Institutional Review Board (IRB)

What is the Risk 1 category? its risk and CSU review?

1- Risk: no positive or neg. physiological /psychological affects CSU review- chair and/or vice-chair of IRB committee

What is the Risk 3 category? its risk and CSU review?

Risk: moderate to substantial. Unusual discomfort as a result of research which would not typically be experienced in daily life; discomfort described as sever and long lasting CSU review: full IRB committee with at least 3 external members

What is the Risk 4-5 category? its risk and CSU review?

Risk: risk or certainty of damage-risk of causing permanent damage including both physiological and psychological harm CSU review: no research in either of these categories will be approved/ conducted

IRB review:

assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study

What must you complete before submitting an IRB proposal?

web based training course: protecting human participants

What is the Institutional Review Board?

-a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects.

What are the 4 CSU types of applications?

-application for exempted study -application for expedited study -student application to engage in course-directed human subjects activity -application for approval of research with human research participants

What is the IRB process?

-idea for research -develop research proposal- obtain grant monies -submit appropriate IRB application -recieve IRB approval-exempted, expedited -conduct research -changes to study design must be reviewed by IRB

What is the mission of the IRB?

Protection encouragement, education and promotion of research.

What is the Risk 2 category? its risk and CSU review?

Risk: minimal and temporary discomfort comparable to daily life CSU review: at least six IRB members and one external member (if available)

Who can submit to IRB?

faculty students

What faculty can submit to IRB?

full time, part time, and adjunct faculty conducting research involving human participants on (or off)) CSU campus

what students can submit to IRB?

graduate and undergraduate -includes research required for a course requirement, undergraduate thesis/ senior thesis, or master's thesis -all students MUST have a faculty supervision/ advisor who is responsible for student compliance with IRB policies and procedures