P3 015 Informed Consent_Surgery Device_Usability
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
Volunteer’s Statement
for study P3 015
between
Bruchstr. 5
60594 Frankfurt
and Volunteer
I have been given a chance to ask questions about this research study. These questions have been answered to my satisfaction.
I understand that my participation in this research project is voluntary. I know that I may quit the study at any time. I also understand that the Study Facilitator in charge of this study may decide at any time that I should no longer participate in this study.
If I have any questions about my rights as a research subject in this study, I may contact the person that invited me at Focus on Boston.
TITLE OF STUDY: P3 015 - RSVt - Surgical Device 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.
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 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 November 29th and December 16th, 2023 in an animal lab at Tufts University, Boston.
Procedure and 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, you will be compensated
Please tick the relevant box:
Step 1 - Animal Lab (2,5 hours) $ 1,200 Step 2 - Animal Lab (2,5 hours) $ 1,200 and follow up* web phone interview (1 hour) $ 350
*follow up (24-48 hours after)
You will be asked to complete a series of tasks focusing on the usage of the device and then 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:
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 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.
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
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 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
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 tick box:
Please confirm that you have read and agree with the conditions listed above:
(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:
Declaration of Consent for Processing Personal Data
NON DISCLOSURE AGREEMENT
TITLE OF STUDY: Surgical Device Usability Evaluation
PHONE NUMBER: (781) 35 67 318
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.
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. I will be given a copy of this signed and dated form for my own.
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