Neue Texte veröffentlicht

13.10.2020

Anforderun­gen an die Prüfer­qual­i­fika­tion bei bes­timmten klin­is­chen Prü­fun­gen nach dem MPG

Der Arbeit­skreis Medi­zinis­cher Ethik-​Kommissionen hat mehrere Texte aktu­al­isiert und neu erstellt, u.a.:

• Anforderun­gen an die Prüfer­qual­i­fika­tion bei bes­timmten klin­is­chen Prü­fun­gen nach dem MPG
• Han­dre­ichung zur DSGVO

Weit­ere Texte sind in fol­gen­den Rubriken zu finden:

• Biobanken
• AMG-​Studien
• Koor­dinierte Bear­beitung mul­ti­zen­trischer Forschungsvorhaben

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New book published

In spring the Asso­ci­a­tion of Med­ical Ethics Com­mit­tees pub­lished a new vol­ume of its pub­li­ca­tion series:

The Devel­op­ment of Med­ical Devices — Eth­i­cal, Legal and Method­olog­i­cal Impacts of the EU Med­ical Device Regulation

Dirk Lanz­erath, Sebas­t­ian Graf von Kiel­mansegg, Joerg Has­ford (eds.)

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Covid-​19 and its effects — Infor­ma­tion for spon­sors and investigators

Last update: 28.4.2020

+++ On Tues­day 28 April 2020, the 3rd ver­sion of the Guid­ance on the Man­age­ment of Clin­i­cal Tri­als dur­ing the COVID-​19 (Coro­n­avirus) Pan­demic was pub­lished in Eudralex. We kindly ask for your atten­tion and point out that reg­u­lar updates of this doc­u­ment are to be expected. +++

+++ The work group CTR/​AMG of the Asso­ci­a­ton of Med­ical Ethics Com­mit­tees pub­lishes notes on how to deal with clin­i­cal tri­als in times of the COVID 19 pan­demic. The notes sup­ple­ment the Euro­pean Guid­ance (2nd ver­sion) with ref­er­ence to the spe­cific Ger­man legal frame­work and high­light the prac­ti­cal con­se­quences in mat­ters of ethics com­mit­tees (avail­able only in Ger­man) +++

+++ On Fri­day 27 March 2020, Eudralex pub­lished the 2nd ver­sion of the guid­ance on cur­rent issues related to the Covid 19 pan­demic and clin­i­cal tri­als. +++

+++ On Fri­day 20 March 2020, Eudralex pub­lished guid­ance on cur­rent issues regard­ing the Covid 19 pan­demic and clin­i­cal tri­als. +++

The Ethics Com­mit­tees have not been spared the effects of the Sars-​CoV-​2 pan­demic and cur­rent polit­i­cal mea­sures. Of course, the ethics com­mit­tees try to ful­fil their tasks care­fully and quickly despite all adver­si­ties, i.e. in com­pli­ance with the legal dead­lines. How­ever, in view of the threat posed by SARS-​CoV-​2, we ask for your under­stand­ing that, until fur­ther notice, all research appli­ca­tions relat­ing to this virus or the cor­re­spond­ing dis­ease will be processed with pri­or­ity, both in accor­dance with the Ger­man Med­i­c­i­nal Prod­ucts Act (AMG), the Ger­man Med­ical Devices Act (MPG) and the advi­sory pro­ce­dure in accor­dance with § 15 of the Pro­fes­sional Codes for Physi­cians in Ger­many. In the sec­ond pri­or­ity all other AMG and MPG stud­ies will be processed. We assume that the dead­lines can gen­er­ally be met here. Should this not be the case in excep­tional cases, we ask for your under­stand­ing that this was not pos­si­ble due to exter­nal spec­i­fi­ca­tions and mea­sures (force majeure).

It is clear to all par­ties involved that, in view of the pos­si­ble restric­tions of pub­lic life, the GCP-​compliant con­duct of clin­i­cal tri­als may also be affected. When deci­sions are to be made, it is first and fore­most impor­tant to ensure the safety and well-​being of the study par­tic­i­pants. For exam­ple, the sup­ply of inves­ti­ga­tional med­i­c­i­nal prod­ucts in stud­ies where patients are depen­dent on con­tin­u­ous ther­apy, e.g. in onco­log­i­cal stud­ies or stud­ies on the treat­ment of rare dis­eases, more gen­er­ally speak­ing, stud­ies with ther­a­pies for which there are no equiv­a­lent ther­a­peu­tic alter­na­tives, must be ensured. Ongo­ing stud­ies should only be dis­con­tin­ued in excep­tional cases and after care­ful con­sid­er­a­tion of eth­i­cal aspects. It should be remem­bered that patients have given their con­sent under the con­di­tion that only with the help of this study med­ically impor­tant ques­tions can be answered. Should you come to the con­clu­sion that the con­duct of a clin­i­cal trial in accor­dance with the trial pro­to­col can no longer be reli­ably guar­an­teed, a less intru­sive option should be con­sid­ered, e.g. a tem­po­rary stop of the recruit­ment of new trial par­tic­i­pants. The record­ing of adverse events and effects and their trans­mis­sion and eval­u­a­tion must also be def­i­nitely guar­an­teed. In gen­eral, the rel­e­vant laws and reg­u­la­tions con­tinue to apply. Thus, the respon­si­ble ethics com­mit­tees must also be involved accord­ingly in upcom­ing deci­sions and mod­i­fi­ca­tions, e.g. of the trial pro­to­col in terms of sub­se­quent changes. § 11 of the GCP-​V reg­u­lates the mea­sures to be taken imme­di­ately, if nec­es­sary, to pro­tect against imme­di­ate dan­ger. It is rec­om­mended to doc­u­ment all devi­a­tions from the test plan that are due to the pan­demic sit­u­a­tion. Of course, all study patients should be informed with­out delay of any changes in the course of the clin­i­cal trial that are rel­e­vant to them

Of course you can always con­tact the ethics com­mit­tee respon­si­ble for you with any ques­tions that fall within the com­pe­tence of ethics com­mit­tees. We thank you for your under­stand­ing and remain hope­ful that you will remain healthy and that the pan­demic will be brought under con­trol as soon as possible.

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Impor­tant Infor­ma­tion regard­ing the “Update Course” on EU Reg­u­la­tion No. 536/​2014

The EU Reg­u­la­tion No. 536/​2014 will sig­nif­i­cantly change the approval pro­ce­dure and the con­duct of clin­i­cal tri­als. An “update course” focused on this will enable doc­tors to pre­pare appro­pri­ately for the new legal sit­u­a­tion. The Asso­ci­a­tion of Med­ical Ethics Com­mit­tees and the Ger­man Med­ical Asso­ci­a­tions will pub­lish a cor­re­spond­ing cur­ricu­lum at the begin­ning of 2020, which should serve as a root posi­tion for the rel­e­vant courses.

Joint Let­ter by the Euro­pean Com­mis­sion, EMA and HMA

We kindly ask for attention:

• Let­ter to Stake­hold­ers regard­ing the require­ments to pro­vide results for autho­rised Clin­i­cal Tri­als in EUDRACT (June 2019)