Dr. Daneshmand began his talk by focusing on the various types of trials, reviewing their unique regulatory issues and IRB considerations. For instance, data analysis from an already established IRB approved database does not require additional IRB approval only a data request form, while specimen analysis from the same registry would require an additional expedited IRB. New chart review, similarly, typically require expedited IRB review, as would chart review with patient contact. On the other hand, new databases, with potential patient contact or specimen collection require a full IRB review which is associated with a longer approval process. For multi-institutional studies or collaborations, he briefly touched on data use agreements in addition to IRB review. Overall, throughout his talk, he highlighted how many of these requirements are institutionally specific and the need to develop a strong working relationship with your home IRB.
Dr. Daneshmand continued his talk by reviewing the essential steps for the initiation of a study. Following approval of the study, continued compliance and oversight are needed throughout the study conduct period. He highlighted that in clinical studies, clinicians have a dual role being both the physician and the investigator and that one needs to act in the best interest of the patient while still following the protocol to the letter. As the principal investigator, one is ultimately responsible for the study conduct and needs to verify the training of the team, accurate documentation, timely reporting and ensuring that the protocol is followed at all times. With that, Dr. Daneshmand went over the FDA form 1572, a legal document that the principal investigator signs to endorsing this commitment.
Informed consent was a specific area of focus. Dr. Daneshmand reviewed that consent should only be conducted by individuals listed on the delegation log and the IRB application. Documentation should include the following:
- Who was present (subject, individual conducting the consent, impartial witness IF patient doesn’t speak, hear or read English and interpreter is utilized, subject’s legal representation if applicable)
- Who described the study
- Whether the participant had time to ask questions
- Agreement to participate in the study
- That copies of the consent form were provided to the participant
- Date and Time
Adverse events reporting was the last major area covered by Dr. Daneshmand. Specifically, he reviewed expected versus unexpected events. An expected event is one for which the specificity and severity of the event are consistent with the information in the investigator brochure, protocol, or product label and unexpected results are all others. Further if during the course of the trial an adverse event becomes expected it is the responsibility of the investigator to update all content. All events should be documented and graded with a specific distinction between severe and serious complications. Dr. Daneshmand defined serious adverse events as those events that results in results in death, are life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity.
In conclusion, Dr. Daneshmand provided a succinct overview of navigating regulatory and IRB concerns. He finished his talk by focusing on the importance of these measures to prevent fraudulent reports and data fabrications, ensuring that the data that is reported is of the highest quality to drive improved patient care.
Presented by: Sia Daneshmand, MD, Associate Professor of Urology (Clinical Scholar); Director of Clinical Research, Department of Urology, Keck School of Medicine of University of Southern California
Written by: Adrien Bernstein, MD, Society of Urologic Oncology Fellow, Fox Chase Cancer Center, Fox Chase Cancer Center, Philadelphia, PA at the 20th Annual Meeting of the Society of Urologic Oncology (SUO), December 4 - 6, 2019, Washington, DC