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(b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence additional safeguards have been included in the study to protect the rights and welfare of these subjects. While we will address informed consent component in the next publication, understanding the role of the critical IRB and its importance in clinical research is both legally mandated and essential to ensure that appropriate safeguards to protect patients in the clinical setting.

The MHRA has not issued specific warnings about B12 toxicity from supplements, reflecting the vitamin's excellent safety profile in the general population