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Detailed Instructions and Example
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Data Collection Methods
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Describe in detail the method of data collection being used and provide details of any instruments used. Breakdown by phases, participant groups, or types if required. Complete the section on "online data collection" if relevant. (Fully describe or include a copy of any questionnaires, surveys, interview guides, or other data collection instruments).
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Detailed Instructions:
Describe data collection methodologies used.
QUESTIONNAIRES/SURVEYS:
For online surveys:
What survey company/software will be used?
Is the host survey company Canadian-owned with servers based in Canada?
If not, in what country will the host data be stored?
If survey software is hosted at Carleton, provide details on the software and hosting setup/configuration.
Does the survey company collect IP addresses and if so, will the feature be disabled?
Please note: Some companies do not delete data from their servers even after it is transfered to the researchers.
CUREB recommends the following disclaimer language: "Your data will be stored and protected by [ORGANIZATION] in [SERVER LOCATION], but may be disclosed via a court order or data breach."
If the survey is not anonymous or is above minimal risk:
Describe the process for transferring the data from the host server to you and verification that the host server is no longer in possession of the data. (If you are using a US-based server you are required to inform participants that all data on those servers may be disclosed via a court order)
If using a standardized questionnaire:
Provide details on validity, etc.
Has permission been secured to use the questionnaire?
INTERVIEWS:
Provide a copy of the interview questions. (Questions must be provided even for semi-structured interviews.)
Describe data collection methodologies used.
Use this section to describe the interviews.
FOCUS GROUPS:
Provide a copy of the focus group questions.
Describe data collection methodologies used.
Use this section to describe the focus groups.
ORAL &/OR VISUAL STIMULI:
Provide a copy of all stimuli being used.
Describe data collection methodologies used.
Use this section to describe the stimuli.
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Example #1:
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Example #1:
| The study will take place on laboratory computers. The researcher will introduce the purpose of the study and the interface for ABCD (verbal script is attached). In the first condition, participants will complete a series of online tasks using the new interface for ABCD (description of online tasks is attached). They will then use a link provided to access a Qualtrics survey which will ask them for feedback regarding their experience with ABCD. In the second condition, participants will complete a series of online tasks using the old interface for ABCD. They will then use a link provided to access a Qualtrics survey which will ask them for feedback regarding their experience with ABCD.
Questionnaire data will be stored and protected by Qualtrics, which has servers located in Toronto. Data may become disclosed via a court order or a data breach.
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Example #2:
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Example #2:
| The survey that the parents complete will ask them short questions about the foods the child participants eat and the amount of exercise the children perform on a daily basis. The survey is a paper survey and responses will be anonymous. A copy of the survey is attached. |
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Example #3:
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Example #3:
| Interviews will be conducted to learn how clinical social workers conceptualize, engage and enact social justice principles in their everyday assessment and treatment work in contemporary practice environments. A copy of the interview guide has been attached.
Interviews will also be conducted on Skype. Consequently, participants will be told in the informed consent that skype servers are located in the United States and are subject to U.S. laws on data privacy. |
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CUREB A&B: Research Ethics Form – Detailed Instructions
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1.
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Title and Date
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Project Title
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Title of Research Project
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Detailed Instructions:
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Indicate the full title of the research project.
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Example #1:
| Does a new software user interface make computer users more productive? |
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Example #2:
| Stress and obesity levels in children (Phase Two) |
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Example #3:
| Clinical Social Work Practice within a Social Justice Framework: Developing an Empirically-Informed Model (Pilot Study) |
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Submission Date
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Date of completion of this form. Update each time form is revised.
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Detailed Instructions:
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CUREB uses this information to identify versions of this document submitted in response to requested changes
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Example #1:
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Example #2:
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Example #3:
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Attachments
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List documents included with this application (e.g. consent materials, invitations, permissions)
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Detailed Instructions:
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In a list, identify the file name and a brief (<10 word) description of the attached documents
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Example #1:
| - Consent-formA.pdf (Consent form for participant group A)
- Consent-formB.pdf (Consent form for participant group B)
- Invitation letter.docx (Invitation letter) |
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Example #2:
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Example #3:
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2.
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Project Team
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Lead Researcher
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Last name/First name
######
Official university (or other institution) email address:
######
Department, faculty and institution
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Detailed Instructions:
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Clearly indicate the lead researcher's last name and first name. (Use the format Last name/First name.) Provide the official email address from your institution. Indicate the department and faculty of your primary appointment; include the institution if other than Carleton University.
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Example #1:
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Example #1:
| MAY, Sally, Undergraduate Student, Computer Science, Carleton University, maysally@cmail.carleton.ca |
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Example #2:
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Example #2:
| SMITH, Jim, Academic Staff, MacOdrum Library, Carleton, jim.smith@carleton.ca |
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Example #3:
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Example #3:
| DOE, Jane, Master's Candidate, School of Social Work, Carleton University, janedoe@cmail.carleton.ca |
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Academic Supervisor
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Academic supervisor(s) Last name/First name. (Note, the supervisor must be copied on all correspondence with CUREB.)
######
Official university (or other institution) email address:
######
Department, faculty and institution
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Detailed Instructions:
List the academic supervisor(s) here by providing the following information:
1. Last name/First name
2. email address
3. department and institution
NOTE: The academic supervisor is responsible for the student researcher and the research project. As such, the supervisor must be copied on all correspondence with CUREB.
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Example #1:
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Example #1:
| BROWN, Dan, dan.brown@carleton.ca, research supervisor, professor in Computer Science at Carleton. |
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Example #2:
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Example #2:
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Example #3:
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Example #3:
| Smith/John, john.smith4@carleton.ca, research supervisor, professor in Social Work at Carleton. |
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Project Team Members
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List the project team members:
1) Last name/First name
2) Email address
3) Role in project
4) Department and institution
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Detailed Instructions:
List the project team members here, including collaborators, research assistants, etc.
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Example #1:
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Example #1:
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Example #2:
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Example #2:
| Smith, Tim, Collaborator, Faculty member, Health Sciences, McMaster University, smitht@mcmaster.ca
Downing, Blair, Collaborator, Research Assistant, Health Sciences, Carleton University, blair.downing@cmail.carleton.ca
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Example #3:
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Example #3:
| Truman/Harriet, co-PI, assistant professor in Social Work at Carleton, harriet.truman@carleton.ca. |
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3.
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Study Overview
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Study Goal
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What research question(s) will this study seek to answer (1-2 sentences)?
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Detailed Instructions:
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What is the specific goal of this research project? Briefly describe it in 1-2 sentences.
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Example #1:
| A new user interface for our software ABCD has been developed. We want to know if computer users can complete tasks faster with the new interface. |
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Example #2:
| Do stress levels predict obesity in school-age children. |
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Example #3:
| How do clinical social workers employ social justice principles in the provision of therapeutic assessment and treatment? |
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Study Purpose and Benefits
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Study rationale: why should the research be pursued; what are the benefits, and to whom?
(Benefits can be to research community, companies, or society in general.)
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Detailed Instructions:
As the risks of the study increase, it is important to demonstrate how the benefits outweigh the risks.
If relevant, provide the scientific context of the study.
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Example #1:
| Most users of the previous version of ABCD like it, but say that it is often difficult to use. We want to make an easier-to-use version to help users be more productive. |
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Example #2:
| This is a two part study that will help us understand the extent to which the stress that children experience is a factor in obesity. Phase one examined the relation between stress an obesity in a Hamilton student sample. This, the second phase of the research, will provide a complimentary data set drawn from an Ottawa student sample. |
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Example #3:
| Little is known about how clinical social workers conceptualize, engage and enact social justice principles in their everyday assessment and treatment work in contemporary practice environments. This empirical pilot study seeks to advance social justice oriented clinical practice among social workers. |
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Participant Interactions Overview
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Briefly describe what will happen to, or will be required of, the participants during the research. (Only a project overview is required).
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Detailed Instructions:
Describe the steps involved from the start of contact with participants to the end of contact.
Is the research entirely secondary analysis of data which has already been collected? (This means that there is no direct interactions with participants as the data has already been collected.)
If so, describe the following:
1. the nature of the data, and was it acquired (i.e. were the original data acquired ethically)
2. the scope of the original consent (i.e. is the proposed research consistent with the consent given by the participants)
3. the permission to use the data (i.e. does the researcher have permission to use these data)
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Example #1:
| -Participants who contact the researcher will be sent the Letter of Invitation and an interview will be scheduled.
-Participants will be provided with a consent form at the interview and will be reminded that the study is video-recorded.
-The study will begin when consent is given. Participants will fill out a demographic form.
-The researcher will introduce the purpose of the study and ABCD. There will be two conditions: the experimental condition (using the new, coloured, interface for ABCD) and the control group (using the previous version of ABCD).
-Participants will be prompted to complete a series of online tasks using the software provided.
-Participants will then complete a questionnaire regarding the usability of ABCD. (Questionnaire is attached). |
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Example #2:
| - The parents of the participants will complete a survey on the child's behalf.
- Child participants will do some jumping-jacks, and then take a saliva sample.
- Heart-rate will be measured before and after. |
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Example #3:
| -Participants who contact the researcher will be sent the Letter of Invitation via email and an interview will be scheduled.
-Participants will be provided with a consent form at the interview and will be reminded that the study is audio-recorded.
-The study will begin when consent is given. Participants will fill out a demographic form. The interviewer will then commence the interview following the attached interview guide. |
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Minimal Risk Review Request
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Should this protocol be considered for minimal risk review? If so, please briefly justify. If not requesting a minimal risk review, leave this section blank. (CUREB will decide whether an application is reviewed at full board or via a delegated process).
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Detailed Instructions:
The REB will determine whether a protocol is reviewed as minimal risks, considering the researcher's justification of a minimal risk review request.
The answer should address how much additional risk the protocol brings into the participant's daily life.
www.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter2-chapitre2/#toc02-1b
Definition of Minimal Risk:
The TCPS2 defines minimal risk as "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."
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Example #1:
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Example #1:
| The participant group is not exposed to any more risk than they would experience in their daily lives as Computer Science students. |
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Example #2:
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Example #2:
| The vulnerable group are children who will feel compelled to participate.
If a child refuses to participate, even if they have parental consent,
they will not be part of the study. (There will be a separate activity
going on for those children who do not want to participate.) |
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Example #3:
|
Example #3:
| The topics discussed in interviews are not considered to be any more challenging than professional social workers experience in their everyday lives as they complete their everyday assessment and treatment work in clinical and practice environments. |
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Dates of Recruitment/Participant Interaction
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Estimated date when will you start recruiting participants? (YYYY-MM-DD)
######
Estimated date when you will end participant interactions? (YYYY-MM-DD)
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Detailed Instructions:
The exact dates may not be known. Provide estimates in this case.
Recruitment dates are not required for secondary data analysis.
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Example #1:
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Example #2:
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Example #3:
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Additional Reviews
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Has this project been reviewed for academic merit (not required, but for the Board's information). By whom? As part of a Tri-Council grant application or student's thesis committee?
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Detailed Instructions:
|
The REB uses information on additional review if it is necessary to consider the scientific merit of a protocol. For example, there may be a question of whether the benefits of the research outweigh the associated risks.
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Example #1:
|
Example #1:
| This protocol was reviewed by NSERC. |
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Example #2:
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Example #2:
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Example #3:
|
Example #3:
| Reviewed within the School of Social Work for an internal award. |
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4.
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Methods: Participants
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Description of Participants
|
Describe the participants and any inclusion and exclusion criteria. If using a separate sample of control participants, describe this group.
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|
Detailed Instructions:
Describe the participants and the inclusion criteria. (If applicable, indicate details such as the age group, gender, language, race, ethnicity, and medical conditions.)
If applicable, describe any exclusion criteria. What would make a participant ineligible to participate in the study?
Exclusion criteria refers to participants that match the original inclusion criteria but have something that would make them ineligible.
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Example #1:
| Participants are undergraduate students in Computer Science. They must speak English fluently, be at least seventeen years of age, and be students of Carleton University. Participants may have experience using the previous version of ABCD.
Individuals who do not speak English fluently, who are not in the School of Computer Science, or who are not at least seventeen years of age will be excluded from the study. |
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Example #2:
| Participants are grade 1-6 students (6-12 years old).
Kindergarten age children, pre-school children, children above grade 6, and adults will be excluded from the study. |
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Example #3:
| We will recruit a total of 20-25 study participants who meet the following inclusion criteria:
-English speaking clinical social workers
-with a Master of Social Work (MSW) degree (as a minimum)
-with a minimum of 3 years of post-MSW clinical experience in Canada or the U.S.
-Engage in clinical assessment and treatment from a social justice orientation
Exclusion criteria:
-Bachelor of Social Work practitioners will not be recruited for the study
-participants with less than 3 years of post-MSW clinical experience in Canada or the US will be ineligible
-participants who do not speak English will be ineligible for the study
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|
Number of Participants (Sample size)
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How many participants will be recruited? If multiple groups of participants are involved, breakdown by participant type. Provide a justification including a statistical rationale if appropriate.
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Detailed Instructions:
If the number of participants is a large sample, or there are significant risks to participants, provide a justification.
If a number is not available, an estimate must be provided.
For studies in which the participant numbers were calculated using statistical methods (e.g. power analysis), please briefly explain the rationale
If the number increases during your research, you must inform the REB.
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Example #1:
| A total 20 participants will complete the user study.
Group #1: 10 participants who will use the old version of ABCD.
Group #2: 10 participants who will use the new version of ABCD. |
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Example #2:
| 200 participants. The number of participants is required in order to achieve statistical significance based on statistical analysis of the number of groups and estimated effect size. (See attached calculations.) |
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Example #3:
| 20-25 participants will be interviewed. It is expected that the study will receive saturation after this number of participants have been interviewed. |
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|
Vulnerable Population
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Describe any vulnerabilities of the participant group(s) that may compromise their ability to give free and informed consent or cause additional risks.
Describe your mitigation strategy to ensure valid consent.
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Detailed Instructions:
Vulnerable groups are those who have a reduced capability to give free and informed consent. If there are other group-specific risks they should be described here.
Examples of vulnerable groups are hospital patients, prisoners, and marginalized groups in society. Note that a group is not automatically vulnerable, but may become vulnerable in the context of the research (e.g. children, elderly, indigenous groups). For example, students are not normally a vulnerable group, but would become so, if they perceived that participation in the research would affect their grades.
If the participant group is considered a vulnerable population, explain the vulnerability, associated risks, and the mitigation strategy.
Tri-Council policy is: www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter4-chapitre4/#ch4_en_a4.7
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|
Example #1:
|
Example #1:
| Participants are undergraduate students are not considered vulnerable. |
|
Example #2:
|
Example #2:
| Children are a vulnerable group who may feel compelled to participate. To mitigate this, we will ensure that, if a child expresses reluctance to participate, even if they have parental consent, they will not be part of the study. (There will be a separate activity going on for those children who do not want to participate.). |
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Example #3:
|
Example #3:
|
Clinical social workers are not considered a vulnerable population. |
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Participant
Relationship
to Researcher
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Describe any relationship that exists between the participants and the research team or any recruiting party or sponsor.
Indicate how relationships will be managed so there is no undue pressure on participants.
|
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Detailed Instructions:
|
The REB uses this information to inform questions about conflicts of interest. Such relationships are not by themselves unethical; however, they must be explained and managed to avoid undue influence on participants. If these specific participants were in a previous study (especially if this is a follow-up) by the researcher, give details (study # or title and date).
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Example #1:
|
Example #1:
| Participants may be friends or student colleagues of the lead researcher who may feel pressured to participate. The researcher will emphasize that participation is completely voluntary and that participants may withdraw at any time. Participation will not affect personal relationships in any way. |
|
Example #2:
|
Example #2:
| There is a power relationship between the child and the researcher/parents/teachers. For this reason, as indicated in the vulnerable population section, children will be told that even if they are given the OK to participate, the final decision is the child's. |
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Example #3:
|
Example #3:
| The Primary Investigator has over a decade of experience working as a Social Worker in Canada or in the US. It is possible to know some of the study participants. In such cases, the researcher will emphasize that participation is voluntary and will not impact any working relationships. |
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Benefits to Participants
|
Describe any potential direct benefits to the research participants as opposed to society or knowledge.
|
|
Detailed Instructions:
Describe any direct benefits to the research participants (as compared to benefits to society or knowledge)?
If you are working with an agency (including companies, NGOs, etc) or community groups, describe what benefits, if any, they may receive from this research.
(A justification in terms of significant benefits is required if the research exposes participants to significant risks.)
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|
Example #1:
|
Example #1:
| Participants will be exposed to a new software interface for ABCD which may improve the future version of ABCD and make participants more productive. |
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Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
| There are no direct material benefits to study participants. |
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Benefits to Participant Community
|
Describe any benefits to the community of your research participants (e.g. indigenous community), such as capacity building, knowledge sharing, and fulfillment of community research priorities.
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Detailed Instructions:
|
Example #1:
|
Example #1:
| This research does not specifically involve indigenous participants. |
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Example #2:
|
Example #2:
| This research does not specifically involve indigenous participants. |
|
Example #3:
|
Example #3:
| This research does not specifically involve indigenous participants. |
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|
Conflict
of Interest
|
Describe any conflicts of interest, and indicate how they will be managed.
|
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Detailed Instructions:
|
Conflicts of interest occur where the researcher could have conflicted motivations. Examples are where the researcher benefits financially from the success of the research, or is compensated for achieving participant recruitment targets. Other examples are where the researcher has an ownership stake in a company who may benefit from the research. Such relationships are not by themselves unethical; however, they must be explained and managed to avoid undue influence on participants. In most cases, it is sufficient to inform participants of the additional benefits from the research.
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|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
| The researcher is receiving personal payment of $20,000 from PharmaKids, if at least 100 participants are recruited. This personal benefit may be seen as a conflict of interest by some participants or parents. This personal funding has been clearly identified on the participant information form and the consent form. |
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Example #3:
|
Example #3:
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Researcher Training with Participant Group
|
In addition to the TCPS2 training, describe any additional training the researcher(s) have (or will receive) to work with the proposed participants (e.g. research with Indigenous communities).
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Detailed Instructions:
Is training needed?
Researchers should complete this section to indicate how the student has been adequately prepared to carry out the research with these participants.
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Example #1:
|
Example #1:
| Researcher has no specific training. |
|
Example #2:
|
Example #2:
| The researcher has first aid training and has over 10 years of experience conducting studies with school-age children. |
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Example #3:
|
Example #3:
| Researcher has taken a course on qualitative research methods, including observational research. The researcher has also been given specific training in working with street-engaged youth. |
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5.
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Indigenous Peoples and Community Engagement
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Research involving Indigenous/Aboriginal peoples
|
If none of the statements are applicable, please skip this section of the form
|
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Detailed Instructions:
|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
|
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|
|
Consultation
|
Describe the consultation process with the indigenous community(ies). What is the community's involvement in governance of the research? With whom did you consult and what arrangements, if any, were made to implement Tri-Council (TCPS 2 Chapter 9) principles? If no consultation has taken place, please explain.
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Detailed Instructions:
|
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Example #1:
|
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Example #2:
|
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Example #3:
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|
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Approvals/Agreements
|
As part of the above process, describe what approvals/agreements you have made with the participating community(ies).
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Detailed Instructions:
|
|
Example #1:
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Example #2:
|
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Example #3:
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|
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Benefits to Participant Community
|
Describe how the research will provide fair benefits to the participating community(ies), meet community research priorities, support capacity building through enhancement of the skills of community personnel, and recognize the role of elders and other knowledge holders.
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Detailed Instructions:
|
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Example #1:
|
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Example #2:
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Example #3:
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|
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Participant involvement in research findings
|
Describe how participants will be given the opportunity to participate in the interpretation of the data and review of research findings prior to the completion of any reports or publications? If such participation will not occur, explain.
|
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Detailed Instructions:
|
|
Example #1:
|
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Example #2:
|
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Example #3:
|
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|
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Data Ownership, Control. Access and Possession
|
Describe arrangements for the participating community(ies)’ ownership and/or sharing of project data and findings, including the OCAP principles (ownership, control, access and possession). http://fnigc.ca/ocapr.html
|
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Detailed Instructions:
|
|
Example #1:
|
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Example #2:
|
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Example #3:
|
6.
|
Methods: Recruitment
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|
|
Recruitment Methods
|
Describe each step of how participants will be recruited. This includes how prospective participants will be identified, how contact information will be obtained, how participants will be made aware of the study, and how participants can express their interest. Provide a copy of all the recruitment material(s) including any oral scripts, recruitment posters, recruitment emails, social media postings etc.
|
|
Detailed Instructions:
How are the names and contact information for participants being collected? Recruitment methods are of particular interest to the REB, as Tri-Council has identified undue influence and coercion in recruitment strategies as threatening the voluntariness of consent: www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter3-chapitre3/#toc03-1a
Researchers planning to recruit participants online, must specify:
(1) what program they will use to do so (e.g., Fluid Surveys);
(2) where the link to the study will be placed online (e.g., forums, Facebook);
(3) as well as the recruitment notice.
For example, if you are planning to place the link to your study on Facebook, specify where on
Facebook the link will be placed (e.g., a paid ad will be created or the link will be posted on the
wall of an existing group).
If participants are being recruited by e-mail for your online study, describe how e-mail notifications and reminders to participate will be done.
|
|
Example #1:
|
Example #1:
| 1. Recruitment posters will be placed on billboards at Carleton in accordance with Carleton's posting policy. (The poster is attached to application.)
2. The researcher will send the letter of invitation, along with the poster, to the School of Computer Science for distribution within their mailing list. (The Letter of Invitation is attached).
3. Social Media: the researcher will advertise the study poster on the School of Computer Science Facebook group (social media recruitment notice is attached).
4. Snowballing will be used. Participants may tell others about the study, who may likewise be interested in participating (oral script is attached for recruitment).
5. Participants who call or email us will be invited to take part in the study (oral script is attached). |
|
Example #2:
|
Example #2:
| 1. Information letters for the parents will be sent home with the kids. (The school has agreed to distribute the attached letter.)
2. Participants can either email or mail the researcher to indicate their interest to participate (an oral script will be used by the researcher for recruitment and this script is attached). |
|
Example #3:
|
Example #3:
| Initial study participants will be recruited primarily through various email listservs available for clinical social workers across regions (See Appendix A for email invitation). Access to Listservs will be through professional organizations, such as Ontario Association of Social Workers And National Association of Social Workers.
Many schools of social work also have active social media presence especially through Facebook, and their alumni often subscribe to the school pages on Facebook (social media invitation attached).
We will also employ a Grounded Theory sampling strategy. |
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|
|
Location of
Recruitment
|
List all recruitment locations.
If some locations require permission prior to recruitment, indicate if permission has been secured.
|
|
Detailed Instructions:
|
Some recruitment locations have their own ethics review process. Examples are schools, hospitals, correctional facilities. It is the researcher's responsibility to find out about any requirements.
|
|
Example #1:
|
Example #1:
| Recruitment will occur at Carleton and online. |
|
Example #2:
|
Example #2:
| Location is at the Alpha Kids Private Academy. The school's Principal has given permission for the researchers permission to recruit. (See attached email confirmation.) |
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Example #3:
|
Example #3:
| In order to gain a variety of social justice lenses/frameworks and clinical expertise among study participants, recruitment will take place both in the US and in Canada.
For example, participants from the Ottawa area are likely graduates of the Carleton School of Social Work, which have a very specific theoretical framework and practice ("Structural Social Work").
Recruitment from the US is also needed because of the significantly higher number of schools of social work that teach clinical social work from a social justice lens (e.g., Smith College and Simons College in Massachusetts) in comparison with those in Canada. |
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Third Parties
in Recruitment
|
If using third parties to recruit, indicate who is doing the recruitment and how it will be accomplished. Does the third party have the prospective participant contact information? Are community leaders involved in identifying potential participants?
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Detailed Instructions:
|
"Third parties" refers to people or organizations other than the research team who will be assisting with recruitment. Examples are schools and hospitals where teachers or clinical staff may identify potential participants for the researcher.
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|
Example #1:
|
Example #1:
| The School of Computer Science will circulate the Letter of Invitation and the study poster on our behalf to computer science students through their Facebook group and email distribution list. |
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Example #2:
|
Example #2:
| Alpha Kids will send letters to the parents on our behalf. Participants (and parents) who want to take part in the protocol will be given a self-addressed envelope and an email address to indicate their desire to participate.
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|
Example #3:
|
Example #3:
| The Carleton School of Social Work, and Social Work departments at Smith College and Simons College will circulate the Letter of Invitation within their departments and on Social Media. Individuals who are interested in the study will contact the researcher directly. |
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Recruitment
risks to
Participants
|
Describe any risks to participants during the recruitment phase, including risks to privacy.
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|
Detailed Instructions:
Are there risks to participants during the recruitment phase? (E.g., could a participant's safety be in jeopardy if they are seen speaking to a researcher?)
Probability is the researcher's best guess as to the likelihood of identified risk outcomes.
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|
Example #1:
|
Example #1:
| Yes. There is a low probability that participants may feel obligated to participate even if they don't really want to. The researcher will mitigate this risk by assuring participants that their participation is completely voluntary and they are free to skip questions or withdraw at anytime. |
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Example #2:
|
Example #2:
| Yes. There is a low probability that participants may feel obligated to participate even if they don't really want to. The participants will be told that they do not have to take part in the study and will not be in trouble if they choose not to participate. Moreover, a second activity will take place at the same time as the study and children will be informed that they may take part in the second activity if they withdraw or choose not to participate. |
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Example #3:
|
Example #3:
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|
Recruitment
risks to
Researcher
|
Describe any risks to the research team during the recruitment phase.
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|
Detailed Instructions:
Are there risks to any member of the research team during the recruitment phase? (E.g., unstable politics/violence in the recruitment region, participants have history of violent behaviour.) CUREB recommends researchers discuss such situations with Carleton's risk manager with respect to insurance and risk mitigation strategies.
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|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
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Compensation
|
Describe all participant compensation and remuneration (including its monetary value) and indicate when participants will receive the compensation.
What happens to the compensation if a participant withdraws?
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Detailed Instructions:
|
Example #1:
|
Example #1:
| Participants will be given a $15 gift card to Tim Horton's. Refreshments will also be offered (cookies, fruit, and juice). |
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Example #2:
|
Example #2:
| All children participating in the Ottawa study, regardless of whether they choose to participate or not, will receive a small token (stickers). |
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Example #3:
|
Example #3:
| No compensation will be provided to study participants. |
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7.
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Methods: Informed Consent
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Obtaining
informed
consent
|
Describe the process for obtaining informed consent from the participants (or guardians/legal representatives). If written consent is not used, explain the alternative method chosen. Include a copy of all consent forms, scripts and other materials.
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|
Detailed Instructions:
Describe the consent process. If consent will be accepted from a guardian or other legal representative, describe this process, and whether assent will also be obtained from the participant.
Include all consent and assent materials: E.g., written consent form, oral consent script, implied consent text provided as part of an anonymous survey.
Written consent is the norm; all alternative forms of consent will need to be justified by the researcher.
Implied consent is when a participant is given full details of the study and indicates consent by submitting their responses/data. (An example would be including consent information at the beginning of an anonymous online survey. Participants complete the survey and by clicking submit, they acknowledge that they consent to participate.)
In addition:
Oral consent - Indicate why oral consent is being used instead of signed consent.
Parent/Guardian - How will consent be obtained from the parent (or legal guardian) when a participant cannot fully consent? How will the participant then assent?
Implied consent - Indicate why implied consent is being used.
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|
Example #1:
|
Example #1:
| Participants will first read the online consent form on a lab computer and be reminded that the study is video-recorded. If the participant consents to participate (e.g. they select the “I agree to participate” box, they select "I agree to be video recorded“, and then select the "Next” button), video-recording will begin. A copy of the online consent form is attached. A secondary consent form will also be given electronically at the end of the study (see attached). |
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Example #2:
|
Example #2:
| Ottawa Participants will receive a survey form and a pre-stamped envelope. The choice to participate is implied by completing the form and mailing it to us.
This consent information is printed onto the survey (attached).
Children will be given the chance to assent by listening to an age-appropriate assent script (attached). A child who chooses not to participate, even with parental consent, will not be required to participate. There will be an alternative activity for children who do not assent to participate or who later withdraw from the study. |
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Example #3:
|
Example #3:
| Participants will be given a consent form to complete. They will be asked their consent to participate and be audio-recorded (consent form is attached). When the form is signed, research will begin. |
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|
Deception
|
Describe and justify any deception and/or partial disclosure (e.g. what information is withheld). Describe the magnitude and likelihood of harm due to deception. Describe any planned secondary consent and include forms or text?
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|
Detailed Instructions:
What is Deception? DECEPTION occurs when researchers intentionally provide false information or intentionally omit key information with the expressed purpose of fabricating false beliefs among participants.
Deception requires debriefing and secondary consent forms. The secondary consent form allows the participant to consent to the use of their data when they have been informed of the true nature of the study. Partial disclosure requires a debriefing form.
Deception should not be used in any of the following circumstances:
· when the deception is expected to cause severe emotional distress or physical pain;
· when the harm resulting from the deception is expected to be long lasting ;
· when the study risks do not outweigh the study benefits ;
· when the study goals can be met using an alternative approach (without deception) commensurate in terms of disciplinary norms and methodological rigour.
Deception Examples:
• Giving participants false feedback (negative or positive) about their performance on a task ;
• Using a confederate in a research study. A confederate is an individual who poses as a participant, but whose behaviour in the study is actually part of the researcher's experimental design;
• Creating a false cover story about the true purpose of the study.
What is partial disclosure?
PARTIAL DISCLOSURE occurs when a researcher withholds certain information about the specific purpose, nature, or some other aspect of the research. Partial disclosure may or may not be considered deception.
PARTIAL DISCLOSURE without deception example:
• Participants are initially told that the researchers are interested in how people think about future events. They are also told that the study will involve thinking about and describing aspects of an upcoming event in their life. But the complete purpose of the study is to examine how people might use different time metrics (i.e., days, weeks, months) when thinking about future events that they are vs. are not looking forward to experiencing. Participants were also unknowingly randomly assigned to one of two experimental conditions (either a negative future event condition or a positive future event condition). In this case the purpose of the study was not inaccurate or intentionally designed to mislead participants but rather omitted details about the study purpose (i.e., use of time metrics) and the study research methodology (i.e., use of random assignment).
PARTIAL DISCLOSURE with deception example:
• Participants are initially told that the purpose of the study is to understand political ambition in university students. But the complete purpose of the study is to understand whether inducing negative stereotypes about women (e.g., women do not make good political candidates) actually makes women less motivated to pursue political jobs. Thus, while the general purpose of the study is not fabricated, key information is being withheld—whether negative stereotypes impact a woman’s decision to pursue a political position.
Mild Deception Examples:
• Creating a false cover story about the true purpose of the study
• Presenting fictitious stimuli as real events (e.g., false newspaper stories, crime stories)
• Covert recording of individuals in public places with NO intent of obtaining consent after the fact
• Misleading information about the research sponsor
• Providing incorrect information about research procedures (e.g., instructions for tasks, content of articles or quotes)
• Incomplete information about the study investigator(s)
• Misleading settings or incorrect duration of study session
More than Mild Deception Examples:
• False explanations of scientific or measurement instruments
• Fictitious information about the study investigator(s)
• Using a confederate in a research study. A confederate is an individual who poses as a participant, but whose behaviour in the study is actually part of the researcher's experimental design (i.e., it is scripted)
• False promises (e.g., concerning incentives, rewards, or remuneration)
• Misleading information concerning other participants who may be present in another location or who do not exist
• Misleading participants about the tasks they will be asked to complete (e.g., initially telling participants they will be asked to complete an innocuous questionnaire, however the study concerns their reactions to or memory of an unexpected but staged event)
• Creating false beliefs about important aspect of self or personal behaviour
• 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
Deception of any kind (even partial disclosure with deception) warrants that participants complete a secondary consent form following a full debriefing explaining the false information participants received and why deception was necessary (see section 6C. Debriefing). In contrast, partial disclosure (with no deception) warrants a debriefing following the study but normally will not warrant a request for secondary consent. The debriefing should clearly disclose the aspects of the study that participants were not told about up front. See the following link for an example of a secondary consent form required in the case of deception: carleton.ca/psychology/wp-content/uploads/2012-Guidelines-for-Ethics-Approval.pdf#page=20
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|
Example #1:
|
Example #1:
| Participants will be told that the purpose of the study is to investigate the usability of abcd. However, the complete purpose of the study is to compare the usability of a new version of abcd with a previous versions of the same software. Participants will not be told that they will be randomly assigned to an experimental condition (using the new interface of abcd) or a control group (using the previous version of abcd). They will only be told the true purpose of the study in the debriefing and will be informed that they were randomly assigned to the experimental or the control group at this time. This partial disclosure with deception is necessary to avoid the probability that participants will guess the true purpose of the study and answer the questionnaire in a socially desirable manner regarding the efficiency of one version of abcd over another. (The debriefing and secondary consent form are attached for REB review). The likelihood of harm from the deception is minimal and participants will be informed of the necessity of the deception (in the debriefing form) and will have the opportunity to withdraw their data (secondary consent form). |
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Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
|
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|
|
Debriefing
|
Describe if, when and how participants will be debriefed. (Include a copy of any documents that will be provided to participants). Describe any risks during debriefing and how they will be mitigated.
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Detailed Instructions:
According to Tri-Council, debriefing is required in cases of deception, "whenever possible, practicable, and appropriate": www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter3-chapitre3/#ch3_en_a3.7a
Although debriefing will differ across projects, the goal should be to educate the participants, to undo any potential harm caused as a result of the study (e.g., by deception, embarrassment), and to provide resources for future reference. Debriefing is not always required. However, written debriefing is the norm when used in research.
Sample debriefing materials are available on research ethics website: carleton.ca/researchethics/forms-and-templates/
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|
Example #1:
|
Example #1:
| Participants will receive debriefing (attached). |
|
Example #2:
|
Example #2:
| Participants will receive a short oral debriefing (attached). A more detailed debriefing will be sent home for the parents/guardians (also attached). |
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Example #3:
|
Example #3:
| There will be no debriefing.
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|
|
|
Withdrawal Procedures
|
Describe the procedures for a participant to withdraw. What will happen to data from participants who withdraw? Describe any deadlines and limitations on withdrawal, during the study or after research participation is complete. Explain if compensation amount is affected by withdrawal.
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|
Detailed Instructions:
Generally, participants can withdraw at any time with no consequences to them but sometimes this is not possible. Are there any times when it would be unsafe for a participant to withdraw? (For example, if they are in the middle of an operation, or are tethered to dangerous equipment.)
Describe how the participant's request to withdraw will be managed.
Researchers must explain if withdrawal will affect the levels of compensation. If participants are receiving remuneration (e.g., paid) for participating in a study, they should still receive remuneration even if they withdraw. For multiple session studies in which participants are being paid a lump sum, they are entitled to the full amount. However, if a payment schedule is used for multiple sessions, then it is only necessary to pay participants in proportion to their participation.
|
|
Example #1:
|
Example #1:
| Participants can withdraw during the study and up to three months afterwards (at which point identifiers will be deleted). This withdrawal procedure will be clearly explained in the informed consent. |
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Example #2:
|
Example #2:
| Ottawa participants can withdraw at any time during the session by informing the researcher. There will be an alternative activity for children who withdraw from the study or do not assent to participate. Participants cannot withdraw after completion and mailing of survey, since received surveys are anonymous.
No new data will be collected from Hamilton participants. The deadline for withdrawal from phase one of the study was May 30, 2012. |
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Example #3:
|
Example #3:
| Participants will be informed (both verbally and in the written consent form) that they have the right to withdraw from the study without penalty during or after the interview. However, participants can only withdraw up to 4 weeks after completion of the study, as this is when data analysis begins. All data will be deleted after analysis. |
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8.
|
Methods: Data Collection
|
|
|
Data Collection Methods
|
Describe in detail the method of data collection being used and provide details of any instruments used. Breakdown by phases, participant groups, or types if required. Complete the section on "online data collection" if relevant. (Fully describe or include a copy of any questionnaires, surveys, interview guides, or other data collection instruments).
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|
Detailed Instructions:
Describe data collection methodologies used.
QUESTIONNAIRES/SURVEYS:
For online surveys:
What survey company/software will be used?
Is the host survey company Canadian-owned with servers based in Canada?
If not, in what country will the host data be stored?
If survey software is hosted at Carleton, provide details on the software and hosting setup/configuration.
Does the survey company collect IP addresses and if so, will the feature be disabled?
Please note: Some companies do not delete data from their servers even after it is transfered to the researchers.
CUREB recommends the following disclaimer language: "Your data will be stored and protected by [ORGANIZATION] in [SERVER LOCATION], but may be disclosed via a court order or data breach."
If the survey is not anonymous or is above minimal risk:
Describe the process for transferring the data from the host server to you and verification that the host server is no longer in possession of the data. (If you are using a US-based server you are required to inform participants that all data on those servers may be disclosed via a court order)
If using a standardized questionnaire:
Provide details on validity, etc.
Has permission been secured to use the questionnaire?
INTERVIEWS:
Provide a copy of the interview questions. (Questions must be provided even for semi-structured interviews.)
Describe data collection methodologies used.
Use this section to describe the interviews.
FOCUS GROUPS:
Provide a copy of the focus group questions.
Describe data collection methodologies used.
Use this section to describe the focus groups.
ORAL &/OR VISUAL STIMULI:
Provide a copy of all stimuli being used.
Describe data collection methodologies used.
Use this section to describe the stimuli.
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|
Example #1:
|
Example #1:
| The study will take place on laboratory computers. The researcher will introduce the purpose of the study and the interface for ABCD (verbal script is attached). In the first condition, participants will complete a series of online tasks using the new interface for ABCD (description of online tasks is attached). They will then use a link provided to access a Qualtrics survey which will ask them for feedback regarding their experience with ABCD. In the second condition, participants will complete a series of online tasks using the old interface for ABCD. They will then use a link provided to access a Qualtrics survey which will ask them for feedback regarding their experience with ABCD.
Questionnaire data will be stored and protected by Qualtrics, which has servers located in Toronto. Data may become disclosed via a court order or a data breach.
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|
Example #2:
|
Example #2:
| The survey that the parents complete will ask them short questions about the foods the child participants eat and the amount of exercise the children perform on a daily basis. The survey is a paper survey and responses will be anonymous. A copy of the survey is attached. |
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Example #3:
|
Example #3:
| Interviews will be conducted to learn how clinical social workers conceptualize, engage and enact social justice principles in their everyday assessment and treatment work in contemporary practice environments. A copy of the interview guide has been attached.
Interviews will also be conducted on Skype. Consequently, participants will be told in the informed consent that skype servers are located in the United States and are subject to U.S. laws on data privacy. |
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|
Location of
Participant Interactions
|
Where will the research procedures involving participants take place?
|
|
Detailed Instructions:
Specify where the research will take place. (Include room/lab number if known/applicable.)
If the location has special requirements, such as police checks for researchers, indicate it here. Provide a copy of all necessary documentation.
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Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
| Gymnasium and private offices at Alpha Kids Academy. (See attached letter of invitation from AKA.)
No new data will be collected from Hamilton participants. |
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Example #3:
|
Example #3:
| Interviews will be conducted both in person and via telephone/skype. When participants live/work in the Ottawa area or other nearby or accessible cities, face-to-face interviews will be conducted. These will take place at the Carleton University School of Social Work, the participant's office, or a mutually agreeable public space where an adequate amount of privacy and confidentiality would be provided (e.g., study room in a local library). |
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|
Frequency and Duration of Participant Interactions
|
How many times will you interact with participants? How long will each interaction take?
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Detailed Instructions:
If you interact only once with participants, estimate how long it will take?
If multiple interactions occur over time, explain how long each interaction is planned to take.
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Example #1:
| One interaction of 1 hour is planned. |
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Example #2:
| One interaction of 30 minutes |
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Example #3:
| One interaction of 90 minutes |
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|
|
Photography or Recordings
|
If the participant will be photographed, video-recorded or audio-recorded, indicate how the data will be acquired and protected. How will consent for recordings be obtained? Can participants opt out of recordings and still participate?
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|
Detailed Instructions:
How will participants be informed?
Will images appear in reports? If so, will the participants be identifiable?
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|
Example #1:
|
Example #1:
| Video recordings may be taken of user studies to document the user experience with ABCD. Participant consent will be obtained prior to conducting any video recording. Participants will be told in the informed consent that they may still participate if they do not wish to be video recorded. Footage will be saved on a password protected lab computer at Carleton University using participant ID numbers. Video will not be used in future publications. Original video footage will be destroyed post-analysis (one year after collection) as will the Master list with participant ID numbers. |
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Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
| We will audio-record the interview using a digital voice-recorder. Audio data will be saved on a password protected USB key and sent out for professional services (please see confidentiality agreement). Data will be deleted from the USB key and recorder when data has been verified (e.g., comparison between the audio data and transcriptions) and de-identified. Transcribed data will be saved on a password protected USB key. Both the USB key and the recorder will be stored in a locked cabinet in the PI's office (ABCD Carleton University). Participants will be made aware of the use and protection of audio-data in the informed consent. |
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|
Translation or Transcription
|
If you require the services of a translator or transcriber, describe what services you will use and how you will interact with the translator and/or transcriber. If a confidentiality agreement will be used, include a copy.
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Detailed Instructions:
Describe how you will hire / interact with the translator or transcriber.
Describe what steps will be taken to ensure the privacy and confidentiality of the participants. Please provide a copy of any confidentiality agreements.
Note: Include information on the destruction of any audio recordings related to the transcription. If you are not destroying the recordings explain why.
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|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
| Audio data will be saved on a password protected USB key and sent out for professional services to be transcribed (please see confidentiality agreement). Data will be deleted from the USB key and recorder when data has been verified (e.g., comparison between the audio data and transcriptions) and de-identified. Transcribed data will be saved on a password protected USB key. |
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|
|
Online data collection
|
Describe the software platform used for online data collection, and the security of data storage. Where will data be stored? Will participant IP addresses be recorded? Are there any special limitations on privacy?
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Detailed Instructions:
When researchers select an online survey tool or service, it is important for them to know and describe in their proposal the geographical location of the servers that host the survey and store participants’ data. The location of their server is often listed on the survey program main page. If not, researchers should contact the program administrator directly for this information.
Data anonymity and confidentiality may be vulnerable due to access from governments and companies. When data are stored outside of Canada, the researcher has less control over data protection. For example, data stored on servers based in the USA are subject to the United States Patriot Act that permits US law enforcement officials to seek a court order that allows access to the personal records of any person without that person’s knowledge.
Given this, if the risk to the participants of such a data breach are significant, researchers should explain the data storage in the informed consent. For example, this requirement would differ depending on whether the survey is anonymous and/or the survey topic sensitive or not.
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|
Example #1:
|
Example #1:
| Questionnaire data will be stored on a secure website, Qualtrics. Qualtrics employs multiple layers of security to make sure that data remains private and secure. All surveys created are placed in a Secure Survey Environment (SSE) and the web pages are encrypted with secure socket layer (SSL). Only persons with authorized access to a survey account can download the data from this server. Qualtrics is SAS 70 certified and meets the rigorous privacy standards imposed on health care records by the Health Insurance Portability and Accountability Act (HIPAA). All Qualtrics accounts are protected by password-access, and Qualtrics employees will not access the protected accounts without express permission by the account owner. The Qualtrics server is located in the U.S. and subject to U.S. laws on data privacy. All responses will be anonymous. Researchers will disable the option in Qualtrics to collect IP addresses. |
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Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
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|
|
Biological specimens or fluids
|
Describe the apparatus and methods to collect biological specimens or fluids (e.g., blood, saliva, tissue samples).
How will specimens be stored? If any will be retained or transferred to another institution/research group, explain the research purpose, and plans for eventual destruction, if any.
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Detailed Instructions:
|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
| The saliva samples will be taken at the school and, once transported back to Carleton, will be stored in the lab of the lead researcher.
A request for biohazards clearance has also been submitted.
Hamilton samples have already been collected. They will be sent to Carleton University by courier where they will be stored in the lab of the lead researcher for a period of two years. Please see the research agreement attached. |
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Example #3:
|
Example #3:
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|
|
Biological or physical interventions
|
Describe any drugs, devices or diagnostic apparatus being studied or used, or any physical or physically intrusive research interventions, such as sending energy into the body (e.g. electrodes, MRI/X-ray), or physiological activities (e.g. exercise or stress). Explain any risks to the participants and compare the dose to established safety standards.
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|
Detailed Instructions:
|
Bio-instruments include wristbands and other worn sensors. The category would also include in-home sensors. Other examples include novel medical instruments, intense exercise, and stress-provoking scenarios
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|
Example #1:
|
Example #1:
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Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
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|
|
Risk of Psychological Harm
|
Explain the nature, magnitude and probability of these risks and how they will be mitigated.
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|
Detailed Instructions:
If the magnitude of psychological harm was rated mild, moderate, or extreme, please answer the following:
1. Describe the magnitude of psychological risks.
2. Indicate how likely the psychological risks are to occur.
3. Describe how the psychological risks will be mitigated.
If available, provide evidence (e.g., past research, experience, clinical opinions) in support of the psychological harm probability rating.
Magnitude:
This item addresses two dimensions: First, the extent to which participants may feel uncomfortable, demeaned, embarrassed, anxious or upset and second, the degree of personal intrusiveness associated with the research. Importantly, researchers are to consider the potential for psychological harm during any stage of the research (e.g., recruitment, informed consent, screening, actual data collection, debriefing, follow-ups, publication). Researchers should also consider psychological harm to the research team.
- none or not applicable (research is not sensitive nor personally intrusive in any way. For example, participants are presented with a row of numbers and are asked to indicate which numbers are even or odd, or participants are required to rate the effectiveness of a new ergonomically designed keyboard)
- mild (research is mildly sensitive or personal. For example, the participants are asked to report their attitudes (e.g., how much they support or agree with a series of statements) about a sensitive topic (e.g., religion, politics, the sex trade, pro life/choice, crime)
- moderate (research is moderately sensitive or personal in nature. For example, the participants are asked to self-report personal information about themselves (e.g., existence of physical or mental health diagnoses, abuse history) or self-report sensitive behaviours that they themselves have engaged in such as abusing alcohol/drugs, cheating, criminal conduct, criminal activity).
- high (research is extremely sensitive or personal in nature or expected to induce upsetting emotions. Some examples include using visual/audio recording of sexually explicit images or messages of rape, visual images intentionally designed to invoke disgust, the intentional
manipulation of attitudes/emotions in short term (e.g., Trier Stress Test), or the long term (clinical intervention to change attitudes or behaviours, interviewing terminally ill individuals about their views about doctor-assisted suicide).
Probability:
- low (less than 1 in 100 participants are expected to experience harm)
- moderate (between 2 and 5 participants out of 100 are expected to experience harm)
- high (more than 6 participants out of 100 are expected to experience harm)
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|
Example #1:
|
Example #1:
| The study does not involve psychological risks which exceed risks encountered in daily life. |
|
Example #2:
|
Example #2:
| 1. The magnitude of any psychological risks is expected to be mild with some participants questioning their food choices.
2. The likelihood of the risks occurring are very low with this age of participants.
3. If any participant appears to be in distress, the researcher will speak with the participant and bring them to the school counselor if needed.
The lead researcher has conducted many similar studies with this age group and has not had any occurrences of any participants experiencing psychological risks. There are not expected to be any psychological risks in asking anyone to complete a form as the questions are innocuous.
There are no psychological risks for Hamilton participants as the data collection phase has ended. |
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Example #3:
|
Example #3:
| The topics discussed in interviews are not considered to be any more emotionally challenging than professional social workers experience in their everyday lives. Regardless, we will emphasize that participation is completely voluntary and will not result in any negative consequences. If emotional distress occurs, we will refer participants to the appropriate Health Services.
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Risk of Physical Harm
|
Explain the nature, magnitude and probability of these risks and how they will be mitigated.
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|
Detailed Instructions:
If the magnitude of physical harm was rated mild, moderate, or extreme, please answer the following:
1. Describe the magnitude of physical risks.
2. Indicate how likely the physical risks are to occur.
3. Describe how the physical risks will be mitigated.
If available, provide evidence (e.g., past research, experience, clinical opinions) in support of the physical harm probability rating.
Magnitude:
This item considers the degree of physical invasiveness and the degree of physical harm associated with medical procedures, the administration of a physically painful
stimulus, or the ingestion of a substance. Importantly,
researchers are to consider the potential for physical harm during any stage of the research (e.g., recruitment, informed consent, screening, actual data collection,
debriefing, follow-ups). Researchers should also consider physical harm to the research team (e.g., possibility of torture or incarceration when conducting research in an unstable region).
- none or not applicable (e.g., procedures involve self-report questionnaires, height/weight measurements, heart rate, blood pressure, temperature, galvanic skin response)
- mild (e.g., procedures involve saliva samples, startle blink reflex, electrodes)
- moderate (e.g., procedures may cause nausea, involve moderate level exercise, brief blood draw via pin prick)
- high (e.g., procedures involve intense or lengthy exercise designed to promote fatigue, lengthy intravenous blood draw, use of invasive catheters, procedures that are painful, may result in injury, death, torture or incarceration)
Probability:
- low (less than 1 in 100 participants are expected to experience harm)
- moderate (between 2 and 5 participants out of 100 are expected to experience harm)
- high (more than 6 participants out of 100 are expected to experience harm)
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Example #1:
|
Example #1:
| The study does not involve physical risks which exceed risks encountered in daily life (sitting at a computer to complete a 20 minute task). |
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Example #2:
|
Example #2:
| 1. The magnitude of any physical risks is expected to be mild with some participants possibly possibly tripping.
2. The likelihood of the risks occurring are very low as jumping jacks are a mild form of exercise that this group regularly participates in as part of gym class.
3. Participants will be separated from other participants so the risk of hurting themselves is less likely. Jumping jacks will also only be performed on padded mats to reduce any possibility of serious injuries.
The lead researcher has conducted many similar studies with this age group and has not had any occurrences of any participants experiencing any physical risks.
There are no physical risks for Hamilton participants as the data collection phase has ended. |
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Example #3:
|
Example #3:
|
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|
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Risk of Social and/or Economic Harm
|
Explain the nature, magnitude and probability of these risks and how they will be mitigated.
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|
Detailed Instructions:
If the magnitude of social and economic harm was rated mild, moderate, or extreme, please answer the following:
1. Describe the magnitude of social and economic risks.
2. Indicate how likely the social and economic risks are to occur.
3. Describe how the social and economic risks will be mitigated.
If available, provide evidence (e.g., past research, experience, clinical opinions) in support of the social and economic harm probability rating.
This item considers the magnitude of social harm (e.g., loss of status, reputation, stigma, or privacy) as well as economic harm (e.g., financial loss, legal risk following disclosure of duty-to-report events).
Importantly, researchers are to consider the potential for
social or economic harm during any stage of the research (e.g., recruitment, informed consent, screening, actual data collection, debriefing, follow-ups, publication). Researchers should also consider social and economic harm to the research team (e.g., animal rights activist
vandalizes researcher’s office door or holds demonstrations outside research facility).
- none or non-applicable (e.g., research is completely anonymous, researcher has no face-to-face interaction with participants)
- mild (e.g., personal identifiers collected and research
covers mildly sensitive topics that if breached would not result in social or economic harm)
- moderate (e.g., personal identifiers collected and research covers moderately sensitive topics that if breached would result in some social/economic harm—passed up for promotion, detained temporarily by
the authorities)
- high (e.g., participant identifiers collected and if a data breach occurred serious social/economic harm would
result such as job loss, reputational damage, civil/criminal litigation, or incarceration)
Probability:
- low (less than 1 in 100 participants are expected to experience harm)
- moderate (between 2 and 5 participants out of 100 are expected to experience harm)
- high (more than 6 participants out of 100 are expected to experience harm)
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|
Example #1:
|
Example #1:
| The study does not involve social/economic risks which exceed risks encountered in daily life.
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Example #2:
|
Example #2:
| There are not expected to be any social or economic risks in asking anyone to complete a form as the questions are innocuous and the survey is anonymous. Saliva, blood pressure, and heart-rate samples will be coded to protect the privacy of each participant.
There are no economic/social risks for Hamilton participants as the data collection phase has ended. Data are permanently stripped of identifiers. |
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Example #3:
|
Example #3:
| Given that the PI's position as a clinical social worker who also holds a university faculty position, some participants might feel intimidated or perhaps insecure when discussing their clinical practice. Participants will be reminded that there are no right or wrong answers to the questions asked of them. Furthermore, the research is voluntary, confidential, and will not result in any negative consequences, including future professional relationships. |
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Incidental Findings
|
Describe possible incidental findings and how they will be managed (e.g. becoming aware of abuse of a child, imminent harm to a participant or third party, or potentially significant clinical findings). Any resulting limitations of confidentiality should be communicated to participants.
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Detailed Instructions:
Incidental findings are unanticipated discoveries that affect the welfare of participants or others, but are unrelated to the study objectives.
If there is a possibility of discovering information about abuse of a child, or imminent harm to a participant or third party, Canadian law (and sometimes professional practice) imposes a "duty to report". CUREB recommends the following language in the consent form: "All data will be kept confidential, unless release is required by law (e.g. child abuse, harm to self or others)". Your approach to managing any findings should also be described in the informed consent.
Other examples include becoming aware of possible health risks (via DNA or device testing) to the participants.
Additionally, is there a likelihood that information on a participant may be requested via a subpoena? If so, how will you handle this? The participants must be made aware of your approach in your informed consent.
The TCPS2 provides guidance on cases in which when the researcher's ethical duty of confidentiality must give way to their ethical duty to disclose information: www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter5-chapitre5/#toc05-1b
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|
Example #1:
|
Example #1:
| The research team does not anticipate any incidental findings. |
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Example #2:
|
Example #2:
| Researchers will be working with children. It is possible that the researcher may learn of past or ongoing child abuse. If such information became known, the researcher has a duty to disclose the information to the local authorities and the Children's Aid Society. The procedure for breaking confidentiality is outlined in the informed consent. |
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Example #3:
|
Example #3:
| Participants will be reminded in the informed consent of the PI's professional duty to report in cases of suspected child abuse (children 15 and under) and/or potential harm to self/others. Furthermore, provided that any research records can later be subject to subpoena or court order about illegal activities if such activities are discussed during the interviews, I will make sure to de-identify the data (i.e., transcripts) to protect the participants' privacy. |
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9.
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Methods: Data Storage and Analysis
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Identifiability
of collected data
|
Describe the identifiability of research data at the point of data collection.
If there are different levels of anonymity for different groups, describe.
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|
Detailed Instructions:
|
Example #1:
|
Example #1:
| Data are collected in person from participants recruited through the SONA student pool. |
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Example #2:
|
Example #2:
| Survey responses will be anonymous.
Data provided by child participants will be identifiable during data collection. |
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Example #3:
|
Example #3:
| When potential participants contact the researcher, their identifying information (e.g., pseudonym, phone number, Skype ID, email address) will be saved in a password protected and USB key, which will be stored in a locked cabinet in the PI's office. |
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|
|
|
Identifiability
of stored data
|
Describe the identifiability of stored research data. If a link to participant identities is retained (e.g. to permit compensation or withdrawal), also explain storage of linking data. Describe the process of anonymization if applicable.
|
|
Detailed Instructions:
|
Example #1:
|
Example #1:
| Participants will be assigned a code number during analysis to identify video recordings. Participant names will be retained for three months to allow withdrawal and compensation of participants. After this deadline, the Video recordings and participant ID codes will be deleted. Questionnaires completed on Qualtrics will be downloaded and the link to identities deleted after this deadline. |
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Example #2:
|
Example #2:
| Survey responses will be anonymous.
Data provided by child participants during the jumping jacks, blood pressure and saliva samples will be coded so no child will be identifiable in any research reports.
The Hamilton data set is anonymized. |
|
Example #3:
|
Example #3:
| After data collection, each participant will be given a code name, and the transcripts will be labelled with this code name. Interview transcripts will be altered to remove all names and identifying information (e.g., where they work). Once interview data are transcribed, verified, (e.g., comparison between the audiorecorded interviews and transcriptions have been made), and de-identified, the audio data will be destroyed. |
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|
|
Identifiability
of published data
|
Describe the identifiability of data that will appear in publications, including how pseudonyms will be assigned, if applicable.
If there are different levels of anonymity for different groups, describe each level here.
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|
Detailed Instructions:
Describe the identifiability of participants in the published data. Possibilities are
- Be anonymous
- Pseudonymous (responses non-attributable)
- Be identified, where
a) Responses and data will be attributable to participants.
b) Responses and data will be non-attributable to participants.
c) Participants will have selected responses remain non-attributable.
Some projects have different categories of participants with different levels of anonymity.
Optional Anonymity: Participants may be given the option in the consent form of choosing if they would like to be identified or not. They do not, however, have the option of being identified afterwards (if anonymity has already been promised to all participants).
|
|
Example #1:
|
Example #1:
| Reports and presentations will include anonymized data only. |
|
Example #2:
|
Example #2:
| Survey responses will be anonymized.
Data provided by child participants during the jumping jacks, blood pressure and saliva samples will be coded so no child will be identifiable in any research reports.
The Hamilton data set is anonymized. Comparisons between the Hamilton and Ottawa data sets will not reveal any identifying information in research reports. |
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Example #3:
|
Example #3:
| Responses will be non-attributable. Participants will be assigned a code number during analysis. Reports on the research will be average responses. |
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|
|
|
Data Storage (during the project)
|
How will data be stored and kept safe. Provide details for each type of data (e.g. raw data, contact lists, consent documents, anonymized data, recordings and images, electronic data and paper documents).
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|
Detailed Instructions:
Describe the details of data storage, including its location and any software used to provide data security (including backups of data or passwords/security keys). The more risks involved in the project, the more secure the data needs to be. (Typically, the highest standard of data security is encrypted storage. For sensitive data in which data breach implies significant risks to participants, special data storage and transport arrangements may be required.)
If you have to travel with the data, will there be additional steps taken to protect it?
Hard copies of data:
- Where will the data be stored?
- Who will have access to it?
- Is it under lock and key?
Electronic data:
- Where will the data be stored?
- Where are the servers located?
- Will the computer be password-protected? (USB keys cannot be password-protected.)
- Will the data be encrypted? If so, what software will be used and what steps will be taken to encrypt the data?
Cloud storage options (dropbox, google drive, etc) are generally poor. If you wish to use these, justify why they are necessary, based on the project requirements and risks.
According to Carleton University Computing and Communications Services, all sensitive and confidential information must be protected from unauthorized access or encrypted should it be stored on the following portable media devices: USBs, memory cards, removable or external hard drives and CDs/DVDs, Smartphones, tablets, or iPods: carleton.ca/fasscsu/wp-content/uploads/Handling-of-Personal-Information-Sensitive-Data.pdf
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|
Example #1:
|
Example #1:
| Data is stored on password protected lab computers at Carleton University. |
|
Example #2:
|
Example #2:
| Data are anonymized and will be stored on password-protected computers in Lab A43 that only the research team has access to. Paper based surveys will be stored in a locked filing cabinet in the researcher's office. The anonymized data set will also be stored electronically on password protected computers in Lab A43.
The coding list for the Ottawa data set will be kept separate from all other data and will be stored on an encrypted USB stick purchased from CCS, kept in a locked filing cabinet in the researcher's office. There is no coding list for the anonymized Hamilton data set.
The saliva samples will be taken at the school and, once transported back to Carleton, will be stored in the lab of the lead researcher. The saliva samples from Hamilton will be transported by courier to Carleton and stored in the lab of the lead researcher. Please see research agreement attached. |
|
Example #3:
|
Example #3:
| Audio-data will be stored on a password protected USB key in the PI's locked office. The audio-recorder will be stored in a locked cabinet in the PI's office. Data will be deleted from the USB key and recorder when data has been verified (e.g., comparison between the audio date and transcriptions) and de-identified. Transcribed, de-identified data will be saved on a password protected USB key and also stored in a secure, encrypted server provided by Dedoose (www.dedoose.com). This online server is protected by a personal password, and we will change the personal password every two weeks to ensure data security. All other paper based data will be stored in a locked cabinet in the PI's office. |
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|
|
Data Disposition (after the project)
|
After project completion, describe whether and how the data will be stored for future use. If shared, with whom? If made public, how (e.g. online)? If archived, provide details. Describe any restrictions on access. Will personal identifiers be deleted and when? If data will be destroyed, when? Will participant contact information be kept for future recruitment? (Include data disposition plans in the consent materials)
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|
Detailed Instructions:
After analysis and completion of report), what will happen to data? In the view of the REB, the participants time is typically best valued by retaining archived data, as long as it is properly stored and anonymized. It is also acceptable to destroy data; this is a decision for the researcher in the context of the research. Note that some journals, as a condition of publication, insist that data be made publicly available indefinitely to allow replication or future research.
Returned to participants:
- When will it be returned to participants?
- How will it be returned to the participants? (Electronically? By mail?)
Data to be stored and for possible use in future projects:
- How will the data be stored? (If different from response to previous question.)
- What is the anticipated use of the data in the future?
- Will identifiers be removed, and how?
- Are the data to be used for the same topic?
- Will data be made publicly available to other researchers?
Destroyed with no future use of data:
- When will the data be destroyed?
- How will the data be destroyed? (Shredded? Formatted? Other?)
If biological samples are acquired (e.g. saliva), the planned storage / destruction / sharing of these samples should be described.
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|
Example #1:
|
Example #1:
| Anonymized data will be stored for possible future on the same topic; data will be stored on password protected lab computers. Identifiable data (video recordings and participant ID codes will be destroyed after one year). |
|
Example #2:
|
Example #2:
| We will audio-record the interview using a digital voice-recorder. Audio data will be saved on a password protected USB key and sent out for professional services (please see confidentiality agreement). Both the USB key and the recorder will be stored in a locked cabinet in the PI's office (ABCD Carleton University). Data will be deleted from the USB key and recorder when data has been verified (e.g., comparison between the audio data and transcriptions) and de-identified. Transcribed data will be saved on a password protected USB key for a period of two years, when it will be deleted. The Master List and Ottawa saliva samples will be destroyed after two years. |
|
Example #3:
|
Example #3:
| Electronic data will be deleted after five years. Paper based data (e.g., consent forms, demographic forms) will also be shredded after five years, after the completion of the study. |
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|
|
|
Sharing Study Results
|
Do you intend to share a report (or summary) of the research findings with participants once the study is complete? (Include response box for explanation). If yes, include this option in the consent form.
|
|
Detailed Instructions:
|
Example #1:
|
Example #1:
| This study does not specifically involve indigenous participants. |
|
Example #2:
|
Example #2:
| This study does not specifically involve indigenous participants. |
|
Example #3:
|
Example #3:
| This study does not specifically involve indigenous participants. |
|
|
|
|
Data Breach
Risks
|
Describe the likelihood of a data breach and the resulting risks to participants. If risks are significant, how will they be mitigated?
|
|
Detailed Instructions:
For example, what if the server on which the data was stored became compromised? What if the data became searchable on the internet? The participant's privacy may be compromised by a breach and the level of risk to the participant will vary based on the level of psychological, physical, social and economic risk within the study.
(Probability is the researcher's best guess as to the likelihood of identified risk outcomes.)
|
|
Example #1:
|
Example #1:
| Data breach risk is minimal. As no personal information is being asked of the participants, any effects from a breach would be minimal as the study does not involve any psychological, physical and social/economic risks to the participant. |
|
Example #2:
|
Example #2:
| The risk of a data breach risk is minimal because the saliva, blood pressure and heart rate samples are coded and the master list is stored separately. The harm caused by a data breach would be mild as the study contains mild risks.
The Hamilton data set has been permanently stripped of identifiers and the affects of a data breach would also be minimal. |
|
Example #3:
|
Example #3:
| Data breach is unlikely, because the data is coded. The Master List is stored separately. However, the study involves mild social/economic risk to participants and they we anticipate mild risks should a breach occurs.
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10.
|
Funding and Approvals
|
|
|
Project Funding
|
Who is funding this project? If applicable, include the funding source/agency/company, program, award name, and number (from CUResearch). Note if the researcher applied for a release of funds for this project funding.
|
|
Detailed Instructions:
The REB uses information on funding in cases where there is an appearance of conflict of interest.
Note that it is not unethical to receive funding from, for example, a company which benefits from the research; however, the participants need to be aware of the funding source.
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|
Example #1:
|
Example #1:
| Funding from NSERC Engage grant in collaboration with XYZ company. XYZ is currently selling the previous version of ABCD. |
|
Example #2:
|
Example #2:
| CIHR funding with matching funds from PharmaKids |
|
Example #3:
|
Example #3:
| The researcher has internal funding from Carleton University. |
|
|
|
|
Researcher Funding (for research contracts and personal consulting only)
|
For research that will pay personal income to any researcher: how will any resulting conflicts of
interest be managed? How much funding (dollar amount and the percentage of the total) will the researcher(s) receive as income? Provide the title and date of any contracts. (The REB may review the contract.)
|
|
Detailed Instructions:
List who will be receiving any funds directly, how much they will receive, and indicate the percentage of the total funding awarded.
The REB uses this information to inform decisions on conflict of interest. While it is not unethical to receive personal income, the possibility for a conflict of interest must be considered.
|
|
Example #1:
|
Example #1:
| The supervisor is receiving $5000 from XYZ company. $1000 will be used for research purposes over the course of one year. The supervisor will receive $4000 as a personal stipend.. |
|
Example #2:
|
Example #2:
| Contract attached. Researcher will receive personal stipend of $10,000 over the course of two years. |
|
Example #3:
|
Example #3:
|
|
|
|
Additional Approvals Required
|
Is organizational permission required to conduct research (e.g., schools, employers, other universities, correctional services, indigenous communities, or other data collection locations)? If conducting research in another country, is local permission, including local ethics review, required? Indicate if permission/approval has been secured and provide a copy. Research with biohazards or animals must also secure approval from the appropriate committee at Carleton University.
|
|
Detailed Instructions:
|
Example #1:
|
Example #1:
| No other approvals required |
|
Example #2:
|
Example #2:
| The Principal of Alpha Kids Private Academy has given permission for the researchers permission to recruit. (See attached email confirmation.) |
|
Example #3:
|
Example #3:
| The participant will be contacted at their place of work. Permission has been obtained from the employer. See attached.
|
|
|
|
|
TCPS Tutorial
|
TCPS CORE Tutorial training is required for all researchers listed on the protocol. Justify any cases where researchers have not completed the TCPS tutorial
|
|
Detailed Instructions:
|
CUREB requires researchers to complete the TCPS tutorial, unless appropriate justification is available (www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel)
|
|
Example #1:
|
Example #1:
| All researchers have completed the TCPS, except for ABC (Based at the Australian National University), who has completed equivalent training (DEF) and will only participate in analysis of the data |
|
Example #2:
|
Example #2:
| The researcher has not completed the TCPS2 tutorial. |
|
Example #3:
|
Example #3:
| Completed the TCPS tutorial. |
|
11.
|
Declarations
|
|
|
Supervisor Approval
|
For student projects, please indicate the date that the supervisor approved the application. Such approval indicates that the supervisor has read the entire submission and associated documentation, and is satisfied that the project is appropriately prepared and meets applicable disciplinary standards.
|
|
Detailed Instructions:
|
Supervisors can indicate approval by: 1) emailing their approval to ethics@carleton.ca, 2) completing the supervisor signature form and attaching it to the protocol.
|
|
Example #1:
|
Example #1:
| Supervisor approved the application on September 1, 2015. Prof. Brown signed the supervisor signature form (attached). He will also be copied on all correspondence with the REB. |
|
Example #2:
|
Example #2:
| Not applicable - faculty research |
|
Example #3:
|
Example #3:
| Supervisor approved the application on September 1, 2015. The supervisor will be copied on all correspondence with the REB. |
|
|
|
|
Declaration #1
|
This ethics application accurately describes the research project or scholarly activity that I plan to conduct.
|
|
Detailed Instructions:
|
The researcher must declare their agreement with this statement.
|
|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
|
|
|
|
Declaration #2
|
No recruitment or data collection for this protocol will commence before ethics clearance.
|
|
Detailed Instructions:
|
The researcher must declare their agreement with this statement.
|
|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
|
|
|
|
Declaration #3
|
No changes will be made to the research project as described in this protocol without receiving clearance from the Research Ethics Board.
|
|
Detailed Instructions:
|
The researcher must declare their agreement with this statement
|
|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
|
|
|
|
Declaration #4
|
The Research Ethics Board will be notified immediately of any alleged or real ethical breaches or concerns, adverse events, or participant complaints that arise during or after the course of this research project.
|
|
Detailed Instructions:
|
The researcher must declare their agreement with this statement
|
|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
|
12.
|
Comments
|
|
|
Comments (optional)
|
Do you have any comments or suggestions on the form
|
|
Detailed Instructions:
|
This section is for comments and suggestions on this form or the ethics process.
|
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|
Example #1:
| Here are some suggestions |
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|
Example #2:
|
|
Example #3:
| Here are some suggestions |
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