Ellen Roche research

1. Ellen Roche
Ethical Presentation
Research in Nursing Practice MSN 6606
Tamekia Bugam
Laurie Capriotti
Barbara Feeny

2. Objectives
 The learner will be able to describe the purpose and research process of the
study involving Ellen Roche
 The learner will be able to list the violations of ethical standards and regulations
that occurred in the research study
 The learner will be able to identify how the events of the Ellen Roche incident
impacted the research community
 The learner will be able to list safeguards that have been created to prevent
similar events from occurring and describe how they are monitored
 The student will be able to describe the key elements of an informed consent
and analyze which components were missing in Ellen Roche’s case

3. Research study
 In 2001, Johns Hopkins University researcher Dr. Alkis Togias submitted an IRB
for study “Lung Inflation in Airways Hyper-Responsiveness”
 Researcher aimed to learn more about the
reflex that protects the lungs of healthy
people against asthma attacks
 The study’s design was to generate a mild asthma attack in healthy people
 The volunteers were asked to inhale a chemical named hexamethonium
 Researchers would monitor the lung’s response to the irritant
(Resnik, 2011)

4. Research population
 Three healthy volunteers were selected to participate in the study
 The first volunteer experienced mild symptoms of a cough
 The second volunteer experienced no symptoms
 The third volunteer, Ellen Roche, initially developed a cough, but within 5
days her condition deteriorated and she was admitted to an intensive care
unit for respiratory distress
 She died one month after joining the study from progressive hypotension
and multi-organ failure

5. Ethical dilemma
 The three ethical principles of beneficence,
respect for human dignity and justice/fair treatment
were not used to guide the research decisions and
conduct in the case of Ellen Roche
 Inadequacies in the protection of human research subjects
 Researchers and IRB failed to obtain literature from the 1950’s
demonstrating effects of lung toxicity and hexamethonium
 Failure to obtain IRB approval when changes were made to the original
protocol
(Resnik, 2011)

6. Ethical dilemma cont:
 Failure to obtain informed consent
 Hexamethonium was not approved by the Food and Drug
Administration (FDA)
 Failure to report an unanticipated side effect to the IRB
 The IRB failed to take proper precautions and did not follow federal
regulations
 (Resnik, 2011)

7. Resulting Changes in Research
 The IRB must include members outside the institution with no financial ties to
the research facility or the drug being tested.
 Patients and IRB must be kept abreast of all new findings. Written
documentation and signatures are mandatory.
 The Partners Human Research Committee (PHRC) must approve written
and oral information (including recruitment materials) provided to subjects
before and during the informed consent process.
 IRBs are responsible for critical oversight functions for research conducted
on human subjects that are "scientific," "ethical," and "regulatory."
(Keiger & DePasquale, 2002)

8. Consequences for the
Researcher Dr. Alkis Togias
Johns Hopkins Hospital took full responsibility
for this tragedy because the institution did
not have written safety requirements to
protect subjects. The institution did not make
it mandatory to share adverse reactions of
previous participants. Therefore, although
Dr. Togias was at fault for not providing full
disclosure, the hospital took responsibility
and all human research projects were
suspended at Hopkins
(Keiger & DePasquale, 2002)
• On July 17, Johns Hopkins
accepted full responsibility for Ms.
Roche’s death and they
suspended all studies which were
being conducted by Dr. Alkis
Togias, the principal investigator.
• On July 22, the ORHP authorized
Hopkins to resume research but
only research involving “minimal
risk”, but it had to restructure its
system for protecting subjects.

9. How do we prevent a similar future
event?
Safeguards to protect to human subjects
 Adoption of the Belmont report
 The National Institutes of Health (NIH) requires that NIH-supported projects
must meet the current human subjects protections requirements.
 Informed Consent
 Protection of vulnerable populations
 Human subject research is reviewed and approved by an IRB using certain
criteria
(U.S. Department of Health and Human Services, 2014)

10. How are these safeguards monitored?
 Institutional Review Board (IRB) is an administrative body established to protect the rights
and welfare of human research subjects recruited to participate in research activities
 The IRB has the authority to approve, require modifications in, or disapprove all research
activities that fall within its jurisdiction as specified by both the federal regulations and local
institutional policy
 All IRBs must meet certain criteria set forth by federal policy requirements.
 Before any human subjects research can be conducted, the institution must provide the
department or agency a written Assurance that it will comply with the requirements of the
Policy
 The Assurance must be approved by the department or agency; and the institution must
certify to the department or agency head that the research has been reviewed and
approved by an IRB established in accordance with the requirements of the Policy
 FDA uses a system of inspections and audits for ensuring compliance with human subjects
regulations
(U.S. Department of Health and Human Services, 2014

11. Was the ‘research’ hindered?
 The study was halted and an investigation followed. On July 19th of the same
year, the Office for Human Research Protection (OHRP) suspended all federally
funded research involving humans at Hopkins.
 This did hinder the research slightly by setting back the chances of finding the
answer the researchers were in search of from the beginning. A new study
would need to be conducted to find a safer method.
 Overall, NO. In all clinical research studies, there may at some point be a death.
This death proved that this medication was not be safe for this type of use.
 (Research with Health Volunteers, 2009)

12. What Should the IFC have Included?
 “The consent form called the hexamethonium a “medication” that had
been “used during surgery, as a part of anesthesia”—giving the impression
that it was approved by the Food and Drug Administration (FDA) as a
medicine and was, therefore, safe. There was no mention that inhaling the
chemical was experimental “ (science.education.nih.gov)
 The consent form should have gone into more detail concerning this
medication and the fact that it too was being studied and that it had not
been approved by the FDA.
 (Resnik, 2011)

13. References
 Becker, L. C., Brower, R. G., Faden, R., Johns, R. A., Lipsett, P. A., Petty, B. G.,& McFadden, E. R. report of
internal investigation into the death of a research volunteer.
 Keiger, D., & DePasquale, S. (2002, February 1). Trials and tribulations. Johns Hopkins Magazine, 1-14.
 Resnik, D. (2011). Limits on risks for healthy volunteers in biomedical research.
 Theor Med Bioeth, 137-149. Retrieved September 3, 2014, from
http://www.ncbi.nlm.nih.gov/pubmed/22198413
 Savulesco, J., & Spriggs, M. (2002). The hexamethonium asthma study and the
death of a normal volunteer in research. J Med Ethics,28/(1),
3-4. Retrieved September 3, 2014, from
http://jme.bmj.com/content/28/1/3.full#cited-by
 Research with Healthy Volunteers. (2009).Education Development Center, Inc., Retrieved from
http://science.education.nih.gov/supplements/nih9/bioethics/guide/pdf/Master_5-3.pdf
 U.S. Department of Health and Human Services (2014). IRB guidebook. Retrieved
from http://www.hhs.gov/ohrp/archive/irb/irb_chapter1.htm