IRB Policies and Guidelines

TypeTitleDescriptionDate Approved
Policies, GuidelinesReview of Research Involving Human SubjectsAppalachian's policy (policy #209) on Review of Research Involving Human Subjects. 5/18/2010
Payments to Human SubjectsAppalachian's policy (policy #210) on payment methods and amounts to participants in human subjects research.  Note: Special Funds Accounting, and not the IRB, is responsible for this policy.7/9/2012
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
Principal Investigator (PI) ResponsibilitiesProvides a description of the PI's responsibilities when conducting human subject research3/25/2013
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.6/25/2014
 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.1/21/2019
SOP#2: Initial ReviewTo describe the procedures for conducting an initial review of human subject research.1/21/2019
SOP#3: Continuing Review of ResearchTo describe the procedures for conducting continuing review of human subject research.1/21/2019
SOP#4: IRB Review of Modifications and AddendumsTo describe the procedures for conducting reviews of modifications and addendums for approved human subject research.10/24/2019
SOP#5: Expedited Review of ResearchTo describe the procedures for conducting expedited review of human subject research.1/21/2019
SOP#6: Full IRB Review of ResearchTo describe the procedures for conducting full review by the Institutional Review Board (IRB).9/15/2014
SOP#7: NoncomplianceTo describe the policies and procedures for reporting and addressing allegations of noncompliance.11/2/2012
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.1/7/2013
SOP#9: Exempt Review and Determination ProcessTo describe the policies and procedures for determining what human subject research activities are considered exempt1/21/2019

SOP#10: Post-Approval MonitoringTo describe Post-Approval Monitoring (PAM) selection procedurs, monitoring, and follow-up education.1/21/2019