Institutional Review Board (IRB)

Tips for Submitting a Successful Protocol:

 

 

Researchers planning on conducting studies are required to attain Collaborative Institutional Training Initiative (CITI) certification in Human Subject Research. Certification information is kept on file per compliance regulations and accessed when you submit a protocol. Certification needs to be renewed every 3 years.

To complete CITI Certification:

1.     See the Completing CITI Certification help file to get started.
2.     Visit www.citiprogram.org.
3.     Be sure to save your CITI registration information for future reference.
4.     To complete your certification, click on the Main Menu and follow the instructions.
5.     When you complete the course, SAVE AND PRINT your certification for your records.
6.     Your certification information will be accessed automatically by Axiom when you submit a research protocol.

A help file is available from the Center for Teaching, Learning, and Technology at ctlt@su.edu.

Please use the forms below when submitting your documentation to the Axiom Mentor system.

• IRB Checklist 2018
• IRB Decision Charts
  • The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. 
• Application for Use of Human Subjects (Form B) Revised 2018 (example; questions must be answered online in Axiom Mentor) 
• Informed Consent Template Revised 2019
• Minor Assent Template Revised 2018
• Electronic Anonymous Survey Consent Template Revised 9_2018
• Electrical Equipment Safety Check Memo
• Sponsored Research Form
  Required for all researchers not affiliated with Shenandoah University 
• Request for Amendment (Form C) Revised 2018
  To request an amendment/modification to previously approved protocols, complete this form an upload to the Amendments tab of Axiom Mentor.

If you have any questions about whether or not your project needs to be evaluated or how to go about IRB submission please contact your IRB representative below:

Administration: Adrienne Bloss

Arts and Sciences: Mark Chan, Scott King, Kim Orrell, Jessica Peacock

Education & Human Development: Sarah Daniel, John Goss, Karen Huff

Business: Gokce Palak

Conservatory: Rosemary Green, Anthony Meadows

Community: Polly Porter, PA-C

Nursing: Cathy Brendell, Elizabeth Courts

Pharmacy: Tracey Nickola, Katerina Petrov, Ranjani Varadarajan

Health Professions: Rachel Carlson, Donna Colaianni, Kimberly Pritchard (chair), Ed Schrank

IRB Timetable

The expected turnaround times for the IRB committee to process applications are as follows**:

• Exempt – 2-4 weeks
• Expedited – 3-6 weeks
• Full review – 6-8 weeks

**Assuming that the proposals are complete and that no major revisions are requested. Please allow enough time for review.

IRB Related Links

• U.S. Department of Health & Human Services (HHS) Office for Human Research Protections

• DHHS Federal Regulations–45 CFR 46 – Protection of Human Subjects

• HHS: Expedited Review Categories

• International Compilation of Human Research Protections

• U.S. Food and Drug Administration (FDA)

• 21 CFR 50 – Protection of Human Subjects (FDA)

• 21 CFR 56 – Institutional Review Boards (FDA)

• National Institutes of Health

• Guidelines on the Inclusion of Women and Minorities in Research

• Inclusion of Children in Research

• Research Involving Individuals with Questionable Capacity to Consent

• NIH Bioethics Resources on the Web

• Office of Civil Rights (OCR)

• HIPAA-Health Information Privacy for Research

• Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule

• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

• World Medical Association’s Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

• Public Responsibility in Medicine and Research (PRIM&R)

• NIH National Human Genome Research Institute (NHGRI)

• President’s Council on Bioethics