1. 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.
2. I placed my documents into IRBNet, but I haven’t gotten a response from the IRB Office about my submission. What happened and what should I do?
Initial Reviews (also called "pre-reviews") are generally conducted within 3 business days. Please contact the IRB Office if you haven't received comments by the end of this time.
One of three possibilities may have occurred:
1) You forgot to submit the initial package in IRBNet. Select “Submit this Package” from the left hand menu of your selected protocol in IRBNet. An email will then be sent to the IRB Office indicating that a protocol is ready for review.
2) You have received reviewer comments and made changes but forgot to relock the package. Select “Mark Revisions Complete” from the upper right hand corner of the Designer page in IRBNet. An email will then be sent to the IRB Office indicating that a protocol is ready for review.
3) You have submitted or relocked the package appropriately but have received no notification of a pre-review or review. Contact the IRB Office and inform them of the situation.
3. I completed my human subjects training over a year ago. Why can’t the IRB Office locate my certificate?
The IRB Office can only locate completed human subjects training through CITI Program and only then if you affiliated yourself with Radford University. You can affiliate yourself with Radford University within CITI Program. Please contact the IRB Office if you experience difficulties with this.
If your training was completed through another source (e.g., NIH or WebCT), the IRB Office will not be able to view your certificate electronically and may not be able locate a hard copy of your certificate. You will also need to upload your certificate to IRBNet with your submission.
Please see the Human Subjects Training page for information regarding NIH Human Subjects training.
4. 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.
5. I registered for IRBNet but it still isn’t allowing me to enter the site. Can the IRB Office fix this?
Once you have registered for IRBNet, you will be sent a confirmation email. You must click a link that is included in the email to finalize your registration process. Your login information will not work until this step has been completed. You may contact the IRB Office if you have questions, but the we can’t finalize your registration for you.
6. 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.
7. I made the requested revisions to my IRBNet submission during the pre-review / review process. How do I resubmit them?
Once revisions are complete, you must re-lock the package. To do so, select the “Designer” page on the left hand menu of your selected protocol’s screen. Then select “Mark Revisions Complete” from the top right corner of the Designer page. The review process will not continue if the protocol has not been re-locked. The IRB Office will receive an email notice automatically once you click on “Mark Revisions Complete”.
8. I need to make modifications to my approved project. How do I do this?
To request an amendment or modification to your protocol, you must submit a Request for Modification form (located on IRBNet) to the IRB Office by uploading it to your Project in IRBNet, along with any supporting documentation such as new recruiting materials or revised consent forms.
The form and any supporting documents are uploaded to IRBNet in the form of a new Package (the IRBNet ID number will have a "-2" or higher at the end of it for the new Package) within your Project (which has the "-1" suffix at the end of it's IRBNet ID number).
To create a new Package for your project, select “Project History” from your desired protocol in IRBNet and click on the “Create New Package” button in the middle of the resulting webpage.
Once all of the desired documents have been uploaded to this new package, you may sign the Package and submit as usual.
Please remember that additions of new personnel require the inclusion of their CV/resumes and their completed Investigator Agreements (located on IRBNet).
Also, please name the individuals to be added (or deleted) and describe their roles and duties on the project in the amendment form, e.g., it is not sufficient to say "adding new 2013/2014 graduate students."
For more instructions on to how to submit an amendment to IRBNet, please see our IRBNet How To's page.
9. 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.
10. 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.
11. 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.
12. Can I upload a resume instead of a CV?
13. Why am I getting expiration notices on my protocols?
60 and 30 days prior to the expiration date, IRBNet will send automated messages informing the PI of the upcoming expiration of their Expedited or Full Board protocols. The expiration date is 1 year following the issued approval date. At that point, any expired protocol must have a continuation request approved by the IRB or the research must stop.
If you feel you are receiving these notices in error, please contact the IRB Office.
14. 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.
15. 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.
16. 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.