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P2 013 Informed Consent

KDA Marktforschung GmbH

Bruchstraße 5

60594 Frankfurt, Germany

Phone: +49 69 973077-0

Fax: +49 69 973077-20

E-Mail: info@kdagmbh.de

Website: https://kdagmbh.de

INFORMED CONSENT TO TAKE PART IN A RESEARCH STUDY

Agreement between KDA Marktforschung GmbH and:

Full Name

Street address

Zip Code, City

TITLE OF STUDY: P2 013 - RSVt - Usability Formative Study No.3

INVESTIGATOR: KDA Marktforschung GmbH

SUB-INVESTIGATOR: Fresh Perspectives Market Research

You are being asked to participate in a research study. It is important that you read the following explanation of the proposed procedures. A member of the study staff will explain the study procedures to you and answer any questions that you may have about the study or the consent form. When you think you understand the study, you will then be asked if you agree to take part. If you agree, you will be asked to sign this consent form. You will be given a signed and dated copy of this consent form for your records(1).

Your participation in this research study is voluntary. You may quit the study at any time without harming any future medical care or losing any benefits to which you are entitled.

To conduct this study and to fulfill this informed consent, we store your contact details (name, address, potentially your phone number and email address) and the answers you have given in the interview. The storing and transferring of your contact details and the personal data contained in this informed consent via e-mail, streaming, data transfer and postal services within Ireland and to Germany also serves to document your services and the compensation that you received and informs you of the purpose and the study procedure(2).

Purpose: The purpose of this study is to evaluate an atomizer device to be used for injecting a medication into the nose. The manufacturer wants to understand if the design will be safe and easy to use and will best meet the needs of the intended device users like you. The study will be conducted in December 2022 in Dublin, Ireland.

Procedure: Your total participation in the study will require a minimum of 45 minutes. You will be asked to use the atomizer device and inject into a dummy and then questions about your handling experience will be asked.

PLEASE NOTE CAREFULLY: You will be asked to simulate an injection into a dummy.

You will:

Sign an appropriate consent and non-disclosure form,
Receive an introduction to the study,
Answer some demographic and background questions,
Look at and use the device, including different use situations and including an injection into an injection pad,
and answer a series of questions about your experience with the device and the procedures.

You do not have to answer every question or complete every task. However, we would like you to do your very best to complete every task and question.

Confidential Research: This study is confidential. That means that only members of the research team, the study sponsor, its collaborators in the research study, and their affiliates, representatives, and agents (including laboratories and other third-party contractors working in connection with the study), have access to the information you gave. Any information you provide will be kept strictly confidential: your name will not be associated with this information. Instead a unique identification number will be assigned to each participant as a means of identification. During our analysis, and in any reports or other presentations of this research, your data will be identified with that number only.

Compensation: You will be compensated for your time and will receive a monetary honorarium for completing your assigned test session(s). Compensation is dependent on your role and time commitment for your test session. Based on participation of up to 45 minutes, you will receive the respective amount of compensation. Please confirm the agreed amount:

EUR

Risks: During the interview you will be handling a semi-blunt needle, a vial containing a Placebo and an atomizer device. Because there is a minimal risk to prick or scratch yourself on the needle or the vial seal, we ask you to handle the device with special care. All additional equipment normally used for an injection will be provided. During the study it would be sufficient to verbally confirm how to use it. A moderator will be present at all time during the interview.
Though unlikely, there is a small risk of loss of confidentiality in the event of a breach. Efforts have been made to minimize this risk.

Research Related Injury: If you experience an injury during the interview, please notify the moderator and/or principal investigator. Treatment for the injury will be paid for by the sponsor of the study.

Benefits: As a research participant, you will not benefit directly from this research.

Alternatives to Participation: Since this study is not intended to provide any therapeutic or other health-related benefit, your alternative is to not participate in this study.

Costs: There are no direct costs for your participation in this study.

Data Privacy: During the sign-up process and possibly during your study session you have provided personal data, and possibly will provide more personal data, about your age, medical conditions, experience with injections, etc. This information is secured to protect your privacy. The sponsor needs your data to assess the tested app and to show that the study observations were valid and accurate, for example when the results of this study are presented to regulatory authorities. At any time during or after the study you are entitled (allowed) to see, correct and limit access to your personal data. According to the GDPR regulations, the video recording and the informed consent will be kept for 10 years and will be deleted no later than 10.5 years after your participation(3).

If you have complaints, you can call the investigator under the number listed at the top of this page.

Future Use and Retention: The data collected during this study will be stored with other documents for the development of the medical device that you will be testing. Your data and some of the background information you gave us (such as age and experience with injections) will only be labeled with your participant number. The study facilitator will remove all personal information that you provided and its connection to your participant number after the study report is finalized. After that time, the study data will be considered to be anonymous because it will not be possible to connect the data with your name and therefore is not subject to data protection anymore.

The study facilitator will keep your name and contact information in case an injury occurs so that they can follow up with you afterward if needed, but they will not keep a record of what your participant number was.

Audio and Video Recording:

A video-recording of the interview is made for analysis and control purposes. You may decide not to give permission for audio and video-recording of your session. In that case, you will not be able to participate in the study. This is because the study personnel would not be able to collect the data needed to evaluate the study device. If you do allow the study personnel to audio and videotape your session, these recordings may be used by the study personnel for later review and analysis (if necessary). Your comments will be transcribed and the recordings will be labeled with the date of the session and your participant number only (not your name). The video recording will be forwarded to external contractors and technical service providers of KDA for data analysis and video editing within Ireland and to Germany. The recording will be digitally stored on (a) password-protected computer(s)(4).

Termination of Your Participation: The study facilitator or the study sponsor can take you off the research study if:

You are unable to meet the study requirements,
For any other reason, or
The study is cancelled by the sponsor.

You may choose to withdraw your consent to allow the study facilitator and study sponsor to use your personal data for the purposes of the study as described above either during the study session or after the study session is over.

Study contact: If you have any further concerns, complaints, or questions, you may contact the Principal Investigator mentioned above or the moderator/ your local contact at:

Colin Boylan, Director

Ph: +353-(0)85-2813600

Email: Colin@freshperspectives.ie

Please confirm that you have read and agree with the conditions listed above:

I understand that my participation in this research project is voluntary. By signing this form, I have not waived any of my legal rights. I have read the above information. I agree to participate in this study as described above. I can download a copy of this signed and dated form for my own records.

I confirm that I have read the conditions listed above and I had the opportunity to ask questions to a member of study team who introduced me to the study.

(1) In accordance with GDPR Art. 6 Section 1a, and Art. 9 Section 2a

(2) In accordance with GDPR Art. 6 Section 1b

(3) In accordance with GDPR Art. 6 Section 1c, Art. 9 Section 2g

(4) In accordance with GDPR Art. 28

Information on our privacy policy

The General Data Protection Regulation we informed you in detail to what purpose KDA collects, records or transfers your data. The company responsible for data processing is

KDA Marktforschung GmbH, Bruchstr. 5, 60594 Frankfurt, Germany.

Your Rights are

Under the General Data Protection Regulation, you have the rights to:

Withdraw your consent with future effect. To that end, you can tell your study contacts or the KDA manager (Thomas Jahnke, phone: +49-69-973077-11, thomas.jahnke@kdagmbh.de). In case of withdrawal of consent we are allowed to process the data concerned, insofar as this is necessary to fulfill legal requirements.
If your personal data is being processed on the basis of legitimate interest, you have the right to object to the processing of your personal data, if there are reasons stemming from your particular situation.
Be informed about your personal data which we process. You may in particular require information as to the purpose of processing, the category of personal data, the categories of recipients with whom your data was or is shared.
Immediately require the correction or completion of your personal data stored with us.
Require the deletion of your personal data stored with us.
Require the restriction of procession of your personal data.
Receive the personal data you have provided us with in a structured, common and machine-readable format or demand forwarding the data to another competent person.
Contact our privacy officer Dr. Christiane Farnbacher (christiane.farnbacher@kdagmbh.de, phone: +49-69-973077-26) or file a complaint with the competent privacy authority.

Declaration of Consent for Processing Personal Data

I agree in the processing of my personal data as described above. I am aware that I can choose not to answer individual questions, and that I can withdraw this consent at any time.

NON DISCLOSURE AGREEMENT

Non-Disclosure: You agree that you will not disclose to any person (third party), or use for your own benefit, any confidential ideas, concepts, designs, or any information relating to any products or potential products, methods, client identities, business leads and relationships, intellectual property of various kinds, or other confidential information of the Study Sponsor, which may be disclosed to you in the course of this study.

Inventions, Discories, and Improvements: You agree that any input that you provide during the course of the study can be freely employed by the Study Sponsor with no restrictions. You further agree that all inventions, improvements, or discoveries, whether patentable or un-patentable, made, devised, or discovered by you during the course of this study, as well as all data generated during the course of the study and any copyright or other rights in such data or inventions will become the property of the Study Sponsor and will remain its sole and exclusive property, and further that you shall not acquire any rights in such data or material by your participation in the study.

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14. November 2022 16:22 CEST

P2 013 Informed Consent Uploaded by Christiane Farnbacher - christiane.farnbacher@kdagmbh.de IP 95.222.28.135

18. November 2022 16:55 CEST

Miriam Simianer - miriam.simianer@kdagmbh.de added by Christiane Farnbacher - christiane.farnbacher@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110

18. November 2022 16:55 CEST

Thomas Jahnke - thomas.jahnke@kdagmbh.de added by Christiane Farnbacher - christiane.farnbacher@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110

23. January 2023 11:49 CEST

Miriam Simianer - miriam.simianer@kdagmbh.de added by Christiane Farnbacher - christiane.farnbacher@kdagmbh.de as a CC'd Recipient Ip: 95.222.28.135

23. January 2023 11:49 CEST

Thomas Jahnke - thomas.jahnke@kdagmbh.de added by Christiane Farnbacher - christiane.farnbacher@kdagmbh.de as a CC'd Recipient Ip: 95.222.28.135