| Type | Title | Description | Date Approved |
|---|---|---|---|
| Policies, Guidelines | Review of Research Involving Human Subjects | Appalachian's policy (policy #209) on Review of Research Involving Human Subjects. | 01/27/2025 |
| Human Subject Research Recruitment | Appalachian's policy (policy #216) on recruitment of human subjects for research, including when an external researcher seeks to recruit subjects at Appalachian. | 11/30/2012 | |
| Guidelines: Biomedical Research Techniques Performed in a Non-Clinical Setting | Provides Appalachian's guidelines for investigator qualifications to perform biomedical research techniques, including a competency assessment. | 06/25/2014 | |
| Guidelines: VO2 Max Testing | Provides Appalachian's guidelines for conducting VO2 Max tests on participants who are considered low risk for a cardovascular event per the ACSM guidelines. | 02/22/2013 | |
| Standard Operating Procedures | SOP#1: Determination of Activities that Need IRB Review | To describe policies and procedures for determining whether a project qualifies as human subject research or a clinical investigation and therefore requires prior Institutional Review Board (IRB) review and approval. | 07/06/2022 |
| SOP#2: Initial Review | To describe the procedures for conducting an initial review of human subject research. | 07/06/2022 | |
| SOP#3: Continuing Review of Research | To describe the procedures for conducting continuing review of human subject research. | 01/21/2019 | |
| SOP#4: IRB Review of Modifications and Addendums | To describe the procedures for conducting reviews of modifications and addendums for approved human subject research. | 07/06/2022 | |
| SOP#5: Expedited Review of Research | To describe the procedures for conducting expedited review of human subject research. | 01/21/2019 | |
| SOP#6: Full IRB Review of Research | To describe the procedures for conducting full review by the Institutional Review Board (IRB). | 09/15/2014 | |
| SOP#7: Noncompliance | To describe the policies and procedures for reporting and addressing allegations of noncompliance. | 11/02/2012 | |
| SOP#8: Unanticipated Problems Involving Risks to Subjects or Others, Adverse Events, and Other Problems | To describe the policies and procedures for identifying and reporting unanticipated problems, related or unrelated events affecting subjects, subject complaints, protocol deviations, or events involving risk. | 01/07/2013 | |
| SOP#9: Exempt Review and Determination Process | To describe the policies and procedures for determining what human subject research activities are considered exempt | 10/07/2021 | |
| SOP#10: Post-Approval Monitoring | To describe Post-Approval Monitoring (PAM) selection procedurs, monitoring, and follow-up education. | 01/21/2019 | |
| SOP#11: Human Subjects Research Subject to FERPA | To describe the procedures for applying the Family Educational Rights and Privacy Act of 1974, as amended ("FERPA") to human subjects' research that involves access to or the generation of student education records. | 01/22/2025 | |
| SOP#12: Participant and Local Context Reviews and Consultants | This document details Appalachian State University’s IRB’s standard for research with human participants’ review process involving consultants to assist in the review of a study where a local or participant “context” review may be needed to assess risks and benefits to participants. These requirements are designed to address contextual vulnerability of participants and/or regional contexts that must inform research design. | 02/18/2025 | |
| SOP#13: Cooperative Research and sIRB | This document details Appalachian State University’s Institutional Review Board’s (IRB) standard for multi-site or cooperative research involving participants. | 02/18/2025 | |
| SOP#14: Clinical Trials | This document details Appalachian State University’s IRB’s standard operating procedures for research with human subjects that also meet the criteria as a clinical trial. Studies considered clinical trials must comply with varying requirements that do not apply to other types of human subjects’ research. These requirements are designed to address the increased participant vulnerability and risks of many clinical trials compared with other research. The requirements | 04/25/2025 | |
| SOP#15: Closures and Transfers | This document details Appalachian State University’s IRB’s unit standard for research with human participants regarding approved protocol transfers and closures. The requirements in this document apply to studies qualifying for exemptions and studies deemed non-exempt. | 04/24/2025 | |
| SOP#16: Research Involving Incarcerated People | This document details Appalachian State University’s IRB’s standard for research with human subjects who are incarcerated. Studies involving people who are incarcerated must comply with varying requirements that do not apply to other types of human subjects’ research. These requirements are designed to address contextual vulnerability of participants who are incarcerated compared with other research. The requirements that apply to research with people who are incarcerated are described below. | 04/24/2025 |
