Ch. 4 Research and Ethics
Ch. 4 Research and Ethics
Ch. 4 Research and Ethics
Prepared by:
Florencia Carlino, Ph.D.
Professor and Sault College REB’s Chair
This presentation aims to:
In health research, a placebo is a fake drug. It looks and tastes like the real drug that
researchers want to try. It usually has the form of a pill (known as the “sugar pill”), but
it does not contain any real medicine.
– The control group receives the placebo or sugar pill, while all other variables
(such as age, nutrition, etc.) remain under control.
– The researcher compares the results in both groups to find out if the
anticipated improvement was due to the drug intake or due to the fact that the
Bryce, E. (April 4, 2016).
The power of the placebo
effect. [Video File].
https://www.youtube.com/
watch?v=z03FQGlGgo0
Before 1990…
• Researchers, colleges, and universities didn’t
have the ethical concerns/discussions we have
today.
researchers explain the real purpose of the research and why they could
not disclose it up front;
Published in 1998 (the original Policy), which was updated in 2010 giving birth
to the second edition.
Even though it is like a “bible” that guide the decisions of the REBs, it is also a
living document that is updated periodically to ensure that its content remains
current and clearly communicated, based on the feedback of Canada’s research
community.
• At Sault College, our REB was created in 2011. It reports to the Applied
Research Office.
Respect Concern
for for
persons Welfare
Justice
Respect for Persons
• It respects the participants’ autonomy and their
ability to decide if they want to participate in the
study.
22
The informed consent must explain:
• The research goals.
• The professional qualifications and affiliation of
researchers.
• What participants are expected to do.
• Participants’ benefits and risks.
• The volunteer character of participation and the
participants’ right to withdraw at any time without
consequences.
• Who to contact if participants have any questions.
• How participants can access the research results.
• The fact that the study has ethical approval by the
corresponding REB (research ethic board).
Sample of a letter of invitation and
informed consent
This is a clear example of both the letter and the
consent.
https://onlineservices.concordia.ab.ca/documents/
common/reb/generic_letter_consent_form.pdf
Respect for Persons (cont’d)
Researchers need to provide measures to guarantee:
• The voluntary nature of the participation: make sure that participants participate
only if they wish to do so.
• Participants’ awareness of their potential risks & benefits of being involved in the
study.
• When the participation in the research may cause certain risks to participants,
access to supportive resources will have to be provided (e.g., counselling in the case25
Concern for Welfare
• The premise is that participants’ welfare is more
important than the goals of the researchers.
Risks Benefits 26
Concern for Welfare (Cont’d)
All research endeavors entail potential and real risks and
benefits for the participant population.
Risks Benefits 27
Concern for Welfare (Cont’d)
The risks is anything that has a negative effect on the
participants’ welfare. The nature of the harm can be social,
behavioural, psychological, physical, academic, or economic.
• Participant selection:
– Equitable distribution of research risks and benefits among participants.
– Equitable selection of participants within the population
• ACCC (2013). The college and institute applied research advantage: Innovation
for small businesses and communities, cited by Holmes, K. (2016), p. 23.