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Frequently Asked Questions - Ethics Review

 

Ethics Background Information

Am I required to have an ethics review?

All research involving human subjects (funded or not) conducted at Western must be reviewed and approved by a University Research Ethics Board (REB), before the research begins. This includes student research projects conducted as part of a thesis or course requirements. Research conducted in other institutions, or in the field, whether in Canada or internationally, must be reviewed and approved by the REB before the research may begin. Valid ethics approval must be provided before funds from granting agencies, contracts, internal funding or student research fellowships will be released.
Ethics approval is not provided retroactively.

What is human subjects research?

Research involving human subjects can include anything from observing people in the mall to conducting a clinical trial. It can include surveys and questionnaires, individual interviews or focus groups, physiological, psychological or educational testing, etc.

What is a Research Ethics Board (REB)?

This is the review body established within each institution to help ensure that ethical principles are applied to research involving human subjects. Western has main REBs and subREBs (eg. the Sub-REB at the Faculty of Education).

Where can I learn more about Research Ethics?

Ethics Review in Canada is guided by the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.

Ethical Considerations

Can I submit my research for ethics approval to the Faculty of Education's Sub-REB?

The Faculty of Education Research Ethics Board is a sub-board of the Western University Non-Medical Research Ethics Board (NMREB), and has been delegated to review and approve research by Faculty of Education and the Department of Music Education researchers that involves no more than minimal risk. For information on delegated review and minimal risk refer to the Western REB Guideline 1-G-004, and this web page. If you have questions about whether your study is minimal risk, please contact Karen Kueneman.
If your research involves more than minimal risk to the research participants you must submit your ethics protocol to Western's NMREB.

Are there deadlines for submitting ethics proposals?

There are no deadlines for submission to the Faculty of Education's Sub-REB. Ethics proposals are reviewed shortly after they are submitted.

How long will it take to obtain ethics approval?

Applicants should allow approximately one month for the completion of the review process. All reviews are processed as expeditiously as possible and the committee often completes the process in a shorter period, but this cannot be guaranteed. You may not begin your research project until you receive official ethics approval.

How do I submit my ethics protocol?

Email submissions: are preferred by the Faculty of Education Sub-REB.

    1. Submit the protocol form and all attachments (new, adapted or standardized instruments (e.g. questionnaires), recruitment ads or posters, letters of information and consent forms) to edu-ethics@uwo.ca. Note that only email submissions in MS Word format can be accepted. (Mac users may submit pdf documents)

    2. Also submit the signature pages (Section 1.1 to 1.7) of the protocol form in paper format. (Original or faxed signatures are acceptable.)

    3. Faculty of Education Student Thesis protocols must also be accompanied by Thesis signature forms (“Form A”) along with one copy of the research proposal in paper format. Information and forms available at http://www.edu.uwo.ca/programs/graduate-education/guidelines.html (Online students may arrange to send forms electronically to the Research Office and ask faculty supervisors to drop by the office to sign.)
    Faculty of Music, Department of Music Education students - submit only your ethics protocol form and all attachments. Follow the other requirments of your own Faculty and Department for your thesis or research proposal.

Paper Copies: If you submit by paper copy, you are expected to provide 1 original signed by PI (and student, visiting professor as required). The original should include any new, adapted or standardized instruments (e.g. questionnaires), recruitment ads or posters, letters of information and consent forms. Submissions must be collated and stapled or clipped with sturdy, well-anchored clips (please note that paperclips frequently become dislodged resulting in disordered protocols.) Paper submissions must be delivered to the Research Office (Room 1163).

What is the process of ethics review in the faculty?

  1. Proposal arrives at the office. (See instructions for preparing your proposal.)
  2. Assigned a number and entered into a “database”.
  3. Research Officer (RO) reads the proposal thoroughly to make sure everything is included.(If missing major parts, researcher is asked to provide those parts before it is sent to the reviewers.)
  4. RO makes preliminary recommendations –obvious spelling errors – missing parts in the letters of information. Ethics issues are left to the reviewers.
  5. Two reviewers (out of a committee of 7) review the proposal and send their recommendations to RO.
  6. Recommendations are sent to the researcher by RO.
  7. Researcher makes the changes, answers the questions and sends response to Research Officer (RO).
  8. Changes are checked to ensure they are what was requested.
  9. Chair of Research Ethics Board reviews the responses and signs approval.
  10. The ethics approval is sent to the researcher.
  11. Researcher (if a Faculty of Education student) can only start the research once the Associate Dean also signs off on the thesis proposal.

What is the expiry date of my ethics approval?

The expiry date for your ethics approval is based on the date that you enter in Section 1.2a (Completion Date) of the ethics protocol form. You should estimate the completion date according to how long it will take you to complete your data collection from the human participants (including all member checking, if applicable). Data collection may take only a few months or, in some cases, several years. The REB recommends that you be generous with your end date as it often takes longer to collect data than most researchers estimate.

When you receive your official ethics approval form the expiry date will be on it. You may not collect research data from human participants if your ethics approval has expired. Please see below for information on how to revise your study end date.

What if I need to revise/amend my study once it has been approved by the REB? What happens if I need/want to change or add a question to the data collection process? Does this need to go back to the REB?

You cannot change anything about your study without REB approval. However, if you do find that you need to make changes after the approval has been granted you would come back to the REB with a "request for revisions to an approved protocol" and provide the reasons for the change. (The form is available on this web site). Generally these types of changes would only be reviewed by the Chair of the REB and would be processed in a few days unless they are substantial. There are often requests for revisions - most often with expiry dates on the ethics approval. We find that researchers often underestimate how long data collection will take. (The expiry date is determined by what you put in section 1.2 of the protocol form.)

I will be collecting data for my research at a school board. Should I obtain ethics approval from UWO or from the school board first or should I seek both approvals at the same time?

It is recommended that you obtain ethics approval from Western first.

I intend to collect my data from one of the local school boards, the Thames Valley District School Board (TVDSB), or the London District Catholic School Board (LDCSB). Once I obtain ethics approval from UWO what do I need to send to the school board and how do I send it?

Note that you must complete a "school board form" and submit it for Ethics Review when you send in your ethics protocol to the Faculty of Education REB. Once you have obtained ethics approval from UWO, you need to submit: 1) the Ethics Protocol form and all attachments (such as letters of information, consent forms and surveys/interviews) with all changes as required by the REB during the review process; 2) the Ethics Approval Form, and; 3) the school board form. You may submit these to Steve Killip at TVDSB or Terry Spencer at LDCSB either in paper format at the Board Office or via email.

As a student I would like to do a research project that is not my thesis and not required as part of a course. What do I need to know?

As a Western student, you must obtain ethics approval for all human subjects research that you do. Student research must always have a faculty member as the principal investigator. You will need to find a faculty member who is willing to supervise your research.

I intend to use data that has been collected by someone else for my research. Do I need ethics approval to use this "secondary data"?

Secondary data is information that was initially collected for a purpose involving a specified research project (or another use – such as administrative) but is subsequently proposed for use in a different research project. Ethics review and approval is required whether or not personally identifiable information is available to the second research study (unless the original data was collected anonymously – then no Ethics Review is required). Researchers are not required to obtain consent from individuals if the data does not contain identifiable information. More information is available at TCPS- 2

I am a researcher involved with a team of other researchers from outside of Western. My involvement is mainly as a consultant. I am not involved in data collection. My role is to provide expertise in study design and in how data collected elsewhere should be interpreted. Do I need to obtain ethics approval from Western if ethics approval for the study has been obtained elsewhere?

Western’s Office of Research Ethics’ general policy is that if the local researcher is only involved in study design and data analysis (no interactions with participants or potential participants) then local ethics approval is not required. However, the researcher should provide a copy of the approval notice from the institution that did approve the study.

Procedures

Who is considered a vulnerable person?

Those who lack competence or decision-making capacity are considered vulnerable. Children, institutionalized persons or others who are vulnerable are entitled to special protection against abuse, exploitation or discrimination.

Who is considered to be a minor and thus need parental consent?

In general there is no age of consent for research studies. However, minors are generally considered to be those under the age of 18 years. All university students are considered to be sufficiently mature to make their own decisions about research and therefore no parental consent is required. For those under the age of 18 (approximately 16- 18 years of age) it may depend on the nature of the research whether or not parental consent is required. The researcher must make the argument to the REB if he/she believes that the requirement for parental consent should be waived. Note that School Boards generally require parental consent for all students under the age of 18 years.

Why is inclusiveness important?

No segment of the population should be unfairly burdened by the risks or benefits of research. Inclusiveness also ensures that individuals or groups who may benefit from advances in research are not discriminated against or neglected. Example: If you choose to include only female participants you need to have a reason for disregarding the male population.

How does one balance harms and benefits?

The forseeable harms in research should not outweigh the anticipated benefits.

Minimizing harm: Researchers have a duty to avoid, prevent or minimize any harm or risk to the participant. Procedures that might cause serious or lasting harm to a participant must not be used unless their absence would expose the participant to a risk of even greater harm. Participants must not be subjected to unnecessary risks. Research should use the smallest number of participants and the smallest number of tests on them that will ensure scientifically valid data. Should adverse effects result from research, the researcher has an obligation to assist the participant in reducing or minimizing those effects.

Maximizing benefits: Researchers have a duty to maximize benefits. Benefits may be to the participant him/herself, other individuals, society as a whole or the advancement of knowledge.

Please explain the difference between "anonymity" and "confidentiality" of data collected for my research.

Research should maintain the privacy & confidentiality of its participants in the majority of research studies. Sometimes confidentiality and anonymity are confused by researchers.

Anonymity – researcher & audience cannot identify a given response with a given person (example – a survey where participants do not provide their name)

Confidentiality – researcher can identify a given person’s responses but promises not to do so publicly (example – an interview). The researcher knows the name of the person being interviewed but is careful when collecting data and presenting the study not to divulge names or other identifying information.

If you are unable to ensure confidentiality because of the person's position or how he/she may respond to questions you must inform the participant of your inability to maintain confidentiality. He/she may then make his/her decision regarding whether to participate based on the fact that his/her identity may be known by those who hear the results of the research. See also the guidance document on "using small identifiable populations".

Completing your ethics proposal

I plan to recruit participants using "snowball" sampling (Section 5 of the Protocol Form). What do I need to know?

You may recruit participants using "snowball" sampling (a technique for developing a research sample where existing study participants recruit future participants from among their acquaintances). However, in general, please note that while current participants may refer others to your study, you should not solicit the names of those potential participants from them. You should ask participants to mention your study to others and they can provide your contact information (such as a business card or letter of information) to them. If the potential participant is interested they can then contact you.

What should be included in an advertisement for participants? (Section 5.4 of the Protocol Form)

Generally, you should include:

  • The study title
  • indicate that you are looking for participants for a research study being conducted by researchers from Western University
  • brief description of what study participants will be asked to do (i.e., participate in an interview about...)
  • if you have specific inclusion criteria you should list it (i.e., single persons aged 20-25)
  • contact information (email address and/or phone number) for questions about the study and to volunteer to participate

What if the participants want to be cited or thanked by name in reports of the research? Section 12.1 of the Protocol Form indicates that researchers must ensure the confidentiality of research participants.

Participants may decide to give up their confidentiality by indicating their choice to do so on the consent form by initialing a statement to that effect. This is perfectly acceptable and the participant can now be named in any reports pertaining to the research.

How long am I expected to keep my research data? (Section 12.3 of the Protocol Form)

You should consult with your professional organization. For example, the American Psychological Association dictates that data must be retained for 5 years after publication of the study results. If your research is funded by SSHRC, please see their data archiving policy.

Are there any recommendations as to how my data should be stored? (Section 12.3 of the Protocol Form)

Data in paper format or stored on DVDs, CDs, USBs or other portable devices should be stored in a locked cabinet in a locked office. Recorded information should not include the name of the participant; only use an identification code. Transcribed data should not include participant names or any other identifying information. Participant names or contact information should not be stored in the same location, on the same computer, CD, or any other electronic devices as the transcribed data or audio recordings. All electronic data should be stored on a password protected device.

If electronic data is particularly sensitive or potentially of high risk to the participant, it should be encrypted.

In the protocol form, should I name the institutions from which I am recruiting participants or should I refer to them in more generic terms (e.g., an adult ESL program in Canada & an adult EFL program in Turkey)?

In the ethics form you should name the institutions. This helps the reviewers to assess risks to participants. Ethics applications are kept confidential by the reviewers and by the office. Generally, in all reports of the results of the study, you would refer to the institution more generically to protect the confidentiality of the participants.

Am I allowed to pay (compensate) the participants in my research?

In general, you may compensate participants for any out-of-pocket expenses they might incur as a result of participating in your study - parking, transportation, child care expenses, etc. In some cases, you may offer compensation in appreciation for the participant's assistance with the research project. When offering compensation, you must be careful that the amount of compensation does not induce the potential participant to participate without taking into consideration the possible risks the study may pose to him/herself. The Research Ethics Board considers requests to provide compensation to participants on a case-by-case basis.

Do all surveys, questionnaires, and interview questions have to be submitted to the REB as part of the review process?

The REB MUST see all surveys, questionnaires and interview questions and approve them. Please submit them with your ethics application.

What should be included in the Letter of Information/Consent Form written to potential participants?

The REB recommends you use this template as a guide. In general, you should include:

  • Title of Study
  • Introduce the study & Identify the Researchers
  • Describe the Purpose of Study briefly
  • Describe what potential participant is being asked to do in sufficient detail
  • Indicate that participation is voluntary
  • Describe Confidentiality / Anonymity
  • Describe the Risks (and the Benefits if there are any to the participants)
  • Indicate who they can contact if they have questions about their rights or about the study
  • A template is also available from the Office of Research Ethics

Do I need a separate Letter of Information and Consent Form for child participants in addition to the one written to parents?

Researchers are encouraged to fully involve children in the consent process for studies in which they will be participating. While children are often not in a position to consent to the research (i.e. they are not capable of making a truly informed decision), they should be told what is happening and what their rights are. In lieu of consent, minor children may sign documents indicating that they assent to the research. This can be accomplished in two ways: a) they may sign the regular study consent document or b) a separate assent document with wording more appropriate to their age and comprehension level. See sample assent form for more information.

What is meant in the checklist (Section 13.5) by these 2 items, 1. “No waiver of rights” 2. “No indication of institutional or REB approval”?

The purpose of the Checklist is to assist you in ensuring that you have included all necessary items in the Letter of Information (not to ensure that you have included all information in the application itself).

No waiver of rights – this means that you have included a sentence in the letter indicating that the participant does not waive any of their rights by signing the consent form. In Education research we generally don’t need to put this in. It is mainly used in medical research where the person is undergoing an experimental procedure or taking some new drug and means that the participant could still sue the company even if they sign the consent form.

No indication of institutional or REB approval – you cannot put in the letter that the study has been approved by the University or the Research Ethics Board (REB). It is felt that if you put a statement such as this in the letter, then the potential participant might think that if the study has been approved by the REB or the University then it is perfectly OK for them to participate without considering the potential consequences to them personally of their participation in the study.

When is it appropriate to use implied consent (not require the participant to sign a consent form)? Section 13.2 of the Protocol Form

If your data collection involves only a survey or questionnaire, then completion of the questionnaire would indicate the consent of the participant. You must provide a letter of information and will need to add this sentence (or similar wording) to your letter of information: "Completion and return of the questionnaire indicates your consent to participate in this study."

Telephone interviews may also involve implied consent. However, in the case of a telephone interview, the researcher will still provide information about the study (similar to a letter of information) and then ask the potential participant to verbalize his/her consent to participate before continuing with data collection. The researcher will make a note of the person's consent.

Other situations may also be appropriate for implied consent. The researcher must describe why implied consent is appropriate and the REB will make decisions on a case-by-case basis.

I plan to collect data using an online survey. What do I need to know?

You need to ensure that the confidential data you are collecting will not be accessible to the company hosting the online survey - that it will only be available to you, the researcher.

If your online survey uses "radio buttons", please note that those questions that use radio buttons must include a “no response”or“prefer not to respond” option. This is so that when a respondent initially chooses a certain response and then changes his/her mind and goes back he/she can decide not to respond to a question. If you prefer that respondents not be able to choose a 'no response' option then you must design your survey so that they can "uncheck" their responses.

See also the Guidelines on the Ethics Review page

Other questions? Please contact Karen Kueneman.