Posted on December 17, 2014
Objectives:
- To understand the role of surveillance in control of vaccine preventable diseases.
- To be aware of appropriate use of data collected for public health purposes and used secondarily for research.
Instructions for trainees: Please read the case, questions and resources prior to the seminar.
Case:
Following her pediatric residency, Amy is uncertain of her ultimate career path, but decides a good next step would be a locum at a remote hospital in northern Manitoba. Part of her role includes serving as acting medical officer of health for her region. A nursing student, Adele Moreau, arrives at the hospital as a volunteer. She is also taking time from her nursing studies to train in Northern Manitoba for the Iditarod Trail Sled Dog Race, an annual 1,200 mile race in Alaska when weather permits. Amy and Adele soon become good friends.
Amy has been collecting data on reportable infectious diseases in a folder on her desk as the reports are submitted. She requests permission from her employer to enter the paper-based health-information on reportable infectious diseases into an electronic database, so that she can more easily keep track of trends and identify outbreaks. This is a perfect job for Adele who needs the money to pay expenses. During the day, Adele trains for the race, and in the evening she enters data from 15 years of paper records on her laptop. Adele finishes the task by the time she leaves in late winter.
One day, a nine-year-old girl from a First Nations community presents with a rash on her arms and legs. The child soon becomes desperately ill and Amy realizes she has meningococcemia, a severe infection caused by Neisseria meningitidis, serotype B. After being stabilized the child is evacuated by air to Winnipeg for critical care. Amy telephones the communicable disease nurse (CDC) to begin control measures for close contacts and notifies the provincial public health office.
Two weeks later, a 13-year-old boy from a different community presents with meningococcal meningitis, of a different serotype. In conversations with a nurse practitioner, Amy learns that there have been several such infections in these two communities in past two years. She reviews the electronic database and finds eight cases of meningococcal infection in these two communities over 5 years and only one case in the other five communities. Amy alerts provincial medical officer of health of her analysis and a task force is created to review the data and determine if a mass vaccination program is necessary.
Amy thinks these findings may be of interest to her colleagues outside the region, and prepares an abstract for an upcoming public health conference. In recognition of Adele’s data entry work and her CDC nurses, she adds them as authors to the abstract and submits it one hour prior to the deadline.
Questions for discussion:
- How would you define surveillance?
- What is the purpose of surveillance?
- What is the national definition for invasive meningococcal disease?
- The primary purpose that Amy collected infectious disease data was for public health purposes. How would you describe the use of this data for research purposes? What guidelines would govern its use?
Readings and Resources:
- Public Health Agency of Canada – Surveillance programs at < http://phac-aspc.gc.ca/surveillance-eng.php>
- Nationally notifiable Infectious Diseases and Definitions at <http://dsol-smed.phac-aspc.gc.ca/dsol-smed/ndis/list-eng.php> .
- Notifiable disease surveillance system at http://dsol-smed.phac-aspc.gc.ca/dsol-smed/ndis/index-eng.php#top_list
- Consent and use of identifiable information for research purposes. Chapter 5, TriCouncil Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2), 2014. Available at http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter5-chapitre5/#toc05-1d
- SockettPN_idmm_1995_06165
Further discussion:
- What is Amy’s research question?
- What research designs might be used to address Amy’s questions?
- Should Adele be an author on publications about the research?
Developed 2011 by: Dr. Robert Bortolussi, Dalhousie University
Revised: 25 March 2015, J M Langley MD
Posted on December 17, 2014
Objectives:
- From readings and discussions, students will describe the need for active surveillance systems in reporting serious adverse events (SAEs) to maintain vaccine safety during clinical trials.
Instructions for trainees: Please read the case, questions and resources prior to the seminar.
Case:
Amy is a seasoned nurse but a new recruit in vaccine research at a children’s hospital for sick kids. It’s July, and many of the senior staff are on summer vacation. Therefore, she must cover off on many duties of others. She is working on a study for influenza vaccine in toddlers with egg allergies. The participants are between one year and three years old with a non-anaphylactic egg allergy for which they were tested with a skin test by an allergist prior to the study. Each was given graded doses. An initial dose of 10% of the vaccine was given. Then the children were observed for 30 minutes. If there was no reaction, the children were given the remaining 90% of the vaccine and again observed for 30 minutes. One of her duties is to report severe adverse events (SAEs).
As she is reviewing the vaccination reports from the nursing staff, she notes the various reactions. On the one hand, there are some mild to moderate solicited reactions: urticaria (hives), pruritus (itching and scratching), hypotension (abnormally low blood pressure), diarrhea, vomiting, agioedema (rapid swelling) of the tongue, and oculo-respiratory syndrome (with conjunctivitis and sore throat), a fever of 38.2 degrees Celsius, and respiratory wheezing. On the other hand, there are some severe unsolicited reactions: facial paralysis three weeks after the injection and hospitalization of four days for respiratory problems.
In her opinion, most of these reactions appear to be temporal and solicited such as a sore arm or low-grade fever. Since she is extremely busy, she really doesn’t have the time to complete any adverse events following immunization (AEFIs) reports. She is not even sure what is necessary to report, to whom, and why. In fact, she isn’t sure whom to contact for advice while the senior staff are away on holidays. A few of the reactions seem quite severe like Bell’s palsy or Guillain-Barré syndrome (GBS). At first, she wonders if the reports could simply wait until August when the IMPACT nurse coordinator returns. Then, she wonders if someone should be notified to investigate, stop, or intervene in the study. Finally, she is worried that she will be held responsible for the adverse events if she fails to act, or that she will be fired if the study loses funding due to her reports.
Seminar Discussion Questions:
- What are the features of the three different types of surveillance for diseases like influenza?
2. What are the barriers to reporting adverse events following immunization (AEFIs)?
3. What are the classifications for AEFIs?
4. What are mild, moderate, and severe adverse events (SAEs) to influenza vaccine? in patients with egg allergies?
5. What events should be reported?
6. During clinical trials, why is an active surveillance system necessary to monitor influenza vaccinations?
Readings and Resources:
- An online guide with sections about vaccine safety and adverse events in the Canadian Immunization Guide from the Public Health Agency of Canada (PHAC), p.59-89
http://www.phac-aspc.gc.ca/publicat/cig-gci/pdf/cig-gci-2006_e.pdf
- A 56-page online guide to monitoring, investigating, and reporting adverse events following immunization from the World Health Organization (WHO), p.9-18, 23-26
http://www.wpro.who.int/publications/pub_9290611820.htm
- A 24-page article about the evolution and types of surveillance systems from the WHO, p.294 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2486528/
- A 22-page online journal article about multi-dose graded vaccination in egg allergic children
http://www.ncbi.nlm.nih.gov/pubmed/20579720
- A web site about the Immunization Monitoring Program ACTive (IMPACT) http://www.cps.ca/English/surveillance/IMPACT/IMPACT.htm
- A 5-page article about the history and occurrence of Guillain-Barré Syndrome and correlation with influenza vaccination from the Center for Disease Control and Prevention (CDC)
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5921a3.htm
- An 8-page research article about incidents of Bell’s palsy after influenza vaccination in Switzerland
http://content.nejm.org/cgi/content/full/350/9/896
Developed 2011 by: PHAC/CIHR Influenza Research Network (PCIRN)
Posted on November 18, 2014
Objectives:
- Recognize the ethical requirements for use of human tissue for research purposes A
- Appreciate the requirements for published authorship
- Prepare an appropriate reaction for possible misconduct in research
Instructions for trainees: Please read the case, questions and resources prior to the seminar.
Case:
Following the earthquake in Haiti, a number of refugees are brought into the Montréal clinic and are assessed. Amy is working at the clinic on a research project. The refugees arrive during a flu outbreak in the community, and many of its staff are sick.
Given Amy’s emergency medical training, she is asked to assist the clinic by assessing the refugees as they arrive for TB and other underlying diseases and to collect blood for a serological test (Hepatitis B).
Amy carefully explains the plans to the refugees as she assesses them. She collects, labels and brings the blood to the laboratory for analysis. She assures them that the information from the tests on each patient will be held in strict confidence and will be relayed back to them and documented in their records. She will also inform the attending physician at the clinic of the results so that the refugees can get ongoing help and be vaccinated against diseases as normally done in Canada.
One day Amy drops by the laboratory to pick up some notes she had forgotten. When she enters the lab, she notices that a research assistant, Steve, is removing blood samples from the ‘to be destroyed’ container in the lab. Amy asks what he is doing there. Steve replies that his supervisor is testing the samples of blood that Amy collected for HIV. This is part of the final stages of a study on HIV detection and spread. Amy assumes that Steve’s boss has gone through the proper channels of approval and thinks nothing more about it.
A few months pass, and the Haitians are getting actively integrated into the community. Amy is back in the research lab, and everything seems to be going according to plan until she reads an article on the front page of the Montréal Gazette – “Haitian refugees bring new strain of HIV to Montréal”.
Amy quickly skims the article and notices that Steve’s supervisor is the lead researcher on the study. She wonders how he would have been able to gain consent from the refugees to test their blood for HIV and disclose this information. HIV tests are performed in strict confidence to avoid stigmatizing a person (or population), something this article has clearly done.
Suddenly, she remembers the day in the lab, and wonders if her samples are linked to this study. Amy quickly looks up the journal that is quoted in the Gazette, and is shocked to see that both Steve and herself are listed as co-authors on the paper. In disbelief, she heads directly to the clinic to get to the bottom of this and tell her supervisor of her concerns.
Questions for discussion:
- What situations are considered secondary use of data/samples and when is it appropriate to use samples in this way?
- What are the implications of this development? Should Amy take action? Why or why not?
- What are the research ethics requirements that would have to be met?
- How should the potential misconduct be reported and who should be involved?
- What are the implications for Amy and Steve as researchers?
- What are the requirements for authorship?
- As a researcher/physician, what could you do to protect yourself from a similar situation occurring?
Readings and resources:
- An online guide to national immunization practices, vaccine administration practices, and immunization records in the Canadian Immunization Guide from the Public Health Agency of Canada (PHAC), p. 22-28, 38-44, 55-56, 144-146
visit: http://www.phac-aspc.gc.ca/ type: Canadian Immunization Guide into the search on the website and you will find the most recent guide.
- An online guide in dealing effectively with allegations of non-compliance provided by Canadian Institute of Health Research (CIHR) in the Canadian Procedure for Addressing Allegations of Non-compliance with Research Policies, http://cihr-irsc.gc.ca/e/25178.html
- Council of Science Editors white paper on promoting integrity in scientific journal publications. Download PDF at: http://bit.ly/researchethics
- An article in the Journal of Medical Ethics entitled, “Should blood-borne virus testing be part of operative consent? When the doctor becomes the patient”, J Med Ethics 2011;37:476-478 doi:10.1136/jme.2010.038638 http://jme.bmj.com/content/37/8/476.short?q=w_jme_current_tab
- Department of Justice, Personal Information Protection and Electronic Documents Act (S.C. 2000, c. 5), available at: http://laws-lois.justice.gc.ca/eng/acts/P-8.6/index.html
- State of Research Integrity Policies in Canada prepared by the Canadian Research Integrity Committee (2009). Download PDF at: http://www.nserc-crsng.gc.ca/_doc/NSERC-CRSNG/HAL_Report_e.pdf
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, prepared by Government of Canada Panel on Research Ethics (2011). Review it at: http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
- Use of Data from the Electronic Health Record for Health Research– current governance challenges and potential approaches prepared by: Donald J. Willison Sc.D., Associate Professor, Dept. of Clinical Epidemiology & Biostatistics, McMaster University for Office of the Privacy Commissioner of Canada (2009). Download PDF at: http://www.priv.gc.ca/information/pub/ehr_200903_e.pdf
Developed 2011 by: Christina Carew, ABC, Dalhousie University
Revised: 11 September 2011, B Bortolussi MD