Ellen Roche

Ethical Presentation

Research in Nursing Practice MSN 6606

Tamekia Bugam

Laurie Capriotti

Barbara Feeny

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

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)

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

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)

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)

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)

Resulting Changes in Research

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. AlkisTogias, 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.

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)

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

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)

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)

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