Desperate Times: Protecting the Public From Research Without Consent or Oversight During Public Health Emergencies

• DOI: 10.7326/m20-4631
• Publication Date: 2020-07-27T19:01:18Z
• Authors: Mary Catherine Beach; Howard M. Lederman; Megan Singleton; Roy G. Brower; Joseph Carrese; Daniel E. Ford; Bhakti Hansoti; Craig W. Hendrix; Ellen Verena Jorg...; Richard D. Moore; Philip Rocca; Jonathan M. Zenilman
• Keywords: Research Ethics

Ideas and Opinions1 December 2020Desperate Times: Protecting the Public From Research Without Consent or Oversight During Health EmergenciesFREEMary Catherine Beach, MD, MPH, Howard M. Lederman, PhD, Megan Singleton, JD, Roy G. Brower, Joseph Carrese, Daniel E. Ford, Bhakti Hansoti, MBCHB, Craig W. Hendrix, Ellen Verena Jorgensen, Richard D. Moore, MHS, Philip Rocca, MAT, Jonathan Zenilman, MDMary MPHBerman Institute of Bioethics, Johns Hopkins University, School Medicine, Baltimore, Maryland (M.C.B., J.C.)Search for more papers by this author, PhDJohns Medicine (H.M.L., M.S., R.G.B., D.E.F., B.H., C.W.H., E.V.J., R.D.M., P.R., J.M.Z.)Search JDJohns MDJohns MPHJohns MHSJohns MATJohns authorAuthor, Article, Disclosure Informationhttps://doi.org/10.7326/M20-4631 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The coronavirus disease 2019 (COVID-19) pandemic demands a sweeping public health response. State governors have restricted movement private citizens with stay-at-home orders mandated business closures. We collectively, necessarily, and—in many cases—willingly given up our personal freedoms greater community benefit. Amid crisis, however, preventing unnecessary sacrifice fundamental human rights under pretext is critical.One area where concern arises differentiating activities classified as surveillance from those that constitute research. Both are necessary in understanding epidemiology transmission. In 2018 revision federal regulations governing subjects research (the “Common Rule”), occur “during course an event crisis threatens health” (Table) were specifically excluded regulation (1). One can hardly imagine than COVID-19.Table. Regulatory Ethical Guidance on Surveillance Informed ConsentYet, defining has profound implications because there then no further ethical oversight, legal requirement United States informed consent, specific protection vulnerable participants communities. Protections arose abuses, Tuskegee syphilis study, which researchers unethically justified sacrificing individual current pandemic, when fear, uncertainty, temptation rebalance interest over exist, it paramount institutions heighten their vigilance avoid repeating past mistakes.As institutional review board (IRB) members, authors responsible ensuring meets ethical, scientific, regulatory standards. we seen increase requests IRB determine projects qualify surveillance. Many these already been designated agencies other IRBs, included long-term storage undefined future use biological specimens (related unrelated COVID-19), required submission genetic information publicly available databases (such dbGaP), incorporated plan creation cell lines. some cases, would receive sheet; others, be provided participants. Recently, IRB, determined consent was before genomic data COVID-19 activity could made available, sponsor investigator not participate requirement.We believe Common Rule exclusion protections amid does justify unlimited without consent. At Hopkins, particularly cognizant issue. 1951, cervical cancer cells collected 31-year-old woman named Henrietta Lacks. These became HeLa cells, among most widely used important This line created permission, thereby contributing deep distrust within surrounds Hospital depends clinical care. Lacks story exemplifies potential damage trust ensues tissue consent.The collection during extremely aimed at controlling virus. Data may collected, tested, even stored legitimate surveillance, but subsequent exempt consistent guidance Office Human (2), Centers Disease Control Prevention (3), World Organization (4), Kingdom's Authority (5), Nuffield Council Bioethics (6). part will valuable If so, should proceed research—with oversight. impracticable point, grant waiver. However, if know advance research, such lines whole genome sequencing databases, must obtained time collection. Modern technology makes increasingly difficult truly deidentify specimens.Obtaining activities. basis using emergency situations, serves compelling common good (7). Many—including authors—agree possible undermine effective response absence requirement, considered possible. Obtaining difficult, especially prospectively. Even impracticable, about scope purpose (7).There general sense obtaining approval unnecessarily bureaucratic delay recognize urgent need collect data, well importance Combining collecting additional storing samples public's delay. Our institution others responded needs caused streamlining processes approving flexible methods including remote platforms oral desire so broadly invoking exception represents speed, recommend establishing rapid rather protections.COVID-19 international emergency. invoke Rule's questionable pretenses clearly also intent, whether extant downstream. Storage Activities regulated such, done execute governance infrastructure maintain abuses past.References1. Subpart A 45 CFR Part 46: Basic HHS Policy Protection Subjects As revised January 19, 2017 amended 22, June 2018. Google Scholar2. Protections. Deemed Not Research: Requirements. Accessed www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-activities-deemed-not-be-research-public-health-surveillance/index.html 22 May 2020. Scholar3. CDC-SA-2010-02. Distinguishing NonResearch. Published online July 29, 2010. www.cdc.gov/os/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf Scholar4. Organization. Managing Issues Infectious Outbreaks. Organization; 2016. Scholar5. Authority. Seeking www.hra.nhs.uk/covid-19-research/seeking-consent-covid-19-research/#infononemergency 14 Scholar6. Bioethics. Global Emergencies: Issues. www.nuffieldbioethics.org/topics/research-ethics/research-in-global-health-emergencies Scholar7. Surveillance. 2017. Scholar8. Standards Distilling Existing Support R&D. www.who.int/publications/i/item/WHO-RFH-20.1 Scholar Comments0 CommentsSign Submit Comment Charles R. MacKay*28 2020 Matter Principle comment blurring timely. drafter original official overseeing compliance 25 years OPRR, NIH, vital principle autonomy era extensive them exploited intentioned purposes compromise privacy individuals. funding agency disregarded basic advised error directed OHRP, modifyti mistaken policy. Disclosures: author nothing disclose. Author, InformationAffiliations: Berman J.C.)Johns J.M.Z.)Disclosures: Disclosures viewed www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M20-4631.Corresponding Author: Mary 2024 East Monument Street, Room 2-511, MD 21287; e-mail, [email protected]edu.Current Author Addresses: Dr. Beach: 21287.Dr. Lederman: CMSC 1102 Pediatrics, 600 North Wolfe 21287.Ms. Singleton Mr. Rocca: 1620 McElderry Reed Hall B-130, 21205.Dr. Brower: 1800 Orleans Zayed 9121, Pulmonary CCM, Carrese: General Internal 301 Building, 1st Floor, Mason F Lord Drive, 21224.Dr. Ford: 733 Broadway, Suite 115, Hansoti: 5801 Smith Avenue, Davis 220, 21209.Dr. Hendrix: Harvey 502, Pharmacology Med, Jorgensen: Morsani College MDC 62, 12901 Bruce B Downs Boulevard, Tampa, FL 33612.Dr. Moore: 1830 8059, Zenilman: Div ID MFL Center Twr 381, 5200 Eastern 21224.Author Contributions: Conception design: M.C. H.M. R.G. J. D.E. B. C.W. E.V. R.D. P. J.M. Zenilman.Drafting article: Zenilman.Critical intellectual content: Zenilman.Final Zenilman.Administrative, technical, logistic support: Rocca.This article published Annals.org 27 PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byThe impact speech–language hearing professions low- middle-income countries: Challenges opportunities exploredCochleovestibular findings linked COVID-19: scoping care planning South AfricaConducting pandemic: lessons Speech-Language Pathology Audiology researchA global perspective embryological fetal collections: Where here?Ethical, regulatory, practical barriers research: stakeholder-informed inventory concernsCoordinating SARS-CoV-2 StatesGenomic diversity early introduction into Baltimore–Washington metropolitan areaChallenges learned procedures 1 2020Volume 173, Issue 11Page: 926-928 ePublished: Published: Copyright & PermissionsCopyright © American Physicians. All Rights Reserved.PDF downloadLoading ...