| 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. | 05/18/2010 |
|---|
| Payments to Human Subjects | Appalachian'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. | 07/09/2012 |
| 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 |
| Principal Investigator (PI) Responsibilities | Provides a description of the PI's responsibilities when conducting human subject research | 03/25/2013 |
| 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 |
