1. In accordance with Section 10 of the Chamber Act for the Health Professions (HKG), Hannover Medical School establishes an Ethics Committee to assess ethical and legal aspects of research projects involving humans. It is called:
   Ethics Committee of Hannover Medical School
   The Ethics Committee works on the basis of the Declaration of Helsinki of the World Medical Association as amended and the applicable laws.
2. The members of the Ethics Committee are independent in the performance of their duties and are not bound by instructions. They are responsible only to their conscience

The Ethics Committee has the task of advising employees of Hannover Medical School and members of the teaching staff of Hannover Medical School on the ethical and professional aspects of research on and with human subjects within the framework of the applicable laws, or to decide on applications in accordance with other legal bases relevant to the Ethics Committee, insofar as the research project in question affects the area of responsibility of Hannover Medical School. The Ethics Committee is only responsible for applications from employees of the Hannover Medical School's teaching hospitals if the Hannover Medical School has declared its patronage of the project and this declaration is enclosed with the application. In addition, the Ethics Committee of the Hannover Medical School advises on applications that are based on a multicenter procedure and for which it is responsible for the medical study management. If the Ethics Committee of the Medical School is not responsible for the medical study management, but is involved locally, a certificate of receipt will be issued after notification by the medical study management.

For clinical trials subject to review in accordance with Regulation (EU) No. 536/2014 of the European Parliament and of the Council of April 16, 2014 on clinical trials on medicinal products for human use, the responsibility of the Ethics Committee is based on the joint schedule of responsibilities to be issued in accordance with Section 41b (2) of the German Medicinal Products Act (AMG). Clinical trials in accordance with EU Regulation 536/2014 are advised by the "AMG" subcommittee of the Medical School's Ethics Committee. The "AMG" subcommittee of the Ethics Committee shall adopt rules of procedure in accordance with the AMG and these statutes. The procedure and decision-making of the "AMG" subcommittee shall be governed by the rules of procedure to be issued.

1. the Ethics Committee shall consist of at least seven members, of whom at least

• a) three physicians with experience in clinical medicine, one of whom shall be a specialist in clinical pharmacology or in pharmacology and toxicology,
• b) one member with scientific or professional experience in the field of ethics in medicine,
• c) one lawyer,
• d) a member with experience in experimental design and statistics,
• e) and one layperson.

For applications to which the AMG, the Medical Devices Law Implementation Act (MPDG), the Transfusion Act (TFG) or the Radiation Protection Act (StSchG) apply, the composition of the members of the Ethics Committee shall be ensured in accordance with the legal requirements as amended.

2. the appointment of deputies by the members for the duration of the Ethics Committee's term of office is permissible. Paragraph 1 shall apply accordingly to the deputies.

3. The members and deputies are appointed by the Senate of Hannover Medical School for a term of office of four years; reappointment is permissible.

4. The Ethics Committee elects a chairperson and up to two deputies from among its members, who take over the duties of the chairperson if he/she is unavailable.

5. The composition of the Ethics Committee is set out in an annex to these Articles of Association.

6. Any member may resign at his/her own request without giving reasons.

7. A member or deputy member may belong to several Ethics Committees.

8. The Ethics Committee may consult experts in an advisory capacity if necessary.

9. The Ethics Committee of Hannover Medical School shall set up the "AMG" subcommittee. Members of the Ethics Committee may also be members of the "AMG" subcommittee.

The chairperson is responsible for the management of the Ethics Committee. If they are unable to do so, the task is performed by the deputy chairperson. If they are unavailable, the managing physician takes over the management of the committee. An office is set up to support the management. Hannover Medical School shall provide the Ethics Committee with the necessary personnel, space and material resources.

1. The Ethics Committee acts upon application. Any person named in § 2 is entitled to submit an application. The Ethics Committee may admit voluntary consultations in connection with research on or with humans.
2. Applications must be submitted using the application forms provided by the office.
3. The application must be accompanied by a statement as to whether, where and with what result applications with similar content have been submitted before or at the same time.
4. The Ethics Committee may request additional documents, information or justifications from the applicant, which shall be attached to the application.
5. In accordance with the task of the Ethics Committee as formulated in Section 15 "Research" of the Professional Code of Conduct of the Lower Saxony Medical Association, the applicants will be advised on professional ethics and professional law.
6. If the Ethics Committee acts on the basis of legal requirements, the procedure is governed by the respective legal basis.
7. The Ethics Committee generally makes its decision following an oral discussion. Written resolutions by way of circulation are permissible, provided this does not conflict with statutory provisions and no member objects.
8. Members of the Ethics Committee who are involved in an application under discussion are excluded from the decision-making process. This shall be noted in the minutes and in the notification of the outcome of the consultation to the applicants.
9. The chairperson convenes the Ethics Committee and determines the time and place of the meeting. He/she shall convene the Ethics Committee as often as the business situation requires. The chairperson opens, chairs and closes the meetings.
10. The Ethics Committee does not meet in public. The members are bound to secrecy. Experts and auxiliary persons consulted in an advisory capacity are also bound to secrecy.
11. Minutes are kept of each meeting and contain the main decisions taken. These minutes shall be made available to the members.
12. The Ethics Committee should strive to reach a consensus on the decision to be taken. If such a consensus is not reached, the Ethics Committee shall decide by majority vote. At least half of all members shall constitute a quorum. Abstentions are deemed to be rejections. In the event of a tie, the chairperson has the casting vote. At the request of individual members, a special vote is formulated which supplements the result of the consultation.
13. The applicant shall be informed of the result of the deliberation in text or written form and reasons shall be given.
14. At the request of the Ethics Committee, the applicant may be heard by the Ethics Committee.
15. In order to expedite and simplify the procedure, the Ethics Committee may instruct the chairperson and/or his/her deputy and/or the managing director/managing physician to decide alone or in agreement with one or more members in medically, legally and ethically unproblematic cases, insofar as this is legally permissible.
16. In the case of multi-center studies that are not subject to the AMG or the MPDG, processing according to the above procedure will only take place if the Ethics Committee of Hannover Medical School is responsible for the medical study management. If the Ethics Committee is only locally involved in such multicenter studies, the review of the documents and the preparation of the certificate of receipt is usually carried out by the chairperson and/or his/her deputy and/or the managing physician in order to speed up the procedure, insofar as this is legally permissible.

Irrespective of the opinion of the Ethics Committee, the applicant remains responsible for his/her actions.

The cost regulations are set out in an annex to these statutes.

The statutes enter into force on the day following their adoption by the Presidium of the MHH. In all other respects, the provisions of the Administrative Procedure Act apply.

The statutes enter into force on the day following their adoption by the Presidium of the MHH. In all other respects, the provisions of the Administrative Procedure Act apply.