Ethical and Legal Issues

Regarding Objectives I and II, ethical approval has already been granted (brain samples UK: NHS South East London REC 3; brain samples USA: Banner Sun Health Research Institute [BSHRI] Institutional Review Board [IRB] Approved; #11-002; according to guidelines of the U.S. Food and Drug Administration [FDA] and the Office for Human Research Protections). Regarding ante-mortem blood sampling (UK), informed consent on according to the Declaration of Helsinki. AT the BSHRI, written informed consent for autopsy was obtained for all cases in compliance with institutional guidelines of BSHRI.

The BSHRI review board approved this study including recruitment, enrolment, and autopsy procedures. All donors and their respective next-of-kin consented to brain autopsy for the purpose of research analysis as participants in the BSHRI autopsy program. Likewise, regarding Objective III (, ethical approval has already been granted (Dutch IRB/METC number 2008/230; 0-27-2009). The AgeCoDe study was approved by the local ethics boards of all participating centres. Participants of this study were recruited in primary care and written informed consent was obtained from all individuals. All in all, all studies involving human subjects are either ongoing or have already been finalized, which minimizes the degree of ethical and legal constraints.