Another issue to consider in scheduling planning is that project approval will likely not be granted outright. Upon review, the IRB may determine that certain changes are required in order to obtain approval. These could include recommended changes to the protocol, consent document, data collection sheet, etc. The investigator will need to respond to the IRB’s suggested revisions in writing and resubmit the materials for review by the IRB.
It is the responsibility of the investigator to maintain IRB approval at all times. This means that continuing reviews must be submitted in a timely manner to avoid a lapse in approval. All study amendments must be submitted for approval prior to their implementation. Protocol deviations or violations and adverse reactions must be reported.
It is important for oncology fellows to communicate with their local IRB office. The IRB staff can review materials (such as study protocols, consent forms, etc) prior to the formal submission to the full IRB committee and can provide answers to many questions. This can save investigators valuable time and avoid aggravation in the long run.
Breaches in compliance can lead not only to bad headlines in newspapers, but also a suspension of all federally funded research at the institution. The ultimate responsibility for the protection of human subjects in research rests with the investigator and is congruent with the declaration in the Hippocratic Oath to “Do no harm.”
The primary mission of the IRB is to protect human subjects. But it is important to note that in so doing, they can serve as a resource and can also protect investigators who are conducting the studies.
Nancy Fell Hill, MPH, is a New Jersey– based research administrator and freelance author. She has more than 10 years of experience working with IRBs in both a hospital setting and a large university.