TCPS 2-CORE Review-with 100% verified solutions- 2024-2025.docx, Exams of Advanced Education

Download TCPS 2-CORE Review-with 100% verified solutions- 2024-2025.docx and more Exams Advanced Education in PDF only on Docsity! TCPS 2-CORE Review-with 100% verified solutions- 2024-2025 Research Ethics Board (REB) research oversight group that evaluates research to protect the rights of participants in the study Researcher's intention is to... -to NOT deliberately harm the people who agree to participate in a research project -The intent to do no harm, however, is not a guarantee that no harm will occur. The Stanford Prison Experiment -Philip Zimbardo's study of the effect of roles on behavior. -Participants were randomly assigned to play either prisoners or guards in a mock prison. -guards became sadistic and prisoners became depressed and showed signs of extreme stress. -The study was ended early because of the "guards'" role-induced cruelty. 1) A Quiet Sunday Morning... --police car swept through the town picking up college students as part of a mass arrest for violation of Penal Codes 211, Armed Robbery, and Burglary, a 459 PC. (fake arrests/charges) 2) Volunteers --What suspects had done was to answer a local newspaper ad calling for volunteers in a study of the psychological effects of prison life. --simulated prison and then carefully note the effects of this institution on the behavior of all those within its walls. --More than 70 applicants but were left with a sample of 24 college students from the U.S. and Canada who happened to be in the Stanford area and wanted to earn $15/day by participating in a study. --divided into two groups by a flip of the coin. Half were randomly assigned to be guards, the other to be prisoners. 3) A State of Mild Shock... --Blindfolded and in a state of mild shock over their surprise arrest by the city police, our prisoners were put into a car and driven to the "Stanford County Jail" for further processing. The prisoners were then brought into our jail one at a time and greeted by the warden, who conveyed the seriousness of their offense and their new status as prisoners. 4) Humiliation --Each prisoner was systematically searched and stripped naked. He was then deloused with a spray, to convey our belief that he may have germs or lice 5) Enforcing Law --The guards were given no specific training on how to be guards. Instead they were free, within limits, to do whatever they thought was necessary to maintain law and order in the prison and to command the respect of the prisoners. --Warden David Jaffe --began with nine guards and nine prisoners in our jail. Three guards worked each of three eight-hour shifts, while three prisoners occupied each of the three barren cells around the clock. The remaining guards and prisoners from our sample of 24 were on call in case they were needed. The cells were so small that there was room for only three cots on which the prisoners slept or sat, with room for little else. 6) Asserting Authority --At 2:30 A.M. the prisoners were rudely awakened from sleep by blasting whistles for the first of many "counts." The counts served the purpose of familiarizing the prisoners with their numbers (counts took place several times each shift and often at night). But more importantly, these events provided a regular occasion for the guards to exercise control over the prisoners. 7) Asserting Independence --Because the first day passed without incident, we were surprised and totally unprepared for the rebellion which broke out on the morning of the second day. --At first they insisted that reinforcements be called in. --but, got a fire extinguisher which shot a stream of skin-chilling carbon dioxide, and they forced the prisoners away from the doors. he came the next day to interview the prisoners with a standard set of legal questions, even though he, too, knew it was just an experiment. At this point it became clear that we had to end the study. We had created an overwhelmingly powerful situation -- a situation in which prisoners were withdrawing and behaving in pathological ways, and in which some of the guards were behaving sadistically. Even the "good" guards felt helpless to intervene, and none of the guards quit while the study was in progress. Indeed, it should be noted that no guard ever came late for his shift, called in sick, left early, or demanded extra pay for overtime work. Ethical Issues of 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. Ethical Issues of 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. Ethical Issues of 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. Participant Perspective 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? Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 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). -Respect for Persons -Concern for Welfare -Justice 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. 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 Individuals are generally presumed to have the ability to make voluntary and informed decisions: autonomy. Respect for persons means respecting every individual's ability to give or refuse their consent to participate. Their decision must be based on clear information about the foreseeable risks and potential benefits of the study and must not be coerced or influenced. In practical terms within the research design and REB review process, the principle of respect for persons translates into policies governing how consent by research participants is sought. Consider participant autonomy in research design -The decision to participate in research should be voluntary (free of undue influence or coercion), informed, and ongoing Consider factors that can diminish participant autonomy -not enough information about the experiment or an incomplete understanding of the risks and benefits fear of offending researchers in positions of authority worry that their decision will affect their level of care, privileges, or other quality of life issues - most relevant to institutionalized populations pressure from one's family, friends or community Consider how to respect the dignity of those lacking autonomy -Children, people with a cognitive impairment, or people with mental health issues may not be able to make decisions on their own behalf. They may also be more vulnerable to coercion or controlling forces. Normally, researchers must seek consent for members of these groups to participate in research from a guardian or parent or someone legally able to act on their behalf (an authorized third party). It is important to involve the participant in the consent process as much as possible, by providing explanations appropriate to their level of understanding, asking how they feel about participating, and seeking their agreement to participate (or assent) in addition to seeking the consent of an authorized third party. Concern for Welfare -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: 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 in their decision to either consent or refuse to participate in the research. To help people make an informed decision, the consent materials must give an accurate account of the 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. Consider potential impacts on participants' physical and mental health, on their social or economic circumstances, and on their privacy -Could participants come to any physical harm as a result of the study? Could any part of the study be distressing or uncomfortable for participants? Would participating in this study put a participant at risk: of losing their job? of being ostracized? Summary of Module 1: Core Principles 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. 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. There are many ways of designing research so that the risks to participants are minimized and the goal of the researcher is not compromised. Quality Assurance, Testing and Performance Review 1. 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. 2. However, a Quality Assurance project may also be research (or become research) requiring REB review if: a. it is not within the mandate of the organization b. it is not a condition of employment or training c. the results are intended for research purposes d. the results are later used for a research purpose Creative Practice ○ Writing a play and analyzing the process; interpreting the work of a sculptor; examining the art of film making; these are all examples of creative practice. ○ 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 involves human participants (e.g., asking a concert audience to participate in a focus group with the musicians), then it will require REB review. 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: § involves living human participants § involves human biological materials (In TCPS 2, human biological materials include tissues, organs, blood, plasma, serum, DNA, RNA, proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids as well as materials related to human reproduction such as embryos, fetuses, fetal tissues and stem cells. This applies to materials derived from living and deceased individuals.) 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. 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. ○ Some types of research may be exempt (Whenever you have any doubt about whether a research project should have a research ethics review, contact your REB for an opinion. Guessing about what is and what is not research requiring REB review is risky. Projects that proceed without REB review can run into problems (e.g. safety issues, participant complaints and possible refusal of publication in peer-reviewed journals). With REB approval you have the backing of your institution in any complaint procedure. If you have consulted with an REB and been assured that your project does not require ethics review this also gives you a basis for dealing with participant or publishing concerns.)from REB review. Ex. a) Publicly Available Information b) Observations in Public Places c) Secondary Use of Anonymous Data or Biological Materials Publicly 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 (Examples of circumstances under which exemption from REB review must be demonstrated. Because many journals now require proof of REB review as a condition of consideration for publication, researchers may need to request a letter of exemption from their REB. To issue this letter, the REB will need to see a rationale from the researcher demonstrating why their project should be considered exempt from REB review. Some institutions require researchers to apply for REB exemption for projects that may meet one of the exemptions from REB review specified by TCPS 2.) that the information required for the project is: a) legally accessible and protected by law; or b) publicly accessible and free of reasonable expectations of privacy -Be aware that there are situations where information is publicly accessible but the people involved nevertheless have some expectation of privacy (e.g. religious ceremonies, internet chat rooms). In these cases, REB review is required. Observations 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: ® No staged intervention or no direct interaction with those being observed ◊ In some observational research, the research question may require some manipulation of a situation to see how those being observed react. Sounding an alarm, making a false announcement over a loudspeaker, or placing a particular object in the observation area, are all examples of staged interventions. This type of observational research requires REB review. Similarly, if the research design requires a member of the research team to pose as a member of the observed group, or to have any kind of interaction with observed individuals, for the purpose of manipulating their behaviour, then REB review is required. ® Those observed have no reasonable expectation of privacy; and ◊ Observing the interaction between people in an online support group or at a large meeting may seem unobtrusive, but it may be a violation of expectations of privacy. If a website or a meeting notice indicates that only members of a particular group are welcome, then observational research with that group will require REB review. ® No identification of specific individuals in the dissemination of results ◊ If the results of the research do not pose any risk of identifying the individuals or groups observed, REB review is not required. However, if there is any possibility that those observed could be identified in the dissemination of results through publications, presentations, posted photos or videos, etc., REB review is required. Because observational research does not seek the consent of the individuals being observed, researchers and REBs must take special care that appropriate privacy and confidentiality measures are part of the research design (e.g. blurring faces in photos, altering frequencies of voice recordings, changing screen names, paraphrasing direct quotes) reasonable expectations of privacy Information available in the public domain through print or online publications (news media, blogs), recordings (video, audio), or artistic events (e.g. exhibitions, readings) may or may not contain personal information. As long as the individuals involved have no reasonable expectation of privacy then research using this information can proceed without REB review. 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. (To assess the level of risk involved in a study to a particular participant group, it is helpful to compare what is asked of them in the study to what may be asked of them in their everyday lives. For example, a questionnaire study that involves filling out a form is normally considered minimal risk as filling out forms is an experience most people encounter from time to time in their everyday lives. However, if the questionnaire includes questions of a sensitive nature or questions that may be disturbing (e.g. questions about suicide, domestic abuse, addictions, etc.) it may be considered above minimal risk. Similarly, a study that involves exposing healthy volunteers to an experimental drug poses a higher risk than the same study involving patients already taking a similar drug.) 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 ○ including them as participants does not increase their vulnerability. 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. Types of Risk Depending on the nature of the study (e.g. sociological, psychological, observational, biomedical), different types of risk may be assessed. Physical Harm Psychological Harm Economic Harm Social Harm Physical Harm There are many types of physical harm that can occur in a research study depending on the situation, including 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.). § 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. Psychological Harm Although sometimes less obvious than physical harms, the risk of psychological harms to participants should not be treated lightly. Some of the types of psychological harms that can occur are: § 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. Economic Harm Sometimes participation in a study may have economic consequences. For example, in a study interviewing employees of an organization, what the employee says, or their mere participation might put their job security or career progress at risk. 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. REBs will want to see that researchers have anticipated these risks as they may apply to their study, that measures to eliminate or minimize these risks are part of the study procedure, and that unavoidable risks are discussed with prospective participants in the consent process. Social Harm 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. REBs will want to see that researchers have anticipated these risks as they may apply to their study, that measures to eliminate or minimize these risks are part of the study procedure, and that unavoidable risks are discussed with prospective participants in the consent process. Types of Benefits People participate in studies for a variety of reasons. Sometimes it is for a perceived direct benefit to themselves. Sometimes it is in the hope that the outcome of the study will benefit others in their circumstances. When identifying potential benefits, researchers and REBs should be aware that most research yields no identifiable benefits for participants or their groups but may contribute to our existing body of knowledge. -Direct Benefit -Indirect Benefit -Advancement of Knowledge Direct Benefit 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. Indirect Benefit Beyond the actual participants, 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. additional consent Different jurisdictions may have different laws governing consent. Quebec, for example, has its own research ethics guidelines. Research involving schools will need to follow the consent guidelines of a schoolboard. Similarly, research in prisons, hospitals or other institutions will be subject to institutional policies regarding consent. Free (principles of consent) Individuals who participate in research should do so voluntarily, free of coercion or pressure to consent. If a prospective participant decides against participating or chooses to withdraw from the study, their decision must be respected. Under no circumstances may researchers conduct research with anyone who has refused to participate. Informed (principles of consent) 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. Ongoing (principles of consent) 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. The Consent Process -Consent is not a single act of someone agreeing to participate in a study. It is a process that begins with the recruitment and screening of participants and continues throughout their involvement in the research. The consent process must be complete and should not be rushed ○ Recruitment ○ Information ○ Documenting Consent ○ Debriefing (when required) Rushing a participant Rushing a participant through consent, or treating it as a perfunctory routine, violates the principle of Respect for Persons. The time required for consent will depend upon the magnitude and probability of harms, the setting where the information is given (e.g. hospital, laboratory, home) and the participant's situation (e.g. level of anxiety, degree of autonomy, physical and mental condition) Recruitment (The Consent Process) Prospective participants must not be recruited using materials that create a false impression of study conditions, or the foreseeable risks and/or potential benefits of participation. 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. Materials that appear to offer rewards that may constitute undue influence, or that misrepresent the conditions of the study in any way, are likely to be flagged by an REB for revision before ethics approval can be granted. Information (The Consent Process) Prior to signing a consent form, prospective participants must be given a detailed description of the study in lay language (Using lay language means writing or speaking in a way that the greatest number of people are likely to understand. Only 20% of adult Canadians read at a college level. Most newspapers are written at a grade 6 to 8 reading level. When people are ill or stressed their literacy level drops even lower. Where language barriers exist researchers are expected to use an intermediary such as a translator. It is important that information about the research is communicated so that participants truly understand the risks and benefits of being involved in the study.) including, but not limited to: § 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 Documenting Consent (The Consent Process) Researchers must document the consent process in some fashion: a signed consent form; a video-taped oral consent; implicit consent; (Consent may be demonstrated solely by the actions of a participant. For example, a questionnaire may indicate that by completing and returning it to the researcher, the participant is indicating their consent to have their data used in the study.) documentation of verbal consent in research field notes, etc. Whatever means of consent is appropriate to the situation, when the researcher engages in the consent process with a participant, the following elements must be included: § 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 Debriefing (when required) (The Consent Process) When a study protocol uses deception or partial disclosure, (Misleading or misinforming people of the nature, objectives or consequences of research must always be explained and justified. The use of deception or partial disclosure is unethical when: § it conceals information about the risks of a study that could affect a participant's decision to become involved § it is not necessary because another non-deceptive methodology could satisfy the research goal § it is not adequately explained or justified § it is not mitigated by an explicit debriefing procedure included in the study protocol) participants must be debriefed once their involvement in the study has ended. Depending upon the complexity of the study this may be done verbally or with the provision of a written explanation. A debriefing should include: § 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 Keeping Consent Free When someone consents to be a participant in a study it is important that they have done so entirely of their own free will. ○ Incentives ○ Authority/Power relationships ○ Undue Influence Incentives 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. foreseeable risks and potential benefits of their participation. Capacity to consent can change depending upon: ○ the complexity of the choice being made ○ the circumstances surrounding the decision ○ any change in the participant's condition If a participant regains capacity at any point in time after an authorized party has provided consent, the researcher must seek consent directly from the participant before they can continue in the study. Assent & Dissent Even when an individual's authorized third party gives consent, it is important to involve the individual to the greatest extent possible. As prospective participants they may agree (assent) or not agree (dissent) (Researchers should not count on the assent of prospective participants who lack capacity. For example, parents may consent to have their children participate in a questionnaire study at their school, but if any children choose not to participate, their decision must be respected.) with their authorized third party's decision to consent. Many of those who lack capacity are nevertheless able to express their wishes - for example: ○ children whose capacity is still developing ○ adults whose capacity is diminishing or fluctuating due to illness or injury ○ those whose capacity remains only partially developed (e.g. congenital conditions) When individuals know that their capacity is likely to diminish, they may make their wishes known in the form of a research directive (Research directives are written instructions from individuals that clearly indicate whether or not they wish to participate in research in the event that they lose the capacity to consent for themselves. For example, some people diagnosed with early stage dementia may wish to ensure that their authorized third party knows that they do, or do not, want to participate in research involving people with dementia. The directive may specify certain types of research they do or do not wish to be involved in, or it may specify the circumstances that should guide the authorized third party consent on their behalf. Research directives currently have no legal status but their use is in accordance with the TCPS 2 principle of Respect for Persons) Alterations to Consent According to TCPS 2, research may only begin if prospective participants, or authorized third parties, have given their consent to participate. There are, however, circumstances under which the requirement can be altered or waived. Observing Children in a Daycare Setting This would be considered naturalistic observation. The children themselves could not be approached for permission without jeopardizing the research. However, their parents or guardians and the daycare administration would have to give their consent to allow the researcher access to the observation site. The researcher would also need to address concerns about how the data will be used, and how the privacy of the children and their families will be protected at all stages of the research. Conducting an Online Survey About Voting Intentions Whether a survey is conducted in person, over the phone, by mail, or online, the same consent procedures apply. The researcher would have to provide information regarding the purpose of the research, as well as the proper contact information in case of questions or concerns. Online consent forms need to spell out the key points the participant must be aware of before offering a clickable choice to agree and begin the study, or to disagree and not do the study. Analyzing Trial Transcripts to Assess Truthfulness of Witnesses Normally, a trial transcript is a public record and as such can be used without the consent of the people to whom it refers. However, in some cases court proceedings may be sealed for a period of time and there may be restrictions on usage to protect the identity of minors and/or endangered persons. Acceptable Alterations of Consent The consent process may be altered (waived, delayed, presented in a different format) with REB approval if all of the following conditions apply: • research involves no more than minimal risk • waiver or alteration is unlikely to have a negative effect on participants' welfare • it would be impossible or impracticable to do the research without the waiver or alteration • whenever possible, participants will be provided with all information pertinent to their consent at the earliest possible opportunity, and will be given the option to withdraw their consent waived or altered consent does not involve a therapeutic, clinical, or diagnostic intervention Waiver of Consent Procedure ○ Observational Research ○ Critical Inquiry Observational Research When the goal of the study is to find out how people normally behave in a specific environment, it can be argued that approaching them for consent would compromise their normal behaviour. However, because those being observed would be participating in research without their knowledge or consent, a request to waive the consent procedure is not taken lightly. Researchers must satisfy REBs that: -the research question cannot be addressed by any other means involving a consent procedure -those being observed will not be exposed to any risks beyond what they would normally experience in their daily lives -those being observed do not have some expectation of privacy (e.g. a members- only support group, a funeral) there is no risk that those observed could be identified in the dissemination of results -observational research that guards against identification of participants, is not staged, and does not violate expectations of privacy may be exempt from REB review. Critical Inquiry Some research seeks knowledge that may critique or challenge an organization (e.g. a hospital, government, interest group or corporation). The consent of the organization (e.g. its governing body) is not required for this type of research. This allows research to be conducted on matters that might otherwise stay hidden, such as institutional sexual abuse, or a government policy of silencing dissident scientists. Critical inquiry research can yield important knowledge and insights on many social issues. REBs may need to adjust their risk-benefit analysis accordingly. (Some critical inquiry research - such as that which is legitimately critical of public, political or corporate institutions - may negatively affect the welfare of individuals in a position of power in those organizations but be of benefit to society. For example, a study investigating the anti-union policies of an international clothing manufacturer may reveal information that is damaging to the reputation of the company which in turn may affect its sales. However the exposure of unfair labour practices by this company may be of benefit to society in the making of better laws to protect other workers in this industry. REBs must weigh the potential benefits of new knowledge with the foreseeable risks to the employees of the company and the local community - but should not block research that is in the public interest on the grounds that it may damage the company. REBs and researchers should also consider the professional standards of the relevant discipline as well as the articles of TCPS 2 that apply.) REBs and researchers need to consider the possible effects of critical inquiry on participants and ensure participants know: § The organization's view of the research If researchers plan to approach members of an organization, they must fully disclose whether the organization is aware of the research, and whether it is viewed positively or negatively. Researchers must also disclose whether permission was sought from the organization and whether it was given or refused. b) When the agreement with participants has included some form of deception c) When the researcher is interested in learning more about participants' experiences in the study b In which of the following examples is the likelihood of obtaining free and informed consent in the most jeopardy? a) A teacher examining the impact of a new instructional strategy talks to his grade 9 students about analyzing their responses to their final assignment. b) A graduate student offers undergraduates $5.00/hour to participate in her study. c) The Chief Executive Officer of an advertising firm asks her employees to volunteer for a study she is funding on effective work habits in advertising. c Module 5: Privacy & Confidentiality's Objectives Upon completion of this module you will be able to: • describe what is meant by identifiable information • identify situations in which an REB may allow research without consent of individual participants generate strategies for safeguarding participants' privacy and confidentiality major advances example -When participants provide personal information in the context of a study this creates a trust relationship between participant and researcher. Researchers have a duty to treat personal information respectfully and confidentially. -In addition to accepted ethical principles TCPS 2, researchers must also be aware of the laws governing privacy and confidentiality in the jurisdiction where the research will be conducted (e.g. PHIPA (Personal Health Information Protection Act); PIPEDA (Personal Information Protection and Electronic Documents Act)) -The identification of the relationship between tobacco and lung cancer was made possible by giving researchers access to individual patient records and information about their tobacco usage. Individual patients were not identified unless they wanted to be. Some were featured in public service announcements to alert others to the dangers of using tobacco Privacy The state of being free from intrusion or interference by others. Individuals have privacy interests in relation to their bodies, personal information, expressed thoughts and opinions, personal communication with others, and the spaces they occupy. Confidentiality Researchers have an ethical obligation to keep anything participants reveal to them in confidence - that is, not sharing this information in such a way that would identify participants, and protecting it from unauthorized access, use, disclosure, modification, loss or theft. Fulfilling the ethical duty of confidentiality is essential to the trust relationship between researcher and participant, and to the integrity of the research project. Expectations of Privacy Participants may reasonably expect that any personal information given in a research study that could be used to identify them will: • not be linked to other information about them (e.g. health, employment, or educational records) without their consent • not be made available to anyone except those involved in collecting, analyzing, or monitoring the data for that research project • be stored securely until no longer needed and then be destroyed not be released to anyone outside the study, unless permission to do so has been explicitly granted Used to identify someone Information that may reasonably be expected to identify an individual, alone or in combination with other available information, is considered identifiable information. Examples include age, occupation, contact information, unique physical characteristics, and/or educational, medical or employment histories. unless permission to do so has been explicitly granted In some circumstances participants may choose to waive their right to privacy. For example, in a research project that involves a group of HIV patients putting on a play about their challenges, the participants may choose to be quoted in research publications, and in media releases, in order to be recognized for their contributions. Degrees of Identifiability Researchers and REBs need to consider whether the type of information being gathered and used in a study could be used to identify participants. TCPS 2 provides the following categories as a guide to help researchers and REBs assess the potential identifiability of participants in the context of a research proposal: • Directly identifying information • Indirectly identifying information • Coded information- once direct • Anonymized information • Anonymous information Directly identifying information identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number). Indirectly identifying information could reasonably be expected to identify individuals if combined with other indirect identifiers (e.g. date of birth, place of residence, or unique personal characteristic). Coded information- once direct identifiers are removed from the information and replaced with a code, only those with the key to the code can identify individual participants. The code is only retained if there is a foreseeable need to identify participants for follow-up contact or for any other reason. Anonymized information one step further than coded information in that once the data is stripped of direct identifiers, a code is not kept to allow future re-linkage. The risk of re-identification of individuals from remaining indirect identifiers must also be low or very low. Anonymous information