CUREB A&B: Research Ethics Form – Detailed Instructions

1.

Project Team

1A.

Lead Researcher
Instructions:
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.
Example #1:
Academic Staff
Library or Other Staff
Post-doctoral Fellow
Ph.D. Student
Master's Student
Undergraduate
Student Association/Club
Other
Example #1:
MAY, Sally, Undergraduate Student, Computer Science, Carleton University, maysally@cmail.carleton.ca
Example #2:
Academic Staff
Library or Other Staff
Post-doctoral Fellow
Ph.D. Student
Master's Student
Undergraduate
Student Association/Club
Other
Example #2:
SMITH, Jim, Academic Staff, MacOdrum Library, Carleton, jim.smith@carleton.ca
Example #3:
Academic Staff
Library or Other Staff
Post-doctoral Fellow
Ph.D. Student
Master's Student
Undergraduate
Student Association/Club
Other
Example #3:
DOE, Jane, Master's Candidate, School of Social Work, Carleton University, janedoe@cmail.carleton.ca

1B.

Academic Supervisor
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.
Example #1:
Same as lead researcher
Example #1:
BROWN, Dan, dan.brown@carleton.ca, research supervisor, professor in Computer Science at Carleton.
Example #2:
Same as lead researcher
Example #2:
No academic supervisor
Example #3:
Same as lead researcher
Example #3:
Smith/John, john.smith4@carleton.ca, research supervisor, professor in Social Work at Carleton.

1C.

Project Team Members
Instructions:
List the project team members here, including collaborators, research assistants, etc.

Example #1:
Not applicable/No other team members
Example #1:
N/A
Example #2:
Not applicable/No other team members
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

Example #3:
Not applicable/No other team members
Example #3:
Truman/Harriet, co-PI, assistant professor in Social Work at Carleton, harriet.truman@carleton.ca.

1D.

Researcher Training
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.
Example #1:
No training provided/Not applicable
Researcher will be trained
Researcher is trained
Example #1:
Researcher has no specific training.
Example #2:
No training provided/Not applicable
Researcher will be trained
Researcher is trained
Example #2:
The researcher has first aid training and has over 10 years of experience conducting studies with school-age children.
Example #3:
No training provided/Not applicable
Researcher will be trained
Researcher is trained
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.

2.

Study Overview

2A.

Project Title
Instructions:
Indicate the full title of the research project.
Example #1:
Does a new software user interface make computer users more productive?
Example #2:
Stress and obesity levels in children (Phase Two)
Example #3:
Clinical Social Work Practice within a Social Justice Framework: Developing an Empirically-Informed Model (Pilot Study)

2B.

Study Goal
Instructions:
What is the specific goal of this research project? Briefly describe it in 1-2 sentences.
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.
Example #2:
Do stress levels predict obesity in school-age children.
Example #3:
How do clinical social workers employ social justice principles in the provision of therapeutic assessment and treatment?

2C.

Study Purpose and Benefits
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.
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.
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.
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.

2D.

Dates of Recruitment/Participant Interaction
Instructions:
The exact dates may not be known. Provide estimates in this case.

Recruitment dates are not required for secondary data analysis.
Example #1:
Not applicable/Secondary Data
Example #1:
01/01/2016
to
31/03/2016
Example #2:
Not applicable/Secondary Data
Example #2:
2/2/2016
to
01/04/2016
Example #3:
Not applicable/Secondary Data
Example #3:
01/01/2016
to
31/12/2016

2E.

New or Previously Recorded Data
Instructions:
Note: secondary analysis requires ethics clearance, except when data are truly anonymous).

Secondary analysis categories are as follows:

- Anonymous: information never had identifiers associated with it.

- Coded: direct identifiers are removed and replaced with a research code. The master list that links direct identifiers to research codes is maintained separately so that the personal identifiers can be
relinked. If the master list will be destroyed, that should be explained later in the protocol.

-De-identified: data is anonymized so that identifiers are removed. A code is not kept to re-link the data to identifiers.

- Indirectly Identified: Includes identifiers such as date of birth, place of residence, and email address.
- Directly Identified: Includes identifiers such as names, social insurance numbers, and student identification numbers.

NOTE: If the research only involves secondary analysis of anonymous (not anonymized) data, you do not need REB clearance to proceed. If in doubt, ask us at ethics@carleton.ca.
Example #1:
Primary Analysis (New Data are Collected)
Secondary Analysis of Directly Identifying Data
Secondary Analysis of Coded or De-identified Data
Example #1:
Interactions with participants will take place by observing them complete a 20 minute task using either the new or old version of ABCD. This study will collect new information based on the participant's experiences with the new or old version of ABCD.
Example #2:
Primary Analysis (New Data are Collected)
Secondary Analysis of Directly Identifying Data
Secondary Analysis of Coded or De-identified Data
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.
-The researcher has also been given access to the anonymized data set from Phase One. This data is provided by Tim Smith, Faculty Member, McMaster University. The anonymized data set contains previously collected saliva samples and heart-rate measurements from 200 elementary students in Hamilton (students were in grades 1-6). The research agreement for the 2012 data set is attached.
Example #3:
Primary Analysis (New Data are Collected)
Secondary Analysis of Directly Identifying Data
Secondary Analysis of Coded or De-identified Data
Example #3:
We will interact with the participants in the form of in-depth interviews in person, by phone, or by skype.


2F.

Additional Reviews
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.
Example #1:
No additional review
Departmental review
Grant council review
Example #1:
This protocol was reviewed by NSERC.
Example #2:
No additional review
Departmental review
Grant council review
Example #2:
CIHR Review.
Example #3:
No additional review
Departmental review
Grant council review
Example #3:
Reviewed within the School of Social Work for an internal award.

3.

Funding and Approvals

3A.

Project Funding
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.
Example #1:
Unfunded
Tri-Council Funded
Other Award/Grant
Contract Funded
Personal Consulting or Personal Work
Scholarship
Example #1:
Funding from NSERC Engage grant in collaboration with XYZ company. XYZ is currently selling the previous version of ABCD.
Example #2:
Unfunded
Tri-Council Funded
Other Award/Grant
Contract Funded
Personal Consulting or Personal Work
Scholarship
Example #2:
CIHR funding with matching funds from PharmaKids
Example #3:
Unfunded
Tri-Council Funded
Other Award/Grant
Contract Funded
Personal Consulting or Personal Work
Scholarship
Example #3:
The researcher has internal funding from Carleton University.

3B.

Researcher Funding (for research contracts and personal consulting only)
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:
Not applicable/Not contract funded research
No funds are paid directly to the researcher as personal income
The researcher will receive a portion of the funds as personal income
A copy of the contract/agreement has been submitted to the Research Compliance Office
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:
Not applicable/Not contract funded research
No funds are paid directly to the researcher as personal income
The researcher will receive a portion of the funds as personal income
A copy of the contract/agreement has been submitted to the Research Compliance Office
Example #2:
Contract attached. Researcher will receive personal stipend of $10,000 over the course of two years.
Example #3:
Not applicable/Not contract funded research
No funds are paid directly to the researcher as personal income
The researcher will receive a portion of the funds as personal income
A copy of the contract/agreement has been submitted to the Research Compliance Office
Example #3:
N/A

3C.

Minimal Risk Review Request
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."
Example #1:
No
Yes
Example #1:
The participant group is not exposed to any more risk than they would experience in their daily lives as Computer Science students.
Example #2:
No
Yes
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.)
Example #3:
No
Yes
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.

3D.

Additional Approvals Required
Instructions:
For more information, visit the following web pages:
Biohazards: carleton.ca/curo/ethics-and-compliance/biohazards/biohazards-review-process/

Animal Care: carleton.ca/curo/ethics-and-compliance/animal-care/animal-care-committee/

Example #1:
Not applicable/No other approvals required
Organizational Permission
Visa/Travel Permits
Other REBs or Institutional Approvals
Biohazards
Animal Care Committee
Other (please specify)
Permission letters attached
Letters to follow
Example #1:
No other approvals required
Example #2:
Not applicable/No other approvals required
Organizational Permission
Visa/Travel Permits
Other REBs or Institutional Approvals
Biohazards
Animal Care Committee
Other (please specify)
Permission letters attached
Letters to follow
Example #2:
The Principal of Alpha Kids Private Academy has given permission for the researchers permission to recruit. (See attached email confirmation.)
Example #3:
Not applicable/No other approvals required
Organizational Permission
Visa/Travel Permits
Other REBs or Institutional Approvals
Biohazards
Animal Care Committee
Other (please specify)
Permission letters attached
Letters to follow
Example #3:
The participant will be contacted at their place of work. Permission has been obtained from the employer. See attached.

4.

Methods: Participants

4A.

Participant Interactions Overview
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)
Example #1:
Directly interacting with participants
Interacting with participants online (e.g. online surveys)
Observing participants
Secondary Analysis of Data
Other
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).
Example #2:
Directly interacting with participants
Interacting with participants online (e.g. online surveys)
Observing participants
Secondary Analysis of Data
Other
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.
Example #3:
Directly interacting with participants
Interacting with participants online (e.g. online surveys)
Observing participants
Secondary Analysis of Data
Other
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.

4B.

Description of Participants
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.

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.
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.
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

4C.

Number of Participants
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.

If the number increases during your research, you must inform the REB.
Example #1:
100 participants will complete the user study. This number of participants is requested to ensure that researchers can effectively compare the efficiency of users who complete tasks using the two versions of abcd.
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.)
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.

4D.

Vulnerable Population
Instructions:
Are there any pre-existing vulnerabilities associated with the proposed group's participation in the study that may have a bearing on the likelihood that a member of this group might experience physical, psychological, social or economic harm as a result of participating in the research?

Vulnerable groups may include hospital patients, prisoners, marginalized groups in society, and aboriginal populations.

If the participant group is considered a vulnerable population, explain the vulnerability, associated risks, and the mitigation strategy.

Tri-Council is commited to protecting vulnerable research populations: www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter4-chapitre4/#toc04-1b
Example #1:
Not Vulnerable Population
Vulnerable Population
Example #1:
Participants are undergraduate students are not considered vulnerable.
Example #2:
Not Vulnerable Population
Vulnerable Population
Example #2:
Children are a vulnerable group 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.).
Example #3:
Not Vulnerable Population
Vulnerable Population
Example #3:

Clinical social workers are not considered a vulnerable population.

4E.

Participant Relationship to Researcher
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.
Example #1:
No previous relationship
Instructor-Student
Client
Employee
Friends/Family
Other
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:
No previous relationship
Instructor-Student
Client
Employee
Friends/Family
Other
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.
Example #3:
No previous relationship
Instructor-Student
Client
Employee
Friends/Family
Other
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.

4F.

Conflict of Interest
Instructions:
Conflicts of interest could be financial, such as if 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.
Example #1:
No conflicts
Financial
Commercial Entity Benefits
Other
Example #1:
The supervisor is receiving funding from XYZ. The personal benefit may be seen as a conflict of interest to participants. This funding has been clearly identified on the participant information form and consent form.
Example #2:
No conflicts
Financial
Commercial Entity Benefits
Other
Example #2:
The researcher is receiving personal funds from PharmaKids. 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.
Example #3:
No conflicts
Financial
Commercial Entity Benefits
Other
Example #3:
No conflicts.

5.

Methods: Recruitment

5A.

Recruitment Methods
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 coersion 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:
Not applicable
Posters
Social Media
Online Panels (e.g. Qualtrics)
Student Participant Pool (e.g. SONA)
Emails
Letters
Telephone
Snowballing
Other
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:
Not applicable
Posters
Social Media
Online Panels (e.g. Qualtrics)
Student Participant Pool (e.g. SONA)
Emails
Letters
Telephone
Snowballing
Other
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:
Not applicable
Posters
Social Media
Online Panels (e.g. Qualtrics)
Student Participant Pool (e.g. SONA)
Emails
Letters
Telephone
Snowballing
Other
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.

5B.

Location of Recruitment
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:
Not applicable
Carleton
Other Canadian School/University
Canada
Online
Other
Example #1:
Recruitment will occur at Carleton and online.
Example #2:
Not applicable
Carleton
Other Canadian School/University
Canada
Online
Other
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.)
Example #3:
Not applicable
Carleton
Other Canadian School/University
Canada
Online
Other
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.

5C.

Third Parties in Recruitment
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.
Example #1:
Not applicable
Third Parties
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.
Example #2:
Not applicable
Third Parties
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.
Example #3:
Not applicable
Third Parties
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.

5D.

Recruitment risks to Participants
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.
Example #1:
No risks / Not applicable
Mild risks
Moderate risks
High risks
Example #1:
Yes. There is a low probabiliy 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.
Example #2:
No risks / Not applicable
Mild risks
Moderate risks
High risks
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.
Example #3:
No risks / Not applicable
Mild risks
Moderate risks
High risks
Example #3:
N/A

5E.

Recruitment risks to Researcher
Instructions:
Are there risks to the research team during the recruitment phase? (E.g., unstable politics/violence in the recruitment region, participants have history of violent behaviour.)

Probability is the researcher's best guess as to the likelihood of identified risk outcomes.
Example #1:
No risks / Not applicable
Mild risks
Moderate risks
High risks
Example #1:
No risks.
Example #2:
No risks / Not applicable
Mild risks
Moderate risks
High risks
Example #2:
None.
Example #3:
No risks / Not applicable
Mild risks
Moderate risks
High risks
Example #3:
N/A

5F.

Benefits
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.)
Example #1:
No Direct Benefits to Participants / Not applicable
Direct Benefits to Participants
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.
Example #2:
No Direct Benefits to Participants / Not applicable
Direct Benefits to Participants
Example #2:
No direct benefits.
Example #3:
No Direct Benefits to Participants / Not applicable
Direct Benefits to Participants
Example #3:
There are no direct material benefits to study participants.

5G.

Compensation
Instructions:
The REB has no formal policy on compensation; however, compensation should be reasonable, but not excessive. Overcompensation may endanger the voluntariness of participant consent.

Tri-Council has provided advice on the use of incentives in research: www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter3-chapitre3/#toc03-1a
Example #1:
No Compensation/Not applicable
Money / Gift Card
Reimbursement of Travel Expenses
Refreshments
Course Credit
Other
Example #1:
Participants will be given a $15 gift card to Tim Horton's. Refreshments will also be offered (cookies, fruit, and juice).
Example #2:
No Compensation/Not applicable
Money / Gift Card
Reimbursement of Travel Expenses
Refreshments
Course Credit
Other
Example #2:
All children participating in the Ottawa study, regardless of whether they choose to participate or not, will receive a small token (stickers).
Example #3:
No Compensation/Not applicable
Money / Gift Card
Reimbursement of Travel Expenses
Refreshments
Course Credit
Other
Example #3:
No compensation will be provided to study participants.

6.

Methods: Informed Consent

6A.

Obtaining informed consent
Instructions:
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.
Example #1:
Signed consent
Online consent
Oral consent
Implied consent
Parent/Guardian consent
Assent
Other
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).
Example #2:
Signed consent
Online consent
Oral consent
Implied consent
Parent/Guardian consent
Assent
Other
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.
Example #3:
Signed consent
Online consent
Oral consent
Implied consent
Parent/Guardian consent
Assent
Other
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.

6B.

Deception
Instructions:
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.

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. Put simply, deception is equivalent to lying.

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
Example #1:
Full Disclosure (i.e. no deception)
Partial Disclosure
Mild Deception
More than Mild Deception
Example #1:
Participants will be told that the purpose of the study is to investigate the useability of abcd. However, the complete purpose of the study is to compare the useability 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 efiicency 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).
Example #2:
Full Disclosure (i.e. no deception)
Partial Disclosure
Mild Deception
More than Mild Deception
Example #2:
N/A
Example #3:
Full Disclosure (i.e. no deception)
Partial Disclosure
Mild Deception
More than Mild Deception
Example #3:
N/A

6C.

Debriefing
Instructions:
Although debriefings will differ across projects, the goals 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. If debriefing is applicable to the study, a copy of the written debriefing must be included in the ethics submission.


Researchers are encouraged to consider the following user-friendly headings in debriefing forms:

-What are we trying to learn in this research? (Purpose of the research).

-Why is this important to researchers or the general public? (Brief review of the research issues).

-Why was the use of deception necessary (if applicable)?

-What are the hypotheses, predictions, or implications of the research?

-Where can I learn more? (Provide a couple of academic or other appropriate references).

-What if I have questions later? (As participants may have questions about the research or ethical concerns, include the following information: the contact information of research personnel and their the faculty supervisor; the name and contact information of CUREB-A or CUREB-B in case of ethical concerns).

-Additional Resources (In special cases in which studies include sensitive material or procedures that might result in continuing concerns by participants, applicable resource contact information should be provided for follow-up consultation (e.g., Carleton University Health and Counselling Services, 520-6674; Distress Centre of Ottawa and Region, 238-3311).

-Consent to participate in follow up studies: if the researchers plan on any follow up studies with the same participants and intend to contact them in the future, this information should be disclosed as part of the debriefing. A second informed consent should be obtained to get participants’ permission for this future contact, along with assurances that their identity will remain confidential and separate from their data.
Example #1:
Not applicable/not required
Participants will be debriefed
Example #1:
Participants will receive debriefing (attached).
Example #2:
Not applicable/not required
Participants will be debriefed
Example #2:
Participants will receive a short oral debriefing (attached). A more detailed debriefing will be sent home for the parents/guardians (also attached).
Example #3:
Not applicable/not required
Participants will be debriefed
Example #3:
There will be no debriefing.

6D.

Withdrawal Procedures
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.

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:
Not applicable
Participants can withdraw
Participants can only withdraw during the study session
Special withdrawal procedures
Example #1:
Participants can withdraw during the study. Collected data sets are anonymous. As a result, participants cannot withdraw after they submit the online questionnaire in Qualtrics. This withdrawal procedure will be clearly explained in the informed consent.
Example #2:
Not applicable
Participants can withdraw
Participants can only withdraw during the study session
Special withdrawal procedures
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.
Example #3:
Not applicable
Participants can withdraw
Participants can only withdraw during the study session
Special withdrawal procedures
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.

7.

Methods: Data Collection

7A.

Data Collection Methods
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.

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 is subject to the USA Freedoms Act and may be accessed by -US federal authorities.)

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.
Example #1:
Questionnaires / Surveys
Interviews
Focus Groups
Oral and/or Visual Stimuli
Equipment and/or software testing
Other
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 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. Data will be downloaded off Qualtrics after a two month period. This anonymous data will be retained on a password protected lab computer at Carleton indefinitely for use in future research.






Example #2:
Questionnaires / Surveys
Interviews
Focus Groups
Oral and/or Visual Stimuli
Equipment and/or software testing
Other
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.
Example #3:
Questionnaires / Surveys
Interviews
Focus Groups
Oral and/or Visual Stimuli
Equipment and/or software testing
Other
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.

7B.

Location of Data Collection
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.
Example #1:
Carleton
Canada (other than Carleton)
Workplace
Public venue
Online
Other
Example #1:
Carleton in lab M234
Example #2:
Carleton
Canada (other than Carleton)
Workplace
Public venue
Online
Other
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.
Example #3:
Carleton
Canada (other than Carleton)
Workplace
Public venue
Online
Other
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).

7C.

Photography or Recordings
Instructions:
How will participants be informed?

Will images appear in reports? If so, will the participants be identifiable?
Example #1:
Not applicable
Photographs
Audio Recording
Video Recording
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.
Example #2:
Not applicable
Photographs
Audio Recording
Video Recording
Example #2:
N/A
Example #3:
Not applicable
Photographs
Audio Recording
Video Recording
Example #3:
We will audio-record the interview using a digital voice-recorder. Audiodata 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.

7D.

Translation or Transcription
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.
Example #1:
Not applicable
Translation
Transcription
Researcher will translate or transcribe
Example #1:
N/A
Example #2:
Not applicable
Translation
Transcription
Researcher will translate or transcribe
Example #2:
N/A
Example #3:
Not applicable
Translation
Transcription
Researcher will translate or transcribe
Example #3:
Audiodata 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.

7E.

Online data collection
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.


Example #1:
Not applicable
Carleton-based server
Commercial server (based in Canada)
Commercial server (outside Canada)
Other
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.
Example #2:
Not applicable
Carleton-based server
Commercial server (based in Canada)
Commercial server (outside Canada)
Other
Example #2:
N/A
Example #3:
Not applicable
Carleton-based server
Commercial server (based in Canada)
Commercial server (outside Canada)
Other
Example #3:
N/A

7F.

Bio-interactions
Instructions:
The TCPS2 outlines researcher obligations when acquiring biological specimens for use in research in Article 12.2: www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter12-chapitre12/#toc12-1b
Example #1:
Not applicable
Biological specimens/fluids
Example #1:
N/A
Example #2:
Not applicable
Biological specimens/fluids
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 courrier where they will be stored in the lab of the lead researcher for a period of two years. Please see the research agreement attached.
Example #3:
Not applicable
Biological specimens/fluids
Example #3:
N/A

7G.

Bio-instruments
Instructions:
Bio-instruments include wristbands and other worn sensors. The category would also include in-home sensors.
Example #1:
Not applicable
Bio-instruments
Example #1:
N/A
Example #2:
Not applicable
Bio-instruments
Example #2:
N/A
Example #3:
Not applicable
Bio-instruments
Example #3:
N/A

7H.

Bio-interventions
Instructions:
Examples include novel medical instruments.
Example #1:
Not applicable
Bio-interventions
Example #1:
N/A
Example #2:
Not applicable
Bio-interventions
Example #2:
N/A
Example #3:
Not applicable
Bio-interventions
Example #3:
N/A

7I.

Risk of Psychological Harm
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)
Example #1:
Not applicable/No risks
Mild risks
Moderate risks
High risks
Example #1:
The study does not involve psychological risks which exceed risks encountered in daily life.
Example #2:
Not applicable/No risks
Mild risks
Moderate risks
High risks
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.
Example #3:
Not applicable/No risks
Mild risks
Moderate risks
High risks
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.


7J.

Risk of Physical Harm
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)
Example #1:
Not applicable/No risks
Mild risks
Moderate risks
High risks
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).
Example #2:
Not applicable/No risks
Mild risks
Moderate risks
High risks
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.
Example #3:
Not applicable/No risks
Mild risks
Moderate risks
High risks
Example #3:
N/A

7K.

Risk of Social and/or Economic Harm
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)
Example #1:
Not applicable/No risks
Mild risks
Moderate risks
High risks
Example #1:
The study does not involve social/economic risks which exceed risks encountered in daily life.
Example #2:
Not applicable/No risks
Mild risks
Moderate risks
High risks
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.
Example #3:
Not applicable/No risks
Mild risks
Moderate risks
High risks
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.

7L.

Incidental Findings
Instructions:
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
Example #1:
Not applicable/No incidental findings anticipated
Low probability
High probability
Example #1:
The research team does not anticipate any incidental findings.
Example #2:
Not applicable/No incidental findings anticipated
Low probability
High probability
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.
Example #3:
Not applicable/No incidental findings anticipated
Low probability
High probability
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.

8.

Methods: Data Storage and Analysis

8A.

Identifiability of stored data
Instructions:
Describe the identifiability of participants in the stored data. The TCPS2 provides guidance on assessing the extent to what types of information regarding a partcipant are deemed identifiable: www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter5-chapitre5/#toc05-1a
Example #1:
Anonymous
Pseudonyms/Coded
Real participant names with data attributable
Real participant names with data non-attributable
Different levels of anonymity for different groups of participants
Example #1:
Participants will be assigned a code number during analysis to identify video recordings. Video recordings and participant ID codes will be deleted after one year. Questionnaires will be anonymous when submitted.
Example #2:
Anonymous
Pseudonyms/Coded
Real participant names with data attributable
Real participant names with data non-attributable
Different levels of anonymity for different groups of participants
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:
Anonymous
Pseudonyms/Coded
Real participant names with data attributable
Real participant names with data non-attributable
Different levels of anonymity for different groups of participants
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. 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.

8B.

Identifiability of published data
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:
Anonymous
Aggregate data only
Pseudonyms/Coded
Real participant names with data attributable
Real participant names with data non-attributable
Different levels of anonymity for different groups of participants
Example #1:
Reports and presentations will include anonymized data only.
Example #2:
Anonymous
Aggregate data only
Pseudonyms/Coded
Real participant names with data attributable
Real participant names with data non-attributable
Different levels of anonymity for different groups of participants
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.
Example #3:
Anonymous
Aggregate data only
Pseudonyms/Coded
Real participant names with data attributable
Real participant names with data non-attributable
Different levels of anonymity for different groups of participants
Example #3:
Responses will be non-attributable. Participants will be assigned a code number during analysis. Reports on the research will be average responses.

8C.

Data Storage (during the project)
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
Example #1:
Encrypted
Password-protected
Anonymous data
Physical documents
Other
Example #1:
Data is stored on password protected lab computers at Carleton University.
Example #2:
Encrypted
Password-protected
Anonymous data
Physical documents
Other
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:
Encrypted
Password-protected
Anonymous data
Physical documents
Other
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 audiodate anad 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.

8D.

Data Disposition (after the project)
Instructions:
After analysis and completion of report), the data will be:

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 publically 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?)
Example #1:
Retained by the researcher(s)
Stored in a depository
Archived
Shared with research agreement
Shared publicly
Returned
Destroyed
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:
Retained by the researcher(s)
Stored in a depository
Archived
Shared with research agreement
Shared publicly
Returned
Destroyed
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 detroyed after two years.
Example #3:
Retained by the researcher(s)
Stored in a depository
Archived
Shared with research agreement
Shared publicly
Returned
Destroyed
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.

8E.

Data Breach Risks
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:
Mild risk to participants
Moderate risk to participants
High risk to participants
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:
Mild risk to participants
Moderate risk to participants
High risk to participants
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:
Mild risk to participants
Moderate risk to participants
High risk to participants
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.

9.

Declarations

9A.

Supervisor Approval
Instructions:
Example #1:
Not applicable
Supervisor Approved
Supervisor has not approved
Example #1:
Supervisor approved the application on September 1, 2015. Prof. Brown will approve the CUREB-B application using the online system. He will also be copied on all correspondence with the REB.
Example #2:
Not applicable
Supervisor Approved
Supervisor has not approved
Example #2:
Not applicable - faculty research
Example #3:
Not applicable
Supervisor Approved
Supervisor has not approved
Example #3:
Supervisor approved the application on September 1, 2015. The supervisor will be copied on all correspondence with the REB.

9B.

Declaration #1
Instructions:
The researcher must declare their agreement with this statement.
Example #1:
I agree
Example #1:
Example #2:
I agree
Example #2:
Example #3:
I agree
Example #3:

9C.

Declaration #2
Instructions:
The researcher must declare their agreement with this statement.
Example #1:
I agree
Example #1:
Example #2:
I agree
Example #2:
Example #3:
I agree
Example #3:

9D.

Declaration #3
Instructions:
The researcher must declare their agreement with this statement
Example #1:
I agree
Example #1:
Example #2:
I agree
Example #2:
Example #3:
I agree
Example #3:

9E.

Declaration #4
Instructions:
The researcher must declare their agreement with this statement
Example #1:
I agree
Example #1:
Example #2:
I agree
Example #2:
Example #3:
I agree
Example #3:

10.

Comments

10A.

Comments (optional)
Instructions:
This section is for comments and suggestions on this form or the ethics process.
Example #1:
Here are some suggestions
Example #2:
[]
Example #3:
Here are some suggestions

11.

Office Use

11A.

Office Use
Instructions:
Example #1:
Example #2:
Example #3: