Guidelines for the review of pathology in the research context M aire A. Duggan, MD, FRCPC, a Rashmi Goswami, MD, FRCPC, b Antony M. Magliocco, MD, FRCPC, c Miguel Burnier, MD, PhD, d and Davinder Sidhu, MD, LLB, a on behalf of the Canadian Association of Pathologists (Association Canadienne des Pathologistes) Working Group, Calgary, Alberta, Toronto, Ontario, and Montreal, Quebec, Canada, and Tampa, FL Background. Research involving a retrospective review of a patient’s pathology could change the original pathologist’s diagnosis and alter management, treatment, and prognosis. In the interests of patient safety, this review diagnosis needs to be validated and the impact on patient care assessed before disclosure to the patient occurs. The Canadian Association of Pathologists-Association Canadienne des Pathologistes (CAP-ACP) did not have a guideline for managing this scenario. Methods. Under CAP-ACP executive committee sponsorship, a working group was formed to develop a comprehensive guideline for this scenario. To inform the document’s development, the group carried out an extensive literature review, surveyed practices in laboratories across Canada, and reviewed practices in pathology colleges in the United Kingdom, Australasia, and the United States. The Tricouncil Interagency in Research Ethics in Canada, the Canadian Medical Protective Association and members of the CAP-ACP were consulted. Results. Neither the published literature nor the trans-Canadian laboratory survey identified a guideline document. The Royal College of Pathologists of Australasia had a policy and procedure for the scenario; other colleges did not. The guideline developed by the working group listed roles for the ethics committee, researcher, original pathologist, and laboratory in managing the scenario and incorporated the input acquired in the consultation phase. The final document was endorsed in 2012 by the CAP-ACP executive committee and is available on the website (available from: http://www.cap-acp.org/psqa.cfm). Conclusion. The guideline is anchored in principles of patient safety and can be used to minimize and/ or manage changes in the pathologic diagnosis which arise from a research-based review of prior pathology reports. (Surgery 2013;154:111-5.) From the Departments of Pathology and Laboratory Medicine, University of Calgary, a Calgary, Alberta; University of Toronto, b Toronto, Ontario, Canada; the H. Lee Moffitt Cancer Center, c Tampa, FL; and McGill University, d Montreal, Quebec, Canada CLINICAL AND TRANSLATIONAL RESEARCH involving hu- man subjects may include a review of pathology material belonging to individual patients. The ma- terial is usually hematoxylin and eosin-stained glass slides obtained from formalin-fixed, paraffin-em- bedded blocks of tissue. Research-based pathology reviews are conducted mostly to establish an accu- rate pathology diagnosis against which associations between the variables or factors (eg, clinical, path- ologic, treatment, biomarker expression, genetic profiling) under investigation are measured and correlated with disease outcome. These reviews could change the original diagnosis. Other reviews are done merely for the selection of tissue samples representative of the patients’ original diagnoses and generally do not create a potential for a change in their diagnosis. Research involving humans requires ethical and scientific approval from the appropriate Research Ethics Board, and patient information including their pathology material is coded, namely, anony- mized and/or de-identified to maintain patients’ privacy. The major issue stemming from research which includes a pathology review is how to handle any changes to the ‘‘original diagnosis’’ generated by the ‘‘review diagnosis,’’ which may have a poten- tial impact on patient care. Nondisclosure of changes to the ‘‘original diagnosis’’ to the patient or their health care team is a common practice and promoted as a standard of practice by some Accepted for publication February 5, 2013. Reprint requests: M aire A. Duggan, MD, FRCPC, Department of Pathology and Laboratory Medicine, Foothills Hospital, Room C1135, 1403 29th Street NW, Calgary, Alberta, Canada T2N 2T9. E-mail: duggan@ucalgary.ca. 0039-6060/$ - see front matter Ó 2013 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.surg.2013.02.009 SURGERY 111