Human Subjects Research: Policy & Process
Policy | Stamp Policy | Process | Reporting Adverse Events
Union University, in accordance with its Multiple Project Assurance (MPA) filed with the Department of Health and Human Services, and 45 CFR part 46 establishes the Institutional Review Board for the Protection of Human Subjects (IRB).
Charge of the Committee
The IRB is responsible for reviewing research involving human subjects to ensure that such research is consistent with the principles of :
Scope of Review
All research involving human subjects must be submitted for review and approved by the IRB before it is initiated. The IRB reviews all research using human subjects regardless of funding source and regardless of whether the investigator is faculty, staff or student. Failure to comply with University policy may result in penalties (see Non-Compliance).
Definition of Human Subject
"Human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (Title 45 CFR 46.102(f)).
Definition of Research
"Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (Title 45 CFR 46.102(d)).
In accordance with 45 CFR 46, the IRB is required to report all instances of non-compliance to the federal Office for Protection from Research Risks, Washington, DC.
Additionally, non-compliance with this policy by faculty/staff members may result in one or more of the following:
Non-compliance with this policy by students may jeopardize awarding of the degree being sought.
Any application approved for research using human subjects will require that the approved consent form include a stamp from the IRB giving the protocol number and the date approved. This will ensure that the correct, approved version is being used. It will also serve as a reminder of when the protocol must be reviewed again.
The Principal Investigator determines that research will involve human subjects. The PI completes and submits an application to the Institutional Review Board (IRB) at email@example.com who then determines what level of review is needed (exempt, expedited, full) and initiates the appropriate review process for that level. The Institutional Review Board communicates the results of the review to the PI (exemption, approval, recommendations, etc).
PI provides progress report at the time of continuing review, which is due at intervals no less often than 12 months.
The IRB Office maintains record of all protocol approvals, disapprovals, continuing reviews, and other actions of the IRB, as well as Federal and institutional written policies and procedures.
Union University assures compliance of Federal regulations by all collaborators in human subject research.
The IRB shall report to appropriate University and federal government officials:
The report of the event should discuss:
These reports usually receive expedited review, but in some cases the full IRB is involved.The University's policies on adverse events are based on Food and Drug Administration regulations. According to the FDA, a "serious adverse drug experience" with respect to human clinical experience includes "any experience that suggests a significant hazard, contraindication, side effect, or precaution," including "any experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose." An "unexpected adverse experience" is any adverse experience whose nature, severity, and frequency of risk are not described in the information provided for IRB review or in the consent form. (See 21 CFR 312.32 [4-1-92])