Form: Application Checklist and Research Ethics Application for Research Involving Human Participants

Niagara College Research Ethics Board Form: Application Checklist and Research Ethics Application for Research Involving Human Participants

This form is for researchers who are planning to conduct research involving human participants at multiple colleges in Ontario.

It is the researcher’s responsibility to contact the Research Ethics Board Co-ordinator at each college to check site-specific requirements and to determine where and how this form is submitted.

"*" indicates required fields

Step 1 of 16

Section A: General Information

1. Title

Title of Research Project*

2. Investigator Information

Principal Investigator

Name*

First Last

Position*

School/Department*

Email*

Enter Email Confirm Email

Phone*

Co-Investigators

Name

Position

School/Department

Telephone

E-mail

Student Investigators

Name

Position

School/Department

Telephone

E-mail

Other Investigators

Name

Position

School/Department

Telephone

E-mail

3. Project Dates

Estimated Start Date*

MM slash DD slash YYYY

Estimated End Date*

MM slash DD slash YYYY

3. Project Locations

Project Locations*

Specify Institutional Sites

College/University

City

5. Other Research Ethics Board Approval

Has any other institutional ethics board approved this project?*

Yes

If YES, please attach a copy of the clearance certificate/approval.*

Accepted file types: jpg, gif, png, pdf, Max. file size: 97 MB.

If YES, please provide title of research project and name of ethics board.*

If YES, please provide date of decision.*

MM slash DD slash YYYY

6. Project Funding

Is this project currently funded?*

If there is a sponsoring organization(s), please identify the period of funding, the organization(s) and the contact person(s).

Yes

Period of Funding Start Date

MM slash DD slash YYYY

Period of Funding End Date

MM slash DD slash YYYY

Sponsoring Organization

Contact Person

First Last

Mailing Address

Street Address City Province Postal Code

Phone & Extension

Enter Email Confirm Email

If yes, describe the sponsorship by value and type (grant, gifts in kind, resources, cash contribution, staff, equipment, etc).

If the funding source changes, or if a previously unfunded project receives funding, you must submit a change/amendment form to each Research Ethics Board that has approved your project.

Value

Type of Contribution

Conflict of Interest

a) Will the researcher(s), members of the research team, and/or their partners or immediate family members receive any personal benefits (for example a financial benefit such as remuneration, intellectual property rights, rights of employment, consultancies, board membership, share ownership, stock options etc.) as a result of or connected to this study?*

Yes

N/A

If yes, please describe the personal benefits below. (Do not include conference and travel expense coverage, possible academic promotion).*

b) Are there any real, perceived or potential conflicts of interest of which you are aware (for example, researchers who will benefit financially from the research, research which may be in conflict with institutional roles and responsibilities, faculty members who may be responsible for awarding participant grades)?*

Yes

If YES, please explain those conflicts of interest and how you will address them.*

c) Are there any restrictions regarding access to or disclosure of information (during or at the end of the study) that the sponsor or institution has placed on the investigator(s)?*

Yes

If YES, please explain:*

d) Is there the possibility of commercialization of the research findings?*

Yes

If YES, please explain:*

Section B: Summary of the Proposed Research

8. Rationale

Describe the purpose and background rationale for the proposed project, as well as the hypothesis(es)/research question(s) to be examined:*

9. Methodology

Please attach copies of all documents used for the purpose of collecting data including questionnaires, interview guides, intervention protocol or other test instruments.*

Drop files here or

Accepted file types: jpg, gif, png, pdf, Max. file size: 256 MB.

a) Explain the methodology:*

b) Describe data collection sequentially and in detail. Outline all procedures in which the research participants will be involved (e.g., paper and pencil tasks, interviews, surveys, questionnaires, physical assessments, physiological tests, time requirements, etc.)*

c) Describe participants, sampling method and sample size and rationale for sample size:*

d) Describe inclusion/exclusion criteria:*

e) Explain the process of data analysis briefly:*

10. Recruitment

Attach a copy of any advertising, correspondence and/or scripts to be used for the purpose of recruiting participants.*

Drop files here or

Accepted file types: jpg, gif, png, pdf, Max. file size: 3 MB.

a) How do you plan to recruit participants? (Please check all that apply)

Investigators will approach their own students/patients

Investigators will receive referrals from other faculty

Educational records (e.g., academic performance information, Student Information System)

Indirect advertising (e.g., poster, e-mail, web-based)

Database of people who consented to future contact

Direct approach (e.g., random digit dialing, blogs and chat room)

Other

If other, please specify*

b) Will any of the investigators have a position of power or authority over the participants?*

Yes

If YES, how will you manage and minimize any undue influence?*

c) Does your recruitment plan require you to contact potential participants by (Please check all that apply):*

Telephone

Personal E-mail

Anonymous Email

Letter

Describe permission you have been given or plans to obtain permission to contact the participants.

d) Does your study involve any of the groups listed below (please check all that apply)?*

People with relevant health issues

Children

People in medical emergencies

Elderly people

Indigenous people

People in poverty

People in long-term care

People in prison

People with mental-health issues

People who are unable to consent

Other

If other, please specify*

e) Do you screen personal health information to identify potential participants?*

Yes

Section C: Description of the Risks and Benefits fo the Proposed Research

11. Possible Risk to Participants

In your best judgment, how much risk does the study involve?*

Minimal Risk

Greater Than Minimal Risk

a) Identify who will be collecting the data and where:

b) Indicate if the participants might experience any of the following risks:

Physical risk (including any bodily contact or administration of any substance)

Psychological risks (including feeling demeaned, embarrassed worried or upset)

Social risks (including possible loss of status, privacy and/or reputation)

Economic risks (including incurring expenses, loss of incentive)

Academic risks (including loss of bonus marks or course standing)

Potential access to personal data

Are any possible risks to participants greater than those the participants might encounter in their everyday life?

If you selected any of the options above, please explain the risk:

c) Please comment on the magnitude of harm participants are likely to encounter i.e. would you assess it as minimal, substantial, transient or longer lasting?*

d) Please comment on the probability that participants will encounter harm, i.e. would you assess it as low, medium or high?*

e) Describe how the risks will be managed (including an explanation as to why alternative approaches could not be used).*

If applicable, please attach a copy of any additional relevant correspondence, resources, or materials for managing risks to participants.

Max. file size: 256 MB.

f) Describe time and any travel demands expected of participants:*

Possible Risks to Researchers

Possible Risks to Researchers*

Please explain any risks to researchers which you anticipate:

13. Possible Benefits to Participants

Possible Benefits to Participants*

Discuss any potential direct benefits to the participants from their involvement in the project. This may include the (potential) benefits to the scientific community/society that would justify involvement of participants in this study:

14. Informed Consent

a) Will you be seeking written consent from participants?*

Yes

If YES, please attach a copy of the Information/Invitation Letter and Consent form for participants.*

Drop files here or

Accepted file types: jpg, gif, png, pdf, Max. file size: 256 MB.

b) If consent will not be written, please provide details of how you will obtain consent:*

c) Will any participants be minors (ie., age 0-15)?*

Yes

d) Will all participants be competent to consent?*

Yes

e) If the participants are minors or are not competent to consent, describe the proposed alternate source of consent and attach any permission/ information letter to be provided to the person(s) providing alternate consent.

f) Who will obtain consent to participate for minors or those not competent to consent?

g) When and where will this be done?

h) Will participants have the option to withdraw from this study?*

Yes

If YES, please explain what they have to do to withdraw:*

If NO, please explain why not:*

i) Indicate what will be done with the participant’s data and any consequences to the participant withdrawing from the study:*

j) Will you be using deception in your research?*

Yes

If YES, provide rationale and debriefing plans: Who will advise the participants of the true nature of the study? When and how will that be done?*

15. Collection and Protection of Personal Information

The collection, use and disclosure of Personal Health Information (PHI) are regulated by the Personal Health Information Protection Act (PHIPA). Researchers must comply with this legislation
Collection of participant SIN (social insurance number) is prohibited, unless payments to participant exceed $500/year (required for tax purposes)
Personal data should be collected at the lowest level of identifiability possible (e.g. initials instead of a name, age instead of DOB)
Note: Coding
- Identifying and/or identifiable data should be protected by a coding system
- The code (study ID and identifiable data) must be isolated from study data and stored in a secure manner
- You are required to destroy identifiers or links at the earliest possible time.

a) Will all data be treated as confidential?*

Yes

N/A

If NO, please explain*

b) Will you use a coding system to protect identifiable information?*

Yes

N/A

If NO, please explain*

c) Please check all types of data which you intend to collect:*

Anonymous information in which no identifiers are collected

Anonymized information in which all identifiers are removed and no code is kept.

De-identified/coded information in which identifiers are removed and replaced with a code; the code can be used to re-identify participants

Identifiable information which could identify a participant through a combination of indirect identifiers (e.g. DOB plus address)

d) If collecting indentifiable information, which identifies a participant through direct identifiers (e.g. full name, medical record number), please detail the specific identifiers required for this study. Complete all that apply and explain why it is necessary.

Name

Initials

Student/Employee Number

Social Insurance Number

Health Card Number

Medical Records Number

Address

Full Postal Code

Partial Postal Code

Telephone Number

Physician

Date of Birth

Age

Other: Specify

16. Storage of Information

PHIPA Requirements
Paper files with identifiable information must be kept in a locked cabinet within a locked office (but not at home)
Electronic files with identifiable information may be stored on a password-protected computer on a secure network (i.e., virus protection, file backup, firewall) or encrypted
Electronic files with identifiable information may be stored on mobile devices (e.g. laptop, CD, USB, PDA) with no alternative method of storage; these files must be encrypted
Identifying and/or identifiable PHI cannot be transmitted by email unless it is encrypted

Secondary Use of Data
Use of data for purposes other than those for which the data was originally collected is considered to be secondary use of data and requires participant’s permission

Duration of Storage
Individual funding and research organizations have different requirements. This review defers to these external requirements and it is the responsibility of the researcher to identify and comply with those requirements

a) How will you store and protect data without identifiers?*

b) How will you store and protect the study code (or other data with identifiers)?

Leave blank if not applicable

c) How long will you keep the study data?*

Please enter a number from 0 to 9999.

d) Who will take responsibility for data destruction after that time period?*

e) What will you do with the study data after this period?*

17. Moving and the Transmission of Data

Data sent to the United States, or uploaded to American servers (e.g. Survey Monkey), is open to access by American regulatory bodies. Researchers must inform study participants of this possibility
If you require outside sources to have access to participant data, you need to ensure that mechanisms are in place to ensure data security, confidentiality and anonymity

a) Do you plan on physically moving the data?*

Yes

N/A

If YES, how will the data be secured while in motion?*

b) Will the research data be physically or electronically moved outside its original location of collection (for example, data on a laptop is brought to the office, sent for transcription or uploaded to a central data repository)?*

Yes

N/A

c) If YES, does this data include identifiers?*

Yes

N/A

If YES, please provide details on steps taken to ensure data security and privacy:*

d) If data are being transmitted, where will the data be sent?

e) Please list the names and affiliations of persons outside of your research team who will have access to the identifiable data.

Name

Affiliation

f) How will the data be transmitted?

Fax

Email (Note: Encryption protocol must be attached)

Private Courier (Note: Delivery must be traceable)

Canada Xpresspost (Note: Regular mail may not be used)

Other

18. Secondary Use of Data

Any secondary use of data must be approved by the REB prior to its use

a) Will you combine your research data with any other data sets?*

Yes

N/A

If YES, identify the data set:*

If YES, provide a list of data items contained in the data set:*

If YES, explain how the linkage will occur:*

b) Will your data be entered into another database for future use?*

Yes

N/A

If YES, please specify where your data will be stored:*

If YES, please specify who will be the custodian?*

If YES, please specify who will have access to the database?*

If YES, please specify what security measures will be in place?*

19. Experience

The NCREB requires that researchers complete the free online TCPS CORE (Course on Research Ethics) training, available at: www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel

a) What is your experience and what qualifications do you have for doing this kind of research?*

20. Compensation

a) Will participants receive compensation or an incentive for participation?*

Financial

Non-Financial

If YES to either, please provide details:

b) If participants choose to withdraw, how will you deal with compensation?

21. Participant Feedback

Feedback should be provided in a way which is accessible to participants. For example, some participants may not have access to a computer so uploading results to a website may not be sufficient.

a) Explain what feedback/ information will be provided to the participants after participation in the project. (For example, a more complete description of the purpose of the research, or access to the results of the research). Indicate when results will be available.*

22. Annual Review and Adverse Effects

It is the Principal Investigator’s responsibility to notify the REB the project is completed, or if it is cancelled, using the appropriate form

Adverse events (i.e. unanticipated negative consequences or results affecting participants) must be reported to each Research Ethics Board and the Research Ethics Coordinator as soon as possible using the form available on individual college websites. This must be reported to EACH institution directly

Protocol review requires the completion of a “Renewal/Completed Status Report” at least annually

a) Will this project require any additional monitoring or review?*

Yes

N/A

If YES, please explain:*

23. Additional Information

a) Is there any other information relevant to the project that you wish to provide the Research Ethics Board?

Signatures

Principal Investigator (PI) Assurance:*

First Last

Signature Date:*

MM slash DD slash YYYY

Check the following:*

I have the ultimate responsibility for the conduct of the study described in this application including my responsibilities as an advisor to any students involved in this project. I have read and am responsible for the content of this application. The information provided is complete and accurate. I understand that, as Principal Investigator, I will be the primary link with the REB at each institution, other researchers involved with this project, and the research participants. I agree to conduct the research in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, this individual college’s policies and procedures for ethical Conduct of Research, and the conditions of approval indicated by the Niagara College Research Ethics Board.

I also understand that if I make any changes whatsoever to the sample documents provided with this application (including, but not limited to, the recruitment scripts, information and consent letters, survey questions, interview or focus group questions), I need to complete a change request form and submit this to each REB for review. I further understand that these changes, if determined to be substantive by the REB, may require a new application if they constitute new research. If any changes are made in the above arrangements or procedures, or if adverse events are observed, I will bring these to the attention of the all institutional Research Ethics Coordinators immediately. I further understand that I may not start any research without receiving a Certificate/Letter of Ethical Acceptability. I further understand that ethical approval does not constitute institutional approval of this research.

I understand that if I fail to advise the participating REBs of any changes or adverse events, or fail to comply with research protocols outlined in this application, or make any unauthorized changes to any document submitted with this application, the Certificate of Ethical Acceptability may be rescinded by the REB.

This form has been adapted with permission from a form developed by Conestoga College, which in turn was adapted from forms from the University of Guelph and McMaster University with their permission.

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