Created by on 11/15/2011

Earlier this year, the U.S. Department of Health and Human Services (HHS) issued an Advance Notice of Proposed Rulemaking (ANPRM) to gather input on proposed revisions to its human subjects protections regulations. In an October 26th letter to HHS’s Office of Human Research Protections, FASEB provided its perspective as to how the department’s regulations and guidance could be improved to better protect research participants, reduce burden on investigators, and minimize delays in human research studies.
FASEB noted that the current process of reviewing human subjects research protocols is not calibrated to the risks of research, regulations have not kept pace with changes in the way that clinical research studies are conducted, and rules and guidance documents are not harmonized across or within agencies. The Federation agrees with many of the changes that HHS is considering and believes that this rule-making process will lead to improvements in the overall regulatory framework. Among the proposals that FASEB supports are requiring researchers to obtain written consent to use data and identifiable biospecimens collected for research purposes, streamlining Institutional Review Board review of minimal risk studies, reducing the amount of information included in consent forms, expanding the categories of research that qualify for expedited review, strengthening the security of research data, developing a standard system for collecting data on adverse events, and harmonizing regulations and guidance within and across agencies.
There are, however, several points on which FASEB disagrees with HHS. FASEB believes that all data, but not biospecimens, should be considered potentially identifiable and subject to the same consent requirements. The line between identifiable and de-identifiable data is neither clear nor immutable. Experts have shown that de-identified data can often be re-identified with relative ease and accuracy, and this is likely to become even easier as computing technologies advance. The Federation does not support the concept that biospecimens are identifiable in and of themselves, because they do not identify individuals without some a priori knowledge (or other linked information) about an individual or his or her relatives. Along those lines, FASEB also does not believe that researchers should have to obtain consent to conduct research on biospecimens collected for non-research, clinical purposes except in circumstances in which they make an attempt to re-identify those specimens. It is not always possible to obtain consent for future research at the time specimens are acquired or to contact patients retrospectively to ask them for consent,yet this information is extremely valuable to researchers and has helped them make important contributions to research and medical care.