Section Overview

Before continuing, you should:

: : Read the Section Summary
: : Review the Section Objectives

Ethics Context

: : Origins
: : Development of Canadian Guidelines
: : Continuing Vigilance

The modern history of research ethics began in the aftermath of World War II. In 1947, the Nuremberg Military Tribunals condemned the experiments performed by Nazi researchers on prison camp inmates during World War II as "crimes against humanity." A section of the judges' verdict became known as the Nuremberg Code. The Nuremberg Code brought the issue of human experimentation to the forefront of public debate and influenced a series of international documents created to ensure that all countries respect adequate standards of human dignity. These documents include the Universal Declaration of Human Rights (1948), the Declaration of Helsinki (first adopted by the World Medical Association in 1964, and regularly amended), the International Covenant on Civil and Political Rights (1966), and the Belmont Report (1979).

Despite the Nuremberg Code and other human rights protections in place at the time, some research undertaken after World War II, such as the Tuskegee Syphilis Study and the Willowbrook Studies, raised ethical concerns. Controversial research put at risk the trust relationships between research subjects and researchers, research sponsors, institutions, their professional bodies, and society. As a consequence, research ethics guidelines, codes and regulations were further developed in many countries, including Canada.

In the 1970s, the Medical Research Council of Canada (MRC) (Canadian Institutes of Health Research [CIHR] as of 2000) and the Canada Council developed guidelines for research involving human subjects. In 1978, when the Social Sciences and Humanities Research Council was created, they adopted the Canada Council Guidelines. In 1987, the MRC revised its guidelines and, in 1990, produced Guidelines on Somatic Cell Gene Therapy. The Canadian guidelines were influenced by international codes of ethics, as well as professional association codes of ethics. Canada began the practice of formulating official research ethics policies as funding agency guidelines. Given that the Natural Sciences and Engineering Research Council (NSERC) did not have its own guidelines, research involving humans funded by NSERC was subject to either SSHRC or MRC guidelines (whichever was most appropriate). In 1998, MRC, SSHRC and NSERC jointly published the TCPS as a single Canadian standard to replace their previous guidelines. The agencies have committed to keeping it a living or "evolving" document in order to respond to new developments and identified gaps.

Unfortunately, ethical controversies in research involving humans have not ceased. Most unethical behaviour results from a lack of awareness of ethical concerns and/or various pressures on researchers, Research Ethics Boards (REBs), and institutions. The insights gained from historical and more recent ethical controversies demonstrate why vigilant ethics review is necessary and appropriate. Research ethics policy must continue to evolve to protect research subjects and maintain trust between researchers and society as a whole.

Protection of research subjects is a central concern for Canada. Key to an effective ethics review system are mechanisms for education and training for all people involved in research. Education in research ethics engenders public trust in institutions, researchers and the research process. Education also promotes a culture of research ethics.

	>> The Need for Research >> Academic Freedoms and Responsibilities

Case Study 1
Evacuation From an Office Building Fire

The ability to evacuate a large building in an emergency requires knowledge about appropriate building design, and also about effective procedures for rapid exit, including training of occupants. In order to obtain adequate information about evacuation of large buildings, it is important that researchers learn from actual experiences.

Researchers designed a project to learn from survivors of a catastrophic fire in a multi-story office building. In particular, the researchers wanted to know 1) how occupants perceived and interpreted the situation, and how they made decisions during the emergency, and 2) the extent to which building design and emergency procedures influenced how people responded. They also wanted to document the conditions, such as flame, smoke and behaviour of people in various locations in the building.

A questionnaire approach was used. The companies that had occupied offices in the building were asked to contact their employees who had escaped from the buildings, inviting them to respond directly to the research team.

The questionnaire dealt with issues such as awareness of escape procedures, leadership demonstrated by those designated to act in emergencies, abilities to find exits and use stairs, and the overall comportment of people in the emergency. The questionnaire was sent by mail to the individuals who had escaped from the building. Post-trauma counselling was offered to those who participated in the research.

Questions

Under what circumstances would the TCPS apply to this research? Which guiding ethical principles might apply to this research? How might the perspective of the subject be taken into account in the conduct of the research

: : Tri-Council Policy Statement : : Ethical Principles and Their Application

a. Under what circumstances would the TCPS apply to this research?

The researcher's privilege to conduct research involving human subjects is accompanied by a responsibility to apply contemporary research ethics standards. The TCPS provides the Canadian ethical standards for the conduct of research involving humans. All Canadian researchers or researchers conducting research in Canada should apply it.

Researchers must apply the TCPS if they are:

• members of research institutions administering funds awarded by any of the three federal granting agencies (CIHR, NSERC and SSHRC), or
• employees of any other agency that has adopted the TCPS.

b. Which guiding ethical principles might apply to this research?

Respect for human dignity, respect for free and informed consent, respect for privacy and confidentiality, respect for justice and inclusiveness, balancing harms and benefits, minimizing harm, and maximizing benefit are all applicable. Whether this research will involve vulnerable persons (i.e., individuals with diminished competence and/or decision-making capacity) is not clear. It is possible that some of the survivors of the fire might be unable to provide free and informed consent because of physical injuries or emotional trauma sustained in the fire. If vulnerable persons are among the potential research subjects, the ethical principles of respect for vulnerable persons and aspects of respect for justice and inclusiveness must also apply.

Potential research subjects might be involved in the design of the research procedure and questionnaire, perhaps through participation in a focus group. Such a focus group would itself constitute a research project, and would require ethics review.

The researchers should strive to anticipate and understand how a written questionnaire about such a traumatic event might affect research subjects. If this questionnaire has not been used in similar research and its potential impact on subjects is unknown, the researchers might conduct a pilot test of the questionnaire, in consultation with mental health workers, to learn about subjects' responses to it. Again, this would constitute a research project and would require ethics review.

Case Study 2
Language Choice of Chinese/English Speakers

In the last two decades, slightly over one million ethnic Chinese have settled in Canada. Most immigrants learn English and/or French in order to help them integrate into Canadian society. Even though there is a desire to integrate, the Chinese-Canadian community also wants to retain its culture and language.

Researchers examined the language choice and language switching patterns of a subgroup of the Chinese-Canadian community: Cantonese-speaking Chinese who arrived from Hong Kong in the 1980s. This research increases society's understanding of the relationship between language choice and language switching patterns as well as the wider social norms of the community to which the speakers belong.

Data were collected using participant observation of 60 speakers from 11 families. An audiotape was used to record 25 hours of spontaneous conversation in the families' homes. Data were analyzed in terms of the language choice patterns at the generational level, and language switching at the intergenerational level.

Families were recruited through the local Chinese community association. The study's principal investigator was an active member of a Chinese community association for a number of years prior to the commencement of the study. During this time, she developed extensive contacts within the local Chinese community. Such involvement within the community made the researcher acceptable as an observer of family communication and less likely to affect the data collected.

Questions

Under what circumstances would the TCPS apply to this research? Which guiding ethical principles might apply to this research? How might the perspective of the subject be taken into account in the conduct of the research?

: : Tri-Council Policy Statement : : Ethical Principles and Their Application

a. Under what circumstances would the TCPS apply to this research?

The researcher's privilege to conduct research involving human subjects is accompanied by a responsibility to apply contemporary research ethics standards. The TCPS provides the Canadian ethical standards for the conduct of research involving humans. All Canadian researchers or researchers conducting research in Canada should apply it.

Researchers must apply with the TCPS if they are:

• members of research institutions administering funds awarded by any of the three federal granting agencies (CIHR, NSERC and SSHRC), or

• employees of any other agency that has adopted the TCPS.
  

b. Which guiding ethical principles might apply to this research?

Respect for human dignity, respect for free and informed consent, respect for privacy and confidentiality, respect for justice and inclusiveness, balancing harms and benefits, minimizing harm, and maximizing benefit are all applicable. This research may also involve vulnerable persons, such as family members who are children or family members who are not able to consent for themselves. If vulnerable persons are among the potential research subjects, the ethical principles of respect for vulnerable persons and aspects of respect for justice and inclusiveness may also apply.

However, because these ethical principles are the product of Western culture, care should be taken in their application to research involving subjects from other cultures. For example, respecting the exercise of individual consent is inconsistent with the importance some cultures give to family or community decision-making. Similarly, rights to privacy and confidentiality may be less applicable. But, because the research subjects in this study lived in Hong Kong during the time the country was a British protectorate and have lived in Canada for a number of years, some subjects will probably have adopted Western ethical principles to some degree. Thus, the relevance of these ethical principles to a family or an individual may be difficult to predict.

Researchers should ask the perspective of each family and each individual concerning the application of ethical principles. Potential research subjects might be involved in the design of the research procedure and during data interpretation, and may review manuscripts prior to their dissemination.

The researchers should strive to anticipate and understand the families' reaction to being observed and audio taped, as well as the impact this might have on the individual research subjects and each family.

Case Study 3
Treatment of Hypertension: An Open-Label Phase II Clinical Trial

Approximately one quarter of all Canadians have been diagnosed with hypertension (high blood pressure), a major risk factor for heart disease and Canada's leading cause of death. Over time, high blood pressure may lead to heart problems, damage to the kidneys, and stroke. Two out of three people with high blood pressure have conditions that are not well controlled, and many people with high blood pressure receive two or more medications daily. Side effects from blood pressure medications are common.

Researchers designed a clinical trial to test an experimental drug that would enable people to take only one pill, which would control hypertension over a 24-hour period. Men and women 18 years of age and older were recruited for this study. To be eligible, participants needed to have:

• been initially diagnosed through a routine medical assessment with a systolic blood pressure of between 140 mmHg and 180 mmHg and a diastolic pressure of over 90 mmHg to 105 mmHg, and
• taken previous blood pressure medication for at least four weeks and experienced undesirable side effects from it and/or showed no improvement.

The study began with a two-week washout period (that is, time the patient spends off his or her usual medication). This was followed by two to four weeks of single blind treatment to determine the optimum dose, and then a 16-week open-label treatment period. (An open-label study is a drug clinical trial in which both the researchers and the patient know the identity of the test drug.) The total duration of the study could be as long as 22 weeks. Participants monitored their blood pressure at home, kept a daily diary of their blood pressure and any symptoms for 22 weeks, and underwent regular blood tests and further blood pressure checks at the clinic. The study was intended to determine if the new drug taken once daily would control high blood pressure for a 24-hour period without causing undesirable side effects, and, if so, to identify the optimum dose.

Possible risks of the new medication were:

• The patient could experience mild to moderate worsening of hypertension during the washout phase while off his or her usual medication, and mild to moderate dose-range side effects during the adjustment phase. Hypertension could also worsen during the treatment phase.
• These side effects occur occasionally (though they are temporary and gradually go away once the treatment is stopped): headache, fatigue, infection, nausea, diarrhea, chest pain, sore throat, thirst, increased urinary frequency, acid indigestion, dizziness and sleepiness. Mild to moderate laboratory abnormalities could occur, including decreased potassium levels.
• Blood drawing could cause mild discomfort, bruising, bleeding, swelling, and/or light-headedness.

Study subjects were asked to contact the blood pressure clinic if their systolic blood pressure was higher than 180 mmHg or if they experienced any of the side effects from the study medication.

a. Under what circumstances would the TCPS apply to this research?

The researcher's privilege to conduct research involving human subjects is accompanied by a responsibility to comply with contemporary research ethics standards. The TCPS provides the Canadian ethical standards for the conduct of research involving humans. All Canadian researchers or researchers conducting research in Canada should apply the TCPS. Researchers must apply the TCPS if they are:

• members of research institutions administering funds awarded by any of the three federal granting agencies (CIHR, NSERC and SSHRC), or
• employees of any other agency that has adopted the TCPS.

b. Which guiding ethical principles might apply to this research?

Respect for human dignity, respect for free and informed consent, respect for privacy and confidentiality, respect for justice and inclusiveness, balancing harms and benefits, minimizing harm, and maximizing benefit are all applicable. Due to a more-than-minimal risk of harm, vulnerable patients (i.e., individuals with diminished competence and/or decision-making capacity) would not be included, because the study can be conducted without their inclusion.

The researchers should strive to anticipate the subject's reaction to the need for daily monitoring involved in this study. The patients could find this schedule inconvenient or experience potential anxiety from the increased awareness of their condition. The researchers should consider the accessibility of the blood pressure clinic, as well as the education level of subjects who are asked to use the blood pressure monitoring equipment and to keep a daily diary.