Terms and Conditions

Welcome to the OSCUM Study conducted by Biodata Pty Ltd under the mandate of the Pharma-Ethics Committee according to sections 71 and 72 of the Health Act, as well as International Good Clinical Practice (GCP) guidelines. I confirm that I am eligible to participate in this study. I have read the information provided about the study, understand its purpose and procedures, and voluntarily consent to participate, confirming my details are correct and that the method and objectives of the study were clearly explained to me. I understand that under POPIA (Protection of Personal Information Act), my personal information will be protected and handled in accordance with privacy regulations. Furthermore, I confirm that I am currently not using any chronic medication and have no known history of a mental disorder. By signing this onboarding form, I confirm that the information provided is accurate and correct.

1. Crowdfunding Terms and Conditions

  • The Study shall be funded with funds raised via a non-investment, reward-based crowdfunding model ("the Crowdfunding Model").
  • The contributions collected from participants are used solely to support the research study, including all expenses related to product development, data collection, analysis, and future research studies or clinical trials.
  • A once-off non-refundable administration fee of R150 (one hundred and fifty rand) shall be charged per participant, which will be covered by the Study Sponsor.
  • Participants in the study make voluntary financial contributions to fund the research study. In return, participants will receive medicinal cannabis products strictly for research purposes as part of the study and not as a commercial transaction.
  • The amount contributed by each participant is voluntary, and there are no minimum or maximum contribution requirements.

2. Participant Eligibility

  • Only individuals aged 18 and older who are residents of South Africa may participate in the Study.
  • Participants must provide accurate and truthful information, including valid identification and contact details, as required for compliance and research purposes.
  • By participating, you confirm your eligibility under South African law and your understanding of the non-commercial nature of the Initiative.

3. Data Protection

  • The Sponsor and Biodata (Pty) Ltd ("Biodata") is committed to safeguarding the privacy and personal data of all participants in compliance with POPIA and other applicable laws.
  • The Sponsors and Investigators will only use the Participating Patient's personal information as set out in the Study or as required by applicable regulations. The Sponsors and Investigators may disclose personal information to their service providers and agents under confidentiality agreements.
  • The Sponsors and Investigators will retain personal information for as long as necessary, having regard to applicable legislation.
  • A Participating Patient has a right to access personal data held by the Sponsors and Investigators. A copy of such personal data may be requested on payment of a fee determined by the Sponsors and Investigators.
  • The Sponsors and Investigators may transfer a Participating Patient's personal data to or process it in other countries that have equivalent data protection legislation to that in South Africa.
  • The Sponsors and Investigators shall use reasonable measures to ensure that personal data is protected to standards applicable in South Africa.
  • With the Participating Patient's consent, personal information may be used to comply with legal or regulatory obligations, perform checks, conduct relationships, and for analysis, marketing, or research assessments.
  • The Sponsors and Investigators will treat personal information as confidential and not disclose it to third parties except where legally compelled, public duty requires it, the Sponsor's interests necessitate it, or the participant consents to it.
  • The Sponsors and Investigators shall not be liable for any loss or damage where information is disclosed or withheld pursuant to lawful order or otherwise in accordance with applicable legislation.

4. Risks and Disclaimers

  • By participating in the Study, you acknowledge that the use of medicinal cannabis carries certain risks. Biodata is not liable for any adverse effects, injuries, or health complications resulting from participation in the research study.
  • Participants should consult with a healthcare professional before using any medicinal cannabis products provided.
  • Biodata makes no guarantees regarding the outcomes of the research study or the effectiveness of the medicinal cannabis products.

5. Research Study Participation

  • Participants in the research study may receive medicinal cannabis products as part of their involvement. All products must be used as directed by the research team and in accordance with the study's guidelines.
  • Participation in the study may require compliance with additional terms and conditions, informed consent, and regular communication with the research team.
  • Participants may be required to complete surveys, attend research consultations, or provide feedback on their experiences as part of the study.

6. Terms and Conditions in Respect of the Study

  • Participation in the Biodata research study is governed by the specific research protocols and guidelines established for the Initiative. These protocols are designed to ensure the scientific integrity of the study and the safety and well-being of all participants. By participating in the study, you agree to adhere to these protocols.
  • Before participating in the study, you will be provided with detailed information about the research objectives, methods, potential risks, and benefits. You will be required to give informed consent in writing, acknowledging your understanding of the study and your voluntary participation.
  • You have the right to withdraw from the study at any time without penalty. If you choose to withdraw, you must notify the research team, and any unused medicinal cannabis products or materials must be returned to Biodata as instructed.
  • For your safety and the integrity of the research study, you agree to follow all safety measures and precautions outlined in the study protocols. Any adverse effects or health concerns experienced during the study must be reported immediately to the research team.

Participating Patient Declaration, Consent & Indemnity Form

  • I, the undersigned Participating Patient hereby declare and agree that:
  • I am over the age of 18 years old with full capacity to act as a Participating Patient and do all things necessary therefor and incidental thereto;
  • The Study and my participation therein has been fully explained to me and before having applied to be a Participating Patient and signing this Declaration, Consent & Indemnity Form, I had been provided with sufficient information about the Study and its potential Risks and Discomforts in a way that I understand and fully comprehend so as to provide my informed consent to participate, as I hereby do;
  • My participation in the Study is voluntary and I do so at my own risk;
  • I am aware that as a result of my participation in the Study, I may be exposed to Risks and Discomforts and further potential risks associated with me being a Participating Patient in the study and I accordingly accept same, voluntarily and I undertake at all times to act with due caution and to take the utmost care to limit the Risks and Discomforts where possible and mitigate any further potential risks where possible;
  • I have been given ample opportunity to ask any questions or raise any concerns I may have regarding the Study and my participation therein and I am satisfied with the responses received thereto where applicable;
  • I hereby indemnify, release and hold harmless the Sponsors, Investigators and their officers, directors, employees, agents, members and advisors from all liability for any Risks and Discomforts, claims and proceedings, losses, damages, injuries, death or otherwise that I may experience, sustain or suffer as a result or arising out of my participation in the Study;
  • This Declaration, Consent and Indemnity shall not apply in respect of loss attributable to the gross negligence or malpractice of the Sponsors, Investigators and their officers, directors, employees, agents, members and advisors;
  • All information provided by me in respect of the Study and my application to be a Participating Patient and is true and correct; AND
  • I have read this Declaration, Consent and Indemnity Form in its entirety, that I have fully understood the content, nature and implications hereof and that I shall be bound hereto.
I Consent, Return to Form