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It's Not Just about Consent

Posted by kjmaschke on 29 Jun 2010 at 13:51 GMT

As the Editors note, it’s likely that many readers will object to their decision to publish 23andMe’s report of a genome-wide association study. My concerns have more to do with what appears to be troubling misconceptions and knowledge gaps on the part of the Editors and the 23andMe authors about the three issues that delayed publication of the study: ethical review, consent, and data access. A random review of IRB policies available on their institutions’ website suggests that some IRBs would have determined that the collection and storage of saliva to store in a biorepository for a specific study and for future research does constitute human subjects research as defined by 45 CFR 46 because at the stage of biospecimen collection, 23andMe was interacting with identifiable individuals through a communication portal. Although others may have different experiences, in my experience as an IRB member the prospective collection of biospecimens from identifiable individuals requires IRB approval of the research study and participant-related documents such as a consent form. Even when IRBs determine that a study does not require IRB approval because in the IRBs view it does not meet the regulatory definition of human subjects research, many IRBs will review and approve the consent form to avoid the problems that the Editors identified in 23andMe’s document, e.g., technical jargon and ambiguity about participants’ understanding regarding disclosure of their genomic data.

The Editors and authors also seem to be unaware that researchers – including genetics researchers – IRBs, patient advocates and research ethics scholars have deliberated with each other in many settings to develop informed consent templates and standardized policies and procedures for genetic research studies, including GWAS research. For instance, based on workshops with all of these stakeholders, the NCI developed the Best Practices for Biospecimen Resources (2007) that offers clear guidance on the three issues of concern to the Editors. Moreover, The Cancer Genome Atlas (TCGA) program at the NIH has developed a clear, readable consent document that is a model for other institutions (disclosure: this writer is an IRB member and was a participant at the NCI best practices workshop and at the NHGRI’s TCGA workshop on data sharing). And in 2007, the NIH published a Points to Consider document for IRBs and institutions regarding GWAS research and data that addresses the three issues of concern. In a footnote in that document, the NIH states that NIH, as a “policy matter, will not accept data into the GWAS repository without the appropriate certifications from the institution and verification by an IRB and/or Privacy Board that the submission criteria stipulated in the policy have been met.”

The NIH GWAS policy requiring IRB review – and the policies of IRBs that may differ from that of Independent Review Consulting, Inc. – reflects an enduring tension legal standards and values-based standards. The guidance statement from the Office for Human Research Protections (OHRP) is a nod to institutions and IRBs that when certain conditions are met, some research can go forward without IRB review and approval, and in those circumstance OHRP will not rule that the institutions are in noncompliance with 45 CFR 46. Yet, OHRP’s guidance is legal interpretation of a regulation – it is not a statement about whether it is ethical for research with biospecimens to go forward without an IRB approving the collection and storage of the biospecimens or reviewing and approving the consent form. The enduring tension between law and ethics may never be resolved, but to simply call for standardized process and procedures for consent misses the point about what constitutes a ethical framework for genetic research, which will necessarily include attention to a broader set of issues: ethics review and approval of the collection, storage, and use of biospecimens; conflicts of interest on the part of researchers, sponsors, and institutions; and on-going ethics governance of biorepositories, including policies for access to genetic data.

Karen J. Maschke, PhD
Research Scholar
Editor, IRB: Ethics & Human Research
The Hastings Center

Competing interests declared: Participant: NCI workshop on best practices for biospecimen repositories; TCGA workshop; NCI caHUB ethics subgroup.