Principles for Responsible Custodianship

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 and the integrity of associated data, 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.

C.1.1. Governance

Biospecimen resources should address formal and continuing responsibility for custodianship of collected biospecimens and associated data as part of their protocols. The following issues should be addressed in the governance plan: (1) How does the biospecimen resource propose to ensure the physical integrity of biospecimens? (2) How does the biospecimen resource propose to ensure the integrity of the human research participant data that accompany the biospecimens? (3) What plans and protocols are in place for the distribution of samples to investigators? and (4) What are the roles and responsibilities of the biospecimen resource director and his or her institution? (Also see Section C.4, Access to Biospecimens and Data.)

C.1.2. Legacy or Contingency Plans

Biospecimen resources’ legacy or contingency plans should be part of the overall governance plan and should address the handling and disposition of biospecimens and associated data at one or more of the following points: (1) End of the budget period of the grant, (2) loss of management or termination of funding, (3) accomplishment of the specific research objectives of the study, (4) depletion of biospecimens, (5) achievement of critical data end points, and/or (6) discontinuation of participation by human research participants. At any of these points, an assessment of whether the stored biospecimens still have value for research should be conducted. If the stored biospecimens still have research value, the resource should consider whether to become financially self-sustaining. Alternatively, the resource should consider announcing the availability of the biospecimens for transfer to suitable research facilities by means appropriate for reaching a wide audience, if permitted by the informed consent document and the relevant IRB. Biospecimen resources should use the same decision making criteria for allowing transfer of biospecimens to other biospecimen resources as they do when allowing transfer of biospecimens to investigators. The transfer of such biospecimens should be consistent with human subjects regulations, the informed consent under which the biospecimens and data were initially collected, and any other prior agreements and institutional policies that may apply (Also see Section C.2, Informed Consent.).

C.1.3. Policies on Retention

Biospecimen resources should establish and document transparent policies governing the retention of biospecimens and data. In addition, usage agreements, such as MTAs, should specify the retention policies of the recipient investigator. Other considerations related to biospecimen retention include the following:

• The retention of clinical biospecimens may be governed by Federal and/or State laws.
• For research biospecimens, permanent storage is generally preferred, subject to sufficient resources and storage space and foreseeable research utility; i.e., poor-quality biospecimens as determined via QA/QC processes should not be stored indefinitely.
• Biospecimen availability should be reviewed periodically (e.g., at the time of funding renewal) to determine the utility of the retained biospecimens and the need for new biospecimens.

C.1.4. Conflicts of Interest

Biospecimen resources, as responsible custodians, should manage existing or potential COIs and adhere to regulations regarding COIs at 42 CFR Part 50 Subpart F [71], as well as other applicable regulations and policies (Also see Section C.6.1, Investigator Financial Conflicts of Interest).

C.1.5. Confidentiality and Security

Biospecimen resources should implement transparent policies for maintaining the confidentiality and security of the biospecimens and associated clinical data, if applicable. Specifically, biospecimen resources that store coded samples and data should establish policies regarding how the link or code that allows identification of human research participants will be secured.

C.1.6. Public Communication