Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:

Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:

A. They only involve changes to the consent form.

B. The changes must be immediately implemented for the health and well-being of the subject.

C. They are eligible for review using expedited procedures.

D. The investigator keeps careful records of all changes and includes them in the final report.

Answer: B. The changes must be immediately implemented for the health and well-being of the subject.

In general, any modification to the protocols approved by the IRB needs the approval of the IRB so that the human subjects’ rights are protected as and when required. However, there is one crucial caveat when subjects’ health can become a risk when testing is delayed owing to the necessity to obtain proper approval. In such emergent circumstances, a researcher can enact alterations without necessarily seeking the permission of the IRB since the consideration of participants’ safety is paramount. For instance, if in the middle of the clinical trial, the researchers found that people receiving a tested drug experience dangerous side effect, they may have to change the drug’s dosage for some people or stop treatment with the drug altogether for some patients. In this case, waiting for the approval of the IRB is also disadvantageous to the participants; therefore, urgent action is required. An example might be in a psychological assessment of a patient where the latter displays symptoms of severe anxiety or thoughts of self-harm. This may occasionally require the researcher to diverge from the stipulated procedure to offer assistance or refer the person to a mental health professional. However, it is worth to know it that this movement in emergencies may be made without seeking the IRB’s approval because these changes are considered as the freedom of the researcher to make any changes the way he or she wants it to be done but it should be reported to the IRB as soon as possible, preferably within 24-48 hours. The submitting party will subsequently explain each change to the IRB where the IRB will then review the report and the determinations made and see whether the changes were proper, and in the process, decide whether or not further alterations to the protocol can be made. This exception is justified as necessary since on one hand the use of human subjects requires scrutiny and on the other participant’s safety and well-being have to be taken into consideration.