IRB education, training and guidance
IRB Drop In Training:
Expedited & Exempt Research Review (see eProtocol sessions below)
For more information or to schedule an education session, please contact IRB Training Coordinator, Heather Park-May at 313-993-7157 or firstname.lastname@example.org
Missed a Session?
see the Archived Training Session Information below
IRB Full Board Pre-Review Service is now Available!!!
Pre-Review Service Flyer
For more information please contact IRB Training Coordinator, Heather Park-May at 313-993-7157 or email@example.com.
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 with the PH1 IRB, with subsequent IRBs accepting and reviewing full board submissions via eProtocol.
Currently all WSU IRBs are accepting New/Initial Full Board submissions via eProtocol (excluding VA).
NOTE: VA Submissions will continue to use the traditional submission process (see Protocol Summary Form on Forms page for Instructions)
eProtocol training is also available to register for a training sessions please e-mail WSUIRBInfo@wayne.edu.
IRB eProtocol Quick Tips
eProtocol IRB Submission Guidance Tools:
Upcoming eProtocol-IRB 2019 Education Sessions
Initial Full Board Submission
IRB Administration Office
87 East Canfield 2nd Floor
|September 17, 2019||2pm - 3:30pm|
|October 22, 2019||2pm - 3:30pm|
|November 5, 2019||2pm - 3:30pm|
|December 3, 2019||2pm-3:30pm|
Please register at WSUIRBInfo@wayne.edu
Please indicate in your e-mail if you will need parking.
Socia, Behavioral, Education (SBE) Sessions
This session will consist of a review of the expedited and exempt categories , as well as submitt to eProtocol.
Tenative roll-out date for Biomedical expedited and exempt submissions accepted via eProtocol is October 1, 2019
|September 24, 2019||11am-12noon|
|October 8, 2019||11am-12noon|
|October 22, 2019||11am - 12 noon|
All sessions are held at the IRB Administration Office
87 East Canfield 2nd Floor
To register e-mail WSUIRBInfo@wayne.edu
Please indicate in your e-mail if you will need parking
at 87 East Canfield 2nd Floor
November 12, 2019
at 87 East Canfield 2nd Floor
October 29, 2019
For eProtocol technical questions, guest WSU Access ID assistance, sign up for the listserv for eProtocol information, or to register to attend an eProtocol Education Sessions please email: WSUIRBInfo@wayne.edu.
Archived training sessions
Missed the recent External IRB Request Education Session? from August 2018 The PowerPoint slide presentation is available here.
- Human Participant Research - When Does Research Require IRB Review? - April 27, 2015 Webinar
- The Human Subject' Protection Regulations and You: What Everyone Should Know - Presented at WSU on October 25, 2012 by Elyse I. Summers, J.D., Director, Division of Education and Development, Office for Human Research Protections (OHRP)
- International Research Training
- Doing Research with the Veterans Health Administration – Presented at WSU in November, 2013, by Patricia Fox, Administrative Officer for Research, Department of Veterans Affairs John D. Dingell VA Medical Center. This training walks you through how to gain permission to recruit VA participants as well as what you need to know to submit a research proposal to the VA.
- Defining Human Participant Research: How to Determine if Your Project Requires IRB Oversight -IRB Drop in Training Session June 13, 2018 Slides are available for review.
- Policy Updates Human Participant Research - Presentation May 9, 2019 presenters: Monica Malian & Heather Park-May
- Video of Presentation:
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.
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: WSUIRBInfo@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:
Guidance for getting started
Guidance for WSU Students Conducting Research
- What Students Should Know Before Conducting Research (PDF)
- Steps for Getting WSU IRB Approval (.docx) - social, behavioral, education research
- Steps for Getting WSU IRB Approval (.docx) - medical research
- What to Include in a Research Proposal/Protocol (PDF)
Guidance for Research That May Not Require IRB Review
- HHS - Quality Improvement FAQs
- Human Participant Research vs. Quality Improvement (PDF)
- Oral History Projects (PDF)
- Human Participant Research Determination Tool (.doc)
- Guidance Tool for Activities Not Considered to be Human Participant Research
Guidance for research with humans
- What to Include in a Research Proposal/Protocol
- Advertising to Recruit Participants
- International Research (PDF)
- Letters of Support (PDF)
- Informed Consent Templates
- Privacy and Confidentiality Guidance (PDF)
- Key Personnel Guidance Tool
Guidance for addressing characteristics of study design
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), Technology Commercialization and Sponsored Program Administration have established procedures available at:
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 firstname.lastname@example.org . 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.
- Retrospective Chart Review (PDF)
- The Genetic Information Nondiscrimination Act of 2008 (GINA) (PDF)
- DECISION CHART (PDF): Reporting Serious Adverse Events (SAEs) and Problems Involving Risks to Students or Others in VA Research
- How do I tell if my study can be exempt or expedited?
- Do I need WSU IRB review if I have approval at another IRB? (.docx)
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 http://research.wayne.edu/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
Below is a link to the Guide for Department of Defense Researchers using Military Health System Data. This guide provides an overview of the MHS as well as guidance regarding the types of research data available within the MHS, reviews specific to the protection of human subjects, and requirements of the TRICARE Management Activity (TMA) Privacy and Civil Liberties Office (Privacy Office) for requesting MHS data. Although this document is not comprehensive, it seeks to provide useful information for DoD researchers about MHS data and required reviews. Investigators from outside the DoD need to be aware that there are requirements beyond those listed in this Guide, and they 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/
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://www.ncbi.nlm.nih.gov/pmc/articles/PMC4656225/table/Tab2/?report=objectonly.