Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

The ethics of researching Ebola

Ruth Macklin, PhD
Conditions
November 12, 2014
Share
Tweet
Share

As we learn of new suspected cases of Ebola infection in the United States, causing worries among the population and renewed efforts by the Centers for Disease Control and Prevention to contain the epidemic.

A student in the postgraduate course in research ethics that I teach at Albert Einstein College of Medicine recently asked whether we could discuss the Ebola epidemic in class. Because I had prepared the syllabus for the course months ago, I hadn’t thought of including a discussion of ethics in research on Ebola. But the time was ripe, and I gratefully accepted the student’s suggestion.

A letter published online in the Lancet on October 10 is titled “Randomised Controlled Trials for Ebola: Practical and Ethical Issues.” The authors are a distinguished group of scientists, ethicists and physicians from all over the world, including several from West Africa, where the epidemic is raging. The letter makes an urgent plea for embarking on research for experimental treatments that would not randomize patients to a control arm that provides only conventional care or conventional care along with a placebo.

Departing from the randomized clinical trial

Instead, the letter argues, “When conventional care means such a high probability of death, it is problematic to insist on randomising patients to it when the intervention arm holds out at least the possibility of benefit.” To do so would violate clinical equipoise, the situation in which genuine uncertainty exists about whether an untested treatment has benefits or risks that exceed those of conventional care. There is no such uncertainty in the case of Ebola. Nevertheless, the authors’ proposal rejects the gold standard in research methodology — the randomized clinical trial (RCT). How that departure from the widely accepted orthodox trial design will be viewed by research methodologists remains to be seen.

The proposal to use alternative methodologies to explore a beneficial treatment for patients already infected with the Ebola virus also departs from widely accepted ethical guidance for the use of placebos in research. The most prominent international ethical guideline is the Declaration of Helsinki, issued by the World Medical Association. Paragraph 33 says: “The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances: Where no proven intervention exists, the use of placebo or no intervention, is acceptable.”

To say that the use of a placebo or no treatment, is “acceptable” is not to say that a placebo or conventional care must be used as a comparator. The underlying assumption is that patients will not be made worse off if they receive a placebo when an experimental treatment is not yet proven. The Lancet authors state that “ethical arguments are not the same for all levels of risk,” and an experimental treatment holds out at least the possibility of benefit. They make several suggestions for alternative research methods that can obtain provisional answers quickly, eventually leading to RCTs in which patients are randomized to one or another experimental treatment, with no one receiving standard care.

Implications for future vaccine-safety trials

I agree with the ethical analysis and conclusions in the Lancet article. But they lead me to wonder about the design of preventive vaccine clinical trials in the future. The article mentions that vaccine safety trials are currently under way, and these would have to demonstrate safety before moving on to the phase in which efficacy is studied. Because there is currently no efficacious vaccine against Ebola, the same question about a placebo-controlled RCT is likely to arise. Participants in a vaccine trial are healthy volunteers, so it may be argued that they do not have the same urgent need as patients suffering from a disease with a high fatality rate. However, those at high risk of being infected with the Ebola virus (healthcare workers and family members of sick patients) do have an urgent need for prevention, and there exists an urgent public health need as well.

Clinical prevention trials typically require a large number of participants in order to demonstrate efficacy, but there may well be sufficient numbers in Guinea, Sierra Leone and Liberia, the three most deeply affected countries in West Africa.

It is a question for methodologists, rather than ethicists, to determine whether the results of a nonrandomized trial of an Ebola vaccine would be interpretable. If the same arguments offered by the authors of the Lancet letter are applicable to preventive-vaccine clinical trials, they could result in another example of a departure from the gold standard of research methodology.

Ruth Macklin is a professor, department of epidemiology and population health, Albert Einstein College of Medicine, Bronx, NY. She blogs at The Doctor’s Tablet.

Prev

Patient complaints: Sometimes sorry is all it takes

November 12, 2014 Kevin 2
…
Next

When patients seek a second opinion: It's not about you

November 12, 2014 Kevin 11
…

ADVERTISEMENT

Tagged as: Infectious Disease

Post navigation

< Previous Post
Patient complaints: Sometimes sorry is all it takes
Next Post >
When patients seek a second opinion: It's not about you

ADVERTISEMENT

More by Ruth Macklin, PhD

  • Is the National Institutes of Health stifling academic freedom?

    Ruth Macklin, PhD
  • How can we fix the research bias from industry sponsorship?

    Ruth Macklin, PhD
  • The erosion of informed consent in medical research

    Ruth Macklin, PhD

Related Posts

  • The COVID vaccine selfie: The caption matters as much as the picture

    Alicia Billington, MD, PhD
  • The ethics of rationing care during COVID

    M. Bennet Broner, PhD
  • Do we need to temper our expectations of Paxlovid?

    Benjamin Geisler, MD, MPH
  • No, the HPV vaccine isn’t optional

    Chad Hayes, MD
  • The basics of the MMR vaccine from a pediatrician

    Roy Benaroch, MD
  • A view from Canada: Defending vaccine passports

    Bryan Thomas and Colleen M. Flood

More in Conditions

  • Inside the high-stakes world of neurosurgery

    Isaac Yang, MD
  • Why I left the clinic to lead health care from the inside

    Vandana Maurya, MHA
  • One injection dropped LDL by 69 percent. Should we celebrate?

    Larry Kaskel, MD
  • Does cycling hurt male fertility?

    Martina Ambardjieva, MD, PhD
  • How community and buses saved my retirement

    Raymond Abbott
  • How changing your self-talk can transform your entire life

    Faust Ruggiero
  • Most Popular

  • Past Week

    • Why your clinic waiting room may affect patient outcomes

      Ziya Altug, PT, DPT and Shirish Sachdeva, PT, DPT | Conditions
    • The backbone of health care is breaking

      Grace Yu, MD | Physician
    • Nuclear verdicts and rising costs: How inflation is reshaping medical malpractice claims

      Robert E. White, Jr. & The Doctors Company | Policy
    • How new loan caps could destroy diversity in medical education

      Caleb Andrus-Gazyeva | Policy
    • Why transplant equity requires more than access

      Zamra Amjid, DHSc, MHA | Policy
    • The ethical crossroads of medicine and legislation

      M. Bennet Broner, PhD | Conditions
  • Past 6 Months

    • Health equity in Inland Southern California requires urgent action

      Vishruth Nagam | Policy
    • Why transgender health care needs urgent reform and inclusive practices

      Angela Rodriguez, MD | Conditions
    • How restrictive opioid policies worsen the crisis

      Kayvan Haddadan, MD | Physician
    • Why primary care needs better dermatology training

      Alex Siauw | Conditions
    • New student loan caps could shut low-income students out of medicine

      Tom Phan, MD | Physician
    • mRNA post vaccination syndrome: Is it real?

      Harry Oken, MD | Conditions
  • Recent Posts

    • Why AI in health care needs stronger testing before clinical use [PODCAST]

      The Podcast by KevinMD | Podcast
    • How AI is reshaping preventive medicine

      Jalene Jacob, MD, MBA | Tech
    • How transplant recipients can pay it forward through organ donation

      Deepak Gupta, MD | Physician
    • Inside the high-stakes world of neurosurgery

      Isaac Yang, MD | Conditions
    • Why I left the clinic to lead health care from the inside

      Vandana Maurya, MHA | Conditions
    • How doctors can think like CEOs [PODCAST]

      The Podcast by KevinMD | Podcast

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

Leave a Comment

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

ADVERTISEMENT

  • Most Popular

  • Past Week

    • Why your clinic waiting room may affect patient outcomes

      Ziya Altug, PT, DPT and Shirish Sachdeva, PT, DPT | Conditions
    • The backbone of health care is breaking

      Grace Yu, MD | Physician
    • Nuclear verdicts and rising costs: How inflation is reshaping medical malpractice claims

      Robert E. White, Jr. & The Doctors Company | Policy
    • How new loan caps could destroy diversity in medical education

      Caleb Andrus-Gazyeva | Policy
    • Why transplant equity requires more than access

      Zamra Amjid, DHSc, MHA | Policy
    • The ethical crossroads of medicine and legislation

      M. Bennet Broner, PhD | Conditions
  • Past 6 Months

    • Health equity in Inland Southern California requires urgent action

      Vishruth Nagam | Policy
    • Why transgender health care needs urgent reform and inclusive practices

      Angela Rodriguez, MD | Conditions
    • How restrictive opioid policies worsen the crisis

      Kayvan Haddadan, MD | Physician
    • Why primary care needs better dermatology training

      Alex Siauw | Conditions
    • New student loan caps could shut low-income students out of medicine

      Tom Phan, MD | Physician
    • mRNA post vaccination syndrome: Is it real?

      Harry Oken, MD | Conditions
  • Recent Posts

    • Why AI in health care needs stronger testing before clinical use [PODCAST]

      The Podcast by KevinMD | Podcast
    • How AI is reshaping preventive medicine

      Jalene Jacob, MD, MBA | Tech
    • How transplant recipients can pay it forward through organ donation

      Deepak Gupta, MD | Physician
    • Inside the high-stakes world of neurosurgery

      Isaac Yang, MD | Conditions
    • Why I left the clinic to lead health care from the inside

      Vandana Maurya, MHA | Conditions
    • How doctors can think like CEOs [PODCAST]

      The Podcast by KevinMD | Podcast

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Leave a Comment

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...