Frequently Asked Questions
1. May I upload a protocol from Info Ed into IRBManager?
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").
2. How do I know when to submit a project to the IRB and what type of IRB protocol review to apply for?
DHHS regulations define research as "a systematic investigation, including research development, testing, and evaluation, utilizing human subjects, that is designed to develop or contribute to generalizable knowledge. To be considered research, the activity must be characterized by systematic investigation AND the primary goal is to 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 Radford University IRB for review. For further information, please contact the IRB Office at 540.831.5290 or email@example.com.
3. 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.
4. 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.
At a minimum, in most cases of online research, 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 within the first page of the survey. Potential study participants provide consent by clicking on "I agree", "Continue", the survey URL, or similar.
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.
5. Why do you need my old consent form when continuing a Full Board submission?
New AND potentially revised consent form(s) in addition to the previously stamped approved consent form(s) must be uploaded to a Continuation package when researchers intend to continue enrolling new participants in the new approval year. Both consent forms are required for direct comparison of any changes made between approval years.
6. Can I upload a resume instead of a CV?
5. Do Expedited and 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. Should you need to make changes in your protocol, you must submit a request for an amendment for review to determine if the application still remains in an Exempt review category before implementing the changes. Amendments must be submitted via IRBManager.
45 CFR 46.109(f)(1)(i) states a continuing review of research is not required for research eligible for Expedited review in accordance with §46.110.
Instead, the Radford University IRB requests the submission of a Three-Year Check-in for Exempt and Expedited projects.
If the project is modified or amended (via the Request for Modification Form) sufficiently to elevate the submission to Full Board review, the project will then require the submission of a continuation. Please contact the IRB office for assistance.
6. I am a Radford employee enrolled at another university to complete a degree and will be completing a project involving human subjects research that will be approved by the other university. As a Radford employee, is there anything I need to do to satisfy any Radford University requirements for this project?
Because you are employed by Radford University and involved in human subjects research (which technically makes you an "agent" of Radford even though the research is not being conducted through or even with Radford University), you will need to submit your approved materials from your degree-seeking university to the Radford IRB for review.
For more information, see IRB Reliance Agreements
7. 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 Radford University. Do I need to have my research project approved by Radford before beginning my project at or with Radford 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 Radford University 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 firstname.lastname@example.org.
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.