“Research participants should have full autonomy to decide whether their specimens are donated to research in the first place,” said Kayte Spector-Bagdady from the Center for Bioethics and Social Sciences in Medicine at the University of Michigan Medical School, in Ann Arbor.
“But, if researchers invest many resources in converting participant specimens into cell lines, we argue that there should be a higher standard for participants withdrawing their cell lines from research in the future,” she told Reuters Health by email.
In a report online January 31 in JAMA Oncology, Spector-Bagdady and colleagues assert that cell lines are distinct from traditional fixed specimens and should, therefore, receive separate consideration as regulators develop informed consent and other standards for federally funded research with biospecimens collected for another purpose.
Since the early 1990s, identifiability was an important deciding factor for determining whether consent is needed for secondary research using biospecimens.
The latest regulations abandoned a proposal that these rules apply to research with all human biospecimens, regardless of identifiability. But they mandated reexamination of the definition of identifiability by appropriate experts, leaving open the possibility that a biospecimen that is presently deemed nonidentifiable could be recategorized as identifiable, and thus regulated, in the future.
Compared with other biospecimens, the authors argue, the creation and characterization of cell lines requires a considerable commitment of time, money and expertise.
From a “property interest” perspective, they write, even if the contributors of the tissue can be viewed as having some interest in their biospecimen, “when researcher labor is added to develop a cell line, the contributor’s interest becomes at least shared with the interest held by researchers.”
In many cases, the researchers may even have a superior interest based on their contribution, according to the authors.
This distinction has important legal ramifications. Identified participants who provide consent have the right to withdraw from that research, although whether participants have a right to withdraw their identified biospecimens from research remains an open legal question.
Absent an explicit exclusion of identifiable biospecimens from the right to withdraw, participants at present might retain that right, with potentially serious implications for cell line research.
The authors argue that regulators should reassess the concept of identifiability and ensure that: “1. Expertise in ethics and health policy is represented on future panels reconsidering the concept of identifiability to advise on the critical balance between autonomy, public beneficence, and justice inherent to the definition of the concept; 2. Future expert panels approach the definition of identifiability with the understanding that the creation and use of biospecimens in research is not methodologically homogenous, as the potential for identifiability and its implications vary along with different types of specimens and require nuance; and 3. If, in the future, such an expert committee labels all biospecimens as inherently identifiable, additional guidance will be provided regarding how the unique properties of different types of biospecimen research will be reconciled with the default standards applicable to other types of human research (e.g., the right of withdrawal).”
“Physicians and researchers should be aware of the critical implications of the human-subjects research regulations on their work,” Spector-Bagdady said. “Too often regulators and researchers work in silos and do not pay enough attention to the important work the other is doing. We want to encourage researcher engagement in the regulatory process and regulator engagement in science. If researchers and regulators do not work together, health policies may be advanced that neither protect patients nor advance the science.”
JAMA Oncol 2019.