If the study involves sensitive material, then there is potential anxiety, pain, or embarrassment. Researchers must assess whether their procedures may cause anxiety, pain, or embarrassment to participants. If so, the ethics application should include: (1) a description of the nature of the anxiety, and (2) a detailed description of the precautions that will be taken to safeguard the participants (e.g., informing participants, providing contact information).

Special procedures, which may include providing resources or reporting to authorities, must be followed in the case of potential harm to self, harm to others, or child abuse. Please contact a Research Compliance Coordinator for further information about these special procedures.

In addition, studies that involve purposefully or potentially anxiety-inducing procedures should have a mood neutralization procedure as the final step of their study (e.g., viewing pleasant pictures).

In accordance with the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans, the REB relies on the principle that more invasive or hazardous research requires a more careful ethical analysis afforded by a full-board review. In contrast, research proposals with no more than minimal risk to the participants (research subjects and personnel) may be expedited. Expedited review means that the research proposal is reviewed by a subset of the full board. Researchers may recommend an expedited review, but the decision rests with the Chair of the REB or their designate.

The Tri-Council has recognized the difficulty in assessing risk. To help determine what constitutes minimal risk research, the Tri-Council has defined the term:

For the purposes of this Policy, “minimal risk” research is defined as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research (p. 23 TCPS2).

The Tri-Council Policy indicates that researchers and REBs must take into account (A) the type of risk; (B) the extent and likelihood of experiencing harm; and (C) known pre-existing individual or group vulnerabilities that might exacerbate or alter the likelihood or extent of harm. Each of these is described below.

A) Type of risk has been interpreted as risk that is physical (e.g., risk of harm through bodily contact or administration of a substance, or by administering a painful stimulus), psychological or emotional (e.g., feeling uncomfortable, embarrassed, anxious, or upset), and social risk (e.g., risk of loss of status, reputation, or privacy, financial loss, legal risk following disclosure of duty-to-report events).

B) The extent and likelihood of experiencing one of these harms (physical, psychological, social) must also be taken into account. The magnitude of the harm (e.g., a little emotional discomfort, loss of reputation, experience of pain) and the likelihood of harm (very unlikely to certain) are independent constructs.

C) With respect to individual and group vulnerabilities, the Tri-Council has indicated that REBs (and researchers) “have special ethical obligations to individuals or groups whose situation or circumstances make them vulnerable in the context of a specific research project, and to those who live with relatively high levels of risk on a daily basis. Their inclusion in research should not exacerbate their vulnerability (see Article 4.7)” (p. 23 TCPS 2). This does not imply that any research involving a vulnerable group should necessarily require full board review. To qualify for minimal risk, however, researchers must make the case that participation in the research is unlikely to exacerbate the participant’s (or group’s) vulnerability or increase their risk of physical, psychological, or social harm.

Designating a group as vulnerable presumes that the researcher or the REB believes that there is a reasonable expectation that at least one member of the group will experience a physical, psychological, or social harm in the course of or as a result of participating in the study or experiment. This is a question of probabilities that should be substantiated with empirical evidence or advice from those with extensive and direct experience with the group (e.g., clinicians for those with a disorder, teachers for children). Such evidence or advice must take into account the nature of the study or experiment being proposed. Where there is a reasonable expectation that at least one member of the group will experience harm in the course of or as a result of participating in the study or experiment, researchers must have a plan for mitigating the harmful consequence.

Deception: Experiments involving serious deception (e.g., giving false negative feedback about an important aspect of self; creating a fearful environment; convincing someone they have a serious medical condition; covert recording of individuals with the intent of obtaining consent after the fact) should be considered more than minimal risk if there is a reasonable expectation that at least one member of the sample will experience a physical, psychological (e.g., feelings of emotional upset or anxiety), or social harm.

Stress induction: Experiments involving the instigation of stress or anxiety (e.g., where the Trier Stress Test is used) should be considered more than minimal risk if there is a reasonable expectation that at least one member of the sample will experience a physical, psychological (e.g., feelings of emotional upset or anxiety), or social harm.

The Tri-Council Policy notes that, in assessing risk, special attention must be given to the culture, values, and beliefs of the population being studied. Where expertise is lacking, REBs should consult ad hoc advisors as needed (p. 24 TCPS 2).

Researchers in the Psychology Department can recruit participants from PSYC 1001, 1002, 2001, 2002, and from NEUR 2001, 2002 through the SONA system. These students can earn a maximum of 4% towards their final mark in each of these courses. Because we want the students to gain knowledge about research, it is important that researchers who recruit from the participant pool provide a debriefing that is as informative as possible.

Researchers in the Institute of Cognitive Science can recruit participants from CGSC 1001. These students can earn a maximum of 4% towards their final mark in each of these courses.

Researchers must use SONA to recruit student participants within Psychology or Cognitive Science.

If participants are being recruited by email or through social media for your study, describe how notifications and reminders to participate will proceed (i.e., specify the email program or social media website that will be used).

Note: You must use an email client program (e.g., Microsoft Outlook or Mozilla Thunderbird) rather than a web-based email program (e.g., Gmail, Hotmail, Yahoo) and you must use your official University email address for all communications.

Social media sites have their own regulations about who owns the content posted on their websites. If using social media, you must describe to the REB which site you will be using and what their policies are regarding data storage and ownership. As with all recruitment methods, you must submit to the REB copies of all your recruitment materials whether they are ads, emails, or posters.

Yes. Approval from both CUREB and the outside organization (e.g., businesses, hospitals, schools, prisons) are needed. Some organizations require ethics approval from Carleton before giving approval from the organization. As each case is unique, we encourage you to contact the Research Ethics and Compliance Office for guidance on how to proceed.

Note: Your Carleton Ethics clearance is always conditional on securing clearance from the other organization. Conditional approval does not permit researchers to collect data. Final approval will be granted once a copy of that outside approval, scanned and uploaded, as an addendum to a conditionally approved protocol has been processed by the REB. Final ethics clearance must be obtained before any data are collected.

You cannot proceed with your project until it has been cleared by one of the Research Ethics Boards and you have received a clearance certificate via email.

When children or adults of limited cognitive capacity participate in research, researchers must secure the assent of the potential participant as well as the permission of the parent or guardian (in place of the consent of the participant). The assent process should involve taking the time to explain to the participant what will happen in the study, why the study is being done, what will be done to the participants, and that, if they object, the research will be terminated and the participant will not be punished or scolded. The assent must be provided in a language that the participants can understand, while communicating the essential elements of consent without obscuring the important information in a lot of detail. The greater the cognitive capacity of the participant, the greater the amount of information that should be shared.

The assent information can be presented orally or in writing, depending on the literacy level of the participants. When using assent, parents and guardians must sign a permission form rather than a consent form. If a participant refuses to participate, even if a parent has signed the permission form, the research will not take place.

To respect the requirements of the Freedom of Information and Protection of Privacy Act (FIPPA), researchers need to indicate clearly, in the informed consent, the length of time for which any personal information collected (e.g., signatures on the consent forms, contact information, identifying information from audiotapes or in a dataset) will be kept in a secure location before being destroyed. Researchers also need to indicate that personal information will only be viewed by researchers directly involved in the study. Signed informed consent forms, raw data that contains identifying information, and any other personal data (contained in any format) should be retained for at least three years following: (a) the completion of the study, or (b) after a report of the work is published or otherwise publicly presented. Researchers might need to keep these records for longer periods depending on the requirements of individual funding agencies, psychological associations, or publishers. Anonymized datasets (i.e., with all identifying information removed) or anonymous datasets (i.e., where participants never provided identifying information) can be retained indefinitely. However, if researchers wish to utilize these data in the future for purposes beyond the initial intent of the study (e.g., educational purposes, secondary data analyses), this possibility must be clearly indicated on the informed consent.

To respect the requirements of the Freedom of Information and Protection of Privacy Act (FIPPA), you need to indicate clearly, in the informed consent, the length of time for which any personal information collected (e.g., signatures on the consent forms, contact information, identifying information from audiotapes or in a dataset) will be kept in a secure location before being destroyed. You also need to indicate that personal information will only be viewed by researchers (and supervisors) directly involved in the study.

Search the Secretariat Policy Listings for “Mobile Technology Policy“.

According to the TCPS2, electronic research data should be encrypted and password-protected. Physical copies of data must be kept in a secure location that only the researcher and supervisor can access. In the case of funded data, ensure you are in compliance with the requirements of the funder. Anonymized datasets (i.e., with all identifying information removed), or anonymous datasets (i.e., where participants never provided identifying information), can be retained indefinitely. However, if you wish to utilize this data in the future for purposes beyond the initial intent of the study (e.g., educational purposes, secondary data analyses), this possibility must be clearly indicated on the informed consent form.

Depending on the level of sensitivity of a survey, researchers may wish to include a withdrawal link for the participant. Try following the directions below in Qualtrics:

• Step 1: Create two surveys in Qualtrics. The first survey will include the full survey. The second survey should only contain a copy of the debriefing page (The participant will see this separate debriefing form if they select the withdrawal link).
• Step 2: Add a link within the full survey. In the full survey, select “Edit Survey.” You may then select “Look and Feel,” followed by “Advanced.”
• Step 3: You can now insert a sentence into the “Footer” box, which will serve as a link to the second survey with the withdrawal debriefing form. For example, “Click here if you would like to withdraw from the survey.” This sentence will serve as a link on the bottom of each page in the survey.
• Step 4: Using the “Edit” Function, turn the footer sentence into a hyperlink that will link to the separate debriefing page created in Step 1.

Every study that is approved by CUREB A or B receives an ethics clearance certificate that includes a set time period during which the study may be conducted. Before the expiry date, researchers must submit an Annual Status Report request to either renew their project or close it. Failure to do so will halt your project and affect your research funding.