by László M. Szabó, Esq., Director of the Office of Research Regulatory Affairs at Rutgers, The State University of New Jersey
While the 2013 Advancing Ethical Research (AER) Conference has drawn to a close, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference happenings.
The 2013 AER Conference was accompanied by a special kind of buzz: many thought-provoking programs and meetings with colleagues who are only seen at PRIM&R conferences. One of the highlights of the first day was a session titled Innovations in Genomics and Biobanking, moderated by Paul S. Appelbaum and featuring panelists Francesca Gould, Dina Paltoo, and Jennifer Shaw.
The panelists discussed how research involving the use of biospecimens is on the rise, while best practices remain lacking. Such research has long been the foundation of medical advancement, but it has also resulted in lessons in the field of human subjects protections (e.g., Henrietta Lacks). Members of this panel leveraged their diverse experiences to explore how to draft best practices through a discussion of thematic and pressing questions about research involving biospecimens. For example:
- What special considerations, if any, should be implemented if the biospecimens are those of children? Similarly, what about findings for adults?
- Should there be a threshold for disclosing the genomic findings that result from the research?
- How is pharmacogenomic research perceived in communities where past research has resulted in harm to subjects?
- What best practices exist for biorepositories? How might an accreditation program improve the quality of biorepositories?
I would add to these questions: What “wrinkles” do state laws and regulations add to the oversight of biorepositories? What considerations are relevant for biospecimens coming from abroad (e.g., how can local context in research be ensured)? Who owns the genomic data, especially in light of the legally developing nature of this question?
The panelists also provided background on the rise of research with biospecimens. In 2008, the National Institutes of Health (NIH) issued a Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS). The purpose of the policy was clear: sharing pre-publication data cuts down on costs and ensures more robust science. The policy lays out a two-tiered access: open to the public and controlled. IRBs must ensure that the level of access is conveyed in the consent forms.
More recently, NIH issued a draft policy that added to the 2008 GWAS policy in an effort to address informed consent, data sharing, and similar communicative concerns. It is expected that this policy will be issued in early 2014. It should be noted that this policy would permit the use of biospecimens collected before the effective date in early 2014, but would require IRBs to review the consent forms and protocols for those biospecimens.
When it comes to possible genomic findings from research, several concerns arise: What is the clinical (not research) veracity of the genomic findings? When children are involved, when should parents be informed of the results? When should the child be informed? I believe that it is more appropriate for the parent to determine whether to inform the child, regardless of whether the child is 8 or 17. Additionally, should parents know “everything”—especially when no genetic counseling is available?
The consensus of the panelists and audience members was that best practices should include: re-consenting subjects at the age of majority; indicating that research findings may not always meet clinical standards (and often lack genetic counseling as a debriefing component); and if disclosure of some genomic findings is deemed necessary, then the IRB and principal investigators need to define the scope of disclosure (e.g., a child carrying the Alzheimer’s gene may not need that disclosed because she is a child, not an older adult).
Panelist Jennifer Shaw presented a noteworthy perspective on the perceptions of genomic research by Native Americans. She explained that because Alaskan Native Americans are relationship focused, research and medical outreach must be structured accordingly. The impact of this belief structure on the informed consent process was critical because it emphasized the “process,” as well as the need to continue to keep subjects informed. IRBs should therefore be mindful of local review and remain aware of the possibility of health disparities or societal stigma that could result if research results are shared.
The presentations during the panel drew from three poster presentations:
- By panelist Francesca Gould: Managing Genomic Findings of Pediatric Clinical Research Studies: Challenges, Ethical Considerations and Best Practices
- By panelist Jennifer Shaw: Risk, Reward, and the Double-Edged Sword: Alaska Native Perspectives on Pharmacogenetic Research and Testin
- By panelist Dina Paltoo: From GWAS to Omics and Beyond: A Large Institution Expands its Expectations for Sharing Genomic Research through the Draft Genomic Data Sharing Policy
My takeaways from this session include:
- Keep state laws in mind when reviewing studies involving biospecimens.
- For consent forms, remember that such research often goes on for decades and the use of the specimens may evolve beyond the scope of what was initially proposed.
- Research findings are not clinical findings and that needs to stay on the radar for each constituency in the research process: subjects, parents, PIs, and IRBs.