Institutional Review Board (IRB)

We strive to ensure 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清单 开始吧.
   1. Each research team member must electronically sign the protocol before it can be submitted for review.
   2. Before review, all protocols require approval from the department/division chair or dean.
2. All forms and templates can be found below under the IRB形式 header. Please use only SU-provided forms to avoid delay.
3. All PIs, Co-PIs, and 教师顾问 must complete Collaborative Institutional Training Initiative (CITI) Program training before the Institutional Review Board will approve any protocol. CITI training should be completed before submitting a protocol for review. CITI Training is valid for three years following successful completion of 要求 modules. 
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 the subject population can easily read, 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 in the second person (e.g. 你，你，你的).
6. The completed protocol application must include anything being used to gather data from participants, 如:
   1. 调查,
   2. 问卷调查、
   3. 评估,
   4. 作业,
   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 in the initial submission, which will delay the review process.
8. The protocol must include all recruitment materials, 如:
   1. 广告,
   2. 传单,
   3. 电子邮件邀请,
   4. letter invitations, 
   5. and other relevant recruitment materials
9. If you are conducting research at a non-SU site, permission is 要求 from each site on their letterhead and signed by the site facilitator, 学校校长, school superintendent, 等. before approval will be granted.
10. Only electronic submissions in Sitero 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 Sitero 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 from the IRB. 在大多数情况下, 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.

All primary 调查人员 (PIs), Co-PIs, 教师顾问, and department/approving chairs of PIs planning to conduct studies are 要求 to attain Collaborative Institutional Training Initiative (CITI) certification in Human Subject Research. Certification information is kept on file per compliance regulations and accessed when a protocol is submitted. Certification needs to be renewed every 3 years. A 帮助文件 for registering and enrolling in CITI courses is available through the Center for Teaching, 学习, 及科技(ctlt@softqatest.net). 

To complete CITI Certification:

1.     看到 Completing CITI Certification or CITI Certification Renewal 帮助文件启动.
2.     访问 www.citiprogram.org.
3.     Be sure to save your CITI registration information for future reference.
4.     To complete your certification, click the Main Menu and follow the instructions.
5.     When you complete the course, save your certification for your records.
6.     Your certification information will be accessed automatically by Sitero when you submit a research protocol.

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

• IRB清单2018
• IRB决策图
  • The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), 调查人员, 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 健康 and Human Services (HHS) regulations at 45 CFR part 46. 
• Application for Use of Human Subjects in Research SAMPLE (example; questions must be answered online in Sitero Mentor) 
• Informed Consent Revised July 2022
• Minor Assent Template Revised July 2022
• Survey Consent Template July 2022
• Electrical Equipment 安全 Check Memo July 2022
• Request for Amendment Form C July 2022
  To request an amendment/modification to previously approved protocols, complete this form and upload it to the Amendments tab of Sitero 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: Karen Abraham, Beth Rogers (Compliance Coordinator)

Arts and 科学: Scott King, Kim Newberry, Kim Orrell

教育 & 领导: Sarah Daniel, Karen Huff

Business: Clifford Thies

Conservatory: Anthony Meadows

Community: Polly Porter, PA-C

Nursing:  Melissa Dixon

Pharmacy: Sean Kim, Katerina Petrov

健康 Professions: Lindsay Carroll, 摩根运气, Kim Pritchard (Interim IRB Co-Chair), Morghen Sikes (Interim IRB Co-Chair)

IRB的时间表

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

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

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

IRB相关连结

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

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

• HHS: Expedited Review Categories

• Guidelines on the Inclusion of Women and Minorities in Research

• Inclusion of Children in Research

• Research Involving Individuals with Questionable Capacity to Consent

• Office of Civil Rights (OCR)

• HIPAA-健康 Information Privacy for Research

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

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

2023 IRB手册