Wayne State University

Warrior strong
Login
Search

Division of Research

IRB

IRB forms and submissions requirements

Where & How to Submit to the IRB 

 Location & Office Hours

IRB Administration Office
87 E. Canfield, 2nd Floor
Detroit, MI 48201

Telephone Number 313-577-1628

Hours: Monday - Friday, 8:30am - 5:00pm
CLOSED 12:00pm - 1:00pm (for lunch)

Note:  The IRB Administration Office follows the WSU closure schedule. 

 

Shortcuts to Forms

Always download the most current version of the forms from this website. If you submit an older version of the form, your submission will be returned to you.

Determining If IRB Review Is Required
Initial Submissions
Informed Consent Templates
Amendments
Continuations & Status Check In Reports
Study Closures

Treatment Use (Investigational Drugs and Devices)
Unanticipated-Unexepected Problem and Adverse Event Reports

Need eProtocol Assistance?

send an email to irbstatus@wayne.edu, Contact the IRB Administration Office at 313-577-1628

or

visit the IRB's eProtocol Virtual Office Hours

Tuesdays 1:00 pm - 2:00 pm

Via Zoom

Meeting ID: 953 4534 4223
Passcode: 577514

Visit the IRB's Education website for more education offerings.

PLEASE NOTE:  There will not be a Virtual Office Hour session on:

Tuesday September 26, 2023, December 26, 2023 and January 4, 2024.

Submissions UPDATE

The IRB Administration Office is currently accepting Virtual appointments.

Paper copy documents are not accepted.

Submissions are accepted via eProtocol or per instructions noted for submissions forms.

IRB Pre-Review Service & Self Review Tool

The IRB is excited to provide pre-review of initial full board study submissions! The IRB is piloting offering a pre-review of submission documents before submission to the full board. In addition, the IRB now has a Self Pre-Review Assessment Tool that can be used prior to IRB submission. This service is part of a pilot project aimed at improving overall completeness of new study submissions by providing investigator support. 

Pre-Review Process: 

  • Start an eProtocol application
  • Attach the Protocol/Proposal, Consents/Assents, and all other application documents for the application
  • DO NOT submit the application for authorized signatory review.
  • Email IRBQuestions@wayne.edu with "Pre-Review" in the subject line and the IRB Number
  • Submit pre-review request at least 2 weeks prior to the IRB submission deadline you are aiming for to give enough time address the pre-reviewer's recommendations.
  • Pre-review requests will be reviewed in the order in which they are received.
  • At the conclusion of the pre-review an acknowledgement letter will be sent to the submitter listing the documents that have been received, reviewed, along with a stamped pre-review checklist.
  • The Pre-Review Acknowledgement Letter and stamped Pre-Review Checklist must be included in the final submission package for the full board's deadline. 

Note: Pre-review is designed to prepare submissions for IRB review and ensure the study meets criteria for review. While the expected outcome is approval of the submission, this is not a guaranteed outcome. Official review and determinations are made by the full board. Submission deadlines still apply for pre-reviewed studies that require a full board review. 

Determining If IRB Review Is Required

If you are not sure that a project requires IRB review, use the following tool to describe the project and email to IRBQuestions@wayne.edu for assistance. Also, send any written proposal or data collections tools, if available.

Human Participant Research (HPR) Determination Tool (updated 11/2021)

For information regarding activities that are not considered Human Participant Research please view the HPR Guidance Tool (4.2019 update).

Shortcuts to Forms

Always download the most current version of the forms from this website. If you submit an older version of the form, your submission will be returned to you.

Determining If IRB Review Is Required
Initial Submissions
Informed Consent Templates
Amendments
Continuations & Status Check In Reports
Study Closures

Treatment Use (Investigational Drugs and Devices)
Unanticipated-Unexepected Problem and Adverse Event Reports

Shortcuts to Submission Requirements and Other Information


IRB Research Listserv
About Exempt and Expedited Research Categories
Institutional or Departmental Review and Approvals
Status of IRB Submissions

New/Initial Submissions

All Initial Submissions accepted via eProtocol

eProtocol Submission Instructions

Full Board, Expedited, Exempt, & External IRB New/Initial Submissions (including VA) accepted via eProtocol

Submit to eProtocol by clicking here

IRB eProtocol Submission Instructions

Don't Forget to "Submit Form" for review!

eProtocol Frequently Asked Questions

Full Board Submission Guidance Tool (Update 10/2022)

Expedited Exempt Guidance Tool (Update 10/2022)

External IRB Submission Guidance Tool (May 2023)

 

Start Early

Key Personnel Instructions:

  • ALL USERS: PI, co-investigators, key personnel, Faculty Sponsor/Mentor/Supervisor  MUST COMPLETE the required IRB CITI Training BEFORE submitting via eProtocol
  • All Users must add their WSU Access ID to their CITI profile
  • CITI Training connects with eProtocol via the WSU Access ID (6 character letter number combination) (previous day's CITI content updates/refreshes each morning in eProtocol)
  • All Key Personnel will need to log in to complete an Obligations Statement and Conflict of Interest (COI) Disclosure Statement 
    • Only one key personnel can log in at a time to sign-off
  • Guest Users: Key personnel that are not WSU faculty, staff, or students will need to request a WSU guest access ID in order to be listed on the eProtocol submission. 
  • To request a WSU guest access ID see instructions here.
  • The Dean/Chair/Authorized signatory will need to also complete the Obligations and COI Statements as well as authorize submission to the IRB. 

Submission Instructions:

  • Use the IRB Guidance Tools and manuals for Assistance on the eProtocol webpage) 
  • Do not copy and paste text into eProtocol from other sources (i.e. PDF, html). Do not copy and paste the study title when creating a Protocol.
  • Remember to attach all supporting documents:
    • Consent & Information Sheets: Attach under Protocol Information-Consent Information
    • Assents: Attach under Protocol Information-Assent Information
    • Other Supporting Documents: Attach under Protocol Information-Attachments section:
      • Research Protocol/Proposal (if not included submission will be returned)
      • PI's CV/Resume
      • Investigator Brochures/Package Inserts (if applicable)
      • Data Collection Tools (questionnaires/surveys)
      • Recruitment Tools (flyer & advertisements)
      • Administrative Approvals (PRMC, DMC, Psychiatry, etc)
      • Appendices F, G, H, & D (if applicable)
  • Remember to complete the applicable eProtocol Addendums (i.e. Children, Pregnant Women, Fetusues & Neonates, Internet etc)
  • Attach all applicable PSF Appendices (PSF Appendix H, PSF Appendix F, Appendix G, Appendix D, Appendix M etc.)
  • Administrative Approval Process still must be completed as per the affiliates instructions (PRMC, DMC, Psychiatry etc.)
  • New Submissions require Dean/Chair/Authorized signatory sign off
    • In order for Dean/Chair/Authorized signatory to sign off you must select "Submit Form" 
    • The selected Dean/Chair/Authorized signatory receives an email notification when you have submitted your application for their review. 
    • After Dean/Chair/Authorized signatory Sign Off is complete you will receive an email notification 
    • You must "Submit Form" again to route the submission to the IRB for review 

Additional Submission Notes: 

  • Attend an eProtocol Training Session or virtual office hour session to learn the eProtocol submission steps (see Education website for schedule)
  • After submitting via eProtocol check your WSU email for review notifications/updates/requests
  • UP REPORTING: Submit UPs via eProtocol using the Unanticipted Problem Form
  • Need Help? Call the IRB Office 313 577-1628

Note: Submissions approved before the implementation of eProtocol will continue to use the applicable forms available on the IRB's website below.

 

Exempt Review

Exempt Initial Submissions accepted via eProtocol (see instructions above)

Expedited Review

Expedited Initial Submissions accepted via eProtocol (see instructions above)

Other Initial Submissions

Appendices

Single IRB Submissions-WSU as IRB of Record (Reviewing IRB)

WSU IRB Serving as the Reviewing IRB (Single IRB) Guidance Tool

For assistance in completing a single IRB submission in which WSU is the reviewing IRB, send an email to relyirb@wayne.edu 

Additional Forms That May Be Required

Data Use Agreements

Effective August 1, 2023 all Data Use Agreements (DUAs) are managed by the Business Innovation and Technology Commercialization Office.  Please email mtainfo@wayne.edu for assistance with a Data Use Agreement or Limited Data Set. 

Visit the Material Transfer Agreements website for additional information.

Data Use Agreements and Limited Data Sets IRB Guidance Tool (update July 2023)

Amendments

Note: studies not approved via eProtocol must use the amendment forms listed here and must be emailed to: eIRBManager@wayne.edu

eProtocol Amendment Submissions 

  • For Active protocols on the submitter's dashboard select "Start Amendment" and complete the amendment form
  • See eProtocol Amendment submission guidance tool on the IRB Education website

Continuations & Status Check-In Reports

All IRB approved research has one of two progress report requirements: 

  • Continuation approval with an assigned expiration date, that requires submission of a Continuation
  • Status Check-In:  No Expiration Date, requires submission of a Minimal Risk Status Check in Report

All key personnel's CITI training must remain current.  The Basic Course in Human Subject Research (Biomedical or Social Behavioral Investigators) refresher course is required every 3 years. To complete required CITI training go to the CITI website: www.citiprogram.org.

Continuations:

Studies not approved via eProtocol must use the Continuation Submission Form below and must be emailed to: eIRBManager@wayne.edu

Please submit continuations 6 weeks prior to the expiration date.

Single IRB Submissions 8-10 weeks prior to the expiration date.

eProtocol Continuation Submission 

  • For Active protocols on the submitter's dashboard select "Start continuing review" and complete the continuation form.
  • See eProtocol submission guidance tools on the IRB Education website

Status Check-Ins:

The Status Check-In Report must be submitted 6 weeks prior to the Status Check-In due date. Due dates are indicated on the initial IRB approval/concurrence memorandum. It is the PI's responsibility to take note of this date and submit the Status Update report.  

If modifications to the study or study documents are being made and amendment form will need to be submitted seperately. 

eProtocol Expedited & Exempt Submission approved on or after 11/6/2023:

  • On the Investigator’s Dashboard
    • Look under Active Protocols
    • Select Status Report Form
    • The Status Report Form will open as a pop-up
    •  Do not select the "Start Report Form" option as that is not a STATUS Report Form
    • Complete the Status Report Form a
    • Select Submit Form on the left side

eProtocol Exempt Submissions Approved before 11/6/2023:

eProtocol Expedited Studies Approved before 11/6/2023:

  • Complete the Minimal Risk Status Update Form available on the IRB’s website
  • Start a Continuation in eProtocol.
  • Select “Status Update Report” on the Continuation Form 
  • Attach the Minimal Risk Status Update Form at the end of the Continuation Form. Do not complete the remainder of the Continuation Form.
  • Select “Submit Form” 

Paper Based Non eProtocol Instructions:

Study Closures

All IRB approved research reviewed as expedited or by the full board requires either a continuation or closure before the date of expiration.

Exempt studies that received Concurrence of Exemption after January 21, 2019 must submit a closure form or a Status-Check in report before the status due date.  

Closure Submission Instructions:

Paper-Based Non-eProtocol:

  • complete the following closure form and submit to eIRBManager@wayne.edu: 
  • Closure Form (updated 09/2021, admin correction 10/12/2021) Open, complete, and save in Adobe.  Previous version accepted until 11/1/2021)

eProtocol Submissions Study Closure/Final Report:

  • Complete the Final Report Form via eProtocol.

How to access the eProtocol Final Report/Closure Form?

  • From the list of approved studies on your eProtocol dashboard:
    • click on the Protocol ID
    • Select Start "Final Report Form" 
    • Complete the Final Report Preliminary Questions 
    • All Responses must be "Yes" for study closure eligibility
    • Select "Continue" to complete the "Final Report Form" 

 

Treatment Use

Contact the IRB Administration Offfice, HRPP director Monica Malian for assistance with these submissions (monica.malian@wayne.edu)

Unanticipated Problem and Adverse Event Reports

(Unanticipated) Unexpected Problems and reportable Adverse Events must be reported to the IRB as soon as possible, but within 5 working days.

PLEASE ALSO USE THESE FORMS  FOR eProtocol UP REPORTING:

To submit an Unanticipated Problem via eProtocol:

  • Log into eProtocol

  • Look for "Approved Protocols" on the submitter's dashboard:

  • Select the Protocol's ID
  • A pop-up window will appear with an "Approved Protocol Decision" listing
  • Select the applicable option:
    • "Start Serious Adverse Event Form"
    • "Start Protocol Violation Form"
    • "Start Report Form"
  • Please see the Unanticipated Problems & Event Reporting Form for the descriptions of Serious Adverse Events, Protocol Violations, and General Reports for the Report Form selection. 

Click here to review the eProtocol UP submission process presentation

National Institutes of Health (NIH) 

NIH Certificates of Confidentiality policy (effective October 1, 2017) 

Effective October 1, 2017 NIH now automatically issues Certificates of Confidentiality (CoC) to all NIH funded or conducted research studies that are collecting or using identifiable, sensitive information (see Determining CoC Policy Applicability below).  This policy is retroactive to December 13, 2016.  

Visit the NIH CoC Kiosk

WSU IRB Certificate of Confidentiality Guidance Document 

Questions Determining NIH CoC Policy Applicability 

  • Is the activity biomedical, behavioral, clinical, or other research?

If the answer to this question is no, then the activity is not issued a Certificate. If the answer is yes, then investigators will need to answer the following questions:

  • Does the research involve Human Subjects as defined by 45 CFR Part 46?
  • Are you collecting or using biospecimens that are identifiable to an individual as part of the research?
  • If collecting or using biospecimens as part of the research, is there a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual?
  • Does the research involve the generation of individual level, human genomic data?

If the answer is yes to one the above questions the policy applies and NIH will automatically issue a CoC. 

Submitting to the IRB 

Initial Submissions

When the policy applies please include consent document(s) language provided with the CoC. 

Current Submissions

If the study is a NIH funded or conducted study please review the Determining Applicability questions.  If the policy applies and a CoC is issued to investigators, an amendment should be submitted to the IRB with the updated consent language.

In addition, at the point of continuing review the IRB Administration Office will review NIH submissions to determine if certificate of confidentiality language is needed.  

Review suggested CoC consent form language. 

Extending or Amending Current CoC with NIH

Not sure if you need to extend or amend an existing CoC with NIH? View the NIH kiosk page on extending and amending an existing Certificate of Confidentiality.

 

IRB Research Listserv:

Join our Listserv to keep up to date on changes to the forms, IRB training opportunities, policy changes, and other occasional announcements.

To Join send an email to: irbstatus@wayne.edu

About Exempt and Expedited Research Categories:

Refer to the research categories below to determine if the research meets the requirements for an Exempt or Expedited approval. If the research does not meet requirements for either, then it should be submitted for Full Board review.

Institutional or Departmental Review and Approvals

A letter of approval from the scientific review committee for research conducted at or by investigators from the following institutions or departments is required:

Detroit Medical Center (DMC), DMC Nursing Research Council, Karmanos Cancer Institute, Veterans Administration Medical Center, WSU Department of Psychiatry, and any other internal review that may be required by your department, but not by the IRB.  

For more information on the DMC Research Review process, see: http://www.dmc.org/researchreviewprocess/

Status of IRB Submissions:

To check on the status of an IRB submission for expedited or exempt review, email irbstatus@wayne.edu.  Provide the project title and the PI name in the subject line. IRB memos will be sent (inter-office mail or post mail) and emailed approximately 7-10 business days following the review of the submission by the assigned IRB member.

To check on the status of an IRB submission for full board review, please wait to the end of the 10 business days after the IRB meeting date and email irbstatus@wayne.edu.  Provide the project title, the committee submitted to, and the PI name, in the subject line. IRB memos will be sent (inter-office mail or post mail) and emailed approximately 7-10 business days following the the date of the full board meeting.

Please note, in order to receive information about an IRB submission you must be listed on the study documents.

 

COVID-19 and In-Person Research Activities 

IRB initial and amendment applications are to be submitted per the standard procedures indicated on this website. 

See the WSU IRB's Coronavirus-COVID-19 website for current COVID-19 precautions and considerations to protect research participants for in-person activities.

Effective December 1, 2022 submission of Appendix N is no longer required. 

All in-person research activities must include precautions and procedures to mitigate the spread of a virus that has risen to the level of a public health pandemic (i.e. COVID-19). The plan must include the following procedures/precautions:

  1.  A means to inform participants/patients, staff and visitors about the health pandemic's risks;
  2. A method to screen participants/patients, staff and visitors; Screening methods can be conducted via phone call or information sent to the participant regarding in-person risk of COVID-19 and symptoms.  (see reference to tools below)
  3. Provide guidance for the conduct of person to person visits that includes social distancing, PPE, handwashing and disinfection.

The plan/precautions should be included as part of the study's procedures and does not need to be submitted via Appendix N. 

For research activities occurring at a WSU campus site or non-affiliate site that are not standard of care medical facilities: The following tools are available to assist in informing participants of in-person precautions:

  • COVID-19 Participant Information Sheet Template
  • COVID-19 Phone Script Template

These templates are available on the WSU IRB Informed Consent/assent templates website