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Ethics Modules

Module 1

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Ethical Issues in Research I.

Social Sciences – you are an international student in Canada and you have secured a much-needed part-time job in a research lab. Your supervisor is doing a study on culture shock and announces he is having trouble finding enough participants. You and your co-workers, who are also international students, are asked to participate in the study and told that this is valuable research experience. You fear that refusing to participate in the study will cause you to lose your job or affect your chances for future employment.

II.

Humanities – you are a business owner in an isolated community. A historical research team comes to town and gets permission from the local officials to interview citizens about the town's history. You and a number of other members of the community agree to be interviewed. During the interview the questions turn from historical issues to current issues and local politics and you freely give your opinions. The local officials find out about this aspect of the study and ask the researchers to leave. They threaten legal action against the researchers if they don't release the transcripts of all the interviews. You and the other participants are pressured by local officials to directly request the release of your transcripts.

III.

Health sciences – you are serving a two year sentence in a Canadian prison. The warden announces that a research team will be doing weekly health assessments on volunteers for a study of air quality in the prison. It is implied that volunteering for the study will result in extra privileges. You volunteer and after the second week start experiencing headaches and diarrhea. You are given common remedies but the symptoms persist. You overhear the research assistants talking about your symptoms as known side-effects of a drug that has been added to your food each day. They say it is hoped that the drug will prevent skin cancer but all the side effects are not known.

*In Canada, we have the 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. This document, commonly known as TCPS 2, is supported by the three federal research agencies: The Canadian Institutes of Health Research (CIHR); the Natural Sciences and Engineering Research Council (NSERC); and the Social Sciences and Humanities Research Council (SSHRC).

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TCPS 2  The foundation of TCPS 2 is the value of respect for human dignity. This value is expressed through the three core principles listed below.

I.

II.

Respect for Persons Recognizes the intrinsic value of human beings and the respect and consideration that they are due. The essence of this principle is that it is unacceptable to treat individuals solely as means (mere objects or things) to an end (a research goal). The welfare and integrity of the participant must take priority over all else in human research. Includes individuals or groups directly involved in research as participants and individuals or groups involved in research through the use of their data or biological materials Concern for Welfare Recognizes that research participation can affect the welfare of an individual or group in many ways. Respecting the principle of Concern for Welfare means doing your best to ensure that participants are not exposed to unnecessary risks. Aspects of welfare that researchers and REBs need to consider include: o o o o o

physical, mental and spiritual health physical, economic and social circumstances privacy and the control of personal information the treatment of human biological materials according to the consent of the donor the possible effect of the research on the welfare of participants' friends, family, or other groups

** Ultimately it is the individual who decides whether the benefits justify the risks. To help people make an informed decision, they must be given accurate foreseeable risks and potential benefits. To ensure the participants fully understand this account it must be in the language and format (e.g. written, verbal, pictorial) most suitable to the participants.

III.

Justice -

Refers to the obligation to treat all people fairly and equitably. Fairness is treating all people with equal respect and concern for their welfare – it does not necessarily mean treating everyone the same.

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Equity involves the distribution of the benefits and burdens of research participation. No segment of the population should be unfairly burdened with the harms of research. Nor should any individuals or groups be neglected or discriminated against in the opportunity to benefit from knowledge generated by research.

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Ethical Research Designs I.

Social Sciences – A high school has asked you to do a study comparing the student evaluations of educational assistants (EAs) with the ratings they receive from their supervising teachers. One issue is that EAs have complained that student feedback is negatively affecting their performance evaluations. Another issue is that the rating tools in place may be outdated. You decide to work with the supervising teachers to develop new EA evaluation tools and collect ratings from students and teachers at the end of the current term. There are concerns, voiced by the EAs about the role of the teachers in the ratings development and how well the new instrument can fairly assess their job performance. They are concerned that their professional reputations may be unduly harmed. You meet with a representative group of EAs and teachers and discuss possible strategies to address their concerns.

II.

Humanities – you are making a documentary about life in a nomadic culture in another country. You are working with a team of local historians, anthropologists, and cultural geographers who have built a relationship with the community. You are all invested in creating a record of a way of life that is rapidly disappearing and respecting the traditions of the community. The elders have given permission for the documentary to take place but they will not sign consent or release forms and they will not allow any members of the community to do so. In this culture, asking for a signature after a verbal agreement has been made is considered disrespectful. Your translator is a member of the community and you discuss several strategies with him.

III.

Health sciences – You are planning to investigate the incidence and progression of a rare genetic disorder. In your study, people with the disorder, or who have reason to believe they may be at risk of developing the disorder, agree to provide DNA samples of themselves and both parents (with the parents' consent). The direct benefits to them are finding out whether they are at risk, and if they are, having an opportunity to participate in clinical trials of a new treatment. In order for someone to be at risk for the disorder both parents must have the recessive gene. You realize that there is a risk that the DNA analysis may also reveal concealed parentage. That is, if both parents of an individual have the recessive gene but the individual does not, or, if someone has the disorder and one of their parents does not have the gene, then one parent is not their biological parent. You must come up with a strategy for dealing with this possibility.

Summary -

History has shown us that without clear guidelines to help researchers identify potential risks of their design to participants, psychological and/or physical harm can occur.

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The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) is the minimum standard adopted by all Canadian research institutions to protect human research participants.

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There are many ways of designing research so that the risks to participants are minimized and the goal of the researcher is not compromised.

Practice Questions

Canadian researchers are responsible for making sure that their work adheres to the guidance provided in TCPS 2. This means that: (choose the best answer)

a. Pursuing research interests without also considering the implications of the research for participants is unethical.

b. Researchers must have respect for people in vulnerable circumstances and ensure that their research neither exploits nor unfairly excludes them.

c. Individuals and groups who are thinking about participating in research should know about TCPS 2 and be familiar with its guidelines for ethical research before agreeing to participate.

The Texas Vampires incident captures a number of practices that could easily be labeled unethical. For example, as a way to increase the sample size for the study, individuals were told that not participating in the research could put them in danger of sudden death. Which core principle was violated most by this behaviour?

a. Respect for Persons b. Concern for Welfare c. Justice

The purpose of the Stanford prison experiment was to understand the development of norms and the effects of roles, labels, and social expectations in a simulated prison environment. The simulation became so real, and the guards became so abusive, that half the prisoners were released early due to severe emotional or cognitive reactions. What ethical principle could be used to make the strongest case for shutting down the study after only 6 days rather than the planned two weeks?

a. Justice b. Concern for Welfare c. Respect for Persons

Module 2

Research - "an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation." (I.e. not QA or creative practice)

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Quality Assurance, Testing and Performance Review When an organization is interested in assessing or improving some aspect of its performance (e.g. job satisfaction, safety compliance), they may conduct quality assurance or improvement studies. Similarly, schools may test their students within normal educational requirements (e.g. to assess knowledge retention). These activities are usually not considered research as defined by TCPS 2 and do not require REB review.

**However, a quality assurance project may also be research (or become research) requiring REB review if: -

it is not within the mandate of the organization it is not a condition of employment or training the results are intended for research purposes the results are later used for a research purpose

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Creative Practice Writing a play and analyzing the process; interpreting the work of a sculptor; examining the art of filmmaking; these are all examples of creative practice. Creative practice activities may involve some research techniques but are not normally considered to be research as defined by TCPS 2. Different creative disciplines may have their own established ethical practices. When creative practice involves human participants (e.g., asking a concert audience to participate in a focus group with the musicians), then it will require REB review.

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What is Research Involving Humans? -

Arguably any research that studies some aspect of humans is research involving humans. However, according to TCPS 2 research involving humans is research that: o Involves living human participants

o

Involves human biological materials

**Human participants (more commonly referred to simply as 'participants') are individuals whose data, or responses to research interventions, stimuli or questions, are relevant to a research question.

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When -

is REB review required? An analysis of public opinion of same-sex marriage based on census data A study of the rate of decomposition of white blood cells in cadavers A study investigating the correlation between employee satisfaction and new workstations

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When is REB review NOT required? *a project that meets the TCPS 2 definition of research and involves human participants, their data, or their biological materials generally will require REB review. I.

Publically available information Usually research based entirely on existing, stored documentary material, publications, or records, is NOT considered to be research involving humans that requires REB review. To qualify for an exemption from REB review, it must be demonstrated that the information required for the project is legally accessible and protected by law; or publicly accessible and free of reasonable expectations of privacy

II.

Observation in public places Observational research is a way of studying human behaviour under natural circumstances (e.g. shoppers in a mall, hockey fans in an arena, passengers on a bus). If an observational research proposal meets the following criteria, it does not require REB review: o No staged intervention or no direct interaction with those being observed o Those observed have no reasonable expectation of privacy o

III.

No identification of specific individuals in the dissemination of results

Secondary use of data or biological materials Sometimes information is gathered for purposes other than research (e.g. patient or school records, biological samples, online opinion sites) and then may be discovered to have research value. Data files or samples from one study may be useful for other research purposes on their own or when combined with information from another study. This is called "secondary use of data". This type of research activity does not require REB review as long as the data or samples are anonymous and there is no way the data can be linked to the individuals who provided it.

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If the nature of the research requires follow-up contact with the original study participants or providers of the biological samples, or produces identifying information of any kind, then REB review will be required.

Summary   

As a general rule, all research involving humans, other than the specific exemptions listed in TCPS 2 requires REB review and approval. Not every activity involving inquiry and/or human participation is considered to be research involving humans that requires REB review Whenever you have any doubt about whether a particular research project should undergo research ethics review, seek the opinion of your REB.

Practice Questions

How does TCPS 2 define research?

a. To study (something) thoroughly so as to present it in a detailed, accurate manner b. An undertaking intended to establish facts, principles or generalizable knowledge c. An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation

Which of the following will likely require a submission for REB review?

a. An instructor decides to analyze data from an anonymous on-the-street opinion poll about environmental attitudes. The data was collected by her students for a class project in a course she has taught for the past three years.

b. An evaluation of a managerial certificate program with the goal of program improvement c. A study on the impact of discrimination and bullying on adolescent Métis attitudes and behaviours

Which of the following examples of research could likely proceed without REB review?

a. A study to determine which resources and facilities do the best job of meeting the physical needs of people living in retirement homes

b. A study relying on data from Statistics Canada to examine the economic status of Canadians who were dropped from welfare due to budget cut-backs in the 1990's

c. A study to assess the satisfaction of clients of a new community-based rehabilitation therapy program

Module 3 

The Proportionate Approach

 TCPS 2 characterizes the assessment of the foreseeable risks and potential  

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benefits of research participation as the proportionate approach to REB review. The REB considers the foreseeable risks to participants along with the potential benefits and ethical implications of the research. The goals of REB review are to: o Ensure that participants are not exposed to unnecessary or avoidable risks o See that the potential benefits outweigh the foreseeable risks o Help research proceed in accordance with the core principles of TCPS

Aspects of Risks in Research I.

II.

III.

PROBABILITY: How likely is it that any participant will suffer any harm as a result of the study? Are rates of harm reported in previous publications? Is there any other empirical evidence? Is this an emerging area of research with little or no information on rates of harm? If so, are there other ways of assessing probable harm? MAGNITUDE: How severe could the harm be? Would it be minor (e.g. inconvenience) or major (e.g. severe physical or psychological trauma)? Would the harm be temporary or longer lasting? Would the harm extend to others beyond the participants, such as their family, co-workers or community? MINIMAL RISK: If participants can be expected to judge that the probability and magnitude of possible harms stemming from their involvement in a study is no greater than those encountered by the participant in those aspects of their everyday life that relate to the research then the study may be of minimal risk.

*For those individuals or groups who live with relatively high risk on a daily basis, researchers and REBs have a responsibility to ensure that their circumstances are not used as a rationale to expose them to unnecessary risks and that including them as participants does not increase their vulnerability. IV.

ABOVE MINIMAL RISK: When the probability and/or the magnitude of risk to participants in a study is judged to be greater than they would encounter in

their everyday lives, the research is subject to a higher degree of scrutiny. More risk will require proportionately more provision for the protection of prospective participants. *Researchers and REBs need to agree that any unavoidable risks are justified by the potential benefits of the research. Ultimately, it is prospective participants, in the consent process, who decide if they can accept the risks of participating in the research.

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Types of Risk I.

Physical Harm Harms posed by the study procedures (e.g. over-exertion, exposure to allergens, injury due to use of dangerous equipment, sensory deprivation, side-effects due to experimental treatment, etc.). Harms to the participant posed by agreeing to be in the study (e.g. a survey in an unstable country asking probing questions about political problems could result in physical harassment or imprisonment).

REBs must be satisfied that all potential physical harms of a study have been identified and that measures are in place to minimize their occurrence and to offer follow-up care.

II.

Psychological Harm -

Activation of PTSD from answering questions that trigger memories of a traumatic event Depression due to perceived poor performance in an experiment or triggered by the subject material Feelings of betrayal and/or anger due to the discovery of an experimental deception

REBs must be satisfied that all potential psychological harms of a protocol have been identified and that measures are in place to minimize their occurrence and to offer follow-up care.

III.

Economic Harm -

Sometimes participation in a study may have economic consequences. For example, participation might put their job security or career progress at risk.

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This risk may be more prevalent in research involv...