The task of the Medical Ethics Committee is to advise researchers with the following objectives:

• Protecting healthy test subjects and patients from dangerous research
• Protection of the researcher not to exceed the limits of what is ethically or legally permissible in the drive to increase knowledge
• Protecting future patients from incorrect therapies due to errors in the planning of the research project or study design.
• Protecting research institutions from the adverse consequences of ethically and legally questionable research.
• The obligation to advise doctors is based on §15 BO ÄKN(link)

Important note:

The ethical and professional advice provided by the ethics committee can only ever be cursory. It does not release researchers from their own legal responsibilities in the various areas. Particularly in data protection law, special procedural obligations apply (e.g. entry in the procedure directories of the institutions involved and the data protection impact assessment in accordance with Art. 35 GDPR ), which are not fully covered by the activities of the ethics committee.

We recommend that you always contact the Data Protection and Information Security Unit(uol.de/dism) at the same time as the Ethics Committee in order to avoid any delays in project progression. (see also FAQ data protection)

General principles

Our Medical Ethics Committee is a committee established in accordance with Section 10 (III) HKG to provide ethical and legal advice to scientists planning research on living and deceased human beings. The ethics committee is intended to protect the rights and safety of patients and test subjects in accordance with the Declaration of Helsinki.

The Declaration of Helsinki (2013) states:

Legal basis

The Medical Ethics Committee of the University of Oldenburg is established in accordance with state law (§10 (3) HGK*).

It advises on research projects at the proposal of researchers in accordance with

• §40ff of the German Medicinal Products Act (AMG)
• Medical Devices Implementation Act (MPDG/MDR)
• §Section 36 of the Radiation Protection Act (StrSchG)
• §15(1) and §15(3) Professional Code of Conduct of the Lower Saxony Medical Association (BO ÄKN)
• §28 Model Professional Code of the Chamber of Psychotherapists (MBO PsychTherK), or the Chamber of Psychotherapists (reference to the Declaration of Helsinki)

At the request of researchers (voluntary counselling): Researchers may require an ethics vote due to the statutes of the University of Oldenburg or due to the requirements of funding bodies or journals, or may wish to receive counselling out of their own motivation due to research in ethical borderline areas.

The procedure is regulated in the statutes of the Medical Ethics Committee and in the procedural regulations.

Before a clinical trial of medical devices is conducted, regardless of whether it is conducted on patients or test subjects and regardless of which professional group is involved in the conduct, consultation must be provided by an ethics committee formed in accordance with state law.

Clinical trials of medicinal products (drug studies) require the involvement of a doctor and must be advised by an ethics committee formed in accordance with state law or an ethics committee formed in accordance with Section 41a AMG in accordance with Section 40 AMG.

In Germany, advice on research projects that do not fall under the AMG or MDR/MPDG is regulated by the professional codes of conduct of the state medical associations or the state chambers of psychotherapists.

According to §15(1) of the professional code of conduct of the Lower Saxony Medical Association (BO ÄKN), the following applies:

Both the professional code of conduct of the German Medical Association (§15 (3) BO ÄKN) and the professional code of conduct for psychotherapists (§28(1) MBO PsychTherK) require compliance with the Declaration of Helsinki, Article 23 of which also calls for consultation by an ethics committee (formed in accordance with state law).

If you are not sure whether your study needs to be advised by a (medical) ethics committee, you can submit an enquiry to the office of the Medical Ethics Committee. You can find more information on an enquiry about the obligation to consult here.

The most common question regarding the duty to consult arises prior to the implementation of research projects with exclusively retrospective data collection. This is clearly regulated both in the BO ÄKN and in the Declaration of Helsinki:

Only if the research is conducted exclusively on anonymous data is consultation with an ethics committee not required. These are, for example, research projects in which data from the Federal Statistical Office or the DIMDI healthcare data ("DaTraV data") are used.

If the anonymisation only takes place during data collection or after collection from the source system, this does not fall under this exception rule. Examples of the use of non-anonymised data include the use of data from medical records, clinical information systems or medical practice systems or data warehouse systems. In this case, non-anonymised data is accessed and the responsible ethics committee is obliged to provide advice. This is independent of whether or not anonymisation takes place after collection.

Research databases (e.g. registers and cohorts) and biomaterial databases are a special case. These are discussed separately.

Pseudonymised data is considered personal data.

If you are not sure whether your research project requires consultation by a (medical) ethics committee, you can submit an enquiry to the office of the Medical Ethics Committee regarding the obligation to consult.

The ethical and legal consultation of the research project aims to ensure that the health, well-being and rights of the subjects and patients in the research project are safeguarded and to protect the researcher from violations of legal regulations. The ethics committee can express legal or ethical concerns about the implementation of the research project and provide advice on how to improve the research project.

These could not be implemented if the research project has already been started. This would contradict the purpose of counselling. Accordingly, all statutory and sub-statutory regulations stipulate that counselling must only take place BEFORE the start of the research project.

Subsequent counselling by the Medical Ethics Committee is not possible according to the statutes!

Important notes

Carrying out research projects without prior consultation with an ethics committee can have consequences under professional law as well as lead to the subsequent withdrawal of publications and the revocation of qualifications.

Starting a clinical trial of medicinal products or medical devices or a research project in accordance with the StrSchG without the approval of the responsible ethics committee may have consequences under regulatory/criminal law.

According to the statutes, the Medical Ethics Committee has the task of advising the responsible researchers if they are

1. Members of the University of Oldenburg,
2. Employees, members and affiliates of the Institutes and affiliated institutes of the University of Oldenburg,
3. employees of the hospitals on the University's medical campus
   or
4. employees and members of the teaching hospitals and teaching practices associated with EMS

or the study is conducted under the other auspices of the University of Oldenburg.

The Medical Ethics Committee is the responsible ethics committee for monocentric studies according to AMG and/or MDR/MPDG if the investigators and deputies belong to the group of persons 1 - 4.

In the case of multi-centre studies according to AMG and/or MDR/MPDG, the Medical Ethics Committee is the responsible (lead) ethics committee if the head of the clinical trial belongs to the group of persons 1-4. The Medical Ethics Committee is the involved ethics committee if an investigator / deputy belongs to the group of persons 1-4.

With the implementation of EU Regulation 535/2014 and the 4th Act Amending Drug Law and Other Regulations of 20 December 2016, the competent ethics committee for drug studies is assigned by the higher federal authority (BfArM).

The relevant statutory and sub-statutory regulations and the Declaration of Helsinki do not distinguish between study and qualification projects and research without an educational or qualification objective. Therefore, the same rules on the duty to consult apply to all research projects involving human subjects as described above. This is understandable, as the primary protection goal is the safety and well-being of the subjects or patients involved.

The Medical Ethics Committee expressly welcomes the training of students and scientists. As a supporter of training, it is in favour of students and apprentice scientists presenting the research project at the meeting. However, the following points should be noted:

• Supervisors are responsible for the research project.
  => Applicants are therefore always supervisors.

A presentation of the research project by the students / apprentice scientists during the consultation of the research project by the Ethics Committee in the meeting is expressly desired, but only in the company of the responsible supervisors.

• Students will not be advised without the presence of the applicant.

Important note

Allow sufficient time so that any necessary subsequent submissions or corrections to the study protocol or study documents do not jeopardise the timely start of the study.

Advice on professional law

Once the application documents have been received, they are formally reviewed by the office and the Chairs. If the documents are not complete or if deficiencies are already apparent during this initial review, the applicants will be asked to rectify them by the time the Ethics Committee deliberates (meeting dates).

To ensure that your research project can be discussed at the next meeting, we recommend submitting the documents 3 weeks before the next meeting date.

If the documents are complete in terms of form and content, the research project will be discussed at the committee meeting. A member of the Ethics Committee will present the study as rapporteur. All applicants receive an invitation to attend the meeting. This is often helpful as many questions can be answered directly and lengthy correspondence can be avoided.

The members of the ethics committee then vote on the research project. As a rule, the applicants receive the written vote or a letter of deficiency within two weeks of the committee meeting.

Legally regulated consultation procedures

For consultations under the German Drug Law, MDR / Medical Devices Implementation Act or the StrSchG, the Ethics Committee follows the statutory and sub-statutory regulations.

AMG / MDR / MPDG

For studies according to AMG and MDR / MPDG, the consultation procedure, including the reasons for failure, is regulated by law. For this reason, reference is only made here to the AMG / GCP Regulation or MDR / MPDG and DIN EN ISO 14155.

Professional legal advice

The Ethics Committee examines the documents submitted for conformity with the Declaration of Helsinki, relevant statutory and sub-statutory regulations (e.g. on informational self-determination) and the recommendations based on these, including those of the following organisations:

• WHO recommendations
• Working Group of Medical Ethics Committees in Germany e.V.
• Central Commission for the Safeguarding of Ethical Principles in Medicine and its Frontier Areas
• Ethics Council of the Federal Government

The Medical Ethics Committee uses the following documents for its assessments:

• Checklists for mono- and multicentre studies of the Recommendation for the handling of multicentre studies outside AMG or MDR / MPDG by ethics committees in accordance with the resolution of the Working Group of Medical Ethics Committees in the Federal Republic of Germany e.V. of 10.06.2016 (link)
• "Empfehlungen zur Begutachtung klinischer Studien durch Ethikkommissionen" Deutscher Ärzte-Verlag 2012, 2nd revised and updated ISBN 978-3-7691-1305-1
• Checklist for informed consent

The Medical Ethics Committee participates in the pilot project for the coordinated consultation of prospective, non-interventional studies of the German Working Group of Medical Ethics Committees.

Professional counselling

Article 22 Declaration of Helsinki:

Formal requirements

• Study protocol checklist: Prospective study, possibly with retrospective part
• Study protocol checklist: Project with material from existing biobank / sample collection
• Study protocol checklist: Project with data from existing database / registry
• Study protocol checklist: Retrospective analysis of data from routine clinical practice

Research projects can be very different and not all points always apply. The standards of the Equator Network, such as the Defining Standard Protocol Itemsfor Clinical Trials(SPIRIT), provide good guidance.

The most common errors in study protocols submitted to the ethics committee are

• Essential information on the comprehensibility of the study design is missing:
  • Objective and research question are not clearly defined
  • Information on which parameters are measured and how is missing
  • Insufficient information on the type of study design
• Proof of efficacy, performance, safety or benefit necessarily requires a confirmatory study design
• No distinction is made between primary and secondary endpoints
• A confirmatory study design requires a comprehensible case number planning (see also study protocol). This requires the following information (see also DOI: 10.3238/arztebl.2010.0552 or DOI 10.1186/s13063-014-0526-8):
  • Definition of the clinically relevant effect with justification
    (literature reference required)
  • Definition of the hypothesis and null hypothesis
  • The error of the first type must be determined (significance level)
  • The error of the second type must be specified (and thus the power)
  • Specification of corrections for multiple endpoints (multiple testing)
  • Specification of the statistical method (information on the presumed distribution required)
  • Calculated number of cases (surcharges for test method, dropouts, if applicable)
  • Justification of the size of the dropout (with literature reference)
  • Software used with version
  • Explanation of the feasibility of the calculated number of cases
• A non-confirmatory study design requires a case number analysis:
  • Description of the planned number of cases
  • Explanation of the feasibility of the planned number of cases
  • Justification of the necessity of the number of cases for the successful completion of the study
• Non-inferiority or equivalence must not be inferred from unproven superiority (DOI: 10.3238/arztebl.2012.0674)

Note: We would like to point out that for interventional studies, as well as for research projects with invasive or burdensome study-related measures, the person responsible for study planning (including case number analysis / case number calculation) and data analysis must be specified and this person must sign the study protocol and protocol.

The basis of research involving human subjects, personal data or body materials is the voluntary, informed consent of the test subjects (patients or test persons).

In addition to the Declaration of Helsinki (Articles 25-33), there are numerous other ethical and legal requirements for patient information and consent.

The Medical Ethics Committee recommends

• The use of the sample texts of the Working Group of Medical Ethics Committees in the Federal Republic of Germany e.V.
• The eTIC tool can help you with this, see also information under eTIC - electronic Tool for Informed Consent documents - AKEK - Working Group of Medical Ethics Committees
• Further documents and templates for university research projects can be found at Data Protection and Information Security Unit

Further information can also be found here:

Ethical and legal requirements for study information and informed consent in research

Declaration of Helsinki

In addition, the relevant data protection laws apply to all research projects, in particular the EU General Data Protection Regulation (EU GDPR) since 25 May 2018.

Further information on this can be found

• on the website of the University's Data Protection and Information Security Unit (Data Protection and Information Security Unit). The Ethics Committee advises applying to the Data Protection and Information Security Unit and the Data Protection Officer at the same time as seeking advice from the Ethics Committee in order to avoid delays in project progression.
• in the Guidelines for researchers in medicine", prepared by the Hessian Commissioner for Data Protection and Freedom of Information (HBDI) and the German Society of Internal Medicine (DGIM).

Studies in accordance with the German Drug and / or Medical Devices Act

When assessing the suitability of investigators and deputies, the Medical Ethics Committee follows the recommendations of the Central Ethics Committee of the German Medical Association and the Working Group of Medical Ethics Committees in the Federal Republic of Germany.(Link)

We recommend using the sample documents of the Working Group of Medical Ethics Committees and the German Medical Association:

• Proof of qualification to be submitted for investigators, deputies and review bodies for AMG studies
• Documents required to prove the qualifications of the investigators and the review body for studies according to the MPG/MDR

non-AMG / non-MPG studies

The Declaration of Helsinki states the qualifications of study physicians/ investigators:

These requirements should be demonstrated by the curriculum vitae and, if applicable, proof of qualifications (licence to practise medicine, specialist certificate, additional qualifications, etc.). This also applies to persons involved in the study who are entrusted with the recruitment and education of the subjects/patients or the performance of invasive, diagnostic, therapeutic or risky measures as part of the research project.

Suitability of the trial site

Particularly in the case of interventional studies or research projects involving invasive or stressful measures, it must be demonstrated how risk minimisation measures are implemented in the institution and how these are continuously monitored, assessed and documented (quality management). Furthermore, it must be explained how the care of the trial participants (patients and test subjects) is ensured in the event of unexpected and adverse events, as well as after the end of the trial, discontinuation of the trial or withdrawal of consent.

Studies according to StrSchG

For research projects involving the use of X-rays, radioactive substances or ionising radiation, the corresponding qualifications of investigators, deputies and physicians of the study team must be demonstrated, which enable them to use the corresponding diagnostic and therapeutic procedures.

Patients and test subjects voluntarily consent to participate, especially in studies without individual benefit, if they see a benefit for other people with their condition or a social benefit in participating. This is only the case if the study results are reported completely and correctly.

Research on humans is only justifiable if the number of subjects and patients exposed to study-related risk or burden is limited to the necessary number. Therefore, the results of previous studies must be included in the study planning and benefit/risk assessment of a research project (see also case number planning). Non-published results therefore contradict the ethical principles of the Declaration of Helsinki, as do studies planned in parallel.

The aim of study registries is that

• the results of planned research projects are reported completely and correctly, regardless of the results (see also Publication BIAS, p-Hacking)
• planned and ongoing research projects are publicly known in order to avoid duplicate studies.

A detailed explanation can be found in the statement of the Working Group of Medical Ethics Committees(link)

The registration of research projects involving test subjects in a publicly accessible database promotes transparency in clinical research. The International Committee of Medical Journal Editors (ICMJE) requires prospective registration in a register recognised by the WHO for all clinical studies that are to be published in one of the participating journals.

With the amendment to the Declaration of Helsinki (October 2024), this requirement now applies to all interventional clinical trials, including those not covered by the German Medicines Act or the Medical Devices Regulation, such as epidemiological studies, studies in surgery or studies on other non-drug interventions.

The Medical Ethics Committee agrees with the recommendations and makes recommendations:

• All research projects should be entered in a study register recognised by the WHO.
• For national studies, the Medical Ethics Committee recommends an entry in the German Clinical Trials Register (DRKS, www.drks.de ).
• The study registry number should be stated both in the study protocol and in the patient information. The latter should include an explanation for patients so that they become aware of the problem and transparency is created.

How do I register with a trial registry?

• Register with a study registry - e.g. the DRKS.
• You can then (provisionally) register your study there and you will receive a provisional processing number. You will only receive the study number once you have received a favourable vote from the ethics committee.
• Submit this processing number with the documents for the ethics committee.
• Once you have received the ethics vote, you can finalise your entries in the study register and you will receive the unique study register number. The study can now be found under this number.
• Notify the ethics committee of the number in the study register at the latest when you report the start of the study (start of recruitment or inclusion of the first patients/test subjects).

Study-related measures are all measures that go beyond or deviate from routine patient care. The distinction between routine measures and study-related measures depends on whether these measures are also given to patients who are not included in the studies.

The study-related measures and the resulting risks and burdens for patients or test subjects

• are a relevant component of patient information and consent and must therefore be presented there in a way that is understandable to patients. Only when patients have understood this can they consent to the measures.
• are the basis for the ethical consideration of benefit vs. risk/burden
• are not to be financed by the payer (health insurance companies). Therefore, the financing of study-related measures must be explained. It must be shown how responsibilities and liability issues are regulated in the event of damage caused by study-related measures.
• may be relevant for the legal classification of the research project.

The difference between study-related measures and routine measures should be illustrated using an example: The study protocol for a research project prescribes the collection of one laboratory parameter. In this case, a distinction must be made between sample collection, sample size and sample analysis:

• Sample collection (puncture for blood sampling) is considered an invasive study-related measureunless the sample is taken as part of a blood collection that is already taking place (e.g. as part of a preoperative blood collection in line with guidelines) or via an access that is already in place (e.g. in intensive care patients, where it can be assumed that an arterial or central venous access is present)
• The size (in this case the volume of blood taken) of the sample serves as a measure of measure of the burden of study-related measures.
• There is no study-related exposure if only residual material is taken, i.e. the study-related analysis is performed on material that would otherwise be discarded in the laboratory.
• If the laboratory parameter is not determined for all patients with the indication, the analysis is to be regarded as study-related.

For further information on this topic, please refer to the following recommendations and information leaflets:

"Additional invasive or other stressful investigations according to § 23b MPG" - Recommendation of the Working Group of Medical Ethics Committees in the Federal Republic of Germany e.V. in accordance with the resolution of the General Assembly on 11 November 2016

Note

Misjudgements or false statements can have consequences under professional law, liability law and criminal law (e.g. Medical Devices Act: §41 No. 4 and 5 in conjunction with §23b or §24 or Medicinal Products Act §96 No. 10 and No. 11)

It can happen that applicants feel that they have been treated unfairly by the Medical Ethics Committee or that they have the impression that the opinion does not meet the standards of a proper ethical and legal assessment. As applicants often do not want to make this public and thus expose their own reputation and/or that of the research project to the risk of damage and do not want to take legal action, the Working Group of Medical Ethics Committees has set up an ombudsperson's office.

The task of the ombudsperson is to act as a moderator to resolve such concerns in an independent, neutral and strictly confidential manner in co-operation with the complainant and, if applicable, the ethics committee concerned. When appealing to the ombudsperson, it is assumed that the complainant has already attempted to resolve the issue with the ethics committee concerned.

Further information on the Ombudsman's Office of the Working Group of Medical Ethics Committees can be found here.