TLT Services, ext. 2900 Questions on protocol packages, reports, … · 2020-01-08 · Step Two: Obtain forms and templates • In Forms and Templates, select WSU IRB – Documents

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WSU IRB: HOW TO DO EVERYTHING IRBNet allows for electronic protocol preparation, signing and submission of protocols, approval process communications, protocol modifications, and electronic review of protocols and electronic approvals. Click here for the complete text of WSU Policy 3-7 Policies and Procedures for Use of Human Subjects in Research.

STEPS IN THE PROTOCOL SUBMISSION & APPROVAL SYSTEM

PLEASE READ Enroll in IRBNet Complete the D2L Brightspace Human Subjects Education Module Download and Add Education Documentation to your User Profile Submit a New Protocol Request Using IRBNet Smart Forms Working with Co-Investigators and Faculty Sponsors Student Co-Investigator Instructions Faculty Sponsor Instructions Class Projects in IRBNet IRB Package “Unlocked” Messages – IRB Office Requests for Missing or Incomplete Information Board IRB Document Published Messages – Accessing and Responding to Requests for Modifications Reports – Amendments, Modifications, and Progress Reports Package Checklist

Instructions If you need more detailed instructions: http://www.irbnetresources.org/tresources/training.html The username is winona and the password is training01 (you may have to enter the user name and/or password more than once).

• Enrolling in IRBNet – see User Registration for a Power Point presentation.

• New protocol preparation, submission and revisions at IRB Office request – see R1: New Project Submission for a video and Power Point presentation.

• Revising protocols if modifications are required – see R2: Post-Submission Advanced Topics for a video and Power Point presentation.

Contacts Technical questions about enrolling or accessing D2L or using the IRBNet System:

TLT Services, ext. 2900 Questions on protocol packages, reports, or study modifications:

Brett Ayers, Human Protections Administrator, [email protected] or ext. 5519

http://www.winona.edu/faculty/3-7.pdf

http://www.irbnetresources.org/tresources/training.html

mailto:[email protected]

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Enroll in IRBNet

Who needs to enroll in IRBNet? Anyone submitting a protocol to the WSU IRB, any co-investigators, any faculty sponsor approving student requests, and all WSU IRB members. How do you enroll in IRBNet?

• Go to www.irbnet.org

• In the log-in area in the upper right-hand corner, click New User Registration

• Enter your name, a username (recommend using your WSU username) and a password

• Accept the terms of use

• Search for and highlight Winona State University

• Click Continue

• Provide your phone and email address (use your WSU email)

• Click Continue

• Click Register

• Check your WSU email for an IRBNet notification

• Follow the instructions to activate your IRBNet account Back to list of steps

http://www.irbnet.org/

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Complete the D2L Brightspace Human Subjects Education Module Who needs to complete the WSU Human Subjects Education Module? Anyone submitting a protocol to the WSU IRB, any co-investigators, any faculty sponsor approving student requests, and all WSU IRB members. Documentation of successful completion of the WSU Human Subjects Education Module (80% score on an online, 20-question quiz) must be submitted with IRB protocol requests. How do you self-enroll in D2L to complete the Human Subjects Education Module?

• Log-in to D2L Brightspace

• Click Self-Registration at the top right

• Select Human Subjects Education Module

• Click Register

• Click Submit

• Click Finish

• A Registration Summary will appear

• Click Go to course offering Human Subjects Module

• Complete the course and quiz

• If you do not want to go to the course immediately after enrolling, click Done

• The next time you login to D2L, in the “No Semester” list, click Human Subjects Education Module

Contact TLT Services (ext. 2900) if you have any problems with enrolling in or accessing the course. Note: The WSU IRB may, at its discretion, accept documentation of completion of other human subjects education programs required by other institutions Back to list of steps

https://winona.learn.minnstate.edu/d2l/home/4671451

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Download and Add Education Documentation to Your User Profile

How do you download the Human Subjects results for submission with a protocol request?


• In the “No Semester” list, click Human Subjects Education Module

• Click Assessments and select Grades To save an image of the screen to a file on a PC:

• Press control and print screen (on a laptop, press ctrl and fn and prt sc)

• Open a blank Word document

• Click the Paste button in the top left of the Home tab

• Save the Word document (remember where you saved it!) To save an image of the screen to an image file on a Mac:

• Click File and select Print

• Click PDF in the bottom left-hand corner

• Click Save as PDF and save the file on your computer (remember where you saved it!) How do I add results to my user profile?

• Log-on to IRBNet and click User Profile in the top right-hand corner

• At the bottom of the page, click Add New Record

• Select the appropriate Document Type from the drop-down box (for most this is the IRB HSEM-D2L)

• Enter the effective date of the posting

• Browse and attach the appropriate file

• Click Attach

• Click Submit

• Search for and select the Winona State University IRB

• You have the option of sending a message with your submission

• Click Submit The next time you prepare an IRB protocol, on the Designer page (below the box of document types) see a reference to Training & Credentials:

• Click Link/Un-link Records

• Check your name and click Save

• If you have co-investigators who have added results to their user profiles and you have shared the protocol package with them, their names will also appear here; you can link to their results by checking their names

Contact TLT Services (ext. 2900) if you have problems downloading your results. Back to list of steps


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Submit a New Protocol Request Using IRBNet Smart Forms PLEASE READ (There are 13 steps) Step One: Create your protocol package

• Log in to IRBNet at http://www.IRBNet.org

• Select My Projects

• Select Create New Project

• Enter the title of project, your name, and if applicable, your faculty sponsor’s name under sponsor Ignore keywords and internal reference number

• Click Continue Step Two: Obtain forms and templates

• In Forms and Templates, select WSU IRB – Documents for Researchers

• Download the instructions and forms you need

• At minimum, download the Package Checklist and Consent Form Guidelines & Samples

• Before creating your new package, save the following as Word or PDF files on your laptop: o Consent Form o Volunteer solicitation letter (if that is how volunteers will be recruited) o Questionnaire, survey, interview questions, or any other instruments to be administered o Signed approval, cooperating institution, or agency permission letters (if appropriate)

Step Three: Create a new project

• Select Create New Project (left-hand navigation)

• Provide a title for your project and your name; select Continue

• To start a new protocol smart form, select Start a Wizard

• You can also add documents you’ve created in Step 2 by selecting Attach New Document Step Four: Create your protocol package

• If you are creating a new protocol smart form, select Create a new wizard from scratch

• If you want to “clone” a pre-populated protocol from a previous project and revise it: o Select Clone one of my existing wizards o Select the button next to the project title you wish to clone

• Click Continue and after reading the Introduction, click Next

• Select Winona State University IRB for the reviewing board Step Five: Building your protocol package

• Now that you’ve created your protocol smart form, respond to all questions (those with a red asterisk (*) require a response)

• Navigate the protocol smart form as follows: o Next moves to the next set of questions o Previous goes back to the previous screen o Jump (upper right-hand corner) lets you jump around sections of the protocol o Save and Exit saves your work and exits the smart form o Preview creates a PDF of your protocol form

Step Six: Completing your protocol package

• If your protocol form is complete, select Save and Exit

• To review a previous section, select the it from the drop down (upper right) and then Jump

• Save and Exit takes you to the Designer screen, where you attach new or revised documents or revise your protocol smart form


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Step Seven: What if I want to revise my protocol package after “Save and Exit”?

To revise the protocol To add a new document To revise an uploaded doc

• If you’re on the Designer page, click on the yellow

pencil icon () beside

“Winona State University Researcher Application Form”

• If you’ve logged out of IRBNet: o Select My Projects o Click on the project title o Select Designer

o Click the pencil icon ()

beside “WSU Researcher Application Form”

• To revise a section, select the section from the drop down in the upper right and then click Jump

• Click My Projects

• Click the title of the project

• Click Designer

• Click Attach New Documents

• For each document, select the appropriate Document Type from the dropdown box (consent, questionnaire/survey, letter, other, etc.)

• Use the Browse button to open and attach the document

• Click the document’s paper

icon ()

• Download the file to your computer, make changes and save it



• Click Designer

• To add the revised document:

• Click the document’s pencil

icon ()

• Click Update (if you have not changed the file name, the current doc will be replaced

Step Eight: Activate the link to your Human Subjects Education Module documentation

• Below the box indicating Document Types, see a reference to Training & Credentials


• Check the box by your name and documentation record

• Click Save

Step Nine: Share your project for editing and signatures

• Click Share this Project

• Select Share

• Highlight Winona State University (use the search feature if it is not already highlighted)

• Click Select Organization

• Search for users who need to sign the package (all co-investigators and faculty sponsors must be enrolled in IRBNet)

• Give your co-investigators and faculty sponsor full access so they can upload documents and receive IRBNet notifications

• Click Save.

• You can add Your Comments in the text box, for example, “Please sign,” before saving Step Ten: Add co-investigators and faculty sponsor Human Subjects Education Module documentation

• Below the box of document types, see a reference to Training & Credentials.


• Check boxes by co-investigators’ and faculty sponsor’s names and documentation records

• Click Save (Continue to Step 11 on the following page)

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Step Eleven: Sign package

• Click Sign This Package

• Use the drop down box to identify yourself as the Principal Investigator

• Click Sign

• Ask all your co-investigators and, if applicable, your faculty sponsor to sign the package Step Twelve: Submit package

• Once all signatures have been secured, click Submit This Package

• Highlight Winona State University IRB

• Click Continue

• For submission type, select New Project

• Add Your Comments, if any

• Click Submit

• Your package is now “locked” and you cannot make any changes unless you ask the IRB Office to “unlock” it

Step Thirteen: Watch for an email with the subject Line “IRBNet Board Document Published”

• Login to IRBNet.



• Click Reviews

• Select the letter under Board Documents and follow the instructions Back to list of steps

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Working with Co-Investigators and Faculty Sponsors Note that there are separate Student Co-Investigators Instructions and Faculty Sponsor Instructions in the IRBNet Forms and Templates Library. Upload and send those to your co-workers. PLEASE READ Student co-investigators and faculty sponsors need to do five things:

1. Complete the D2L Human Subjects Education Module (applies only to new faculty sponsors) 2. Download their D2L grades to a file (applies only to new faculty sponsors) 3. Enroll in IRBNet 4. Upload their grades to their user profile 5. Sign the protocol

You can also permit co-investigators to edit the protocol via IRBNet. Before co-investigators and faculty sponsors can upload documents, edit, or sign the package, you must give them write access to your project as follows: Step One: Log in to IRBNet at http://www.IRBNet.org



• Click Share this Project

• Select Share

• Highlight Winona State University (use the Search feature if not already highlighted)

• Click Select Organization

• Search for users who need to sign the package (all co-investigators and faculty sponsors must be enrolled in IRBNet)

• Give co-investigators and faculty sponsors write access so they can upload documents and receive notifications

• Click Save (you can add Your Comments in the text box before saving)

Option One: Communicate with co-investigators and faculty sponsors via IRBNet

• Click Send Project Mail

• Select the co-investigator you want to contact

• In the message area, delete any extraneous text (except the “RE:” line identifying the project); enter your message

• You can ask co-investigators to upload documents, update their user profile, edit documents, sign the package, etc.

• Click Send

• Co-investigators and faculty sponsors can communicate with you through IRBNet Option Two: Check to see who has signed off on the package



• Click Sign this Package

• A list of everyone who has signed off will appear

Back to list of steps


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Student Co-Investigator Instructions Student co-investigators need to do five things:

1. Complete the D2L Human Subjects Education Module (applies only to new faculty sponsors) 2. Download their D2L grades to a file (applies only to new faculty sponsors) 3. Enroll in IRBNet 4. Upload their grades to their user profile 5. Sign the protocol

Step One: Complete the Human Subjects Education Module Documentation of successful completion of the Human Subjects Education Module is required of all WSU students, faculty, and staff who conduct research involving human participants on or off campus. Reviewing the module takes about 20 minutes. Successful completion is documented by scoring 80% the 20-question multiple choice quiz. Login to D2L (Desire to Learn) at https://winona.ims.mnscu.edu/

• Click Self-Registration the toolbar

• Select Human Subjects Education Module

• Click Register

• Click Submit

• Click Finish (a registration summary will appear)

• Click Go to Human Subjects Module

• Complete the course and quiz If you do not want to go to the course immediately after enrolling:

• Click Done.

• The next time you login to D2L, click the + sign to the left of the words “No Semester”

• Click Human Subjects Education Module

• Complete the course and quiz Contact TLT Services (ext. 2900) if you have any problems with enrolling in or accessing the course. Step Two: Download Grade to a File

• Log-in to D2L at https://winona.ims.mnscu.edu/

• In the No Semester list, click Human Subjects Education Module

• Click Assessments

• Select Grades To save an image of the screen to a file on a PC:

1. Press control and print screen (on a laptop, press ctrl and fn and prt sc) 2. Open a blank Word document 3. Click Paste in the top left of the Home tab 4. Save the document (remember where you saved it)

To save an image of the screen to a file on a Mac:

1. Click File and select Prin. 2. Click PDF in the bottom left-hand corner 3. Click Save as PDF and save the file on your computer (remember where you saved it!)

https://winona.ims.mnscu.edu/




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Step Three: Enroll in IRBNet



• Enter your name, a username (recommend your WSU username), and a password

• Accept terms of use


• Click Continue

• Provide your phone and email address (use WSU email)

• Click Continue

• Click Register

• Check your WSU email for an IRBNet notification

• Follow the instructions to activate your IRBNet account Step Four: Upload Grades to Your User Profile

• Log-on to IRBNet

• Click User Profile in the top right-hand corner

• At the bottom of the page, click Add New Record

• Select the appropriate Document Type from the drop-down

• Enter the effective date of the posting

• Browse and attach the appropriate file

• Click Attach

• Click Submit

• Search for and select the Winona State University IRB

• You have the option of sending a message with your submission

• If you have no message, simply click Submit The next time you prepare an IRB protocol, on the Designer page below the box of document types you will see a reference to Training & Credentials:


• Check your name and click Save Note: If you have co-investigators who have added results to their user profiles and you have shared the protocol package with them, their names will also appear and you can link to their results by checking their names. Step Five: Sign the Document (PI must give students write access)

• Log in to IRBNet

• Go to My Projects

• Click on the Title of the project to be signed

• Click on Sign this Package

• Use the drop-down to identify yourself as Co-Investigator

• Click Sign

• The student will receive notification that he or she has signed the package



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Faculty Sponsor Instructions (There are 6 parts) Step One: Enroll in IRBNet



• Enter your name, a username (recommend using your WSU username) and a password

• Accept the Terms of Use


• Click Continue

• Provide your phone and email address (use your WSU email)

• Click Continue

• Click Register

• Check WSU email for an IRBNet notification and follow instructions to activate your account

Step Two: Instructions for Your Students on Accessing Instructions

• Login to IRBNet (each student must be enrolled in IRBNet)

• Click Forms and Templates

• Select Winona State University IRB Documents for Researchers

• Download READ ME FIRST with Instructions and How To documents Step Three: Provide Training Instructions via D2L


• Click the course you are teaching

• Click Import/ Export/Copy Components

• Select Import Components from Learning Object Repository

• Click Next

• Search for IRBNet

• Click Retrieve and choose preference for incorporating the training materials into course Step Four: Review the Student Protocol Package You will receive a notice when a student “shares” a protocol with you, which gives you access.



• Click on the title of the student’s project

• Click Designer

• Review the documents in the package Step Five: Communicate with the student researcher if there are problems

• Click Send Project Mail

• Click the Send Mail option for users of your choice

• In the message area, add questions and/or instructions to the student

• Click Send

• Share these instructions with students on making corrections o Log in to IRBNet o Click My Projects o Click the title of the project o Click Designer



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• On the Designer page, click on the yellow pencil

icon () beside “WSU

Researcher Application Form”


• On the Designer page, click Attach New Documents

• For each document, select the appropriate Document Type from the dropdown box


• Click the document’s

paper icon ()




• Click Designer


• Click the document’s

pencil icon ()


• Notify your faculty sponsor changes have been made. o Click Send Project Mail o Select your faculty sponsor’s name (you may also send copies to co-investigators) o In the message area, add your message o Click Send

Step Six: Approve and sign the package You will receive a notice when a student completes the requested revisions


• Click on the title of the project

• Click Designer

• Review the documents in the package


• Use the dropdown box to identify yourself as the sponsor and click Sign

• The student will receive a notification that you have signed the package


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Class Projects in IRBNet

Sometimes faculty members have a class conduct a class research project and all the students enrolled are co-investigators. There are several different ways of processing this through IRBNet. Students should ask the faculty member which method he or she prefers. The Credential Tool – Students Upload to User Profiles, Faculty Member Links to Credentials If you do not want to allow students full access, instead link directly to their training records if they have attached them to their user profile. The students still have to go in and upload their documentation to their user profiles and they still need to sign the package electronically. The faculty member has an extra step, because he or she will have to go in and check off the names of all the students in the class. Once you've shared the package and given them read access, it's simply a matter of checking names off a list.

• Share the project with all the participants; you may give them read access (if the only thing they need to do is sign the package, read access will allow them to do so).

• Go to the Designer page of your project. Below the box of document types you will see a reference to Training & Credentials. Click the Link/Un-link Records link.

• A list of all individuals with whom you have shared the project will appear (as well as your own name). Click the Link box by the names of those who need to supply documentation.

• Click save. Using Write Access – Students Upload Directly to Protocol Package If you give students write access, they will be able to go into the package and upload their grade documentation and sign the protocol. But they won't be able to submit it. The burden of making sure they submit their documentation and sign the proposal remains on them. This is the easiest method for faculty, but some students find it difficult to follow the IRBNet directions and it means the Human Protections Office has to re-check and email to verify everyone gets it done correctly. That may cause delays in getting the protocol approved. Using PDF – Students Don't Need to Use IRBNet If the faculty member requires his or her students to submit documentation for verification that they have completed the module, they can simply generate a list of students, add a statement verifying that they have all successfully completed the module, and have the students sign off by their names on the list. Once the signatures are secured, scan the signed list into a PDF. Upload the PDF to the IRBNet package. This prevents students from making errors in IRBNet and gives the faculty member the most control over the project. He or she knows exactly when everyone has completed the Human Subjects Education module and signed off on the package. Back to list of steps

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Requests for Missing or Incomplete Information The IRB Office pre-reviews protocols prior to distributing them for review. If anything is missing or the request is incomplete, you will receive an email with the subject line “IRBNet Package Unlocked.” The email will tell you what needs to be revised. Once corrections have been made, exempt and expedited requests will be sent to the IRB for review. Additional modifications or clarifications may also be requested during the review process.

Step One: Access your package

• Log-in to IRBNet


• Click on the title of the project that needs to be revised

• Click Designer

• Follow the appropriate instructions as follows:

To revise the protocol To add a doc To revise a doc To sign the package

• On the Designer page, click on the yellow pencil icon

() beside “WSU

Researcher Application Form”


• On the Designer page, click Attach New Documents




icon ()




• Click Designer



icon ()


• Click Sign This Package in the left navigation bar

• Use the dropdown box to identify yourself as the Principal Investigator, co-investigator, or sponsor

• Click Sign

• The PI will receive a message when co-PIs sign the package.

• The PI may also check who has signed off by going to the Sign this Package page

Step Two: Verify that all changes have been made and/or all signatures secured.

• Login to IRBNet at http://www.IRBNet.org


• Click the title of the project that needs to be revised

• Click Designer

• Click the Mark Revisions Complete link at the top of the page

• You do not have to re-sign or re-submit the package

• To check the project status, pull up the project and click Project Overview



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IRBNet Board Document: Accessing & Responding to Requests for Modifications

(There are 5 steps) Step One: You receive a notice with the subject line “IRBNet Board Document Published.”

• Access the complete text of the message, log in at http://www.IRBNet.org



• Click Reviews

• Under Board Documents, find the Modifications Required Letter

• Click the document icon under “View”

• You may download or print the letter for reference Step Two: Download any documents that need to be revised.




• Click Designer

• Click the document’s paper icon

• Download the file to your computer, make changes, and save it Step Three: Assemble your new package




• Click Project History

• Click Create New Package in the middle of the page (do NOT click create new package on the left-hand side of the page)


• On the Designer page, click

on the yellow pencil icon ()



• On the Designer page, click Attach New Document




icon ()




• Click Designer



icon ()



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Step Four: Sign the package


• Use the drop down box to identify yourself as the Principal Investigator

• Click Sign

• Only the Principal Investigator needs to sign off modifications Step Five: Submit the package

• Click Submit This Package


• Click Continue

• For Submission Type, select Revision

• Add Your Comments, if any

• Click Submit


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Reports – Project Amendments, Modifications, Progress Reports How do I notify the IRB of modifications to my study, changes in the treatment of human subjects, unanticipated problems, or unexpected harm to human subjects? Step One: Download the report form

• Log-in to IRBNet

• Select Forms & Templates and download the AMENDMENTS, MODIFICATIONS, PROGRESS: REPORT FORM

• This form can be used to report the following o Modifications in ending dates, data collection tools, consent form language or methods,

research procedures, treatment of human subjects, conflicts of interests, etc. o Continuing review or progress reports as requested by the IRB o Closure or final reporting o Reportable events (unanticipated problems, harm to subjects) o Requests for information from the IRB o Other project revisions

• If appropriate, in addition to the Report Form you may also add a revised protocol or other documents for which you are requesting revisions

Step Two: Create a new report package



• Click the title of the project that needs to modification or reporting

• Click Project History

• Click Create New Package in the middle of the page (do NOT click create new package on the left-hand side of the page)

To revise the protocol To add a the report form or a new document

To revise an uploaded doc

• On the Designer page, click

on the yellow pencil icon ()



• On the Designer page, click Attach New Document




icon ()




• Click Designer



icon ()


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Step Four: Sign the package


• Use the dropdown box to identify yourself as the Principal Investigator

• Click Sign

• Only the Principal Investigator needs to sign off on reports Step Five: Submit the package

• Click Submit This Package


• Click Continue

• For submission type, select the appropriate type

• Add your comments, if any, and click Submit Back to list of steps

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IRB Package Checklist Incomplete packages will delay the review process. Most of the required forms and document templates can be found in the IRBNet Forms & Templates library (see left-hand navigation bar under “Other Tools”). Required documents for a complete package:

Protocol request form

Consent form

Cooperating institution letter (when recruiting subjects or accessing data from an organization other than WSU)

Recruiting advertisements, letters, emails (when used to recruit subjects)

Sample survey tools, questionnaires, interview questions, test instruments, etc. (when using these tools)

FDA approval document (when conducting investigation drug study)

Other documentation that you believe is necessary or appropriate for a reviewer to understand the study

Other documents that may be necessary for your study: Formal research protocol (as required by your department, thesis committee, etc.)

Consent waiver request (study must meet all criteria for waiver of informed consent)

Cooperating institution sample consent form, HIPAA form (when working with an organization other than WSU)

IRB approval documentation when another IRB has previously reviewed the study

Steps required to fully complete your package: Link or documentation of completion of approved human subjects protection education program

for all co-PIs

Electronic signatures by the PI and all co-PIs (you may not sign “on behalf of” a co-PI or faculty advisor)

Electronic signature by the faculty advisor (for students submitting packages)

Submit the package to the WSU IRB