IRB Policies and Guidelines

Policies, Guidelines Description Date Approved
Review of Research Involving Human Subjects Appalachian's policy (policy #209) on Review of Research Involving Human Subjects.  5/18/2010
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. 7/9/2012
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 3/25/2013
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. 6/25/2014
 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   Date Approved
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. 4/3/2012
SOP#2: Initial Review To describe the procedures for conducting an initial review of human subject research. 08/15/2012
SOP#3: Continuing Review of Research To describe the procedures for conducting continuing review of human subject research. 8/15/2012
SOP#4: IRB Review of Modifications and Addendums To describe the procedures for conducting reviews of modifications and addendums for approved human subject research. 11/23/2015
SOP#5: Expedited Review of Research To describe the procedures for conducting expedited review of human subject research. 9/15/2014
SOP#6: Full IRB Review of Research To describe the procedures for conducting full review by the Institutional Review Board (IRB). 9/15/2014
SOP#7: Noncompliance To 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 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. 1/7/2013
SOP#9: Exempt Review and Determination Process To describe the policies and procedures for determining what human subject research activities are considered exempt

3/25/2013

Contact

Director of Research Protections
Robin Tyndall
828-262-2692
tyndallrs@appstate.edu

Assistant Director of Research Protections
Monica Molina
828-262-4060
molinamm@appstate.edu

Assistant Director of IACUC and IBC Programs
Shante' Mathes
828-262-2901
mathessc@appstate.edu

Compliance Coordinator
Dennis Gabriels
828-262-2721
gabrielsdl@appstate.edu

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