Desperate Times: Protecting the Public From Research Without Consent or Oversight During Public Health Emergencies
Authors: Mary Catherine Beach, Howard M. Lederman, Megan Singleton, Roy G. Brower, Joseph Carrese, Daniel E. Ford, Bhakti Hansoti, Craig W. Hendrix, Ellen Verena Jorgensen, Richard D. Moore, Philip Rocca, Jonathan M. Zenilman
Journal: Annals of Internal Medicine (2020)

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