An innovative therapy is a newly introduced or modified therapy with unproven effect or side effect, and is undertaken in the best interest of the patient. The ethical use of innovative therapies has been controversial. In paediatrics, the conflict between withholding potential rescue therapy and protecting a vulnerable population's rights and welfare must be considered. Therefore, it is necessary to ensure that this innovation is conducted within an ethical framework that recognizes that the therapy is not standard. This should integrate the patient's autonomy, the role of the institution, professional consensus and innovation evaluation. Innovative therapy represents a justifiable departure from inferior conventional therapy in the absence of an accepted standard therapy. Innovation shares with research its experimental nature, but differs from research in its goal and context that exempts innovative therapy from direct governance by research ethics board. Innovative therapy is part of the continuum of hypothesis generation in the advancement of medical knowledge, and its evaluation is a transforming point for clinical research.

Objectives: To assess a newly developed educational video about lumbar puncture (LP), in the parents' native language, tailored to their social background, and whether it facilitates their consent for LP. Methods: The randomized, controlled trial was conducted at outpatient pediatric clinics at a teaching hospital, Riyadh, Saudi Arabia. The conventional arm used LP verbal explanation. The second group utilized a standardized video with similar information. Parents' knowledge, perceived LP risks, and willingness to consent were measured, before and after the intervention. Results: We enrolled 201 parents, with similar baseline characteristics. Both groups had an increase in knowledge scores, with Wilcoxon signed-rank test showing significant knowledge gains (Verbal Explanation: W=2693, n=83, P<0.001, and Video: W=5538, n=117, P< 0.001). However, the conventional verbal counseling resulted in more consistent knowledge gain (SD=14.5) as compared to the video group (SD= 18.94). The video group reported higher perceived risk (Mean 8.2, SD 3.59) than the verbal group (mean 7.12, SD 2.51). The less-educated parents perceived higher LP risk after watching the video (P< 0.001). Conclusions: LP video education in parents' native language is as effective as conventional verbal education for the informed consent, with the additional advantage of reproducibility and more illustrations. While videos could facillitate remote procedural consenting process during infectious disease outbreaks; however, this should be followed by direct verbal interaction with parents, to ensure their full understanding and address any further concerns.