRBs / Reviewing IRBs / Reliance IRBs: [https://s
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7. If you get reviewer notes, you can find them in the “History” section or “Reviewer Notes” section
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1. You must ‘reply’ to each comment by the reviewer, as well as fixing it
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eCOI, Institutional Affiliation, CITI Courses
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### eCOI, Institutional Affiliation, CITI Courses
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If anyone listed on the IRB needs to submit an eCOI, Institutional Affiliation or CITI Course, you’ll be emailed an alert. Below are the procedures for each of these steps:
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**eCOI Disclosure**
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1. log into the eIRB with your netID at this link: [eirb.rutgers.edu](http://eirb.rutgers.edu)
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### **eCOI Disclosure**
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1. Log into the eIRB with your netID at this link: [eirb.rutgers.edu](http://eirb.rutgers.edu)
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2. If you’re already part of an IRB, select that IRB
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On the left-hand side, under “My Activities”, select “Submit eCOI Disclosure”
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3. Follow the steps to submit the disclosure.
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**MORE INFORMATION**
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eCOI [Quick Start Guide](https://uec.rutgers.edu/wp-content/uploads/eCOI-Quick-Reference-Guide53.pdf) for a step-by-step guide to form completion.
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3. On the left-hand side, under “My Activities”, select “Submit eCOI Disclosure”
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4. Follow the steps to submit the disclosure.
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***Helpdesk**: eCOI holds helpdesk sessions on Wednesdays from 1:30pm-2:00pm and Thursdays from 10:00am-10:30am. There is no appointment necessary to join the helpdesk sessions. You can find Zoom links and information by visiting the [eCOI+ FAQs](https://research.rutgers.edu/researcher-support/research-compliance/conflict-interest).*
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**Institutional Affiliation**
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### **Institutional Affiliation**
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1. Have the study staff log into eIRB.
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2. Click on the ‘My Profile’ tab on the personal page.
*Follow these steps to see what action you need to take regarding CITI courses.*
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1. Have you completed any CITI course before?
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1. YES – go to Step 2
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2. NO – go to Step 4
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2. Is it any of these courses?
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*Log into your account at [citiprogram.com](http://citiprogram.com) to see what courses you’ve taken. (If you’ve taken them at another institution, log into your account with that institution’s login.)*
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-*Log into your account at [citiprogram.com](http://citiprogram.com) to see what courses you’ve taken. (If you’ve taken them at another institution, log into your account with that institution’s login.)*
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- “Biomedical / Clinical Research Investigators **Basic”**
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- “Social & Behavioral Research **Basic”**
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- “Biomedical Research **Basic/Refresher”**
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a. YES – Go to step 3
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b. NO – Go to step 4
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3. Log into [CITIprogram.com](https://www.citiprogram.org/index.cfm?pageID=14) (Click ‘Log in through my organization’ and specify ‘Rutgers the State University’) with your Rutgers NetID. Are any of the required courses listed under “Completed Courses”?
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1. YES – Go to step 5
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2. NO – You need to link your completed CITI courses with your Rutgers NetID. Let the lab manager know this!
5. Check the expiration date on your course(s)— are any of them still active?
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1. YES - if they’re not expired,
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## After getting IRB Approval:
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# After getting IRB Approval:
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**you must do these things, otherwise you’ll be put on probation
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### Reporting to IRB
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[**Didn’t Expect that to Happen: Events that must be Reported Promptly to the IRB**](https://info.advarra.com/didnt-expect-that-to-happen-wbnr-od)
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## How to Create a Modification
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1. Create folder in the relevant IRB folder named by the amendment number (eg `MS3` for Rutgers).
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2. For the documents you want to edit in this modification, copy the most recent approved version of that doc from the Currently Approved Docs folder
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3. Create a tracking document (text file or word doc) in the folder called `MS#_description_of_changes`.
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4. Rename the document from "_clean" to "_tracked". Open the document to edit and turn on 'tracking changes' (under 'Review' tab).
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5. Create any changes you'd like to make for the modification, with tracking on.
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6. Describe all the changes you make in the AME#_description_of_changes doc.
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7. Once you've made all the changes necessary, create a clean version of the document by duplicating the "_tracked" document, renaming the copy to "`_clean`", opening the document in word, highlight the whole document with command+A, click Review > Track Changes > Accept all changes. Now there should be a popup saying "there are no tracked changes in your document." Press "OK" and then save the document. Now this document should reflect all the newest changes without any actual 'tracking' marking up the document.
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7. Upload the `_tracked` and `_clean` versions of the document to the modification in eIRB
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8. Copy and paste the description of changes into the relevant field for the modification
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9. When it gets approved, add the ReviewLetter to [`Approval_letters`] folder (if relevant)
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10. Update all the new approved docs in the Currently Approved Docs folder, so that it reflects the most recent docs
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## File structure
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**MGB**
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- Files located at `/Box-Box/Holmes_Lab_Wiki/Active_IRBs`
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- Files should be tracked using this structure:
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**Original Submission Folder Structure**
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```bash
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├── orig_ProNUMBER # ProXXXXXX
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│ ├── Protocol
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│ ├── Scales
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│ ├── Consent
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│ ├── Attachments
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```
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**Example Amendment Folder Structure**
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```bash
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├── MS3_in_progress #change to 'approved' or 'rejected' when updated
- This is because the updated docs will be scattered across multiple amendment folders making it difficult to keep track of what is the most current form without going to the IRB website or looking through all folders
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```bash
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├── current_approved_docs
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│ ├── Protocol
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│ ├── Scales
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│ ├── Consent
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│ ├── Attachments
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```
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[**Didn’t Expect that to Happen: Events that must be Reported Promptly to the IRB**](https://info.advarra.com/didnt-expect-that-to-happen-wbnr-od)
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