SBSIRB Read-Me-First
IRBNet User Guide
for Researchers
Please see the “Notes on New Items” before proceeding
IRBNet login page: www.irbnet.org
Training Resources for Researchers
(available in video and .pdf)
http://www.research.buffalo.edu/rsp/irbnet/
Username: ubsuny
Password: training12
If you have questions regarding this initiative, please email:
irbnet@buffalo.edu
April 15, 2014
Table of Contents
When In IRBNet Be sure to select the correct Library for the IRB you will submit your project to
(SUNY University at Buffalo HSIRB, CYIRB, or SBSIRB) or you may use incorrect documents.
Notes on New Items (Watch this Space before Every Submittal) ................................................................... 3
Frequently Asked Questions (FAQs) ................................................................................................................. 3
Who MUST register for IRBNet? ................................................................................................................ 3
How do I register for IRBNet? .................................................................................................................... 3
How will I get trained to learn how to use IRBNet?................................................................................... 4
Can I access IRBNet from my home computer? ........................................................................................ 4
What is a “Package”? ................................................................................................................................. 4
What are Messages & Alerts in IRBNet? .................................................................................................... 4
Where can I find the documents I need for submittals? (The Forms and Templates Library) .................. 4
What is the Lock Status? What does “locked” and “unlocked” mean? ..................................................... 5
What level of review should I submit for? ................................................................................................. 6
Registration and User Profile Maintenance ..................................................................................................... 6
I.
How to register with IRBNet .................................................................................................................. 6
II.
Updating Your User Profile: (e.g., changing phone number, email address, or IRBNet password) ...... 7
III.
Linking CITI and IRBNet ...................................................................................................................... 8
How to Submit Materials. Step-by-Step Submittal Instructions. ................................................................... 8
IV.
IRBNet Icons ....................................................................................................................................... 8
V.
Instructions for Submitting the first package of a Project in IRBNet ..................................................... 8
VI.
Instructions for Submitting Subsequent Packages to a project that is already in IRBNet (Renewals,
Amendments, SEP reports, etc.) .................................................................................................................. 14
VII.
Revising Documents within a Project .............................................................................................. 16
A.
To Revise the Core Data Form ......................................................................................................... 16
B.
To Revise Other Previously Submitted Documents ......................................................................... 17
C.
To Add an entirely new document to the package .......................................................................... 17
VIII.
Responding to IRB Requests for Modifications................................................................................ 18
A.
Revising a project when the IRB has UNLOCKED a package for revisions ....................................... 18
B. Revising a project when the IRB has NOT UNLOCKED a package for revisions because a Board
Action of Modifications Required has been Posted ................................................................................ 18
IX.
“Sharing” - Adding Personnel to a Study ......................................................................................... 19
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X.
Choosing the correct Submission ‘TYPE’ from the IRBNet List ............................................................ 19
What to Submit - SBSIRB Guidance on what to include in common submittals. ......................................... 20
XI.
General Information on what to submit .......................................................................................... 20
XII.
What Should I Consider or Think About before Starting to Assemble a Protocol Submittal? ......... 21
XIII.
What typically needs to be submitted for a new study? ................................................................. 25
XIV.
Protocol “Parts” in the document library and how to use .............................................................. 26
XV.
Submitting revisions and/or amendments via IRBNet..................................................................... 28
XVI.
Deciding when to update a document and when to provide a new document: ............................. 29
XVII. Additional Information for Submitting Serious Events and Problems (SEPS) both External from a
Sponsor and Local Reportable Events.......................................................................................................... 30
XVIII.
Other Types of Submissions ......................................................................................................... 30
Other Guidance ............................................................................................................................................... 31
XIX.
Saving a pdf as a “Reader Extended” file so that it can be filled in using Adobe Acrobat Reader. . 31
A.
Reader Enabling using Adobe Acrobat 9.0 or X. .............................................................................. 31
B.
Reader Enabling using Adobe Acrobat 11.0..................................................................................... 31
XX.
Using My Virtual Computing Lab to Access Adobe Acrobat Professional Version for filling out of
pdf forms ...................................................................................................................................................... 32
A.
Instructions for using My Virtual Computing Lab to access Adobe Acrobat using a PC computer . 33
B.
Instructions for using My Virtual Computing Lab to access Adobe Acrobat using a Mac computer
34
XXI.
Printing from documents with tracked changes .............................................................................. 36
XXII.
Accessing IRB Approved/Published Documents .............................................................................. 37
XXIII.
Renewal Reminders ..................................................................................................................... 37
XXIV.
Version Date Requirement for Consent Documents- No More Stamps/Watermarks ................ 37
XXV.
What should I do if reviewers’ comments/requests seem unreasonable? ..................................... 38
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Notes on New Items (Watch this Space before Every Submittal)
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This section will be updated with a short bulleted list of major changes over the past few
months in reverse chronological order so that you can quickly see if there is anything new
that will have an effect on your submittal.
As of May 7th 2014, the SBSIRB will no longer accept NEW protocol submittals in word
document format (i.e. protocol parts 1-3). The pdf “Protocol Study Plan Addendum” will
be required for all NEW protocols not reviewed prior to that date. Word .doc/.docx
formats will still be accepted for previous submittals and all supplemental documents
(consent forms, recruitment materials, study instruments, etc.).
The pdf “Protocol Study Plan Addendum” now incorporates most of the documents that were
listed in the IRBNet Library under Protocol, Addenda, and Forms that were required for
initial submittal. All items that have been replaced by the pdf protocol are currently listed
under OldFormat in the forms and templates library.
The OldFormat documents will eventually be removed to a separate website because most
studies that require these forms will already contain the document in prior packages.
The read-me-second file has been deleted. Pertinent information from the read me second
file has been incorporated into this read me first file.
A new pdf “Protocol Study Plan Addendum” has replaced a number of documents in the
SBSIRB Forms and Templates Library. Most importantly, The Protocol “Parts” have been
replaced by this document so anywhere in the Read-Me file that refers to the Protocol
Parts can be assumed to be replaced by the Protocol Study Plan Addendum. The read-me
file will be updated after the new pdf has been in use for a few months. Over time we will
be adding many of the addenda to this file in order to help simplify the submittal process.
The new pdf “Protocol Study Plan Addendum” format should be used for all new submittals to
the SBSIRB. If you are requesting an amendment or otherwise making changes to a
previously reviewed/approved protocol and require access to the former protocol “parts”
or other old addenda they can be found at the end of the SBSIRB IRBNet Forms and
Templates Library under the category of SBSIRBOldFormat.
Frequently Asked Questions (FAQs)
Who MUST register for IRBNet?
 ALL Investigators and ALL members of their research staff are required to “register” on IRBNet
in order to track research study personnel and completion of CITI training requirements.
 CITI training completion records will now be integrated into our IRBNet system. In order for
that to function properly, all study staff must be “registered” in IRBNet
How do I register for IRBNet?
 See the “Registration and User Profile Maintenance” section of this Guide
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How will I get trained to learn how to use IRBNet?
 All Researchers will be able to self-train using online training materials (video and printable
document) that are available on the IRB websites.
 This SBSIRB “Read-Me-First” User Guide is available in IRBNet in the Document Library.
 Please Do Not Request A Demo from the IRBNet Homepage. This is not a training application,
it is for their marketing purposes and it will not be helpful to you.
Can I access IRBNet from my home computer?
 Investigators will be able to access IRBNet from any location where they have Internet access
and by using any browser.
 Investigators will have access to their entire project file at all times, will be able to see where
the project is in the review process, view Committee decision letters as they are published, and
view their entire study project history.
What is a “Package”?
Each project submitted to IRB Net has a unique project [protocol] number. Each time a new
submission is made, you submit it under the same project number, but the package submission
number will change. For example “888888-1” is an Initial Application. If you submitted an Amendment
package to the project, the number would change to “888888-2.” Protocol and package numbers are
two difference aspects of the same study.
What are Messages & Alerts in IRBNet?
The Messages & Alerts tools are located in IRBNet at the bottom of the left side toolbar when you are
in your study. Click on it to see a complete history of project messages - including messages between
investigators and the IRB office. If the IRB requests modifications as a part of its preview and unlocks a
package, a copy of the requested modification can also be found here. When review has been
completed on a package a Board Action Message will appear here. A message indicating that a board
document has been published will also usually be present. In most cases the packages will then remain
locked; any requested modifications are contained in the board document that can be found by
clicking on the “Reviews” tab in the Project Administration menu for the project.
Where can I find the documents I need for submittals? (The Forms and Templates Library)
 Most documents are contained within the Forms and Templates library.
 Make sure you are using the UB SBSIRB document library, as the other IRB’s have their own
document libraries.
We recommend that you download documents directly from the library for each new submittal, so
that any updated material that we request in the library documents is contained in submitted
materials.
The SBSIRB Forms and Templates Document library within IRBNet is organized along the following lines:
1. Consent Templates and Examples- these include consent documents, information sheets, assent
documents and parental permission documents.
2. Forms- used to report information to the SBSIRB
a. Forms for use after initial submittal/once a study is approved
i. Form SBSIRB Amendment
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ii. Form SBSIRB Closure
iii. Form SBSIRB Continuation Renewal
iv. Form SEP Report
b. Other Forms
i. Form FeeForm Sbsirb
ii. Form Not Human Subjects or Not Engaged
3. HIPAA – Only required when accessing medical records or providing treatment as a part of the
study. Note that the HIPAA Worksheet.doc is used for guidance only and never submitted.
4. Protocol Study Plan Addendum which replaces the “Protocol Parts” that have been moved to the
Old Format documents section.
5. SBSIRBOldFormat documents includes all documents like the protocol parts and addenda that have
since been replaced by the pdf Protocol Study Plan Addendum.
What is the Lock Status? What does “locked” and “unlocked” mean?
Lock Status
Color of Lock What does it mean?/How does this affect me?
Locked
Gray
 A project “package” is currently under review by the IRB.
 It is “locked” to prevent changes to the submitted “package”
while it is under review.
 After review, the package will remain “locked” and you will
either receive an approval letter or a modifications required
letter.
 You will need to create a subsequent package to address any
requested changes (see below for guidance on how to do this).
Unlocked –
Pending PI’s
Revisions
Red
Locked –
PI’s Revisions
Complete
Green
 The IRB in pre-review has decided that modifications or
additional materials are needed before the submission is
complete.
 By unlocking the package, the IRB has stopped their review
process until your modifications have been made.
 The PI must “Mark Revisions Complete” so that the IRB knows
that the materials are now updated and control of the materials
is passed back to the IRB.
 The PI has submitted modifications so the IRB can continue its
review.
 The PI has addressed the IRB’s requested modifications and
marked the modifications complete to notify the IRB that review
of the application may resume.
 To mark that modifications are complete:
o Click on the DESIGNER page, located on toolbar on the left
hand side.
o At the top of the page, you will see “This package is… Unlocked
– Revisions Pending” and the lock will be red.
o To Mark Revisions Complete, click the second link to the right
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of the Lock Status, “Mark Revisions Complete.”
o The lock will then turn green and read “Locked – Revisions
Complete.”
What level of review should I submit for?
The IRB makes the final determination of the level of review. The new pdf protocol study plan addendum
has a section on Level of Review that will guide both researchers and the IRB in this determination. Once
you complete this section the box at the top of this section will indicate possible levels of review. If this box
indicates both exempt and expedited review are possible, you should submit for exemption. If the exempt
reviewers determine that a higher level is needed, the study will automatically be “bumped up” to the level
necessary. When full review is needed, the IRB will notify you once the study is placed on a meeting
agenda and then a few days before the meeting you will be sent a message with the meeting location and
approximate time for review of your submittal.
There is very little down side to submitting for a lower level of review because the SBSIRB gets almost the
same submittal materials for all three review levels. In the case of an exemption that is “bumped up” to
expedited review, in most cases, only a loss of 2-3 days occurs while members evaluate the exemption
request. When expedited reviewers decide that a protocol requires full board review, the reviewers then
become the primary reviewers for the full board and request changes before the full board meeting so that
the protocol will require less work afterwards so no time is lost in this process.
Registration and User Profile Maintenance
I.
How to register with IRBNet
1. Go to https://www.irbnet.org
2. Click the New User Registration link (upper right hand corner of the screen).
3. Enter your legal first and last names in the appropriate fields (please use appropriate
capitalization as you register into the system; the system does not alphabetize names that begin
with lower-case letters)
4. Create your User Name - if you know your UBITname, please try to use it as your IRBNet User
Name (see below for information on how to check your UBIT information), otherwise, create a
User Name you will remember. Note that because IRBNet is used at other institutions, your
particular UBITName may already be in use by someone else in IRBNet and you will have to use
a different User Name.
5. Create your Password (at least 8 characters); confirm your password, and enter a password hint.
6. Click on Continue
7. Accept the Terms of Use
8. On the next screen, type “SUNY” in the “Search for an organization” field and click “Search” OR
scroll down and select “SUNY - University at Buffalo” from the list on the screen.
9. Review info for accuracy, edit if needed, then Click on Continue
10. On the next screen, enter your telephone number and email address
11. Click on Continue
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12. Click Register
13. Click Continue
14. You will receive an email from IRBNet. The email will contain a link that you need to click on
in order to activate your account.
15. Once you click on the link, you will be able to enter your name and password in the IRBNet
login page and access the site. (If this does not work the first time, close out of the IRBNet
homepage and open it again: irbnet.org). Then enter your username and password and it
should work.)
How do I check my UBIT information?
It is preferred that UB-Affiliated Investigators and UB-Affiliated research staff members
register for IRBNet using their UBITname and UBITname password.At minimum, it is
requested that the UBITname is used as the username for IRBNet. Note that because
IRBNet is used at other institutions, your particular UBITName may already be in use by
someone else in IRBNet and you will have to use a different User Name.
Please note that the IRB offices cannot assist you with your UBITname.
If you have questions about whether or not you have a UBITname, have forgotten your
UBITname password, or have other UBIT questions you will find answers to your questions
by following directions on the UBIT resource pages:
The main UBIT resource page:
http://ubit.buffalo.edu/ubitname/
Finding your UBITname
http://www.buffalo.edu/directory/find-yourself-page.html
Finding out your UBITname password
http://ubit.buffalo.edu/ubitname/password/password.php
II.
Updating Your User Profile: (e.g., changing phone number, email
address, or IRBNet password)
A. How to Change Your IRBNet Password
Step 1.
Log in to irbnet.org
Step 2.
Click on “USER PROFILE” (top –upper right).
Step 3.
Click on the appropriate yellow "edit" button to change your password and make your
changes.
Step 4
Be sure to click “SAVE” to save the changes.
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B. How to Change Your IRBNet E-Mail Address
Step 1.
Log in to irbnet.org
Step 2.
Click on “USER PROFILE” (top –upper right).
Step 3.
Click on the appropriate yellow "edit" button to change your email address and make
your changes.
Step 4.
Be sure to click “SAVE” to save the changes.
III.
Linking CITI and IRBNet
Please see the separate pdf document “Tracking CITI records in IRBNet.”
How to Submit Materials. Step-by-Step Submittal Instructions.
For information on WHAT to submit see the later sections of this document.
IV.
IRBNet Icons
Delete
View a document
Edit or replace a document
Required field
You have pending project reminders
V.


Instructions for Submitting the first package of a Project in IRBNet
VERY IMPORTANT. A Project is denoted by a 6-digit IRBNet id number while each package in a
project is denoted by the number following the dash (-). All transactions (such as revisions,
renewals and amendments) for a given project should be submitted into the same project
usually as a subsequent package and not as a new project.
Please refer to the step-by-step instruction below for specific UB IRB requirements and tips.
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
For general information, you may access the IRBNet Training videos and the pdf version of the
video by visiting www.irbnetresources.org and entering in the following:
username: ubsuny
password: training12
Step 1:
Log In to www.irbnet.org using your username and password (for first time users, you
must Register with IRBNet - see the “Registering with IRBNet” section in this Guide.
Step 2:
The default page will be MY PROJECTS, where you will have access to all of your studies
and can create new studies. The Research Institution box should default to SUNY
University at Buffalo(If SUNY University at Buffalo does not appear, you may have
affiliated with the incorrect institution when you registered. Contact
irbnet@buffalo.edu for assistance.) Otherwise, Click CREATE NEW PROJECT and fill in
the relevant information about your project, click ‘Continue’
Step 3:
You will now be on the DESIGNER page.
Go to Step 2 and click on “Add New Document”
On the “Attach Document” page, Go to the on-line document at the bottom of the page
(SUNY Buffalo – Core Data Form) and click ‘ADD
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The IRB Document Wizard will open. When this happens you will have two choices: a) cloning, or b)
not cloning (The SBSIRB has found very few instances where cloning is appropriate or helpful):
a) Clone: If a project already has a Core Data Form you should NOT CLONE it to
update the CDF for the current project, rather just edit the current CDF. If you have
previously submitted a “SUNY Buffalo –Core Data Form” for another project,
cloning may be an option for you. Cloning creates an exact copy of your existing
wizard and can be useful if you are submitting a project that is very similar to a
current project.
Whenever you choose to clone, you should always review every answer copied
from your existing core data form to make sure it is up to date.
b) NOT CLONE: ALL SUNY- University at Buffalo first-time users of IRBNet will select
“not clone” to create a first-time Core Data Form for each project.
 Select “Create a new wizard from scratch” .
 Read the instructions, then click “Next”.
 Continue through all the pages by answering the questions and clicking “Next”
when you are ready to proceed.
 When you arrive at the page that says “Form Complete”, you may see a list of
supplements that you will be required to submit as part of your application.
While SBSIRB terminology for these items may differ, this list can be used as a
guide to help ensure a complete submittal.
 You can preview the Core Data Form (CDF) before saving and exiting by clicking
on “Preview” (be sure to close the preview window when done with your
preview).
 When you are ready to save the document click ‘SAVE AND EXIT ‘and your
document will be saved and automatically attached to your project (you will be
taken to the “Designer Page”).
Step 4:
To add other required documents to your submission package, return to the DESIGNER
page.
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Under Step 1 in the Designer Page, Select a Library for your forms: Be sure to select
the correct Library for the IRB you will submit your project to (SUNY University at
Buffalo HSIRB, CYIRB, or SBSIRB). Forms for a different University at Buffalo IRB will
not be accepted for review. In the “Select a document” drop-down menu, you will find
all of the IRB Forms, Checklists, etc
Select the document(s) you need from the dropdown list, download and save them to
your computer.
All required forms should be completed and saved in your computer. When they are
complete, you will attach them to the submission by uploading them to your project in
IRBNet.
Step 5
When you have completely finished filling out and saving your documents, return to
the Designer page for your project and click “Add New Document.”
You will then see the Attach Document page, where you will select an “Attachment
Type” from the drop down menu for whatever it is you plan to attach (for example,
Consent Form). Be sure to ADD a description of document (be descriptive so you and
the IRB can tell what this is when they see it listed in your project document list: e.g.,
Amendment Form, Adult Consent: treatment group, Adult Consent: control group,
Continuing Review Form, HIPAA Authorization Form, or SEP report.)
Click “Browse” to locate the document that you plan to attach (once found click
“Open”)
Then Click ‘ATTACH’.
Your document is now attached to the project package (Repeat steps for each item you
wish to attach – such as forms you have completed, copy of your grant if receiving
funding, consents, supplements, external institutional approval, or any other document
you need to attach).
Be sure all documents are attached and in the final version prior to submitting. Any
incomplete submissions will be sent back and will not be reviewed by the IRB.
Step 6:
Click SHARE THIS PROJECT to identify your research team for this study. Click the
‘Share this Project’ button in the left hand column;
***The Principal Investigator must be shared and given full access to the project.
***For Student/Resident Submittals, the faculty sponsor must be shared and given full
access to the project.
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Additional study personnel need not be shared immediately, but must be added to the
project by sharing it with them BEFORE they may perform any study activities.
Click the blue ‘Share’ link.
Select ‘SUNY University at Buffalo’ from the organization box;
Click ‘Select Organization’ and search for ALL members of your research staff. (NOTE:
ALL members of your research staff must be registered on IRBNet in order for you to be
able to enter them here.)
Locate the individuals from a list of names. (If a specific name is not found, either you
selected the incorrect Institution or the individual is not registered with IRBNet.)
Grant each user a level of access as follows:
 FULL: User may add/edit/delete project documents, share the project with
other users, and submit the project. Individuals with full access to a project will
receive auto-notification when an action has been taken regarding the project.
Students must give this level of access to their Faculty Advisors.
 WRITE: User may add/delete project documents, but cannot share the project
with other users or submit the project.
 READ: ALL members of your research staff MUST retain a minimum share
level of “Read” access in order for the CITI training integration feature to
function properly. Users with Read access can view project documentation,
communicate with the project team and add their signature.
All individuals “Shared” on your study will be notified automatically via email that the
project has been shared with them; you may enter comments to be included within the
email.
[NOTE: If your study requires IRB approval from another institution that uses IRBNet
you can share a copy of your project with a PI at that institution. Click ‘Share this
Project’ then ‘Multi-Site’. Find the organization then click ‘Select Site’. Select a user and
add comments if necessary.]
Click ‘Save.’
Step 7:
Click SIGN THIS PACKAGE. The PI (and Faculty Sponsor, when applicable) MUST sign
the project before it is submitted. Select your role and click ‘Sign’
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The Principal Investigator (and Faculty Sponsor, when applicable) MUST sign all
New/Initial Submissions. A designee may NOT sign for the PI or Faculty Sponsor.
The Faculty Sponsor should sign as the “Advisor”
Note: Studies will not be scheduled for review if required signatures are missing.
Step 8:
Click SUBMIT THIS PACKAGE. Select “SUNY University at Buffalo” in the “Search for
Organization” drop down menu (This will be your default location and should be
highlighted already).
Click on the IRB that you will be submitting to:



Health Sciences IRB (HSIRB)
Children & Youth IRB (CYIRB)
Social & Behavioral Sciences IRB (SBSIRB)
Click the ‘Continue’ button.
In the Submission Type drop-down menu, select the appropriate submittal type (usually
‘New Project’, ‘Continuing Review/Progress Report’, ‘Amendment/Modification’, ‘
Unanticipated Problem (UP)’ or ‘Adverse Event (non-UP)’) click ‘Submit’
*******************
TIPS:




When submissions are incomplete, you will receive an email and a notification in ‘My
Reminders’ that will list what needs to be addressed. You should log in, go to your project, add
missing documents and resubmit your package by using the “Mark Revisions Complete”
function in the Designer. See “Responding to IRB Requests for Modifications.”
The MY PROJECTS screen can be found by clicking on ‘My Projects.’ This will show you the list
of studies to which you have access – those you have created and those that have been shared
with you. Studies that have not been submitted are labeled “Work in Progress” in the Status
column. Studies that have been submitted but not reviewed by the IRB are labeled “Pending
Review.”
Clicking on the title of any project will take you to the PROJECT OVERVIEW for the selected
project, which contains project details.
Subsequent new packages for the same project should rarely be created when a current
package has been unlocked by the IRB, is a Work in Progress, or is currently under review.
Cases when a second new package may need to be started while a current package is already in
process of submittal/review should be limited to situations when submittal of a new package
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

needs to be made in a “timely” manner (e.g. while revising an amendment, you have to report
an SEP to the IRB) or after consultation with the IRB administrator.
To know when your Faculty Sponsor or PI has signed off on a study, ask them to click the send
mail button when complete. This will send an automatically generated email from them letting
you know they have completed it. If they do not do this, you can log-in and review if they have
signed by clicking on “Sign This Package” (left hand side). This will bring you to a list of who has
signed this study and when it was completed.
To change a level of “share” access you granted with someone, follow the same steps in SHARE
THIS PROJECT and change the share level. Keep in mind that ALL members of your research
staff MUST have a minimum share level of “Read” access in order for the CITI training
integration feature to function properly.
.
VI.
Instructions for Submitting Subsequent Packages to a project that is
already in IRBNet (Renewals, Amendments, SEP reports, etc.)
The submission of an Amendment, Continuing Review Request, Closure, Serious Event Report or
other type of submittal to an open study in IRBNet requires the creation of a subsequent
“package” for the project.
***Note that in most cases when a project has an unlocked package, you should not submit a new
package but rather you should make any changes in the unlocked package and mark revisions complete
to submit materials to the IRB.
***For subsequent packages, you do NOT have to attach every document over again. Only the
documents that you are updating or providing for the first time as a part of the package need to be
included in the new package.
Step 1:
Login to IRBNet: www.irbnet.org. This will take you to the MY PROJECTS page. This is
where all of the studies that you have access to will be listed.
Step 2:
Click on the Title of the project that you would like to revise. Then click on the PROJECT
HISTORY
Step 3:
Click on the CREATE NEW PACKAGE button and then the NEW DOCUMENT PACKAGE
Step 4:
You will now be on the DESIGNER page. (Directions and Guidance for the uploading of
any revised project documents can be found in Section VII: Revising Documents
within a Project)
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From here, you can see the documents that have been previously uploaded as part of
this project in previous packages at the bottom of the page and also access documents
from the library (make sure you are in the SBSIRB library). In many cases when you
need to revise a document that was previously submitted you should download the
document to your desktop from either “New and Revised Documents in this Package”
or “Documents from Previous Packages that you can Revise” and then edit the
document on your desktop so that it can later be uploaded. You can also download a
completely new document from the library if needed.
Select your library (select the library of the IRB to which you originally submitted this
study’s documents, the SUNY University at Buffalo HSIRB, CYIRB, or SBSIRB).
Be sure all needed documents are attached and in the final version prior to submitting.
Any incomplete submissions will be returned or withdrawn and will not be reviewed by
the IRB.
Step 5:
If adding /changing any Co-Investigators, Coordinators, or other staff members, etc.,
“Share” the project with your research team by clicking SHARE THIS PROJECT and Click
the blue ‘Share’ to grant access to this project.
Select SUNY University at Buffalo from the organization box, click ‘Continue’
Note: To ‘share’ your research with someone, they must be registered with irbnet.org
Grant each user a level of access: FULL, WRITE, or READ
Selected users will be notified automatically via email that the project has been shared
with them. You may enter comments to be included in this email in the ‘Your
Comments’ section. Click ‘Save’
Step 6:
Click SIGN THIS PACKAGE. In all cases, the person submitting the package should sign
it. Select your role and click ‘Sign’. In some cases, the PI (and Faculty Sponsor, when
applicable) will also need to sign a package before it is submitted. See “What do I need
to submit the first time I use IRBNet?” for details about who needs to sign different
package types.
The Faculty Sponsor should sign as the “Advisor”
Note: Studies will not be scheduled for review if required signatures are missing.
Step 7:
Once you have attached all of your documents and project is signed, you should be
ready to submit your project. Click SUBMIT THIS PACKAGE. Select “SUNY University at
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Buffalo” in the “Search for Organization” drop down menu (This will be your default
location and should be highlighted already).
Click on the IRB that you will be submitting to:



Health Sciences IRB (HSIRB)
Children & Youth IRB (CYIRB)
Social & Behavioral Sciences IRB (SBSIRB)
Click the ‘Continue’ button.
In the Submission Type drop-down menu, select the appropriate submission type (See
Choosing the correct Submission ‘TYPE’ from the IRBNet) List and click ‘Submit’
To review what has been sent, click PROJECT OVERVIEW. The submission will be under
‘Pending Review’ status until a decision has been made.
VII.
Revising Documents within a Project
With the exception of the core data form, any editing to or creation of new documents must occur
locally on your computer and then the documents must be uploaded into IRBNet.
Documents can only be updated within IRBnet if you create a new package with a status of work in
progress or when a package is unlocked by the IRB for editing. Note that in most cases when a project
has an unlocked package, you should NOT submit a new package but rather you should make any
changes in the unlocked package and mark revisions complete to submit materials to the IRB.
Once you have made any edits to documents locally you should access the unlocked package in which
you wish to include the documents from your MY Projects list, or create a new package as per the
directions in section VI: Instructions for Submitting Subsequent Packages to a project that is already in
IRBNet.
To access the location within an unlocked package where you can upload materials you should Click
the DESIGNER.
A. To Revise the Core Data Form
If you need to modify the “SUNY Buffalo Core Data Form” you previously submitted, you can find
it in the list of documents either “New and Revised Documents in this Package” or under the
words “Documents from Previous Packages that you can Revise”. Unless there has been a
mistake in the past (in which case you should edit the most recent Core Data Form) the Core
Data form will only appear once and only in one of these locations.
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Step 1
Once you have located the document, click on the pencil icon
next to the “SUNY
Buffalo Core Data Form” and you will be taken to the IRBNet Document Wizard page
where you can make changes to the “SUNY Buffalo Core Data Form.”
Step 2
Once you have finished your changes, click “Save and Exit”.
Your revised “SUNY Buffalo Core Data Form” is now attached to the current project
package.
B. To Revise Other Previously Submitted Documents
If you need to modify a document you already submitted (NOT including “SUNY Buffalo Core Data
Form”), follow the instructions below:
Step 1
Find it in the list of documents either under “New and Revised Documents in this
Package” or under the words “Documents from Previous Packages that you can
Revise.”
Step 2
Once you have located the document, click on the paper icon
next to the
document you plan to modify. This will open the document for editing.
Step 3
Do your edits and save the document locally to your PC Desktop.
Step 4
Return to the DESIGNER page and click on the pencil icon
next to the document
you just updated and you will be taken to the Attach Documents page
Step 5
Click “Browse” to locate the document that you plan to attach. Click the document and
click “Open”. Then Click “Attach.”
Step 6
Your document is now attached to the project package as a replacement (Repeat steps
for each document you wish to revise).
C. To Add an entirely new document to the package
Note: A new document should only be added when the document to be added is NOT a
replacement for or revision to a document that is already in the project.
Step 1
Step 2
Step 3
Create the document either from scratch or a template that you have downloaded
from the library and save it locally on your computer.
Return to the DESIGNER page and then Click the “Add New Document” Button.
You will then see the Attach Document page, where you will select an “Attachment
Type” from the drop down menu for whatever it is you plan to attach (example,
Consent Form). Be sure to ADD a description of document (be descriptive so you and
the IRB can tell what this is when you see it listed in your project document list: e.g.,
Amendment Form, Adult Consent: treatment group, Adult Consent: control group,
Continuing Review Form, HIPAA Authorization Form, or SEP report.)
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Click “Browse” to locate the document that you plan to attach (once found click
“Open”)
Then Click ‘ATTACH’.
Your document is now attached to the project package.
VIII. Responding to IRB Requests for Modifications
See also, “Submitting Revisions/Amendments to the IRB via IRBNet” and “When should I
update a document and when should I provide a new document in IRBNet?”
A. Revising a project when the IRB has UNLOCKED a package for revisions
You will receive an email that is also posted in the Project Messages and Alerts. The message
will list what is missing or what changes need to be made to your package documents. If the
IRB informs you that your package has been ‘unlocked’ for revisions, follow steps 1-3 below.
Step 1:
Login to IRBNet; www.irbnet.org. This will take you to the MY PROJECTS page.
Step 2:
Click on the Title of the project of which you submitting missing/corrected documents.
Step 3:
Click the DESIGNER.
From here, you can access current documents and upload revised documents for your
study (See Revising Documents within a Project). Please make all requested revisions
before you “relock” the package.
To re-lock the package and pass access back to the IRB that unlocked the package, Click
on ‘Mark Revisions Complete’ at the top of the page If you accidentally click submit
this package, the IRB that you want to send this back to (the one that unlocked the
package) will not be visible so you will know you went down the wrong path.
B. Revising a project when the IRB has NOT UNLOCKED a package for revisions because a
Board Action of Modifications Required has been Posted
In this case there has been an IRB action taken on the previous package and in order to
maintain the record of what has been reviewed, it will not be unlocked.


To view the requested modifications see “Accessing IRB Approved/Published Documents”
You will need to submit your revisions as a new package (see “Instructions for Submitting
Subsequent Packages to a project that is already in IRBNet”).
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IX.
“Sharing” - Adding Personnel to a Study
New personnel additions to a study are done in two places. The IRBNet “share” process is used to update
the Project Team Tracking for all study personnel while the Core Data Form (CDF) may also need to be
updated for some specific cases.
You should first add personnel to an IRBNet project itself by “sharing the project” with other study
personnel- See the IRBNet Energizer videos and pdfs for directions on this process (they do a much better
job than your IRB staff could at presenting this). Note that only people who have registered with IRBNet
will be listed. Most people should only be given READ access. Full access should be reserved for the PI,
Faculty Sponsor and possibly lead study coordinators. Co-PIs should usually be given write access so that
they can prepare materials for submittals but the PI can decide if they should be submitted.
If a new person is to be a PI, Co-PI, Faculty Sponsor or will be obtaining consent, the CDF must also be
updated. You will have to access the project DESIGNER to do this and then update the current core data
form by clicking on the pencil icon to edit. Do NOT create a brand new core data form or clone. The
information regarding personnel is on the pages right after “Principle Investigator Information” so JUMP to
that page as a starting point.
X.
Choosing the correct Submission ‘TYPE’ from the IRBNet List
ITEM
Submission Type
Exempt Initial Submission
New Project
Expedited IRB Initial Submission
New Project
Continuing Review
Continuing Review/Progress Report
Amendment
Amendment/Modification
Study Closure
Closure/Final Report
Response to Modifications Needed from the IRB
Use the same Type as used for the package for
which modifications were requested
Response to Additional Materials Request from IRB
Use the same Type as used for the package for
which modifications were requested
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Correspondence
Other
Any Communications from Sponsor (DSMB reports,
Other
Investigator Brochures, Clarification Memos,
Package Inserts)
External SAEs from Sponsor - NOT REQUIRING AN
Adverse Event
AMENDMENT/MODIFICATION
Local SAEs
Reportable Event/ (Non AE)
Protocol Deviation
Reportable Event/ (Non AE)
Unanticipated Problem
Reportable Event/ (Non AE)
Compliance Concern
Reportable Event/ (Non AE)
What to Submit - SBSIRB Guidance on what to include in common
submittals.
XI.
General Information on what to submit
**Note: The online “Core Data Form” found in IRBNet replace the previously used HS-1A Application
Form.
Application
Type
New/Initial
Amendment –
Submit as a
Subsequent
Package.
Continuing
Core Data Form
(CDF) in IRBNet
Yes
No – unless
submission
includes an
amendment to
information in
the CDF
No – unless
Required Signatures
Other documents
 Principal Investigator
 Faculty Sponsor (for students,
residents, and fellows)
 Others –if required by the Sponsor or
the nature of the research
 Note that there are
specific IRB documents
and study materials that
MUST be completed for a
new/initial review. Follow
instructions below under
“What typically needs to
be submitted for a new
study?”
 Amendment form
 Any materials that are
changing/being added
 See “Revising Documents
within a Project” in this file
for guidance.
 See last page of the form for
signature requirements
 Principal Investigator
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 Unless you are also
Review –
Submit as a
Subsequent
Package.
Human
Subjects
Research
Determination
Revisions
requested by
the IRB
XII.
submission
includes an
amendment to
information in
the CDF
Yes
Only if/when
changes are
being made to
the information
in the CDF
 Faculty Sponsor(s) for students,
residents, and fellows
 Others –if required by the Sponsor or
the nature of the research
 Principal Investigator
 Others –if required by the Sponsor or
the nature of the research
Usually none (unless a HIPAA
document is being added or updated)
because the previous package was
signed.
amending at this time,
only the “Form SBSIRB
Continuation Renewal”
will be needed
 “Form Not Human
Subjects or Not
Engaged”
 Any materials that are
changing/being added
 See “Revising Documents
within a Project” in this file
for guidance.
What Should I Consider or Think About before Starting to Assemble a
Protocol Submittal?
Before you try to put together your submittal you should spend 10-15 minutes doing the following:
A.
B.
C.
D.
E.
List the ways in which you will collect data from/about participants.
List the Participant Groups.
List the consent Processes to be used.
List the recruitment Processes to be used.
Put your information from A-D in a chart like the ones in the examples below. This need not be
formal and should not be submitted to the IRB, but just done as a draft for your own reference.
Every group of research participants should have a corresponding recruitment and consent process
or waiver and reason listed.
F. Make a list of documents based on the chart. In most cases, each data collection procedure will
need some type of study instrument, each recruitment process will need either a script or
document and each consent procedure will need a script, information sheet or signed consent
form.
Example 1- Study includes only one type of adult interviews done in person. Recruitment occurs via
responses to flyers and newspaper ads.
Data collection
procedure
Participants
Consent Process or
Waiver
Recruitment Process
In-person Interview
Any adult who responds
to the flyer and shows
up
Signed consent process
before in person
interview
Flyer posted on bulletin
boards around campus
and newspaper ads.
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Example 2- Study includes only a records review no recruitment will occur and no consent will be obtained.
Data collection
procedure
Participants
Consent Process or
Waiver
Recruitment Process
Data extracted from
Records
Every person with a
record in the database
we look at
Waived for records
review
None- we will not
interact with
participants
Example 3- Study includes participation in an in-laboratory experience with people who are 16-19 years
old. The same procedures will occur with all participants. Recruitment occurs via respond to a newspaper
advertisement and no information will be collected from participants prior to arrival in the lab.
Data collection
procedure
Participants
Consent Process or
Waiver
Recruitment Process
Lab experience and
associated
questionnaires
Adult (18-19 year old)
Participants
Verbal consent process
where participants are
given an information
sheet and agree orally to
participate
Newspaper ad recruits
both adults and youth.
People call in to get an
appointment.
Every person with a
record in the database
we look at
Parental Permission is
signed process
Assent is verbal using
the same information
sheet and process as the
adult verbal consent
process
Example 4- Study includes interviews with both teachers and 5th grade children using different interview
procedures for each group. Teachers are first recruited via a posting in the faculty lounge. Once a teacher
agrees to participate, recruitment of students occurs via letters sent home to parents who respond to the
letters.
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Data collection
procedure
Participants
Consent Process or
Waiver
Recruitment Process
Interviews with teachers
Teachers
Verbal consent process
where participants are
given an information
sheet and agree orally to
participate
Response to flyers in the
Lounge
Interviews with students
Students
Parental Permission is
signed process via mail
Response to letters sent
home to parents.
Assent is verbal using an
age appropriate verbal
assent process
Example 5- Study includes weight loss intervention with adults but an extensive prescreening telephone
interview is needed to ensure that participants meet eligibility criteria. Recruitment occurs via participants
calling the researcher in response to an ad on a website.
Data collection
procedure
Participants
Consent Process or
Waiver
Recruitment Process
Prescreening interview
Everybody that calls in
response to the ad, both
eligible and ineligible.
Oral Verbal consent
process over the phone
Response to ad posted
on website
Participation in weight
loss intervention and
follow up measurements
Only participants who
meet screening criteria
and show up to the
office for the
intervention
Signed Consent Process
Recruitment occurs via a
scripted procedure at
the end of the
prescreening phone
interview
Example 6- Study includes adult students who come to the lab to participate in one of three computer tasks
that are investigating 3 slightly different low risk paradigms. The study also included an incomplete
disclosure so that participants are not influenced by knowledge of the study purpose. Recruitment occurs
via a departmental research participation group where students sign up for studies.
Data collection
Participants
Consent Process or
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Recruitment Process
procedure
Waiver
Screening through the
RPG mass testing to
determine eligibility
All students who
participate in
departmental mass
testing.
Verbal consent process
where participants click
a button after reading
the on line information
sheet.
Departmental RPG
approved procedures for
announcement and in
the syllabus.
Participation in
experiment 1
Only participants who
meet screening criteria,
respond to electronically
schedule an
appointment through
the departmental
recruitment mechanism
and show up for the
experiment.
Verbal consent process
where participants are
given an information
sheet and agree orally to
participate
Recruitment occurs via
the departmental
recruitment on-line
eligibility website
Participation in
experiment 2
Participation in
experiment 3
Example 7- Study includes adult students at UB who are asked to take an electronic survey about their
educational experiences. Participation is to be limited to students who have failed a course more than
once. The students are to be identified by the research team through a review of records and then are
recruited via e-mail.
Data collection
procedure
Participants
Screening by review of
All students with records
university records to
at UB
locate names of students
who meet eligibility
criteria
Survey Participants
The students who
respond to e-mail and
participate via the
internet
Consent Process or
Waiver
Recruitment Process
Waived for Records
Review
None- we will not
interact with this group
of participants
Verbal consent process
where participants click
a button after reading
the on line information
sheet.
Recruitment occurs via
e-mail to eligible
students
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Example 8- Study includes an observation of a teacher instructing a second grade class on arithmetic
followed by an interview of the teacher for his rationale for the teaching process and exercises he used.
Parents of the children then receive a survey to find out if their children talked about the class at home.
Data collection
procedure
Participants
Consent Process or
Waiver
Recruitment Process
Classroom Observation
Students
Waiver for observation
of public activities of the
students
No recruitment of
students occurs
Teacher
Signed consent process
that includes both the
observation and the
interview
Recruitment occurs via a
scripted verbal
announcement made at
a faculty meeting
Parents respond by
mailing the survey back
to the researcher
Verbal consent process
where participants
consent by the action of
mailing their survey back
to the researcher.
Recruitment occurs via
an introductory letter
provided to parents
along with the
information sheet,
survey and SASE.
Interview
Parent Survey
XIII. What typically needs to be submitted for a new study?
Here is a list of what typically needs to be submitted for a new review:
1. Core Data Form (this is done online- no need to save and upload anything)
2. Protocol Study Plan Addendum (Replaces Protocol Parts 1-3 and many other forms and addenda)
3. Usually there will be one or more consent documents that could include any of the following:
a. Signed Consent Documents
b. Verbal consent information sheets and/or scripts
c. Signed Parental Permission Documents
d. Signed Assent Documents, verbal assent info. Sheet, or scripts
4. Usually there will be some sort of recruitment materials such as
a. Flyers
b. Script for verbal recruitment pitch
c. Web page
d. Newspaper/Radio or other media Advertisements
5. In just about all cases there are study instruments such as questionnaires, interview questions,
survey instruments, etc. You may need to upload multiple docs for this one.
6. A few SBS protocols working in a medical or treatment setting will need HIPAA Documents
7. Form FeeForm - Only if commercially sponsored
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XIV. Protocol “Parts” in the document library and how to use
Note- If you are using the new Protocol Study Plan Addendum pdf then the protocol parts are no longer
used and this guidance is no longer relevant.
The IRB is aware that one size of protocol does not fit all, but also wants to minimize the time that it takes
to get complete and correct information from researchers so that the reviewers can make required ethical
and regulatory determinations. In the absence of a very complex computer driven form, we have
determined that the best way to do this involves the use of multiple “parts” for protocol submittal based on
the specifics of the study. The SBSIRB library therefore contains protocol documents for three distinctive
portions of the protocol. The three sections are as follows:
1. Protocol Part 1: Protocol Starter
2. Protocol Part 2: Consent Processes
3. Protocol Part 3: Research Procedures
The Protocol Starter [Part 1] should only be included once in any application and every application should
at least contain one document in each of the other two sections but may have/need multiple documents in
each section. Studies that do not have multiple participant groups or interventions probably will need only
one of each document. When uploading multiple documents from each category, name each upload
descriptively (e.g. consent for teacher interview, Procedure for child observation).
The CDF generates a list of documents that are recommended for submittal and can be used as a guide but
won’t necessarily cover everything. The following examples are provided to assist you in deciding which
and how many of each protocol part to submit. It would be impossible to anticipate every possible
combination so your study may fall into a combination of these that is not specifically given.
***Note that these examples only deal with the protocol “parts” and other items will be needed for the
submittal such as consent documents, study instruments, recruitment materials, etc.
Example 1- Study includes only one type of adult interviews done in person. Recruitment occurs via
responses to flyers.
This submittal would likely include:
Protocol Part 1 Protocol Starter
Protocol Part 2 Either Adult Signed Consent Process or Adult Verbal Consent Process
Protocol Part 3 Research Procedures
Example 2- Study includes only a records review no recruitment will occur and no consent will be obtained.
This submittal would likely include:
Protocol Part 1 Protocol Starter
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Protocol Part 2 PSD for Waiver or Alteration of Consent
Protocol Part 3 Research Procedures- Records Review
Example 3- Study includes participation in an in-laboratory experience with people who are 16-19 years
old. The same procedures will occur with all participants. Recruitment occurs via respond to a newspaper
advertisement and no information will be collected from participants prior to arrival in the lab.
This submittal would likely include:
Protocol Part 1 Protocol Starter
Protocol Part 2 Either Adult Signed Consent Process or Adult Verbal Consent Process…for use with
the 18-19 year old adults
Protocol Part 2 Children Consent Process and PSD for use with the 16-17 year old adolescents
Protocol Part 3 Research Procedures
Example 4- Study includes interviews with both teachers and children. Recruitment occurs via letters sent
home to parents who respond to the letters.
This submittal would likely include:
Protocol Part 1 Protocol Starter
Protocol Part 2 Either Adult Signed Consent Process or Adult Verbal Consent Process…for use with
the teacher
Protocol Part 2 Children Consent Process and PSD
Protocol Part 3 Research Procedures for teacher
Protocol Part 3 Research Procedures for children
Example 5- Study includes weight loss intervention with adults but an extensive prescreening telephone
interview is needed to ensure that participants meet eligibility criteria. Recruitment occurs via participants
calling the researcher in response to an ad on the recruitment study finder.
This submittal would likely include:
Protocol Part 1 Protocol Starter
Protocol Part 2 Adult Verbal Consent Process…for use prior to the phone screening interview
Protocol Part 2 Either Adult Signed Consent Process or Adult Verbal Consent Process…for use with
eligible participants who enter the weight loss program
Protocol Part 3 Research Procedures for phone screening
Protocol Part 3 Research Procedures for the weight loss program
Example 6- Study includes adult students who come to the lab to participate in one of three computer tasks
that are investigating 3 slightly different low risk paradigms. The study also included an incomplete
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disclosure so that participants are not influenced by knowledge of the study purpose. Recruitment occurs
via a departmental research participation group where students sign up for studies.
This submittal would likely include:
Protocol Part 1 Protocol Starter
Protocol Part 2 Either Adult Signed Consent Process or Adult Verbal Consent Process…
Protocol Part 2 Protocol Part 2 PSD for Waiver or Alteration of Consent due to the incomplete
disclosure
Protocol Part 3 Research Procedures for experiment 1
Protocol Part 3 Research Procedures for experiment 2
Protocol Part 3 Research Procedures for experiment 3
Example 7- Study includes adult students at UB who are asked to take an electronic survey about their
educational experiences. Participation is to be limited to students who have failed a course more than
once. The students are to be identified by the research team through a review of records and then are
recruited via e-mail.
This submittal would likely include:
Protocol Part 1 Protocol Starter
Protocol Part 2 Protocol Part 2 PSD for Waiver or Alteration of Consent for the records review
Protocol Part 2 Adult Verbal Consent Process…for the survey
Protocol Part 3 Research Procedures- Records Review
Protocol Part 3 Research Procedures for the survey
XV.
Submitting revisions and/or amendments via IRBNet
How to update materials so that the IRB can easily review changes (i.e. track changes when and when not
to use)
1. The new Protocol Study Plan Addendum pdf. This document has a change “tracking” feature built
in so that the IRB reviewers can more easily locate what has changed. In most cases, when
submitting a new package, all previous tracking should be cleared before you start making new
changes by clicking the “Reset Amendment Summary” button located in the top level Summary
Section of the document. Then in any section in which you edit, check the box to indicate revisions
at the top of the section (it will appear with a yellow border once you do) and fill in the description
of section changes as shown below.
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2. Other items in the Document Library that are “protected” forms (i.e. word documents with grey
checkboxes and text fields like the protocol parts and addenda)- track changes cannot be used with
these as the protection disables the track changes function. Rather, you should describe the
changes you made in these documents in the “Your Comments” box when you submit these
materials.
3. Free form word documents (e.g. consent documents, word versions of new questionnaires
developed for the study)- Track changes can and should be used with these documents when
submitting a revision so that the IRB can tell what is changing. Be sure to “accept all” previously
tracked changes in the starting document before starting the revision and after you are done, make
sure that the file you will send will appear as you wish it to (pagination, formatting, etc.) once
changes are accepted. You should also describe the changes you made in these documents in the
“Your Comments” box when you submit these materials.
4. Other types of files (e.g. .pdf files of standardized study/survey instruments or websites, .mp3 files
of radio advertisements)- In most cases, track changes cannot be used with these documents when
submitting a revision but revisions are seldom needed. You should describe the changes you made
in these documents in the “Your Comments” box when you submit these materials.
XVI. Deciding when to update a document and when to provide a new
document:
The best way to address this is with an example. Consider a simple study in which the attachments consist
of the following:
1.
2.
3.
4.
5.
Core Data Form
Protocol Template
Consent form
Newspaper Ad for recruitment
Study instrument (interview questions)
Case A: You need to update the address and phone number in the consent form because your office has
moved. In this case the current consent form will no longer be valid for use. You should “update the
document” by clicking on the “pencil” icon. The old consent form will be archived in IRBNet and the new
one will be the top one in the “Pile of paper” icon.
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Case B: You decide that you want to add another newspaper ad to be run in another paper. In this case I
would add a new document because the current add will still be valid and used for recruitment. It is not
replaced. Rather both ads run simultaneously. Once this is approved you will have 8 attachments in your
Case C: You decide that you want to add a recruitment flyer to the study to be posted around campus as
another method of recruitment. In this case you would “update” the protocol to reflect the new
recruitment method and also add a new document for the flyer. Your revised study will have 6 documents
and the protocol will reflect that a historical version prior to the use of the recruitment flyer exists while the
new protocol will be the top one in the “Pile of paper” icon.
XVII. Additional Information for Submitting Serious Events and Problems
(SEPS) both External from a Sponsor and Local Reportable Events
**If this submission is for a STUDY that is OPEN in IRBNet, it requires the creation of a subsequent package
in the project. Follow instructions in this Guide for Section V: Instructions for Submitting Subsequent
Packages to a project that is already in IRBNet
When creating/gathering documents to upload in the designer:
**If submitting External SAEs from Sponsor: a) ask the sponsor to provide the reports to you in
electronic format, OR b) scan the reports received from the sponsor and save to your computer.
Upload these documents. You do not have to complete any forms to submit these documents.
**If submitting a Local Reportable Event or Serious Event or Problem (SEP), select the appropriate IRB
library (HSIRB, CYIRB, or SBSIRB) and select the Serious Events and Problems Report Form, or Protocol
Deviation, Violation & Exception Reporting Form. Fill out the appropriate form/s and upload them to
the submission along with any other additional materials such as sponsor reports, etc.
XVIII. Other Types of Submissions
(Examples: Other Correspondences or Communications from Study Sponsor)
An investigator is responsible for reporting any new information as it is obtained during the study.
Simple correspondence that does not require submittal of additional documentation usually will not
require a new package. Rather, it can be done by using the project mail function. This will create a
documented string of correspondence associated with the study.
When a submission does require provision of documentation, it should be handled as described in
the following section:
V.
Instructions for Submitting Subsequent Packages to a project that is already in IRBNet.
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Other Guidance
XIX. Saving a pdf as a “Reader Extended” file so that it can be filled in using
Adobe Acrobat Reader.
We are unable to enable pdf forms for use with the free Adobe Acrobat Reader due to licensing limitations
but users can do so individually. This can be done using any copy of Adobe Acrobat Professional 9.0 or
higher including those in UB Public Labs.
A. Reader Enabling using Adobe Acrobat 9.0 or X.
Open the pdf file you wish to enable using Adobe Acrobat Professional. From the drop down menus select
file, Save As, Reader Extended PDF, Enable Additional Features (shown below).
In the subsequent message box click the Save Now button and then select a location to save the file to in
the usual Save As Box.
We recommend that you then close the file and reopen it with Adobe Acrobat Reader, fill out the title field
and save the document, close and reopen with Acrobat Reader to make sure that you have done this
correctly.
B. Reader Enabling using Adobe Acrobat 11.0.
Open the pdf file you wish to enable using Adobe Acrobat Professional. From the drop down menus select
file, Save As Other, Reader Extended PDF, Enable More Tools (shown below).
In the subsequent message box click the Save Now button and then select a location to save the file to in
the usual Save As Box.
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We recommend that you then close the file and reopen it with Adobe Acrobat Reader, fill out the title field
and save the document, close and reopen with Acrobat Reader to make sure that you have done this
correctly.
XX.
Using My Virtual Computing Lab to Access Adobe Acrobat Professional
Version for filling out of pdf forms
Only UB faculty, staff and students have access to My Virtual Computing Lab but if you have Adobe
professional version 9.0 or higher on your local computer, you will not need to access it through My Virtual
Computing Lab. Currently UB’s licensing agreement with Adobe does not permit the use of Adobe Acrobat
Professional on My virtual Computing Lab. If/when UB and Adobe come to a licensing agreement you will
again be able to access this program through My Virtual Computing Lab. Non-UB personnel will need to
obtain a copy of Adobe Professional 9.0 or higher in order to use the pdf forms. We are unable to enable
pdf forms ourselves for use with the free Adobe Acrobat Reader due to licensing agreements.
If you do not know how to upload files to your personal UB drive or access them, please see the link
below. You will need to have the IRB PDF saved to your drive in order to access it remotely:
http://www.buffalo.edu/ubit/service-guides/file-storage-and-sharing/accessing-myfiles-fromanywhere.html
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A. Instructions for using My Virtual Computing Lab to access Adobe Acrobat using a PC
computer
The directions in this section have been based on the materials posted by UB IT services and are provided
as a quick reference guide. As individual settings on your computer may affect how the interaction
between the virtual lab and your personal machine occur andyou experience problems using My Virtual
Computing Lab, the IRB cannot assist you. You will need to contact the CIT Help Desk for assistance.
CIT Help Desk
Questions about IT services? Troubles
with your UBITName?
Call: 716-645-3542
Email: cit-helpdesk@buffalo.edu
Fax: 716-645-3617
1.
Go to http://www.buffalo.edu/ubit/service-guides/software/my-virtual-computing-lab.html
2.
Scroll down and select the
Windows
(service
hours) icon
3.
In the next page, click on "download AnyConnect software" and follow the directions (you
need to run Cisco AnyConnect software to be able to access My Virtual Computing Lab).
4.
Once you have the Cisco AnyConnect software installed, there will be two ways to access
My Virtual Computing Lab:
Walk in: Lockwood 2nd Floor Cybrary
A. To connect using Remote App:
(Note that RemoteApp works only with Internet Explorer 6 or above, not Firefox, Chrome, Safari or
any other browser.
1.
In Internet Explorer 6 or above, browse to https://ubvcl-web.buffalo.edu/rdweb (link opens in
a new window).
2.
On this new page, enter the following information:
Domain\user name: ad\UBITName (where UBITName is your UBITName)
Password: your password
Select private or public computer
B. To connect using Remote Desktop:
1.
Go to:
http://www.buffalo.edu/ubit/service-guides/software/my-virtual-computing-lab/windowscomputers.html
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2.
3.
Click on “Accessing using Remote Desktop”
Scroll down and click on "Launch the Microsoft Remote Desktop Client"
4.
5.
6.
You will be asked, "Do you want to open or save this file?" Select “Open”.
On the following window, select "Connect" or "Allow".
A window appears advising, "The publisher of this remote desktop connection cannot be
identified." Click the Details arrow.
The window expands to reveal options to use drives, printers and devices while in My
Virtual Computing Lab. Be sure to check the box next to Drives if you want to save files to
your UBfs Myfiles (S: drive) or your hard drive (C: drive).
Click Connect.
A Windows Security window appears.
If your UBITName appears, enter your UBIT password in the Password field.
If you UBITName does not appear, select Other User and enter the following:
User name: ad\UBITName
Password: your password
7.
8.
9.
10.
Click OK. You are now connected to My Virtual Computing Lab. Click Start > All
Programs to view all programs, utilities and help files.
B. Instructions for using My Virtual Computing Lab to access Adobe Acrobat using a Mac
computer
The directions in this section have been based on the materials posted by UB IT services and are provided
as a quick reference guide. As individual setting on your computer may affect how the interaction between
the virtual lab and your personal machine occur, If you experience problems using My Virtual Computing
Lab, the IRB cannot assist you. You will need to contact the CIT Help Desk for assistance.
CIT Help Desk
Questions about IT services? Troubles
with your UBITName?
Call: 716-645-3542
Email: cit-helpdesk@buffalo.edu
Fax: 716-645-3617
Off-Campus Tutorial – To connect from off campus- Once you have completed these steps, go to the OnWalk in: Lockwood 2nd Floor
Campus Tutorial below
Cybrary (service hours)
1. Download Cisco Any Connect
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a. http://www.buffalo.edu/ubit/service-guides/software/downloading/macintoshsoftware/managing-mac-software/anyconnect.html
2. You may have to change your computer security settings [briefly] to allow the download
3. Once installed, double-click on the CISCO AnyConnect software icon to launch the program
4. Enter ubvpn.buffalo.edu in the Connect to: box. Click Select to initiate the connection.
5. Enter UBITName and password when prompted
6. Click “Accept”
7. Go to the “On-Campus Tutorial” above and complete those steps.
On-Campus Tutorial – to connect from On Campus or after completion of the Off-Campus connection
Process
1. Download Microsoft Remote Desktop from App Store
http://www.buffalo.edu/ubit/service-guides/software/downloading/macintosh-software/managingmac-software/anyconnect.html
2. Open Microsoft Remote Desktop
3. Click on “Preferences” and fill in the server information as listed below and your personal
information (you can use any ‘Gateway name’)
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4. Click on “New” and complete the information in the picture below
5. Select your new connection and click on “Start”
6. A warning will come up that you are sharing your disks which might be unsecure – select “OK”
XXI. Printing from documents with tracked changes
When study documents like consent forms or advertisements need to be used with participants and you
want to ensure that the correct versions are used, they can be printed right from the documents reviewed
in IRBNet. This may seem problematic if the document in IRBNet has tracked changes but can be overcome
fairly easily. In Word 2003 the typical track changes view is the “final showing markup” the track changes
toolbar allows you to also view the “final” version without the markup. If printed from this version, you
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should get a “clean” printout. In Word 2010 select the “Review” menu to access the toolbar that allows
you to change the markup setting to “final”. You will need to consult your local computer support for
further assistance or if you are using other versions/word processing programs.
XXII. Accessing IRB Approved/Published Documents
Step 1
After logging in, access your project from the “MY PROJECTS” tab (left side of the page).
Step 2
Click on the title of the project to take you to the “DESIGNER” page.
Step 3
On the “DESIGNER” page click “Review Details” to get to the “Review Details” page
where you will find all letters, as well as any other documents published by the IRB
Step 4
Click on the “Document Type” highlighted in Blue for the Item you wish to access.
Be sure to read the instructions in the letter carefully.
XXIII. Renewal Reminders
IRBNet Renewal reminders will no longer contain a “deadline” date because the reminders will no longer
need to be sent as a batch for a given month but rather will be sent individually and automatically based
upon the expiration date of the study. Keep in mind that full board renewals will need to be scheduled for
a meeting so get them in right away. Expedited renewals will usually have plenty of time for approval but
you never know when an amendment at the time of renewal will result in the need for full board review.
XXIV. Version Date Requirement for Consent Documents- No More
Stamps/Watermarks
One of the benefits of moving to IRBNet is that some processes that were required with paper/e-mail
submittal systems are no longer necessary. One of these is the “stamping” of consent documents which
was in place to let the research team know that there was an approval of the document. The stamping of
consent documents is something that will no longer be done for SBSIRB studies. Rather the most recently
approved consent document should be downloaded from IRBNet and printed/copied for use with
participants. The SBSIRB is however requiring that a version date be put in the header of each consent
document/revision that is submitted through IRBNet. The version date must be very close to the
submittal date (within a day or two). This is so that study personnel (who will all have at least read access
to the study) can easily verify that the paper copy of a consent document they are going to use with
participants is the most recently approved version. Consent documents will not automatically “expire”
every year but rather, as long as there are no changes/amendments to a consent document, they will still
be valid after your renewal is approved so the unsigned paper copies in your file cabinet won’t have to be
destroyed and new ones printed that only differ in the dates on the stamp.
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XXV. What should I do if reviewers’ comments/requests seem unreasonable?
If you feel that an impasse has been reached, you should consult with the IRB Administrator. An
investigator may, at any point in the review process, request full board review at the next available
convened meeting. The decision to do this should not be made lightly because, once a protocol is brought
to the full board, the board may determine that additional substantive changes must be made and
reviewed at a subsequent convened meeting before approval will be granted.
Before requesting full board review, keep in mind that part of the IRB’s job is to provide you with feedback
that will help make your study compliant with regulations, safer for participants and, in general, more
ethical. Feedback from the IRB is never intended to try and prohibit research on its face. Ask yourself the
following questions. Does doing what is requested really have an adverse effect on the study? Does doing
what is requested improve the respect for persons, beneficence or justice afforded to participants? Is the
request based on something that I may have missed in directions or templates? If the answer is yes to any
of these, you may see that the request is actually reasonable.
The reason that some requests may seem unreasonable to you is because there is an imperfect distribution
of information in that you know more about what you want to do in than the reviewer because it is YOUR
study. The reviewer, on the other hand, probably knows more than you about the human subjects
regulations and may also have seen many different ways for achieving what you intend with lower risk to
participants. Given this, the best response is to provide information/clarification as a part of your revised
materials so that the reviewer better understands what your intention is or how the study will actually be
carried out. When you do this, you should also take care of any other items that do not seem unreasonable
so that as few issues as possible remain.
If in the end you decide that an impasse has been reached, you can request full board review by sending an
e-mail message to the SBSIRB requesting full board review. The e-mail message must include in the first
sentence the statement that, “the investigator wishes full board review of protocol (include protocol
number and title).” The administrator will then schedule the protocol for the next available convened
meeting.
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