Since the 1990 s deep brain stimulation (DBS) has provided an effective tool for the treatment of Parkinson's disease. About fifty thousand Parkinson patients have been treated by DBS so far. Although a relatively safe intervention, there are still some considerable side effects, psychiatric and non-psychiatric. We conducted a structured search using PubMed and included publications from 1999 to February 2011 to provide an overview of the current data concerning psychiatric side effects of DBS in Parkinson's disease. There was a tremendous variety and inconsistency concerning methods and results of the studies we included. However, it became apparent that postoperatively increased attention should be paid concerning a potentially increased suicidality and affective alterations (particularly manic states). We suggest frequent pre- and postoperative evaluations of Parkinson patients treated with DBS.
Health crises such as the current COVID-19 pandemic pose challenges to the conduct of clinical studies. Aspects of research ethics, such as obtaining informed consent (IC), can be complicated. We are concerned with whether or not the proper IC procedures were followed in the context of clinical studies at Ulm University in the years 2020 to 2022. We identified all protocols of clinical studies dealing with COVID-19 that the Research Ethics Committee of Ulm University has reviewed and voted on in the years 2020 to 2022. We then performed a thematic analysis regarding the following aspects: study type, handling of IC, type of patient information, means of communication, applied security precautions, and the approach to participants from vulnerable groups. We identified n = 98 studies that dealt with COVID-19. In n = 25 (25.51%), IC was obtained traditionally in written form, in n = 26 (26.53%) IC was waived, in n = 11 (11.22%) IC was obtained delayed, and in n = 19 (19.39%) IC was obtained by proxy. No study protocol was accepted that waived IC in case IC would have been required in times outside of pandemics. It is possible to obtain IC even in times of severe health crises. In the future, it is necessary to address in greater detail and with legal certainty which alternative methods of obtaining IC are possible and under which circumstances IC can be waived.
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