Current Status and Future Challenges of Biobank Research in Malaysia

Abstract

The establishment of MyCohort in 2005 showed that there is a growing interest on the part of the Malaysian government in the creation of biobanks in the country. This project can be considered as the biggest and most comprehensive cohort study in Malaysia, where hundreds of thousands of human samples are stored for epidemiological and biomedical research. However, little is known about the current issues or the situation related to biobank research in Malaysia. There are pressing issues that need answers such as the governance of the national biobank as well as other privately owned biobanks in the nation, the public perspectives and perceptions regarding biobanks, and other matters such as the ethical, legal, and social issues related to biobank research. This article will highlight the status and issues related to biobank research in Malaysia and provide suggestions on future research practices that we feel need to be seriously considered. These suggestions are designed to advance and enlighten researchers’ knowledge, as well as provide the public with information on issues associated to biobanking. Good governance increases public knowledge and trust, and religious acceptance of biobank research and accountability can lead to increased participation in biobank research. The direct implications of the discussion about the ethical, legal, and social issues of biobanks are pertinent for the foundation of knowledge relating to biobanks, as well as the forward gestures for future medicine for mankind.

Introduction

For the past few years, biobank research and technologies have developed dynamically and rapidly (De Sauza and Greenspan 2013). This is mainly because of their great contribution to the field of public health. It is hoped that with broader and more in-depth knowledge about the genetic, behavioral, and environmental factors relating to various diseases, there will be the greatest support for the continuous development of new drugs, diagnostic methods, and treatments, which eventually will improve care in terms of a movement towards more personalized medicine (Hewitt and Hainaut 2011). According to Gregersen et al. (2015) and Simeon-Dubach and Henderson (2014), having access to genotype-to-phenotype relationship databases makes it possible for researchers to undertake various forms of biobank research and improve our understanding of medical diagnoses, prevention, and treatment. Biobanks comprise organized collections of human biological samples, which are normally associated with individual personal health information for the purpose of biomedical research. Given the potential benefits, many biobanks have been established across the globe, including in Europe, North America, Asia, Australia, and the Middle East (Abdul Aziz 2018).

Recently, biobanks have undergone a rapid proliferation and have become increasingly complex in term of their research purpose, type, and source of samples. Such complexity indirectly gives rise to various ethical issues related to different aspects of biobanking (Budimir et al. 2011). The most highlighted issue of biobanking is related to the issue of privacy and confidentiality of donors’ personal information (Vaz et al. 2014; Hawkins Virani and Longstaff 2015; Kinkorova 2016). Previously, Hansson (2011) mentioned that firstly, the protection of donors’ identity and personal information is crucial when it involves the collection and storage of a vast amount of data regarding human specimens. This is not surprising, as most participants have voiced concern as to who has access to such data, fear of unauthorized personnel misusing the information gained from the specimen, and fear of such individuals being stigmatized as a result. Secondly, when human subjects are involved, informed consent is an essential tool to ensure ethical conduct and to protect those who participate as donors in biobank research (Widdows and Cordell 2011; WMA 2013; Karlson et al. 2016). In biobank research, the donor’s consent does not only protect their right to decide how their body parts will be used for research, but it also decides who will have access to their data (Budimir et al. 2011). With different types of consent, those responsible for collecting data and specimens from the research participants need to decide which type of consent will be appropriate for their research. Thirdly, there is an issue about ownership of the samples and of the data collected (Chalmers 2011; Hawkins and O’Doherty 2011; Bledsoe 2017). Questions have been raised as to who the ‘owner’ of the sample will be once it is deposited in the biobank, and whether research participants still have ownership over their specimen donated to the biobank. Fourthly, there are also issues about commercial activities such as the commercialization of biobank resources or products derived from research using biobank resources (Caulfield et al. 2014; Nicol et al. 2016; Turner et al. 2013; Evers et al. 2013; Caulfield and Murdoch 2017). Despite being currently used mainly for research purposes, it does not stop the public from being concerned that there will be some possibility that biobank research can become commercial in the future. This has led to possible issues of exploitation, unfairness in terms of studying participants, and an imbalance of risks and benefits (Steinsbekk et al. 2013).

At the same time, public acceptance of biobanks is also influenced by how they think that biobanks can benefit humanity, and what kind of risks are associated with using them, as well as how the samples or resources stored by biobanks are being used (Ahram et al. 2012; Gottweis et al. 2011; Pullman et al. 2012; Ahram et al. 2014). For those who are more religiously inclined, religious acceptance of ethical issues related to biobanking is particularly important as they do not wish to go against the beliefs of their religion. Another issue that has been raised is regarding the return of results to the research subject. This has led to questions such as what kind of results should be shared with the subject, how should such results be communicated to the subject, and by whom? (De Clercq et al. 2017; Wolf 2013; Zawati and Rioux 2011). On the other hand, some authors have argued that returning results to the research subject is not to be encouraged, particularly when it is not clinically relevant as this may lead to misinterpretation and to the creation of unnecessary anxiety, thus leading to psychological, social, or economic harm to the subjects (Budimir et al. 2011).

Based on previous research regarding public attitude towards biobanks, it is clear that a large proportion of the public do not have a problem supporting the purpose of having biobanks storing human biological materials (Domaradzki and Pawlikowski 2019; Simon et al. 2011; Lewis et al. 2013). However, their supports are very much dependent on their knowledge and awareness regarding biobanks (Porteri et al. 2014); their trust in the stakeholders involved in collecting, managing, and monitoring biobank activities (Burgess 2014; Gottweis and Lauss 2012); the risks and benefits associated with biobanking (Tomlinson 2013; Pullman et al. 2012; Hashim et al. 2017); and their religious and moral acceptance of biobanks (Amin et al. 2018; Ahram et al. 2014; Eisenhauer and Arslanian-Engoren 2016; Alahmad and Dierickx 2018). These factors also relate to their willingness to donate or participate in biobank activities (Amin et al. 2018; Domaradzki and Pawlikowski 2019). Malaysia currently has both private- and government-owned biobanks.

Attitudes towards biobanking are based on how participants perceive the benefits and risks of biobanking, issues related to personal information or data, the acceptance of various religious teachings on the applications of biobanks, and moral concerns about biobanks (Amin et al. 2011). Previous study in Malaysia regarding biobank research also found that Malaysian stakeholder’s attitudes towards biobanking is positive despite having some concerns regarding biobanking, thus indicating that more study is needed to explore the concerns that exist on the part of the general Malaysian population (Amin et al. 2011).

Despite having its own national biobank and several privately owned biobanks, studies regarding the current and possible future challenges associated with biobanking in Malaysia have never been deliberately discussed. Not only is there a lack in terms of quantitative studies relating to public attitudes to biobanking, but there is also limited information regarding biobanks that is available to the public. Additionally, Malaysia has yet to introduce specific legislation to govern biobanking, although there are relevant laws and guidelines to be used as a benchmark for regulating biobanks. Therefore, the aim of this paper is to highlight the status and issues of biobank research in Malaysia, and to suggest few future research practices that we feel need to be seriously consider advancing and enlighten researchers’ knowledge, as well as that of the lay public with regard to issues associated with biobanking. The highlights are separated into categories including public knowledge and awareness, governance of biobanking, public trust, and religious acceptance. In conclusion, we will discuss and highlight how such challenges can be overcome and make suggestions about future research related to biobanking in Malaysia.

Current Status of Biobanks in Malaysia

Malaysia is a country in Southeast Asia with a multiethnic and multicultural population. Malaysian citizens are divided along local ethnic lines. According to the latest data from the Department of Statistic Malaysia (2020), the current population in Malaysia is 32.6 million, with 25.4 million of urban population. This showed that majority of Malaysian stay in the urban area within the 14 states. Out of the 29.7 million citizens, the composition of Bumiputera is 69.6% (the largest group of Bumiputera are ethnic Malays, followed by non-Malay indigenous group in Sabah and Sarawak, and the Orang Asli), Chinese is 22.6%, Indian is 6.8%, and other ethnicity is 1.0%. Approximately 61.3% of the population practice Islam, 19.8% practice Buddhism, 9.2% Christianity, 6.3% Hinduism, 1.3% practice other traditional Chinese religions, 0.7% no religion, and the remaining 1.4% do not provide information regarding religious practices.

In 2005, The Malaysian Cohort Project (www.mycohort.gov.com) was established whereby more than 100,000 participants from various socioeconomic groups from all over the country were recruited, with different educational levels. The 151 recruitment locations for this project comprise 95 rural and 56 urban locations (Jamal et al. 2015). The participants of the TMC project consist of 42.2% males, and 57.8% females, with most of them are ethnically Malay (43.9%), followed by ethnic Chinese (32.5%), Indian (15.2%), and others (8.4%) (Jamal et al. 2015). From the 100,000 participants, 28.4% are between the age of 35 and 44 years old, 43.1% between the age of 45 and54, 27.3% between the age of 55 and 64 years old, and 1.2% between 65 and 70 years old. Participant’s educational levels are categorized into no formal education (3%), primary (26.6%), secondary (45.6%), and tertiary (24.8%) level (Jamal et al. 2015). This made it the largest storage of human specimens and the most comprehensive cohort to be studied nationally. At the same time, Abdul Aziz (2018) noted that The Malaysian Cohort Project is also part of the Asia Cohort Consortium. However, the storage of human specimens in Malaysia is not confine to The Malaysian Cohort Project as there are other biobanks in the country including Assisted Reproductive Technology (ART) clinics and tissue-specific-based biobanks that store certain types of human tissue, such as the Malaysian Periodontal Database and the Malaysian Oral Cancer Database (Abdul Aziz 2018). Based on the data published by the Malaysian Society for Assisted Reproductive Technology, there are 17 ART clinics in the country that provide treatment and carry out research as well as storage program donors for sperm, eggs, and embryos. In addition, a general search on Google Maps indicates that there are 19 other ART clinics in Malaysia.

Public Knowledge About Biobanks

Currently, there have been a limited number of studies which specifically explore and investigate public knowledge and awareness regarding biobanking in Malaysia. To a certain extent, this limits the exposure regarding societal knowledge about biobank research. Is the Malaysian public aware of what a biobank is? Do they know that biobank facilities exist in the country, and do they have any knowledge about the types of services that biobank providers offer? To what extent is their knowledge regarding the purpose, benefits, and risks, and what biobanks can and cannot do? The answer to all these questions is that Malaysians are still very much uninformed regarding biobanking. We do not have the ‘big picture’ about how much Malaysians know about biobanking, either through educational information, media, or through personal day-to-day communication. There is still little information available concerning the level of awareness and knowledge on the part of the Malaysian public about biobanking, albeit the implementation of MyCohort Project in 2005.

However, previous study conducted by Hashim and colleagues (Hashim et al. 2017) who explored the acceptance of biobanks on the part of various stakeholder groups in Malaysia, including policy makers, scientists, representatives of selected NGOs, religious scholars from different religion, media professionals, the public and university students, concluded the stakeholders’ awareness, knowledge, and engagement in modern biotechnology applications is still at a moderate level. The study showed that the mean score regarding Malaysian society’s awareness of modern biotechnology applications stands at 6.02. Despite being at a moderate level, the mean score does show an improvement based on studies conducted in 2007 and 2010, in which the mean score was 3.88 and 5.06 respectively (Amin et al. 2007; Ahmad Azlan 2010). On the other hand, Navarro and Hautea (2011) feel that this level is still considered to be low when compared to other countries such as the USA or the UK. According to them, this is probably due to the lack of scientific communication between the industry’s key players, in addition to little interest on the part of the media in highlighting articles related to science and biotechnology. The mainstream and online local newspaper in Malaysia are less focused on issues related to medical sciences and biotechnology compared with their counterparts in more developed countries such as the USA or the UK (Amin et al. 2011).

These early studies conducted in Malaysia, however, did not explore in any depth issues associated with biobank research that may have raised concerns among the participants, and why. The Malaysian public was moderately concerned about the risks which included feelings of anxiety and worry about long-term effects, possibility of threats to future generations that may give rise to unknown consequences (Hashim et al. 2017). They were also concerned about the moral aspects of biobanking, such as issues of ownership and possible misuse of data and specimens by researchers. However, Hashim’s study was only conducted among participants in the Klang Valley, which placed limitations on of its findings. The location is selected due to its status as Malaysian social economy hub. Hence, whoever that resides within the Klang Valley area come from diverse background, thus meeting the study’s requirement (Hashim et al. 2017). However, there is a need to further the study to those outside the Klang Valley as this might produce different outcomes. In addition, new pertaining issue may emerge that can provide new knowledge regarding societal perceptions of biobank research. At the same time, it is also quite concerning that there is a lack of study of the ethical, legal, and social concerns of biobank research from the local perspective, since this may be due to a complete ignorance of the views of the very people who will be most heavily affected by the new policy or regulation of biobanking services.

Governance of Biobanking

Currently, Malaysia has not introduced any specific laws governing biobanking. However, there are relevant laws that regulate private healthcare facilities and services in Malaysia (Abdul Aziz 2018). At the same time, in 2006, the National Committee for Clinical Research introduced guidelines on the use and handling of human biological tissue for research. These guidelines provide information on how to ethically collect, store, use, handle, and discard used human tissue, gathered either for research or for therapeutic purposes. However, these guidelines are not legally binding, and with little evidence of monitoring, it is difficult to make sure that all parties follow them. In addition, if they do not follow the guidelines, prosecuting them in a court of law would be difficult. What makes it more difficult is that most biobank services are privately owned. Consequently, such services are left to their own devices if they visibly abide by the regulations and guidelines set by the governing body. The only regulatory document that was established specifically for biobanking was the National Standard for Cord Blood Banking and Transplantation 2008. Despite having these regulations and guidelines, appropriate legislation specifically for biobanking should be established, not only to protect the service providers, but also to protect the individuals who wish to participate as donors or as research subjects.

Ethical Issues

Without a proper framework to regulate the activities of biobank research and to regulate the existence of privately owned biobanks, the number of which has grown rapidly, there will be many challenges in making sure that these service providers and scientists engaged in biobanking are conducting their research ethically. When it comes to biobanking, making sure that the service providers undertake their sampling and research ethically is equally important as protecting the right of the donors or participants to privacy. With the establishment of the Personal Data Protection Act 2010 (Mohamed 2010), individual personal data is protected from being use commercially, and this law is considered relevant to biobanking applications because it protects donor’s data and results from being misused by those who are not authorized to do so. Biobanking data is overly sensitive as it contains information that can be traced back to the donor (Abdul Aziz 2018). But is it enough or do we need more to protect all the stakeholders in the biobanking industry, especially the donors? Based on a previous study, most of the stakeholders who were not scientists and producers expressed moderate concerns regarding issues related to ownership and to the misuse of data and specimens, regardless of their level of education (Amin et al. 2011). This indicates that despite the existing regulations and guidelines, there are still some obvious concerns among the public regarding the level of protection they are going to get when they decide to store part of their bodily data with a biobank.

Accountability

The governing of biobanks is also important in the case of data exchange, when there is a need to collaborate with other researchers, biobanks, or research institutes, or when it involves the commercialization of biobank research. The Malaysia Cohort Project is the biggest biobank in the country, and since it is also part of an international network, it is important that the governing aspect is given priority. It is argued that without specific legislation protecting the service providers as well as the donors, low- and middle-income countries may at the mercy of high-income countries due to the lack of research capacity and the governing mechanism relating to biobanks (Abdul Aziz 2018), which could possibly lead to the exploitation of resources relating to genetic biodiversity. However, we do not have any knowledge as to whether there is any commercial collaboration between biobanks in Malaysia and any pharmaceutical company. Consequently, we are not aware of the precautionary measures or legislation that exists to prevent exploitation and ensuring fairness when it comes to studying participants. Thus, questions should be asked, including who should be made accountable in cases of exploitation of donors’ data or samples, either in the form of individuals or institutions? How should they be hold accountable and why? Where should suspicion of exploitation and misuse of information be reported? These are important questions that need to be addressed when biobanks exist to protect participants as well as the service providers. However, if these questions have been answered, this information should be made available, either through publication or through media interaction. If these questions remain unanswered, it is about time for us to find the answers.

Informed Consent

The main ethical issue that is constantly being raised in biobank research revolves around matters related to informed consent. According to Domaradzki and Pawlikowski (2019), informed consent in biobanking is a paramount issue, and commonly related to ethical and societal issues. Biobank research such as cloning and genetic modification raises public concerns about playing God, violating privacy, and discrimination by employers and insurers (McDonald et al. 2014; Shabani et al. 2014; Trinidad et al. 2010; Baker 2014; Liang et al. 2015). It is agreed that participation in biobank research should be voluntary and without coercion, and participants must be fully informed regarding the purpose of the research, including the expected benefits and risks (Hansson 2011; Chalmers 2011; Gertz 2008), and they can withdraw their consent to participate in the study at any time without facing sanction or penalty. Currently, most biobanks use either specific, broad, blanket, dynamic, or tiered consent (Abdul Aziz and Mohd Yusof 2019). When a donor or a participant in biobank research decides to choose specific consent, they only provide consent for their body specimen to be use for a specific research purpose with a well-defined aims, risks, and benefits (Master et al. 2012). Meanwhile, for those who choose broad consent, they consent to donating their body specimens for a broad range of unspecified future studies, but with some restrictions. However, in the case of blanket consent, the donors provide their samples without any restrictions (Hansson et al. 2006). The latest type of informed consent used by biobanks is dynamic consent. It is digital decision support system, in which donors are constantly being updated using modern IT communication strategies. Dynamic consent is also used to inform donors about future research that might need their specimens, and to offer them the choice as to whether to provide consent for its use (Kaye et al. 2015). Tier consent is another type of informed consent that is provided to donors where research can be subdivided into tiers or categories, and participants can specifically choose which of their donated specimen can be used for different biobank research (Sanderson et al. 2017). Despite the availability of different types of informed consent, most biobanks prefer the use of broad consent (Master et al. 2015). This is because samples and information can be reused without obtaining a new consent, if the use falls within the scope of the original broad consent and fulfill other regulatory requirements (Grady et al. 2015).

Studies related to informed consent in biobank research in Malaysia is largely unavailable, hence the limited literature on the subject. What little knowledge we have is about its governance. Additionally, information about the type of informed consent that is currently being used is also limited or unavailable for layman’s use. The process of obtaining informed consent is particularly important to make sure that the consent used is valid. Such validity depends on where, when, who, and how it was taken, and whether the donors understand the consequences of providing their consent to biobanks. With the various types of informed consent, it is difficult to pinpoint which type of informed consent is the most appropriate, and this has been debated extensively. However, it has yet to be solved (Abdul Aziz 2018). According to Abdul Aziz and Mohd Yusof (2019), concerns surrounding the current practice of consent regarding biomedical big data in Malaysia are mainly focused on whether the current practice of consent will be able to respect the individual’s autonomous rights, and the fact that current practice is not in accordance with the legal principles of the Personal Data Protection Act 2010. These concerns include the implementation of informed consent and the regulations associated with maintaining the privacy and confidentiality of biomedical data in Malaysia. Therefore, it raises questions as to the credibility of the Malaysian informed consent framework, raising questions such as whether Malaysia needs a revamp of the framework, and whether the existing regulations related to biobanking is sufficient to protect the store of specimens in the biobanks as well as the donors’ information.

Additionally, issues of informed consent are also related to issues of ownership of samples, data exchange between one biobank and another, and the returning of results. Who will own the biological samples that the donor donates to the biobank? Does the biobank automatically own the sample once donated, or it is included in the consent form stating that the donor gives permission for the biobank to own it once it is deposited? Is it written somewhere in the consent form that the donor can withdraw the sample if they ever change their mind about it being used? It is not only in Malaysia but in general the issues of ownership create a dilemma within the biobanking industry. Ownership of stored samples, commercialization of research findings, and benefit sharing with research participants and community are much debated contentious issue (Wolf et al. 2008). According to a study conducted in India by Vaz et al. (2016), the study participants, which consist of ethics committees and medical researchers, have different opinions on who should own the specimens. Some argued that the ownership belongs to the donor or patient, storage facilities as virtual owner, or researchers who obtained the sample through the consent of donors. Therefore, we feel that there is a need to raise concerns about the issues such as to make sure that donors or participants are aware that they are still, or are no longer, owners of their biological sample whether consent has been given. Chalmers (2011) argued that issues related to legal ownership of samples remained unsettled, despite some authors arguing that the sample is still owned by the donor and is only under the custodianship of the biobank. Therefore, the donor can withdraw the sample at any time (Yassin et al. 2010). For some, the ownership of the sample should be co-shared by the biobank, the donor, and the researcher (O’Brien 2009).

Public Trust

Public trust is important in making sure biobank research receives the support it needs to proceed (Budimir et al. 2011). Without the trust of the public, it may stall any research related to biobanks and may cause a grievance, particularly for those who really need and expect improvements from medical and healthcare systems (Hansson 2011). Public trust in biobanking can also increase the public’s willingness to become donors and participate in research. A hypothetical study in Sweden found that public willingness to participate in biobank research is very much influenced by their trust in science, and in the researcher and hospital where the research will be conducted, thus leading to the success of biobank research (Kettis-Lindbald et al. 2005). Similarly, in Australia, Critchley et al. (2010) found that the most important factor that contributes to the success and willingness to participate in biobank research is public trust in the biobank. In fact, Critchley et al. argued that public trust in biobanking is estimated to be almost ten times more important than belief in the potential benefit, and five times more important than feeling comfortable with blood donation and DNA analysis. According to Haverson and Ross (2012), participants’ issues of mistrust may not be directed towards the producers or scientist, but more to the commercial entities and the authorities involved, including police officers. This is probably due to their own personal experience with authority or their distrust of insurance and pharmaceutical companies, which to them are just money-making entities without much concern regarding ethics.

Trust in the key players is the third direct predictor of participants’ willingness to participate in biobank research (Amin et al. 2018). This indicates that the more trust the public has in the key players, the more willing they are willing to participate in research related to biobanking, as they are inclined to rate biobank research as beneficial. However, besides this, there has been no other research done to investigate and explore the level of trust on the part of the Malaysian public. There is still a gap on research related to who the key players associated with biobanks are, and what are the issues that make the public distrust or trust these key players. Other research questions also include considerations of their level of trust related to the issue of privacy and confidentiality. If such trust exists, what are the issues of concern? Or does their trust relate to how much information they have gained or the knowledge they have about biobank research? Or does it have anything to do with having confidence that their data or results will only be use for medical purposes and not for commercial gain? To gain informed insight into these questions, we need a more in-depth study that involves the use of qualitative interviews to support the statistical evidence. This information would be valuable because it is through such information that we can find a suitable program and methods to address any lack of trust on the part of the public.

Religious Acceptance/Perspectives

Religion can play a pivotal part regarding an individual’s life, which they use for guidance when making important decisions. Religious judgments on biobanks can influence an individual’s decision to participate and support biobank-based research. The connection between religious acceptance and support for biobank research was also highlighted in a study conducted in Malaysia which demonstrated a positive and direct association between religious acceptance and attitudes towards modern biotechnology applications including biobanking (Amin et al. 2014). For a society such as the Malaysian one, this finding is not surprising considering the importance of religion and culture for most Malaysians in their daily lives. This therefore highlights the importance of religious teaching and the acceptance of modern biotechnology applications to stakeholder’s views and support for biobank research. Previous studies have also shown that the public supports biobanks and is willing to donate their samples to biobanks if they find that the application meets with minimal resistance from their religion authorities (Amin et al. 2013; Igbe and Adebamowo 2012; Nasrella and Clark 2012). This also concurs with the findings of Ahram et al. (2013) who reported that when religious authorities provide permission to make biospecimen donations for the purposes of biobank research, donors are more willing to donate their specimens. These findings show that when an individual is closely attached to religious teaching, they become more critical of the purpose of biobank research.

However, despite claiming the importance of religion in the daily lives of most Malaysians, thorough research related to the impact of religious views on biobanks is still limited. The availability of statistical results in terms of Malaysian stakeholders’ attitudes and their acceptance of biobanks does not really provide a detailed explanation of the type of biobank research they accept and what kind of issues may or may not change their acceptance of biobanks. According to Tomlinson et al. (2015), when potential donors are presented with potential research scenarios that may raise moral concerns or issues, such as abortion or genetic modification research, they are less willing to proceed with the donation, or they may proceed but most do not wish to choose to consent using blanket consent. According to a previous study, Buddhist scholars strongly believe that biobanking is acceptable according to their religion, while Christian scholars, on the other hand, were found to have the lowest mean score in terms of religious acceptance compared with Muslim, Hindu, and Buddhist scholars (Hashim et al. 2017). It is good to be aware of such findings, but it will be better if such findings are supported with reasons for their rejection, objection, and acceptance of biobank research, and to what extent they still consider it to be acceptable in terms of their religious beliefs.

Future Direction

Given the convincing evidence of the factors mentioned above including governance of biobanks, public trust or mistrust in biobank research, public knowledge and awareness regarding biobanks, types of informed consent available, and religious views or concerns about biobank research, it is critical that we identify and try to understand what drives these factors. This is because, without exploring and investigating what can be the ‘drivers’ of these factors, we may not be able to ensure that all segments of the population are represented in biobanks (McDonald et al. 2014).

Firstly, there is a need to know the extent of public knowledge and awareness regarding biobank research. Despite previous studies conducted in Malaysia (Amin et al. 2007, 2011; Hashim et al. 2017; Ahmad Azlan 2010; Alahmad et al. 2018), there is still a lack of information regarding public perceptions that highlight their concerns on issues related to biobank research. Currently, statistical data on public awareness, knowledge, and engagement in modern biotechnology research is available albeit limited, there is still more to be explored. Consequently, numerical data need to be coupled with qualitative research. Through in-depth interviews with participants, researchers can explore issues relating to biobank research more extensively, and highlight concerns raised during such interviews. Such information could assist policy makers and government agencies to find the best possible solution to addressing society’s concerns. Since all the previous studies were conducted within the Klang Valley, future studies should include those who reside outside the Klang Valley. This would answer the concern that results may differ between respondents who stay in an urban area such as the Klang Valley and respondents who reside in rural areas. Those who stay in the urban areas may have better access to information regarding modern biotechnology as compared to those who stay in the rural area. Therefore, it is important that such studies involve a more diverse population in terms of geographical location to ensure a better understanding of the level of knowledge and awareness of the Malaysian population regarding biobank research, and what are the factors that influence these differences or similarities. It is through such research results that we may identify factors that influence the level of knowledge and awareness and find a solution to how best to increase it and use appropriate methods for them to understand the issues related to biobanking.

At the same time, it will be good to see whether there are any changes in terms of stakeholder or public attitudes, knowledge, and acceptance of biobank research. This is because social attitudes can change from time to time (Domaradzki and Pawlikowski 2019), and these changes can easily influence the public’s acceptance of biobank research and their perception on issues related to biobanking. Awareness levels can also change over time, as has been seen in several studies conducted in Malaysia, where the awareness level regarding modern biotechnology has increased from 2007 (Amin et al. 2007) to 2010 (Ahmad Azlan 2010). However, a study by Navarro and Hautea (2011) showed a decline in the level of awareness due to lack of highlighting of scientific articles by the media. Therefore, it is crucial to highlight the need to conduct research on the topic and see whether society’s awareness and knowledge has increased with the improvements in media communication. It is assumed that when public knowledge and awareness regarding certain topic increases, so too does their acceptance, and thus they will have a positive perception of technology. However, this might not be true for all topics, and therefore, we need to explore and evaluate public knowledge regarding biobanking and do not be alarmed that, with too much knowledge, they might feel the need to reject it or they may not be willing to participate as a donor in biobank research. This would have negative implications for the progress of biobank research, as well as the progress in medicine. At the same time, a different group of stakeholders may be included in the future study such as research funder, bioethicist, hospital administrator, and donors. These groups of stakeholders might provide researcher with different perspective on issues related to biobanking research.

Secondly, despite the existing regulations, it is arguable that Malaysia needs to revisit its regulatory framework for biobanking to ensure not only that its approach is in line with international regulations but also to safeguard local samples. This idea was also suggested by Abdul Aziz (2018) who felt that there is essential to revisit the existing regulatory framework about biobanking in Malaysia because, with the increasing number of samples or specimens stored within biobanks, and with the existing research collaboration with other biobanks globally, we need to have appropriate regulations, policies, or laws to protect both the donors and the data stored in the biobanks. He added that the current regulations may not be sufficient to fully protect donors’ information from being abused by irresponsible parties. However, to suggest a new regulatory framework or policies related to biobanks, we need to know about the current governance situation regarding biobanks in Malaysia, which unfortunately is not easily accessed. There is also a lack of knowledge regarding how protective the current regulatory framework is in terms of protecting the stored data from being manipulated by irresponsible parties for personal gain; how these hundreds of thousands of pieces of data are being stored, managed, and used ethically by scientists; what kind of regulations currently exist to protect donors or minimize the risk to donors when there is a need for data exchange for collaborative research purposes. This information is not only scarce for scrutiny by the public but is also of limited availability for researchers who are interested in biobank research.

Thirdly, it will be novel to explore the perceptions and opinions of the public, especially potential participants in biobank research, regarding the appropriateness of the type consent that is currently being used. According to Hoeyer (2008), issues related to informed consent have created intense debate among academics when it comes to biobank research; hence, it will be most appropriate to include the opinions and views of the public regarding these issues. When we incorporate public participation into this study, we will be able to obtain useful information regarding their views on the current use of informed consent, how they feel about it, what can be done to improve the consent process, why they are of the opinion that one type of consent is more appropriate than another, and what other aspect that should be included when developing or improving the current means of consent. Or maybe no changes are needed. But we will never know if no related study is conducted. In the case of previous qualitative studies among potential and actual donors that have focused on reasons for providing consent, the findings are more homogenous compared to the survey measurements. This shows that there is a disparity between qualitative studies and surveys when it comes to how consent requirements are viewed by potential and actual donors (Hoeyer 2008). At the same time, factors that may encourage or discourage the public from participating in biobank research may be potentially related to the content of the informed consent. Unfortunately, the donor’s opinion on the current requirements and types of informed consent use by Malaysian biobanks is unavailable. Whether or not they understand the existence of various types of informed consent and the purpose of giving such consent for biobank research is still in question. This is because donors rarely read, recall, or use the information with which they are provided (Ducournau 2007). There are only two articles related to informed consent and biobank written consent in the Malaysian context, but there is none which provides empirical findings. Therefore, an empirical study related to informed consent and public perception should be undertaken so that researchers know the issues that concern the public the most in terms of informed consent for research in terms of biobanks. At the same time, through such a study, we could also obtain information on whether we need to improve and revamp our current regulatory framework and, if so, how it should be done. It will also be useful for researchers and policy maker when they need to develop a new governing framework for biobanking in Malaysia.

Fourthly, there is a need to determine the level of trust that the Malaysian public has regarding biobank research, and the factors that influence their trust in key players associated with biobanking. According to previous studies, better knowledge and more positive views on biobanking can lead to higher public trust and confidence in such key players as these factors do greatly influence public attitudes and trust in biobanking (Critchley et al. 2010; Gaskell and Gottweis 2011). This in turn makes them more willing to donate sample for use in biobank research. According to a study conducted in Malaysia (Amin et al. 2011), the public trust in key players has a direct influence on the participants’ willingness to be involved in biobank research. Additionally, it highlights the fact that public trust in biobanking is normally associated with the perceived benefits and risks of biobank research. Such trust relates to the belief that the institutions where the research is conducted will be responsible when handling the information and results. Even when the participants do not really understand what biobanking all is about, if they trust that the research result will benefit them, their families, and those who are medically incline, then this will increase their willingness to become donors. People in general are excited, willing to donate, and supportive of biobank research, which explains their genuine willingness to participate in biobank research (Budimir et al. 2011). However, this momentum in terms of excitement needs to be maintained and continuously supported, and trust on the part of the public needs to be remain at a highly positive level. The Malaysian public’s trust has not been specifically surveyed and evaluated so far, although there is a study that shows that public trust in key players associated with biobanks has a direct effect on their positive attitudes towards biobanking and thus increases their willingness to donate samples (Hashim et al. 2017). We need to have some knowledge as to what it is that they trust when it comes to biobanking, and why they feel like that. We need to know the current and potential factors that may increase or decrease their level of trust in the key players specifically, and biobanking, generally. It is only through such information that we can provide them with the necessary measures to address their concerns and hope. One of the methods that have been proven successful is through public open forums and discussions where they are encouraged to learn, debate, and discuss the aims, goals, and issues related to the use of biobanks. These engagement events are good in terms of stimulating the citizens and providing a platform for the public to openly discuss, debate, and raise concerns in relation to biobanking, as well as helping the key players in the biobanking industry when it comes to structuring or developing regulations or laws related to biobanks, or improve the current governance of biobanks (Longstaff and Burgess 2010; Hawkins and O’Doherty 2010). Therefore, this method can be adopted and adapted by the research community in Malaysia for future research.

Fifthly, religion has a vital role to play in the Malaysian community, and since Malaysian society has a diverse range of religious beliefs, it is no surprise that studies on public attitudes or perceptions about a specific modern biotechnology has always included their religious views and acceptance. Malaysian stakeholders in general moderately believed that the application of biobanking is accepted by their religion and customs (Hashim et al. 2017). However, when they think that biobanks pose some risks then they think that it will be less religiously acceptable (Amin et al. 2018). This shows that those who are more religiously inclined tend to be more critical of biobanking, and religious view is clearly observed by them when making decisions related to biobanking. However, what exactly makes these religiously inclined individuals reject or accept biobanks is still unclear because, so far, there has been no study that had focused on this matter. Religious beliefs cannot be separated from those of Malaysian society, and it is considered important to include religious views when discussing issues that particularly involve human subjects and the use of human specimens from different body parts, either for transplant into another human body or used as an ‘object’ in research activities. Therefore, a thorough study involving various religious organizations is important to educate its followers as to what is acceptable and unacceptable about biobanking. Despite several quantitative studies having been conducted in Malaysia, qualitative studies on issues related to biobanking and religion are still lacking. It will be remarkably interesting to see how views differ and why, and how it is possible to influence those who believe in the same religion, and how this affects their decision-making when it comes to biobank research. The findings can also be especially useful for policy makers when they need to develop a new regulatory framework for biobanks in Malaysia.

Conclusion

Since the establishment of The Malaysia Cohort Project as part of the government’s effort to improve the healthcare and well-being of Malaysian society, more than 100,000 donors have donated different parts of their bodies to the biobank. This shows that the Malaysian public in general supports biobank research and has a positive attitude to its purposes and goals. However, since its establishment in 2005, there has been limited research conducted regarding biobanking research in Malaysia. The few articles or studies that have been conducted in Malaysia are related to the ethical and legal issues about biobank research. Therefore, there is a need to explore these issues further. At the same time, exploring the ethical issues of biobank research can provide researchers with knowledge of the ethical issues that concern the public, why they feel this way, and how we can increase their support of biobank research in the future. We need to conduct an in-depth study such as a qualitative study including in-depth interviews with various stakeholders, to really evaluate the reasons and factors that influence their support or lack of support for biobank research, and provide useful knowledge and insights to the public, policy makers, and the research community.

Funding

This study is funded by Universiti Kebangsaan Malaysia under the grant no. MI-2018–005.

Data Availability

Not applicable.

Declarations

Conflict of Interest

The authors declare no competing interest.