Table 5 Benefit sharing challenges in biobanking

Tensions with other ethical principles

(a) Payment or compensation of research participants/specimen donors: may be in conflict with conventions or guidelines that state that the human body should not be a source of income (commodification/commercialization of human body). Payments may also be considered coercing individuals to participate therefore a form of undue influence/coercion

[24,25,26, 29,30,31,32,33, 36,37,38, 41, 43,44,45, 50]

(b) Claims of ownership of samples: It becomes difficult to distribute benefits when it is unclear who owns the samples

(c) De-identification of samples (individuals and communities): makes it difficult to share benefits with donors or return results if they are unknown

(d) Providing healthcare as a benefit: May be seen as undue inducement if provided to vulnerable individuals who have no other means of accessing care. Also brings up question of whose responsibility it is to provide care; researcher or government?

(e) Conflict between protection against undue inducement on the one hand and exploitation on the other

(f) Conflict between business enterprise required to fund research and claims of commercialization of human body in the process

Practicality Issues

(a) Long periods between tissue collection and development of interventions: benefit not immediate or apparent

[24, 25, 28, 32, 33, 35, 37, 39,40,41, 44,45,46,47, 50]

(b) Low yield: numerous attempts before successful intervention

(c) Nature of research: Samples may be used for basic research where no intervention is developed. Benefits such as post study access therefore become impractical

(d) Absence of royalties, profits and patents: Difficult to distribute benefits

(e) Nature of sample collection: Small amounts of tissue may be collected over wide geographical regions. If and when an intervention is developed, it may be difficult to share benefits among all

(f) Oversight: Due to long periods between sample collection and development of intervention (sometimes decades) it becomes difficult for Ethics committees or governments to perform oversight of benefit sharing

(g) Uncertainty: Not possible to tell how samples will be used, what interventions will be developed and therefore what benefits may accrue

Weak governance

(a) No requirement for benefit sharing in legislation nor enforcement mechanisms

[24, 32, 33, 35, 37, 39, 42, 43, 45, 46, 48, 50]

(b) No protections for poor countries from exploitation by richer countries

(c) Guidelines do not describe which benefits shall be shared and how benefit sharing would work practically

(d) Lack of clarity in guidelines on whether direct or indirect benefits should be shared

(e) Poor or absent medical and patents laws and/or regulatory frameworks in most countries

(f) Organizations and policies provide inconsistent and incomplete frameworks, and none of them possess supra-national status, authority or enforceability

(g) Laws prohibiting sale of tissues may work against compensation of sample donors (misconstrued as payment)

(h) Non-committal language in legislation e.g. “may”, “could be considered”

(i) Non-reliance by states of international declarations e.g. Declaration of Helsinki by the United States of America

(j) Inability by ethics committees to enforce benefit sharing requirements

(k) Narrow focus on one kind of benefit e.g. post study obligations by international guidance documents precludes other benefits

(l) Explicit exclusion of human biological materials from CBD

(m) No means for redressing past injustices e.g. samples already shipped out

(n) Precedence provided by some court rulings in which specimen donors have been denied right to share in benefits from their genetic materials

Not current practice

(a) Superseded by other principles e.g. privacy, consent

[24, 27, 31,32,33, 35, 37, 39, 44, 50]

(b) No ethical precedence/ long-standing ethical tradition for paying/compensating donors of biological material

(c) Attitude: Seen as unworkable or idealist by detractors; even questioning the need for benefit sharing

(d) Scant attention to governance of benefit sharing

(e) Presumption that tissue donation is purely altruistic

(f) Benefit sharing is still poorly understood and implemented, including by many key research stakeholders, such as researchers, sponsors, regulators and, sometimes, ethics committees

(g) Guidelines, checklists and templates from most ECs and Institutional Review Boards (IRBs) do not include “benefit sharing” among the issues to be checked/reviewed

(h) Negotiations about benefit sharing not a part of informed consent processes

Undermining altruism

Focus on the sharing of financial benefits could attenuate people’s willingness to participate for idealistic reasons

[25, 26, 29, 31, 32, 36, 37, 45, 47]

Expensive

Implementing benefit sharing could increase cost of doing biobanking and research

[8, 28, 29, 31, 37, 39, 50]

Insufficient evidence to support/justify benefit sharing

(a) No empirical studies to demonstrate need for and how to execute benefit sharing in biobanking

[26,27,28, 32, 35, 37]

(b) Little empirical research on what types of benefit sharing arrangements members of the public may wish to see incorporated into biobank governance and regulatory frameworks

(c) Seems intuitive to compensate tissue donors when their samples lead to generation of revenue but there are no specific arguments for this

(d) Specific, strong arguments for financial compensation to individuals are hard to find

Procedural issues

(a) Who negotiates for benefit sharing?

[30, 37, 40, 42]

(b) How is community defined?

(c) How are representatives to negotiate benefit sharing selected given existing structures may be undemocratic or exclude certain members

(d) Need for inclusion of other interest groups e.g. religious leaders

Difficulty in quantifying contributions

(a) Donors vs donors: Should donors whose specimen can be directly attributed to intervention be the ones to be compensated?

[30, 32,33,34,35,36,37, 44, 47, 50]

(b) Virtually impossible to determine the relative importance of any one sample to the overall success of the study

(c) Researchers vs donors: Does the sample provided by the specimen donor have inherent value or is value created by what the researcher does?

(d) Researchers vs researchers: How should benefits shared between providing entity/biobank and recipient entity/biobank. Also, researchers from low-income countries compared to those from rich countries