It is not easy for industry researchers to find suitable academic biobanks. For one thing, the biobank needs to have the clinical samples required. For another, it must have policies that allow industry access. Unfortunately, biobank access policies may contain exclusion criteria that prevent industry access. Or they may have conditions that many companies would find unacceptable. Furthermore, biobanks may not make their access policies available.
Biobank Access Policies
A biobank’s access policies show the core values of its leadership. As has been noted by Catchpoole (2015):
‘Motivation can be captured in policy which sets boundaries of practice of the biobank and reflects the core values of the different authorities, community groups, and stakeholders who consider it a ‘biobank.” J Health Serv Res Policy. 2015;21:140– 142.
For institutional biobanks, the policymakers will be senior representatives of the institution. Chiefly these include academics and research-oriented clinicians. Whoever handles the biosample requests follows the rules set out in the access policy.
Conditions Of Access To Biospecimens
For some biobanks, it is a condition of access that the requesting company agrees to collaborate with the biobank’s institution. However, research collaboration is an unacceptable condition for many industry requesters, for reasons including intellectual property issues.
One important fact that needs to be considered here: the development of life-saving new drugs and diagnostics by industry depends on the support of public sector biobanks. Without this support, what are the alternatives for industry, and are they ethically acceptable?
Transparency About Biobank Access Policies
Langhof et al. (2017) surveyed 523 biobank websites. They found that only 9% included a publicly available access policy for biospecimens. According to the authors:
‘The lack of publicly available access policies would not only contradict (the) obligation of stewardship but could also diminish public trust, willingness to donate samples and public funding. Biobanks, therefore, should have meaningful access policies and make them publicly accessible.’
The authors found that 16 of 74 access policies prohibited industry access. This was the most common exclusion criterion.
Transparency about biobank access policies is essential for ensuring public trust. Furthermore, biobanks depend on public support to build up biospecimen collections. So the public can expect information on the sharing and use of their samples.
Transparency also facilitates biosample supply to external requesters like industry researchers. In particular, if eligibility requirements are made clear, this avoids wasted time on applications that cannot succeed.
In order to encourage transparency, Langhof et al. (2017) recommend the following:
‘… infrastructures such as BBMRI-ERIC and P3G could require access policies as a prerequisite to listing in their registries. Similarly, public funders might require (and not only recommend) publicly available access policies with at least some opportunity for external access’.
This article is on the Biosample Hub blog. Other posts in this blog include:
- Why Academic / Hospital Biobanks Should Provide Biosamples to Industry
- Ensuring Public Support For Biobank Cooperation With Industry
- The Main Actors Providing Biosamples To Industry
- Biosample Needs of Different Industry Players
- The Dual Role of Academic Biobanks
- What is Commodification?
- Acceptable Transactions in Biobanking
- Why Biobank Access Policies Should Be Publicly Available
- Biospecimen Provenance: What Researchers Need To Know
The Biosample Hub platform https://biosamplehub.org/ encourages ethical sourcing of biosamples for the industry sector.