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Summary Protocol Form (SPF)
University Human Research Ethics Committee
[pic]Office of Research – Ethics and Compliance Unit: GM 1000 – 514.848.2424 ex. 2425

Important

Approval of a Summary Protocol Form (SPF) must be issued by the applicable Human Research Ethics Committee prior to beginning any research involving human participants.

The University Human Research Ethics Committee (UHREC) reviews all Faculty and Staff research, as well as some student research (in cases where the research involves more than minimal risk - please see below).

Research funds cannot be released until appropriate certification has been obtained.

For faculty and staff research

Please submit one signed copy of this form to the UHREC c/o the Research Ethics and Compliance Unit, GM-1000. Please allow one month for the UHREC to complete the review.

Electronic signatures will be accepted via e-mail at ethics@alcor.concordia.ca

For graduate or undergraduate student research

• If your project is included in your supervising faculty member’s SPF, no new SPF is required.

• Departmental Research Ethics Committees are responsible for reviewing all student research, including graduate thesis research, where the risk is less than minimal. In Departments where an ethics committee has not been established, please contact the Research Ethics and Compliance Unit.

• In cases where the student research is more than minimal risk (i.e. the research involves participants under the age of 18yrs, participants with diminished capacity, participants from vulnerable populations or participants from First Nations), an SPF must be submitted to the UHREC, c/o the Research Ethics and Compliance Unit, GM-1000, by the Course Instructor/Supervisor on the student’s behalf.

Instructions

This document is a form-fillable word document. Please open in Microsoft Word, and tab through the sections, clicking on checkboxes and typing your responses. The form will expand to fit your text. Handwritten forms will not be accepted. If you have technical difficulties with this document, you may type your responses and submit them on another sheet. Incomplete or omitted responses may cause delays in the processing of your protocol.

|Does your research involve |
| |
| |Participants under the age of 18 years? |
| |Participant with diminished mental or physical capacity? |
| |Aboriginal peoples? |
| |Vulnerable groups (refugees, prisoners, victims of violence, etc. )? |

1. Submission Information

Please provide the requested contact information in the table below:

|Please check ONE of the boxes below : |
| |
| |This application is for a new protocol. |
| | |
| |This application is a modification or an update of an existing protocol: |
| |Previous protocol number (s): |

2. Contact Information

Please provide the requested contact information in the table below:

|Principal Investigator/ |Department |Internal Address |Phone |E-mail |
|Instructor | | |Number | |
|(must be Concordia faculty or | | | | |
|staff member) | | | | |
| | | | | |
|Co-Investigators / Collaborators |University / Department |E-mail |
| | | |
|Research Assistants |Department / Program |E-mail |
| | | |

3. Project and Funding Sources

|Project Title: | |

In the table below, please list all existing internal and external sources of research funding, and associated information, which will be used to support this project. Please include anticipated start and finish dates for the project(s). Note that for awarded grants, the grant number is REQUIRED. If a grant is an application only, list APPLIED instead.

|Funding Source |Project Title |Grant Number |Award Period |
| | | |Start |End |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |

4. Brief Description of Research or Activity

Please provide a brief overall description of the project or research activity. Include a description of the benefits which are likely to be derived from the project. Do not submit your thesis proposal or grant application.

5. Scholarly Review / Merit

Has this research been funded by a peer-reviewed granting agency (e.g. CIHR, FQRSC, Hexagram)?

| |
| |Yes |Agency: | |
| |No |If your research is beyond minimal risk, please complete and attach the Scholarly Review Form |
| | | |

6. Research Participants

a) Please describe the group of people who will participate in this project.

b) Please describe in detail how participants will be recruited to participate. Please attach to this protocol draft versions of any recruitment advertising, letters, etcetera which will be used.

c) Please describe in detail how participants will be treated throughout the course of the research project. Include a summary of research procedures, and information regarding the training of researchers and assistants. Include sample interview questions, draft questionnaires, etcetera, as appropriate.

7. Informed Consent

a) Please describe how you will obtain informed consent from your participants. A copy of your written consent form or your oral consent script must be attached to this protocol. Please note: written consent forms must follow the format of the sample consent form template provided for you at the Ethics and Compliance webpage

b) In some cultural traditions, individualized consent as implied above may not be appropriate, or additional consent (e.g. group consent; consent from community leaders) may be required. If this is the case with your sample population, please describe the appropriate format of consent and how you will obtain it.

8. Deception and Freedom to Discontinue

a) Please describe the nature of any deception, and provide a rationale regarding why it must be used in your protocol. Is deception absolutely necessary for your research design? Please note that deception includes, but is not limited to, the following: deliberate presentation of false information; suppression of material information; selection of information designed to mislead; selective disclosure of information.

b) How will participants be informed that they are free to discontinue at any time? Will the nature of the project place any limitations on this freedom (e.g. documentary film)?

9. Risks and Benefits

a) Please identify any foreseeable risks or potential harms to participants. This includes low-level risk or any form of discomfort resulting from the research procedure. When appropriate, indicate arrangements that have been made to ascertain that subjects are in “healthy” enough condition to undergo the intended research procedures. Include any “withdrawal” criteria.

b) Please indicate how the risks identified above will be minimized. Also, if a potential risk or harm should be realized, what action will be taken? Please attach any available list of referral resources, if applicable.

c) Is there a likelihood of a particular sort of “heinous discovery” with your project (e.g. disclosure of child abuse; discovery of an unknown illness or condition; etcetera)? If so, how will such a discovery be handled?

10. Data Access and Storage

a) Please describe what access research participants will have to study results, and any debriefing information that will be provided to participants post-participation.

b) Please describe the path of your data from collection to storage to its eventual archiving or disposal. Include specific details on short and long-term storage (format and location), who will have access, and final destination (including archiving, or any other disposal or destruction methods).

11. Confidentiality of Results

Please identify what access you, as a researcher, will have to your participant(s) identity(ies):

| |Fully Anonymous |Researcher will not be able to identify who participated at all. Demographic |
| | |information collected will be insufficient to identify individuals. |
| |Anonymous results, but identify |The participation of individuals will be tracked (e.g. to provide course |
| |who participated |credit, chance for prize, etc) but it would be impossible for collected data to|
| | |be linked to individuals. |
| |Pseudonym |Data collected will be linked to an individual who will only be identified by a|
| | |fictitious name / code. The researcher will not know the “real” identity of |
| | |the participant. |
| |Confidential |Researcher will know “real” identity of participant, but this identity will not|
| | |be disclosed. |
| |Disclosed |Researcher will know and will reveal “real” identity of participants in results|
| | |/ published material. |
| |Participant Choice |Participant will have the option of choosing which level of disclosure they |
| | |wish for their “real” identity. |
| |Other (please describe) | |

a) If your sample group is a particularly vulnerable population, in which the revelation of their identity could be particularly sensitive, please describe any special measures that you will take to respect the wishes of your participants regarding the disclosure of their identity.

b) In some research traditions (e.g. action research, research of a socio-political nature) there can be concerns about giving participant groups a “voice”. This is especially the case with groups that have been oppressed or whose views have been suppressed in their cultural location. If these concerns are relevant for your participant group, please describe how you will address them in your project.

12. Additional Comments

a) Bearing in mind the ethical guidelines of your academic and/or professional association, please comment on any other ethical concerns which may arise in the conduct of this protocol (e.g. responsibility to subjects beyond the purposes of this study).

b) If you have feedback about this form, please provide it here.

13. Signature and Declaration

Following approval from the UHREC, a protocol number will be assigned. This number must be used when giving any follow-up information or when requesting modifications to this protocol.

The UHREC will request annual status reports for all protocols, one year after the last approval date. Modification requests can be submitted as required, by submitting to the UHREC a memo describing any changes, and an updated copy of this document.

I hereby declare that this Summary Protocol Form accurately describes the research project or scholarly activity that I plan to conduct. Should I wish to add elements to my research program or make changes, I will edit this document accordingly and submit it to the University Human Research Ethics Committee for Approval.

ALL activity conducted in relation to this project will be in compliance with:

• The Tri Council Policy Statement: Ethical Conduct for Research Involving Human Subjects http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

• The Concordia University Code of Ethics: Guidelines for Ethical Actions

Signature of Principal Investigator:________________________________________

Date: ____________________________
Note that SPF’s with electronic signatures will be accepted via e-mail