The ins & outs of ethics

Guidelines try to ensure human and animal subjects aren’t being exploited for research purposes

Research involving humans, such as the infant cognition lab above, must be approved by the department’s Research Ethics Board to ensure the wellbeing of participants is accounted for.
Research involving humans, such as the infant cognition lab above, must be approved by the department’s Research Ethics Board to ensure the wellbeing of participants is accounted for.
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Any research project involving human subjects, whether funded or not, must receive ethics approval of either the General Research Ethics Board (GREB) or the Research Ethics Board (REB) prior to the start of the project. To determine if your project requires ethics approval, consult either the Tri-Council Policy Statement or the Ethics Office.
Any research project involving human subjects, whether funded or not, must receive ethics approval of either the General Research Ethics Board (GREB) or the Research Ethics Board (REB) prior to the start of the project. To determine if your project requires ethics approval, consult either the Tri-Council Policy Statement or the Ethics Office.

Before researchers begin their work it’s important they understand the ethical implications and how to ensure the ethical treatment of their subjects, said Laura-Lee Balkwill, ethics education and compliance advisor at the University’s Office of Research Services.

“The fundamentally important principle is respect for human dignity. … What that means in practical terms is making sure people participating in research are not simply used as a means to an end—that they’re not being exploited.

“It’s not just about physically protecting the participants: Will it cause psychological distress? Are the questions going to cause people to experience really distressing memories? Has the researcher thought of this and put access to counselling? … It’s not about assuming anyone’s out to do people harm, it’s simply the truth that you can’t anticipate everything. It helps to have an objective assessment of the risks to the participant.”

All research involving humans has to be approved by the department’s research ethics board before it can begin.

“We’re trying to take the stress and confusion out of research ethics,” she said.

The University’s piloting an on-site presence program which will monitor selected research projects after their initial approval.

“Our first-year goal is to review at least 10 per cent of all the studies that are happening at Queen’s and use human participants, between 70 to 100 studies.”

Balkwill said there are a number of reasons a research study might be visited, including random selection, a complaint or the researcher inviting the board for educational purposes.

“The more serious reason you would get a visit is that there has been a complaint,” she said. “The other reason is if you have a high-risk study and the board wants to approve it, you’d want to go in and look and make sure they aren’t out of line with what was expected and what’s in line with other studies.”

Although Balkwill said it’s rare to shut down a research project, she said there’s a procedure to follow if a project’s research practices are unethical.

“If we get a complaint from a participant then it is investigated [immediately]—we send someone to talk to the researcher, we look through their paperwork and their data and investigate the substance of the allegation.

“Then it’s up to ... the board to decide what action is necessary,” she said. “It may be just to remove the participant’s data and apologize to them if there is some violation of their ethics. If something really serious is going on then the board has the ability to suspend the research until it’s become ethically compliant again.” Balkwill’s developing an online education tutorial for researchers at Queen’s to better understand research ethics. She said the tutorial’s meant to help clarify the ethics of research.

“People in general don’t have a really terrific understanding of the research process,” she said. “They tend to get a bit anxious about it. The whole purpose of the tutorial is to alleviate that anxiety, walk people through the regulations and show them how it applies to their research.”

The tutorial, called the Course on Human Research Participation and Protection, is directed at Queen’s graduate students. Balkwill said it should be available for pilot testing in a couple of months.

Queen’s researchers adhere to the Tri-Council Policy Statement, the national guideline for research involving humans. It includes rules governing consent, confidentiality, conflict of interest, Aboriginal and genetic research.

Balkwill said although there’s an online tutorial hosted by the Interagency Panel on Research Ethics that gives a very detailed tour of the Tri-Council Policy Statement, the Queen’s tutorial provides a link between these principles and their real-life application.

“Our goal was not just to have students read a long list of regulations but to have them really understand how these ethics apply to everyday research situations,” she said.

Gabrielle Salmers, ArtSci ’09, is a biology major. She was in first year, she took PSYC 100 in first year and took part in different psychology studies to get an extra five per cent added to her final grade.

Salmers said she knew what she was getting into when she signed up, adding that the process of every study was explained to her.

“From what I can remember … they gave you information and a debriefing afterwards; you’re always told that you didn’t have to finish it if you didn’t want to,” she said.

Salmers said she participated mainly in survey-based studies and she signed up to do more than the number required for her extra five per cent.

“I thought it sounded like a pretty good idea, [to] help out the department,” she said. “I signed up for it last year also and I did it for money last year a little bit … I didn’t feel pressured to do it at all, it was pretty voluntary so I don’t really see a downside.”

University veterinarian Dr. Bonnie Beresford said most people don’t realize how thorough the ethical guidelines governing animal research are.

“[The regulations have] actually gone from almost nothing 35 years ago to … thousands of pages today. And they continue to change,” she said. “There are ethical guidelines that apply to almost every aspect of research.”

Although there are numerous projects underway using animals as part of their research, Beresford said most of the research involving animals going on at Queen’s isn’t strictly animal testing.

“Testing usually implies you’re administering something like a drug and then looking to see what happens,” she said. “Testing, specifically, is not something we do here. What we do, really, is research. Testing is part of research, but not all research activities require testing.”

An example of animal research not involving testing is to train a rat to go through a maze and compare its physiological responses to an untrained rat going through the same maze.

Beresford, who’s also the director of animal care at Queen’s, said many people misunderstand the purpose of animal experimentation and research. In cases such as behavioral tests, she said the animal isn’t harmed.

“Very often people study animals because they’re interested in what is happening to the animals,” she said. “Animals can be used for models in animal disease [research] so we can provide better veterinary care.”

Often when animals are used for testing purposes it’s in situations where it would be unethical to use humans, Beresford said, adding that the potential for unforeseen side-effects is one such situation.

“If you’re looking at something like drugs … it would be tested on animals first,” she said. “The best way to test drugs that are meant for humans is on humans … but it’s not ethical to do that.

“Because mammals share so many simple physiological processes, rodents are considered a reasonable initial model to discover what might happen in humans.”

Every step of a research project involving animals is regulated and monitored by several different levels, Beresford said. She oversees the monitoring at Queen’s and outside bodies such as the Canadian Council of Animal Care oversee the University’s animal research.

“There is … a very stringent procedure for the scientists to get approval to do anything to those animals,” she said.

Beresford said once a research project has been approved it falls under the post-approval monitoring system, which ensures nothing unexpected is done to the animals and that the animals’ welfare is looked after at all steps before, during and after the research project.

“They have to be basically nursed the way humans would be.”

—With files from Angela Hickman

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