1.
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Project Team
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Lead Researcher
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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.
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Example #1:
|
Example #1:
MAY, Sally, Undergraduate Student, Computer Science, Carleton University, maysally@cmail.carleton.ca |
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Example #2:
|
Example #2:
SMITH, Jim, Academic Staff, MacOdrum Library, Carleton, jim.smith@carleton.ca |
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Example #3:
|
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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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:
|
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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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:
|
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:
|
Example #3:
Truman/Harriet, co-PI, assistant professor in Social Work at Carleton, harriet.truman@carleton.ca. |
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Researcher Training
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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. |
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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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2.
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Study Overview
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Project Title
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Instructions:
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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Study Goal
|
Instructions:
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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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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Dates of Recruitment/Participant Interaction
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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 #1:
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Example #2:
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Example #2:
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Example #3:
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Example #3:
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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.
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Example #1:
|
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. |
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Example #2:
|
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. |
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Example #3:
|
Example #3:
We will interact with the participants in the form of in-depth interviews in person, by phone, or by skype.
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Additional Reviews
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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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3.
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Funding and Approvals
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Project Funding
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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:
|
Example #1:
Funding from NSERC Engage grant in collaboration with XYZ company. XYZ is currently selling the previous version of ABCD. |
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Example #2:
|
Example #2:
CIHR funding with matching funds from PharmaKids |
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Example #3:
|
Example #3:
The researcher has internal funding from Carleton University. |
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Researcher Funding (for research contracts and personal consulting only)
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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.. |
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Example #2:
|
Example #2:
Contract attached. Researcher will receive personal stipend of $10,000 over the course of two years. |
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Example #3:
|
Example #3:
|
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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."
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Example #1:
|
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:
|
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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Additional Approvals Required
|
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.
|
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4.
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Methods: Participants
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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:
|
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:
|
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:
|
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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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
|
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|
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Number of Participants
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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. |
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|
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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:
|
Example #1:
Participants are undergraduate students are not considered vulnerable. |
|
Example #2:
|
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:
|
Example #3:
Clinical social workers are not considered a vulnerable population. |
|
|
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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:
|
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. |
|
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. |
|
|
|
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:
|
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:
|
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:
|
Example #3:
|
5.
|
Methods: Recruitment
|
|
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:
|
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. |
|
|
|
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:
|
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.) |
|
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. |
|
|
|
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:
|
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:
|
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:
|
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. |
|
|
|
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:
|
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:
|
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:
|
Example #3:
|
|
|
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:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
|
|
|
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:
|
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:
|
Example #2:
|
Example #3:
|
Example #3:
There are no direct material benefits to study participants. |
|
|
|
Compensation
|
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). |
|
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). |
|
Example #3:
|
Example #3:
No compensation will be provided to study participants. |
|
6.
|
Methods: Informed Consent
|
|
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:
|
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:
|
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:
|
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. |
|
|
|
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
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Example #1:
|
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). |
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Example #2:
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Example #2:
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Example #3:
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Example #3:
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|
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Debriefing
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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.
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Example #1:
|
Example #1:
Participants will receive debriefing (attached). |
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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
|
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.
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Example #1:
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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. |
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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:
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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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7.
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Methods: Data Collection
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Data Collection Methods
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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.
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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 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.
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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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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.
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Example #1:
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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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Photography or Recordings
|
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:
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Example #3:
|
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. |
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|
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Translation or Transcription
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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:
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Example #1:
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Example #2:
|
Example #2:
|
Example #3:
|
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. |
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|
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Online data collection
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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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Bio-interactions
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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 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. |
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Example #3:
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Example #3:
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Bio-instruments
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Instructions:
Bio-instruments include wristbands and other worn sensors. The category would also include in-home sensors.
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|
Example #1:
|
Example #1:
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Example #2:
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Example #2:
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Example #3:
|
Example #3:
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Bio-interventions
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Instructions:
Examples include novel medical instruments.
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|
Example #1:
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Example #1:
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Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
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|
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Risk of Psychological Harm
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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
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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). |
|
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:
|
|
|
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)
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|
Example #1:
|
Example #1:
The study does not involve social/economic risks which exceed risks encountered in daily life.
|
|
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. |
|
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
|
Instructions:
|
Example #1:
|
Example #1:
The research team does not anticipate any incidental findings. |
|
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. |
|
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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8.
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Methods: Data Storage and Analysis
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Identifiability
of stored data
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Instructions:
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Example #1:
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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. |
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Example #2:
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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. |
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Example #3:
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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. |
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Identifiability
of published data
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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. |
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Example #2:
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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)
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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. |
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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. |
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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 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. |
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|
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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:
|
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). |
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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 detroyed after two years. |
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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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|
|
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:
|
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. |
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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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9.
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Declarations
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Supervisor Approval
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Instructions:
|
Example #1:
|
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. |
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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. |
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|
|
Declaration #1
|
Instructions:
The researcher must declare their agreement with this statement.
|
|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
|
|
|
Declaration #2
|
Instructions:
The researcher must declare their agreement with this statement.
|
|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
|
|
|
Declaration #3
|
Instructions:
The researcher must declare their agreement with this statement
|
|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
|
|
|
Declaration #4
|
Instructions:
The researcher must declare their agreement with this statement
|
|
Example #1:
|
Example #1:
|
Example #2:
|
Example #2:
|
Example #3:
|
Example #3:
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10.
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Comments
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Comments (optional)
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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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11.
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Office Use
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|
Office Use
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Instructions:
|
|
Example #1:
|
|
Example #2:
|
|
Example #3:
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