Application for Ethics Review of Research Involving Human Participants

Application for Ethics Review of Research Involving Human Participants

(Please select this option if your study has already received REB approval at another institution OR if you will be using secondary de-identified data OR if you are seeking confirmation of whether or not your project requires REB approval.)

SECTION –COMMENTS TO CHAIR

Comments to Chair

This section can be used to indicate any special circumstances or requests related to your application on your first submission of your application. It is also used for you to respond to our reviews and address the required elements that are included in your review. Please note that this textbook allows only 4000 characters. In many cases, your resubmission comments may be greater than 4000 characters. In that case, please attach a separate document labeled 'Comments to Chair' in the attachment section of the application. Thank you.

SECTION –INTRODUCTION AND INVESTIGATORS

Title of Research Proposal

INVESTIGATORS

a. Principal Investigator

First Name:Last Name:

Dept/Office:Email:

Institution:Telephone:

Type:

Investigator Experience

Please provide a brief summary of the investigator's relevant research

experience/training (there is no need to include a curriculum vitae).

If the principal investigator is a graduate student and the research

is being conducted for a thesis or dissertation project, also include

a brief summary of the faculty member who is supervising the research.

Unless indicated below, all correspondence pertaining to this protocol will be directed only to the Principal Investigator's email

Co-Investigator(s)

Last Name / First Name / Email Address / CC Email To / Department / Institution

Student Researcher(s)

Last Name / First Name / Email Address / CC Email To / Department / Institution

Access to Protocol

In addition to the original creator of this protocol, you may designate authority to other individuals to access this protocol. Please bear in mind that two people cannot access the protocol simultaneously and that if this occurs the system will only accept changes made by one person. Other requested changes may be lost. If you are a graduate student, please ensure your supervisor is granted access.

BB Username / On Email List / Email Address

SECTION –ABSTRACT

ABSTRACT

Please provide a brief abstract of no longer than 400 words. The abstract must be in lay terms. Please avoid jargon and scientific terms. Please include a brief description of the methods, potential benefits, potential risks and risk management procedures.

SECTION – FUNDING

Is the research being funded or is there an application for funding being reviewed currently?

Funding Body/Sponsor / Account Code/Reference / Start Date / End Date / Awarded/Requested Amount / Status (Funded or In Progress)

SECTION - REVIEW BY ADDITIONAL RESEARCH ETHICS BOARDS

(A)Does this study involve other institutions or sites or are co-investigators affiliated with other institutions? NOTE: If “yes”, your study may require additional REB review at another institution.

Please note that federal guidelines state that REB approval must be provided from ALL relevant REBs as well as Ryerson’s REB before research can begin. This may affect your timelines for starting your research.

If Yes:

List of approved or currently reviewed protocols by other REBs

Institution / Approved

If No:

Please indicate if REB approval will be sought from another institution in the future.

(B)Does this study involve one or both of the following:

• Recruitment of students in elementary and secondary schools (public, private)?
• Recruitment of teaching or administrative staff in elementary or secondary schools (public or private)?

If YES, please note that REB approval may be required from the relevant School Board (e.g. TDSB, TCDSB, Durham Region School Board, etc.) as well as Ryerson’s REB before research can begin.

Please indicate if School Board approval has already been provided, is in progress, or will be sought after Ryerson REB approval:

(C)Does this study involve one or both of the following:

• A co-investigator whose institutional affiliation is at a hospital or clinic?
• The recruitment of patients, or staff in any hospitals or clinics?

If Yes:

If YES, please note that REB approval must be sought from the relevant hospital Board (e.g. Sick Kids, Bloorview, UHN, etc.) as well as Ryerson’s REB before research can begin.

Please indicate if hospital approval has already been provided, is in progress, or will be sought after Ryerson REB approval:

SECTION - OTHER APPROVALS TO CONDUCT RESEARCH

Do you foresee any other research ethics permissions that may be required to conduct this research?

These may include situations such as:

• Formal permission to conduct research in an agency or institution;
• Permission to access documents or personnel in a company;
• Permission from a School Principal to recruit staff, or students in a school.
• Permission from a First Nations, Inuit or Métis community/organization (see Chapter 9 of the Tri-Council Policy Statement)

If Yes: please describe what permissions you may need to seek. Please note if permissions have already been granted, please attach any letters of support or letters of permission at the end of the application.

SECTION - START AND COMPLETION DATES

Please note that estimated time from a full submission to first response from the REB is approximately 4-6 weeks. Time to approval varies with each application, but a first response will be sent to you in 4-6 weeks. The date that you anticipate to begin recruitment should not be a date before that unless you have already contacted the REB Chair or REB Coordinator to discuss this

Begin Recruitment Date:

Anticipated Completion Date:

SECTION - SECONDARY DATA AND CONTENT ANALYSIS

(a) Are you conducting secondary data and/or content analysis of existing data?

(i)If YES, please indicate if you are conducting Secondary Data and Content Analysis of existing data that is an anonymous dataset (i.e. with no identifying information within the data or accessible to the researcher).

If YES, please note that you may not require REB approval.

If NO,please indicate if you are conducting Secondary Data and Content Analysis of existing data that has identifying information within the dataset.

If YES, please indicate if you will be seeking consent from original participants:

If NO, please confirm the following:

The use of this information is essential to the research.

The use of this information is unlikely to result in any hard or adverse events for the participant whose data you access

You will be securely and safely storing the information.

You will ensure that any specific previously-stated wishes regarding data are respected.

It is impractical or impossible to seek individual consent from participants.

Other appropriate permissions have been sought.

(ii)Does this data originate from a specific First Nations, Inuit or Métis community or segment of the First Nations, Inuit or Metis community at large and does it involve the linking of two or more anonymized data sets?

If Yes, this research is subject to research ethic review as per Article 9.20 Chapter 9 of the Tri-Council Policy Statement and engagement of the community from which the data originate is required prior to initiating secondary use.

(b) Are you conducting a Secondary Data and Content Analysis of biological materials?

If YES, please describe how these materials have been obtained:

Is this biological material identifiable as originating from First Nations, Inuit or Métis communities or peoples?

If YES, this research is subject to research ethic review as per Article 9.20 Chapter 9 of the Tri-Council Policy Statement and engagement of the community from which the data originate is required prior to initiating secondary use.

(c) Does this study involve the content analysis of existing documents and records that are NOT public records?

If Yes, please describe the private or non-public documents and records indicate how access to such materials will be obtained.

SECTION - SCHOLARLY REVIEW

Please check one:

Please provide details:

SECTION - CONFLICT OF INTEREST

Are there any potential or perceived conflicts of interest that you foresee in conducting the research?

The Tri-Council Policy Statement defines Conflict of Interest as follows:

"A conflict of interest may arise when activities or situations place an individual or institution in a real, potential or perceived conflict between the duties or responsibilities related to research, and personal, institutional or other interests."

More generally, Conflict of Interest arises in any situation in which an individual is expected to exercise judgement on behalf of someone else, but has some 'outside' or personal interest that could threaten the impartiality of that judgement. Often the competing interest here will be a financial interest, but it need not be.

For more information please visit the REB guideline on Conflict of Interest at:

For a detailed explanation of Conflict of Interest please see our Guideline.

If Yes, please explain:

SECTION - RESEARCH METHODS/DESIGN

a. Please check all research designs and/or methods that apply to your project:

Qualitative Research

Quantitative Research

Mixed Methods Research (qualitative and quantitative methods)

Case Study

Intervention Research (Please upload a document outlining full details of the intervention)

Clinical Trial or Clinical Research (Please upload a document outlining the full details of the clinical trial)

Experimental Laboratory Study

Experimental Behavioural Study

Field Experiment

Action Research

Survey Research Design

Internet Based or Online Research [please complete Internet-Based or Online Research section]

Observational Study

Documentary/Filmmaking

Ethnography

Autoethnography

Oral/Life History

Photovoice

Arts-Based Methods

Secondary Analysis of Existing Data [please complete Secondary Data & Content Analysis Section]

Content Analysis of Non-Public/Private Data, Documents or Records

Research Involving Human Tissues

Research Involving Children [please complete Involves Children section]

Research Involving Aboriginal Persons [please complete Involves Aboriginal Persons section]

Research Involving Deception [please complete Involves Deception section]

University Course-Based Research (e.g. all students in a class conducting research).

Please see our FAQ on Students as Researchers

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Others

b. Please check all methods of collecting data that may applyand note the total number of participants you will be recruiting for each method:

In-person interviews

Maximum number of participants for this method

Phone or Skype interviews

Maximum number of participants for this method

Paper surveys or questionnaires

Maximum number of participants for this method

Surveys or questionnaires

Maximum number of participants for this method

Focus Groups

Maximum number of participants for this method

CoCollecting publicly-accessible documents (e.g. information from websites, city archives, land registry information, anonymous census data, etc.)

Collecting non-publicly-accessible documents (e.g. personal documents, student grades, patient chart data, corporate or company data not made public)

Collecting personal/demographic information

Audiorecording

Videorecording

Taking photographs

Asking participants to take photographs

Maximum number of participants for this method

Collection of biological material

Maximum number of participants for this method

Review of patient records or patient material (x-rays, MRI, patient charts)

Sharing or Talking Circles

Maximum number of participants for this method

Other(s)

c. Please provide information regarding the design and the rationale underlying the proposed research, design and data collection. Specify aims of the research that may include the expected outcomes or goals of the research, any hypotheses to be tested, or research questions to be answered.

d. Will you be collecting demographic data from participants?

Demographic data are things like age, gender, ethnicity, income level and might also include identifying information such as name, address, telephone numbers and email address.

If YES, please indicate what data will be collecting (and attach any demographic data collection forms to the protocol):

Address

Age

Citizenship/immigration status

E-mail Address

Education level

Ethnicity

Gender/Sex

Income

Name

Place of employment

Telephone number

Other

If you are collecting and storing: NAME, ADDRESS, TELEPHONE NUMBER and/or E-MAIL ADDRESS, please provide your reasons for collecting and storing this personal and identifiable data, and explain how it will be used:

e. Will you be collecting demographic data on ethnicity and will this variable include ‘Aboriginal’ (First Nations, Inuit or Métis)?

If Yes, Article 9.1 (d) of the Tri-Council Policy Statement states that if the interpretation of research results will refer to First Nations, Inuit or Métis communities, peoples, language, history or culture there is a requirement that researchers engage the community. This does not mean that you should not ask people if they identify as Aboriginal but if your research has a strong likelihood that you will be able to interpret the results based on Aboriginal as a sole variable, engagement is required.

SECTION - SELECTION AND RECRUITMENT

(A) Inclusion and Exclusion criteria

Please describe, in detail, the inclusion and exclusion criteria for potential participants.

(B) How will recruitment be conducted? Please describe all possible ways that you are planning on recruiting potential participants. If you will be emailing or phoning, please include how you will access contact information such as email addresses and phone numbers.

(C) Are there any already-existing relationships between the researcher and potential participants that may possibly contribute to feelings of obligation or undue influence to take part? (e.g. instructor-student, service-provider-client, manager-employee, etc.)

If YES, please describe these already-existing relationships and outline strategies you will put in place to avoid potential participants feeling unduly obligated to take part, e.g. having someone other than the researcher inform the potential participants about the study):

(D) Will you be using recruitment flyers/brochures/advertisements to recruit potential participants? (see template for information to include on recruitment material)

If YES, please attach these, labeled clearly, at the end of the application.

(E) Will you be sending e-mails or using social networks to recruit participants (e.g. Twitter, Facebook)? Please note, if using websites like Kiiji to advertise please place the notice under ‘volunteering’, not under ‘jobs’. (See template for information to include on recruitment

If YES, please attach e-mail recruitment notice, 140-character tweet, or FB notice.

(F) Will you be recruiting people in-person or over the phone?

If YES, please attach a recruitment script at the end of the application if you will be talking to participants about the study in order to recruit them.

(G)Will you be recruiting from introductory psychology courses at Ryerson University (PSY 102 or PSY 202)?

If YES, you must use the SONA system for recruitment and attach the SONA recruitment ad to the application.

SECTION – CONSENT

(A)Will you be obtaining consent?

If YES, Please describe the process by which consent will be obtained. Please describe when the consent process will occur, who will obtain informed consent and confirm that there is adequate time for reviewing the consent with participants, discussion and questions:

If NO, Federal guidelines require consent be obtained from research participants except for some circumstances. Please explain why you will not obtaining consent.

(B)What method of obtaining consent are you using?

Written and signed consent form (attach consent form at end of application)

Please see our Consent/Assent Form Template

Oral consent (attach consent script at end of application)

Federal guidelines require that if you are using oral consent instead of written consent, you must provide clear and detailed justification for not using written consent.

Consent form before an on-line survey (attach consent form at end of application)

Sacred tobacco as culturally appropriate method of consent with some First Nations and Métis people (attach consent script/letter of information at the end of the application)

(C)Are you providing the potential participants with the consent form ahead of the time of participation in order for them to have adequate time to reflect upon potential participation? (If not applicable, simply indicate N/A)

If YES, please indicate how you will be providing the consent form to participants ahead of time:

If NO, please indicate why this is not possible::

(D)Does your research involve any persons who cannot provide consent for themselves and require a guardian, proxy or substitute decision-maker to provide proxy consent?

If YES, please describe how you will ensure the voluntary participation of these persons:

SECTION - VOLUNTARY NATURE OF PARTICIPATION

a. Please describe strategies you will use to ensure participants know that they have the right to withdraw voluntarily from participation or parts of participation. Please describe how participants will be informed about this right in the informed consent process. Please also indicate what will happen to their data if they withdraw after or during participation:

SECTION - POTENTIAL RISK AND BENEFIT

(A) What level of potential risk does this research involve, for participants?

(B) Please identify the kinds of potential risks and briefly describe the risk and why you feel the risk is low, medium or high.

Physical risk (e.g. involving risk of physical injury or contact)

Describe the risk:

How will the risk be managed minimized or mitigated?