Week 3 Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)

What is the participant perspective? - Answer- Circumstances of the people they will be approaching to become participants What are some questions to ask about the participants of the project? - Answer- Is there a power relationship between the researcher and the participants (e.g. doctor/patient, teacher/student, supervisor/assistant)? Are there any cultural norms or practices that need to be factored into the recruitment, consent, or debriefing process? What are the economic circumstances of the prospective participants? Could there be any social repercussions of participation in this project? How can the privacy and confidentiality of participants be protected? What are the 3 federal research agencies responsible for TCPS 2? - Answer- The Canadian Institutes of Health Research (CIHR); the Natural Sciences and Engineering Research Council (NSERC); and the Social Sciences and Humanities Research Council (SSHRC) What is the respect for persons principle? - Answer- 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. Respect for Persons includes: individuals or groups directly involved in research as participants individuals or groups involved in research through the use of their data or biological materials How to apply the principle of respect for persons? - Answer- Consider participant autonomy in research design Consider factors that can diminish participant autonomy Consider how to respect the dignity of those lacking autonomy What aspects of welfare should researchers consider? - Answer- 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 affect of the research on the welfare of participants' friends, family, or other groups How to apply the principle of concert for welfare? - Answer- Consider potential impacts on participants' physical and mental health, on their social or economic circumstances, and on their privacy Consult any groups that may be affected by the research to assess the risk of negative impacts such as stigmatization and discrimination Eliminate and/or minimize risks Maximize benefits Provide accurate and accessible information What is fairness? - Answer- treating all people with equal respect and concern for their welfare - it does not necessarily mean treating everyone the same What is equity? - Answer- 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 How to apply the principle of justice? - Answer- Who are the participants? Why this group and not others? Are any participant groups over- or under-represented because of their vulnerable circumstances? Are there measures in place to treat people in vulnerable circumstances justly in the context of the research? Is there an imbalance of power between participants and researchers? What has the Stanford Prison Experiment taught us? - Answer- 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. Canadian researchers are responsible for making sure that their work adheres to the guidnce provded in TCPS2, this means? - Answer- Pursuing research interests without also considering the implications of the research for participants is unethical. 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? - Answer- Respect for persons, The use of undue pressure in terms of rewards or scare tactics makes voluntary and informed consent improbable if not impossible. Consent without coercion is a cornerstone of the principle of Respect for Persons. 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? - Answer- In the researcher's words, "After observing our simulated prison for only six days, we could understand how prisons dehumanize people, turning them into objects and instilling in them feelings of hopelessness". In essence the simulated Stanford prison study had done this to its volunteers. Concern for Welfare was the primary reason for terminating the prison experiment. How can a quality assurance project be research? - Answer- 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 When does creative practice require REB review? - Answer- When it involves human participants What is research involving humans? - Answer- Involves living human participants, involve human biological materials When is REB review NOT required? - Answer- Publicly available information: legally accessible and protected by law or publicly accessible and free of reasonable expectations of privacy What is observational research? - Answer- Studying human behaviour under natural circumstances When will observational research not require REB review? - Answer- No staged intervention or no direct interaction with those being observed Those observed have no reasonable expectation of privacy and No identification of specific individuals in the dis What is the secondary use of data or biological materials? - Answer- 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 When will the secondary use of data not require REB review? - Answer- 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 How does TCPS 2 define research? - Answer- An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation Why would a study on the impact of discrimination and bullying on adolescent Metis attitudes and behaviours require a submission for REB review? - Answer- Doing research with Aboriginal populations demands attention to cultural norms in every aspect of the research (see TCPS 2 Chapter 9). For example, although TCPS 2 promotes a decision-making capacity-based approach to consent, it may be cultural norms that determine whether collecting data from adolescents under 18 will require the consent of a parent or guardian. The community may also conduct its own review of the research according to community-driven research policies. Talking with or surveying adolescents about sensitive issues such as discrimination or bullying also has the potential to trigger emotional discomfort. This researcher may need to provide participants with contact information for community support or counseling services in accordance with applicable cultural norms. What is the proportionate approach? - Answer- Assessment of the foreseeable risks and potential benefits of research participation as the proportionate approach to REB review What are the goals of REB review? - Answer- Ensure patients are not exposed to unnecessary or avoidable risks See that, on the whole, the potential benefits outweigh the foreseeable risks Help research proceed in accordance with the core principles of TCPS What do researchers consider in terms of probability? - Answer- 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? What do researchers consider in terms of magnitude? - Answer- How severe could the harm be? Would it be minor/major, temporary/long lasting? Would it extend to others beyond the participants (family, coworkers, community)? What is minimal risk? - Answer- No greater than those encountered by the participant in those aspects of their everyday life that relate to the research What should researchers do for individuals/groups who live with relatively high risk on a daily basis? - Answer- Ensure circumstances are not used as a rationale to expose them to unnecessary risks, include them as participants does not increase their vulnerability When is a study above minimal risk? - Answer- When probability and/or magnitude of risk to participants in a study is judged to be greater than they would encounter in their everyday lives. More risk = more provision for the protection of prospective participants What is physical harm? - Answer- - 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.). - 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). What is psychological harm? - Answer- - 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 What is economic harm? - Answer- This risk may be more prevalent in research involving critical inquiry, if participants are asked to provide information about an employer or business associate that may prove damaging. What is social harm? - Answer- Studies that have very specific selection criteria or topics that are sufficiently sensitive may have the potential to alter a person's standing in their community or social group. For example, people who agree to participate in a study about attitudes towards a particular illness may subsequently be avoided by those who mistakenly think they have that illness. Publication of a study that identifies a community (e.g. one that has a high rate of drug addiction) can stigmatize the entire community. What is a direct benefit? - Answer- Some studies can directly benefit participants at the time of their involvement. For example, a study of exercise and pregnancy directly benefits participants by providing exercise classes and health evaluations. The opportunity to assist in the advancement of knowledge or the possibility of benefiting others can also be a source of immediate satisfaction to participants. Incentives offered for participation (financial or otherwise) that may be perceived as benefits by participants, are not typically considered by REBs as benefits in the context of the risk/benefit assessment. What is an indirect benefit? - Answer- Research may benefit a group to which the participant belongs. For example a study exploring the views of fishermen whose livelihoods were destroyed by an engineering project that diverted their river, may or may not be of direct benefit to them but may help their community, and may help alert engineers to the need to consult with communities in the planning of such projects. What is an advancement of knowledge in research? - Answer- The basic desire for new knowledge and understanding is the driving force for research. Researchers can describe the potential addition of new information to their discipline as a valuable contribution to existing knowledge. In most research, the primary benefits produced are the advancement of knowledge for future generations that may positively affect the welfare of society as a whole. What is an example of a risk to a researcher? - Answer- Conducting research in a volatile region may put researchers at risk of physical injury, stress, or imprisonment. Doing door-to-door or on-the-street interviews without a partner can also expose researchers to risks (e.g. unexpected attack, theft, etc.). What is free consent? - Answer- Individuals who participate in research should do so voluntarily, free of coercion or pressure to consent What is informed consent? - Answer- The decision to participate must be based on an understanding of the purpose of the research, its foreseeable risks and potential benefits. Prospective participants must be given full disclosure of all information relevant to their decision, sufficient time to consider it, and the opportunity to ask questions or seek clarification about the study. What is ongoing consent? - Answer- Whenever any new information arises that affects participants in a study, researchers are obligated to inform them. If the new information may affect whether they wish to participate, the participants must be asked whether or not they wish to continue in the study. Once consent is given, it can also be withdrawn. What are the different steps of the consent process? - Answer- Recruitment, information, documenting consent, debriefing What happens during recruitment? - Answer- Recruitment materials (i.e. posters, emails, social media bulletins, advertisements) must provide accurate information. Some REBs require that recruitment materials clearly state whether the study has received REB approval. What happens when the patient is informed of the study? - Answer- general purpose of the study and clear description of what the participant is expected to do foreseeable risks and potential benefits alternatives to participation (e.g. other treatments, other activities) contact information of the researcher contact information of the relevant REB assurance that the participant can choose to end their involvement at any time What is involved in documenting consent? - Answer- a restatement of the purpose of the study and the provision of a clear description of study tasks and conditions sufficient prompts to encourage participants to ask questions a reminder of their right to refuse to do anything they find disturbing or uncomfortable an assurance of their right to leave the study at any time without penalty a statement indicating that by consenting, participants do not waive any legal rights the provision of contact information for the researcher and the REB that approved the study What happens during debriefing? - Answer- clear statement of the research question disclosure of any deception involved in the study and the rationale for its use explanation of how the participants' data will be used to seek an answer to the question opportunity for participants to ask questions and/or seek clarification contact information for the researcher and the REB that approved the study What is an incentive? - Answer- When large sums of money or other unusually attractive incentives are offered for participation in a study, this is regarded as undue inducement. People may become involved in a study because their need or desire for the incentive may lead them to recklessly disregard the risks of participation. People who are financially secure are less likely to feel pressure to participate based on offers of money or other items of value. Incentives tend to place pressure disproportionately on the financially disadvantaged. Undue inducement need not take the form of financial reward. For example, creating the perception that participation will improve a participant's social standing or result in their gaining favour is also considered unethical. What is an authority/power relationship? - Answer- When prospective participants are members of organizations with authoritarian structures (such as the military, police, or some religious groups), their consent may not be entirely voluntary. They may feel pressure from the organization to take part in the study. Or they may have the perception that they will benefit in some way within the organization if they agree to participate (e.g. perks, career advancem