Table 4 Governance mechanisms for benefit sharing

1

Convention on Biological Diversity

(a) Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization[51]

Both monetary (e.g. access fees, upfront payment, joint ownership of relevant IP rights) and non-monetary (e.g. sharing of research and development results, collaboration, development programs to build local capacity) benefits ought to be shared

[41, 42, 46, 49]

(b) The Nagoya Protocol on Access and Benefit-sharing [52]

Various provisions on the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of their utilization

[24, 30, 37, 40,41,42, 45, 47]

2

UNESCO

(a) Universal Declaration on the Human Genome and Human Rights[53]

Benefits from advances in biology, genetics and medicine, concerning the human genome, shall be made available to all, with due regard for the dignity and human rights of each individual

[24, 27, 31, 39, 40, 45,46,47,48]

(b) Universal Declaration on Bioethics and Human Rights 2005[54]

Benefits should be shared with society as a whole, within the international community and with developing countries. Such benefits include “special and sustainable assistance to, and acknowledgement of, the persons and groups that have taken part in the research”

[24, 27, 33, 37, 41, 43, 46, 50]

3

HUGO statement on benefit sharing [38]

Undue inducement for human genetic samples through compensation ought to be prohibited

[24, 27, 40,41,42,43,44, 47,48,49]

Technology transfer, local training, joint ventures, health care provision, infrastructure provision, payment of expenses, and the use of royalties for humanitarian purposes ought to be encouraged

1–3% of net profits be donated to local, national and international humanitarian efforts

4

The Nuffield Council report on Human Tissue Ethical and Legal Issues [55]

Discussions on the link between commercialization and benefit sharing: i.e. property rights over the actual tissue, claims of entitlement to share in any benefits arising from the exploitation of the tissue and, any consequent intellectual property rights

[45]

5

WHO guidelines

(a) International Guidelines on Ethical Issues in Medical Genetics and Genetic Services [56]

Families or ethnic groups with a particular variant or disease, whose genetic information results in a patent, should receive some benefit in return

[39, 45, 50]

(b) European partnership on patients’ rights and citizens’ empowerment [57]

Some kind of benefit will ultimately be returned, either to the individual from who the materials were taken, or to the general class of person to which that individual belongs

6

Council for International Organisations of the Medical Sciences (CIOMS) guidelines[58]

Give priority to direct benefits over indirect benefits

[33, 43, 45, 50]

All research in developing countries and sponsored by developed countries, should be of relevance to the developing countries

7

OECD Guidelines for Human Biobanks and Genetic Research Databases[59]

Sharing of knowledge is an important benefit to be derived from human biobanks and genetic research databases (HBGRDs)

[27, 46, 48]

8

UN Declaration on Human Rights[60]

Everyone has the right freely to “share in scientific advancement and its benefits”

[46]

9

The Declaration of Helsinki[61]

At the end of any research study, every subject entered in the project should be assured of the best proven prophylactic, diagnostic and therapeutic methods identified by that study

[33, 37, 43, 50]

10

Governmental laws, policies and regulations

Countries specific laws, policies and regulations including:

[24, 30, 31, 34, 35, 37, 39, 42, 43, 46, 48, 50]

(a) Mandating return of benefits to participants and families

(b) Regulations on proprietary claims in respect of human tissue

(c) Laws on apportionment of profits or tools for benefit-sharing

(d) Statutory categories of benefit

11

Ethics committees and regulatory bodies

(a) Checking for presence of benefit sharing provisions in protocols

[25, 33, 35, 37, 39, 43, 44, 46, 50]

(b) Ensuring communities and individuals are not exploited

(c) Ensuring commercially exploitable projects make considerations for benefit-sharing

(d) Approving benefit-sharing proposals presented to them

(e) Providing guidance on who should provide benefits in order to ensure compliance

12

Institutional policies and frameworks for benefit sharing

(a) Intellectual property policies

[25, 33, 40, 42, 44]

(b) Information to be included in ICFs

(c) Requirements for benefit sharing agreements

(d) Return of results and compensation of participants

13

Benefit sharing agreements

Specifies under which conditions benefits are to be shared, which benefits to be shared and proportion of sharing. Can exist at different levels:

[25, 29, 32, 41, 49]

(a) International level e.g. conventions between governments and industry players

(b) Between industry and researchers

(c) Between biobanks and researchers

(d) Between/among biobanks

(e) Between all above players and research participants/specimen donors

14

Material transfer agreements (MTAs)

Stipulates ethico‐legal requirements regarding the transfer of human biological materials

[35]