Royal Roads University
Request for Ethical Review For Research Involving Humans
Approved by RRU Academic Council
16 February, 2011
If your research involves human participants then it most likely requires an ethical review by the Royal Roads University Research Ethics Board (or one of its subcommittees). Please refer to the Royal Roads University Research Ethics Policy (16 February, 2010) for specific guidance on identifying research that requires ethical review.
Reference to the Royal Road University Research Ethics Policy will assist you in understanding the questions below and will help you formulate your responses. If you have additional inquires, contact your Faculty Project Supervisor, the Dean of your Faculty or the Head of your Unit, the School Director, the Associate Vice President Research, or the Research Ethics Coordinator.
Research involving human participants cannot be initiated until the Request for Ethical Review has been approved.
Please have your academic supervisor submit the completed form, via email, to .
Please allow four weeks for the decision of the Research Ethics Board.
Please do not delete any of the questions or prefatory materials.
I. Principal Investigator (your name):
A. Faculty / Program:
Faculty:
Graduate Student
Undergraduate Student
Staff
Other Specify:
Address:
Telephone:
Mail Correspondence and/or approval to:
Email (please use current email address which you are checking regularly):
Fax:
If student (or research assistant) specify Faculty Project Supervisor/Advisor and Sponsor/Client
Faculty Project Supervisor/Advisor:
Telephone:
E-Mail address:
Project/Thesis Sponsor/Client:
Sponsor contact name:
Telephone:
E-Mail Address:
If faculty member, specify your Supervisor:
Co-Investigators (name, position, and if applicable, affiliation with other institution, mailing address, email address, and telephone):
B. Conflict of Interest
What is your position within the sponsoring organization?
Provide full details of any actual, perceived, or potential conflict of interest, economic, family-related or otherwise, on the part of the principal investigator and co-investigators. (For example, if you are the teacher of students or the employer or manager of employees who you will be inviting to be part of your research, that would be a conflict of interest situation which would need to be addressed. Are you an employee of an organization where your fellow employees will be potential research participants? That too would be a conflict of interest situation.) Indicate how this conflict of interest will be addressed with your research participants. What measures will you be taking to ensure that your research participants are apprised of the conflict of interest? Any and all conflicts of interest must be disclosed in your consent documentation (as outlined in Question IX).
Do you have a supervisory or role of possible influence over the individuals in the study? If so, please explain how you would mediate undue influence or coercion for participants to "participate" in the study?
Is there any possibility that the activities or results of your study could impact negatively on the organization? If so, please explain how you would mediate this impact.
II. Short Title of Project (no more than 10 words):
Keywords
Provide 4 keywords/key phrases that describe this project.
1.
2.
3.
4.
III. Summary of Proposed Research
Provide a brief but complete description, in non-technical language, of the purpose, objectives and research questions of the project (USE NO MORE THAN ONE PAGE).
A. Purpose – [what is at stake?]
B. Objectives – [what are you hoping to accomplish through your
research?]
C. Research Questions:
IV. Summary of Methodology and Procedures
Provide a brief but complete description, in non-technical language of the methodology and procedures. USE NO MORE THAN ONE PAGE.
Note: Attach to this application a copy of your questionnaire, interview guide, survey, test instrument, or other research instrument. If it is not complete, then please submit your “best draft” or gist of the instrument. When your final instrument is available, please submit to your faculty project supervisor for approval. If there are significant changes, approval may be sought from the REB or appropriate subcommittee that monitors the amended submissions.
V. Description of Population
A. How many participants will be used?
B. Who is being recruited and what are the criteria for their selection? (Justify any exclusion of prospective or actual research participants on the grounds of attributes such as race, sex, age, culture, race, and mental or physical disability.)
VI. Recruitment and Withdrawal
A. How are the participants being recruited?
By letter (enclose a copy)
By telephone (If yes, complete “Telephone Contact Form”)
Advertisement, poster, flyer (enclose a copy)
Other (explain)
B. How and when are participants informed of the right to withdraw?
C. What procedures will be followed for participants who wish to withdraw at any point during the study?
VII. Research Project Details
A. Where will the project be conducted?
B. Does your sponsoring organization or any of the organizations involved in your research require an ethical review?
Yes No
If yes, has approval been granted?
Yes No
Your ethical review at RRU may be approved before the ethical review at your sponsoring organization. Once you receive feedback from ethical review processes at other institutions, please forward that information via email to or by surface mail to: Colleen Hoppins, Office of Research, Royal Roads University, 2005 Sooke Road, Victoria, BC, V9B 5Y2 or by fax to 250-391-2500.
Whether or not your organization requires a formal ethical review, have you had discussions with your client/sponsor on the ethics of your research?
Yes No
C. Are you aware of additional considerations that are necessary to have in place prior to conducting your research in other countries? It is the researcher’s responsibility to investigate these.
D. Is this an amendment from a previously approved protocol?
Yes No Date:
VIII. Involvement of Aboriginal Individuals or Communities
Will the research involve aboriginal individuals?
If yes, will any of the following considerations apply? (Provide a brief explanation of any relevant considerations and indicate how approval of the community as a whole will be obtained.)
Property or private information belonging to an aboriginal group as a whole will be studied or used.
Leaders of the group will be involved in the identification of potential participants.
The research is designed to analyze or describe characteristics of the group.
Individuals are selected to speak on behalf of, or otherwise represent, the group.
IX. Free and Informed Consent
Evidence of free and informed consent by the participant or authorized third party should ordinarily be obtained in writing. (See Checklist for Consent Form and include a copy of the consent form or other format by which you will obtain consent in writing). Obtaining informed consent from your research participants is mandatory; however, the method by which the informed consent is obtained may vary. For example, in completing a survey, one method of handling the need to inform research participants is to include, as a preface or preamble to the survey, the same sort of information that would otherwise be included in a consent form.
A. Have you included, attached to this “Request for Ethical Review,” a sample consent form?
Yes No
If no, document the procedure by which free and informed consent will be obtained.
B. Will the participants have any problem giving free and informed consent on their own behalf? (Consider physical or mental condition, age [e.g., under 18], language, incarceration or other barriers.)
Yes No
C. Are participants competent to give free and informed consent?
Yes No
If no, who is empowered to give consent on the participants’ behalf? What is the process for seeking this consent?
D. Is any form of deception of participant part of the research design?
Yes No
If yes, describe and justify the proposed deception.
X. Risks
A. Does the research in your view conform to the standard of “minimal risk”?
“Minimal Risk”: if potential participants can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered in those aspects of his or her everyday life that relate to the research, then the research can be regarded as within the range of minimal risk.
Yes No
If no, please explain how it exceeds minimal risk.
B. Describe the potential and anticipated risks of the proposed research.
C. What inducements (monetary or otherwise) will be offered to prospective participants? If payment is to be made, provide details or amounts, payments schedules and other relevant details.
D. How much time will a participant be expected to dedicate to the project?
XI. Benefits
The likely benefits that justify asking participants to participate:
A. Benefits to Researcher:
B. Benefits to Participants:
C. Benefits to Sponsor:
D. Benefits to Society:
XII. Privacy, Confidentiality and Anonymity
A. For some researchers, depending on the nature of your research, your client or sponsoring organization will require you to sign a privacy research agreement. The responsibility is yours to ensure that your research adhere to all privacy legislation and regulations in the jurisdiction where you will be conducting your research. Please check with your client or sponsoring agency to see if they will require a privacy research agreement.
Does your research require a privacy research agreement?
Yes No
If no, have you completed a confidentiality or other agreement with your sponsoring organization to confirm your obligation to protect research participants’ personal information?
Yes No
If no, please provide an explanation of why a research, confidentiality or other agreement is not required:
B. Will the project obtain information from research participants which is not available through publicly available sources? (For example, are names, ages, opinions, views, etc. to be collected?)
Yes No
C. Will such information be obtained only from publicly available information (e.g., from existing books or Stats Canada information) or materials?
Yes No
If no, describe methods for obtaining and handling data, including the following:
a. The type of data to be collected.
b. The purpose for which the data will be used.
c. Limits on the use, disclosure and retention of the data.
d. Appropriate safeguards for confidentiality and security (If you are using US software to warehouse your data, you will need to make your research participants aware that the information they share with you may be subject to the Patriot Act).
e. Any modes of observation (e.g. photographs or videos) or access to information (e.g. sound recordings) that allow identification of particular participants
f. Any anticipated linkage of data gathered in the research with other data about participants whether those data are contained in public or personal records
g. Provision for confidentiality of data resulting from the research
h. Is secondary use of identifiable data anticipated? (I.e. do you plan to use identifiable information that you gather in the course of your research project for a purpose other than your research project?)
Yes No
If yes, describe methods for obtaining and handling data, including the following:
i. Why identifying information is essential to the research
ii. What measures will be taken to protect the privacy of individuals
iii. Proposed methods of obtaining informed consent of those who contributed the data or of authorized third parties
XIII. Feedback to Participants
Will the participants be debriefed at the end of the research project?
Yes. Explain how this will be done.
No. Explain why not.
XIV. Compliance
I understand that the Royal Roads University Research Ethics Board may request from me my research documentation and my research results to demonstrate compliance with the Royal Roads University Research Ethics Policy and to demonstrate my compliance with my approved request for ethical review.
Please check here:
XV. Signatures
For electronic submissions, the researcher’s supervisor/advisor can email his/her approval to or fax the signed signature page, attention Research Ethics Coordinator, Office of Research, to 250-391-2500.
All applicants:
______
Principal Investigator Date
______
Co-investigator Date
If student:
______
Faculty Project Supervisor/Advisor Date
If faculty member or other:
______
Dean Date
Where the Dean is the Principal Investigator, the signature of the Vice President Academic is required.
______
Vice President Academic Date
Checklist for Consent Form
Researchers can obtain free and informed consent by various means, such as having participants sign a Consent Form; by an explanatory letter accompanying a questionnaire; or by an introductory statement (preamble) at the beginning of a questionnaire. Whatever means is used, the burden is on the researcher to ensure that the potential participants understand what they are being asked to do and are giving their free and informed consent to participate in the project. The participant should retain a copy of the Consent Form for their reference. The following information shall be conveyed to participants. Please check each item on this form to ensure that the necessary information is contained.
Title of Project
Identification of researcher and the University affiliation, including contact name and telephone number of Faculty Supervisor and/or School Director
Indication that the individual is being invited to participate in a research project
Clear statement of the research purpose
Nature, and expected duration, of the participant’s participation
Nature of questions to be asked, especially if sensitive questions are to be asked (Warnings may be placed in the body of the interview itself. Indicate how you propose to deal with sensitive items, if any, in your interview.)
Statement about how information obtained will be recorded
Statement about protection for privacy, confidentiality and anonymity
Description of any foreseeable harms and benefits, including any financial costs or benefits and/or inconveniences to the participant
Disclosure of any and all conflicts of interest
Assurance that prospective participants are free not to participate and have the right to withdraw at any time without prejudice to pre-existing entitlements
These assurances apply especially to:
a. Students: Whether they choose to participate or not will have no effect upon their grades and standing.
b. Employees: Whether they choose to participate or not will have no effect upon their employment or advancement.
c. Public: Whether they choose to participate or not have no effect upon medical care or services they are receiving or are to receive, if applicable.