Additional Information
This page provides additional information about what participating in the study means.
Click here to go to the bottom of the page if you would like to download a full document of the Participant Information Sheet.
Voluntary Participation and Withdrawal From This Study
Your participation in this study is entirely voluntary. It is up to you if you take part or not. If you decide to take part you will be asked to sign a consent form. If you don’t want to take part you don’t have to give a reason. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive from us.
If you take part in the study you have the right to access any information about you collected during the study after your completion or withdrawal from the study.
If we learn anything about your health status during the study you will be informed of this.
Any information you give us about yourself will remain private and confidential.
What are the possible risks of this study?
As a part of this research, we will ask you to complete a number of psychological questionnaires. These include questionnaires that ask about depression and suicide. If these cause you distress, our research team is available to support you or refer you to someone else who can.
​What are the possible benefits of this study?
Although you might not receive direct benefits in taking part in this study, previous research has shown that Meaning-Centred Psychotherapy can be helpful in alleviating psychological distress in cancer patients. Given that everyone will receive Meaning-Centred Psychotherapy, we hope that all participants will receive some benefit from this therapy.
What are the alternatives to taking part?
You do not have to participate in this study to receive treatment for any distress you may be experiencing. There are other treatments available that are known to be effective. These can be discussed with your doctor.
Will any costs be reimbursed?
​We recognise that taking part in the study will involve a considerable time commitment from you, so we will provide you with $200 vouchers at the end of the 1- month follow-up phone call in recognition of your time. We may also be able to offer support for your transport to the research centre if that is required.
What if something goes wrong?
As this research study is for the principal benefit of its commercial sponsor, The University of Auckland if you are injured as a result of taking part in this study you won’t be eligible for compensation from ACC.
However, The University of Auckland has satisfied the Southern Health and Disability Ethics Committee that approved this study that it has up-to-date insurance for providing participants with compensation if they are injured as a result of taking part in this study.
New Zealand ethical standards require compensation for injury to be at least ACC equivalent. Compensation should be appropriate to the nature, severity and persistence of your injury and should be no less than would be awarded for similar injuries by New Zealand’s ACC scheme.
Some sponsors voluntarily commit to providing compensation in accordance with guidelines that they have agreed between themselves, called the Medicines New Zealand Guidelines (Industry Guidelines). These are often referred to for information on compensation for commercial clinical trials. There are some important points to know about the Industry Guidelines:
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On their own they are not legally enforceable and may not provide ACC equivalent compensation.
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There are limitations on when compensation is available, for example compensation may be available for more serious, enduring injuries, and not for temporary pain or discomfort or less serious or curable complaints.
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Unlike ACC, the guidelines do not provide compensation on a no-fault basis:
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The Sponsor may not accept the compensation claim if:
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Your injury was caused by the investigators, or;
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There was a deviation from the proposed research plan, or;
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Your injury was caused solely by you.
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An initial decision whether to compensate you would be made the by the sponsor and/or its insurers.
If they decide not to compensate you, you may be able to take action through the Courts for compensation, but it could be expensive and lengthy, and you might require legal representation. You would need to be able to show that your injury was caused by participation in the trial.
You are strongly advised to read the Industry Guidelines and ask questions if you are unsure about what they mean for you.
If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover.
What will happen to my information?
During this study, the study doctors/researchers, nurses, and other study staff will record information about you and your study participation. This includes the results of any study assessments. If needed, information from your hospital records and your GP may also be collected; access to your records is limited to that required for study purposes. As a part of this research, we will need to video record the psychotherapy sessions to ensure that the therapy is delivered as it should be. You cannot take part in this study if you do not consent to the collection of this information.
Identifiable Information
Identifiable information is any data that could identify you (e.g. your name, date of birth, or address). The following groups may have access to your identifiable information:
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University of Auckland investigators, staff and PhD students (to complete study assessments).
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The University of Auckland (the sponsor) and/or the Health Research Council (one of the funders) and its representatives, if you make a compensation claim for study-related injury. Identifiable information is required in order to assess your claim.
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The University of Auckland, the funder, ethics committees, or government agencies from New Zealand, if the study or site is audited. Audits are done to make sure that participants are protected, the study is run properly, and the data collected is correct.
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Your usual doctor, if a study test gives an unexpected result that could be important for your health. This allows appropriate follow-up to be arranged.
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Rarely, it may be necessary for a Study Doctor to share your information with other people – for example, if there is a serious threat to public health or safety, or to the life or health of you or another person OR if the information is required in certain legal situations.
De-identified (Coded) Information
To make sure your personal information is kept confidential, information that identifies you will not be included in any report generated by the study team and any study information sent to the sponsor and/or funders. Instead, you will be identified by a code. The study team will keep a list linking your code with your name, so that you can be identified by your coded data if needed.
The following groups may have access to your coded information:
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The sponsor, for the purposes of this study.
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International and National collaborators / companies / researchers.
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Ethics committees, health, regulatory or other governmental agencies.
The results of the study may be published or presented, but not in a form that would reasonably be expected to identify you.
Anonymised Information.
The sponsor may remove the code from your de-identified information – this is called ‘anonymisation’. This makes it very difficult (but not impossible) to identify the information that belongs to you. The sponsor may use this information for future research (see below).
Future Research Using Your Information.
Your coded information may be used for future research related to microdosing LSD or cancer. Your coded information may also be used for other medical and/or scientific research that is unrelated to the current study.
This future research may be conducted overseas. You will not be told when future research is undertaken using your information. Your information may be shared widely with other researchers or companies. Your information may also be added to information from other studies, to form much larger sets of data.
You will not get reports or other information about any research that is done using your information.
Your information may be used indefinitely for future research unless you withdraw your consent. However, it may be extremely difficult or impossible to access your information, or withdraw consent for its use, once your information has been shared for future research.
Security and Storage of Your Information.
Your identifiable information is held at The University of Auckland during the study. After the study it is transferred to a secure archiving site and stored for at least 15 years, then destroyed. Your coded information will be entered into electronic case report forms and sent through a secure server to the sponsor. Coded study information will be kept by the sponsor in secure, cloud-based storage indefinitely. All storage will comply with local and/or international data security guidelines. Your video data will be kept in password encrypted files for additional security.
Risks.
Although efforts will be made to protect your privacy, absolute confidentiality of your information cannot be guaranteed. Even with coded and anonymised information, there is no guarantee that you cannot be identified. The risk of people accessing and misusing your information (e.g. making it harder for you to get or keep a job or health insurance) is currently very small, but may increase in the future as people find new ways of tracing information.
Your coded / anonymised information may be sent overseas. Other countries may have lower levels of data protection than New Zealand. There may be no New Zealand representation on overseas organisations which make decisions about the use of your information. There is a risk that overseas researchers may work with information in a way that is not culturally appropriate for New Zealanders.
Rights to Access Your Information.
You have the right to request access to your information held by the research team. You also have the right to request that any information you disagree with is corrected.
Please ask if you would like to access the results of your screening and safety tests during the study, however this could result in you being withdrawn from the study to protect the study’s scientific integrity.
If you have any questions about the collection and use of information about you, you should ask the study team.
Rights to Withdraw Your Information.
You may withdraw your consent for the collection and use of your information at any time, by informing a member of the study team.
If you withdraw your consent, your study participation will end, and the study team will stop collecting information from you.
Information collected up until your withdrawal from the study will continue to be used and included in the study. This is to protect the quality of the study.
Ownership Rights.
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Information from this study may lead to discoveries and inventions or the development of a commercial product. The rights to these will belong to the sponsor or the funder. You and your family will not receive any financial benefits or compensation, nor have any rights in any developments, inventions, or other discoveries that might come from this information.
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What are the risks?
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We have designed this approach to protect your privacy and reduce the potential for any personal health information to be accidentally disclosed. However, because information is being transmitted over the internet, there is still some risk of accidental disclosure of your de-identified information.
What happens after the study or if I change my mind?
Meaning-centred psychotherapy is an established form of therapy in New Zealand and you can choose to seek out continued treatment if you wish. Please talk to your doctor about this.
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You may withdraw your consent for the collection and use ofyour information at any time, by informing a member of the study team. If you withdraw your consent, your study participation will end, and the study team will stop collecting information from you. Information collected up until your withdrawal from the study will continue to be used and included in the study. This is to protect the quality of the study.
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Can I find out the results of the study?
It can take quite a long time to analyse data from these kinds of studies. We hope to be able to tell you the final results one to two years after completion of the study. We plan to publish the results in specialised academic journals. If you want us to, we can send you a summary of the results in an easier format to read.
This trial is registered on the Australian New Zealand Clinical Trials Registry (ANZCTR). This can be accessed at anzctr.org.au.
