Consent for Incorporating Subjects’ Data or Tissues in Repositories
In some cases it may be desirable to place health information or tissue samples collected from subjects during a research study into a data or tissue repository for potential future use in other studies. The future use for these data or tissue samples is typically unknown at the time of collection, and therefore it is not possible for subjects to give informed consent regarding these potential future uses of their data or tissue samples at the time they donate them. However, many investigators believe that subjects should be permitted to donate their data or tissues for future use in research if they desire to do so. The data and tissue samples placed into repositories are typically identified or coded so that they can be traced back to the original donor. Uncoded data, or tissue samples or data without identifiers, which cannot be linked to an individual donor, do not raise these issues of informed consent when used in future studies.
The following guidelines apply to the development of a consent agreement when samples are collected prospectively (i.e., the collection is not 100% existing) for the purpose of conducting research and the data or tissues collected will be identified or coded and stored or banked for future use in research. These guidelines also assume that the data or tissues will be collected during a direct interaction, such as an interview or specific research visit, between the subject and the investigator or his or her surrogate (a data or tissue collector). The prospective collection of “leftover specimens” also falls under these guidelines. Leftover specimens; may be defined as tissues or data collected for clinical purposes of which a part may be designated for future research at the time that subject consent is negotiated. An example of a leftover specimen is a portion of a pathological specimen that has been allocated for research (with the subject’s consent) after it has been utilized for clinical purposes. For these studies, the informed-consent process should include a clear description of the following information:
- The operation of the repository, including duration of storage of material.
- The specific nature and purposes of the future research to be conducted.
- The conditions under which the data and tissue samples will be released to recipient investigators (those who are on, or affiliated with, the banking protocol). [Note: If this stored material will be shared with nonaffiliated investigators, approval by an IRB is required.]
- The potential risks (e.g., loss of privacy) and benefits (or lack thereof) associated with banking, including the procedures for protecting the privacy of subjects and maintaining the confidentiality of data. A Certificate of Confidentiality is recommended by the OHRP for repository operations.
- The ability of the subject to opt out of banking while still participating in the primary study, which covers the collection of the tissue or data (i.e., alternatives to participation in the banking).
- The subject’s option to withdraw his or her identified data or tissue samples from the repository at any time during or after the primary study. Withdrawal options include deidentifying data or tissue samples (destroying all links to identifiers so that the samples are truly anonymous) or physically destroying the data or samples. Potential subjects should also be informed that the information derived from their data or tissue samples prior to their withdrawal from the study will continue to be used after the subject’s withdrawal of his or her data or tissue samples.
As a matter of formatting, the information described above may be included in the informed consent document used to obtain consent for the primary research study (i.e., the study for which the tissue sample was originally obtained for analysis by a specific assay). The consent form for banking may also be developed as a separate form from the primary study consent form. Since the banking of tissues or data may extend beyond the duration of the primary study, using a separate informed-consent document and an accompanying banking protocol for the banked specimens or data is often the preferred approach. This approach also provides the subject an easy way to consent to participate in the primary study and not in the banking of his or her tissue samples or data. Having two separate forms also makes it clear that the banking of his or her specimens is distinct from participating in the primary study.
With regard to economic considerations, the consent form needs to comply with the OHRP Guidance concerning unacceptable exculpatory language. The FDA and OHRP regulations prohibit the inclusion of language through which the subject waives or appears to give up any of his or her legal rights or releases, or appears to release, the investigator, sponsor, or institution from liability for negligence. Acceptable language includes statements such as, “Tissue obtained from you in this research may be used to establish a product from which the investigators may derive profit (through a patent). There are no plans to provide financial compensation to you should this occur.” This may be especially important in genetic research in which the cell lines may be established from genetic material.