Letters to the Editor
Crippling Clinical Research?
December issue
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i commend dr. sekeres for his excellent editorial (Take My Leftover Tissue, Please!), which appeared in the December 2015 issue
of ASH Clinical News. The proposed changes to the Common Rule
(Docket ID number HHS-OPHS-2015-0008) would cripple research
in the pathology research community.
I have been a practicing pathologist doing clinical research for
more than 40 years, and I have published nearly 600 articles. I am
among the 400 most highly cited researchers in all biomedical
sciences between 1996 and 2011.1 The number of citations is
evidence of the significance and value of my work. However,
you could toss out 90 percent of the articles in my CV, if the
proposed restrictions were imposed for studies done on biological
specimens considered “excess tissue.”
Most of my published work has been based on novel
observations made in the course of diagnostic work, with
supplemental studies done on “excess tissue,” – sometimes
many years after the diagnosis was initially made to better
understand and characterize the pathological process. My
research has been conducted under an authorized institutional
review board–approved protocol, which allows studies of low risk
to be performed on biospecimens/pathology tissues without
patient consent. Most pathologists do not have direct contact
with patients, and obtaining consent for studies to be performed
on retrospective specimens is not feasible. (Cited below are
representative articles published in Blood that were based on
cases submitted to me in consultation.2-7)
When one undertakes a retrospective review of tissue biopsies
performed years earlier, the location of the patient or his or her
current physician is often unknown. Blocking these research efforts
would halt the discovery of new disease entities, discoveries
that impact patients’ lives and lead to changes in therapy and
management. These studies have led to new insights regarding
diagnosis and classification of disease that are reflected in the
World Health Organization classification of lymphomas.8
My work is representative of much clinical research conducted
by pathologists. Additionally, producing repositories of de-linked
or anonymized specimens would not be a solution, even if such
specimens were exempted from the rule. If one removes patient
identifiers, that specimen is no longer available for clinical review,
should it be relevant to the patient’s care. Thus, the de-linking
causes potential harm to the patient. Furthermore, it limits such
studies to only large surgical resections, which are a rarity in
hematologic disease. Additionally, the clinical correlates that are
critical to clinical research become much more difficult to obtain.
For these reasons, I urge revisions to the proposed Common Rule
to allow continued use of “excess tissue” for studies of low risk.
—Elaine S. Jaffe, MD
Senior Investigator in the Laboratory of Pathology
Head of the Hematopathology Section
Center for Cancer Research
National Cancer Institute
(Disclaimer: This response was written in Dr. Jaffe’s private capacity; the views
expressed do not reflect the opinion of official policy of the U.S. government).
REFERENCES
1. Boyack KW, Klavans R, Sorensen AA, et al. A list of highly influential biomedical researchers, 1996–2011. Eur
J Clin Invest. 2013;43:1339-65.
2. Cong P, Raffeld M, Teruya-Feldstein J, et al. In situ localization of follicular lymphoma: description and
analysis by laser capture microdissection. Blood. 2002;99:3376-82.
3. Jegalian AG, Eberle FC, Pack SD, et al. Follicular lymphoma in situ: clinical implications and comparisons
with partial involvement by follicular lymphoma. Blood. 2011;118:2976-84.
4. Feldman AL, Arber DA, Pittaluga S, et al. Clonally related follicular lymphomas and histiocytic/dendritic cell
sarcomas: evidence for transdifferentiation of the follicular lymphoma clone. Blood. 2008;111:5433-39.
5. Mansoor A, Pittaluga S, Beck PL, et al. NK-cell enteropathy: a benign NK-cell lymphoproliferative disease mimicking
intestinal lymphoma: clinicopathologic features and follow-up in a unique case series. Blood. 2011;117:1447-52.
6. Perry AM, Warnke RA, Hu Q, et al. Indolent T-cell lymphoproliferative disease of the gastrointestinal tract.
Blood. 2013;122:3599-3606.
7. Nicolae A, Pittaluga S, Abdullah S, et al. EBV-positive large B-cell lymphomas in young patients: a nodal
lymphoma with evidence for a tolerogenic immune environment. Blood. 2015;126:863-