P4 012 Informent Consent Form (Nurses)


Ergonomics Factory LLC

Rue du Voisinand 8

1095 Lutry, Switzerland

 

Phone: +41 213 11 11 00

E-Mail: office@efty.ch

Website: https://www.efty.ch/

 

 

ERGONOMICS FACTORY
PARTICIPANT INFORMATION AND INFORMED CONSENT FORM
 
Protocol Title: Formative Human Factors Test Protocol for a Kineret Prefilled Syringe with Needle Trap Label
Protocol #: EFTY-US-31-2024-2
Sponsor: The Swedish Orphan Biovitrum AB (SOBI)
 
Principal Investigator: Dr. Andreas BAIER
Institution: Ergonomics Factory
Address: Rue du Voisinand 8, 1095 Lutry, Switzerland
Telephone: +41 76 26 97 332
 
KEY INFORMATION ABOUT THIS RESEARCH STUDY
You are being asked to participate in a research study, specifically in a Human Factors Study. It is important that you read the following explanation of the research study activities very carefully.
The purpose of this Informed Consent Form is to give you information about this research study, specifically its purpose, procedures, benefits, risks, discomforts, and precautions.
You should only take part in this research study if you want to do so. You may refuse to take part or withdraw from this research study at any time without penalty or loss of benefits to which you are otherwise entitled.  
 
Please read this Informed Consent Form and ask as many questions as needed. This Information and Consent Form may contain words you do not understand.  Please ask the Lead Investigator / Moderator to explain anything that you do not clearly understand.
When you think you understand the information about this research study and agree to take part in this research study, you can sign this consent form. You may keep a signed and dated copy if you choose to. You should not sign this Informed Consent Form if you have any questions that have not been answered to your satisfaction.
 
Purpose: This is a research study to evaluate the usability and use-related safety of a prefilled syringe for subcutaneous injection at home or at a clinic.
During your test session, you will be asked to perform some tasks with this prefilled syringe in a simulated use manner and to answer questions about the usage of the device and the experiences you have made with it.
 
You will NOT receive, nor will you administer to another person, any medication. This research study is focused on the evaluation of the usability (i.e. ease of use) and use-related safety of the prefilled syringe. The use of it during this research study is simulated. The injection is performed into simulated skin (injection pad).
 
The prefilled syringe will contain a sterile needle and placebo (harmless solution) and no real medication.
Voluntary Participation Your decision to take part in this research study is voluntary.
 
Withdrawal If you decide to take part in this research study and change your mind during this research study, you can leave at any time without penalty.
Length of Participation Your total participation in this research study will be no longer than 75 minutes (1h and 15 minutes) during a one-day visit at the testing facility.
Procedures During this research study, you will:
⮚ Sign this Informed Consent and Non-Disclosure Form (at the end of this document)
⮚ Receive an introduction to this research study
⮚ Answer demographic and background questions
⮚ Self-familiarize with the device and study materials (optional) 
⮚ Simulate the use of the prefilled syringe (to administer an injection using the prefilled syringe into injection pad)
⮚ Answer questions about the prefilled syringe use
 
Number of Subjects: This study plans to enroll up to 24 participants.
 
Risks No major risks are to be expected for you due to your participation in this research study. This is a simulated use only study. 
However minor risks exist, including the following:
● Although the risk associated with participating in this user study is low, it is possible that you may experience feelings of frustration, annoyance or stress associated with the simulated use environment.
● During the study session, you will be asked to follow the moderator’s instructions and to behave responsibly throughout the session. The prefilled syringe contains a sterile needle, and you are asked to take caution when handling it. If at any time you believe it to be unsafe, please inform the moderator immediately. 
● In the unlikely event that you may accidentally be injured by the test materials in any way - the activities will be stopped by the moderator and first aid will be provided. If necessary, a paramedic will be called.
● If you experience any injury as a direct result of this research study, notify the Principal Investigator. The sponsor of this research study will pay for reasonable and necessary medical treatment of injuries and illness that are a direct result of study devices and/or study procedures that are required by the study protocol and that were done correctly and only because you were in this study. You must follow the directions of the moderator to be eligible for this coverage.
● Loss of data confidentiality, though highly unlikely, is a potential risk of being in this study.
Benefit As a participant in this research study, you will not benefit directly from this research; however, the information learned may help people in the future.
 
Alternatives to Study Participation No medical treatment will take place in this study. Your alternative is to not participate in this research study.
 
Costs:  There are no direct costs for your participation in this research study.
 
Audio and Video Recording: You will be audio recorded and videotaped during this research study. You may decide not to give permission for audio and video recording. In that case, you will not be able to participate in this research study. This is because the study personnel would not be able to collect the information needed to evaluate the prefilled syringe design.
 
If you do allow the study personnel to audio record and videotape your participation in this research study, it will be to review and analyze the data collected in this research study. The recordings will be labeled with your participant number, not with your name or contact details, in accordance with data privacy and protection policies, laws, regulations, and guidelines including but not limited to GDPR.
 
The recordings will be digitally stored on password-protected computer(s). The computer(s) will be accessible only to the research study personnel and the research study sponsor until the research is done and the recordings are no longer required for supporting the data analysis and market approval of the prefilled syringe. Thereafter the recordings will be destroyed.
The recordings will only be used for purposes described above.
 
Confidentiality: This study is confidential. That means that the Sponsor of this research study, its collaborators in this research study, and their affiliates, representatives, and agents (including laboratories and other third-party contractors working in connection with this research study) will know the information and feedback you provide but will not have access to your name or contact information. 
Any information you provide us (the study team) will be kept strictly confidential (e.g., your name will not be associated with this information). 
We will assign a unique identification number 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 unique identification number only. 
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and possibly other government agencies will be given access to these records at their request and may copy them. The Sponsor and its agents may send a copy of the records to the FDA and EMA as required by law.
 
You have the right to see and get a copy of your records related to this research study for as long as the Lead Investigator has this information.
 
If you withdraw from this research study and withdraw your consent, no new information about you and your participation will be collected. However, all information that has already been collected for the purposes of this research study up to that point will be kept.
 
 
Compensation: You will be compensated for your participation in this research study and will receive a monetary honorarium of  250 USD for completing your participation in this research study.
 
You will be paid upon completing this research study in the form of a check or cash. You have no obligations to use, purchase, lease, recommend, or otherwise arrange for the use of the Sponsor’s products.
 
You may be required to report the payment received for your participation in this research study as taxable income.
Voluntary Participation You should only take part in this research study because you want to. There is no penalty for not taking part and you will not lose any benefits. 
 
You have the right to stop your participation in this research study at any time.
Withdrawal/ Termination The Investigator or Sponsor can take you out of this research study if: 
● You do not meet the study requirements. 
● The study is canceled by the Sponsor. 
● For any other reason that the Investigator believes is in your best interest. 
 
If you exit this research study early, your compensation will be prorated based on the time that you have participated (for example, if you complete half of the study, you will receive half of the total compensation). 
 
We will retain all data collected before and up to the point of your exit from this research study.
 
Getting Answers to Your Questions or Concerns About the Study:
You can ask questions about this Informed Consent Form or this research study before you decide to start your participation in this research study, at any time during this research study, or after the completion of your participation in this research study. 
Questions may include:  
● Who to contact in the case of a research study-related injury or illness; 
● Payment or compensation for taking part in this research study; 
● Your responsibilities as a research study participant; 
● Eligibility to participate in the research; 
● The study investigator’s or study site’s decision to exclude you from participation; 
● Other questions, concerns, or complaints. 
 
Contact the Principal Investigator listed on the first page of this Informed Consent Form with any questions, concerns, or complaints.  
 
Whom to Contact About this Research Study: 
During this research study, if you experience any medical problems, suffer a research study-related injury, or have questions, concerns, or complaints about this research study, please contact the Principal Investigator at the telephone number listed on the first page of this consent document. If you seek medical emergency care, or hospitalization is required, alert the treating physician that you have been participating in this research study.  
 
Legal Rights: 
You do not give up any legal rights as a participant in this research study by signing this Informed Consent Form.
 
New Information About this Research Study: 
You will be told about any new information found during this research study that may affect whether you want to continue to take part in it.
 
ACKNOWLEDGED AND ACCEPTED: 
● I have read the above information. 
● I have been given a chance to ask questions about this research study. These questions have been answered to my satisfaction.
● I can leave this research study at any time without giving a reason and without penalty.
● I agree to the use, sharing, and analysis of my personal information and research study information by the Sponsor and other authorized persons and regulatory agencies as described in this Informed Consent Form.
● I understand that my participation in this research study is voluntary. 
● I do not give up any legal rights that I would otherwise have if I were not in this research study. 
● I agree to participate in this research study. I may keep a copy of this signed and dated Informed Consent Form for my own records.
 
 
STATEMENT OF PERSON EXPLAINING CONSENT: 
I have carefully explained to the subject the nature and purpose of the above research study. There has been an opportunity for the subject to ask questions about this research study. I have been available to answer any questions that the subject has about this research study. 
   
 
 
 
             ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
 
 
 

 

 
Non Disclosure Agreement
 
Non-Disclosure You agree that you will not disclose to any 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 and the Principal Investigator, which may be disclosed to you in the course of this research study.
 
Inventions, Discoveries, and Improvements: You agree that in exchange for the compensation provided by the Sponsor, any input that you provide during the course of this research study can be freely utilized by the Sponsor with no restrictions. 
 
You further agree that all inventions, improvements, or discoveries, whether patentable or un-patentable, made, devised, or discovered during the course of this research study related to or emerging from this research study, as well as all data generated during the course of this research study and any copyright or other rights in such data or inventions will become the property of the 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 this research study.
 
 

 

 

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Document name: P4 012 Informent Consent Form (Nurses)
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28. May 2025 11:55 CESTP4 012 Informent Consent Form (Nurses) Uploaded by KDA Marktforschung - consent@kdagmbh.de IP 2003:c9:f700:fa27:f47a:477b:4a0d:9943
28. May 2025 11:55 CESTJoshua Valentin - joshua.valentin@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 2003:c9:f700:fadc:6874:e3bb:4f5b:7e83
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