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. Refer to the timetable below and the IRB Checklist to get started.
   1. Each member of the research team must electronically sign the protocol before it can be submitted for review.
   2. All protocols require approval from the department/division chair or dean prior to review.
2. All forms and templates can be found below under the IRB Forms header. Please use only SU provided forms to avoid delay.
3. All PIs, Co-PIs, and faculty advisors are required to complete Collaborative Institutional Training Initiative (CITI) Program training before the Institutional Review Board will grant approval for any protocol. CITI training should be completed prior to submitting a protocol for review. CITI Training is valid for 3 years following successful completion of required modules. We do not accept NIH Research Ethics training certificates.
4. Clearly describe the informed consent (and/or minor assent) process. A copy of the informed consent form (and/or minor assent form) must be included in your submission. If informed consent will not be obtained, clearly document the procedures that will be used to protect human subjects and request a waiver of informed consent (note: approval of an informed consent waiver is rare).
5. The informed consent form must be written in language that can easily be read by the subject population and the use of jargon or technical language should be avoided. It is suggested that the informed consent form should be written at no higher than an 8th-grade reading level and should be written in the second person (e.g. you, your, yours).
6. The completed protocol application must include anything being used to gather data from participants, such as:
   1. surveys,
   2. questionnaires,
   3. assessments,
   4. assignments,
   5. interview questions,
   6. focus group questions,
   7. electronic safety check memos, 
   8. and other relevant documentation 
7. Submissions will be considered incomplete if all documentation is not included on initial submission, which will delay the review process.
8. The protocol must include all recruitment materials, such as:
   1. advertisements,
   2. flyers,
   3. email invitations,
   4. letter invitations, 
   5. and other relevant recruitment materials
9. 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.
10. Only electronic submissions in Axiom Mentor will be accepted. All other paper or emailed versions will automatically be returned to PIs to submit electronically.
11. Student protocols will not be reviewed until the faculty advisor has approved the submission in Axiom Mentor. Advisors will be electronically notified of the submission and are responsible for timely acceptance/denial.
12. Do not begin your research until you receive approval the IRB. In most cases, an official stamped and approved copy of the informed consent form will be emailed to the PI. The stamped and approved copy of the informed consent form should be the only copy provided to potential subjects and participants.

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 or CITI Certification Renewal 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 1/2020)
• Minor Assent Template (revised 2018)
• Electronic Anonymous Survey Consent Template (revised 1/2020)
• 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, Beth Rogers (Compliance Coordinator)

Arts and Sciences: Veronyka James, Scott King, Kim Orrell

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: Solomon Adams, Katerina Petrov, Ranjani Varadarajan

Health Professions: Rachel Carlson, Alicia Lutman, 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)

• NIH Department of Bioethics