Frequently Asked Questions
1. How do I access IRB Manager?
To access IRB Manager, login to your MY RU portal. If you are a faculty/staff member, click on your "Employees" icon. If you are a student, click on your "Academics" icon. From here, click on "IRB Manager Protocol Submission System".
2. Can I upload a protocol from Info Ed into IRB Manager?
No. However, you may contact someone in the Research Compliance office and they can upload it for you. You will need to provide the protocol number from your original approval letter (e.g., "FY19-001").
3. How do I add a contact or personnel to IRB Manager?
On the IRB Manager Dashborard, click on the "Contacts" tab and the select "New Contact".
4. How do I request a modification?
On the IRB Manager Dashborard, click on the active protocol that you would like to make a modification to. Then select "Start X-Form". Following this, select "Option for modifications and continuations".
5. How do I know when to submit a project to the IRB and what type of IRB protocol review to apply for?
Projects need to be submitted to the IRB for review when research involving human interaction is about a person or group, and includes a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102.d).
For a detailed breakdown of whether your research may require IRB review or at what review category it should be submitted, please see the OHRP Human Subjects Regulations Decision Charts. Please note that all Exempt studies MUST be submitted to the RU IRB for review. For further information, please contact the IRB Office at 540-831-5290 or firstname.lastname@example.org.
The Radford University IRB website also provides information about each review category and what type of research falls under each category. It further provides information about classroom exercises. The IRB Application form also contains additional information and also includes a logic flow near the end of the application to help you with this determination.
6. I can’t figure out my CITI training password/login information. Where can I find this?
On the CITI Training Program webpage, under the login information boxes, there is a link entitled “Forgot login information”. Follow the directions provided to receive an email with your login information. If CITI Program cannot find your login information after entering in the requested information, you may have taken your training from another source (NIH or WebCT, etc.) NIH also has a link on their website for you to request your login information, but WebCT does not and you will need to retake your training if you cannot locate your WebCT training certificate.
7. Where can I find information about writing informed consent documents for participants?
Several templates have been uploaded to the Radford University IRB Website. You may use these to help you develop your consent form and in deciding what information should be included to be presented to the participant.
8. Do I need informed consent for an online survey?
It depends on the nature of the research. Exempt research does not require consent. However, many researchers choose to provide all of the elements of appropriate informed consent in Exempt research.
Expedited or Full Board online survey research may require completion and receipt of signed informed consent documents prior to completion of the survey research if the nature of the research is sufficiently sensitive.
However, at minimum in most cases of online research, the participants are provided with sufficient information to address all of the elements of informed consent as provided in the online survey template, Cover Letter for Internet Research, either in the introductory email or in the first page of the survey, and provide consent by clicking on "I agree", "Continue", the survey URL, or similar.
However, a separate consent form does not need to be stamped by the IRB Office or signed by the participants for most online surveys. Instead, the consent information is typically uploaded as part of the survey or as a separate document in the project’s submission package and approved as part of the IRB review process.
The online or emailed consent information does NOT have to be on Radford University letterhead but the Radford University logo should be included appropriately in the document.
9. Why do you need my old consent form when continuing an Expedited or Full Board submission?
Both the new and potentially revised consent form(s) along with the previously approved and stamped consent form(s) must be uploaded to a Continuation package when the researchers intend to continue enrolling new participants, thus obtaining consent from new participants, in the new approval year. Both are required for direct comparison of any changes made between approval years.
10. Do class projects require IRB submission and review?
Projects that fall under the category of “Classroom Exercises”, which are specifically for teaching research methodology with no intent of presenting the results of data collection, do not require IRB submission. Any class project that is conducted with the intent to present the results (apart from the Radford University Student Engagement Forum or Masters of Social Work Poster Presentation) requires IRB submission and review.
11. Can I upload a resume instead of a CV?
12. How long does my human subjects training last?
All Human Subjects Training expires 3 years after the completion date at Radford University. At that point, additional training is required prior to conducting any further research involving human subjects.
13. When do IRB protocols expire?
Only Full Board and Expedited protocols have an expiration date. Those protocols expire one year following the issued approval date. Exempt submissions do not expire.
14. Do Exempt protocols need to be renewed each year?
No. As long as a protocol remains Exempt it will not expire, and will not require any form of continuation. However, if it is modified or amended (via the Request for Modification Form) sufficiently to elevate the submission to Expedited status, it will then require renewals, as would any other Expedited submission that is not closed prior to its anniversary date of approval.
15. I'm an RU employee enrolled at another university to complete a degree and I will be completing a project involving human subjects research that will be approved by the other university. What, if anything, do I need to do to satisfy any RU requirements for this project, given that I am an RU employee?
Because you are employeed by RU and involved in human subjects research (which technically makes you an "agent" of RU even though the research isn't being conducted through or even with RU), you will need to submit your approved materials from your degree-seeking university to the RU IRB for review.
Please upload all of the approved materials that you submitted to your university's IRB including the Approval or Exemption letter that you received from them. The IRB Office will review it and contact you either for any more information that might be required or with approval information that tells you that you may being your project.
16. I want to conduct human subjects research at Radford University but I attend another institution and do not work at or have any other formal affiliation with RU. Do I need to have my research project approved by Radford University before beginning my project at or with RU students or personnel? And if yes, how do I go about getting it approved?
All research projects approved by an outside institution that is intended to be conducted at RU needs to be at least reviewed by the Radford University IRB Chair and Institutional Official. Please send all of your approved IRB materials, including approval letters and all approved submission forms and other documents, to the IRB Administrator at email@example.com.
Please also include a brief summary of your project, when you wish to complete it, and other pertinent details about your project. Please allow sufficient time prior to the desired implementation date for this review and possible full review by Radford University's IRB.