Published on Brock University (http://www.brocku.ca)
Submitting an Ethics Application
Where do I find the appropriate application forms?
All forms, templates and guidelines can be downloaded from our forms page.
How many copies do I submit?
Please submit one original and one hard copy to the Research Ethics Office, Office of Research Services, Mackenzie Chown D250A, Brock University, St. Catharines, Ontario, L2S 3A1. Please include all relevant documentation such as consent forms. If applicable, ensure your supervisor has reviewed and signed the application prior to submission.
For Secondary Use of Data or Multi-Institutional research only 1 hard copy is required.
How long does it take for an application to be reviewed and receive ethics clearance?
A proposal submitted for an delegated review (minimal risk) normally requires 15 - 20 working days to process. Quality can make a difference. An application that is complete, accurate and concise might take less time, because there will be less back and forth between the Research Ethics Board (REB) and the researcher to clarify questions or concerns. If an application is found to have significant issues in terms of clarity and/or is missing components, researchers may be asked to resubmit.
Applications requiring full review (greater than minimal risk) will be reviewed at the next scheduled monthly Research Ethics Board meeting. Research protocols requiring full review must be received no later than two weeks prior to each scheduled monthly REB meeting.
What type of review will I have?
The level of review depends on the level of risk:
1. Delegated Review (minimal risk)
2. Full Board Review (greater than minimal risk)
Please note the TCPS definition of Minimal Risk is "The research can be regarded as minimal risk if potential participants can reasonably expect to regard the possible harms implied by participation in the research to be no greater than those encountered by the participant in those aspect of his or her everyday life that relate to research".
Please see sections regarding Secondary Use of Data and Multi-Institutional Research for review information on these types of applications. These types are reviewed directly by the Chair of Research Ethics Board and processed quickly.
What type of research requires ethics clearance?
All research at Brock University, or by a person associated with Brock University (faculty, staff, or students), funded or not, that involves living human subjects must be reviewed and receive ethics clearance from the Research Ethics Board before the research is started.
The REB must also review research involving human remains, cadavers, tissues and biological fluids, embryos or foetuses.
Examples of research involving human subjects (requiring ethics review):
Are there any types of human research that are exempt from review?
The REB is responsible for deciding if projects are excluded from review. If in doubt, researchers are advised to seek the advice of the Research Ethics Office (email: firstname.lastname@example.org or call ex. 3035).
In general, the Brock Research Ethics Board excludes the following from its requirements for ethics review:
a. Undertakings that do not fit the definition of research, as defined by the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). That is, "research is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation" (TCPS2, Chapter 1: pg 7);
b. Research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, archival materials, or third-party interviews. Such research requires ethics review only if the participant is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols;
c. Research involving the observation, assessment, or recording of public behaviour where such research involves the observation of participants in, for example, political rallies, demonstrations, public meetings or similar activities in which it can be expected that participants are seeking public visibility and therefore observation and possible recording;
d. Research that relies exclusively on secondary use of anonymous information or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information. Anonymous information is "information that never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low" (TCPS2, Chapter 5: pg 57);
e. Quality assurance studies, performance reviews of an organization or its employees or students within the mandate of the organization, or testing within normal educational requirements, unless they contain an element of research in addition to assessment. Note that these studies can be submitted for an administrative review by the Research Ethics Office.
I will only be interviewing close friends or family. Do I need ethics review?
If you are interviewing friends and family as part of a course research project you may need ethics review, unless your course instructor has already obtained clearance for the course, in which case the instructor will determine the level of review required. Consult with the Research Ethics Office when in doubt.
How can I write a successful application?
If you are writing an independent thesis or honours paper the research ethics application can help organize and improve the quality of your research. You should try to complete the application yourself but ultimately you are obligated to work with a supervisor to refine your application for ethics review. If you do not have a supervisor, you cannot submit an application. Your supervisor can be from another department and in some circumstance, even from outside the university. Some familiarity with the Tri-Council Policy Statement is a definite help. Attending workshops or presentations given by the department or taking courses on research methodology that have research ethics sections are very useful. There are many research ethics online tutorials. Reading the application carefully is vital in order to complete an application. Consent forms, questionnaires, surveys, and interview questions must all be included with the application.
Are there any sample materials that I can look at to help me design information letters and consent forms for my project?
Please visit the Application Forms & Templates page
Where can I find a copy of the Tri-Council Policy Statement (TCPS)?
Tri-Council Policy Statement
Research Ethics Board (REB)
What is the Research Ethics Board (REB)?
The REB is a committee appointed by the VP-Research to review all research involving human participants from the perspective of participant protection.
Members consist of faculty and graduate students from a wide variety disciplines and research backgrounds as well as community members. The role of the REB is to ensure compliance with the Tri-Council Policy Statement and Brock's Policy. The REB reviews the protocols for all research involving human participants as defined by the TCPS.
What is the REB concerned with?
What can the REB do?
I am instructing a class who will be doing a research project with humans. Can I submit one application for the entire class?
Yes, there are course-based applications for instructors (please see the Application Forms page). An entire class can be covered by one application form, completed by the instructor, if the research is minimal risk, and if the research methodologies employed by the students are basically the same. Sample consent forms or questionnaires, if used, should also be submitted. An Annual Renewal must be submitted on the anniversary of ethics clearance.
Is informed consent required even if the data/specimens will be collected from my friends and colleagues?
Yes. All research involving interaction with human subjects requires informed consent regardless of who the participants are.
Do I need an information letter or a consent form?
There are many kinds of research methodology, and not surprisingly, ways of obtaining the free and informed consent of participants.
If you are a political scientist with interview questions for a high level government or public official, you do not necessarily need a signed consent form. An official can be sent a letter of information, with your contact information, rights to withdraw, assurances in regards to publication of statements, contact information for the Research Ethics Board and the date and time for the meeting. If the official agrees to the interview, that is the same as consent. You still need to document the consent process-that you sent a letter of information with all the details on the consent form checklist and the official agreed to the interview. That's what you can do with a log book or tape recorded consent.
Survey research that is mailed sometimes does not require written consent as completing and returning the survey is the same as consent. However, participants need to know that they do not have to answer all the questions or return the survey, with no consequences to themselves, and that their responses be kept confidential or their name anonymous.
The Tri-Council Policy clearly outlines that written consent is not necessary for Aboriginal peoples who do not have a culture of the written word. Researchers however need to document how consent is obtained in such cultures. Often an information letter and consent form work very well together. The information letter informs participants about the research, in easy to understand language, what will be required in the research, and has contact information. The consent form can be kept by the participant for future contact information and as proof of having understood and participated in the research.
As a researcher, I would like to know how best to obtain consent to tape record an interview.
There are other ways to lay this out, and the exact wording does not have to be adopted here, but the choice to have the interview taped or not should be offered explicitly. This is designed to assure that the interviewee takes a moment to think about the choice and that you have documentation of their consent to be taped. On the consent form, just before of after the place for the signature of the participant, you can ask two questions:
I agree to participate in the research study by participating in a research interview. Further,
A) I agree to the taping of the inteview _______
B) I prefer that the inteview not be taped _______
Secondary Use of Data
In what circumstances does the "use of secondary data" require ethics clearance?
For complete details view our Guidelines for Secondary Use of Data. If you are seeking ethics clearance to access secondary use of data, complete ethics form Secondary Use of Data.
I am working on a research project at another university. I have received ethics clearance at that university. Do I need clearance from the Brock University Research Ethics Board (REB)?
Yes. Our Guidelines for Inter-Institutional Research details the procedure involving research at other universities.
Can I share my Research Ethics Board (REB) protocol approval with colleagues working on similar projects?
No. The REB approves protocols with the understanding that the work will be conducted only by the investigators named in the protocol application. If your colleagues would like to work on your research project, you may modify your existing protocol to add them as co-investigators. Otherwise, they must apply for their own REB clearance. To modify an approved protocol, complete Revision or Modification to an Ongoing Application.
I would like to do a research project in the local district schools but I do not know the procedure for doing so.
Contact the appropriate school board to find out their procedures and timelines. Often this information is posted on websites. Many school boards have their own REB guidelines that you will need to adhere to in order to gain access to research participants. Consideration may be given to teachers conducting research in their own schools but the decision rests with the school board.
Please make sure that you allow yourself sufficient time to go through both REBs before starting any research. Some school boards will allow you to submit to their REB and Brock’s REB simultaneously. Others insist on proof of ethics clearance from the Brock first. We strongly advise that you secure ethics clearance at Brock first and then apply to the school board. This makes it easier to keep track of any clarifications requested by the REBs.
How long is my clearance valid for?
Ethics clearance is valid for one year. The clearance dates will be identified in the clearance letter issued by the Research Ethics Board. If your project extends past one year, you are responsible for submitting an annual renewal on the anniversary of your approval date.
Why does my project need to be "monitored" by the Research Ethics Board?
The REB has the authority to require review more frequently than the time frame approved when:
a) the risks presented by a protocol warrant it;
b) the REB wishes to ensure quality assurance;
c) the REB is concerned with the degree of vulnerability of participant population.
Do I need to submit 3 copies of the Annual Renewal/Final Report form? No. Please submit only one hard copy to the Research Ethics Office, Mackenzie Chown, D250.
I am working on several projects. How will I know when to submit a Annual Renewal/Final Report form?
It is your responsibility as a researcher to keep track of these dates. Annual Renewals are due each year, on the anniversary of your clearance date. A final review is due once you are no longer actively involved with participants/data collection. A reminder will be sent electronically to the Principal Investigator to complete this form.
Amendments/Variations to the protocol
My study already has full ethics clearance. What do I do if I want to make a minor change to my study such as adding or removing a questionnaire or task, or advertising in the newspaper to recruit more participants? Is it necessary to re-apply to the REB?
Prior to implementing any changes you need REB clearance. Please complete a Revision or Modification to an Ongoing Application form to seek REB clearance for modifications to a previously cleared project. Modifications are usually approved within 2 - 5 business days.
Do I need to submit three copies of my amendments?
No. Please submit only one hard copy of the Revision or Modification to an Ongoing Application form to the Research Ethics Office, Mackenzie Chown D250.
I have received a grant for a proposed research project. I need to have ethics clearance before the Office of Research Services will release the funds. I have not fully developed the instruments for my project. Can I have the funds released without ethics clearance?
Yes, this is possible. Complete a Request for Release of Funds to ask Research Services to release research funds for projects which are currently undeveloped, and for which you are not yet in a position to seek REB clearance.
If I am applying for a grant, when should I submit my ethics application?
If you are applying to a funding agency like NSERC, SSHRC, CIHR, you do not need to submit an ethics application until you have been awarded the grant. However, if you submit an application before you are awarded the grant, and have been cleared by the ethics board, your account may be opened right away. After you have won an award the councils have set a six month deadline in which to obtain ethics clearance or the funds will be returned to the councils. If you are applying to a different council, even if it is basically the same project, you must reapply for ethics clearance.
I have been awarded a grant and need to obtain ethics clearance for the funds to be released. However, I will not be doing the research with humans component for another year. Is there anyway I can obtain conditional clearance so the administrative funds can be released?
According to the Tri-Councils, (SSHRC, NSERC, CIHR), funds for research grants that involve human subjects cannot be released until human ethics clearance has been obtained. In special circumstances, a conditional release of funds may be allowed for start up costs for research that does not initially involve a human subject component. Please contact the Research Ethics Manager (Lori Walker, ext. 4876) for more information.
Students' Academic Research Projects
Do students' academic research projects require Research Ethics Board (REB) clearance?
If human participants are involved, yes. Student research that involves human participants, whether of a biomedical or social-scientific nature, requires clearance by the REB prior to initiation. Please note: student researchers must have a faculty member supervise each research project.