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Research Project Registration Form Montréal West Island IUHSSC

Project title in English: ____ Project title in French: ____

Research field: Write (or choose) +Project number: ____

Brief summary (200 words maximum): ____

Type of project ☐ Experimental project ☐ Data collection ☐ Data extraction ☐ Evaluation of a tool, a document, a technique, or an intervention☐ Evaluation of medication treatments ☐ Health Canada clinical trials – Attach Health Canada No Objection letter☐ Pilot project☐ Genetic, biological or non-biological databank☐ Other, specify: ____

1. RESEARCH TEAM AND LOCATIONAll persons implicated in the project must be identified and their participation must be indicated to facilitate the evaluators’ understanding of the project’s feasibility, the distribution of resources, and potential biases. To determine how the project will be evaluated, and identify potential evaluators and resources that may be involved, the locations of the study should be well identified.

1.1. Main investigator +First name and last name, Credential (or choose)Telephone, EmailAcademic or university affiliation (or choose if McGill)University professor’s title (or choose)RSSS affiliation (choose)Position in the installation and directorate/department (or choose)Research privilege at the MWI IUHSSC (choose) - Attach CV

1.2. Local researcher or manager of the MWI IUHSSC +

Academic Affairs, Teaching and Research DirectorateUpdated Version –October 25 2019 on 9

First name and last name, Credential (or choose)Telephone, EmailPosition in the installation and directorate/department (or choose)Research privilege at the MWI IUHSSC (choose) - Attach CV

1.3. Co-researcher +First name and last nameEmailAcademic or university affiliation (or choose if McGill)Contribution: Participate Choose, explain (if necessary): ____ +

1.4. Collaborator +First name and last nameEmailAcademic or university affiliation (or choose if McGill)Contribution: Participate Choose, explain (if necessary): ____ +

1.5. Project coordinator +First name and last nameTelephone, Email

1.6. Student +First name and last nameEmailLevel of education: ChooseProgram of study: ____Supervisor: ____

1.7. Is your project multicentric? ☐ Yes☐ No

1.8. If your project is multicentric, do you want one of the MWI IUHSSC REB to act as the REB project evaluator?☐ Yes, list all the participating sites

Participating sites Local researcher Researcher email AuthorizationChoose ____ ____ Choose

☐ No, indicate who is acting or will act as the REB evaluator for the research project, and specify the status of the ethics review: Choose Choose –Attach ethics approval letter

1.9. Indicate all participating sites not part of the RSSS, whether in Québec (e.g. the universities) or outside Québec

Site: ____, location (city, country): ____ +

PROJECT SUBMISSION INTRUCTIONS


Your project’s ethics and feasibility "convenance" review will be examined, if it is not multicentric or is multicentric and one of our REBs is the REB evaluator. You must:

1) complete the rest of this form and follow all the instructions indicated in the icons2) attach all the required documents in this form to the icons 3) complete the verification list4) complete the feasibility review "convenance" form (FormCONV)

Your project will only be examined for the feasibility "convenance" review if it is multicentric and the REB of another institution is acting as the REB evaluator. You must:

1) submit only section 1 and 2 of this form (exclude the following pages)2) attach the letters of decision of the REB evaluator3) attach all documents submitted or approved by the REB evaluator (the research office will process the selected documents)4) complete the feasibility review "convenance" form (FormCONV)

All documents must be sent to [email protected].

2. FINANCIAL INFORMATIONThe financial information of projects must be reported because it ensures the feasibility of the research project, raises important ethical issues and potential causes of conflict of interests, and requires management by the institution.

2.1. How will this project be financed?☐ The project does not incur any expense. Please explain how this is possible if expenses seem to be

required given the details of the study as described in the protocol: ____☐ Help from funds provided by Name of sponsor (or choose), to First name and last name - Attach the

proof of funds & attach the letter of commitment of the recipient of funds☐ Help from funds of an application submitted to Name of sponsor (or choose) by First name and last

name. How will the project be realized if the application is refused? ____

2.2. The sponsor is Type (choose).

2.3. How are the actual expenses allotted towards the completion of the project?Budget (or choose) - Attach the budget if applicable

2.4. Is your project under contract?☐ Yes, a contract was or will be signed between the following collaborators: ____ - Attach the contract if

applicable☐ No

3. PREVIOUS EVALUATIONSThe previous evaluations provide insight into the issues and obstacles suggested by other evaluators, and the solutions proposed by researchers to address them. These evaluations are helpful to establish the scientific validity of the project.


mailto:[email protected]

3.1. Has your project’s ethics been evaluated by the REB of a site that is not a part of the RSSS; for example, a university or a hospital outside of Québec?

☐ Yes, Choose, was evaluated by: ____ + - Attach the result of the ethics evaluation(s)☐ No

3.2. Has your project been scientifically evaluated by a peer committee linked to an academic or granting body? ☐ Yes, Choose, was evaluated by: ____ + - Attach the result of the ethics evaluation(s)☐ No

3.3. Have the modifications required in previous evaluations been made? ☐ Yes, specify what changes were made, if any? Write (or choose) - Attach responses to comments☐ No, specify why: Write (or choose)☐ No applicable, the project was not evaluated.

Les commentaires n'impliquaient aucun changement significatif ou concernant le présent projet

4. NATURE OF THE DATAThe nature of the data collected for this project determines the procedure for submitting the project and completing the rest of this form.

4.1. Your data will be: ☐ Obtained directly from human participants and therefore, requires recruitment - Attach the consent forms

in all languages☐ Extracted from medical records with the consent of the persons concerned - Attach the consent forms in all

languages☐ Extracted from medical records without the consent of the persons concerned - Attach the PIAForm☐ Extracted from clinical-administrative databases - Attach the PIAForm☐ Extracted from research files from another research project for which participants consented to

secondary analysis of their results or from a databank. - Attach a copy of the consent form to access the databank

INSTRUCTIONS TO FOLLOW TO COMPLETE THE FORM

If the project involves collecting data from volunteers, then recruitment of participants is necessary and therefore their consent is required. For all such projects, you must:

1) Attach information and consent forms2) Complete the rest of the present form, sections 5 to 9.

The project does not involve recruitment if the data comes from research files or databases / materials for which participants do not have to give consent or for which they have already given their consent. For all such projects, you must:

1) Complete section 9 of the present form but not section 5 to 8.2) Provide the required documents in the instructions to the answers in question 4.1.


5. NUMBER OF PARTICIPANTS (only if there is recruitment of participants)The number of participants must be provided, well justified, and well planned to demonstrate the validity of the method and to avoid the unnecessary recruitment of participants.

5.1. The number of participants will be: Number (or choose). Achieving this number could be compromised by: Cause (or choose). How will you prevent this potential problem? - ____ +

5.2. How do you justify the number of participants? Justify (or choose)

5.3. The source of Write (or choose), it is estimated that up to ____ % of participants that could be excluded or lost in the course of the project because of:

- Reason (or choose). How will you limit the chances of this being a possibility? ____ +

6. RECRUITMENT (if there is participant recruitment)It is important to report the methods used to recruit participants to ensure participants’ rights are respected and their decision to participate is made in a free and informed manner, without undue pressure.

6.1. Inclusion criteria Write a list of inclusion criteria used to select the participants of the group: Group +

Age: ____. If there is a criteria related to age, please indicate why? Reason (or choose)Language: ____. If the language is limited to English only, or includes other languages, please indicate

why? Reason (or choose). If the language is other than French or English, how will you communicate with these participants? ____

Sex: ____. If there is a criteria related to sex, please indicate why? Reason (or choose)Other criterion: ____. Why? Reason (or choose) +

6.2. Exclusion CriteriaWrite a list of exclusion criteria used to select the participants

Criterion: ____. Why? ____ +

6.3. What means will be used to ensure the participants learn about the project?☐ Advertisements publicized in the following media and social networks: ____ - Attach the ads☐ Advertisements posted in the following places: ____ - Attach the ads☐ Leaflets placed in the following places: ____ - Attach the ads☐ With the help of a person(s) Choose a part of the research team that will introduce the project Choose

with participants whom they have the following relationship: ____ Attach the documents & materials made available to introducers. Attach a letter of support from people NOT part of a CIUSSS or CISSS

☐ By contacting potential participants who have previously given their permission to be contacted for this purpose or for whom permission to do so has been granted to the research team by a third party. How was the authorization obtained? Explain (or choose) - Attach a copy that participants signed to agree to be contacted again

☐ With the help of another method. Specify: ____.

6.4. How will the participants’ eligibility be verified?Academic Affairs, Teaching and Research DirectorateUpdated Version –October 25 2019 on 9

☐ Using Choose given to the participants Choose Specify the moment? ____. - Attach the triage & other forms used

☐ An in-person interview. - Attach the interview script☐ Based on clinical characteristics (e.g., diagnosis), physical or physiological characteristics obtained

using medical methods (e.g., clinical assessment, blood test) or performance or responses to evaluations or questionnaires measured for: Explain (or choose) - Attach a copy of the signed to consent to their files being accessed for future use

☐ By consulting a list of potential participants held by: ____

6.5. How will the participants and the research team be in contact?☐ The participants are already in contact with the research team.☐ The participants communicate Choose with the research team after gaining knowledge of the project.☐ The research team will contact the participants Choose after the participants have been made aware of

the project and have let an intermediary know that he/she agreed to be contacted.☐ The research team will contact the participants Choose after obtaining his/her contact information,

either by consulting his/her file or by consulting a list of participants.

7. CONSENT (if there is participant recruitment)Consent must be free and informed, which means participants must understand the nature of their participation and their decision to participate should not be influenced by factors other than the benefits presented in the consent form. It is important to remember that even if they have agreed to participate in the project, participants can withdraw from the project at any time and this must be clearly stated in the consent form.

7.1. Are the participants, within the meaning of the law, all able to participate in a research project, which means they, understand the objectives and course of the study, and are able to give informed consent? Write (or choose).

7.2. Are participants experiencing or are likely to experience financial difficulties, mental disorders, physical disabilities or other difficulties that could affect their ability to understand the project and the nature of their participation, and skew their desire to participate?

☐ Yes. What are these challenges and how do you plan to ensure they do not interfere with the understanding of the project and not bias the decision to participate in the project? ____.

☐ No.

7.3. Is there a relationship between the participants and one of the members of the research team? ☐ Yes. Specify whether the relationship may affect the decision to participate in the project or whether

participation in the project may affect the relationship: ____.☐ No.

7.4. How will the participants’ consent be obtained?☐ By one or more person(s) Choose a part of the research team and will hand the consent form to the

participants with whom they have the following relationship: ____. If the person is not a part of the research team, how will you assure the participants have answered their questions? ____.

☐ On the internet, as follow: ____.

7.5. What consent do you ask participants? Academic Affairs, Teaching and Research DirectorateUpdated Version –October 25 2019 on 9

Participants will be asked to consent to Write (or choose); the consent will be obtained with the help of Write (or choose) and is Choose. + Attach the consent forms

8. RISKSThe risks and the disadvantages should be clearly presented to the participants before they decide to participate in the project. Risks are not limited to those that could cause data collection inconvenience, but also data retention measures and privacy protection. The treatment of the research project by the Research Ethics Committee is determined by the level of risk and ability to consent.

8.1. What are the risks or the disadvantages for the participants?Major risks / disadvantages: Write (or choose) +Minor risks / disadvantages: Write (or choose) +

8.2. What are the ways in which the risks can be mitigated? ____.

8.3. What measures are planned in the event of a negative reaction by participants to one of the procedures or to a problem with one of the devices used in the project? Write (or choose).

9. PROJECT DESCRIPTION

INSTRUCTIONS TO FOLLOW FOR PROJECT DESCRIPTION

Attach a description of your project in pdf or word format. The description may be a document prepared as part of another submission, but it must include the following five elements, otherwise it could be returned to you:

1) IntroductionThe introduction should introduce the reader to the knowledge related to the research project and help him to better understand the importance of the problem. The introduction should highlight the need to carry out the proposed project.

2) Objectives and Hypotheses The reader must understand why this project is being conducted and its relevance; as well as, be convinced that researchers have a clear idea of what they are studying and that this project is neither exploratory nor improvised. Describe the objectives and the assumptions of the project in a clear and concise way so as to indicate how the objectives are in line with the problem addressed in the introduction.

3) MethodDescribe the evaluation methods and tools in the project. Clearly describe the experimental conditions, if applicable. The reader should be able to clearly understand all stages of the project as well as the procedures to which participants will be subjected. Figures can be inserted into the text.

4) Data Analysis PlanDescribe the measurements and variables, as well as the statistical methods used to analyze the


results. The analyses should be used to test the hypotheses and achieve the objectives of the project.

5) Transfer of KnowledgeExplain how and to whom the results of the project will be communicated, and where applicable, how these results will help change the practice environment.

6) ReferencesInclude, in the format of your choice, a bibliography of all scientific documents used as references for this project.

Before preparing this document, be sure to answer the questions below as some guidelines depend on the answers to these questions.

9.1. The project summary submitted with this application is a copy of a document written for the following purpose: Write (or choose). If it does not contain all the information required in the guidelines presented above, please make the necessary changes or write down the missing information here: ____

9.2. Which device(s) will be used in the project?☐ None☐ Magnetic resonance imaging scanner (MRI) - Attach the MRRC approval letter☐ Positron emission tomography (PET) - Attach the MRRC approval letter☐ Magnetoencephalography system (MEGRC) - Attach the MEGRC approval letter☐ EEG recording system with surface electrodes☐ EEG recording system with implanted electrodes☐ Transcranial magnetic stimulation (TMS)☐ Transcranial direct current stimulation (tDCS)☐ Recording physiological measurements and vital signs (pulse, ECG, etc.)☐ Other, please specify: ____

9.3. What methods of data collection will be used in the project?☐ None☐ Extracting data from files - If the participant cannot consent to their file being accessed, you must

attach the access to personal information form. - - Attach the PIAForm if the participant cannot consent☐ Interview Choose - Attach the interview guides☐ Focus group - - Attach the interview guides☐ Clinical assessment, neuropsychological tasks – Attach the clinical evaluations☐ Questionnaire or survey Choose - Attach the questionnaires & surveys☐ Audio or video recording☐ Other, please specify: ____

9.4. What tests or medical procedures will be performed as part of this project?☐ Administration of the following drugs: ____☐ Taking the following samples: ____☐ Injection of the following substances: ____☐ Other, please specify: ____


9.5. Who will handle the devices and perform methods, tests, and medical procedures?- Name has the following skills: ____ to conduct the method or use the following device: ____ +

9.6. What is the scheduled timeline for the completion of the research project? Beginning date: ____Data collection period: ____Anticipated end date: ____Other dates: ____ +

9.7. How long will the data be retained? ____

SIGNATURE

I have reviewed this form; I agree to the research protocol mentioned above; and I agree to conduct this research according to policies and procedures of the Montréal West Island Integrated University Health and Social Services Centre (MWI IUHSSC).

________________________________________ __________________________Signature of the principal or local investigator Date

________________________________________Print name

Note:- The form can only be signed by the principal or local researcher- An electronic signature is accepted, but the project must be submitted by a member of the research team- An incomplete or unsigned form will not be accepted- Correspondence will only be made with the person who submits the project, but the letters of approval and

authorization will be forwarded to the principal and local researcher with the submitter in CC.


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