IBEC Portal User Manual - researchcompliance.kaust.edu.sa

Institutional Biosafety and Bioethics Committee (IBEC)

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IBEC Portal

User Manual


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Contents Research Protocol Review Process ......................................................................................................................................... 3

Request System Access ........................................................................................................................................................... 3

Activate a New Account .......................................................................................................................................................... 3

Create a New Research Protocol ............................................................................................................................................ 4

Research Protocol Design ....................................................................................................................................................... 5

a. Navigation ............................................................................................................................................................... 5

b. Repeating Items ...................................................................................................................................................... 6

c. Mandatory Sections ................................................................................................................................................ 6

d. Mandatory fields ..................................................................................................................................................... 6

e. Section 4: Research Team: ...................................................................................................................................... 6

f. Section 20: Certifications and Signature ................................................................................................................. 7

Principal Investigators (PI) ...................................................................................................................................................... 8

1. Notice of Approval ...................................................................................................................................................... 8

2. Research Protocols List ............................................................................................................................................... 9

a. Pending Tab ........................................................................................................................................................... 10

b. Approved Tab ........................................................................................................................................................ 10

c. Protocols Posted by Protocol Delegate Tab .......................................................................................................... 10

3. New Continuing Review Report ................................................................................................................................ 11

4. Continuing Review Reports List ................................................................................................................................ 12

5. Assigned Protocol Delegate ...................................................................................................................................... 12

Protocol delegate .................................................................................................................................................................. 13

1. Research Protocol List ............................................................................................................................................... 13

Team Member....................................................................................................................................................................... 14

Viewer ................................................................................................................................................................................... 16

Reviewer ............................................................................................................................................................................... 17

1. Protocols to review list ............................................................................................................................................. 17

2. Circulation: Review by circulation ............................................................................................................................. 18

3. Meeting: .................................................................................................................................................................... 20

a. Review by Meeting................................................................................................................................................ 20

b. To meeting ............................................................................................................................................................ 21


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Research Protocol Review Process • Different stakeholders will be involved in the submission, review and approval of a research protocol. • The below table demonstrates the flow a protocol will follow from the time it is submitted to its completion:

Cycles Status Explanation

Pre-review

Submitted Confirmation a new protocol has been submitted. Under pre-review RC team reviews the submitted protocol for completeness. With PI PI updates the protocol in response to RC comments. Resubmitted Confirmation the updated protocol has been submitted.

Circulation

Review by circulation IBEC reviews protocol. The protocol can be approved via electronic circulation with no requirement for a meeting.

With PI (C) PI updates the protocol in response to IBEC comments With admin (C) Confirmation the updated protocol has been submitted. RC team

manages review circulation.

Meeting

Review for Meeting IBEC reviews protocol. Decision will occur at a convened meeting With PI (M) PI updates the protocol in response to IBEC comments. With admin (M) Confirmation the updated protocol has been submitted. RC team

manages review circulation. To meeting Protocol is scheduled for discussion at the next meeting.

Complete

Approved Confirmation the protocol has been approved for three years. Continuing review reports may be required to meet NCBE regulation.

Approved with stipulations

Confirmation the protocol has been approved for three years with conditions to be met. Continuing review reports may be required to meet NCBE regulation.

Withhold Approval Approval is not granted by IBEC. Closed Protocol has been closed/terminated. Expired Protocol has expired. Renewal is required to restart research activities.

Request System Access • Email [email protected] to request access to the system.

Activate a New Account • Log in into the IBEC Portal, using your KAUST user name and password. • If a PI wants a team member to have the ability to draft or modify a protocol, see the Protocol Delegate section. • NOTE: when outside of KAUST network, you are required to be on KAUST VPN to access the IBEC portal.

mailto:[email protected]

https://ibec.kaust.edu.sa/


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Create a New Research Protocol There are three ways to create a new research protocol:

• From the “Action Panel”, by clicking on “New Research Protocol” button:

• From the research protocol List, by clicking on “+ Create New Research Protocol” button:


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• From the main dropdown menu, the PI or Protocol Delegate can create a new protocol by clicking on the dropdown list and click on ‘New Research Protocol’:

Research Protocol Design • The research protocol is designed in 20 sections. • Initially, not all 20 sections will be visible. Depending on your answers to Section 3, you will be required to complete

the sections relevant to your research.

a. Navigation • To navigate in between sections, use the navigation pane on the left side or the “next” and “previous” buttons at

the bottom of each section.


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• The system auto-saves content of each page. • If you leave a protocol without submitting, you can find it as a draft when selecting new research protocol. You can

discard it by clicking on “Discard draft” button.

b. Repeating Items • In some sections of the protocol you will be able to add multiple items (i.e. Research staff, list of agents, etc.). To

create a new item you must click the ADD button, enter the required data and then click SAVE. This process may be repeated until all items have been added.

c. Mandatory Sections The following sections are mandatory and the protocol cannot be submitted if these sections are not completed:

Section 1: General Information Section 2: Research Description Section 3: Research Use Classification Section 4: Research Team Section 5: Funding Source Section 20: Certifications and Signature

d. Mandatory fields Mandatory fields are indicated with a red asterisk “*”.

e. Section 4: Research Team: • You can search for a team member by entering the KAUST ID or email address. The name will be auto-populated. • You must complete question “4.4 Position”. Example: Co-PI, faculty, postdoc, student, lab member, etc.

Save


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f. Section 20: Certifications and Signature • Protocol Delegates can save a draft and send it to their PI for review, but only PIs can submit a protocol.


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• Clicking on the “Submit” button is considered the PI signature. A pop up window will appear to confirm the submission.

Principal Investigators (PI)

1. Notice of Approval • Once IBEC approves a protocol, the PI receives an email notification from [email protected] with a ‘Notice

of Approval’ attached. • If a protocol is ‘Approved with stipulations’, the email notification and the ‘Notice of Approval’ contain these

stipulations. • The PI has the ability to request the approval email notification to be resent at any later time by going into

Research Protocol List, and clicking under ‘Action’ button and ‘resend the approval email’.



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2. Research Protocols List From this page, you can see all your IBEC protocols.

• Your protocols are separated in three tabs: o Pending Protocols: List of all IBEC protocols submitted and under review o Approved Protocol: List of all IBEC protocols approved, expired or archived o Protocols Posted by Protocol Delegate: List of IBEC protocols drafted by your delegate but not yet

submitted


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• You can use the search tool at the top of the page to filter or sort your protocols. • Clicking on the header of each columns of the table, allows you to sort the protocols (descending/ascending)

• Lists can be exported to Excel.

a. Pending Tab • For each protocol, clicking on the Action button gives you access to the following options:

Protocol status Function

View All Allow the view of the protocol Edit With PI Used to edit the protocol during the review process Export to PDF All Export a pdf copy of the protocol Print All Print a copy of your protocol History All Display previous version of your protocol

b. Approved Tab • For each protocol, clicking on the Action button gives you access to the following options:


View All Allow the view of the protocol Edit Approved Used to edit the protocol once approved Clone Approved, Expired Creates a copy of the protocol that can be edited Renew Approved Used to extend the approval for three years Resend the approval email Approved Resend the email with the approval notice

Export to PDF All Export a pdf copy of the protocol Print All Print a copy of your protocol History All Display previous versions of your protocol

c. Protocols Posted by Protocol Delegate Tab • On this tab, you can see all protocols drafted by your delegate(s). • For each protocol, clicking on the Action button gives you access to the following option:


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Edit Draft Used to review, edit, and submit

3. New Continuing Review Report • PIs may be required to submit this report to meet NCBE requirements. • You will receive a notification email when a continuing review report is due. • Select the IBEC “protocol” Identification Number from the top dropdown. • A ‘Continuing Review Report’ will be generated. You will be able to disclose any changes in your project (study

design, procedures or personnel), or any adverse events. • For any changes in your project, you must also edit and submit a revised protocol.


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4. Continuing Review Reports List • In this section, all continuing review reports will be visible in two separates tabs:

o Pending: List of all continuing review report submitted and under review o Approved: List of all continuing review report approved, expired or archived

• For each annual report form, clicking on the Action button gives you access to the following option:


View All View the continuing annual review form. When With PI, report can be edited

Exporte to pdf All Export a pdf copy of the report Print All Print a copy of your report History All Display previous versions of your report

5. Assigned Protocol Delegate • To designate a protocol delegate, send a request email to [email protected] with the nominated delegate. • It is recommended to the PI to select only senior staff as a protocol delegate. • The Protocol Delegate can draft a new protocol, an amendment or a renewal on your behalf, but cannot submit

a research protocol; it has to be submitted by the PI.



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• Under the ‘Assigned Protocol Delegate’ section, the PI can see a list of all their assigned protocol delegate(s).

Protocol delegate

1. Research Protocol List On this page, you will be able to see:

• Drafts you sent to your PI • All of your PI’s Protocols • For each protocol, clicking on the Action button gives you access to the following option:


View All Allow the view of the protocol

Edit With PI, Approved Used to edit the protocol during the review process or once approved

Clone Approved, Expired Creates a copy of the protocol that can be edited Export to PDF All Export a pdf copy of the protocol Print All Print a copy of your protocol


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Team Member • The team members can see ALL the approved protocols in which they are listed • For each protocol, clicking on the Action button gives you access to the following option:


View Approved Allows the view of the protocol Export to PDF Approved Export a pdf copy of the protocol Print Approved Print a copy of the protocol


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Viewer • The Viewer can see ALL approved protocols in the system. • For each protocol, clicking on the Action button gives you access to the following option:


View Approved Allows the view of the protocol Export to PDF Approved Export a pdf copy of the protocol Print Approved Print a copy of the protocol History Approved Display previous version of the protocol


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Reviewer • The Reviewer role is reserved for IBEC Committee Members and consultants.

1. Protocols to review list • List of protocols currently requiring reviewer actions, and includes the status and assigned reviewers. • You can use the search tool at the top of the page to find a specific protocol. • Displays your reviewer role: primary presenter, secondary presenter or other reviewer. • Reviewer Group Name will indicate review team pairings (i.e. Primary presenter Name- Secondary presenter Name). • For each protocol, clicking on the Action button gives you access to the following option:


View Review by circulation, Review for Meeting, To meeting

Allows to view, review, and submit comments on the protocol

Export to PDF Review by circulation, Review for Meeting, To meeting

Export a pdf copy of the protocol

Print Review by circulation, Review for Meeting, To meeting

Print a copy of the protocol


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2. Circulation: Review by circulation • All reviewers must provide comments or approval after each revision by the PI. • The reviewer may add comments to any section. • Reviewers’ comments will remain anonymous to the PI, but will be visible for the rest of the reviewers. • To make a comment, click on the ‘Add Your Comment’ green button.

• Once the Reviewer has typed their comments, click ‘Add’ to save the comment in the specific section.

After the Reviewer has commented in all the necessary sections, they need to click on the ‘Decision’ tab in order to submit their review.

• To submit comments, click on “Revision Required”. • If the Reviewer does not have any comment click on ‘Approved’. • A comment is required in the justification field even if approving.

Save


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• If the Reviewer would like the protocol to be discussed at a meeting, it should be requested in the justification field (e.g. I would like this protocol to be discussed at the meeting.)

• If you approve, and another member comments on the protocol, you will received the protocol again with the PI response.

• RC will verify the appropriate training is completed before the “Notice of approval” is issued to the PI.


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3. Meeting: a. Review by Meeting • Primary and secondary presenters are assigned, but everyone is expected to review the protocol. • All reviewers must review the protocol after each revision by the PI. • The reviewer may add comments to any section. • Reviewers’ comments will remain anonymous to the PI, but will be visible for the rest of the reviewers. • To make a comment, click on the “Add Your Comment” green button.

• Once the Reviewer has typed their comments, click ‘Add’ to save the comment in the specific section.

After the Reviewer has commented in all the necessary sections, they need to click on the ‘Decision’ tab in order to submit their review.

Save


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• To submit comments, click on “Revision Required”. • If the Reviewer does not have any comment click on ‘Approved’ to indicated your approval for discussion at a

meeting. If you do not respond by the deadline, this will be considered your approval for discussion at a meeting.

• A comment is required in the justification field even if approving. • If you approve, and another member comments on the protocol, you will received the protocol again with the PI

response.

b. To meeting • When all reviewers indicate “Approved”, or remaining comments require in-person discussion, the protocol will be

placed in the agenda for discussion. • If a protocol is not approved during the meeting, it will be return to:

o the PI for further revision, o the Committee for further comments, o the PI with a final decision to “withhold approval”.

• RC will verify the appropriate training is completed before the “Notice of approval” is issued to the PI. • Approved minutes of the meeting will be attached to document the Committee’s decision.

Documents

IBEC Portal User Manual - researchcompliance.kaust.edu.sa