APC E-NEWS: 

MARCH 2019

Dear Members:

Important Updates from APC:

• Common Rule effective January 21, 2019: What you need to know!
• Academic Pathology: Call for Educational Cases, deadline: June 1, 2019
• APC/PRODS Programming at USCAP 2019!
• Register for APC 2019 - Preliminary Section Programs now posted
• In Case You Missed It:
• Paths to Progress, APC's Newsletter - Spring 2019 issue posted
• Review the latest Academic Pathology publications:
• The importance of autopsy in medicine
• Forensic autopsies for preclinical students
• Releasing surgical pathology specimens to patients

WHAT YOU NEED TO KNOW ON UPDATES TO THE COMMON RULE 

By Steven Peiper, MD, Vice Chair, APC Advocacy Committee

The federal update to the Protection of Human Subjects in Research, known as the Common Rule, became effective January 21, 2019. The first tier of changes applies to the Informed Consent Process, which is designed to facilitate the comprehension of candidates for participation. Requirements include:

• A brief summary of the study that includes specific activities, risks, benefits prior to the content of the consent form, itself.
• Five points are to be presented in the body of the consent
• A statement that the project is research and that participation is voluntary
• A description of the research, including the purpose, duration, list of procedures
• Potential risks and discomforts
• Potential benefits
• Alternative procedures or changes in the course of therapy, if any.
• One of two statements should be included:
• Identification will be removed and data/biospecimens can be used for future research without additional informed consent.
• Information/biospecimens will not be used for future research, even if the identification is removed.
• Three additional requirements include:
• Biospecimens may be used for commercial profit and whether or not the subject may share in the profit.
• Whether clinically relevant research results will be shared with subjects.
• Whether research may include whole genome sequencing.

Additional considerations have been included for the request of waivers for review.

• Activities considered not to constitute research include:
• Public health surveillance - this allows public health authorities to identify biospecimens to monitor, assess, or investigate events of importance to public health, such as disease outbreaks;
• Collection and analysis of identifying information, biospecimens, or documents, when authorized by a court for investigation in the context of criminal justice;
• Scholarly and journalistic activities;
• Activities authorized for the support of national security missions.
• In order to receive a waiver to use identified data and biospecimens, the IRB must consider it would be impracticable to use de-identified data/biospecimens.
• Minimal risk studies that are approved by expedited review no longer have a requirement for annual continuing review. The new requirement is a biannual brief update.
• There is no change in the requirement to submit amendments and report events regarding safety issues.
• The changes in the Common Rule are not relevant to studies regulated by the FDA.
• The consent form approved by the IRB for federally funded studies must be posted to a publicly available Federal website (to be determined) within 60 days of the last study visit/after the last subject is enrolled.
• Guidelines for the use of a “broad consent” have been established. This enables biospecimen storage and secondary research using identifiable private information and biospecimens.
• Policy must be implemented at the level of the institution.
• Tracking of all individuals who decline participation must be performed.
• The IRB may approve a research proposal for screening or determining eligibility for participation in a study without informed consent if appropriate criteria are fulfilled.

Resources from the U.S. Department of Health & Human Services, Office for Human Research Protections:

• Revised Common Rule: www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html
• Revised Common Rule Educational Materials: www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html
• Revised Common Rule Q&As: www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html

Resources from AAMC: www.aamc.org/initiatives/research/257508/humansubjectprotections.html

Resources from ASIP: http://asip.org/SciencePolicy/OVERVIEWOFUPDATEDCOMMONRULE.cfm

 
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ACADEMIC PATHOLOGY JOURNAL UPDATES

Call for Educational Cases for PCME: Submit by June 1, 2019: Want to share your teachable case-based moments? Interested in mentoring your trainees for academic scholarship in medical education? Write and submit Educational Cases aligned to the learning objectives of the Pathology Competencies for Medical Education (PCME)! A Call for Educational Cases has been launched with a deadline to submit by June 1, 2019. See details at: www.apcprods.org/m-academic-pathology.

Index of Educational Cases per Objective and Competency: Want to reference Educational Cases in the classroom? Preparing to write an Educational Case and looking for objectives that need Educational Cases? See the Index of Educational Cases for a complete list of published cases organized by objectives.

Compendium of 2018 Papers: All Academic Pathology papers published in 2018 are now posted as a pdf compendium at: www.apcprods.org/journal! A printed spiral-bound version was distributed to Chairs and PRODS attending USCAP 2019. A compilation of Educational Cases published to date is also posted as a pdf on the APC journal webpage. If you would like a printed copy, email [email protected] with your request and postal mailing address. Quantities are limited. One per member.

 
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OUTSTANDING PROGRAMMING BY THE APC AND PRODS DURING USCAP 2019

Presentations are now available to members at: www.apcprods.org/m-satellite-meetings. 

Machine Learning Boot Camp: Computational Pathology and Artificial Intelligence for the Practicing Pathologist - The field of artificial intelligence is rapidly expanding and has begun to impact pathology. One aspect of artificial intelligence, termed deep learning, is particularly well-suited to anatomic pathology because of its capabilities in image recognition. To date, deep learning algorithms have been applied to the analysis of a variety of tissues, including breast cancer, prostate cancer and colon cancer. This tutorial will provide pathologists with the basic understanding and vocabulary necessary to understand the basics of machine learning and its applications to anatomic pathology. Presented by co-organizer Douglas Clark, MD (University of New Mexico), Andrew Janowczyk, PhD (Case Western Reserve University), and Scott Doyle, PhD (University at Buffalo, SUNY).

PRODS Program at USCAP 2019: 

• Surgical Pathology Subspecialty Practice, Alexandra Kalof, MD, University of Vermont
• Resident Educational Abstract presentations:
• This is Jeopardy! A Service Coverage-Based Schedule Model, Jason Scapa, MD, UCLA Medical Center, David Geffen School of Medicine at UCLA
• Augmented Reality Grossing Manual for Resident Training, Ozlem Kulak, MD, University of Texas Southwestern Medical Center
• "Learning Deeply": Teaching Organ-Systems via Prototyping Deep Learning Algorithms; An example of Intraductal Proliferative Lesions of the Breast, Charisse Liz Baste, MD, University of Illinois Hospital and Health Sciences System
• Updates from:
• United States and Canadian Academy of Pathology (USCAP), David Kaminsky, MD, USCAP
• Accreditation Council for Graduate Medical Education (ACGME), Laura Edgar, EdD, CAE
• American Board of Pathology (ABPath), Rebecca L. Johnson, MD 
• Training Residents in Genomics (TRIG), Rich L. Haspel, MD
• Patient Safety, Yael K. Heher, MD, MPH
• Pathology Informatics Essentials for Residents (PIER), Scott Anderson, MD

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APC 2019 ANNUAL MEETING REGISTRATION

Preliminary Section Programs now available: www.apcprods.org/m-2019-agenda to view, download, and print the “At-A-Glance” preliminary program for your specific Section (Chairs, PRODS, PDAS, UMEDS, GMEAS). Thanks to each Section’s Councils, see the line-up of outstanding speakers for timely and relevant content that have been programmed.  

REGISTER NOW and RESERVE your room at the Boston Seaport Hotel! Visit: www.apcprods.org/m-meetings-2019 and SAVE $100 by registering at the Early Registration Rate no later than Wednesday, May 15th. A reservation link for the group room rate at the Boston Seaport Hotel will be included in your registration confirmation email upon registering for the APC 2019 Annual Meeting. Discounted room rates are only good through June 27th, but rooms in our group block are selling out! Plan to arrive in time for the Welcome Reception on Sunday, July 21st late afternoon (5:00pm ET). Programming begins early on Monday, July 22^nd and ends in the late afternoon of Wednesday, July 24^th.

The APC 2019 Pathology Leadership Academy (PLA): www.apcprods.org/pla - Share this opportunity with your faculty who are on the academic leadership track and encourage them to register today! The APC 2019 PLA will be held on July 20-21, 2019, immediately before the APC 2019 Annual Meeting (separate registration required). For details on the program content, enrollment eligibility and the registration process, see www.apcprods.org/pla - space is filling up!

The APC PLA: Experience from the First 2 Years: Review a recently published article in Academic Pathology that describes how the PLA has met the leadership development needs for individuals and academic departments since 2016, and how the PLA continues to develop its curriculum to address the major needs of academic pathology.

 
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In Case You Missed the Latest APC/Academic Pathology Publications...

• Spring 2019 edition of Paths to Progress: www.apcprods.org/m-paths-to-progress. Read exciting updates about YOUR organization in the spring edition of APC’s biannual newsletter. Includes reports from APC Committees, the Academic Pathology journal, news from each of APC's Sections, and updates from a variety of Working Groups and Task Forces.
• Two new autopsy papers and a surgical pathology paper published in Academic Pathology during March:
• Kemp, WL, Koponen, M, Sens, MA. Forensic Autopsy Experience and Core Entrustable Professional Activities: A Structured Introduction to Autopsy Pathology for Preclinical Student.  Academic Pathology. 2019; 6:1-8. Research Article first published March 5, 2019: https://doi.org/10.1177%2F2374289519831930
• Buja, LM, Barth, RF, Krueger, GR, Brodsky, SV, and Hunter, RL. The Importance of the Autopsy in Medicine: Perspectives of Pathology Colleagues. Academic Pathology. 2019; 6:1-9. Review Article first published March 10, 2019: https://doi.org/10.1177/2374289519834041
• Gibson, BA and Sobonya, RE. Patients Who Take Home Their Surgical Pathology Specimens: A Preliminary Study. Academic Pathology. 2019; 6:1-4. Research Article first published March 10, 2019: https://doi.org/10.1177/2374289519832502

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Association of Pathology Chairs | [email protected] | www.apcprods.org