• Policies/Human Research Protection Program Manual
• Meetings and Deadlines
• IRB Forms, Submission Requirements and Review Categories
• Informed Consent/Assent and Information Sheet Templates
• Education
• Mandatory Training
• Process Improvement and Compliance
• IRB Membership
• IRB Fees
• For IRB Members
• Study Coordinators' Advisory Committee
• CIRB
• WIRB
• Contact Us

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• Research Home

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 jrisk@wayne.edu.

• IRB Training Schedule - April, 2012
• IRB Training Schedule - May 2012

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 jrisk@wayne.edu.

Training by the Research Subject Advocate:  Please contact Corey Zolondek at zolondek@wayne.edu to sign up for Research Subject Advocate training.

• Research Subject Advocate Training Schedule - Spring, 2012

Watch a Pre-Recorded Training Session

• 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)

• IRB 101: The Basics

Resources

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.

Bio Specimen Banking

• Private Info or Bio Specimens Decision Chart
• Resource List for Specimen Banking

Helpful Materials

• Consent of Non-English Speaking Participants
• Requirements for All Protocols
• What Students Should Know Before Conducting Research
• What to Include in a Research Protocol that is Submitted to the IRB
• Research Versus Quality Improvement/Assurance
• Quality Improvement vs. Research FAQs
• 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

Helpful Links

OHRP

• 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

FDA

• 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://ohsr.od.nih.gov/guidelines/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://ohsr.od.nih.gov/guidelines/nuremberg.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/cdrh/devadvice/

HIPAA

• 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
• http://www.va.gov/ORPM/index.asp

Department of Defense

• Department of Defense website / http://www.defense.gov/

 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

• http://biospecimens.cancer.gov/