Canadian Immunization Research Network Education Series Case 1: Testing Tribulations
- 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.
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