Before
PI uses eIRB application for the first time, she must use the IRB site
to signup for an online workshop; determine what "type of review" is
needed; view sample proposals; and complete the worksheet entitled
"Open-Ended Questions for Expedited & Full Board Review
Application."
PI chooses from 3 types of review: Expedited Review; Full Board Review; Exempt
"Type of Review" can not be changed by PI after the proposal is submitted.
PI proposal must include supporting materials.
For Exempt Application, PIs will be prompted to change "Type of Review" if they respond "no" to any of the yes/no questions.
PI will be notified via email each time proposal status changes.
After
proposal is approved, PI can amend application, or renew application.
(we need to keep the original proposal in the database, so amend or
renew creates a new version of the proposal)
We
need to determine maximum chararacters for each question in the
application. We also need to determine maximum file size for supporting
materials. We need to let PIs know about these limits before they use
the online application.`
Reviewers will be assigned to proposals by the IRB chair.
Reviewers
will recieve an email that the proposal is ready for their review after
PI submits application and supporting materials. I will need to make
sure the status messages on the reviewer homepage are adequate for
managing these tasks.
Reviewers will view application, view supporting materials (and download documents) and then review feedback.
The reviewer can only send comments to IRB chair.
The
only feedback required is the radio buttons for "Revisions Required" or
"Recommend for Approval." So comments or document feedback is optional.
Reviewers can see the names of fellow reviewers and their comments, but the PI does not get to view names.
Reviews
should also get an email each time PI submits additional supporting
materials; other reviewers submit feedback, the IRB chair sends
feedback to reviewers or PI.
IRB chair will get an email when a new proposal is submitted, amended, or renewed.
IRB chair will assign reviewers for the proposal. The IRB
IRB chair can select as many revewiers as necessary for each proposal. There is a select all for full board review.
If
the IRB chair changes, "Type of Application" from "Exempt" to
"Expedited" or Full Board" we will need to send a message to the PI to
re-submit application. All data will need to be re-entered by PI. The
IRB chair can remove this rejected proposal from the system at a later
date.
IRB chair can send feedback to the PI or reviewers.
IRB
chair can approve the proposal at any time and override the reviewers.
Once the IRB chair approves a proposal, any reviewers that have
feedback status for "Revisions Required" should be changed to
"Recommend for Approval."?
When all reviewers
(excluding the IRB chair) have selected "Recommend for Approval" the
chair should receieve an email that the proposal has been recommended
for approval.
IRB chair should get an email
when the PI is prompted with "Revisions Required" and then sumbits
additonal supporting materials.
Quick update - june 7th I'll clean this up later.. https://sith.tcnj.edu/webteam/cgi-bin/irb/new/irbn.pl Matt, here's the info you need to demo this thing. Keep in mind, I just barely got it in working condition now, and its early morning, and i haven't been able to do extensive testing. Most things should work. Ill give you a list of what doesn't work in a minute. There's one login. the database stores the type of user you are, so it'll figure it out when you log in. For now, though, I added a set of links on the top right so you can quickly jump between the admin, reviewer, and PI sides. I set you up a full name/info in the database, so use your name to log in. However, there's only one admin now, and thats the chair, lynn smith. In other words, I don't know how she passes her duties to another reviewer, so for now, if you enter the admin side of the application, you are her. Thats about it. The workflow should act pretty much as you set it up. You can easily jump between being an admin/PI/reviewer to simulate the approval process. Keep in mind that in order to do anything on the reviewer side, you'll first need to go in as an admin and assign yourself as a reviewer on an application.
Here's what is not working:
Expiration/Renewal of proposals
amending proposals
document files themselves are not actually saved yet. you can leave the field blank.
Manage Instructions is not in
Printable Approval Forms
Application Archive, Reports - i dont know what these are actually
the program does not send out emails yet
Issues on 10/23/07
The following names should be removed: Ruth Palmer. The following names should be added Sharon Sherman, Ed.D. (Education);
SUSAN BAKEWELL-SACHS, Ph.D. (Nursing, Health & Exercise Science);
Brett BuSha, Ph.D. (Engineering); and Chu Kim-Prieto, Ph.D. (Pyschology)
All urls that point to ~irb/test/ will need to change to ~irb/
[PI] Printable Approval Form (does not work) remove hyperlink until we can make this active.
[PI] Project Title; Project Sponsor (We should display limit next to field so users know the limit) [field] max 255 characters
[PI ]All text-areas (3000 Characters) (We should display limit next to field so users know the limit) [field] max 3000 characters
[Admin] Remove hyperlinks for Application Archive & Reports until we can make this active.
Issues on 11/19/07
I tried to submit a proposal as exempt, and it took me to expedited, so that worked beautifully. But as Lynn noted during the meeting, it did not automatically take me to full board when I clicked materials that turned it into a full board. But I did get some warnings about needing various documents (e.g., needing child assent, etc.)
Under supporting materials, a drop-down menu option for the research rationale/project summary was not available. I suppose the PI could submit this under the "other" heading, but it would be better to have an option for this.
I uploaded .doc, .pdf., .docx, and .mov files to the portal, all of the various documents seemed to upload fine. The .mov file was over 35 MB, others were more in line with expected sizes.
When I logged back in as PI, I did see my own proposal in the system, so that seems to be working fine. However, when I clicked on the "view documents" link under supporting documents, I got a "file not found" message.
Revisions from 04/17/08
Comments and Suggestions from Faculty and Staff 1. Change text to state that PI “prepares” proposal vs. ‘submits” proposal 2. Move type of proposal (exempt,
expedited or full board) to bottom of page. Or state the PI will be
directed to the specific type of review based on the answers to these
questions. Clearly note IRB reserves the right to determine the type of
review. 3. Add a “help’ button and/or a ‘contact us’ button for the IRB (remove Angela’s office) 4. Add additional text boxes for proposals with more than 3 PIs (maybe 5). Final text box should ask for “other PIs.” 5. PIs should be able to ‘save and continue’ each proposal at any stage of the submission process. 6. Consider a check list for
documents submitted. PI should know which documents are essential for
an IRB proposal. PI should be able to view IRB feedback and see what
documents are approved and what documents need to be revised. 7. Review information for amended
IRB proposals. Is this clearly noted on the eIRB website? Does the PI
need to enter all the requested information a second time? 8. After submitting proposal, PI
should receive an email response from the IRB which should include the
type of review, documents received, and expected response date from IRB
(ie, date of agenda item for IRB meeting). The PI should be able to
print out this confirmation of an IRB proposal submission. If approved,
PI should receive an official approval letter (and pdf copy). 9. Continue to explore and define requirements for TCNJ student research projects 10. Update IRB calendar; Add worksheets
