IRB Policies and Guidelines

TypeTitleDescriptionDate Approved
Policies, GuidelinesReview of Research Involving Human SubjectsAppalachian's policy (policy #209) on Review of Research Involving Human Subjects.01/27/2025
Human Subject Research RecruitmentAppalachian'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 SettingProvides Appalachian's guidelines for investigator qualifications to perform biomedical research techniques, including a competency assessment.06/25/2014
 Guidelines:  VO2 Max TestingProvides 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 ProceduresSOP#1: Determination of Activities that Need IRB ReviewTo 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 ReviewTo describe the procedures for conducting an initial review of human subject research.07/06/2022
SOP#3: Continuing Review of ResearchTo describe the procedures for conducting continuing review of human subject research.01/21/2019
SOP#4: IRB Review of Modifications and AddendumsTo describe the procedures for conducting reviews of modifications and addendums for approved human subject research.07/06/2022
SOP#5: Expedited Review of ResearchTo describe the procedures for conducting expedited review of human subject research.01/21/2019
SOP#6: Full IRB Review of ResearchTo describe the procedures for conducting full review by the Institutional Review Board (IRB).09/15/2014
SOP#7: NoncomplianceTo 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 ProblemsTo 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 ProcessTo describe the policies and procedures for determining what human subject research activities are considered exempt10/07/2021

SOP#10: Post-Approval MonitoringTo describe Post-Approval Monitoring (PAM) selection procedurs, monitoring, and follow-up education.01/21/2019
SOP#11: Human Subjects Research Subject to FERPATo 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 ConsultantsThis 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 sIRBThis 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
that apply to clinical trials are described below. Appendices to this document provide resources
for researchers and IRB staff regarding clinical trials 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