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Division of Research

IRB

IRB education, training and guidance

IRB Education 
IRB eProtocol Information (guidance tools, training schedule, FAQs)
Resources & Guidance Documents
Archived Training

eProtocol IRB Submission Guidance Tools & Checklists:

Changing the PI from the Coordinator- Designee, PI Switch before IRB review
 
Consent Waiver Request:

Using a Research Information Sheet: A Waiver of written documenation of Consent is required for minimal risk research study that uses a Research Information Sheet (unsigned consent). 

To request the waiver of written documentation of consent, complete the following steps:

  • Consent Information section select "Add" and complete the pop-up window 
  • Title: type the name of the requested waiver: "Waiver of Written documentation of consent"
  • Consent Information Type: select the appropriate waiver type for the pop-up window:  "Waiver of 'DOCUMENTATION' of Consent or Parental Permission"
  • Respond to the listed waiver/alteration statements and Save
A waiver to screen for study eligibility: This is required if you will screen participants before consent either via chart/data review or retaining screening data that will be included in the data analysis.
  To request this waiver, complete the following steps:
  • Consent Information section select "Add" and complete the pop-up window 
  • Title: type the name of the requested waiver: "Waiver to screen for study eligibility"
  • Consent Information Type: select the appropriate waiver type for the pop-up window:  "Waiver of Consent or Parental Permission"
  • Respond to the listed waiver/alteration statements and select "Save".
Assent Waiver Request:
If requesting to waiver of assent or use of a Assent Information Sheet for ages 13-17 follow the steps indicated for the Assent Information section of eProtocol.

Note: eProtocol users UNANTICIPATED PROBLEM  (UP) REPORTING- Please use the IRB Unanticipated Problem Form found on the IRB Forms and Submission Requirements webpage and attach for the eProtocol Protocol Violoation or Serious Adverse Event options.

Are you a guest Access ID user?  Learn how to forward your wayne email to an external email address.  See instructions here.

Need to reset your Access ID password.  See instructions here.

For instructional videos and manuals of the eProtocol system click the green eProtocol button on the top left of this website.

For eProtocol technical questions, guest WSU Access ID assistance, sign up for the listserv, or request an eProtocol Education Session for your department or college please email: irbstatus@wayne.edu

IRB Training Requests & IRB Questions

For more information or to schedule an education session, please contact IRB Training Coordinator, Heather Park-May at 313-993-7157 or gp2126@wayne.edu

IRB Questions: 

Have a burning IRB Question? 

Need help with determinining whether a submission is full board, expedited, exempt? 

Email your IRB questions to:

IRBQuestions@wayne.edu 

IRB Education On-Demand

The HRPP-IRB is now offering pre-recorded education sessions that can be accessed at your own convenience.   
 
 
 
 
 
 
 

HRPP-IRB Webinar Series

The HRPP-IRB webinars are ongoing touch base opportunities for the research community. 

Upcoming Webinar Dates:

February 27, 2024 10:30 a.m.

March 26, 2024 10:30 am

Registration is now required for the webinar

CLICK HERE TO REGISTER

This is a recurring meeting and a one time register will provide access to future sessions.

An email confirmation will be sent after registration is approved.


 

eProtocol 

eProtocol-IRB is a web-based system for submitting, tracking, reviewing and approving research protocols in a paperless environment.  Select faculty and staff have participated in system testing, evaluation, and pilot submission for eProtocol. eProtocol-IRB was released on Monday, December 18, 2017 in a phased approach, with subsequent IRBs accepting and reviewing full board submissions via eProtocol. 

Currently all WSU IRBs are accepting New/Initial Full Board, Expedited, & Exempt submissions via eProtocol including VA submissions

IRB eProtocol Virtual Office Hour

Tuesdays 1:00 pm - 2:00 pm

Via Zoom

Meeting ID: 953 4534 4223
Passcode: 577514

Please include your name for your Zoom profile. Your name must be provided or entrance will not be allowed.  Members are placed in the waiting room first.  If there is a line, attendees will be remain in the waiting room and notification provided regarding your placement in line. 

 

eProtocol Initial Submission Introduction Session

for Exempt, Expedited, & Full Board Studies

Contact the IRB Office to schedule a training session.

Visit the IRB's Virtual Office Hour for assistance

 

Resources and Guidance

IRB Pre-Review Services

The IRB offers a number of pre-review services, including a pre-review self-assessment tool and pre-review of full board initial submissions.  To learn more about pre-review services visit the IRB's IRB Forms and Submission Requirements webpage.

IRB Questions

Do you have an IRB questions or need assistance with completing IRB forms, send an e-mail to IRBQuestions@wayne.edu.

Join the IRB Research Listserv

Keep up to date of IRB form changes, regulatory changes, submission requirements, and electronic submission implementation by joining the IRB Listserv. 

It's easy to join: To subscribe, send an email to: irbstatus@wayne.edu

Research Design and Analysis Consulting  

The WSU Research Design and Analysis Unit provides assistance with the design of research projects and the statistical analysis of data. The service is available free of charge to Wayne State University faculty, staff, post-doctoral students, and graduate students. The service is not available to undergraduate students. Contact information:

(313) 577-9992
RDAUnit@wayne.edu

Guidance for getting started

Guidance for WSU Students Conducting Research

Guidance for Research That May Not Require IRB Review

Guidance for research with humans

Guidance for addressing characteristics of study design

Specimen Banking

Private Information/Bio Specimens Decision Chart (PDF) - Determining if IRB review is required
RIM&R Collection and Banking Specimens for Research Charts (PDF) - Determining if  IRB review is required
Resource List for Specimen Banking (.doc)

Material Transfer Agreements (MTAs)

When leaving the University and taking research data or specimens or if brining research data or specimens to the University, a Material Transfer Agreement (MTA) may be required. MTAs are contracts between two parties that describe the terms and conditions underlying the transfer of biological materials, chemical compounds, and other tangible research data or materials.

To facilitate the processing of both outgoing MTAs (Wayne State-owned materials to be transferred to an outside organization) and incoming MTAs (materials owned by an outside organization transferred to Wayne State), The Office of Business Innovation and Technology Commercialization have established procedures available at the Material Transfer Agreement website.

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

Radiation Use in Research

If a study requires any imaging, therapeutic and/or diagnostic procedures involving radiation, a Radiation Safety Review is required prior to submitting the IRB protocol for review.  Contact the appropriate Radiation Safety Committee list at the end of Appendix G to receive a review and submit the Initial Protocol Summary form and Appendix G to that committee.  For Karmanos Cancer Institute, the PRMC conducts the radiation safety review for their protocols. For VAMC studies, the radiation safety review is done by the CIC.  

After you have completed the Radiation Safety Review process, you may submit the Initial Protocol Summary form and Appendix G to the IRB.  Please include evidence that the Radiation Safety Review review was completed.

Clinical Trial Registration - clinicaltrials.gov (see ClinicalTrials.gov Requirements-NEW!)

Clinical Trial research studies are required by law to be registered on the clinicaltrials.gov website [U.S. Public Law 110-85 (FDAAA)] and a statement must appear in the informed consent document stating that it is registered.  For more information about this law and requirements for sponsors and/or investigators, visit the PRS and U.S. Public Law 110-85 Information Page: http://prsinfo.clinicaltrials.gov/

Guidance for Advertising and Recruitment for Research

WSU Academica Snippets: A Snippet on WSU Academica is permissible as a means to recruit students and or employees for research however, prior IRB approval is required. Snippet requirements are 256 characters for the title, 512 characters for the summary and a link and image may be included. Spaces and punctuation are included in the characters. Most Departments, Colleges, and Divisions will have a designated snippet manager. If unsure of  a designated snippet manager, contact C&IT at  portalteam@wayne.edu . IRB approval is also required for any changes to already approved snippets. An amendment must be submitted and approved prior to using the modified advertisement.

Guidance for Using Facebook and other Social Media Websites for Advertising and Recruitment:

To use a publicly available social media site for recruiting only: (1) gain IRB approval to advertise on social networking sites (such as Facebook) via Appendix B, (2) ask permission from the site administrators (at various Facebook pages) and (3) post to sites only where you have gained permission to advertise.

To use a social media site that is not publicly available for recruiting only: (1) gain a letter of permission to advertise recruitment from each site/server owner, then (2) proceed to gain IRB approval to advertise there, (3) post to sites only where you have gained permission to advertise.

Guidance for export control and international travel:

Federal Export Control Regulations prohibit disclosure of certain information, technology and products to designated persons or entities, whether on U.S. soil ("deemed exports") or abroad.  If your research protocol involves this or traveling outside of the USA, refer to the Export Control department at https://research.wayne.edu/integrity/export-control  to see if you are required to take an action.

Guidance on General Data Protection Regulation (GDPR):

Effective on May 25, 2018 the European General Data Protection Regulation (GDPR) took effect.  The Office of Human Research Protections (OHRP) has provided compilation guidance for IRBs and also stakeholders involved in human participant research in Europe.  For more information see OHRP's Compilation of European GDPR Guidances.

Guidance on conflicts of interest:

If you have a Conflict of Interest, you must bring this to the attention of the Conflict of Interest Committee prior to submitting your research study to the IRB. If you already have IRB approved studies and develop a conflict at a later point, report this when it becomes known.  For more info, contact the Conflict of Interest Committee: http://research.wayne.edu/coi/

Department of Defense Research

The DOD Directive 3216.02 Protection of Human Subjects and Adherence to Ethical Standards in DOD Supported Research encompasses the DOD Human Research Policy.   Investigators from outside the DOD need to be aware of human research protection policies and should seek additional guidance from the TMA Privacy Office and the TMA Human Research Protection Program (HRPP) regarding specific requirements. Should you have any questions, please contact TMA at 703-681-7500 or TMA_HRPP@tma.osd.mil.

Create surveys with qualtrics:

The Qualtrics Research Suite is a user-friendly, feature rich, web-based survey tool which allows users to build, distribute, and analyze online surveys, collaborate in real-time, and export data in multiple formats.  It is available to all students, faculty and staff at WSU at no cost.  Karmanos also has this available to their employees. For more info at WSU: http://www.computing.wayne.edu/qualtrics/

Helpful Links - Outside Resources

Data Collection Note:

CONSIDER ALTERNATIVES TO THE MORISKY MEDICATION ADHERENCE SCALE (MMAS-4 AND MMAS-8)

Attorneys representing the purported owner of the Morisky Medication Adherence Scale (both MMAS-4 and MMAS-8), and one of its authors, Dr. Donald Morisky, have threatened universities and researchers (including here at WSU), among others, with copyright infringement and breach of contract lawsuits, and have demanded retraction of publications, when a researcher has used either MMAS-4 or MMAS-8 as part of academic research. Here are some related articles:  https://retractionwatch.com/2017/01/26/use-research-tool-without-permission-youll-hear/; https://www.sciencemag.org/news/2017/09/pay-or-retract-survey-creators-demands-money-rile-some-health-researchers. 

           The experience of other universities with payment to MMAS Research, LLC, Dr. Morisky, and/or his associate Steven Trubow in exchange for a license or permission to use the scale has not been positive.  Typically, there is no support by the company after payment in relation to using the scale, and researchers who believe they hold a license continue to be harassed for additional payment based on the nature and extent of their use.  For these reasons, WSU urges researchers to consider using (or, if protected by copyright, requesting permission to use) a publicly-available alternative to the MMAS-4 or MMAS-8 as part of any research involving medication adherence.  For example, researchers at peer universities are now using NIH-funded Self-Reported Medication Nonadherence measurement tools created by Corrine Voils, PhD, available here, as alternatives to MMAS-4 and MMAS-8:  https://www.surgery.wisc.edu/research/researchers-labs/corrine-voils-phd/self-reported-medication-nonadherence-measurement/. Here are a few other options for consideration: https://pubmed.ncbi.nlm.nih.gov/26622919/.

 

Archived training sessions & webinars

Education Spotlight: July 21, 2021 DMC GME Professional Development Series: Intro to the IRB

Meeting Recording

Slide Presentation