P5 013 Surgical Device Design Validation Testing
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
TITLE OF STUDY: Surgical Device Design Validation Testing
SPONSOR: OLYMPUS Medical Systems Corp.
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.
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.
Purpose: The purpose of this study is to evaluate the design of a new electronical device for open surgery. The manufacturer wants to understand if the design is safe and easy to use and will meet the needs of the intended device users like you. The study will be conducted between January 12th and January 23th, 2025 in an animal lab at Tufts University, Boston.
Procedure: Your total participation in the study will be up to 2,5 hours. During the study session you will be asked to complete a series of tasks focusing on the usage of the device. Afterwards you will be asked questions about your handling experience.
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 of 1,500 $ for completing your assigned test session.
Risks: During the interview you will be handling a new electronical surgery device. Live porcine models under anesthesia have been chosen as the representative and most accurate anatomical models for laparoscopic/open surgery.
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.
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).
Termination of Your Participation: The study facilitator or the study sponsor can take you off the research study if:
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 Disclosure: As required by the U.S. National Physician Payment Transparency Program (commonly known as the "Sunshine Act"), companies must report certain payments and transfers of value made to U.S. healthcare professionals. In order to comply, Olympus Medical Systems Corp. will need to collect and report the following information for participants in this study:
Full name:
Professional title and specialty:
Affiliated institution or practice address:
National Provider Identifier (NPI) number:
Amount of honorarium paid for participation: 1,500 $
Please read carefully and check each box:
In accordance with GDPR Art. 6 Section 1a, and Art. 9 Section 2a
In accordance with GDPR Art. 6 Section 1b
In accordance with GDPR Art. 6 Section 1c, Art. 9 Section 2g
In accordance with GDPR Art. 28
Tufts Medical Center Surgical and Interventional Research Laboratories
Address: 800 Washington St, Boston, MA 02111
Room number: n/a, Surgical and Interventional Research Laboratories
Floor: 3rd Floor, Ziskind Building
Phone number: 617-636-5696
Contact person: Courtney Bogins
Check-in instruction
The meeting point will be the Atrium, 1st floor. A lab staff will meet you there and will take you to the lab.
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