P3 015_informed consent_SurgeryDevice_Usability-FoB_Nurses


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 USABILITY RESEARCH STUDY

Agreement between KDA Marktforschung GmbH and:

 

Full Name  
Street address

 

 

Zip Code, City

 

TITLE OF STUDY:               Surgical Device Nurse Usability Evaluation 

INVESTIGATOR:                 KDA Marktforschung GmbH, Frankfurt, Germany

SUB-INVESTIGATOR:        Focus on Boston

 

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.

To conduct this study and to fulfill this informed consent, KDA will 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 and streaming, data transfer within the US to Germany and Japan 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 a new electronical device for open surgery. 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 between April 4th and April 11th, 2024 in a Focus on Boston facility.

Procedure: Your participation in the study will consist of:

  • simulated use tasks
  • product knowledge tests

You will be asked to complete a series of tasks focusing on the usage of the device and afterwards questions about your handling experience will be asked.

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. The Food and Drug Administration (FDA) and possibly other government agencies will be given access to these records at their request and may copy them. The study sponsor and its agents may send a copy of the records to the FDA as required by law.

Compensation: You will be compensated for your time and will receive a monetary honorarium for completing your assigned test session. 

$ 400 for full participation in the study.

 

Risks: During the interview you will be handling a new electronical surgery device.

There will be no substantial risk of hurting yourself when using the device. A moderator will be present at all times 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.

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

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, your working place, etc. This information is secured to protect your privacy. The sponsor needs your data to assess the tested device and to show that the study observations were valid and accurate, for example when the results of this study are presented to regulatory authorities such as the FDA. 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 FDA regulations, the video recording and the informed consent will be kept for 10 years and will be deleted shortly after this.[3]

Further information about data protection can be found under https://kdagmbh.de/data-protection/?lang=en

 

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 electronical devices for open surgery) 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.

 

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 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
  • 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: 

KDA Marktforschung GmbH
Thomas Jahnke

Bruchstr. 5, 60594, Frankfurt, Germany.

phone: +49 69 97307711

If you have any questions about your rights as a research subject, or complaints, concerns or questions regarding this research study, you should call to express concerns, obtain  information or offer input about the study to the local researcher and moderator.

 

Sunshine Act

As you may be aware, the National Physician Payment Transparency Program, (the Sunshine Act”) requires payments and other transfers of value made to US Physicians and teaching hospitals reportable. The sponsor of this market research study interprets the Sunshine Act in a manner that obliges it to disclose the name and honorarium amount paid to health care practitioners taking part in market research if their identity should become known to the sponsor.

 

To mitigate the chances of this identification, the sponsor has structured this project to initiate on a “double blind” basis – that is, you will not know the identity of the sponsoring company, and they will not learn your identity through the course of the interview.

However, should this blinding be broken - either by you revealing your name during the interview, or by a member of the sponsor recognizing you - the Sunshine Act requires that any payment made to you for participating in this research is disclosed by the sponsor.

In the event that the blinding is broken, how would you prefer to proceed?

Please read carefully and check each box:

 

 

Please enter the agreed appointments:

 

 

 

[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

 

Check-In Instructions: 

Meet-up location is the Harbour Conference Room at the Rowes Wharf Facility from Focus on Boston. 

 

Downtown Rowes Wharf

30 ROWES WHARF, BOSTON, MA 02110
 

 

 

 

 

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Zertifikat
Document name: P3 015_informed consent_SurgeryDevice_Usability-FoB_Nurses
lock iconUnique Document ID: b9af1096d3d5bf21dd57f4c01adc1905bec5953b
Timestamp Audit
1. February 2024 16:45 CETP3 015_informed consent_SurgeryDevice_Usability-FoB_Nurses Uploaded by KDA Marktforschung - consent@kdagmbh.de IP 37.24.207.110
2. February 2024 13:51 CETMiriam Simianer - miriam.simianer@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
2. February 2024 13:51 CETThomas Jahnke - thomas.jahnke@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
2. February 2024 13:58 CETMiriam Simianer - miriam.simianer@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
2. February 2024 13:58 CETThomas Jahnke - thomas.jahnke@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
9. February 2024 10:31 CETKDA Marktforschung - consent@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
9. February 2024 10:31 CETJoshua Valentin - joshua.valentin@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
9. February 2024 11:02 CETKDA Marktforschung - consent@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
9. February 2024 11:02 CETJoshua Valentin - joshua.valentin@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110