The Ethics Committee of KIT will only examine your research project for its ethical soundness if you request this and submit a corresponding application. A positive vote by the Ethics Committee is often a prerequisite for third-party funding applications or the intended publication of research results. This applies in particular to research projects that work with/on humans.

It is also advisable to consult the ethics committee in the case of safety-relevant research (scientific work whose results could be misused by third parties to harm people or the environment). For contracts with third parties in particular (e.g. contract research, collaborations), it is sometimes necessary for the ethics committee to certify that the research is ethically sound.

The Ombudspersons for Ethical Principles or the Office for Good Scientific Practice and Ethical Principles will be happy to advise you on whether an ethics application should be submitted.

Important: The Ethics Committee only examines research projects for ethical clearance if data collection has not yet begun!

1. Decide which form of application you would like to submit:
    
   1. The usual form is "single studies". If single studies build on each other, the connection between the studies can be shown in the "Follow-up project" field.
      
      Simplified example of successive single studies: An app is developed to make users laugh. To this end, interviews are conducted to find out what test subjects find funny and this is implemented in an app. The result is a functional app. (≙ Project 1) This app is now to be evaluated through feedback from various groups of test subjects. (≙ Project 2)
      
      Connection between project 1 and project 2: The study design of project 2 can only be assessed by the ethics committee if it is known what content is shown to the test subjects through the app. This only works once the functional app is available as a result. Project 2 is therefore an individual project and a follow-up project to Project 1.
       
   2. The term "study series" refers to projects that are made up of various individual projects, but whose results are not mutually dependent.
      
      Simplified example of a study series: A group of test subjects is to walk for five minutes and cycle for five minutes for sub-project 1, while their spatial vision is to be tested for sub-project 2. The results from both sub-studies are incorporated into the results of the study series. During the work on the study series, it becomes clear that the resting heart rate should also be recorded in order to improve the results of the study - an ethics application with the corresponding form is submitted for this additional sub-project.
      
      Connection of the sub-projects: The sub-projects are independent of each other, i.e. none of the sub-projects builds on the next; the results of all sub-projects flow into an overall result.
       
2. Check whether data protection regulations must be observed in your research project. (The "interactive Virtual Assistant" iVA 1 provides assistance.) If so, you will find further information below in the section "Data protection review for ethics applications".
    
3. Complete the application form in full (do not forget to sign it!). Focus on describing the benefits and risks of your research project - both for the people involved, society as a whole and the environment. Describe which ethical risks you (must) take and for what reasons in order to obtain the desired research results. Describe the research design of your project as specifically as possible ("application prose" should be avoided!); bear in mind that the members of the ethics committee may be unfamiliar with the subject and may therefore require more background information.
    
4. Send the completed form and all other relevant documents (e.g. questionnaires, consent forms, subject information, etc.) in the form of individual PDF by e-mail to the person responsible for organization, Valerie Boda , by the deadline.
   
   Please note: Please also create PDF versions of documents that are only made available to participants online (e.g. online surveys). This will make record keeping and archiving easier.
    
5. You will receive an application number from the person responsible for the organization and confirmation of the session in which your research project will be reviewed.
    
6. You will usually receive the ethics vote by e-mail approximately one week after the meeting date. Please ensure that you fulfill any requirements as quickly as possible.

A lack of data protection measures is a risk for trial subjects. Therefore, the Ethics Committee of KIT requires an examination and approval of research projects in which personal data is processed.

The Data Protection Office (DSB) team is responsible for this. The basis for the data protection review is the General Data Protection Regulation (GDPR) and the Baden-Württemberg State Data Protection Act (LDSG).

If personal data is processed in your research project, the data protection officer must be involved at an early stage in accordance with Art. 38 (1) GDPR. Proceed as follows:
 

1. Be aware of the steps in your research project in which personal data is recorded, stored, passed on or otherwise processed.
    
2. On the basis of this information, create an entry in KIT's electronic procedure directory (eVV).
    
3. Create all documents that are necessary for the interaction with the data provider (usually the test subjects): Data protection declaration, subject information, declaration of consent; and, if necessary, questionnaires or interview guidelines. Templates for documents relevant to data protection law are often already available at the institutes; alternatively, DSB  will be happy to provide you with templates.
   
   The "interactive Virtual Assistant" iVA 2 provides assistance in drafting an effective declaration of consent.
    
4. Send all documents (ethics application and the above-mentioned data protection-relevant documents) by e-mail to DSB  by the deadline. Ideally, send the documents as editable Word versions, as this makes it easier to comment on them.
   
   State the number of the eVV entry and explain that you require data protection approval for your research project for an ethics vote.
    
5. Clarify any queries with the DSB and, if necessary, adapt your documents.
    
6. Continue with point (3) in the "Application procedure" section above.

Every vote of the Ethics Committee of KIT on research projects states:

"We ask you to notify the Ethics Committee of any changes in the research project. In addition, you are obliged to report without delay all serious or unexpected adverse events before or during the implementation of the research project, that affect the safety of the participants or the implementation of the research project."

If you would like to notify the Ethics Committee of a change to your research project, please send an e-mail to the person responsible for the organization, Valerie Boda .

Describe in the e-mail (preferably in keywords)

• what changes you are making,
• why these are necessary
• and whether or what influence you believe the changes will have on the ethical risk-benefit assessment.

Please attach any updated documents, clearly labeled, as PDF documents.

If you are planning major changes, it may be helpful to prepare a so-called amendment application. This makes it easier for the Ethics Committee to review your changes:

• For an amendment request, use the already completed request form in the Word version and mark all changes in the text using the "Track changes" function.
• Send the change request and all other clearly named documents in the form of individual PDF by e-mail to the person responsible for the organization, Valerie Boda , by the deadline.
• Please also describe in the e-mail text,
  • which changes you are making
  • why these are necessary
  • and whether or what influence you believe the changes have on the ethical risk-benefit assessment.

The Ethics Committee will take note of the notified amendment as soon as possible. If it sees no ethical concerns, the committee will formally decide at the next possible meeting that its original vote remains valid. A confirmation will be sent to you by e-mail.