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 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
There will not be a Virtual Office Hour session on Tuesday December 27, 2022
Visit the IRB's Education website for more education offerings.
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:
- 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 (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 & COVID-19 Phase Resumption of Research
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 InstructionsDon't Forget to "Submit Form" for review! eProtocol Frequently Asked QuestionsFull Board Submission Guidance Tool (Update 10/2022)Expedited Exempt Guidance Tool (Update 10/2022) |
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Start Early
Key Personnel Instructions:
Submission Instructions:
Additional Submission Notes:
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)
Exempt Category 2 or Category 3 may require Limited IRB Review. Please complete the eProtocol Exempt paragraphs and follow instructions for submission of Appendix M: Limited IRB Review, if applicable.
Expedited Review
Expedited Initial Submissions accepted via eProtocol (see instructions above)
Other Initial Submissions
- Humanitarian Use Device (HUD) Form (updated 12/2021) Must open and save in Adobe. Previous version accepted until January 31, 2022.
- Administrative Application (updated 12/2021, correction 4.2022) Must open and save in Adobe. Previous version accepted until January 31, 2022.
- Authorization to Use Another IRB for Protocol Approval Agreement (04/2015)
- Authorization to be the IRB of Record for Collaborating Entity (04/2015)
Appendices
- Appendix A - International Research (04/2015)
- Appendix B - Internet Use in Research (04/2015)
- Appendix C - Children as Research Participants (04/2015)
- Appendix D - Adult Research Participants with Impaired Decision Making Ability (RCR update) if applicable include with eProtocol submission
- Appendix E - Prisoners as Research Participants (04/2015)
- Appendix F - Use of Drugs, Biologic Agents, or Devices (04/2015) if applicable include with eProtocol submission
- Appendix G - Imaging/Diagnostic Radiation (04/2015) if applicable include with eProtocol submission
- Radiation Exposure-Risk Calculator
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Radiation Safety Review Contacts
Children's Hospital Cari Dzanbazoff cdz_mpc@comcast.net Detroit Receiving Hospital Richard Joyrich RJoyrich@dmc.org Harper Hospital Richard Joyrich RJoyrich@dmc.org Huron Valley Hospital Victoria Swegles VSweggles@dmc.org Sinai Grace Hospital Tim Applegate TApplega@dmc.org Karmanos Jay Burmeister burmeist@karmanos.org VAMC contact VA CIC
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- Radiation Exposure-Risk Calculator
- Appendix H - The Use of Biological Specimens (RCR update) if applicable include with eProtocol submission
- Appendix I - Research Funded by a Component of the Department of Defense (DoD) (04/2015)
- Appendix J - Studies Conducted at or by the VA (04/2015)
- Appendix K - Pregnancy, Fetuses, Neonates (04/2015)
- Appendix L - NIH Genomic Data Sharing (04/2015)
- Institutional Certification: Genetic/Genomic Data Sharing
- Limited IRB Review Appendix M if applicable include with eProtocol submission
- Appendix N: Resumption of In-Person Research (Effective December 1, 2022 submission of Appendix N is no longer required)
Single IRB Submissions-WSU as IRB of Record (Reviewing IRB)
WSU IRB Serving as the Reviewing IRB (Single IRB) Guidance Tool
- Engagement Determination Checklist
- WSU Preliminary Intake Form (WSU as Reviewing IRB)
- Relying Institution (Non-WSU) Local Context Information Sheet
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
- HIPAA Summary Form (updated 10/2021 previous version accepted until 12/1/2021)
- Additional Key Personnel List (previous version accepted until 11/1/2021, open and save as a PDF)
- Electronic Signature & Attestation (update 10/2020)
- Coordinating Center Application (updated 10/2021 admin correction 1.2022) & Coordinating Center Addendum (dated 10/2021)
- If applicable include the Coordinating Center Form(s) with eProtocol submission attach under Study Location section
- Limited Data Set Data Use Agreement (revised 02/2019)
- VA Studies Documentation of Waiver of HIPAA Authorization for Research
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
- Expedited Amendment Form (update 11/2022) previous version of form accepted until 12/16/2022
- Full Board Amendment Form (updated 11/2022) previous version of form accepted until 12/16/2022 review the IRB Meeting and deadlines website for submission details
- Change in PI Form (updated 09/2021 previous version accepted until 11/1/2021)
- Key Personnel Change Form (updated 9/2021 previous version accepted until 11/1/2021 open, complete, & save as an Adobe Acrobat document)
- (use the Additional Key Personnel List (updated 11/1/2021) if all key personnel changes cannot fit on the Key Personnel Change Form)
- Administrative Application (12/2021 correction 4.2022) - To Amend an Administrative Application
- Include any Appendices or Additional Forms, if necessary
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.
- Continuation Submission Form (update 10.2021 correction 11.2021 previous version accepted until 12/1/2021) Form can be converted to Adobe to provide a digital signature.
- Revised Common Rule Transition Appendix (updated 3.2019)
- Administrative Application (12/2021, correction 4.2022) - To Continue/Renew an Administrative Application
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.
- Minimal Risk Status Update Report Form (updated 9/2021 previous versio accepted until 11/1/2021. Open, complete, and save in Adobe).
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:
- 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
- Single Time Emergency Use of a Test Article (Drug, Biologic or Device) Form (04/2015)
- Compassionate Use Form for Device, please use the new Expanded Access Submission Form
- Note: Compassionate Use does not apply to drugs
- NEW Expanded Access Form with digital signature (must open, complete, and safe as an Adobe Acrobat document for eSignature)
- Expanded Access Submission Form (10/2019) (word version)
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:
- Unanticipated Problems & Event Reporting Form (updated June 2022). Form must be opened and signed as an Adobe Acrobat document.
- Unanticipated Problem Follow-up Form (updated June 2022) Form must be opened and signed as an Adobe Acrobat document. P
To submit an Unanticipated Problem via eProtocol:
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Log into eProtocol
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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.
Attend an information session to learn more. See the schedule on the IRB's Education website.
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.
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.
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:
- A means to inform participants/patients, staff and visitors about the health pandemic's risks;
- 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)
- 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