Research Protections

• If the only reason you are conducting this study is to obtain course credit or meet graduation requirements, then NO.
• Otherwise, please review this flowchart to help you determine if your project requires IRB review.

• You may only begin recruiting for your project after receiving IRB approval. If you recruit and consent human subjects prior to IRB review and approval this will constitute non-compliance.
• Refer to FAQ: “What happens after I submit my IRB application?” for expected review timeline. 

Please review this document for a detailed guidance on submitting your student IRB application.

• The CITI Program was founded in 2000 with the goal of providing researchers comprehensive education on how to conduct research in an ethical and legal manner. Appalachian State University is one of over 2,000 institutions who uses CITI as a training tool and upon course completion, you will be one of over 1,000,000 research personnel who has been CITI Certified.
• 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.
• Click here (https://www.citiprogram.org) to access the CITI website.
• For a visual guide to completing CITI see this guidance document.

• Research proposal/prospectus (if you have prepared one).
• All surveys and questionnaires, including interview guides (if applicable).
• All recruitment materials (including online and in-person flyers and email scripts).
• Informed Consent Form or Statement of Intent document.
• Letter of Agreement (LoA), if applicable. LOA’s are necessary for studies conducted off site. 
• Debriefing, Observation guide, and/or Data Use Agreement, if applicable.

• You are required to list yourself and a Faculty Advisor.

1. 1. List yourself as Principal Investigator (PI)
   2. List your Faculty Advisor (FA) as Faculty Advisor. Every student lead project requires a FA. 

• In addition to listing yourself and your FA on your Human Ethics (IRB) application, you must also list the following people:

1. 1. Anyone who will be consenting participants, interacting with participants, or has access to identifiable participant data, should be listed.
   2. They can be listed as research associates (RA). 

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

1. 1. Anyone from your thesis committee who will not interact with participants or have access to confidential information. 

• Once your application is submitted it will go through the review process.
• For minimal risk research (i.e. exempt and expedited), you should allow 2-4 weeks for the IRB to review your submission before you receive notice from the IRB office. This time range can be shorter or longer depending on the complexity of your study, the availability of staff, and/or seasonal fluctuations. Exempt requests tend to be processed relatively faster than non-exempt requests. Please plan accordingly, especially if you have a strict timeline for data collection. 
• 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.

Vulnerable Populations

• If you are working with children, prisoners, and/or pregnant women you are conducting research on a vulnerable population.

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
• Any other populations that might be at higher risk of being harmed by participating in the study (or if a data breach occurs).

The following chart provides some indication of how vulnerable your population may be.

• Anonymous Information is information for which the identity of individual subjects is not (and was never) known to researchers. Research involving written consent (even if consents cannot be connected/linked with data) is not considered anonymous.
• Confidential Information is information which could reveal the identity of participants, but is guarded against unauthorized access. If the consent documents and other potentially identifying information about the participant are kept separate from the data (preferably locked in a cabinet or in a password-protected file) and never disclosed, then the data can be considered confidential. 
• De-identified Information is data that had identifiers, but the research team has now removed all identifiers from the research. Any key which links subject numbers to participant names must be destroyed before your data can be considered de-identified.

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