Questionnaire

Kindly provide the order number* of the purchased kit
*Your order number can be found on the confirmation email you received when purchasing your kit.

Kindly tick the option that refers to you:
I am… the person submitting the samplea relative or guardian of the person submitting the samplea professional filling in this form on behalf of my client

Consent to Personal Data (Mandatory)

i. I have been fully informed about the vaginal microbiome test (and any additional related test), including its purpose, procedure, limitations, costs, and the implications of the results.
ii. I acknowledge that the test results are not a substitute for a medical diagnosis and that The BioArte does not take responsibility for the use of the results by me or my clinician and any consequences thereof.
iii. I confirm that the personal and medical information I have provided is accurate and truthful. I understand that the clinical team may contact me for additional information, which may be used for result interpretation purposes. I agree that the test report may be forwarded to my clinician for appropriate advice.
iv. I agree to provide a biological sample and consent to its shipping to The BioArte facilities for testing and analysis.
v. I consent to the collection, storage, and processing of my personal data, including health-related information. I understand that my data will be used solely for the purposes of conducting the vaginal microbiome test and providing me with the results. I am aware that my identifiable data will not be shared with third parties without my explicit consent, except as required by law.
vi. I consent to receiving the test report via email to the address provided in the below contact information.

I accept

Mandatory Consent – Sexually Transmitted Infection (STI) and HPV Results

I understand and acknowledge that, in addition to evaluating the vaginal microbiome, this test may detect the presence of DNA from certain sexually transmitted pathogens, if present in my sample. These may include Human Papillomavirus (HPV) and other sexually transmitted infections (STIs) included in the test panel. I understand that if HPV DNA is detected, the laboratory report may identify the specific HPV genotype(s), where applicable. I acknowledge that these findings will be included in my laboratory report and may have implications for my clinical care. I understand that the detection of pathogen DNA indicates the presence of genetic material in the submitted specimen and should be interpreted in conjunction with my clinical history, physical examination, and any other relevant laboratory or diagnostic findings by my healthcare provider. I have been informed of the scope and purpose of this testing and consent to the analysis and reporting of these results.

I accept

Consent for Research Purposes (Optional)

The aim of our research is to explore the role of the vaginal microbiota in women's health and its impact on medical treatments.
The vaginal microbiome plays a vital role in maintaining reproductive and general health. Imbalances in the microbiome have been linked to various conditions such as infections, inflammation, and fertility challenges. We are interested in understanding how differences in the vaginal microbiome may influence health outcomes.
To investigate this, we will analyze vaginal microbiota samples from participants. Your participation involves providing a vaginal swab sample, which will be analyzed for this purpose.
The insights gained from this study could be crucial in improving our understanding of the vaginal microbiome and developing better, more personalized medical treatments in the future.
Your involvement is entirely voluntary, and you can withdraw at any time without affecting your current or future medical care. We assure you that all the data collected will be kept confidential and used solely for research purposes.
By signing this consent form, you agree to provide a vaginal sample for our study and acknowledge that you have been informed about the study's purpose, procedures, and your rights as a participant.
Thank you for your cooperation and contribution to this important research.

I acknowledge that my Personal (Health) Data and remaining sample could contribute to further research, development, and enhancement of diagnostic techniques and potential therapeutic remedies. I consent to The BioArte's storage, once pseudonymized, of:

• My Personal (Health) Data and analytical results.

• Both original and processed sample

and that it will be kept by The BioArte for a minimum period of 10 years.

The company will use this data, along with the remaining samples that have been pseudonymized, for scientific research (both internally and externally) as well as for commercial research in the field related to the human microbiome. The aim is to gain a better understanding of the microbiome's role in an individual's overall health and susceptibility to diseases, as well as their potential response to treatments. Consent can be revoked at any time as explained below.
Public and private healthcare institutions, bio-medical companies worldwide, can be granted access to the patient’s pseudonymized data for research purposes, with the relevant guarantees adopted to ensure legitimacy of the data transfer (especially if the recipient is in a non-EEA country).
Please visit www.thebioarte.com or contact [email protected] for updated information on the research projects in which your pseudonymized data may be used.

Please visit Data Privacy to consult our data privacy policy.

HAVING READ AND UNDERSTOOD THE INFORMATION ABOVE, I CONFIRM THAT:
i. I have read and understood the indication, purpose, characteristics, scope, procedure, success rate, complications, limitations, and economic cost of this test, and have had the opportunity to ask questions and any questions that I had were answered fully and to my satisfaction. I have also been given information on the implications of the test results, any possible follow-up, and where applicable, any further tests that might be required. I am aware that clinical and technical staff will be at my disposal for any questions or additional counseling that I may require once the results of the test are known.
ii. I understand that the results of this test are not a substitute for a medical diagnosis performed in a clinical setting provided by a healthcare professional. I accept that The BioArte does not take responsibility for the use, by me or my clinician, of the results obtained and any consequences of such use.
iii. I confirm that the information I have given, both personal and medical, is accurate and truthful. I acknowledge that the clinical team may reach out to me for additional clinical information, which may include details required for research purposes.
iv. In view of the complexity of the tests, results should be assessed alongside other clinical information by healthcare professionals. Consequently, I agree that the test report may be forwarded to the requesting clinician so that I can be offered the most appropriate advice.
v. I am not receiving any compensation as the participant nor will I be owed any funds, at this moment or in the future, due to any invention(s) resulting from research and development using my specimen(s).
vi. I understand that the results of this study may be used for medical or scientific purposes, may be presented, for example, at meetings, in scientific publications, and that they may be reported or published; however, I shall not be personally identified in any way, either individually or collectively.
vii. I have been informed that this informed consent can be withdrawn at any time.

I acceptI do not accept

Please leave this field empty.

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