FOR OFFICE USE ONLY
SMU REB #:
DATE RECEIVED:
APPLICATION FOR ETHICS REVIEW OF RESEARCH INVOLVING HUMANS
Form 1- Faculty/Student/Staff
The INSTRUCTIONS and tips are located at the end of the form.
Research Ethics Board Frequently Asked Questions
SECTION A
TYPE OF APPLICATION
1. Type of Application:
Faculty
Staff
(Choose one only)
2. Title of the Research:
3. Type of Research:
Choose one
4. (a) Start date:
Note: Recruitment of research participants is considered as the beginning date of the study.
(b) End date:
Note: The research is completed when no further recruitment and contact will be made with research participants, and all data are, collected, recorded and
stored in accordance with the provisions of the cleared application.
CONTACTS (Include all individuals who will have contact with participants and/or access to research participant data.)
5.
*For student research, begin with listing the Faculty Supervisor first, followed by listing the Student Principal Investigator.
For faculty or staff research, begin with listing the Faculty or Staff Principal Investigator.
*Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
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Preparation web link:
Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
(Please list any additional research team members on the "Additional Information" page, Section I at the end of the form.)
6.(a) Funding status:
Funded
Funding pending
Unfunded
Tri-Council Agency:
SSHRC
NSERC
CIHR
Internal (Specify):
Other (Specify):
Grant Number:
Grant Name:
Funding Period:
From: (dd/mmm/yyyy)
To: (dd/mmm/yyyy)
Grant title, if different from what has already been listed in Section A, Question 2 "Title of the Research":
* All fields relating to funding must be fully filled out so the REB can provide the necessary information to the Research Grants Officer that is
required to release any relating research funds upon research ethics clearance. Any changes to these funding related questions must be
promptly reported to the REB throughout the life cycle of the research.
FUNDING
(b)
Not Tri-Agency funded
(c)
(d)
(e)
(f)
(g)
(h)
7. Previous SMU REB Clearance:
Has this or similar application been submitted to the SMU REB and/or is this a sequel to a
previously cleared project?
(If yes, attach a copy of the Form 1 application and the clearance certificate.)
No
Yes
10. Use of Secondary Data:
Does your project involve secondary use of data collected for other purposes than originally
intended/consented to? (i.e., data that has been collected from human participants for other
than the current purpose) If so, please explain.
Previous SMU REB File Number:
Briefly summarize the differences from the previously cleared research:
8. Scholarly Review:
Please describe any scholarly review that has been applied to this proposed research that the REB
should consider (Tri- Agency, Departmental, Thesis committee, etc., where it exists).
N/A
9. Conflict of Interest:
Does the proposed research involve real, potential or perceived conflict of interest as a result of or in connection to
this study?
(I.e., Your or your team's judgment may be influenced or appear to be influenced by private or personal interests such
as renumeration, intellectual property rights, rights of employment, consultancies, board membership, stock options,
commercial interests, etc.) If so, please identify and disclose to research participants any conflicts and explain the
extend of the researcher's involvement.
Be sure to address the presence of any real, potential or perceived conflict of interest on the part of the researchers,
their institutions or the research sponsor(s) and disclose the nature of the confict if a researcher is acting in a dual role
to potential research participants during the informed consent process (via the Informed Consent Form/Script).
No
Yes
Yes
No
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RESEARCH DESCRIPTION
1. Purpose and Rationale
Describe the proposed research project in non-technical language. The REB is composed of members drawn from
across various academic disciplines and members of the general public; therefore, in plain and clear language
describe the purpose and objectives of the study and any hypotheses to be investigated. If available, please include
references to similar research in the area.
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If you wish to include more information, feel free to insert additional pages of relevant text or insert text on the "Section I- Additional Information" at the
end of the form.
SECTION B
2. Methods
Describe in some detail all types of procedures and methods to be used in the study. Provide a sequential
description of what the participants will be invited to do in the study and what information will be obtained from them.
Describe and attach a copy of all materials to be used in the study such as reference measures or scripts of
interview questions. In more methodologically complex research a figure, table, or a timeline may be helpful or
needed for easier comprehension. Please avoid acronyms and jargon.
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If you wish to incude more information, feel free to insert additional pages of relevant text or insert text on the "Section I- Additional Information" page at
the end of the form.
PARTICIPANTS
3. Participants: (Check all that apply and note the availability of custom text.)
SMU Undergraduate Students
SMU Graduate Students
Pre-school Students
Institutionalized
Incarcerated
SMU Faculty
Primary-school Students
Care Facility
SMU Staff
High School Students
Illiterate
Adolescents
Non-english speaking
College Students
Adults
First Nations
Employees
Seniors
Inuit
Employers
Members of Isolated
Communities
Metis
Officials
Minors
(Enter custom text)
(Enter custom text)
(Enter custom text)
Note: Working with children, the elderly, the disabled and other vulnerable groups may require a Vulnerable Sector and/or Child Abuse Registry
clearance.
4. What is the anticipated number of participants?
5. Please specify any other distinguishing characteristics of the participants (e.g., gender, ethnicity).
6. What is the age range of the participants?
Lower age limit:
Upper age limit:
Please consult the REB's Age of Consent guidelines.
7. Are there any exclusion criteria? If so, please detail.
a) Identify any exclusion criteria. b) Justify the rationale for the exclusion criteria.
Yes
No
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If you wish to include more information, feel free to insert additional pages of relevant text or insert text on the
"Section I- Additional Information" page at the end of the form.
8. a) Which linguistic groups will be recuited?
English-speaking
French-speaking
Other:
Enter custom text
b) Is translation required?
Yes
No
Unaware at this time
c) Is a translator required?
Yes
No
Unaware at this time
d) If a translator is required, please provide details.
9. Is there any pre-existing relationship between the researcher(s) and the researched?
(e.g., Instructor-student, Manager-employee, Minister-congregant.) If so, please explain.
Yes
No
10. Is the researcher, associate or research assistant in a direct position of power in
relation to the participants outside the scope of the research study? If so, please explain.
Yes
No
RECRUITMENT
11. Where will the study will take place? (List the city, region, country, organizations as relevant):
SMU Campus
Room #:
Off Campus HRM
Outside HRM NS
Out of Province
Outside of Canada
Online
12. Who will be recruiting the participants?
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13. Will research be conducted outside Saint Mary's University? (TCPS 2, Chapter 8. B)
When conducting research outside the home institution, whether in Canada or abroad,
researchers shall provide their home REBs with the following considerations:
Yes
No
a) Relevant information about the rules governing research involving humans and the ethics review
requirements at the research site, where any exist:
b) The names and contact information for the relevant REB or comparable ethics bodies at the research site:
c) Relevant information/norms about the participants and their circumstances that might have a bearing on the
research ethics review by the researcher's home REB:
14. Is additional institutional, governmental or other permission needed to conduct the research?
(I.e., School Board, Police clearance, First Nations, Inuit, Metis, data holder agreement, letters
of support, etc.). If yes, please demonstrate.
Yes
No
Note: Graduate student researchers are required to obtain clearance from the Faculty of Graduate Studies and Research via the Graduate Research Hazards Assessment
(GRHA) process where applicable, as per university regulations. (The GRHA clearance document does not need to be submitted to the REB. For more information,
please contact the Faculty of Graduate Studies and Research Office and see the procedures involving the required GRHA Form.)
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If you wish to include more information, feel free to insert additional pages of relevant text or on the "Section I- Additional Informaiton" page on the form.
MULTI-JURISDICTIONAL RESEARCH
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18. How will you deal with compensation if participants choose to withdraw from the study? Include breakdown
for partial compensation, if relevant.
17. If you are compensating participants or reimbursing for their time or expenses, please provide details about
the amount and type of compensation.
COMPENSATION
15. Specify how the participants will be identified and recruited. Where participant observation is to be used,
please explain the form of insertion of the researcher(s) into the research setting. (Example: Living in a
community, visiting on a bi-weekly basis, attending organized functions, etc.)
16. (a) Append a copy of all posters, advertisements, flyers, letters, email text or telephone scripts to be
used for recuitment. The appended copies should be exactly as it will appear to research participants.
(b) Verify that recruitment materials, at the minimum, include all of the below noted requirements:
SMU REB File Number (Provided at registration)
Study site location or online
Title of the study (Optional)
Eligibility criteria
Name and contact of investigators and the research facility
Sponsor/funder of the study (if any)
Time commitment
Compensation availability (if any)
Purpose of the study
SECTION C
POTENTIAL BENEFITS
1. Identify any known or anticipated direct and/or indirect benefits (not compensation) of the research. If any, state
the potential benefits on the Informed Consent Letter/Script.) Please describe the benefits of the research below.
(a) Are there potential direct benefit(s) to participants?
Yes
No
(b) Are there potential indirect benefit(s) to participants?
Yes
No
(c) Are there potential benefit(s) to the participant's community?
Yes
No
(d) Are there potential benefit(s) to the scientific/scholarly community and/or society?
Yes
No
SECTION D
POTENTIAL RISKS
The level of foreseeable risk posed to participants by their involvement in research is assessed by considering the magnitude or seriousness of the harm and the probability that
it will occur, whether to participants or third parties.
Minimal risk research:
"Research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in the aspects
of their everyday life that relate to the research." (TCPS 2, Ch.2, B.).
Consider individual as well as group vulnerabilities (e.g., pre-existing physiological/health conditions, cognitive/emotional factors, and social, socioeconomic, legal status,
etc.)
1. Type of research:
Minimal Risk
Exceeds minimal risk
2. Do any of the following potential risks apply?
(a) Physical risk (e.g., bodily contact, administration of any substance, physical discomfort, tiredness)
Yes
No
(b) Psychological or emotional risk (e.g., feeling uncomfortable, embarrassed, worried, anxious or
upset)
Yes
No
(c) Social risk (including possible loss of status, privacy and/or reputation)
No
Yes
(d) Legal risk (e.g., potential of apprehension, arrest, being identified as a member of a legally
compromised group, being sued)
Yes
No
(e) Economic risk (e.g., loss of income, incurred expenses)
Yes
No
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If you wish to include more information, feel free to insert additional pages of relevant text or insert text on the "Section I- Additional Information" page at the end of the form.
(f) If you answered 'yes' to any, please explain the risks that are foreseen:
If you wish to include more information, feel free to insert additional pages of relevant text or insert text on the "Section I- Additional Information" page at the end of the form.
3. Will all reasonable precautions be taken to protect the health and safety of participants?
Yes
No
4. Will your methods induce participants to act against their wishes?
Yes
No
5. Will participants be asked to disclose information that is intimate or sensitive?
Yes
No
MANAGEMENT OF FORESEEABLE RISKS
6. Describe how you will minimize the foreseeable risks and deal with harms that participants may experience.
7. Provide information on what resources you will make available to those who might experience adverse effects
stemming from participation in your research project.
DECEPTION
8. Does this study involve any deception? If so, describe the details of the deception and justify
the use of deception.
No
Yes
9. Will information be withheld from participants that might reasonably lead them to decline to
participate in the study? If yes, please explain below.
Yes
No
10. Will the participants be video or audio taped without their knowledge or consent?
Yes
No
11. Please outline the process to be used to debrief participants about why deception was used.
Append a copy of the debriefing sheet.
N/A
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Free and informed consent is an on-going process that starts with the researcher's first contact with the individual and continues until the
study's completion. (Guidance: http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter3-chapitre3/#toc03-1a)
Although written consent is most common, the REB understands that many disciplines and cultures do not accept written consent as
appropriate. It is the quality of the consent process, not the format, that is most important. Any verbal exchange about the study, the
consent form and all documentation given to participants should provide adequate and full information for the participant to make a free
and informed decision about his/her participation.
Researchers shall provide to prospective participants, or authorized third parties, full disclosure of all information necessary for making an
informed decision to participate in a research project.
At the commencement of any process of consent, researchers (or their qualified representatives) shall provide prospective participants with
the information set out in the following list, as appropriate to the particular research project. Not all the listed elements are required for all
research. However, additional information may be required in particular types of research or under particular circumstances.
If you do not include some of the listed disclosure requirements, please explain to the REB why these requirements do not apply to the
project. It is also up to the REB to consider whether all elements listed, or additional elements, are necessary to the consent process of the
research project.
While it may need to be more or less elaborated, the requirements of a consent form/script are listed below. Ensure to check below all that
apply from (a) to (f) in the consent process used in this research.
SECTION E
FREE AND INFORMED CONSENT PROCESS
1. Check what process will you use to inform the potential participants about the study's details and to seek
consent for participation? (Append copies of the draft consent form or script document.)
Information letter with signed written Informed Consent Form
Electronic Informed Consent Form
Verbal consent
2. CONSENT FORM/SCRIPT CHECKLIST:
Sample SMU Informed Consent Form
Related guidance: TCPS 2, Article 3.2- Consent Shall Be Informed
SMU REB File Number (Provided at the time of registration.)
(a) an invitation to participate in the research project;
(b) a statement of the research purpose in plain language, the identity and contact information of the researcher(s), the
supervisor (for student research), the identity of the funder or sponsor, the expected duration and nature of
participation, a description of research procedures and an explanation of the responsibilities of the participant;
(c) a plain language description of all reasonably foreseeable risks and potential benefits;
(d) an assurance that participants:
~ are under no obligation to participate; are free to withdraw at any time without prejudice to pre-existing entitlement;
~ will be given, in a timely manner throughout the course of the research project, information that is relevant to their
decision to continue or withdraw from participation;
~will be given information on the participant's right to request the withdrawal of data, including any limitations on the
feasibility of that withdrawal;
(e) information concerning the possibility of commercialization of research findings, and the presence of any real,
potential or perceived conflicts of interest on the part of the researchers, their institutions or the research sponsors;
(f) the measures to be undertaken for dissemination of research results and whether participants will be identified
directly or indirectly;
(g) direction about how the participant can find out about the results of the study;
(h) Insert standard SMU REB wording:
"This research has been reviewed and cleared by the Saint Mary's University Research Ethics Board. If you have any
questions or concerns about ethical matters, you may contact the Chair of the Saint Mary's University Research Ethics
Board at ethics@smu.ca or 420-5728.";
(i) an indication of what information will be collected about participants and for what purposes; an indication of who will
have access to information collected about the identity of the participants, a description of how confidentiality will be
protected, a description of the anticipated uses of data; and information indicating who may have a duty to disclose
information collected and to whom such discolures could be made.
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3. If you are not seeking written consent, please explain why. Also, please explain how you are going to ensure
participants understand that their participation is voluntary when obtaining verbal consent.
4. Which member(s) of the research team will seek the consent?
5. Are there participants who cannot give free and informed consent? (Please describe the
group (e.g., minors). Append a copy of the information letter and permission form you will use
to seek permission from the subsitute decision maker, if applicable. Describe and justify the
method you will use to seek the permission of the parent or legal guardian.
Yes
No
6. Describe plans for on-going consent to ensure that consent is current and if necessary, to
convey new information to participants.
7. Do you intend to recontact participants regarding future studies?
If yes, ensure that you seek their permission.
Yes
No
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Note: Anonymity of participants and/or confidentiality of data are often laudable goals but it is not always possible or appropriate
in all types of research. In fact, there are limits to confidentiality as described in the TCPS 2; in some traditions, these notions are
considered inappropriate. Consider whether this is a desirable goal and, if so, the extent to which your methods allow you to keep
the promises that you are making. Ensure that the consent process includes an accurate description of these concepts and the ability
of your study to fulfill any promises to participants. Consider the use of pseudonyms and/or linkages, labels, generics aggregates,
(Example: "a small town in northern Newfoundland") and consider who may access the data.
SECTION F
PRIVACY AND CONFIDENTIALITY
Personal Information defined: Freedom of Information and Protection of Privacy Act, 1993, c.5, s. 1., 3 (1), i.(i.-ix), "identifiable information":
http://nslegislature.ca/legc/statutes/freedom.htm
1. (a) Will personally identifying information be collected? If yes, please detail what will be
collected.
Yes
No
(b) Where the research involves extraction or collection of personally identifiable information, please
describe from whom the information will be obtained and what it will include.
N/A
(c) Will personally identifiable information be collected using a server that stores data outside of
Canada? If yes, ensure that the consent process includes a disclosure statement of this information.
Yes
No
(d) Will personally identifiable information collected in Nova Scotia be taken or stored outside of
Canada? If yes, legislation requires that personally identifiable information 1. must be stored on
campus securely, 2. when it is transferred from research site to campus, it be encrypted and sent via
secure network (i.e., the SMU Virtual Private Network), and 3. when it is taken (or stored) outside of
Canada such plans be reported to the REB.
Yes
No
Related reading: Personal Information International Disclosure Protection Act. 2006, Chapter 3 of the Acts of 2006, amended 2010.
(e) When data is being collected online, what information from the Terms of Use/Service of the program is
relevant and will be conveyed to participants during the informed consent process relating to the privacy,
confidentiality, transfer and storage of their data?
N/A
2. Describe the procedures you will use to ensure anonymity of participants and confidentiality of data both
during the research and in the release of the findings, when applicable.
N/A
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3. Will it be possible to associate specific information contained in your records with specific
participants?
Yes
No
4. Will information on individual participants be disclosed to third parties?
(List any restrictions regarding access to disclosure of information, during or at the end of the
study, that have been placed on the investigator(s). This includes controls placed by the
sponsor, funding body, advisory or steering committee.)
Yes
No
SECTION G
STORAGE OF DATA
If your data deals with sensitive information, describe how your data will be handled in the Informed Consent Form. The TCPS 2 suggestes that judgment
should be made using a proportionate risk approach. Thus, the greater the sensitivity of the data, the more researchers must delineate the steps that will be
taken to ensure the secure storage of data and to make certain that the security of the data is maintained.
Researchers may choose to implement specific policies with regard to their data and the requirements of their departments but should explain this choice on
the application.
If data is stored at the SMU Records Centre, please indicate the details of the agreement as it relates to storage and retention.
1. Describe the procedures you will follow for secure storage of data, including written records, audio/video tapes,
digital media, questionnaires, recordings and computer files.
2. Describe (a) where you will store the data and (b) for how long the data will be retained including the rationale or
applicable requirements.
(a)
(b)
3. Describe the plans involving identifiable data.
Note that deletion of electronic data is not equivalent to destruction of that data.
Page 15 of 19
SECTION H
PARTICIPANT WITHDRAWAL
1. Where applicable, please describe how the participants will be informed of their right to withdraw their
participation from the study. Outline the procedures that will be followed to allow them to exercise this right.
2. Should a participant withdraw their participation form the study, indicate:
(a) What will be done with the participant's data.
(b) Any consequences that withdrawal may have on the participant.
3. Will there be a certain point during the data collection where participants will no longer be able to withdraw
from the study? If yes, please include those constraints in the informed consent process.
FEEDBACK AND DISSEMINATION OF RESULTS
4. Feedback:
Please describe the plans for offering participants feedback on the details of the study.
(Append the feedback form that summarizes the purpose of the study, researcher's contacts, resources relating
to adverse events, etc.; if applicable.)
5. Disseminating the results of the research:
How will participants be able to learn about the study results? (i.e., mailed, emailed, posted on website/at
research site, presented, other appropriate means to the individual participant/group.)
6. Is there a need to translate the results of the research to a different language for your
participants?
Yes
No
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SECTION I
ADDITIONAL INFORMATION
Use this section or an additional page(s) if more space is needed to complete any part of this application form, or
if there is any other information relevant to the project you wish to provide to the Research Ethics Board.
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SECTION J
CERTIFICATION
My signature confirms understanding of the following responsibilities:
INITIAL RESEARCH ETHICS CLEARANCE REQUIRMENTS:
I will ensure that all procedures performed under the project will be conducted in accordance with the SMU REB's approved protocol and consenting process, the
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2, 2018) and all relevant Saint Mary's University, provincial, national and
international policies and regulations that govern research involving human participants. Recruitment of participants will not start until the SMU REB and relating
contract/agreements have been cleared by the appropriate research institute official(s).
CONTINUING RESEARCH ETHICS REVIEW REPORTING REQUIREMENTS:
ADVERSE EVENTS: I am familiar with the Policy on Adverse Events and will respond to such an event immediately and report it to the REB no later than one
business day.
MODIFICATIONS: Any deviations from the project as originally cleared will be submitted as a Modification Request to a previously cleared proposal (Form 2) to
the REB for clearance prior to its implementation.
ANNUAL RENEWAL: Studies are cleared for one year after which time clearance is automatically suspended. 30 days prior to expiry, I will submit an Annual
Renewal Request for previously cleared projects (Form 3) to the Office of Research Ethics to extend the research ethics clearance for multi-year research
projects.
COMPLETION OF RESEARCH: I will notify the Office of Research Ethics when the study is completed by submitting a Completion of Research request (Form
5).
FUNDING: I will notify the Office of Research Ethics if/when funding circumstances for this study change so the Office of Research Ethics can clear the release
of my research funds.
CONTACT INFORMATION: I will notify the Office of Research Ethics if/when applicant contact information changes or new members are added to the research
team.
SMU REB CLEARANCE DOCUMENTS: I will retain a copy of the Certificate of Research Ethics Clearance/Continuation for Research Involving Humans for my
records.
FACULTY SUPERVISOR
~ I have reviewed and approve the scientific merit of the research.
~ I have reviewed and approve this submission for initial research ethics review and will review and approve all forthcoming requests to the REB.
~ I understand that, in case of student research, all requests to the REB must be submitted directly by the faculty supervisor.
~ I will provide the necessary training and supervision to the student investigator throughout the project.
~ I will ensure that the level of risk inherent to the project is managed by the level of research experience that the student investigator has combined with an
extent of oversight that will be provided by me.
_____________________________
*Signature of Faculty Supervisor
(Type name)
Date (dd/mmm/yyyy)
PRINCIPAL INVESTIGATOR
_____________________________
*Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
CO-INVESTIGATOR
_____________________________
*Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
_____________________________
*Signature of
Choose role
(Type name)
_____________________________
*Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
Date (dd/mmm/yyyy)
_____________________________
*Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
_____________________________
*Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
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* Original signature required
N/A
DATE RECEIVED:__________________________________________________
APPLICATION FOR ETHICS REVIEW OF RESEARCH INVOLVING HUMANS
Form 1- Faculty/Student/Staff
RESEARCH REQUIRING ETHICS REVIEW
Please note that ethics review is required for research activities that meet the Tri-Council Policy Statement: Ethical Conduct for Research
Involving Humans (TCPS 2), Article 2.1 definition:
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter2-chapitre2/#toc02-1a
Consult the Office of Research Ethics for guidance if needed.
INSTRUCTIONS
~ Use the application Form 1C, if the research has already been cleared by another Canadian REB
~ Please type your answers
~ Do not skip items (Answer 'n/a' where applicable to avoid delays)
~ Use the "Additional Information", Section I, whenever you need additional space
TECHNICAL INSTRUCTIONS
~ Please open and edit this form in the most recent version of Adobe Reader. You may save, edit and print your work at any time.
HOW TO SUBMIT
Electronic submission option:
Please submit the fully completed application package electronically to ethics@smu.ca. All appendices must be clearly labelled and reflect how
they are referenced in the applicaiton.
Manual submission option:
Please drop-off 1 copy of the applicaiton package at any of the following locations:
1. Office of Research Ethics, Atrium Building, Room 202
2. Faculty of Graduate Studies of Research Office, Atrium Building, Room 210
3. Psychology Department Office, McNally Building South, Room 323
SUBMISSION FOR INITIAL RESEARCH ETHICS REVIEW CHECK LIST
Incomplete application packages cannot be reviewed. Incomplete application packages will cause delays. Please ensure that the following
items are fully completed and forwarded:
FORM 1
Completed Form 1
Section J signed by all (SMU affiliated) parties
APPENDED DOCUMENTS
N/A Yes
Previous SMU REB cleared Form 1 and accompanying Certificate of Research Ethics
Clearance Clearance/Letter from other University /Hospital/Agency REB
Government Approval for International Research
Statement/Letter of Support from Individual/Organization
Proposed Advertisement Script/Poster
Proposed Recruitment Letter/Script/Email
Proposed Information Letter for Participants
Proposed Information Letter for Parent/Guardian/Proxy
Proposed Informed Consent Form/Script for Participants
Proposed Informed Consent Form/Script for Parent/Guardian/Proxy
Proposed Questionnaire, Survey and/or Other Instrument
Proposed Interview Plan
Proposed Interview Questions
Proposed Feedback Letter to Participant
Proposed Feedback Letter to Parent, Guardian, Proxy
Proposed Debriefing Letter to Participant (If study involves deception.)
Proposed Debriefing Letter to Parent, Guardian, Proxy (If study involves deception.)
Other Documents: Please specify in the notes section below.
Additional comments/information relating to the appended documents:
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