JurisdictionMedical Devices IMDEC is authorized by the German Federal Agency for Drugs and Medical Devices to review medical-device studies that are to be carried out in Germany. [Click on the link to view a list of approved IRBs.]
This means that the initiators of medical-device studies can fulfill their IRB obligations by obtaining an approval from IMDEC. Moreover, a research approval issued by IMDEC will automatically apply to all of the German centers of a multicenter study.
Radioactive Materials and Ionizing RadiationIMDEC is authorized by the German Federal Agency for Radiation Protection (as per § 92 of the German Radiation Protection Act and § 28g of the German X-ray Protection Act) to review human subject research involving the use of radioactive materials or ionizing radiation. [Click on the link to view a list of approved IRBs.]
This means that the initiators of human subject research involving the use of radioactive materials or ionizing radiation can fulfill their IRB obligations by obtaining an approval from IMDEC. Moreover, a research approval issued by IMDEC will automatically apply to all of the German centers of a multicenter study.
DrugsThose wishing to conduct drug studies in Germany are required to obtain an approval from a publicly-funded IRB. All such IRBs are either affiliated with one of Germany’s 16 medical associations or with a publicly-funded German university.
As an independent and non-affiliated IRB, IMDEC is not fully authorized in this sense to review drug studies conducted in Germany. In other words, an approval issued by IMDEC for a drug study is neither a necessary nor a sufficient condition for meeting a sponsor’s or investigator’s IRB obligations.
That being said, IMDEC does regularly review drug studies on behalf of sponsors who wish to have their research proposals reviewed by an IRB that operates in accordance with ICH guidelines and FDA regulations.
IMDEC is registered at the Office of Human Research Protections of the U.S. Department of Health and Human Services and is committed to working in accordance with standard operating procedures that comply with FDA specifications.
Healthcare Products, Dietary Supplements, Cosmetics IMDEC regularly reviews human subject research involving healthcare products, dietary supplements and cosmetics.
While German law and European Union law are currently equivocal or silent with respect to these areas of human subject research and the issue of IRB approval, there is a growing consensus in the various research communities and among public officials that such investigations need to be approved by an independent IRB.
Our clients who consult us in these areas have particularly valued our advice in legal matters, matters of insurance and matters of informed consent and data protection.
Our experience also shows that a research approval issued by IMDEC has always been sufficient to enable our clients to meet their publishing requirements.
Behavioral ResearchIMDEC regularly reviews proposals in the area of behavioral research.
While German law and European Union law are currently equivocal or silent with respect to this area of human subject research and the issue of IRB approval, there is a growing consensus in the research community and among public officials that such investigations need to be approved by an independent IRB.
Our clients who consult us in these areas have particularly valued our advice in legal matters, matters of insurance and matters of informed consent and data protection.
Our experience also shows that a research approval issued by IMDEC has always been sufficient to enable our clients to meet their publishing requirements.
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