The success of research across the world lies in the ability to utilise biobanks. In various institutions, these have become vital.
It is in biobanks where you will find a large collection of specimen with associated information that can be used for future research.
The samples stored could include saliva, urine, blood and hair. You can also find the derivatives of the primary samples. That is, those that have been processed and extracted from the primary samples such as blood cells, platelets, parasites extracted from malaria-positive-blood samples and DNA.
Such specimen is usually drawn from donors who remain anonymous. But, the data collected can include illness of the patient, outcome, age and sex if the samples are to be useful in research.
According to a scientist, having a platform providing carefully stored and documented samples, including participant’s health or disease status, makes it possible to investigate genetic component of diseases and provide personalised medicine.
It is for this reason that the Kenya Medical Research Institute (Kemri) set up a biobank in Kilifi. The Kemri-CGMRC (Centre for Geographic Medicine Research, Coast) has nearly 1.8 million biological specimen collected since 1989 mostly from participants in research that are conducted by researchers in the programme.
Inside the biobank, samples are stored in more than 55 freezers. Each freezer has the capacity to carry between 40,000 and 50,000 samples. “These are not the standard freezers you get in homes. There are freezers that can push the temperatures to below -80 degrees centigrade. At least at this temperature we are sure the samples will be in good shape for future use,” said Martin Rono, a biologist at the centre.
Cancer biobanks facilitate research into new diagnostic tests and therapeutic approaches including personalised medicine. “In some countries, patients are contributing to cancer biobanks. They are researchers who are looking at what is causing cancer and why is it such a big problem. In order to have those kind of answers you need to have large samples of different diverse populations,” said Dr Rono.
There is controlled access to the secure room where the freezers are kept. “We only assign access to people who are mandated to keep or retrieve the samples from the freezers,” said Dr Rono.
An information management system also keeps track of all the freezers. “It tells us in real time what is kept where. Each location is tracked by a software where you can see in the freezer, for example number five, in position one on the rack, in position three in a tray is a sample, which is maybe blood or urine,” he added.
All the samples are remains, leftovers and deviates of samples collected in research programmes.
While it is difficult for the researchers to ascertain for sure the number of participants as the data is anonymised, it could more than 100,000 people.
Much of the research has been conducted in the population within a Kilifi Demographic Surveillance System of over 280,000 living in and around the Kilifi County Hospital. However, the research has involved other sites in Kenya, in different parts of Africa and the world.
The researchers have permission from the ethics review committees for storage of the remains of the research samples in the biobank.
According to Dorcas Kamuya, a Kemri Wellcome Trust Society and Ethics fellow, biobanks have been in existence for decades particularly in developed countries and in Sub-Saharan Africa and they are still growing.
“Biobank is a new term, but we have always had storage of samples. Most research institutions all over the world will always have samples stored in labs and repositories. There is an extra software and hardware infrastructure that converts a biorepository to a biobank. In the developed world, biobanks are well established and well-funded and supported,” she said, adding there are also biobanks that store plant and animal materials.
Other biobanks dealing with human samples include the UK biobank, and Human Heredity and Health in Africa (H3Africa) biobank.
At the International Livestock Research Institute in Muguga, Kiambu, there is a biobank that keeps mostly animal samples.
Biobanks also range from small collections to large national population-level biobanks as found in some of the developed countries such as UK, US, Canada and Scandinavian countries.
For example, the UK biobank consists of about half a million participants.
The type of samples kept in human biobanks could have been collected from general population of individuals who donate their samples to a biobank to be used for research, patients who donate for research, for example cancer patients, or participants in a research who give consent for samples that remain to be stored and used for future at the end of the current research.
For the biobanks that store human samples, the type of samples that are stored also differ.
The amount of the individual samples, especially remains or leftovers from research that are then stored in the biobank, are usually very small.
Biobanks can also be physically based in one institution such that only researchers and collaborators in that institution can store the specimen, which is the case for the one in Kilifi.
They can also be networked, that is, there is a large group of researchers storing in one biobank as with The Human Heredity and H3Africa consortium that involves nearly 50 research projects in 34 countries in Africa.
H3Africa has set up biobanks in Uganda, South Africa and Nigeria.
Biobanks, like a microscope, will allow us to see how different risk factors act together to cause disease, but in Kenya we still have a long way to go.
Guidelines on biobanking are still in development. Ethical and social questions about the processes remain, hindering proactive biobanking.
Having a biobank is not the same as bio banking. While a biobank is the storage facility and infrastructure required to maintain high quality samples, biobanking is the sharing of the stored samples.
Dr Dorcas Kamuya, a Kemri-Wellcome Trust Society and Ethics fellow, says the sharing requires a lot of considerations. “Why are samples being shared, that is, the specific reason? What permission did the sample donors (patients, research participants) give/limit to the sharing? Was consent explicitly provided? Whose samples are being shared and in what format? What permission — in addition to that by the donors — has been given and by whom? Which inter-government and inter-institutions agreements are in place on the sharing?,” she says.
Dr Kamuya says the institutional and national ethics research committees and regulatory bodies must be involved in the process.
Where sharing involves shipment out of the country, in addition to these conditions, there must be a signed Material Transfer Agreement (MTA) — a legally binding document that is signed by the institutions involved.
In Kenya, the MTA is signed by the government officer in charge of the research institution. “Having a biobank of 1.8 million specimen idle is not helping anyone. Transforming that into something that can answer research questions is where you want to be, but you have to take several steps to get there,” said Dr Kamuya.
Guidelines and standards for operating biobanks are still in development and maybe very different from one country to another. “While the Western and developed countries have made a lot of headway on this, we are still revising some of the guidelines in Sub-Saharan Africa,” she says.
Sharing of the samples from the Kemri-CGMRC Biobank is restricted to researchers at the programme and collaborators. “Bio banking is where research is because you can learn so much. Just one sample can give you so much data. In 2010, a magazine said biobanking is the 6th biggest idea in the world,” she said.
Despite the limitations, the Kemri biobank has still been able to contribute to groundbreaking research. “Malaria vaccines, pneumococcal conjugate vaccine and the Ebola vaccine research was supported here. Several policies on the guidance of medical practices have been generated from here. And many other researches that have been going on are linked to the biobank and the services here, “said Dr Martin Rono, a biologist.