IRB education, training and guidance

IRB Education Series

IRB Drop In Training:

Topic: Defining Human Participant Research: How to Determine if Your Project Requires IRB Oversight

When: Wednesday June 13, 2018 1:00 pm - 2:00 pm

Where: IRB Administration Office, 87 E. Canfield 2nd Floor Conference Room

Missed this session? Slides are available for review by clicking here.

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

External IRB Request Half-Day Education Session:

Wednesday August 15, 2018, 9:30 am to 1:30 pm

Margherio-Mazurek Medical Education Commons 540 East Canfield

To reserve your spot e-mail WSUIRBInfo@wayne.edu

Topics include:

Submitting WIRB, CIRB, and Reliance Agreements, Single IRB submission, WSU External IRB Policy & Process, using the External IRB Request Forms, Local UP Reporting, Modification Requests, Consent Templates, etc.

Coming Soon.....

IRB Full Board Pre-Review Process!
WIRB Submission Process Overview (meet the WIRB reps!)

Archived training sessions

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.

eProtocol-IRB

eProtocol-IRB is a web-based system for submitting, tracking, reviewing and approving research protocols in a paperless environment. eProtocol-IRB was released on Monday, December 18, 2017 and is currently in pilot testing by select researchers and staff at Wayne State University. eProtocol-IRB implementation is occurring in phases as each of the WSU IRBs are transitioned to the electronic system. The PH1 IRB is currently accepting initial submissions using eProtocol. The B3 Full Board is currently in the pilot phase of implementation of reviewing selected full board submissions only. The remaining medical IRBs will begin eProtocol training fall 2018. Select faculty and staff have participated in system testing and evaluation, and additional faculty and researchers will be sought during the phased implementation.

If submitting to the PH1 IRB please e-mail PH1board@wayne.edu to receive submission information.

Note: All new PH1 IRB submissions will need to submit using eProtocol-IRB effective March 28, 2018.

If you need assistance with an eProtocol submission please e-mail WSUIRBInfo@wayne.edu.

Upcoming eProtocol-IRB 2018 Spring/Summer Education Sessions

Initial Submissions	June 5th 2:00pm -3pm
Initial Submissions	June 19th 2:00pm -3pm
Initial Submissions	July 17th 2:00pm -3pm
Amendment Submissions	July 31st 2:00pm - 3pm
Unexpected Problem Submissions	August 21st 2:00pm - 3pm

All sessions are held at the IRB Administration Office 87 E. Canfield 2nd Floor

Please register to attend an eProtocol Education Sessions by e-mailing WSUIRBInfo@wayne.edu.

Resources

IRB Handbook for Investigators

Handbook for Investigators: A Guide to the IRB and Human Research Protection Program . (March, 2015)

Join the IRB Research Listserv

IRB-info@lists.wayne.edu
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:

(313) 577-9992
RDAUnit@wayne.edu

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

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), Technology Commercialization and Sponsored Program Administration have established procedures available at:

http://www.techtransfer.wayne.edu/industry/mta.php

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.

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 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/index.php

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.

http://www.tricare.mil/tma/privacy/hrpp/downloads/Guide%20for%20DoD%20Researchers%20on%20Using%20MHS%20Data.pdf

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