Broad Guidance Needed to Aid Biobank Sample Stewardship

Results of a recently released survey found that most biobanks do not maintain ongoing relationships with specimen contributors, but they do practice good stewardship over storage and sharing of specimens for research. The authors of the paper, published Dec. 11, 2013, in Science Translational Medicine, say that biobanks need better guidance emphasizing stewardship practices throughout the life cycle of specimens in order to achieve the delicate balance of respecting contributors while advancing research. “Within the context of rapidly expanding genomic and bioinformatic capacities and the rise of next-generation biorepository research, challenges remain in obtaining consent, protecting participant privacy, and maintaining public trust,” writes lead author Gail Henderson, Ph.D., from the University of North Carolina, Chapel Hill. “One response to these challenges is greater emphasis on the stewardship model of governance.” Emerging models indicate that going forward there will be broader responsibilities for biobanks and more complex research relationships than previously experienced.  But despite talk of the need for a stewardship model that encompasses the lifespan of biological specimens – from donation through research use – empirical evidence is scarce for how voluntary stewardship is executed in actual practice. In order to identify trends in implementation of stewardship practices, the University of North Carolina researchers conducted a national survey to examine biobank practices pertaining to contributors, within the biobank, and in relationship to researchers. “Guidance documents do not specifically discuss stewardship as a model of governance, they do address standards for trustworthy acquisition, storage, management, and transfer of specimens and related data,” write the authors. “However, implementing these various forms of guidance recommendations is voluntary, and there is no required registration of biobanks that might facilitate adoption of certain standards. Thus, there are almost no data on the extent to which biobanks are following these recommendations. Our study provides such empirical data.” Practices Related to Contributors The overwhelming majority (96 percent) of respondents (n=404) say that contributors are informed about storage of their specimens. Of these respondents, 79 percent utilize an opt-in approach, while 12 percent utilize an opt-out method. More than three-quarters of those that have an opt-in policy use a broad consent for future research uses, which is consistent with the trend toward unrestricted use. Sixteen percent of those with opt-in policies report a limited consent for certain kinds of research uses. Half of surveyed biobanks are in a position to create and sustain a relationship with direct, living contributors over time. Just under three-quarters (72 percent) of biobanks maintain individual contact information necessary to return results, but only 19 percent offer individual contributors results from research using their specimens. Aggregate results are returned to contributors by 38 percent of biobanks. The majority of biobanks do not offer financial compensation to contributors, but 18 percent do. Those biobanks offering financial compensation are significantly more likely to engage in relationship-building practices, including returning aggregate results. Practices Within the Biobank The vast majority (94 percent) of biobank respondents have standard operating procedures for processing specimens, with 85 percent using a computerized laboratory information management system that incorporates a computerized inventory system that tracks the location and status of every specimen in the biobank. Two business practices previously cited in literature as best practices were explored by the survey and found to be lacking in practice. Only one-third of biobanks (34 percent) have a formal business plan and just over one-quarter (26 percent) have a written plan for specimens upon closure of the biobank. Practices Involving Researchers Requests for use of specimens and biobank data is relatively common, with 70 percent of biobanks receiving 50 requests or less annually, though, more than one-quarter (27 percent) of biobanks only receive one to five requests. Higher-volume biobanks do exist, with 2 percent reporting between 501 and 1,000 requests annually and 3 percent reporting more than 1,000 requests annually. Regarding oversight for research uses of stored specimens, 90 percent of biobanks require institutional review board approval, 26 percent have a community advisory board, and 81 percent reported having other oversight boards (scientific review committee or internal advisory board). The majority of biobanks (82 percent) have application forms for researchers requesting specimen or data use. Approval rates for research use vary substantially, with 41 percent of biobanks approving all requests and 58 percent saying they approve some requests. The two most common reasons for denial of requests were because of the scientific merit of the proposed research (57 percent of denials) and lack of specimen availability (43 percent of denials). On the flip side, priority access is given to some researchers based on scientific merit of the proposed study (66 percent) and the feasibility of the study (56 percent). Researchers are charged for use above shipping and handling fees by 41 percent of biobanks. More than three-quarters (78 percent) of respondents have standardized material transfer agreements. One-third of biobanks require researchers to return remaining specimens, while 21 percent require remaining specimens to be destroyed. Just under one-fifth of biobanks that maintain identifying information (18 percent) report ever providing the identifiers to researchers. Finally, just over half of biobanks (54 percent) require researchers to share aggregate research results with the biobank. “In viewing biobank practices, did we glimpse stewardship in action? We think so,” conclude Henderson and colleagues. “However, what is now needed is a full articulation of the range of best practices for biobanks that address the ethics of stewardship.” Takeaway: Comprehensive guidelines encompassing best practices of specimen stewardship, across the lifespan of a sample from donation through research, are needed so that biobanks can meet increasingly complex challenges surrounding specimen handling and privacy protection.  Side Box:The Stewardship Model The emerging stewardship model, which incorporates obligations on the part of the biobank throughout the life of the specimen, include:

• Community engagement—Forms may include joint governance and return of aggregate level results to participants.
• Improved research design—This includes ensuring that specimens and data are used for agreed-upon purposes, consistent with the terms of consent.
• Proper internal care and oversight of the stored specimens—Professional societies and oversight agencies often maintain these standards and policies.

Source: “Stewardship Practices of U.S. Biobanks” by Gail E. Henderson  et al., published in Science Translational Medicine online Dec. 11. Side Box: Biobanks, Researchers Must Broaden Engagement Efforts All genetic research establishments, including biobanks, must engage ethnic minorities to foster transparency and build trust to broaden research participation, writes Aaron Buseh, Ph.D., an associate professor of nursing at the University of Wisconsin–Milwaukee, in the Dec. 1, 2013, issue of The Scientist. In light of past deception and abuse involving minorities (Henrietta Lacks and Tuskegee syphilis experiments), Buseh proposes use of a community-based participatory research framework that relies upon collaboration between academic and community partners to build inclusivity, education, and discourse. “When geneticists take off their lab coats, leave the confines of their classrooms and workspaces, and venture into ethnic minority communities to share their work, they are fostering open discourse,” writes Buseh. “While ethnic minorities may rightfully wish to focus the discussion on issues of medical mistrust, unethical protocols, and potential deception, genetics researchers can make use of this setting to share technological and scientific advances, and to explain how the participation of minority groups in genetics research proffers potential medical benefits and positive social impacts.”