Is required of all proposed research involving human subjects conducted by, or under the direction of, a Husson University investigator, using any property or facility of Husson regardless of location. Research proposals must be approved by the IRB prior to initiation of any activity and the research may not continue past its approved term. In no cases can the IRB approve a protocol for a period longer than one year and under no circumstances can retroactive approval be granted.
Is required to re-evaluate research projects at intervals appropriate to the degree of risk, but not less than once per year.
Modification or Amendments
To research, including changes in recruitment and the consent form, must be approved by the IRB. Approval must be obtained prior to the implementation of any changes.
Report of Adverse Reaction or Event
Must be reported to the IRB; this includes all unexpected incidents or adverse events or harms caused to research subjects by reason of their participation in the research program. FDA regulations require investigators to notify the IRB when they deviate from the approved protocol in order to protect the life or physical well-being of a subject in an emergency.