Wie hält Drosten es mit der Erklärung von Helsinki zu ethischen Grundsätzen?

Dieser Frage wird sich die Charité im Zusammenhang mit Drostens "Kinderstudie" stel­len müs­sen. Markus Kühbacher hat fol­gen­de Fragen an D.'s Arbeitgeber gerichtet:

»Sehr geehr­te Damen und Herren,

Bezug neh­mend auf die bei Ihnen an der Charité durch­ge­führ­te Studie aus dem Frühjahr 2020, deren Ergebnisse auf einem Ihrer Server unter dem Titel "An ana­ly­sis of SARS-CoV‑2 viral load by pati­ent age"* ver­öf­fent­licht wor­den ist, bit­te ich um Beantwortung der fol­gen­den Fragen:

1. Wer war der Leiter die­ser Studie?

2. Wann hat der Studienleiter einen Antrag auf Zustimmung zu sei­nem Forschungsprotokoll gemäß Punkt 23 i. V. m. den Punkten 1, 2 und 22 der Deklaration von Helsinki bei der hier­für zustän­di­gen Ethikkommission der Charité gestellt?

3. Wann wur­de die­ser Ethikantrag genehmigt?

4. In wel­cher öffent­lich zugäng­li­chen Datenbank wur­de die Studie gemäß Punkt 35 der Deklaration von Helsinki registriert?

5. Wurde die Studie inzwi­schen in einem wis­sen­schaft­li­chen Journal veröffentlicht?

Auszug aus der "WMA DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS":

„1. The World Medical Association (WMA) has deve­lo­ped the Declaration of Helsinki as a state­ment of ethi­cal prin­ci­ples for medi­cal rese­arch invol­ving human sub­jects, inclu­ding rese­arch on iden­ti­fia­ble human mate­ri­al and data.

The Declaration is inten­ded to be read as a who­le and each of its con­sti­tu­ent para­graphs should be applied with con­side­ra­ti­on of all other rele­vant paragraphs.

2. Consistent with the man­da­te of the WMA, the Declaration is addres­sed pri­ma­ri­ly to phy­si­ci­ans. The WMA encou­ra­ges others who are invol­ved in medi­cal rese­arch invol­ving human sub­jects to adopt the­se principles.

[…]

22. The design and per­for­mance of each rese­arch stu­dy invol­ving human sub­jects must be cle­ar­ly descri­bed and justi­fi­ed in a rese­arch protocol

The pro­to­col should con­tain a state­ment of the ethi­cal con­side­ra­ti­ons invol­ved and should indi­ca­te how the prin­ci­ples in this Declaration have been addres­sed. The pro­to­col should include infor­ma­ti­on regar­ding fun­ding, spon­sors, insti­tu­tio­nal affi­lia­ti­ons, poten­ti­al con­flicts of inte­rest, incen­ti­ves for sub­jects and infor­ma­ti­on regar­ding pro­vi­si­ons for trea­ting and/or com­pen­sa­ting sub­jects who are har­med as a con­se­quence of par­ti­ci­pa­ti­on in the rese­arch study.

In cli­ni­cal tri­als, the pro­to­col must also descri­be appro­pria­te arran­ge­ments for post-tri­al provisions.

23. The rese­arch pro­to­col must be sub­mit­ted for con­side­ra­ti­on, com­ment, gui­dance and appr­oval to the con­cer­ned rese­arch ethics com­mit­tee befo­re the stu­dy beg­ins. This com­mit­tee must be trans­pa­rent in its func­tio­ning, must be inde­pen­dent of the rese­ar­cher, the spon­sor and any other undue influence and must be duly qua­li­fi­ed. It must take into con­side­ra­ti­on the laws and regu­la­ti­ons of the coun­try or count­ries in which the rese­arch is to be per­for­med as well as appli­ca­ble inter­na­tio­nal norms and stan­dards but the­se must not be allo­wed to redu­ce or eli­mi­na­te any of the pro­tec­tions for rese­arch sub­jects set forth in this Declaration.

The com­mit­tee must have the right to moni­tor ongo­ing stu­dies. The rese­ar­cher must pro­vi­de moni­to­ring infor­ma­ti­on to the com­mit­tee, espe­ci­al­ly infor­ma­ti­on about any serious adver­se events. No amend­ment to the pro­to­col may be made wit­hout con­side­ra­ti­on and appr­oval by the com­mit­tee. After the end of the stu­dy, the rese­ar­chers must sub­mit a final report to the com­mit­tee con­tai­ning a sum­ma­ry of the study’s fin­dings and conclusions.

[…]

35. Every rese­arch stu­dy invol­ving human sub­jects must be regi­stered in a publicly acce­s­si­ble data­ba­se befo­re recruit­ment of the first subject.”

https://​www​.wma​.net/​p​o​l​i​c​i​e​s​-​p​o​s​t​/​w​m​a​-​d​e​c​l​a​r​a​t​i​o​n​-​o​f​-​h​e​l​s​i​n​k​i​-​e​t​h​i​c​a​l​-​p​r​i​n​c​i​p​l​e​s​-​f​o​r​-​m​e​d​i​c​a​l​-​r​e​s​e​a​r​c​h​-​i​n​v​o​l​v​i​n​g​-​h​u​m​a​n​-​s​u​b​j​e​c​ts/

*https://​zoo​no​sen​.cha​ri​te​.de/​f​i​l​e​a​d​m​i​n​/​u​s​e​r​_​u​p​l​o​a​d​/​m​i​c​r​o​s​i​t​e​s​/​m​_​c​c​0​5​/​v​i​r​o​l​o​g​i​e​-​c​c​m​/​d​a​t​e​i​e​n​_​u​p​l​o​a​d​/​W​e​i​t​e​r​e​_​D​a​t​e​i​e​n​/​a​n​a​l​y​s​i​s​-​o​f​-​S​A​R​S​-​C​o​V​-​2​-​v​i​r​a​l​-​l​o​a​d​-​b​y​-​p​a​t​i​e​n​t​-​a​g​e​.​pdf

Mit freund­li­chen Grüßen
Markus Kühbacher«