Self-Assessment Test at the University Ethics Committee

This questionnaire will determine if and to what extend your project includes aspects that are ethically sensitive and/or require data protection measures. Afterwards, you will get feedback whether an assessment by the University Ethics Committee is required for your project.

Part of the questionnaire are two separate sections:

A check on data protection and ethically sensitive aspects

An assessment of whether an evaluation by the committee is required

After sending us the completed questionnaire, you will receive further information and the necessary documents.

General information

Personal details

First and last name :Klicken oder tippen Sie hier, um Text einzugeben.

Supervision (only for theses/dissertations/habil. theses) by:
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Date of this self-assessment test: Klicken oder tippen Sie, um ein Datum einzugeben.

Department/Scientific Center:Klicken oder tippen Sie hier, um Text einzugeben.

Please note that the faculties 01 Human Sciences and 05 Social Sciences have their own ethics committees. If you are a member of either of these faculties, please contact your faculty-internal committee with your request.

Please enter the type of your project here (multiple selection possible)

☐ Bachelor’s or master’s thesis

☐ PhD thesis or postdocotoral thesis

External doctorate/habilitation

☐ Yes

☐ No

☐ Non-externally funded research project

☐ Third-party funded project

☐ Publication project

Topic or title of your project:

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Publications

Will you produce publications or other interim or final reports on your project, and, if working with participants, will these reports be available for subjects to view?

☐Yes

If yes, please specify how and when

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☐No

Part 1: Data protection and ethical sensitivity

In the first part, we would like to obtain general information about your project and identify sensitive points.

Research with animals

Do you plan to conduct research with animals in your project?

☐Yes

Please provide a brief description:

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For research involving animals, please contact the University's Animal Welfare Officer first to clarify if your project contains (an) animal experiment(s) that must be reviewed by the Animal Welfare Authority.

☐No

Data collection

What data collection methods will be used? (Multiple selection possible)

☐ Questionnaires

☐ Interviews

☐ Psychological tests

☐ Physiological tests

☐ Audio recordings

☐ Video recordings

☐ Projective procedures

☐ Observation

☐ Document analysis

☐ Other: Klicken oder tippen Sie hier, um Text einzugeben.

When will the data collection take place?

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In which country/countries will the primary data collection take place (Multiple answers possible):

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Personal data

Definition:

According to Art. 4 No. 1 DSGVO, personal data are "any information relating to an identified or identifiable natural person (hereinafter 'data subject'); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person." It is important to note in this definition that the reference to a person can arise directly from the data used, but also from the additional knowledge of the person responsible for the data. The inclusion of "indirect" identifiability also covers many cases where the data subject's name is not included.

Question: Does your project collect personal data?

☐Yes

Please briefly state which personal data are going to be collected:

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☐No

Please state briefly why you are not collecting any personal data:

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If you answered no, please proceed with question 12 “Research with humans”

Data management

What kind of data processing records do you require?

☐ Contract on joint responsibility for a processing activity (if an institution or person outside U Kassel jointly decides with you on the means and purposes of the processing of the personal data)

☐ Contract for the processing of personal data (“Auftragsverarbeitungsvertrag”, i.e. AVV) if a natural or judirical person outside U Kassel who processes the personal data according to your instructions

☐ Processing records (“Verarbeitungsverzeichnis”, i.e. VVT) because they collect and store the data independently and on servers of U Kassel

If a submission to the Central Ethics Committee is required, please prepare the relevant list or contract, coordinate it with the Data Protection Officer if necessary, and attach it to your application to the Committee. Templates and advice on data processing can be found on the Data Protection Officer's page (https://www.uni-kassel.de/hochschulverwaltung/organisation/beauftragte/datenschutz)

Type of Data

How is the personal data collected and processed?

☐ Anonymized

Please clarify: Which data is anonymised? At what point in the data collection or data evaluation does the step occur? How will you proceed here?

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☐ Pseudonymised

Which data will be pseudonymised? At what point in the data collection or data analysis does the step take place? How will you proceed here?

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☐ Some data are anonymised, others are pseudonymised

Please clarify: Which data are anonymized, which are pseudonymised, and why? At what point in the data collection or data analysis does the step occur? How will you proceed here?

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☐ Without measures of anonymization and pseudonomisation

Please explain briefly

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If you are unsure about the exact nature of your data collection, we recommend the following definition by the European Commission:: https://commission.europa.eu/law/law-topic/data-protection/reform/what-personal-data_en

Confidentiality

Is confidentiality guaranteed and is there a duty of confidentiality?

☐Yes

☐No

If no, please briefly explain why:

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Data protection information

Are participants informed about the study, esp. about the data collected, the purposes of use, the rights of data subjects, the contact details of the data protection officers, the possibility of withdrawing from participation and the protection of personal data)?

☐Yes

If yes, which documents (in one document or individually) do you provide to participants?

☐ Declaration of consent to participation

☐ Information sheet on the objectives and procedures of the project

☐ Overview of data protection measures and data protection contacts

☐ Information about the possibility of withdrawal

☐ Information about data deletion

If you are requested to submit an application to the central ethics committee, these documents are a mandatory part of the application. For this purpose, please check whether your documents are compliant with the requirements of the data protection officers.

☐No

If no, please briefly explain why:

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If no: Please contact the data protection officer for support, as the information in the documents represents a mandatory component for a project!

Compliance with data protection is a central requirement for clearance by the ethics committee!

Preliminary review of the data protection documents

Have the documents on data protection and declaration of consent already been cleared by the data protection officer, or have you used their template(s)?

☐The documents have already been reviewed by the data protection officer

☐I have used the template provided by the data protection office

☐No

If no, please briefly explain why:

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The templates of the data protection officers can be found here: https://www.uni-kassel.de/intern/datenschutz-1

Right to data deletion

Can participants request the deletion/destruction of their personal data at any time and will they be informed of this right?

☐Yes

☐No

If no, please briefly explain why:

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Research with humans

Please answer this question only if you answered No to question 5 ("Personal data").

If you indicated that you do not collect personal data, it is still possible that your project involves research on/with people, albeit without collecting any personal information on them and thereby guaranteeing their anonymity.

Question: Does your project involve work with participants?

☐Yes

☐No

If no, please briefly explain why:

Klicken oder tippen Sie hier, um Text einzugeben.

If no, please proceed to question 28 „Implications for researchers“

Voluntariness

Is it guaranteed that participation in the project is voluntary?

☐Yes

☐No

If no, please briefly explain why:

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Use of technical devices

Do you plan to experiment with or collect data from people using technical devices?

☐Yes

If yes, please list which (types of) devices you will be using:

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☐No

Questions on research in the university context

The following questions relate to research projects in a university context. Since we receive a large number of applications with such projects, the following questions have been included in the self-assessment.

Research with students

Are you planning to work with students as research participants?

☐Yes

If yes, please briefly explain:

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☐No

Research with participants from the same work area or team

Are you planning to recruit people from your own department or specialist area?

☐Yes

If yes, please briefly explain:

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☐No

Legal capacity

Will persons participate in the study who are not able to give informed consent (e.g., persons under 18 years of age or persons who are not legally capable of giving consent)?

☐Yes

If yes, please briefly explain:

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☐No

Vulnerable persons

Will the study involve individuals who belong to a particularly vulnerable group (e.g., individuals with learning disabilities, individuals in correctional settings, refugees)?

☐Yes

If yes, please briefly explain:

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☐No

Inclusion and exclusion criteria

Are there any criteria for the inclusion and/or exclusion for certain (groups of) participants?

☐Yes

If yes, please briefly explain:

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☐No

Deception about participation

Is it necessary for your study that individuals participate without being informed about their participation prior to it or without having given their consent (e.g., in the case of non-open observation), or that they are not fully informed about the purpose and content of the study (note: this does not include disclosure of the research hypotheses)?

☐Yes

If yes: Please briefly explain and explain how and when the deception is resolved:

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☐No

Deception about study purpose

Are individuals actively deceived about the content and purpose of the study?

☐Yes

If yes: Please briefly explain and explain how and when the deception is resolved:

Klicken oder tippen Sie hier, um Text einzugeben.

☐No

Intimacy / stigmatization

Does your study involve questions on topics that touch on intimate matters for the respondent, or require answers that may be perceived as stigmatizing (e.g., about illegal or deviant behaviour)?

☐Yes

If yes, please briefly explain why:

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☐No

Physical strain

Will participants be physically impacted?

☐Yes

☐ Blood collection

☐ Administering of medication

☐ Invasive measurements

☐ Non-invasive measurements

☐ Other: Klicken oder tippen Sie hier, um Text einzugeben.

☐No

Psychological stress

Are participants likely to experience psychological stress, fear, fatigue, pain, or other negative effects as a result of the study beyond what would be expected in everyday life?

☐Yes, due to:

☐ Duration of activity

☐ Aversive stimuli

☐ Other: Klicken oder tippen Sie hier, um Text einzugeben.

☐No

Personal details of the participants

Are participants likely to disclose personal experiences or attitudes during the study?

☐Yes

If yes, please briefly explain and list the possible thematic areas in question:

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☐No

Precautions

Are precautions taken to minimize negative effects on participants?

☐Yes

If yes, please specify:

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☐No

If no, please explain why:

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Insurance cover

Do participants have insurance cover for their journey to and from the study location, or are they informed that the journey to the location is not insured? (Note: If there is such insurance, the policy should be available for inspection in the secretary's office)

☐Yes

If yes, please briefly explain the format of the insurance:

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☐No

If no, please explain why:

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Implications for researchers

Is it likely that the researchers involved will be exposed to direct or indirect psychological or physical stress and/or other hazards?

☐Yes

If yes, please briefly explain why:

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☐No

Part 2: Information on the application requirement

In the second part, we would like to classify whether an application is required for your project.

Need for a review by the University Ethics Committee

Do you need an ethics approval for your project for an external institution (e.g. third party funding organisation, journal, publishing house etc.)?

☐Yes, it is required by:

Klicken oder tippen Sie hier, um Text einzugeben.

☐No

If an ethics approval is mandated externally, are there specific requirements set by the external institution for that the ethics committee should observe in their review?

☐Yes, they are:

Klicken oder tippen Sie hier, um Text einzugeben.

☐No

Is there a deadline for completing the ethics vote (grant application process, submission to a journal, thesis deadline)?

☐Yes, the deadline is:

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☐No

Has a request for a similar project already been submitted to the Central Ethics Committee (e.g. from the same faculty or department, or regarding a comparable procedure)?

☐No

☐Yes

In this case, please provide some details:

Title: Klicken oder tippen Sie hier, um Text einzugeben.

Applicant(s): Klicken oder tippen Sie hier, um Text einzugeben.

(If known: Sequence number: zEK- Klicken oder tippen Sie hier, um Text einzugeben.)

Please briefly explain in which way your project is similar to the one already reviewed (e.g. methods, experimental design, subject or by the data protection documents that have already been used in the previous application):

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Completion of the survey

By completing the self-assessment, you confirm that all information in this questionnaire is accurate to the best of your knowledge.