This manual outlines the research protocols for human subject research at American Public University System
Scope of Research Subject to IRB Approval
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- TRAINING: Collaborative IRB Training Initiative (CITI) Training
- Research Involving APUS Staff, Students, and/or Faculty
- Working With De-Identified Data Not Collected Through Interaction or Intervention
- IRB Considerations for Class Activities
- Student Research Requiring IRB Approval
- Program Improvement, Assessment of Quality Improvement Studies
- Research Exempt from IRB Review
Scope of Research Subject to IRB ApprovalHuman subjects research at APUS, requires IRB approval. If the research is not being conducted at APUS and does not involve APUS students or resources, but involves human subjects outside the institution, the determination of whether IRB approval is required shall be decided by the IRB Chair or their delegate. For example, if the investigator is an employee of APUS and a graduate student at another institution where research is being conducted, the IRB Chair or their delegate should be notified of such activity to determine if APUS IRB approval is needed. TRAINING: Collaborative IRB Training Initiative (CITI) TrainingAPUS requires all IRB applicants undergo CITI training PRIOR to submitting their IRB application. Proof of successful completion of the Social and Behavior Research Investigator Modules is required. Research will not be approved until the training requirements are met. Documentation of training must be provided to the IRB Office with all new applications. Research Involving APUS Staff, Students, and/or FacultyAny research that involves APUS staff, students and/or faculty must secure not only IRB approval, but also approval from the Internal Research Review Board (IRRB). Researchers interested in conducting research at APUS must complete the “Request to Conduct Research” application. The application should be submitted by the principal investigator. NOTE: There are two different IRB Applications, one for students and one for faculty and staff (see Appendix B for both). If the proposed research is being done as part of a dissertation or advanced course work, the dissertation chair or lead faculty member must sign the form. Contact research@apus.edu for the application. Working With De-Identified Data Not Collected Through Interaction or InterventionThe OHRP has several decision charts designed to provide guidance regarding whether or not obtaining and analyzing data should be considered human subjects research (http://www.hhs.gov/ohrp/index.html). If you are not obtaining either identifiable private information or data through intervention/interaction with living individuals, then the research activity does not involve human subjects. If your data falls under this category, please read the following document: Guidance on Research Involving Coded Private Information or Biological Specimens. Based on this, if you believe your study is NOT human subjects research, but would like to be sure, please contact the IRB for official determination. Be aware that identifiable private information is not limited simply to names or student ID numbers, etc., but also includes circumstances under which data can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. IRB Considerations for Class ActivitiesResearch conducted as part of an in-class assignment is to be considered generally exempt from IRB review. The purpose of an IRB is to review research conducted using human subjects. For the purposes of APUS’ IRB, research is defined as being both: 1. Systematic 2. Generalizable Most in-class projects where research is conducted using human subjects are not systematic or generalizable. Systematic research includes research development, testing, and evaluation, and it is designed to create generalizable knowledge. Generalizable knowledge involves the creation of new knowledge that may be the basis for scholarly publication. In general, if the project is meant to complete an assignment for a class and will not be published, it does not require IRB review. Please note: IRB approval cannot be provided retroactively. If a student believes that he/she will want to use the data for from the project for research purposes, then he/she should seek IRB approval prior to undertaking the research. A student who does not secure IRB approval for the class project, but who wishes to present their project to their course or colleagues, can do so as a classroom research project, but not as a research study. Making the data from the project public via a blog, conference presentation, etc. does however, constitute a research study. Student Research Requiring IRB ApprovalAll human subjects research requires IRB approval, whether it is conducted by APUS faculty, staff, or students. If you are a student and your study requires your advisor’s approval, IRB approval should only be sought after your advisor has approved your research. It is the responsibility of the student investigator AND the Faculty Advisor to ensure appropriate human subjects protection. In order to assure sufficient oversight of student research, IRB proposals from students must include the signature of the faculty advisor. Program Improvement, Assessment of Quality Improvement StudiesStudies and surveys that have limited generalizability may be exempt from IRB review. For example, surveys conducted by the University for internal improvements to programs or services are generally exempt. However, IRB approval may be required if those results form part of a larger research project that will be shared beyond the University. Research Exempt from IRB ReviewCertain types of research protocols may be exempt from review. The IRB is authorized to decide, consistent with applicable federal laws, guidelines and regulations, whether research protocols may be exempt from review or subject to limited or full review. If you believe your research falls into the exempt category, complete the IRB form and submit it via this website to Office of the IRB. If the project is exempt, the IRB will notify you. NOTE: Exemption categories DO NOT APPLY when the research activities include: - Vulnerable populations such as prisoners, fetuses, pregnant women or human in-vitro fertilization;
can be identified, directly or through identifiers linked to the subjects; - Survey or interview techniques which include minors as subjects; - Techniques which expose the subject to discomfort or harassment beyond levels encountered in daily life; - The deception of the subject. Federal categories of research activities eligible for exemption certification are as follows:
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