If you are conducting biospecimen-based research, you are probably aware that on January 18, the long-anticipated revised Common Rule (Title 45 of the CFR, part 46, Federal Policy for the Protection of Human Subjects) was posted to the Federal Register (for some background on the nature of these revisions, see my blog post).
If you haven’t heard, the proposed changes regarding de-identified specimens, and the level of consent required for their use, were all dropped from the final version and are no longer of concern. The revisions in the Common Rule that did become law will not go into effect for at least a year, and some will not take effect for three years.
The proposed changes regarding biospecimen consent requirements for use of specimens caused significant concern, primarily, by requiring informed consent for research on biospecimens originally collected for other purposes. The nature of the consent proposed could consist of a one-time, general, open-ended consent that could be obtained at the time of collection, and applied only to specimens collected in the future, not to existing biospecimen inventory. In addition, researchers would be required to inform participants that their biospecimens might be used for commercial profit, whether or not they would be informed of clinically relevant findings, and ask them whether they could be contacted for additional research.
The Federal government cited a number of reasons for requiring consent for the use of de-identified specimens:
- In 2013, it was demonstrated that by analyzing certain genomic data from publicly available sources, certain individuals who had participated in research could be identified. This raised the issue of whether a sample could be truly de-identified.
- Another concern was the erosion of public trust, resulting from media coverage of a few cases where biospecimens were used in a manner that was both profitable to the end users and unanticipated by their donors—and the donor’s identity became public.
- The government cited several research papers concluding that many prospective participants want to be asked for their consent before their biospecimens are used. The government expressed concern that failure to acknowledge and give proper regulatory weight to participant wishes could diminish public support and further jeopardize research.
Since posting the NPRM in September of 2016, the Federal government received more than 2,100 comments on the proposed changes, from members of the research and healthcare communities as well as members of the general public. The comments regarding the proposed requirements for consent related to biospecimens, contrary to the government’s expectations, were overwhelmingly against the new requirements. Further, in discussing the decision to drop the proposed requirements for consent, the government cited a 2011 study by the University of Chicago that concluded “although it is theoretically plausible to identify a person based on their biospecimen, the likelihood remains remote enough to argue against the presumption that the sources of all biospecimens are identifiable and cited a study showing that the risk of re-identification from a system intrusion of databases was only 0.22%."1
The changes that were introduced by the revised Common Rule primarily serve to:
- Allow the use of broad consent for research conducted with de-identified biospecimens that eliminates the need for a waiver by an IRB;
- Create categories of low-risk (to participants) biospecimen-based research that is subject to only limited IRB review;
- Allow a single IRB to review research conducted at multiple institutions;
- Address the information given to prospective research participants and improve readability of consent forms (which are often structured more to protect institutions than to inform prospective participants);
- Eliminate continuing review of certain types of ongoing and follow-up clinical research; and
- Other changes that are minor and/or unrelated to biospecimen–based research.
The newly enacted legislation will not go into full effect for three years, allowing institutions to adapt.
Do you work in biospecimen-based research? If so, you understand the importance of controlling pre-analytical variability, maintaining sample integrity, and annotating the biosamples with the appropriate data. Collection kits not only assist in controlling variability, but can also serve as an ideal starting point for data collection. To learn more, download your free eBook Standardizing Biosample Management: Why Use Collection Kits?
The full text of the revised common rule is available at: https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf
1) Study of Re-Identification Risk of HIPAA Compliant Records. (2011). NORC at the University of Chicago and Office of the National Coordinator for Health Information Technology. http://www.amstat.org/meetings/jsm/2011/onlineprogram/AbstractDetails.cfm?abstractid=302255.