Since its founding in 1998, IMDEC has offered independent ethical and legal reviews of human-subject research proposals submitted by sponsors and investigators working in a wide range of research environments.
IMDEC’s primary objective in conducting its reviews is to help protect the rights, dignity and welfare of the individuals who volunteer to participate in research activities. The achievement of this objective is both the cornerstone of good clinical practice and the best possible service an IRB can offer the initiators of human subject research.
One of the main motivations behind the formation of IMDEC in 1998 was the desire to introduce an important alternative to the IRB landscape in Europe, and particularly in Germany.
This unique alternative is a non-affiliated or central IRB that is capable of responding quickly to the needs of its clients while also applying a higher standard of independence to the process of reviewing research proposals.
IMDEC enables itself to respond quickly and efficiently to the needs of its clients by maintaining a schedule of weekly meetings and arranging for ad hoc meetings whenever necessary. And, compared to other non-affiliated IRBs in Germany, IMDEC upholds a greater standard of independence by drawing a clear line between its ownership and management on the one hand and its board members on the other. At IMDEC, no managers, owners or relatives thereof may also function as board members.
Finally, IMDEC is also committed to accommodating the needs of sponsors and investigators who are themselves responsible for ensuring that the IRB of their choice also operates in a manner that complies with ICH guidelines and FDA regulations.