At the BC Medical Journal, we often receive submissions from clinicians who want to share their findings, but they aren’t sure how to approach the subject of research ethics. Here is a brief summary for our readers and prospective authors.
What is a research ethics board?
Research ethics boards (REBs) are “autonomous entities whose primary responsibility is to protect the rights and welfare of human participants taking part in research.” They can also help to ensure that research is of high quality and is clinically important. The University of British Columbia has several such boards, including Children’s and Women’s, BC Cancer, Providence Health Care, and the UBC Clinical Research Ethics Board. These committees are composed of individuals from varied backgrounds such as physicians, scientists, researchers, ethicists, and community members. There are also private for-profit ethics boards, which adhere to the same principles and are selected by some researchers for expediency or if the researchers are not affiliated with a university.
Why is research ethics approval necessary?
Involuntary studies on human subjects in the past have had horrendous consequences. The Nuremberg trials exposed the “scientific” evils of the Nazi regime and resulted in the creation of the Nuremberg Code in 1947. Unfortunately, around the world, including in North America, there were many subsequent occurrences of atrocities committed in the name of research. The World Medical Association Declaration of Helsinki (1964, last updated 2013) was created to further address the ethics and safety of human research and its application to special populations.
Today, the standards for research involving humans adhere to the Tri-Council Policy Statement (TCPS2 2018), which is a product of Canada’s three federal research agencies. Applications to UBC’s REBs require all team members to have completed a tutorial on the Tri-Council Policy Statement. The key principle is informed consent, where research participants are fully informed about the potential risks and benefits of the study.
When does a study need research ethics board approval?
In Canada, any research study involving human participants, human tissue, or human data requires research ethics board approval before commencement. If you are undertaking a quality improvement project, it does not require REB oversight. However, it is important to note that REBs cannot review research that has already been done; if there is any doubt about your project constituting research, it is best to consider the intention of the project before beginning. A sorting tool, available on the PHSA website, can be a helpful first step (https://rc.bcchr.ca/redcap/surveys/?s=HNWAAKFF97). If research ethics appear to be required or you are uncertain, contact your local REB.
At the BCMJ, we also receive submissions of quality improvement projects that have been written up for publication. For example, a medical student was supervised by an attending physician to perform a review of treatment times for different diagnoses in the emergency department. This study represents a retrospective chart review, which involved collecting patient data, de-identifying the information, and analyzing the results. Depending on the nature and specifics of the project, the BCMJ may ask the principal investigator to seek confirmation from a local REB that the project was, in fact, quality improvement and, therefore, did not require REB oversight. If the research would have required REB approval, it cannot be granted retrospectively; therefore, the submission would not be accepted for publication.
How can researchers obtain ethics approval?
Research ethics boards have a standardized application process. UBC uses an online platform called Research Information Systems (RISe) to track applications, amendments, and annual renewals. Ethics boards generally allow for two levels of review depending on the type of study: delegated review (subcommittee review of studies deemed minimal risk) and full review (anything beyond minimal risk). The timeline for review and approval can vary due to committee schedules and the number of revisions required, but it may take anywhere from days to months. Researchers affiliated with UBC can get started at www.rise.ubc.ca/guidance-notes-and-tutorials.
Dr Dunne would like to thank Ms Jennie Prasad and Dr Marc Levine of the BC Women’s and Children’s Hospital Research Ethics Board for their editorial input on this article.
—Caitlin Dunne, MD, FRCSC
1. UBC Office of Research Ethics. UBC clinical research ethics general guidance notes. Accessed 22 March 2021. https://ethics.research.ubc.ca/ore/ubc-clinical-research-ethics-general-guidance-notes#A1.
5. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council. Tri-Council policy statement ethical conduct for research involving humans. 2018. Accessed 21 March 2021. https://ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf.
6. Panel on Research Ethics. TPS2: CORE – tutorial. Accessed 21 March 2021. http://tcps2core.ca/welcome.
Above is the information needed to cite this article in your paper or presentation. The International Committee
of Medical Journal Editors (ICMJE) recommends the following citation style, which is the now nearly universally
accepted citation style for scientific papers:
Halpern SD, Ubel PA, Caplan AL, Marion DW, Palmer AM, Schiding JK, et al. Solid-organ transplantation in HIV-infected patients. N Engl J Med. 2002;347:284-7.
About the ICMJE and citation styles
The ICMJE is small group of editors of general medical journals who first met informally in Vancouver, British Columbia, in 1978 to establish guidelines for the format of manuscripts submitted to their journals. The group became known as the Vancouver Group. Its requirements for manuscripts, including formats for bibliographic references developed by the U.S. National Library of Medicine (NLM), were first published in 1979. The Vancouver Group expanded and evolved into the International Committee of Medical Journal Editors (ICMJE), which meets annually. The ICMJE created the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals to help authors and editors create and distribute accurate, clear, easily accessible reports of biomedical studies.
An alternate version of ICMJE style is to additionally list the month an issue number, but since most journals use continuous pagination, the shorter form provides sufficient information to locate the reference. The NLM now lists all authors.
BCMJ standard citation style is a slight modification of the ICMJE/NLM style, as follows:
- Only the first three authors are listed, followed by "et al."
- There is no period after the journal name.
- Page numbers are not abbreviated.
For more information on the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, visit www.icmje.org