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Ethics & Legal

Before a study with human donors or probands may begin, EU law requires the planned project to be reviewed by an ethics com­mit­tee or insti­tu­tion­al review board (IRB), and in some cas­es also by a gov­ern­men­tal author­i­ty. We at ICS see eth­i­cal and reg­u­la­to­ry clear­ance not as an obsta­cle to over­come, but much rather as a wel­come ver­i­fi­ca­tion of our study design. Up to this day, our appli­ca­tions have not received a sin­gle rejection.

Before a study with human donors or probands may begin, EU law requires the planned project to be reviewed by an ethics com­mit­tee or insti­tu­tion­al review board (IRB), and in some cas­es also by a gov­ern­men­tal author­i­ty. We at ICS see eth­i­cal and reg­u­la­to­ry clear­ance not as an obsta­cle to over­come, but much rather as a wel­come ver­i­fi­ca­tion of our study design. Up to this day, our appli­ca­tions have not received a sin­gle rejection.

IRB approval

How and where to apply for IRB approval, dif­fers great­ly from coun­try to coun­try and depends on what type of study is to be con­duct­ed. In some cas­es, e.g. Ger­many, each fed­er­al state has their own laws reg­u­lat­ing the details of IRB appli­ca­tion and review.

In over 20 years writ­ing appli­ca­tions to IRBs world­wide, we have gained more than the nec­es­sary expe­ri­ence and knowl­edge to guar­an­tee suc­cess­ful eth­i­cal clearance.

More than

approvals obtained
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Authority approval

Cer­tain study projects must be reviewed by a gov­ern­men­tal author­i­ty in addi­tion to IRB approval. Whether this is the case or not, is decid­ed by how the sam­ples for the study are col­lect­ed. Inva­sive and risky col­lec­tion pro­ce­dures will require gov­ern­men­tal author­i­ty review.

The amount of time this process can take should not be underestimated.

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Again, the details dif­fer between EU mem­ber states and the def­i­n­i­tions of terms like ‘inva­sive’ or ‘risky’ are far from trans­par­ent. Through our con­tacts with key opin­ion lead­ers from the respon­si­ble par­ties, how­ev­er, we know about all poten­tial pit­falls of author­i­ty approval and will make you prof­it from our experience.

In con­clu­sion, a lot of time and mon­ey can be wast­ed before the study even start­ed. With the right strat­e­gy and plan­ning, how­ev­er, this will be avoid­ed. Expe­ri­ence is key. We will find the most time-effi­cient way through the clear­ance process for your product!

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in.vent Diagnostica GmbH

Neuendorfstraße 17
16761 Hennigsdorf

P: +49 (0) 3302 55199-550
F: +49 (0) 3302 55199-999

Mail: ics@inventdiagnostica.de