Protecting Privacy of Research Participants When Sharing Data
The National Institutes of Health (NIH) has released two resources to the research community that aim to prepare institutions for the implementation of the NIH Data Management and Sharing Policy, which goes into effect in January 2023.
The first resource, “Informed Consent for Secondary Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing,” provides points to consider and sample language for investigators to include in informed consent. Researchers can use this material to learn best practices for developing informed consents to facilitate data/biospecimen storage and sharing for future use.
The second document is a draft supplement to the policy, which is open for public comment until June 27, 2022.
Sharing increases the scientific utility of collected data and biospecimens. It also reduces the burden on research participants who participate in different research studies from being asked multiple times to submit data and biospecimens. However, representatives of the NIH acknowledge that investigators and institutions lack guidance on consistent consent language to facilitate secondary research with data and biospecimens. In response, they have published a downloadable guide that provides modifiable sample language that investigators and IRBs can use to assist in the clear communication of potential risks and benefits associated with data/biospecimen storage and sharing.
The guide from NIH addresses only consent for the storage and sharing of data and biospecimens collected during a primary research protocol, for the purposes of future secondary research. Other federal guidelines address the process for approval, storage, and use of the collected data and specimens, both for primary and secondary research.
Here are a few reminders and highlights from the guide:
- Consider the reading level of anticipated study participants. The NIH suggests targeting an 8th grade reading level. Researchers can also consider other methods of providing information, such as explanatory videos.
- Remain diligent when considering vulnerable populations. This can include prisoners, children, or individuals with impaired decision-making capacity. These populations can be vulnerable to undue influence and coercion.
- Understand and be sensitive to cultural or Tribal preferences. Consult with the appropriate constituents and leaders to determine applicable regulations, policies, and cultural preferences or Tribal laws that will need to be taken into consideration prior to storage and sharing of data and biospecimens.
- Review community standards for the consents regarding genomic data. Several resources are available to investigators and institutions, which provide standards for collecting, storing, and sharing genomic data and specimens. This can include the NIH Genomic Data Sharing Policy.
- Be prepared to revise consent documents. As coding and deidentifying technologies advance and capabilities for linking disparate data together evolve, consider the implications for reidentification, privacy, and confidentiality and adjust language as appropriate.
The sample consent language includes four primary components:
Introduction and Description
The Introduction-Description component provides prospective research participants with an introduction to, and description of, the planned storage and sharing of data and biospecimens. It should include the timeframe for storage, if data and biospecimens will retain identifiers, be deidentified, or coded, and how data may be shared.
Voluntary Participant and Withdrawal of Consent
In this section, the consent should clearly state whether data and biospecimen sharing for future research is voluntary or required for participation in the primary study (e.g. repository protocol). This component describes what happens if the participant initially agrees to the storage and sharing of data and biospecimens, and then changes their mind.
Risks and Benefits
This component describes any foreseeable risks and/or discomforts related to the storage or sharing of data and biospecimens. It can include information on how those risks may be managed or addressed by the investigator or institution. Any anticipated benefit from sharing data or biospecimens will also be included in this section. If no direct benefit is anticipated that should be stated.
This section describes if any of the participants data may contribute to the development of products with potential commercial value, and if they may receive compensation.
The sample consent language is voluntary, with no requirements or expectations that it be used. Researchers should carefully select language appropriate for the study and intended participants, and IRBs should ensure that the study’s primary consent meets all applicable regulatory and policy requirements, including federal, state, local, Tribal, and international requirements.