RESEARCH ETHICS BOARD PROJECT SUBMISSION FORM(adapted from the Ottawa University form, with Research Services’ authorization
of the above mentioned University)
This form must be used by all Saint Paul University researchers submitting to the Research Ethics Board(REB) for ethical review of their projects involving participation of human beings. Such researchincludes, without limitation, projects involving questionnaires, individual interviews, focus groups, testingof equipment, physical endurance tests, etc. For research based on secondary use of data, please click onthe following link:
http://web.ustpaul.uottawa.ca/en/research/forms%20htm/secondary%20use.htm
SECTION A — GENERAL INFORMATION
Title of the Project:
Last Name First Name Initial(s)
Faculty
Telephone - work E-mail-work
InternalUse
ProjectNumber
Telephone - home (optional) E-mail-home (optional)
( )
( )
( )ext.
1. Principal Investigator / Student
Title� Professor � Doctor � Mrs. � Mr. � Other
Preferred language of correspondence: � French � English
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Updated: 01/10/05
Please answer all the questions. The REB will not review incomplete applicationsor documents other than those required.
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2. Co-investigator / Supervisor
Note: If this is a 4th year research project, Master’s or Doctoral project or any other reseachproject, indicate your supervisor’s name and coordinates here:Note: List all co-investigators or students involved in this research. Photocopy this page as needed. Please provideyour permanent postal and e-mail addresses for future correspondence.
Last Name First Name Initial(s)
Faculty
Telephone - work E-mail - work
Telephone - home (optional) E-mail - home (optional)
( )
( )
( )ext.
Title� Professor � Doctor � Mrs. � Mr. � Other
Last Name First Name Initial(s)
Faculty
Telephone - work E-mail - work
Telephone - home (optional) E-mail - home (optional)
( )
( )
( )ext.
Title� Professor � Doctor � Mrs. � Mr. � Other
Last Name Initial(s)
Faculty
Telephone - work E-mail - work
Telephone - home (optional) E-mail - home (optional)
( )
( )
( )ext.
Title� Professor � Doctor � Mrs. � Mr. � Other
First Name
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3. Funding Information
Did you ask for funding? � yes � no
If yes, name offunding agency:
Status of funding: � received � pending
Expected date of beginning of the project: Expected date of completion of the project:
Date (dd-mm-yyyy) Date (dd-mm-yyyy)
4. Type of Research
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Professor’s Research
Doctoral thesis
Master’s thesis
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4th year project
Other (specify)
Note: Students conducting research for their Master’s or Ph.D. (or other) should append their thesis committee’sapproval. The REB will not evaluate thesis-related proposals before the thesis committee has evaluated the project.
Has this project been subject to a scientific evaluation? � yes � no
If yes, indicate by whom this evaluation has been done?
If no, explain the absence of the scientific evaluation?
6. Multi-center Research
Is this project under the responsibility of another center?
If yes, which one?
� yes � no
Does this project involve one or more center(s)? � yes � noIf yes, which one?
5. Scientific Evaluation
Has this project received the ethical approbation of another establishment?
6. Multi-centre Research (continued)
If yes, include the copy or copies of the ethical approbation.
� yes � no
7. Risk Evaluation
How do you evaluate the risk associated to your project as defined by the Tri-council Policy Statement?
� minimal � more than minimal
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Note : Minimal risk as defined by the: The Tri-Council Policy Statement: Ethical Conduct for ResearchInvolving Humans (TCPS) (http://pre.ethics.gc.ca/english/policystatement/section1.cfm). Thestandard risk is commonly defined as follows: if potential subjects can reasonably be expectedto regard the probability and magnitude of possible harms implied by participation in theresearch to be no greater than those encountered by the subject in those aspects of his or hereveryday life that relate to the research then the research can be regarded as within the range ofminimal risk. Above the threshold of minimal risk, the research warrants a higher degree ofscrutiny and greater provision for the protection of the interests of prospective subjects. Thereis a similar threshold regarding undue or excessive offers of benefit. As an offer of payment inrelation to research participation exceeds the normal range of benefits open to the researchsubject, it is increasingly likely to amount to an undue incentive for participation (see Section2B). (...).Reference : http://pre.ethics.gc.ca/english/policystatement/section1.cfm
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SECTION B - SUMMARY OF THE RESEARCH PROJECT
8. Research Project
a) Rationale: Briefly describe the purpose, hypothesis and the objectives of the proposed researchproject (not exceeding 150 words).
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b) Methodology: Briefly describe chronologically all procedures in which the researchparticipants will be involved in (e.g. paper and pencil tasks, interviews, surveys, questionnaires,physical endurance tests, etc.) Note: Please append a copy of all questionnaires, interview guides orother test instruments.
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d) If the research involves only one particular group while excluding another, for example onlywomen or men or only Francophones, indicate why such exclusion is appropriate for the study.
e) Does your experimental procedure involve partial disclosure of information or the use ofsubterfuge?
9. Recruitment
b) When, how and by whom will participants be recruited? Note: Please append a copy of any tools tobe used for recruitment (poster(s), advertisement(s), telephone scripts or letter(s) of information).
8. c) Participants: Describe the number of participants being recruited and their characteristics (agegroup, gender, affiliation, etc.).
Age Group
Gender
Affiliation
Other characteristics
� yes � no
If yes, justify.
a) List location(s) where participants will be recruited.
Number of participants
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9. c) Are there any supervisory or other relationships between the researchers and the participants(e.g. professor-student; manager-employee)?
If yes, please describe:
d) Will you ask participating organizations to provide names of potential participants?
If yes, how will the participants’ permission be obtained?
e) Are participants recruited in organizations or in other premises where permission is required toaccess the potential participants or premises?
� yes � no
If yes, how will you obtain permission to access the premises? Note: Please append written permissionby participating organizations.
f) Will minors (0-17 years old) be asked to participate in the research?
� yes � no
If yes, please specify the age group(s):
� yes � no
� yes � no
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9. g) Consent from the parent or guardian is normally required if the child is less than eighteenyears of age. This consent form must be submitted. If you are seeking an exemption to thisrequirement, please explain.
h) In addition to parental/guardian consent, the child must also confirm his or her agreement toparticipate. This is normally done in writing with an assent form, drafted in age-appropriatelanguage and must be submitted in addition to the parental/guardian consent form. If a child’sunwritten concurrence is sought, researchers must nevertheless obtain and document the child’sunwritten assent. If applicable, please explain below why unwritten assent of the child isnecessary and the measures to be taken to obtain and document such unwritten assent.
i) Are the participants in any other risk group (other than 9 f)
� yes � no
If yes, which one?
10. Selection of the participants:
a) Are inclusion or exclusion criteria in addition to those identified in question 8d, necessary forthe research methodology?
� yes � no, inclusion or exclusion criteria are necessary. All those who wish to participate willbe included.
If yes, explain how the screening of potential participants will be carried out and how theexcluded candidates will be notified. Note: Please append a copy of any selection test or questionnaire, ifapplicable.
How will the preselection be done? How will the excluded persons be advised?
10. b) Is there a risk of negative reaction on the part of excluded candidates, or any otherinconveniences for the excluded candidates?
� yes � no
If yes, describe the nature of such risks or inconveniences, and the measures taken to minimize ormitigate these risks or inconveniences. Note: Please append any script or material used, if applicable.
11. Participation
a) What will participants be asked to do and where will the research take place? If you areinterviewing participants, please indicate where the interviews will take place.
b) In how many sessions will they be asked to participate?
c)How long will each session (including interviews and questionnaires) take?
d)Will participants be compensated?
� yes � no
If yes, please provide details.
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11. e)If participants choose to withdraw, how will you deal with compensation?
f) Will scientific instruments involving direct or indirect physical contact (e.g. electrodes, sensorydevices, etc.) be used?
� yes � no
If yes, provide a description of the apparatus, its function and how it will be used. Note: Please alsosubmit any questionnaire or other material distributed or administered to the participants.
Description Function Use
SECTION C — RISKS AND BENEFITS OF THE PROPOSED RESEARCH
12. Risks and Benefits:
a) Your research project may cause negative reactions or inconveniences to the researchparticipants. Each person reacts differently to experiences. It is important to foresee possiblenegative reactions or inconveniences to prevent any practical problems when obtaining free andinformed consent. Indicate if the participants might experience any of the following potentialrisks.
Physical (e.g. muscle pain, tiredness, weakness, nausea, etc.)
Risk Description Yes No
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Psychological or emotional (e.g. self-image issue, loss of confidence,anxiety or stress, regret for disclosing personal information,boredom, disruption of family routines, etc.)Note: Depending on the level of risk, the REB may ask that a list ofresources be submitted to the participant in the consent form so he/sheknows where to go for help.
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Legal or social repercussions for participating or not participating inthe study (e.g. possibility of marginalization, risk of being judged bypeers or employer, risk of being sued, etc.)
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Economic or other type of inconveniences (e.g. expenses incurredfor participation, long travel to research site, time consumed, etc.)
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b) Please describe any other risks you can foresee but which are not mentioned above.
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c) If you answered yes to any of the above, please explain the risk(s).
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12. d) Indicate the measures taken to minimize such risk(s).
e) Describe the potential benefits of the study (e.g. to the participants, society, science, etc.), andhow these benefits outweigh the risks.
SECTION D — INFORMED CONSENT PROCESS
13. Free and Informed Consent:
a) Describe the process that you will use to obtain free and informed consent of the researchparticipants or of authorized representatives of children participants or other participants who arenot legally competent to give consent. As well, include a description of who will be obtainingconsent and a script/text of what they will say. Note: The Tri-Council Policy Statement: Ethical Conductfor Research Involving Humans (TCPS) (http://pre.ethics.gc.ca/english/policystatement/section1.cfm)states that many individuuals who are not legally competent are still able to express their wishes in ameaningful way. These individuals must still be given an opportunity to express their wish to participate or not(they have the final right), either verbally or non-verbally or via an assent form, as the case may be.
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13. b) Is the researcher or the person recruiting and conducting the consent process in a position ofauthority or trust towards potential participants?
� yes � no
If yes, please explain what measures will be taken to minimize the possibility of coercion.
c) If dealing with specific cultural, social, or ethnic groups, please describe the measures youhave taken to adapt the research protocol and consent process to the divergent values, traditions,privacy issues, and modes of communication of the target group. In cases where there will beverbal consent rather than written, explain why this is so, and describe the alternative means thatwill be used to document consent.
d) Describe how the participants will be informed of their right to withdraw from the project.
e) Indicate if information and consent documents, questionnaires, interview guides etc. will betranslated for participants who may be more comfortable understanding one of Canada’s officiallanguages (or other language, if applicable).
f) If you do not plan to translate your documents, explain why.
g) Do you reserve the right to withdraw a participant at all time?
� yes � no
If yes, for which reason(s)?
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SECTION E — ANONYMITY AND CONFIDENTIALITY
14. Anonymity
a) Will anonymity of research participants be ensured during the conduct of the research and inpublications?
� yes � no
If yes, how will this be done?
b) Will public disclosure of the research results be limited to pooled data only?
� yes � no
If no, how will the anonymity of participants be protected?
c) If participants are interviewed, state whether the interviewees will be quoted, and if so, how theanonymity of participants will be ensured.
� Interviewees will not be quoted.
� Interviewees will be quoted but all personally identifying information will be removed oraltered and contents of quote will not be revelatory of individual identifies.
If other measures are used (e.g. use of pseudonym or number), please provide details:
If yes, explain how anonymity will be ensured.
e) If you are quoting interviewees, will they be given the opportunity to review their transcripts?
� yes � noIf yes, clearly explain the procedure.
f) If anonymity is not to be guaranteed, explain why. Note: This fact must be mentioned on the consentform or information sheet given to the participant.
15. Confidentiality of data:
a) Who will conduct the data collection?
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14. d) Will you quote from written comments?
� yes � no
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15. b) By what means will data be collected (e.g. tape-recorded interview, paper questionnaire, etc.)?
c) Who will have access to collected data (principal investigator, co-investigator, graduate student,etc.)? Note: All the people who have access to the data must sign the present submission form, with theexception of research assistants.
f) For how long will data be preserved (indicate maximum period of preservation)? Note: Mostpublishers request that data be retained for a period of 5 to 10 years after time of publication, but this can varyaccording to the guidelines specified in your field of study.
d) Describe the procedures to be used to ensure confidentiality of data both during the conduct ofthe research and in the release of its findings.
e) Explain where each item (i.e. written records, electronic data, audio/video tapes, transcripts,questionnaires, etc.) will be stored? Note: Generally, data must be kept in the office of the principalinvestigator/supervisor.
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15. g) What will be done with the data at the end of storage? Provide details of their final disposition(e.g. shredding, deletion, etc.).
h) Are there any plans for secondary use of data? As stated in the TCPS “secondary use ofresearch data” is understood to be “the use in research of data contained in records collected fora purpose other than the research itself.” Note: Projects making use of secondary data must also besubmitted for REB approval using the form available at:http://web.ustpaul.uottawa.ca/en/research/forms%20htm/secondary%20use.htm
� yes � no
If yes, provide details.
i) Are there any plans for dissemination of the research results to participants? If so, how?
If no, justify.
SECTION F - SIGNATURES
Saint Paul University and its investigators and students whose research projects involve the participationof human beings as research subjects must comply with the Tri-Council Policy Statement: EthicalConduct for Research Involving Humans (TCPS), the Saint Paul University guidelines, and otherguidelines and legislations. This is both a collective and an individual responsibility.
Signature of Principal Investigator/Student and Co-investigator(s)/Supervisor attesting that:
a) the Principal Investigator/Student and all Co-investigator(s)/Supervisor(s):i) have read the protocol contents;ii) agree with the protocol as submitted;iii) will adhere to the research protocol and documentation (including the consent form,
etc.) as approved by the REB;iv) agree to comply with requests made by the REB during the life of this research;
b) the information contained in this form is complete and accurate;
c) the conduct of the proposed research will not commence until ethical certification has beengranted;
d) the Principal Investigator/Supervisor will notify the REB in a timely manner of any changes inthe project and of any adverse events/experiences encountered by participants;
e) the investigators understand and agree that they are responsible for the ethical conduct of thisresearch project, including that of research assistants, students and any other persons under theirsupervision.
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SIGNATURES
Principal Investigator / Student
Co-investigator(s) / Supervisor
Date
Date
USAGE INTERNE / INTERNAL USE
(photocopy as needed)
DOCUMENTATION REQUIREMENTS AND CHECKLIST
Proposals will be considered for review by the REB only when all relevant documents are included.Please check all applicable documents on the checklist below and provide them in the following order.
Required Documentation
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Research Ethics Board Project Submission Form (mandatory)
Recruitment text of participants, parents, community representative (mandatory)
Consent form or information letter on University letterhead (mandatory)
Assent form for children (if applicable)
Written permission from participating institution(s) (if applicable)
Interview guide, questionnaire, or other instrument (if applicable)
Debriefing form (if applicable)
Thesis committee’s approval (if applicable)
Other (specify)
If you cannot provide all relevant documents at the time of submission, please explain.
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