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

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

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


Need eProtocol Assistance?

send an email to WSUIRBInfo@wayne.edu

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


COVID-19 IRB Submissions UPDATE

The IRB Administration Office is currently accepting Virtual appointments.

Paper copy documents are not accepted please see the Non-eProtocol mitigation plan below.


For non-eProtocol submissions please see the following:

Non eProtocol Submissions Mitigation Plan

Electronic Signature & Attestation (update 10.2020)

The Electronic signature & Attestation must be downloaded and completed as an Adobe Acrobat document.

Click on the PDF file and download to your computer.

Instructions: Steps for Signing a PDF Form with a Digital ID


COVID-19 IRB Submission Guidance (updated 4/24/2020)

Note: COVID-19 focused research must first be submitted to the COVID-19 Research Advisory Committee 

How do I submit to the COVID-19 Research Advisory Committee?

The Principal Investigator should email the following documents to:  COVID19Research@wayne.edu

What should be emailed to the COVID-19 Research Advisory Committee?

  • Brief summary of the proposal and protocol
  • Study Title
  • P.I. name, contact information and affiliation
  • Informed consent (if applicable)
  • Confirmation of Department Chair approval (can be in the form of an email from the department chair)

Phased Resumption of Research Activities 

Many studies have adapted to the pandemic challenges by enabling remote engagement of participants through various platforms and these may continue as such. Continued consideration for managing the number of in-person visits is important for the protection of the participants, the PI and the research staff as we move forward over the next several weeks.

Current Phase of Research:

(I) Human participant research that can maintain remote study activities/visits as per IRB approval.

(II) In-person study visit(s) the coincide with a standard of care visit(s).  Note, study visits that have been modified to virtual/phone/remote formats can continue to conduct those visits as per IRB approval.

(III) In-person research that can provide a potential direct benefit to the participant.

(IV)  Effective June 1, 2021: In-person research without potential for direct benefit conducted at Wayne State University sites and/or established health care facilities will resume.

(V)  Effective July 1, 2021: In-person research without potential for direct benefit to participants conducted at nonaffiliated WSU sites will resume. The study's mitigation plan must include the non-affiliated study sites' approval/letter of support to conduct in-person research activities.

(VI)  Effective September 1, 2021: All visitors to the WSU Campus are required to complete the WSU Guest Campus Screener on the day of the on-site visit and prior to arriving on campus. With the exception of individual participants with prior approval to visit campus, all visitors to campus must be fully vaccinated. The vaccine mandate does not apply to research participants who are visiting campus to participate in research. 

  • For research participants, the participant will select Yes in response to the question: Are you a participant in a WSU research study attending campus as part of that study? 
  • Research participants should be provided with information regarding completing the WSU Guest Campus Screener and the COVID-19 Precautions before their campus study visit.
  • Research conducted at WSU campus sites requires submission of Appendix N Resumption of In-Person Human Participant Research Plan.
Phased Resumption of Research Documents:

Phased Resumption of Research Submission Instructions: 

Amendment Submissions

Full Board Submissions

Expedited Amendment Submissions

If the study was initially reviewed and approved by the Full Board, the Resumption of Clinical-In Person Research amendment will need to be a Full Board amendment. Please review the IRB Meeting Dates and Deadlines schedule for submission to the appropriate IRB committee.  This schedule can be found at https://research.wayne.edu/irb/meetings-deadlines

If the study was initially reviewed and approved as an expedited or exempt submission the Resumption of Clinical In-Person Research amendment will need to be submitted as an expedited amendment.

Please note that if upon review of the amendment it is determined that the study is no longer minimal risk, the IRB Administration Office will contact the PI with instructions to submit as a full board study.

Initial Submissions: Full Board, Expedited, Exempt

Appendix N: Resumption of In-Person Research must be submitted for all research studies in which activities will include in person visits.

NOTE: An amendment submission of Appendix N is not required if research activities are being conducted in a standard medical care/hospital setting and that institution's COVID-19 Standard Operating Procedures (SOPs) includes a plan to:

(a) Inform participants/patients, staff and visitors about COVID-19 risks.

(b) Screen participants/patients, staff and visitors for COVID-19 symptoms.

(c) Provide guidance for the conduct of person to person visits that includes social distancing, PPE, handwashing, and disinfection.

Phased Resumption of Research How to Submit?

Paper-Based Submissions (Non-eProtocol)

See Mitigation Plan above 

Amendments: VA and studies not submitted/approved via eProtocol:

  • Please complete either the Expedited Amendment Form or Full Board Amendment Form per information noted above.
  • Appendix N
  • Participant Information Sheet: COVID-19 Information
  • Phone Script: COVID-19 Information

Initial/New Submissions VA ONLY:

  • Submit per instructions indicated for the Protocol Summary Form. Complete Appendix N
  • Participant Information Sheet: COVID-19 Information
  • Phone Script: COVID-19 Information

All documents including Appendix N must be clearly labeled, placed in a zip file with the PI's name and IRB number (for amendments) and submitted to: eIRBManager@wayne.edu.

eProtocol Submissions

Amendments:

  • Select the active protocol on your dashboard and "Start an amendment" 
  • Complete the Amendment Form and Appendix N.
  • Attach Appendix N to the Protocol Information -Attachments sections. 
  • All other updated forms and documents should be attached to the appropriate sections: Consents and Research Information sheets (Including Participant Information Sheet and Phone Script) attached to the Protocol Information-Consent Information section and all other documents attached to the Protocol Information-Attachment section.

Initials/New Submissions:

  • Submit per instructions provided on the IRB Forms and submissions Instructions website: https://research.wayne.edu/irb/forms-requirements-categories
  • All supporting documents attached for the appropriate sections with Appendix N included for the attachments section, including the Participant Information Sheet and Phone Script if there will be in person visits..

External IRB Submissions

Initial and Modifications Submit Appendix N (and COVID-19 Participant Information Sheet and Phone Scripts if there will be in person study visits) with the Modification Request Form

to the appropriate email box:

NOTE: An amendment submission of Appendix N is not required if research activities are being conducted in standard medical care/hospital setting and that institution's COVID-19 Standard Operating Procedures (SOPs) includes a plan to:

(a) Inform participants/patients, staff and visitors about COVID-19 risks;

(b) Screen participants/patients, staff and visitors for COVID-19 symptoms;

(c) Provide guidance for the conduct of person to person visits that includes social distancing, PPE, handwashing and disinfection.


eProtocol Submission Instructions

Full Board, Expedited, & Exempt New/Initial Submissions Now Accepted via eProtocol (excluding VA)

Submit to eProtocol by clicking here

IRB eProtocol Submission Instructions

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

eProtocol Frequently Asked Questions

 

  • Start Early

  • Key Personnel
    • 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. 
  • 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 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 Notes: 

  • Attend an eProtocol Training 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: Please use the form available on this website below.
  • 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. 


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: 

  •  Complete the Protocol Summary Form, Protocol/Proposal, Consents/Assents, and all other application documents
  • Submit documents to: IRBQuestions@wayne.edu The subject line stating: "Pre-Review"
  • For eProtocol submissions complete the submission and email IRBQuestions@wayne.edu with "Pre-Review" and 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

New Self Assessment Pre-Review Tool

The Self Assessment Pre-Review tool is useful for completing before submitting to the IRB. The tool walks you through the submission requirements based on the many different scenarios unique to each study. This tool can be used as part of the IRB pre-review or used solely by the submitter.  The tool helps submitters know what documents and forms are required for IRB, as well as the type of IRB reviews and a Check for Completeness Assessment. The self-pre-review is not a required IRB form. 

Investigator Assessment/Pre-Review Tool (updated 11/2019)

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. The pre reviewed final submission will be stamped "pre-reviewed", however the submission must be received according to the submission instructions (described on the last page of the Investigator Self-Review Tool). 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 (RCR update)

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

Non VA Submissions must submit using eProtocol (see instructions above on this page)

Veteran Affairs Medical Center (VAMC) Expedited and Full Board Review use the following:



VAMC Exempt Review


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

Please note: For Data Use Agreements which are not Limited Data Set Data Use Agreements, please contact the MTA Assistant at mtainfo@wayne.edu from the WSU's Technology Commercialization Office. 

Data Use Agreements and Limited Data Sets IRB Guidance Tool (updated 6/26/2019)

Informed Consent Templates


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

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-In: For Expedtied & Exempt submissions initially approved after January 21, 2019 under the revised Common Rule a Status Check-In Report must be submitted to the IRB every 2 years or close the study. 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.  

Status Update/Check In Submission Instructions:

eProtocol Instructions:

  • Log into eProtocol and Start an eProtocol Amendment
  • Select Expedited and Status Check-In for the Amendment Form
  • Complete the Minimal Risk Research Status Update Form
  • Attach the Minimal Risk Status Update Form as an Attachment using the label "minimal risk status check-In"

Paper Based Non eProtocol Instructions:

  • Complete the Minimal Risk Research Status Update Form located on the IRB's Forms and submissions website
  • Submit the Minimal Risk Research Status Update Form to eIRBManager@wayne.edu
  • DO NOT SUBMIT an Expedited Amendment Form unless you are requesting modifications to the study

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:

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 dasboard:
    • 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 




 


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: WSUIRBInfo@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.