Training, Resources, and Helpful Links
Training for Researchers, Staff, and Students
Attend a Training
Training by the IRB: Please RSVP to Jo Anna Risk at (313) 577-9534 or firstname.lastname@example.org.
- IRB Training Schedule - March, 2013
- IRB Training Schedule - April, 2013
- IRB Training Schedule - May, 2013
Formal group training classes are also available upon request and can be conducted either at the IRB Administration Office or at your site.
If you have specific questions about the IRB submission process, understanding reporting of adverse events/unexpected problems, or other research-related issues, please contact Jo Anna Risk at (313) 577-9534 or email@example.com.
Training by the Research Subject Advocate: Please contact Corey Zolondek at firstname.lastname@example.org to sign up for Research Subject Advocate training.
- Research Subject Advocate Training Seminars - Winter, 2013
Watch a Pre-Recorded Training Session
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)
Handbook for Investigators
Download your comprehensive, "how-to" handbook for investigators. Simply click on the following link: Handbook for Investigators: A Guide to the IRB and Human Research Protection Program.
Join the IRB Research Listserv
Join our listserv to keep up to date on form changes, training opportunites, polycy changes and other occasional announcements.
To join IRBemail@example.com click here: http://irb.wayne.edu/education/wsu_irb_listserve_7_25_2011.pdf.
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, http://clasweb.clas.wayne.edu/psychology/ResearchDesignandAnalysisConsulting
Bio Specimen Banking
Material Transfer Agreements (MTAs)
If you are planning on leaving the University and taking your specimens with you or if you are bring materials in, you will need a Material Transfer Agreement. MTA are essentially contracts between two parties that describe the terms and conditions underlying the transfer of biological materials, chemical compounds, and other tangible research 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.
Attention PI’s of Investigator Initiated Studies and PIs with Sponsors
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/
Help for WSU Students Doing Research
Here is some help from the IRB for getting you through the IRB approval process to conduct human participant research for the first time. Be sure and take a look at the Handbook for PIs—that is your one stop guide for everything you need to know. We also offer training classes every week at a variety of times and locations. Here are a few overview guides to help you:
- What Students Should Know Before Conducting Research
- Steps for Getting WSU IRB Approval - social, behavioral, education research
- Steps for Getting WSU IRB Approval - medical research
- What to Include in a Research Protocol that is Submitted to the IRB
Quality Improvement or Research? Help...!
- How do I tell if my study is human subject research or not, or just QI?
- Q&A Quality Improvement vs. Research
- Grid Research Versus Quality Improvement
- Human Participant Research Determination Form
Advertising Study Recruitment on Pipeline:
WSU Pipeline Snippets: Snippet is the appropriate place to post recruitment announcements on WSU Pipeline, IRB approval to recruit students &/or employees is also needed to advertise on Pipeline. Most Depts., Colleges, and Divisions have designated snippet managers. 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. If you cannot locate a designated snippet manager, contact C&IT at firstname.lastname@example.org . If you change your snippets announcement, you will first need to file an amendment and gain IRB approval prior to using the modified advertisement.
Advertising Study Recruitment on Facebook and other Social Media Websites:
Facebook is a great place to recruit participants from. If you are using a publically 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.
If you are using a social media site that is not publically 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.
- Consent of Non-English Speaking Participants
- Letter of Support
- What to Include in a Research Protocol that is Submitted to the IRB
- Retrospective Chart Review
- The Genetic Information Nondiscrimination Act of 2008 (GINA)
- DECISION CHART: 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?
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
Conflict 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 703-681-7500or TMA_HRPP@tma.osd.mil.
Required Elements of Informed Consent
- Office of Human Research Protections / http://www.hhs.gov/ohrp
- Human Participants Regulations Decision Charts / http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
- Institutional Review Board Guidebook / http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
- Protection of Human Participants: 45 CFR 46 / http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
- Human Participant Protection (Informed Consent): 21 CFR Part 50 / http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm
- Food and Drug Administration / http://www.fda.gov/
- Information Sheets: Guidance for IRBs, Clinical Investigators, and Sponsors / http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709
- Investigational Device Exemptions: 21 CFR Part 812 / http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm
- Investigational New Drug Application: 21 CFR Part 312 / http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm
- IRB Regulations: 21 CFR 56 / http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
Ethical Principles & Codes
- American Society for Bioethics & Humanities (ASBH) / http://www.asbh.org/
- Belmont Report / http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
- Declaration of Helsinki (World Medical Association) / http://www.wma.net/en/20activities/10ethics/10helsinki/
- NIH Bioethics Resources on the Web / http://bioethics.od.nih.gov/
- Nuremberg Code / http://www.hhs.gov/ohrp/archive/nurcode.html
- National Bioethics Advisory Commission (NBAC) / http://bioethics.georgetown.edu/nbac/
- Public Responsibility in Medicine and Research (PRIM&R) / http://primr.org
- The President's Council on Bioethics / http://bioethics.gov/
Good Clinical Practices
- Good Clinical Practice in FDA-Regulated Clinical Trials / http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
- Good Clinical Practice Contacts / http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm134476.htm
- ICH E6: Good Clinical Practice: Consolidated Guidance / http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf
- Medical Devices (Device Advice) / http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
- IRBs and the HIPAA Privacy Rule (NIH) / http://privacyruleandresearch.nih.gov/irbandprivacyrule.asp
- NIH Guidance on Protecting Personal Health Information in Research (NIH) / http://privacyruleandresearch.nih.gov/pr_02.asp
- NIH Guidance on Research Repositories, Databases, and the Privacy Rule (NIH) / http://privacyruleandresearch.nih.gov/research_repositories.asp
- NIH Guidance on Clinical Research and the HIPAA Privacy Rule / http://privacyruleandresearch.nih.gov/clin_research.asp
Veteran Affairs Administration
- VA Website / http://www.detroit.va.gov/services
- Research Office at the VA Medical Center (313) 576-3430
Department of Defense
- Department of Defense website / http://www.defense.gov/
Guide for Department of Defense Researchers using Military Health System Data
Department of Energy
- Department of Energy website / http://www.energy.gov/
Department of Education
- Department of Education website / http://www.ed.gov/
Department of Justice
- Department of Justice website / http://www.justice.gov/
Environmental Protection Agency
- Environmental Protection Agency website / http://www.epa.gov/
Office of Biorepositories and Biospecimen Research