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

What is 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

What is physical harm?

- 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 free consent?

Individuals who participate in research should do so voluntarily, free of coercion or pressure to consent

What is directly identifying information?

identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number).

When can observational research's consent be waived?

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.

What is harmed when there is a breach of confidentiality?

the trust relationship between the researcher and the research participants other individuals/groups affiliated with participants the credibility of the research institution the reputation of the research community

What is a full board review?

A full-board review begins with the assignment of the proposal to a small number of REB members for review (typically two but this may vary according to institutional policy). The reviewers present their assessment and recommendations to the entire board at an REB meeting.

What is the REB mandate?

Research Ethics Boards (REBs) are mandated by their institution to assess whether the research proposals they review are ethically acceptable according to TCPS 2.

What would observing children in a daycare setting be considered to be?

Naturalistic observation

How does TCPS 2 define research?

An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation

When is the waiver of parental/guardian consent not required?

Emancipated minors, children using counseling services without parental consent/knowledge etc

What happens during the end of study report?

End of study reports are necessary to allow REBs to close the file on completed research and maintain accurate records of research they have approved. These reports should include a summary of the findings of the research if possible, and indicate how participants may gain access to the results of the study.

What should researchers do for individuals/groups who live with relatively high risk on a daily basis?

Ensure circumstances are not used as a rationale to expose them to unnecessary risks, include them as participants does not increase their vulnerability

What is an indirect benefit?

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 minimal risk?

No greater than those encountered by the participant in those aspects of their everyday life that relate to the research

When will observational research not require REB review?

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 can researchers collect during data collection and analysis?

One effective strategy to maintain the confidentiality of data during its collection and analysis is assigning a code to the information obtained from each participant. Once it was common practice to use participants' initials but in small communities, or in cases where an individual has unusual initials, this is not a sufficient safeguard. A better standard practice is to assign an alphanumeric code to each participant's data (e.g. A01, A02 ... Z99). The key to the code must be kept in a secure place (e.g. a locked cabinet or a password-protected file) away from the data set. The researcher in charge of the project is ultimately responsible for controlling access to the data coding key.

How do you manage COI?

One way of managing COI is to disclose it. For example, institutions should disclose an institutional COI to the REB if it may affect an area of research or a specific research project. REB members are required to disclose any COI that may interfere or be seen to interfere with their objectivity as reviewers. Researchers may be required to disclose financial COI to participants in their consent process. The disclosure of COI serves the core principles of TCPS 2 by making the process of dealing with conflicts transparent and open to scrutiny.

What is 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.

What does the REB look for during the consent procedure?

The research purpose and proposed use of data collected Foreseeable risks and potential benefits Extent of confidentiality promised Requirements of the study (e.g. duration, frequency, nature of tasks and/or measures) Withdrawal procedure Extent of incentives Data management (access and safeguards) Plans for provision of new information Plans for dissemination of results

What is 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.

What is ongoing 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.

How to apply the principle of justice?

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?

How will your participants learn of the study results?

Will participants be sent a copy of the published study, a link to a website detailing the results, an invitation to a presentation of the results, or any other opportunity to see a summary of the results of the study they were involved in - regardless of whether the study is considered successful or whether it is published?

What will be disseminated?

Will the data only be published in aggregate form? If you expect to present or publish photos, or video or audio recordings of your participants, do you intend to eliminate or minimize identifying characteristics (and how)? If your participants are a unique population with unusual characteristics, what can be done to protect their privacy?

Is consent required when conducting an online survey about voting intentions?

Yes, 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.

What is the appeal process like?

You can launch an appeal for procedural or substantive reasons. As in the reconsideration process, it is up to you to justify your request for an appeal by identifying any problems with the REB review process or any elements of the REB decision that are inconsistent with TCPS 2. You and a representative of the REB must have an opportunity to speak before the appeal committee. Neither of you may be in the room during the appeal committee's discussion and decision- making. The decision of the appeal committee must be communicated in writing to the researcher(s) and REB. At all times, the people involved in the appeal process are expected to treat each other with respect and work towards a resolution whenever possible.

What should you do if your research involves people in vulnerable circumstances?

You must demonstrate what measures will be taken to eliminate, reduce, or manage the vulnerable circumstances

What is the appeal mechanism?

a permanent appeal committee that is activated as needed an ad hoc appeal committee that is formed as needed and exists only for the duration of an appeal an agreement to bring appeals to the REB of another institution an appeal committee that is shared with one or more institutions

What is the authority of the appeal committee?

a permanent appeal committee that is activated as needed an ad hoc appeal committee that is formed as needed and exists only for the duration of an appeal an agreement to bring appeals to the REB of another institution an appeal committee that is shared with one or more institutions

What is involved in documenting consent?

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

In what situation can the consent process be altered?

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

How do you keep consent informed?

specific invitation to participate in a study statement of the research purpose, the identity of the researcher, the expected duration and nature of participation, and a description of the procedures and responsibilities on the participant description of foreseeable risks and potential benefits assurance of the participant's right to refuse consent or to withdraw at any time after providing consent disclosure of any apparent or actual or potential conflict of interest on the part of researchers, their institutions or sponsors.

How do u assess the capacity to consent?

the complexity of the choice being made the circumstances surrounding the decision any change in the participant's condition

What is equity?

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 do you minimize COI?

An institution that receives an offer of funding from a company that is also sponsoring individual research projects can ensure that the agreement includes language that allows the institution to support their researchers in the event of any conflict with the sponsor, without affecting the funding agreement. If a researcher discovers that one of his research assistants does have a power relationship with potential participants, he can assign that RA to data entry or data analysis rather than recruitment and testing.

What happens when there is research required in publicly declared emergencies?

An official declaration gives special responsibilities and powers to authorities to help them deal with the emergency (e.g. the regulation or prohibition of travel, the establishment of emergency shelters, orders of evacuation or quarantine). The exercise of these powers is limited in time and extent by law at the municipal, provincial, territorial and federal level. It has been widely recognized in the wake of recent crises that institutions need to plan for the review and conduct of research in the context of a publicly declared emergency. REBs are expected to uphold the core principles of TCPS 2 with the support of their institution. Researchers are expected to maintain the highest ethical standards in any research that must be reviewed and conducted during a publicly declared emergency.

What happens during the annual status report?

Annual status reports may receive full-board or delegated review depending upon the level of continuing review required by the REB at the time of initial review (or as adjusted since). Annual reports should have enough information to allow REB reviewers to determine whether the research may continue. You may use your annual report to propose minor changes to the research design or study materials (e.g. adding a question item, changing contact information, adding a new member of the research team). For more significant changes, follow your REB's request for change procedure.

When will the secondary use of data 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

What are two ways of assessing whether real or perceived conflicts of interest exist?

Ask yourself whether an outside observer, aware of your personal or private interests, would question your ability to make objective decisions about the research. If allegations of a conflict of interest were made public, ask yourself if people would be convinced by the facts of the matter that the ethical conduct of the study was not threatened, or, if suspicion of conflict of interest would linger.

What is the proportionate approach?

Assessment of the foreseeable risks and potential benefits of research participation as the proportionate approach to REB review

What is the participant perspective?

Circumstances of the people they will be approaching to become participants

What is an example of a risk to a researcher?

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.).

How to apply the principle of respect for persons?

Consider participant autonomy in research design Consider factors that can diminish participant autonomy Consider how to respect the dignity of those lacking autonomy

How to apply the principle of concert for welfare?

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

How should data be shared?

Data can be presented in aggregate form (percentages, means, etc.) that does not infringe on participants' privacy or confidentiality. Descriptions of participants in papers or presentations that give too many identifying details (e.g. location, ethnicity, rare blood type, etc.) may expose participants to unwanted public attention. Unless participants have specifically consented to being identified, researchers must avoid exposing them to the risk of identification in any dissemination of research results.

What is the secondary use of data or biological materials?

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

How do you promote the equitable distribution of the potential benefits of their research?

Disseminate the results of the research in presentations and publications Provide copies of publications or other reports resulting from the research to their institution, professional association or other recognized body to further the dissemination of new knowledge Provide information about the results of the research to participating individuals, groups, and communities in a language and format that is respectful of their needs

What is the Dorothy Proctor case?

In 2001, Dorothy Proctor, a former inmate of the Kingston Prison for Women who said she was coerced into psychotropic drug experimentation during her incarceration, sued the Canadian government for negligence - and won. The federal documents unearthed by Proctor's case also revealed that a wide variety of research on prisoners was common during the 1950s and 60s in many prisons across Canada. Some research was focused on behavioural control and some was in aid of medical or pharmaceutical ventures. At this time there were no standard procedures for obtaining informed consent from prisoners and these practices differed from prison to prison

Why would a study on the impact of discrimination and bullying on adolescent Metis attitudes and behaviours require a submission for REB review?

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 MKULTRA study?

During the 1950s and early '60s, hundreds of people were given experimental treatment with electro-convulsive therapy (ECT) and LSD without informed consent under the supervision of Dr. Ewen Cameron, a professor at McGill University and head of the Allan Memorial Institute in Montreal. Many of the patients had come to the institute to be treated for depression (which was poorly understood then). Cameron was convinced that all forms of mental illness could be cured by wiping the mind clean of undesired thoughts and behaviours and inserting healthy thoughts. Patients were given ECT frequently and kept in a drug-induced coma while messages were played to them via tape recorders hidden in their beds. Cameron called this "Psychic Driving". The CIA (Central Intelligence Agency, U.S.) and the Canadian government funded Cameron's work for its possible military applications. The program was later found to have been ineffective and many of the patients experienced long-term memory loss.

What are the goals of REB review?

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 is a scholarly review?

For some types of research, such as clinical trials, there is a regulatory requirement that the REB evaluate the scientific aspects of the proposal. If it is evident that a proposal before the REB is in need of scholarly review, TCPS 2 advocates: the establishment of an ad hoc independent peer review committee or having members of the REB with the necessary expertise assume responsibility for the scholarly review

What is the Tuskegee Syphilis Study?

From 1932 to 1973, physicians sought to trace the natural history of syphilis by observing 400 African-American men with syphilis in Tuskegee, Alabama. The subjects, poor share-croppers, were enticed into the study with offers of free medical examinations and special free treatments. These special treatments were actually diagnostic procedures such as lumbar punctures. The false belief that treatment was being administered prevented subjects from otherwise seeking medical treatment for their disease. Even after penicillin was discovered to be an effective treatment for syphilis in the 1940s, this information was withheld from the subjects until the study was exposed in the media.

What has the Stanford Prison Experiment taught us?

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.

What do researchers consider in terms of 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?

What do researchers consider in terms of magnitude?

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 does the REB look for in study materials?

If there are any questionnaire items, interview topics, graphic, video or audio material or other stimuli that may be upsetting to participants, reviewers will want to see your rationale for including them and what measures you plan to take to offset the risk of causing your participants any emotional or psychological distress. As with your recruitment and consent processes, REB reviewers will want to see that any instructions provided to participants are clear, and respectful of their culture, language and literacy and that sufficient time is allotted for questions and consideration.

When is it okay to exclude certain individuals or groups in your recruitment process?

If they are unlikely to provide information of relevance to the research question or they are unlikely to benefit from the results

Are there participant identification issues?

If your participants want to be identified or if it is not possible to avoid some level of identification, have you made this clear in the consent procedure? If one or more participants wish to be identified for their contribution to the research, will this jeopardize the wish of other participants to remain anonymous?

How will your dissemination plan affect the community?

If your research is conducted with a community that could receive unwanted attention as a result of the dissemination of your study, is there anything you can do to shield the identity of the community? Have you included a plan to consult with the community in your research proposal?

What is the Yanonami?

In 1966, anthropologist Napoleon Chagnon was interested in observing one of the last pre-industrial cultures of Brazil and Venezuela, the Yanomami tribe. He lived among the tribe and bartered weapons (axes and machetes) for information about their norms and history. The appeal of the weapons was strong enough to persuade the Yanomami to break their strongest taboo, the sharing of their ancestors' genealogical information. Though the ethnography Chagnon published about the Yanomami, "The Fierce People" was a popular text for anthropology students, it also attracted criticism. In this book, the Yanomami are described as chronically violent, infanticidal, and abusive to women. Critics have charged that this is not a true depiction of the tribe, that some observed events were staged to please the researchers, that Chagnon's presence led to increased violent conflict, and that the book has been used by politicians and private interests to re-settle the Yanomami on reservations so that traditional lands could be opened to gold mining operations. Chagnon has stood by his work, charging that his critics are biased in favour of a romantic ideal of "the noble savage

What does the REB look at when a researcher is deciding on inclusion and exclusion criteria?

In accordance with the Principle of Justice, the inclusion and exclusion criteria must be relevant to the research question. REBs will want to see justification for any exclusion of participants based on characteristics like gender, language, culture, ethnicity, age or disability. If your research depends on the inclusion of people in vulnerable circumstances (e.g. as a function of illness, mental disability or immaturity, poverty, etc.), you will need to show that you have carefully considered the relationship between their circumstances and your research question. Individuals should not automatically be excluded due to assumptions made about their vulnerability.

What does the REB look at in terms of withdrawal?

In some studies, particularly those involving deception, REBs may require researchers to give participants the option of removing their data from the study if they decide to withdraw. Whether withdrawal of data is possible will depend upon how data are entered and identified. Whether withdrawal of data as an option is warranted depends upon the nature and type of information collected, and the extent of deception (if relevant).

When is deception and debriefing used?

In some studies, the quality of the data depends on the participants being unaware of the true research goal. A consent procedure that is not fully informed may be allowed as long as the tasks that the participants will be asked to perform are clearly described, and the deception is revealed and explained to participants at the earliest opportunity. See the example below:

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?

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.

What is institutional COI?

Institutions, such as universities, colleges, and hospitals, have a number of interests (e.g. financial, reputational, educational and ethical) that may come into conflict with one another. Just the appearance of a conflict of interest can affect an institution's reputation among the research community and the general public. In developing an institutional COI policy, openly and transparently with input from its research community

What is research COI?

Interpersonal relationships, expected to identify, minimize or otherwise manage their individual conflicts in a manner that is satisfactory to the REB. Dual roles as both research and therapist, caregiver, a teacher etc., researchers need to clearly identify potential conflicts of interest between their roles and plan in advance how to manage COI when it happens Financial: A real or perceived financial conflict of interest can destroy trust in researchers and in all of their previous work. Unfortunately, it has been established that financial incentives can distort researchers' judgement in regard to the ethical design and conduct of research. It is the responsibility of researchers to disclose and document all kinds and amounts of financial incentives (sponsorship, salary, fee per participant, equipment, other resources, gifts, etc.) in their application for REB approval. In addition to identifying all financial COI, researchers must demonstrate in their proposal how they intend to minimize or manage these conflicts.

What is research involving humans?

Involves living human participants, involve human biological materials

What are some questions to ask about the participants of the project?

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 does the REB look at for data management?

Method of data collection (e.g. paper, computer, online, recordings, physiological measures, photographs, etc.) Format of data for analysis and storage (e.g. with or without identifying information intact, coded, anonymized, etc.) Duration and method of data storage (e.g. hard-copy, digital files, location and access) Method of protecting stored data (e.g. door locks, computer passwords, encrypted files, limited access) Provisions for data sharing (e.g. secure physical transport, encrypted digital transfer, data shared only in aggregate form)

What must be included in critical inquiry research?

Participants must know: The organization's view of the research The potential risks of participation Their privacy will be safeguarded to the fullest extent

When is REB review NOT required?

Publicly available information: legally accessible and protected by law or publicly accessible and free of reasonable expectations of privacy

Canadian researchers are responsible for making sure that their work adheres to the guidnce provded in TCPS2, this means?

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

What is a proportionate approach?

REB as a whole, and each REB member, is required to consider the foreseeable risks, ethical implications and potential benefits of each research proposal in their evaluation of its ethical acceptability.

What does the REB look at involved in the recruitment procedure?

REB members will also look at your method of recruitment. For example, If you will be using social media to recruit, you will need to include a copy of any text or images you intend to post. It is up to researchers to be aware of any privacy legislation that applies to their research, as well as any copyright and/or intellectual property rights protections or restrictions, to obtain appropriate permission to post material, and to ensure all recruitment materials are complete and accurate.

What happens during recruitment?

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 are the different steps of the consent process?

Recruitment, information, documenting consent, debriefing

What is undue influence?

Relationships of trust and dependency, such as doctor/patient or professor/student, can create issues in the consent process. The perception (if not the reality) that one's treatment, evaluation, or career advancement may be affected by consent or refusal to participate in a study can seriously compromise the element of voluntariness. This is a particular risk for studies involving residents in long-term care facilities or psychiatric institutions. Researchers should be alert to whether someone feels pressured or coerced in some way by a caregiver or other associate to participate in a study. Manipulation by friends or family members can also be a more subtle form of undue influence on participants.

When can requests for change be submitted?

Requests for Change can be submitted at any point during the conduct of your research. Depending on the level of continuing review assigned at the time of initial review (or since), the request for change may receive full-board or delegated review. Researchers are expected to provide an account of how the requested change may affect foreseeable risks and potential benefits and include copies of study materials that will need to reflect the requested change (e.g. recruitment, consent, and/or debriefing materials, instructions, etc.).

How do you eliminate COI?

Researchers may be able to eliminate COI by adjusting the research design. Institutions can eliminate the potential for COI by ensuring that people responsible for promoting research are not also involved in research ethics oversight. REBs can eliminate COI by assessing the potential COI of prospective REB members, and screening out those who would be prohibited from reviewing much of the time due to their real, perceived or potential COIs.

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?

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.

What is a 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.

What happens when unanticipated issues arise?

Some unanticipated issues may not be directly related to the research itself, but they must still be reported so that the REB can independently make that assessment. Depending on the nature of the issue REBs may require that you adjust your research procedures to prevent its recurrence.

What is 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.

What is observational research?

Studying human behaviour under natural circumstances

What are the 3 federal research agencies responsible for TCPS 2?

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 does the REB look at during assessment of risks and benefits?

The REB will want to see a thorough and realistic account of the foreseeable risks and potential benefits to participants in your study. Some studies offer incentives or compensation for participation but these do not count as benefits. In fact, as you may recall from Module 3: Assessing Risk & Benefit, if the incentives offered for participation are too great, they may be flagged as a source of undue influence that could lead some participants to recklessly disregard risks they would not normally take.

What does the REB look at for protection of privacy and confidentiality?

The REB will want to see that the promises of confidentiality with respect to safeguarding participant privacy are appropriate given the study recruitment and consent procedures, the conduct of the study, and the plans for dissemination of results. As you may recall from Module 4: Consent, there are instances in which some participants prefer to be recognized for their contributions to the research. If this is the case in your research, you will need to document explicit consent for participant identification.

What is an advancement of knowledge in research?

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 informed 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.

What is the goal of the REB?

The goal of an REB is to represent the interests of participants by assessing the foreseeable risks, ethical implications, and potential benefits of each proposal they review. Researchers can consult with REB staff at the design phase of their project, while they are preparing their application for REB review, and during the review process.

What is REB member COI?

The institution and the public rely upon REBs to review research proposals for their consistency with TCPS 2 core principles, without being influenced by personal or professional interests. To maintain this trust, REB members must be aware of, and fully disclose, any real, perceived or potential conflict of interest they may have.

When is it okay to act without consent?

The research addresses the emergency needs of the individual and does not conflict with any applicable legal or regulatory requirements An REB has approved an emergency no-consent procedure in advance of the research in accordance with the criteria specified in TCPS 2 Article 3.8

How should participant information be stored?

The selection of security measures should take into account the nature, types and state of the data, its content, mobility, and vulnerability to unauthorized access. In the case of online data, researchers and REB members need to be aware of relevant online privacy laws and site terms of use and consider if the data is more vulnerable to third party viewing. Typically, data in paper form should be kept in a locked cabinet not accessible to anyone outside the study. Data in digital form should be encrypted and password protected. The duration of data storage depends on the research discipline, the research purpose, and the kind of data involved (e.g. sensitive personal data, biological samples, anonymized data, etc.).

What are examples of vulnerable circumstances?

The term 'minor' is most often used to describe someone who has not reached 'the age of majority' - an age that legally separates childhood from adulthood (in the view of the government) and affects the ability of citizens to vote, to enter into contracts, and to make other types of decisions. Brain injury: People who have suffered a brain injury and have been enrolled in a study by their authorized third party may be in vulnerable circumstances because the injury has affected their capacity to make decisions. Students: Students attending a research institution are often asked to take part in studies conducted by their instructors, advisors, and/or peers. If a student is approached to participate in a study by someone they view as having a position of authority or being able to influence their academic career, they may be in a vulnerable circumstance in the context of that particular study.

What is economic harm?

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 are some common errors that result in requests for revision?

Too much jargon Inconsistent information Omission of risks Failure to identify measure to deal with risk Misidentification of benefits Misidentification of deception Inadequate debriefing Failure to identify data security measures

How do you not create conditions that make participants vulnerable-or worsen existing conditions?

Watch your language, Using unsuitable language in recruitment, information, consent and debriefing documents is one of the most common mistakes researchers make. Avoid misunderstandings Be careful of context

When does creative practice require REB review?

When it involves human participants

What is an incentive?

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.

When is a study above minimal risk?

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 an authority/power relationship?

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 advancement). Conversely, when the organization is not in favour of the study, its members may feel pressure to avoid becoming involved. Researchers are obligated to inform people of the views of the organization's authorities and the possible consequences of participation. Confidentiality must be protected.

When will additional review need to take place?

When the foreseeable risks are high, or when there other ethical implications of the research that warrant a higher level of scrutiny, REBs can require more frequent reports on the conduct of the research after it has been approved. The REB can also require one or more site visits to observe the conduct of the study and to review the study materials in use at the research site.

What can researchers collect during consent process?

When written consent is obtained, the consent form should be separate from participants' contact information and other information collected from them during the study. This procedure is also appropriate for the documentation of any non-written consent process (e.g. field notes). The separation of identifying information from coded or anonymized data is fundamental to safeguarding participant privacy and confidentiality.

How do you determine if the participant has the capacity to consent?

appreciate the possible impact of foreseeable risks and potential benefits on their own well-being understand how the conditions of the research may affect them (e.g. time required, difficulty of tasks) evaluate whether participation in a particular research project may or may not be in their own best interest when research involves those who are not capable of giving consent on their own behalf, researchers must seek the consent of an authorized third party.

What are examples of people that lack capacity?

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)

What happens during debriefing?

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 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)

What happens when the patient is informed of the study?

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 a delegated review?

involves one or two members of the REB with appropriate expertise who are assigned to assess the research proposal. Their decision to approve the proposal is reported to the Chair for release of approval notification. If the delegated reviewers are considering rejecting the proposal, it must be referred back to the full board for decision.

How can a quality assurance project be research?

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

What are expectations of privacy?

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

What is 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.

What is 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.

What aspects of welfare should researchers consider?

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

What is the respect for persons principle?

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

What can researchers collect during recruitment?

the researcher may collect their names, phone numbers and/or email addresses in order to contact them about study details. All such contact information must be kept apart from the data and stored in a secure place. Institutions should have policies governing who may have access to personal information about participants throughout the life of a research project.

What is anonymous information?

this is information that has never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low.

What is fairness?

treating all people with equal respect and concern for their welfare - it does not necessarily mean treating everyone the same

What does the REB look at for dissemination?

you must indicate how any promises of confidentiality made to participants will be respected. You must also indicate how participants will be able to access the results of the study they were involved in