Institutional Review Board (IRB)

Tips for Submitting a Successful Protocol:

We strive to make sure every researcher has a good experience with the IRB. We want your application to be successful from the start and have developed the tips below to assist you in writing and submitting a successful IRB application.

1. Start early and submit early!  During particularly busy times of the semester (the beginning and end of semesters are always busy times for IRB submissions) or during campus breaks, it may take longer for an approval to come through, so plan ahead and be sure to get your protocol submitted as soon as possible.  Refer to the timetable below and the IRB Checklist.
2. All PIs, Co-PIs, and faculty sponsors are required to complete CITI training prior to the Institutional Review Board granting approval for the protocol.  It’s recommended that CITI training is completed before the protocol is submitted to the IRB for review.  CITI Training is valid for 3 years following successful completion of required modules.  We no longer accept NIH training and all PIs and Co-PIs must complete CITI training prior to protocol approval.
3. Use this IRB site as your only source for application forms, as it will always house the most current forms.
4. Answer all questions on the forms and provide complete and detailed information.  Please type your responses, as handwritten forms are not accepted.  
5. Clearly describe the consent/minor assent process. A copy of the consent form must be included in your submission. If no consent form is to be used, clearly document the procedures to be used to protect human subjects and request a waiver of informed consent (note: this scenario is rare).  The consent form must be written in language that can easily be read by the subject population and any use of jargon or technical language should be avoided.  It’s suggested that it should be written at no higher than an 8th-grade reading level and should be written in the second person.
6. The protocol must include anything being used to gather data from participants, such as surveys, questionnaires, assessments, assignments, interview questions, focus group questions, electronic safety check memos, etc. Submissions will be considered incomplete if all documentation is not included on initial submission, which will delay the review process.
7. The protocol must include all recruitment materials, such as advertisements, flyers, email invitations, letter invitations, etc.
8. If you are conducting research at a non-SU site, permission is required from each site on their letterhead and signed by the site facilitator, school principal, school superintendent, etc. before approval will be granted.
9. Do not begin your research until you receive approval from the IRB office.
10. Only electronic submissions in Axiom will be accepted.  All other paper or emailed versions will automatically be returned to PI’s to submit electronically.
11. Please only submit complete protocols.  If you cannot submit all documents and information at the same time, please wait until you can submit all at once.  If not, you will receive a notice requesting additional documentation and the IRB will consider the protocol incomplete.
12. Student protocols will not be reviewed until the faculty advisor has approved the submission in Axiom. Advisors will be electronically notified of the submission and are responsible for timely acceptance/denial. 

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
• Application for Use of Human Subjects (Form B) Revised 2018 (example; questions must be answered online in Axiom Mentor) 
• Informed Consent Template Revised 2018
• 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