The 2020 revision of South Korea’s Personal Information Protection Act (PIPA) updated procedures for the use of medical data for research. The PIPA provision allowing “pseudonymized information” to be used without the consent of the data subject for scientific research introduced ambiguity regarding the applicability of the PIPA versus the Bioethics and Safety Act (BSA), which allows “anonymized information” to be used for research only after data-subject consent and IRB approval for human-subject research are obtained. The main points requiring clarification include the distinction between “human-subject” and “scientific” research, the definition of anonymization and pseudonymization, the requirements for data-subject consent, and the procedures for institutional review boards (IRBs) and data review boards (DRBs). After reviewing the legal concepts and processes, this article recommends clarification of the guidelines for the use of medical data in research by distinguishing the concept and, in the long run, categorizing medical data based on the degree of risk.

It is well-known that the peroxidase enzyme catalyzes the oxidation of different substrates such as 3,3’,5,5’-thetramethylbenzidine, and 3,3’-diaminobenzidine, however, the affinity of different substrates to the enzyme and consequently and catalytic performances of the enzyme toward different substrates is not same, resulting in different kinetics indexes. As the BSA-gold nanozymes are considered artificial peroxidase enzymes, hence, the kinetics indexes of these nanozymes should also be varied by varying their substrate. Hence, in this work, a comparative study was performed on the kinetics performances of BSA-gold nanozymes for enzyme-mediated oxidations of 3,3’,5,5’-thetramethylbenzidine, and 3,3’-diaminobenzidine. The results showed that the Km value of BSA-gold nanozymes was 0.03 mM and 0.72 mM toward TMB and DAB, in order, to reveal the higher affinity (lower Km) of TMB for binding to nanozyme active nodes compared to its alternative substrate, DAB. In contrast, the Vmax was found to be 263 nM sec^-1 and 185 nM sec^-1 for nanozmye-mediated oxidation of TMB and DAB, respectively. The higher Vmax of the nanozyme-mediated oxidation of TMB revealed that the catalytic efficiency of BSA-Au nanozymes toward TMB oxidation is higher (about 1.5-fold) than that of the DAB oxidation. The difference between the kinetic indexes of TMB and DAB may be related to their different oxidation pathways and their different reactivity. In fact, the DAB oxidizes via an n-electron irreversible oxidation pathway to produce an indamine polymer. While TMB nanozyme-mediated oxidation has occurred upon a 2-electron reversible mechanism for the production of a cation radical. These different pathways resulted in different kinetic performances.

Among the different ways to reduce the secondary effects of antineoplastic drugs in cancer treatment, the use of nanoparticles has demonstrated good results due to the protection of the drug and the possibility of releasing compounds to a specific therapeutic target. The α-isoform of folate receptor (FR) is overexpressed on a significant number of human cancers; therefore, folate-targeted crosslinked nanoparticles based on BSA and alginate mixtures and loaded with paclitaxel (PTX) have been prepared to maximizing the proven antineoplastic activity of the drug against solid tumors. Nanometric-range sized particles (169 ± 28nm - 296 ± 57nm), with negative Z-potential values (between -0.12 ± 0.04 and -94.1± 0.4), were synthesized. The loaded PTX (2.63±0.19 - 3.56 ±0.13 µg PTX/mg Np) was sustainably released along 23 and 27h. Three cell lines (MCF-7, MDA-MB-231 and HeLa) were selected to test the efficacy of the folate-targeted PTX-loaded BSA/ALG nanocarriers. The presence of FR on cell membrane led to a significant larger uptake of BSA/ALG-Fol nanoparticles regarding to the equivalent nanoparticles without folic acid on its surface. The cell viability results demonstrated a cytocompatibility of unloaded nanoparticle-Fol and a gradual decrease in cell viability after treatment with PTX-loaded nanoparticles-Fol due to the sustainable PTX release.