CERA Biobank
Frequently asked questions (FAQ)
We answer some common questions about eye donation for research, and how it works.
Part 1: The donor and donation
What is the purpose of donation?
Donated samples assist medical research groups to understand and uncover new information about the eye and medical conditions impacting the eye and other parts of the human body. Donations also assist in the prevention of diseases and conditions and the development of treatments and technologies to improve prevention and/or treatment options.
What does donation involve?
Donation involves approval (consent) for the Lions Eye Donation Service (LEDS) to recover the donation from the donor and transfer the donation to research via the CERA Biobank. LEDS is the Custodian of the CERA Biobank.
Who decides on the consent?
While LEDS does provide first-person consent in some situations, most donation conversations and consent steps take place after someone has died. Therefore, a majority of LEDS interactions are with a donor’s lawful decision maker, which shall be referred to as their Senior Available Next of Kin (SANOK).
What does the donor/SANOK have to do?
When approached by LEDS or another hospital staff member, the donor or SANOK can decide if donation toward research is the right choice. There is no obligation. This is also the chance to ask questions.
How much ‘donation sample’ will be taken?
This depends on the donation type and reason for the donation, and the consent provided. For example, the whole eyes or just the corneas might be consented for research. It also depends on what researchers are seeking and/or if LEDS have staff available to recover the donation in time. This means that sometimes the donation will not be pursued by LEDS.
Bloods are not routinely requested by researchers and are not routinely taken for research only donors. If bloods are requested, the donor coordinator will also discuss this during the donation conversation.
What information about the donor is needed?
The consent form and the donation discussion generally provide enough information, such as key medical data, for LEDS and the CERA Biobank to determine if there is a research program that can use the donation. Otherwise, LEDS will not proceed with the donation.
How is privacy protected?
The donor’s data will be maintained on the national Organ and Tissue Authorities Electronic Donor Registry, accessible only to the Registry staff, LEDS and sometimes LEDS DonateLife partners who helped to facilitate the donation. The facility where your donation took place will also keep a record of your donation.
Donor information will be stored on a password protected server only accessible to the CERA Biobank/LEDS. Individual researchers will only receive a copy of general de-identified information, such as age, biological gender, sample type and key medical information relevant to their study. Data will be collected and stored in accordance with the Australian Privacy Act, 1988.
Do people have to donate to research?
There is no obligation to donate. Donation is voluntary.
What are the possible benefits of donation?
There are no immediate benefits to a donor and/or their family. However, the donation could potentially be used by research projects that aim to help people by finding treatments for medical conditions.
What are the possible risks and disadvantages of donation?
There are no risks or disadvantages of being involved in a research project.
How is the donation recovered?
The collection of the donation will involve a procedure to remove the whole eye or just the cornea (and occasionally, bloods). These are performed under strict clinical protocols. The recovery of the donation usually takes less than 30 minutes. The recovery will not be visible to others. It will not prevent an open casket funeral or delay funeral proceedings.
What will happen to the donation?
The donation may take one of two pathways.
- If the donor is for ‘research (and training) only’ it will be allocated to researchers and trainees approved to use the donation.
- If the donor has consented to transplant, research and training, it will go to transplant first and then research and training.
Depending on the situation, all or part of the donation may be allocated straight to research/training, even if the donor consented for transplant. For example, this could occur if the cells in the cornea were not at the level required for transplant.
Lastly, donations from one donor may help more than one research project.
What happens when the research project ends?
Once a research project has been completed, the researchers must close their project with the CERA Biobank and their ethics committee. At that time, the researchers must notify the CERA Biobank of the donation’s status. For example, discarded in the laboratory and/or returned to the CERA Biobank for discard or storage and later re-allocation to another research group.
Can donors/SANOK find out the results of the research?
As donation is anonymous, we are unable to inform you where your donation is used. An exception will be if you consent for use in a special project that requires additional information. In that situation, you may be informed of the specific project because additional consent may be involved (see section 15 for more detail on special projects).
Additionally, your donation may be involved in multiple studies – and for some projects, they may take years to compete.
As an alternative, you may wish to check the CERA website and/or subscribe to the CERA Newsletter to keep up to date with the breadth of research taking place across CERA.
What is a ‘Special Project’?
Special projects are unusual projects which seek to perform non-routine experiments on the donated tissue. These projects have additional ethical requirements around consent. They may involve genetic engineering, the development of cell lines or use of donations in animal model work.
If the donor/SANOK ticks ‘yes’ to potentially donating to a special project on the donor consent form, and there is also a special project seeking a donation that matches the donor at that time, then additional steps will be taken.
These steps will start with LEDS/CERA Biobank contacting the donor/SANOK and inviting them to participate in the special project. At that time, they will be provided with specific information about special project. If necessary, the researcher of the project may also be involved in the conversation.
After receiving the information, if the donor/SANOK wishes to proceed, a separate Special Project Consent Form will be signed. Participation in a special project is voluntary.
What if research discovers something of medical importance to a donor’s family?
Researchers follow standard research protocol, whereby any important discoveries are peer reviewed and published.
If while using the donation the researchers discover something specific that is important for the donor’s family to know, the CERA Biobank will contact the SANOK.
What if the donor/SANOK do not want to donate toward research?
There is no obligation to donate to research. In this instance, we recommend you do not tick the research allocation box on the LEDS consent form.
Who recovers the donation?
Once consent is confirmed, a member of the LEDS Team will travel to where the donor’s body is resting and recover the donation. They will return the donation to either LEDS or CERA for further allocation to researchers once ready to allocate.
Can consent be withdrawn?
Yes. Donors/SANOK are encouraged to let LEDS know immediately if they wish to withdraw consent. At that time, a consent withdrawal form will be provided.
While LEDS will immediately cease any further activity on the donor, please note that, in some instances, the donation may have already occurred, and the tissue may have been transplanted or used by a researcher/trainee.
What is the purpose of donation?
Donated samples assist medical research groups to understand and uncover new information about the eye and medical conditions impacting the eye and other parts of the human body. Donations also assist in the prevention of diseases and conditions and the development of treatments and technologies to improve prevention and/or treatment options.
What does donation involve?
Donation involves approval (consent) for the Lions Eye Donation Service (LEDS) to recover the donation from the donor and transfer the donation to research via the CERA Biobank. LEDS is the Custodian of the CERA Biobank.
Who decides on the consent?
While LEDS does provide first-person consent in some situations, most donation conversations and consent steps take place after someone has died. Therefore, a majority of LEDS interactions are with a donor’s lawful decision maker, which shall be referred to as their Senior Available Next of Kin (SANOK).
What does the donor/SANOK have to do?
When approached by LEDS or another hospital staff member, the donor or SANOK can decide if donation toward research is the right choice. There is no obligation. This is also the chance to ask questions.
How much ‘donation sample’ will be taken?
This depends on the donation type and reason for the donation, and the consent provided. For example, the whole eyes or just the corneas might be consented for research. It also depends on what researchers are seeking and/or if LEDS have staff available to recover the donation in time. This means that sometimes the donation will not be pursued by LEDS.
Bloods are not routinely requested by researchers and are not routinely taken for research only donors. If bloods are requested, the donor coordinator will also discuss this during the donation conversation.
What information about the donor is needed?
The consent form and the donation discussion generally provide enough information, such as key medical data, for LEDS and the CERA Biobank to determine if there is a research program that can use the donation. Otherwise, LEDS will not proceed with the donation.
How is privacy protected?
The donor’s data will be maintained on the national Organ and Tissue Authorities Electronic Donor Registry, accessible only to the Registry staff, LEDS and sometimes LEDS DonateLife partners who helped to facilitate the donation. The facility where your donation took place will also keep a record of your donation.
Donor information will be stored on a password protected server only accessible to the CERA Biobank/LEDS. Individual researchers will only receive a copy of general de-identified information, such as age, biological gender, sample type and key medical information relevant to their study. Data will be collected and stored in accordance with the Australian Privacy Act, 1988.
Do people have to donate to research?
There is no obligation to donate. Donation is voluntary.
What are the possible benefits of donation?
There are no immediate benefits to a donor and/or their family. However, the donation could potentially be used by research projects that aim to help people by finding treatments for medical conditions.
What are the possible risks and disadvantages of donation?
There are no risks or disadvantages of being involved in a research project.
How is the donation recovered?
The collection of the donation will involve a procedure to remove the whole eye or just the cornea (and occasionally, bloods). These are performed under strict clinical protocols. The recovery of the donation usually takes less than 30 minutes. The recovery will not be visible to others. It will not prevent an open casket funeral or delay funeral proceedings.
What will happen to the donation?
The donation may take one of two pathways.
- If the donor is for ‘research (and training) only’ it will be allocated to researchers and trainees approved to use the donation.
- If the donor has consented to transplant, research and training, it will go to transplant first and then research and training.
Depending on the situation, all or part of the donation may be allocated straight to research/training, even if the donor consented for transplant. For example, this could occur if the cells in the cornea were not at the level required for transplant.
Lastly, donations from one donor may help more than one research project.
What happens when the research project ends?
Once a research project has been completed, the researchers must close their project with the CERA Biobank and their ethics committee. At that time, the researchers must notify the CERA Biobank of the donation’s status. For example, discarded in the laboratory and/or returned to the CERA Biobank for discard or storage and later re-allocation to another research group.
Can donors/SANOK find out the results of the research?
As donation is anonymous, we are unable to inform you where your donation is used. An exception will be if you consent for use in a special project that requires additional information. In that situation, you may be informed of the specific project because additional consent may be involved (see section 15 for more detail on special projects).
Additionally, your donation may be involved in multiple studies – and for some projects, they may take years to compete.
As an alternative, you may wish to check the CERA website and/or subscribe to the CERA Newsletter to keep up to date with the breadth of research taking place across CERA.
What is a ‘Special Project’?
Special projects are unusual projects which seek to perform non-routine experiments on the donated tissue. These projects have additional ethical requirements around consent. They may involve genetic engineering, the development of cell lines or use of donations in animal model work.
If the donor/SANOK ticks ‘yes’ to potentially donating to a special project on the donor consent form, and there is also a special project seeking a donation that matches the donor at that time, then additional steps will be taken.
These steps will start with LEDS/CERA Biobank contacting the donor/SANOK and inviting them to participate in the special project. At that time, they will be provided with specific information about special project. If necessary, the researcher of the project may also be involved in the conversation.
After receiving the information, if the donor/SANOK wishes to proceed, a separate Special Project Consent Form will be signed. Participation in a special project is voluntary.
What if research discovers something of medical importance to a donor’s family?
Researchers follow standard research protocol, whereby any important discoveries are peer reviewed and published.
If while using the donation the researchers discover something specific that is important for the donor’s family to know, the CERA Biobank will contact the SANOK.
What if the donor/SANOK do not want to donate toward research?
There is no obligation to donate to research. In this instance, we recommend you do not tick the research allocation box on the LEDS consent form.
Who recovers the donation?
Once consent is confirmed, a member of the LEDS Team will travel to where the donor’s body is resting and recover the donation. They will return the donation to either LEDS or CERA for further allocation to researchers once ready to allocate.
Can consent be withdrawn?
Yes. Donors/SANOK are encouraged to let LEDS know immediately if they wish to withdraw consent. At that time, a consent withdrawal form will be provided.
While LEDS will immediately cease any further activity on the donor, please note that, in some instances, the donation may have already occurred, and the tissue may have been transplanted or used by a researcher/trainee.
Part 2: The research
Who organises and funds the research?
Each research team is managed by a senior researcher called a Principal Investigator (PI). Their project must be human research ethics approved and demonstrate approval from their organisation to commence the project. Once these are in place and they meet the CERA Biobank expectations, they are added to the CERA Biobank access list. They are allocated donations that match their project’s requirements (which is provided to the CERA Biobank in their research protocol).
Each project has a different funding arrangement. Some may involve one funding body while others have multiple. Most funding bodies are from government, industry and/or philanthropic grants and scholarships. In some instances, research institutes provide some additional financial support.
How are samples allocated, and who has reviewed the research project?
The CERA Biobank only allocates donations to research projects that have human research ethics approval and organisation approval, and those that meet the CERA Biobank expectations.
CERA researchers work within the expectations of the CERA policy, while non-CERA researchers comply with the same standards of use through an inter-institutional agreement. Each project must provide annual updates to their human research ethics committee and notify the CERA Biobank of the donation’s/sample’s status.
What kind of research would my donation help?
Donations can help research investigating conditions specifically related to the eye, such as glaucoma, or those relating to the eye and other aspects of health, such as diabetic eye disease). Donations also benefit studies looking at gene and cellular understanding, prevention, treatment, development of new technologies and/or future therapies.
As research projects start and finish continually throughout the year, the LEDS Donor Coordinator will provide an overview of the types of projects taking place at the time of your donation.
Where and how will my donation be used?
Researchers will work with your sample inside an approved laboratory of a medical research institute or similar. They will be used in what is termed ‘benchtop’ work, however from time to time, some samples may be involved in more complex ‘special projects’ (which we outline in section 15).
Generally, samples will stay in Victoria. However, some projects can take place elsewhere in Australia and may have collaborators in other countries. This means your sample may be moved outside of Victoria.
Whether your samples are allocated in Australia or overseas, the CERA Biobank will continue to work with the research teams to ensure they can track the sample’s location and ensure ethics, and CERA Biobank allocation agreements and approvals are in place prior to allocation, and the samples are being used in an appropriate manner.
Who to contact for further information?
Please email Dr Heather Machin, Head of the Lions Eye Donation Service and PI for the CERA Biobank, via: biobank@cera.org.au.
Who organises and funds the research?
Each research team is managed by a senior researcher called a Principal Investigator (PI). Their project must be human research ethics approved and demonstrate approval from their organisation to commence the project. Once these are in place and they meet the CERA Biobank expectations, they are added to the CERA Biobank access list. They are allocated donations that match their project’s requirements (which is provided to the CERA Biobank in their research protocol).
Each project has a different funding arrangement. Some may involve one funding body while others have multiple. Most funding bodies are from government, industry and/or philanthropic grants and scholarships. In some instances, research institutes provide some additional financial support.
How are samples allocated, and who has reviewed the research project?
The CERA Biobank only allocates donations to research projects that have human research ethics approval and organisation approval, and those that meet the CERA Biobank expectations.
CERA researchers work within the expectations of the CERA policy, while non-CERA researchers comply with the same standards of use through an inter-institutional agreement. Each project must provide annual updates to their human research ethics committee and notify the CERA Biobank of the donation’s/sample’s status.
What kind of research would my donation help?
Donations can help research investigating conditions specifically related to the eye, such as glaucoma, or those relating to the eye and other aspects of health, such as diabetic eye disease). Donations also benefit studies looking at gene and cellular understanding, prevention, treatment, development of new technologies and/or future therapies.
As research projects start and finish continually throughout the year, the LEDS Donor Coordinator will provide an overview of the types of projects taking place at the time of your donation.
Where and how will my donation be used?
Researchers will work with your sample inside an approved laboratory of a medical research institute or similar. They will be used in what is termed ‘benchtop’ work, however from time to time, some samples may be involved in more complex ‘special projects’ (which we outline in section 15).
Generally, samples will stay in Victoria. However, some projects can take place elsewhere in Australia and may have collaborators in other countries. This means your sample may be moved outside of Victoria.
Whether your samples are allocated in Australia or overseas, the CERA Biobank will continue to work with the research teams to ensure they can track the sample’s location and ensure ethics, and CERA Biobank allocation agreements and approvals are in place prior to allocation, and the samples are being used in an appropriate manner.
Who to contact for further information?
Please email Dr Heather Machin, Head of the Lions Eye Donation Service and PI for the CERA Biobank, via: biobank@cera.org.au.
Part 3: The CERA Biobank
What is the CERA Biobank?
The CERA Biobank (CB) is the research tissue donation, recovery, and allocation arm of the Centre for Eye Research Australia (CERA). The CB works in conjunction with the Lions Eye Donation Service (LEDS) and other partners. They are the Custodians of donations recovered by LEDS and used in research.
The CB works within the expectations of the Victorian Human Tissue Act, 1982; NHMRC National Statement on Ethical Conduct in Human Research, 2023; NHMRC Biobanks Information Paper, 2010; and the OECD Guidelines on Human Biobanks and Genetic Research, 2009, and LEDS policies and procedures. They are responsible for ensuring the allocation to researchers is fair, and donations are maximised. They are the point of contact for any questions and/or to withdraw consent.
How is the CERA Biobank funded?
Today, the CERA Biobank, via LEDS, recovers the cost for their service from researchers who receive tissue through the deceased donation program. This complies with the Human Tissue Act, VIC, 1982 ‘cost recovery approach’ and ensures the service can be sustained.
Will samples ever be sold to a company for profit?
No. While the Service can provide samples, within its fair allocation system, to for-profit companies who are conducting research (for example, those making a new medical device or new drug), the Service itself can only seek reimbursement for what it cost the Service to recover, prepare and allocate the tissue. For example, consumables, staffing and courier costs.
What is the CERA Biobank?
The CERA Biobank (CB) is the research tissue donation, recovery, and allocation arm of the Centre for Eye Research Australia (CERA). The CB works in conjunction with the Lions Eye Donation Service (LEDS) and other partners. They are the Custodians of donations recovered by LEDS and used in research.
The CB works within the expectations of the Victorian Human Tissue Act, 1982; NHMRC National Statement on Ethical Conduct in Human Research, 2023; NHMRC Biobanks Information Paper, 2010; and the OECD Guidelines on Human Biobanks and Genetic Research, 2009, and LEDS policies and procedures. They are responsible for ensuring the allocation to researchers is fair, and donations are maximised. They are the point of contact for any questions and/or to withdraw consent.
How is the CERA Biobank funded?
Today, the CERA Biobank, via LEDS, recovers the cost for their service from researchers who receive tissue through the deceased donation program. This complies with the Human Tissue Act, VIC, 1982 ‘cost recovery approach’ and ensures the service can be sustained.
Will samples ever be sold to a company for profit?
No. While the Service can provide samples, within its fair allocation system, to for-profit companies who are conducting research (for example, those making a new medical device or new drug), the Service itself can only seek reimbursement for what it cost the Service to recover, prepare and allocate the tissue. For example, consumables, staffing and courier costs.
Contact the CERA Biobank
Please email: biobank@cera.org.au