Ethical, Legal, and Policy Best Practices

Custodianship is the caretaking responsibility for biospecimens that extends from collection through research use. Responsible custodianship requires careful planning and transparent policies to ensure the long-term physical quality of the biospecimens, the privacy of human research participants, the confidentiality of associated data, and the appropriate use of biospecimens and data. In the interest of transparency, biospecimen resource policies should be made available to the public either electronically or for onsite inspection.

The custodian is the trusted intermediary and caretaker of biospecimens and associated data, and the custodian's caretaking responsibilities should align with applicable ethical and policy standards. The custodian should be clearly designated and, ideally, be someone other than the research investigator or sponsor(s) of the biospecimen resource; e.g., a biospecimen resource manager, to eliminate any potential conflicts of interest. When the research investigator is the primary holder of the biospecimens and data, he or she should have the same duties of custodianship and abide by the same ethics that apply to research use. Thus, principles concerning oversight and QC mechanisms that apply to traditional biospecimen resources could also be relevant to the collection, storage, distribution, and use of biospecimens in small collections held by individual investigators; e.g., protection of the privacy of human research participants and confidentiality of their data, well-documented QA/QC procedures, etc. Alternatively, research investigators with small biospecimen collections that will be stored for future studies could consider joining an institutional IRB-approved biospecimen resource. This consolidation would help ensure baseline quality standards for smaller biospecimen collections.

In their role as trusted intermediaries, custodians and managers of biospecimen resources should establish a governance plan consisting of the set of authorities, processes, and procedures guiding key operational decisions made within the resource. Governance affects access to biospecimens as well as custodial relationships and responsibilities and should be part of the resource's general custodianship plan. In addition, biospecimen resources should demonstrate their accountability to promote public trust by accepting all of the custodial responsibilities listed below and, as appropriate, establishing advisory boards—with human research participants among the active members—to accomplish them.

• Implementing overall operational, ethical, and legal policies based on feedback from individuals and the community, where practicable and appropriate.
• Ensuring appropriate scientific assessment of access requests and proposed research use as well as management of COIs.
• Providing requested advice regarding publications and dissemination of research data that are potentially stigmatizing or discriminating to groups. Others, including the investigator, IRB, and possibly the groups studied, may share this responsibility.
• Educating the public and obtaining their feedback, where practicable, through the biospecimen resource's public Web site or alternate mechanism.

More specific recommendations by topic area are provided throughout this section.