Tips of the Week

Did you know…

…that the Institutional Review Board (IRB) may suspend or terminate research if the information, gained during the monitoring or auditing process, indicates the human subjects of a research project were exposed to unexpected serious risk or harm, or that the policies of the IRB were not met? [IRB Policy II.A]

Did you know…

…that audits may be conducted at non University of Arizona sites where the U of A IRB serves as the IRB of record? [IRB Procedure II.A.1]

Did you know…

…that conditions may exist in which the IRB requests additional information from the Investigator in order to determine if a change in the risk/benefit ratio has occurred, or if the potential areas of non-compliance exist in a currently approved research protocol? In this circumstance, the IRB Committee, IRB Chair or his/her designee may place specific research activities on suspension until a determination can be made. [IRB Policy II.B]

Did you know…
…that notification of suspension by a sponsor “unrelated to risk” must be submitted to the IRB for review and acknowledgement? [IRB Policy II.B]
Did you know…
…that the IRB will notify the Investigator in writing of the Committee’s determination of suspension? The letter will include an explanation regarding the rationale for the suspension. [IRB Policy II.B]
Did you know...

...that the goals of the IRB in investigating and managing issues of potential noncompliance include (1) Ensuring the safety of human subjects, (2) Developing action plans to prevent reoccurrence and promote future compliance, (3) Educating research staff to ensure they understand the FDA and OHRP guidelines and regulations and HSPP policies and procedures and, (4) Reporting serious or continuing noncompliance? [IRB Policy II.C]

Did you know...
...that findings of serious or continuing noncompliance with 45 CFR 46 and 21 CFR 50 and 56, or the requirements of determinations of the IRB will be reported to the full Committee who will then make a determination and/or recommendation? [IRB Policy II.C]
Did you know...
...that notification of serious or continuing noncompliance will also be forwarded (when applicable) to the Office of Research Contract Analysis, the Office of Sponsored Research, the Faculty Advisor and the appropriate institutional officials at external sites where the University of Arizona IRB serves as the IRB of record?  [IRB Policy II.C]
Did you know...
...that the Director of the Human Subjects Protection Program will promptly notify regulatiory authorities such as the Officecfor Human Research Protections, the Food and Drug Administration, the National Institutions of Health and the Veterans Administration central office or other federal sponsoring departments or agencies of any determinations of serious or continuing noncompliance?  [IRB Policy II.C]
Did you know...
...that the IRB may require whatever additional protections it deems necessary to safeguard the rights and welfare of participants?  [IRB Policy II.C]
Did you know...
...that instances meeting the definition of "research misconduct" will be reported to the Research Integrity Officer by the Director of the HSPP?  [IRB Policy II.C]
Did you know...
...that an example of research misconduct includes attempts to unduly influence and IRB Committee Member or IRB staff?  [IRB Policy IIC]