Research Protections

• You are required to list yourself and a faculty member.

1. Identify your Faculty Advisor as the Principal Investigator (PI).
2. List yourself under “Please select all study personnel affiliated with Appalachian State.”
3. OPTIONAL: Identify yourself as the primary contact, if you wish to be included in all correspondence sent by the IRB and the IRB Office. The option for adding a Primary Contact will become available after you answer “Yes” to the question “Do you want to identify a primary contact other than the PI?”

• You must also list the following people, in addition to yourself and the Faculty PI:

Anyone who will perform any of the below procedures must be listed on the IRB application under “Please select all study personnel affiliated with Appalachian State”:

1. Obtain informed consent from participants (this includes anyone who will administer the consent process, as well as anyone who is listed on the consent form);
2. Interact or intervene with participants;
3. Have access to identifiable private information or identifiable biospecimens.

All personnel listed on your application must complete the required CITI training before you will receive permission to begin the research.

• People who do NOT need to be listed on your IRB:

Anyone from your thesis committee who will not obtain consent, will not interact or intervene with participants, and will not have access to identifiable private information about participants.

If the only reason you are conducting this study is to obtain course credit or meet graduation requirements, then NO.

• Capstone projects and class assignments undertaken for the sole purpose of completing course requirements do not meet the federal definition of research, and do not require IRB approval. In these cases, the student researcher and faculty advisor are responsible for ensuring that the project is conducted ethically. This includes obtaining appropriate permission from participants to collect and use their data.
• You are allowed to upload NCDocks and submit it as supplemental material for any graduate school applications you might complete, without IRB approval. 
• You must never represent these research projects as having IRB approval when uploading or submitting them in these use cases.

Otherwise, please review this flowchart to help you determine if your project requires IRB review. Anything that meets the definition of human subjects research requires IRB approval or an official exemption determination prior to any involvement of human subjects (including recruitment procedures).

If you will be conductingresearch that involves human subjects, then you must obtain IRB approval or an official exemption determination prior to the involvement of human subjects in your research. Research (as defined under 45 CFR 46.102(l)) means a systematic investigation designed to contribute to generalizable knowledge. Human subjects (as defined under 45 CFR 46.102(e)(1)) means a living individual about whom a researcher (1) obtains information or biospecimens through interaction or intervention (including, but not limited to, online surveys, public observation, and in-person communication) and/or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 

Please review this flowchart to determine whether your thesis or dissertation project likely meets these definitions. Contact irb@appstate.edu with any questions about whether your project requires an IRB submission. Please remember that conducting human subjects research without the proper reviews and approvals from the IRB or the IRB Office is a violation of federal regulations and university policy, so it is very important that you obtain all required approvals from the IRB or IRB Office prior to involving human subjects in your thesis project.

You must wait for IRB approval or an official exemption determination before involving human subjects in your research. This includes, but is not limited to: recruitment procedures, consent procedures, and collecting or receiving identifiable information or biospecimens for the research. Involving human subjects in research prior to IRB approval or exemption constitutes non-compliance. 

 NOTE: If you have already involved human subjects in your research without receiving the required approvals, halt the research immediately and contact the IRB Office so that we can assess the situation and help you get back into compliance with University Policy and Standard Operating Procedures.

Please review this document for step-by-step guidance on submitting your student IRB application. For instructions on how to use Cayuse, review this document. Finally, a checklist of steps to take throughout the application and submission process can be accessed at this link.

When filling out an IRB application, it is essential to read all questions thoroughly and ask your faculty mentor for clarification if there is anything you do not understand. Thorough and consistent applications undergo a smoother and faster review process, as they require much fewer revisions following initial review. 

The IRB application does not need to be completed in one sitting. Applications that are not thoughtfully completed may have inconsistencies that require multiple rounds of revision, which can greatly extend the amount of time it takes for your application to be approved. 

The process of applying for IRB approval is an opportunity to understand your project more in-depth and from both a research and a human ethics perspective. The IRB application will ask you to provide information that you may not have thought about when proposing your thesis, but which is essential to consider in order to conduct high-quality ethical research. The process of applying for IRB approval or exemption will assist you in refining and improving upon your methodology and participant protection strategies.

• All personnel listed on your IRB application must complete CITI Training.

  • Note: If you are assisting a faculty mentor with research involving human subjects, you must be listed on the personnel table of the approved application before beginning research procedures with human subjects. CITI training is required before you will be permitted to assist your faculty mentor with the research.
• While CITI offers many different courses, we only accept the following: Biomedical Research Course (Basic or Refresher) and Social/Behavioral Research Course (Basic or Refresher). Once taken, the certification will be valid for three years.

Visit the IRB Training webpage for information about this required training, including a link to the CITI Program website.

• All surveys and questionnaires, including interview guides and observation guides (when applicable).
• All recruitment materials (including online and in-person flyers, email templates, in-person recruitment scripts, and follow-ups to initial contact, when applicable).
• Informed Consent Form or a Statement of Research (for exempt studies) document (see the Consent Corner webpage for templates).
• Debriefing document, if applicable.
• Data use agreements for secondary use of data, if applicable.

• Once your application is submitted it will go through the review process.
• For minimal risk research (i.e. exempt and expedited), you should expect to wait at least 2-4 weeks before you receive notice from the IRB office about the results of the first review of your study. This time range can be shorter or longer depending on the complexity of your study, the availability of staff, and/or seasonal fluctuations. If you do not hear back from the IRB office within 10-20 business days of initial submission or response to stipulations, feel free to email irb@appstate.edu with a request for a status update.
• After your initial submission has been reviewed, you will likely receive questions and requests for clarifications. Once you have resubmitted your application with your response and made the recommended changes, we will review the changes and either approve or exempt your project, or return it to you with additional questions. Please respond to requests for changes in a timely fashion to ensure minimal delays in the review process.
• We recommend submitting initial requests for IRB review or exemption at least 8-12 weeks before you wish to begin data collection. Please plan accordingly, especially if you have a strict timeline for data collection.

Vulnerable Populations

• If you are working with children, prisoners, and/or pregnant women you are conducting research on a vulnerable population. The federal regulations include additional protections specific to these populations.

Higher Risk Populations

Although, not a federal mandate, ASU’s IRB expects that researchers take additional precautions to minimize possible harm for the following populations:

• Individuals diagnosed with medical/psychological conditions;
• Victims of trauma (physical, sexual, emotional, etc.);
• Members of a stigmatized population;
• Cognitively impaired individuals;
• Student athletes;
• Any other populations that might be at higher risk of being harmed by participating in the study (or if a data breach occurs).

ASU has set up guidance on what data/identifiers should be protected and how it should be stored, please refer to this document if you are collecting any participant identifiers: https://security.appstate.edu/policies-standards-and-guidelines/secure-file-storage-and-sharing