BIODATA
Research Project
Ethics number: 210323874
MCSA  Medical Cannabis SA
ONQSA  Clinical Research Organisation
Ethics number: 210323874
MCSA  Medical Cannabis SA
ONQSA  Clinical Research Organisation
BIODATA
Research Project
“Expanding the Boundaries of
 Medical Cannabis Through Clinical Trials”

BioData Research Project Terms and Conditions

1)     Crowdfunding terms and conditions

The Study shall be funded with funds raised via a non-investment, reward based, crowdfunding model (“the Crowdfunding Model”). A successful applicant and Participating Patient will be rewarded with Medical Cannabis for his/her monthly contribution as detailed herein.

1.2  A once off non - refundable administration fee of R150 (one hundred and fifty rand) shall be payable by you before this application can be processed.

1.3  A monthly contribution towards the Crowdfunding Model of R1100 (one thousand one hundred rand) shall be payable by a participating patient who shall, in turn be rewarded with a SAHPRA approved medical cannabis research package.

1.4  Failure to effect the monthly contribution towards the Crowdfunding Model will result in non-delivery of the associated monthly reward.

1.5  A Participating Patient’s participation in the Study and consequent contribution to the Crowdfunding Model can be terminated by either party at any time on written notice to the other party. Should a Participating Patient wish to so terminate, notice may be sent to: info@biodataresearch.co.za.

1.6  Patients will be reimbursed R150 for their time.

2)     Data Protection

2.1  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.

2.2  The Sponsors and Investigators will retain personal information for as long as necessary, having regard to applicable legislation.

2.3  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.

2.4  The Sponsors and Investigators may transfer a Participating Patient’s personal data to or process it in other countries thathave 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 that are applicable in South Africa.

2.5  With the Participating Patients’ consent, the Sponsors, Investigators and their agents and service providers, will use personal information:

2.6  to comply with legal or regulatory obligations;

2.7  to perform applicable checks and conduct the relationship with you; and

2.8  for analysis, marketing (to which you have not opted out), research assessment.

2.9  The Sponsors and Investigators will treat personal information as confidential and not disclose it to third parties, except:

-         where legally compelled to do so;

-        where a public duty to disclose exists;

-        where the interests of the Sponsors or Investigators require disclosure; or

-        where disclosure is made at your request or with your consent.

2.10 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.

3)     Terms & Conditions in

In respect of the Study

Project Title: To investigate the replacement of Opioids with Medical Cannabis for pain management within the South African population.

“Investigator(s)”:       (Principal Investigator) Dr Shiksha Gallow

                                      (Co- Principal Investigator) Dr Regina Hurley

(Other Investigators) Dr Ahmed Jamaloodeen, Dr Omphemetse Mathibe,  Dr Xavagne Leigh Fransman, & Dr Marian Tupy

“Study” shall mean all action required to be taken and necessary to be performed by the Investigators and Sponsors)/(in determining the effects of opioid use vs medical cannabis use on quality of life in respect of patients suffering from chronic pain).If you would like more information about the goals or scientific aspects of this Study please contact info@biodataresearch.co.za.

“Participating Patient/s” shall mean a patient/s participating in this Study on a voluntary and application only basis, completely out of their own free will after having fully considered, understood and accepted any potential benefits and risks that may be associated with the Study.

3.1 Purpose: The purpose of this Study is to examine, over a period of 12 months, the difference in opiate use patterns and its effects on the quality of life in Participating Patients suffering from chronic pain, by replacing the opioids with medical cannabis.

The purpose of this Study is to examine, over a period of 12 months, the difference in the quality of life and effects on chronic pain levels of Participating Patients, by using medical cannabis as an alternative to traditional opioid use.

Participating Patients shall be treated and managed by the doctor specifically assigned and communicated to them by the Investigator. The doctors are located at any 1 of 5 sites in South Africa namely: Kwazulu Natal, Gauteng, Eastern Cape, Western Cape or Mpumalanga. All of the communication will be done online due to Covid-19 regulations.

There will be a total of 1000 Participating Patients. Patients will be recruited from all 5 sites.

The “Sponsors” of this Study are Labat Africa, a JSE listed organization.

3.2 Study Procedure: Once an application to be a Participating Patient has been reviewed and accepted by the Sponsors and Investigators, in their sole discretion and according to acceptance criteria determined by them in their sole and absolute discretion, and the Participating Patient has completed, signed and provided all documentation and information necessary and as may be required in terms of the Study and any applicable law or legislation the Participating Patient will be required to complete six questionnaires during an initial assessment which shall determine the medical cannabis prescription requirements of a particular Participating Patient.

The Participating Patient will be required to answer questions in respect of, amongst others, his/her socio-demographic data, cannabis usage history and patterns, primary pain conditions, opioid dosage and usage, pain metrics and quality of life.

Over the duration of the Study and excluding the initial assessment, a Participating Patient will be required to answer questions as determined by the Sponsors and Investigators in respect of, amongst others, his/her opioid dosage and usage, pain metrics, and quality of life.

3.3 “Risks & Discomforts”: As is the case with the trial of any new medication or similar study, there are a number of potential risks, discomforts and side effects that may be associated with the use of medical cannabis and consequently by participating in this Study which are noted hereunder.

3.4 “Potential Side Effects” may include but are not limited to: drowsiness, light-headedness, confusion, disorientation, loss of co-ordination, fainting, dizziness, increased or decreased heartbeat, loss of contact with reality, headache, nervousness, panic attacks, paranoia, hallucinations, inability to maintain balance, throat irritation, nausea, vomiting.

Long term medical cannabis use may: trigger or aggravate a pre-existing mood disorder (whether known or unknown to the Participating Patient), reduce fertility, lead to higher tolerance or cause addiction and ceasing use of cannabis after long terms use could cause withdrawal symptoms.

3.5 Drug Interactions: Medical cannabis use may affect the interaction of other medications.

The use of cannabis and resultant effects of its active component Tetrahydrocannabinol (“THC”) may be increased by the use of and when combined with certain antidepressants (Fluoxetine, Fluvoxamine, Nefazodone), antacids (Cimetidine, Omeprazole), antibiotics (Clarithromycin, Erythromycin), anti-fungals (Itraconazole, Fluconazole, Ketoconazole, Miconazole), calcium channel blockers used for high blood pressure and heart disease (Diltiazem, Verapamil), HIV protease inhibitors (Ritonavir) Amiodarone, and Isoniazid.

Other drugs that may mitigate the effects of THC include but are not limited to: Rifampicin, Carbamazepine, Phenobarbital, Phenytoin, Primidone, Rifabutin, Troglitazone, and Saint John’s Wort.

3.6 WARNING: Women capable of bearing children shall be responsible for following strict contraceptive measures while participating in this Study. If a Participating Patient falls pregnant during the Study, she is required to notify the Investigators immediately. Participating in this study could potentially increase risk or harm to an unborn baby.

3.7 Benefits: Any potential benefits associated with this Study are not yet known and determining benefits associated with the use of medical cannabis for the purposes of chronic pain relief forms part of the Purpose of the Study.

3.7 Privacy & Confidentiality: Your information will be stored in a PIPA (Personal Information Protection Act) compliant electronic medical record system.

The treating physician will have access to your electronic chart.

All access to patient charts is logged and stored. Your name or any other identifying or private information will not be shared with others without your permission, nor will it appear in any reports or articles published as a result of this study. You will be given a unique anonymous identifier for data tracking.

3.8 Conflicts Of Interest: Several parties involved in this Study may reasonably be perceived to have conflicts of interest relating to the outcomes of this Study.

The Sponsors are all actively engaged in the medical cannabis industry and may materially benefit or be harmed by the results of this Study.

The results of this Study will not be sold or commercialized in any way.

3.9 Withdrawal/Removal from the Study: A Participating Patient may withdraw from participating in the Study at any time for any reason and without consequence.

The Sponsors or the Investigators may revoke a Participating Patient’s approval to participate in the Study and consequently remove such Participating Patient from the Study at any time, for any reason and without consequence.

3.10 Compensation: There shall be no monetary or other form of compensation payable to a Participating Patient for participating in the Study, rather, the medical cannabis prescribed and provided to a Participating Patient in connection with this Study shall be in accordance with the  crowdfunding option selected by a Participating Patient.

If you have any ethical concerns relating to this Study, please contact the Chair of the Research Ethics Board at SAHPRA ethics@sahpra.co.za.

3.11 Informed Consent: By signing below you acknowledge the risks associated with medicinal cannabis. Additionally, you agree to give the Biodata research team informed consent to access the following:

- Anonymous information from the following questionnaires.

- Medical history, cannabis usage, and sociodemographic.

- Opioid Dosage - current opiate dosage, measured (or converted) in morphine equivalents based on    McMaster University Opiate Manager.

- Brief Pain Inventory (BPI).

- EQ-5D on quality of life.

- Pharmaceutical records on opiate usage for duration of the study.

BioData Research Project Terms and Conditions

1)     Crowdfunding terms and conditions

The Study shall be funded with funds raised via a non-investment, reward based, crowdfunding model (“the Crowdfunding Model”). A successful applicant and Participating Patient will be rewarded with Medical Cannabis for his/her monthly contribution as detailed herein.

1.2  A once off non - refundable administration fee of R150 (one hundred and fifty rand) shall be payable by you before this application can be processed.

1.3  A monthly contribution towards the Crowdfunding Model of R1100 (one thousand one hundred rand) shall be payable by a participating patient who shall, in turn be rewarded with a SAHPRA approved medical cannabis research package.

1.4  Failure to effect the monthly contribution towards the Crowdfunding Model will result in non-delivery of the associated monthly reward.

1.5  A Participating Patient’s participation in the Study and consequent contribution to the Crowdfunding Model can be terminated by either party at any time on written notice to the other party. Should a Participating Patient wish to so terminate, notice may be sent to: info@biodataresearch.co.za.

1.6  Patients will be reimbursed R150 for their time.

2)     Data Protection

2.1  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.

2.2  The Sponsors and Investigators will retain personal information for as long as necessary, having regard to applicable legislation.

2.3  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.

2.4  The Sponsors and Investigators may transfer a Participating Patient’s personal data to or process it in other countries thathave 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 that are applicable in South Africa.

2.5  With the Participating Patients’ consent, the Sponsors, Investigators and their agents and service providers, will use personal information:

2.6  to comply with legal or regulatory obligations;

2.7  to perform applicable checks and conduct the relationship with you; and

2.8  for analysis, marketing (to which you have not opted out), research assessment.

2.9  The Sponsors and Investigators will treat personal information as confidential and not disclose it to third parties, except:

-         where legally compelled to do so;

-        where a public duty to disclose exists;

-        where the interests of the Sponsors or Investigators require disclosure; or

-        where disclosure is made at your request or with your consent.

2.10 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.

3)     Terms & Conditions in

In respect of the Study

Project Title: To investigate the replacement of Opioids with Medical Cannabis for pain management within the South African population.

“Investigator(s)”:       (Principal Investigator) Dr Shiksha Gallow

                                      (Co- Principal Investigator) Dr Regina Hurley

(Other Investigators) Dr Ahmed Jamaloodeen, Dr Omphemetse Mathibe,  Dr Xavagne Leigh Fransman, & Dr Marian Tupy

“Study” shall mean all action required to be taken and necessary to be performed by the Investigators and Sponsors)/(in determining the effects of opioid use vs medical cannabis use on quality of life in respect of patients suffering from chronic pain).If you would like more information about the goals or scientific aspects of this Study please contact info@biodataresearch.co.za.

“Participating Patient/s” shall mean a patient/s participating in this Study on a voluntary and application only basis, completely out of their own free will after having fully considered, understood and accepted any potential benefits and risks that may be associated with the Study.

3.1 Purpose: The purpose of this Study is to examine, over a period of 12 months, the difference in opiate use patterns and its effects on the quality of life in Participating Patients suffering from chronic pain, by replacing the opioids with medical cannabis.

The purpose of this Study is to examine, over a period of 12 months, the difference in the quality of life and effects on chronic pain levels of Participating Patients, by using medical cannabis as an alternative to traditional opioid use.

Participating Patients shall be treated and managed by the doctor specifically assigned and communicated to them by the Investigator. The doctors are located at any 1 of 5 sites in South Africa namely: Kwazulu Natal, Gauteng, Eastern Cape, Western Cape or Mpumalanga. All of the communication will be done online due to Covid-19 regulations.

There will be a total of 1000 Participating Patients. Patients will be recruited from all 5 sites.

The “Sponsors” of this Study are Labat Africa, a JSE listed organization.

3.2 Study Procedure: Once an application to be a Participating Patient has been reviewed and accepted by the Sponsors and Investigators, in their sole discretion and according to acceptance criteria determined by them in their sole and absolute discretion, and the Participating Patient has completed, signed and provided all documentation and information necessary and as may be required in terms of the Study and any applicable law or legislation the Participating Patient will be required to complete six questionnaires during an initial assessment which shall determine the medical cannabis prescription requirements of a particular Participating Patient.

The Participating Patient will be required to answer questions in respect of, amongst others, his/her socio-demographic data, cannabis usage history and patterns, primary pain conditions, opioid dosage and usage, pain metrics and quality of life.

Over the duration of the Study and excluding the initial assessment, a Participating Patient will be required to answer questions as determined by the Sponsors and Investigators in respect of, amongst others, his/her opioid dosage and usage, pain metrics, and quality of life.

3.3 “Risks & Discomforts”: As is the case with the trial of any new medication or similar study, there are a number of potential risks, discomforts and side effects that may be associated with the use of medical cannabis and consequently by participating in this Study which are noted hereunder.

3.4 “Potential Side Effects” may include but are not limited to: drowsiness, light-headedness, confusion, disorientation, loss of co-ordination, fainting, dizziness, increased or decreased heartbeat, loss of contact with reality, headache, nervousness, panic attacks, paranoia, hallucinations, inability to maintain balance, throat irritation, nausea, vomiting.

Long term medical cannabis use may: trigger or aggravate a pre-existing mood disorder (whether known or unknown to the Participating Patient), reduce fertility, lead to higher tolerance or cause addiction and ceasing use of cannabis after long terms use could cause withdrawal symptoms.

3.5 Drug Interactions: Medical cannabis use may affect the interaction of other medications.

The use of cannabis and resultant effects of its active component Tetrahydrocannabinol (“THC”) may be increased by the use of and when combined with certain antidepressants (Fluoxetine, Fluvoxamine, Nefazodone), antacids (Cimetidine, Omeprazole), antibiotics (Clarithromycin, Erythromycin), anti-fungals (Itraconazole, Fluconazole, Ketoconazole, Miconazole), calcium channel blockers used for high blood pressure and heart disease (Diltiazem, Verapamil), HIV protease inhibitors (Ritonavir) Amiodarone, and Isoniazid.

Other drugs that may mitigate the effects of THC include but are not limited to: Rifampicin, Carbamazepine, Phenobarbital, Phenytoin, Primidone, Rifabutin, Troglitazone, and Saint John’s Wort.

3.6 WARNING: Women capable of bearing children shall be responsible for following strict contraceptive measures while participating in this Study. If a Participating Patient falls pregnant during the Study, she is required to notify the Investigators immediately. Participating in this study could potentially increase risk or harm to an unborn baby.

3.7 Benefits: Any potential benefits associated with this Study are not yet known and determining benefits associated with the use of medical cannabis for the purposes of chronic pain relief forms part of the Purpose of the Study.

3.7 Privacy & Confidentiality: Your information will be stored in a PIPA (Personal Information Protection Act) compliant electronic medical record system.

The treating physician will have access to your electronic chart.

All access to patient charts is logged and stored. Your name or any other identifying or private information will not be shared with others without your permission, nor will it appear in any reports or articles published as a result of this study. You will be given a unique anonymous identifier for data tracking.

3.8 Conflicts Of Interest: Several parties involved in this Study may reasonably be perceived to have conflicts of interest relating to the outcomes of this Study.

The Sponsors are all actively engaged in the medical cannabis industry and may materially benefit or be harmed by the results of this Study.

The results of this Study will not be sold or commercialized in any way.

3.9 Withdrawal/Removal from the Study: A Participating Patient may withdraw from participating in the Study at any time for any reason and without consequence.

The Sponsors or the Investigators may revoke a Participating Patient’s approval to participate in the Study and consequently remove such Participating Patient from the Study at any time, for any reason and without consequence.

3.10 Compensation: There shall be no monetary or other form of compensation payable to a Participating Patient for participating in the Study, rather, the medical cannabis prescribed and provided to a Participating Patient in connection with this Study shall be in accordance with the  crowdfunding option selected by a Participating Patient.

If you have any ethical concerns relating to this Study, please contact the Chair of the Research Ethics Board at SAHPRA ethics@sahpra.co.za.

3.11 Informed Consent: By signing below you acknowledge the risks associated with medicinal cannabis. Additionally, you agree to give the Biodata research team informed consent to access the following:

- Anonymous information from the following questionnaires.

- Medical history, cannabis usage, and sociodemographic.

- Opioid Dosage - current opiate dosage, measured (or converted) in morphine equivalents based on    McMaster University Opiate Manager.

- Brief Pain Inventory (BPI).

- EQ-5D on quality of life.

- Pharmaceutical records on opiate usage for duration of the study.