FAQ – Ethics Review/Approval for studies with human participants
Disclaimer: The information contained in this document is to be used as a guide only. Always check with the Research Ethics Board for specific details and instructions. Also, check the Tri-Council Policy statement for further information.
1) Who needs to have an ethics review?
2) What is human subject research?
3) What is a Research Ethics Board (REB)?
4) When and how do you get ethics review?
5a) What happens if I don’t apply for ethics approval?
5b)What happens if approval is not granted?
6) Do students need ethics approval?
7) Where can I get more detailed information?
8) When do you need a revision of a previous proposal?
9) Who can supervise a research project?
10) We have to ensure confidentiality of the subjects. But what if the subjects want to be cited or thanked by name in the paper?
11)Who are considered to be minors?
12) Who is considered a Vulnerable Person?
13) Why is Inclusiveness important?
14) How do you balance Harms and Benefits?
15) How do you distinguish Research from Professional Skill Development?
16a) What is required in a Consent Form/Information Letter?
16b) Sample Consent Form/Information Letter
17) Links and Resources
- All research involving human subjects (funded or not) conducted at a University must be reviewed and approved by the Research Ethics Board (REB), before the research begins. This includes student research projects conducted as part of thesis or course requirements.
- Research conducted in other institutions, or in the field, whether in Canada or elsewhere, must be reviewed and approved by the REB before the research may begin.
- Graduate students whose research involves human subjects must provide a copy of the approved ethics certificate for the research they conducted when they submit their thesis.
- Funded projects – whether granting agencies, contracts, internal funding or student research fellowships – will not have the funds released unless valid ethics approval is provided
- There is no retroactive approval
- Ethics approval must be granted before any research is conducted
- Research involving human subjects can include anything from observingpeople in the mall to conducting a clinical trial. It can include surveysand questionnaires, individual interviews or focus groups, physiological,psychological or educational testing etc.
- Research involving human subjects that requires review may include projects where data are derived from:
- the collection of information through any interaction or intervention with a living individual
- the use of identifiable private information of an individual
- interviewing an individual for information about another individual (third-party interviews)
- naturalistic observation
- Naturalistic observation involves the subject behaving as they would normally if they were not being observed
- research involving vulnerable or dependent population (e.g. children, mentally disabled)
- a situation where participants may feel obligated to take part, or participation may not be voluntary (e.g. students in a class, employees in their workplace, prisoners)
- research which involves any risk to the participant, be it psychological, emotional, physical or economical
- the participant receives remuneration/compensation
- deception or concealment:
- Deception is involved when participants are intentionally told something which is untrue.
- Concealment entails the researcher intentionally not revealing all details of the study to the participant before data is collected. Once the data is collected, the researcher may then reveal the complete details.
- Research involving human subjects which does not require ethics approval includes:
- research that only uses publicly available data (Statistics Canada, published reports
- research data which has previously undergone REB approval
- quality assurance studies, performance reviews or testing within normal educational requirements, unless an element of research is involved
- observation of participants where it is evident they are seeking public visibility such as at political rallies, demonstrations, broadcasting (television and radio) or public meetings
NOTE: other naturalistic observation needs ethics review
- interviews with people whose regular duties, such as public relations officers or public officials, involve communicating with the public on behalf of their organization on the selected interview topic
- Researchers are ultimately responsible for ensuring that the research they conduct has received the appropriate ethics review and they should always consult with the REB to clarify what types of research must be reviewed and what exceptions may exist.
- This is the review body established within each institution to help ensure that ethical principles are applied to research involving human subjects.
- Western has a main REB and subREBs (eg. subREB- Linguistics) based on the range of research conducted at the University.
- You must obtain ethics approval from the appropriate REB before the research begins.
- No retroactive approvals are given
- Research can not begin until you have received final approval from the REB
- Student research, such as for dissertations, theses, independent study projects and honours theses, are reviewed in the same manner as faculty research, although student researchers must have a responsible faculty supervisor sign off on the ethics application.
- If a student’s research project constitutes part of their supervisor’s research program that has already received ethics approval, then further ethics approval is not needed provided the student’s activities are covered in the existing approval. The student’s name should then be added as a co-researcher on the proposal
- Students should refer to the REB’s guidelines for information on what may constitute “course research” and can then be reviewed at the departmental level, rather than be submitted directly to the REB.
- Refer to your designated REB for specific information on guidelines, submission deadlines, application forms, etc.
- An REB usually meets on a monthly basis and it may take between 2-8 weeks to receive final approval so check submission deadlines and plan accordingly.
- Approval is only valid for a one-year period. Continuing review and approval is required annually for ongoing projects. The REB is to be notified when a project has terminated.
- Modifications to the project such as changes in research design, subject recruitment or consent procedures, must be reviewed and approved by the REB before they can be initiated.
- Administrative changes to the research projects, such as the addition of funding sources, co-investigators, or title changes, must be documented by making an official modification request to the REB.
- If a project has been terminated, and ethics approval is no longer required, a Final Report form must be submitted to the REB.
- Noncompliance can include, but is not limited to failure to obtain REB approval before starting a research project, inadequate supervision of the research, failure to report adverse events or protocol changes to the REB, failure to provide ongoing progress reports, or significant deviation from the approved protocol without prior approval.
- Actions taken by an REB or the University administration, as appropriate, may include, but are not limited to, education measures, compliance audits, terminating or suspending REB approval of active studies, restrictions on the ability to serve as an investigator on research projects involving human subjects, freezing of research funds, or academic penalties in accord with the Code of Student Conduct and Disciplinary Procedures.
- Graduate students who do not have REB approval for projects involving human subjects risk non-acceptance of their thesis.
- It can be expected that changes or modifications will need to be make to the application or the research project before approval is granted.
- These changes are usually minimal and generally consist of providing more information or the adaptation of a method
- Modifications will be suggested by the REB and once these are made, the application can be resubmitted for approval
- The Tri-Council Policy Statement and the University Guidelines require that projects involving human subjects, at the undergraduate and graduate level, must receive ethics approval.
- For undergraduate course projects, involving minimal risk, ethics approval can be obtained by the professor.
- Course-based research activities vary in scope, but may include:
- having students conduct interviews, administer standard tests, or distribute questionnaires
- conduct mini research projects where students pose research questions, gather data from human participants, and analyze the data for presentation
- other activities that would be considered research within the disciplinary traditions in which the course is being taught
- For graduate theses, a proposal must be submitted to the appropriate REB with the director/thesis supervisor listed as the principle investigator.
- Guidelines for the Ethical Conduct of Research Involving Human Subjects: (http://uwo.ca/research/ethics/guidelines.html)
- Policies and procedures of Research Ethics Boards. For a list of REBs, their guidelines, applications and general information: http://www.uwo.ca/research/ethics/info/which-reb.htm
- Tri Council Policy Statement (TCPS): (http://www.pre.ethics.gc.ca/english/policystatement/introduction.cfm)
- Online TCPS interactive tutorial: (http://www.pre.ethics.gc.ca/english/tutorial/)
- Ileana Paul, at 519-661-2111 x85360 or firstname.lastname@example.org or email@example.com
8) When do you need a revision of a previous proposal?
- All research involving human subjects at the University of Western Ontario needs ethics approval
- If during the course of your research you find that you need to make changes to your measures (i.e. new tasks, change tasks, etc.) a revision of your protocol is necessary before you can proceed
- If during the course of your research you find that you need more subjects a revision of your protocol is necessary before you can proceed
- If you are going to conduct less research than a revision is NOT necessary
- A revision is used for minor changes to the protocol (ie. changes in number of participants, inclusion, exclusion criteria, study team members, minor risks / benefits, etc.) A new protocol is submitted when there is a significant change in methodology, hypothesis, objectives, etc.
- Typically approval for a revision of a previous proposal is much quicker than a new proposal
- You can submit as many revisions as you need
- Make sure that your first proposal has been approved before you submit a proposal
- If you want to make changes to your proposal after you submit it, you must wait until the board has made a decision before you can submit changes
- If you already have approval for a project and just wish to continue (have a new end date), then you only need to submit a revision, using the correct form from the REB website and a cover letter stating why you are extending your end date.
- Students can choose anyone to be their PI (principle investigator) as long as they are affiliated with UWO or LHSC or SJHC
- The PI does not necessarily have to be the student’s supervisor
- The PI has to agree to be the PI
- Sponsors of Visiting Scholars should be the Chair, Director or Dean of the unit where the visitor is primarily located
- The subjects can sign a separate sheet where they give up confidentiality. This is perfectly acceptable and they can now be named in any papers pertaining to that research
- Minors are generally those under 18
- 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 between the ages of 16-18, it may depend on the nature of the research whether or not parental permission is required and it is at the discretion of the REB and the researcher
- Those who lack competence or decision-making capacity
- Children, institutionalized persons or others who are vulnerable are entitled to special protection against abuse, exploitation or discrimination.
- 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 chose to include only female participants you need to have a reason for disregarding the male population
- The foreseeable harms 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 Benefit
- Researchers have a duty to maximize benefits
- May benefit the participants themselves, other individuals, society as a whole, or the advancement of knowledge
- Prior to applying for ethics approval, the instructor should determine whether the course activities require ethics approval from an REB, or should conform to the ethics guidelines associated with the students’ professional development.
- Information gathering projects within the frame of Professional Skill Development are not subject to REB review requirements; however, they must align with the appropriate professional standards or codes of conduct, and review processes required by the relevant Faculty.
- Intent is to educate students on research processes used to explore and expand existing theories and conceptual knowledge
- Students compare new techniques, practices, programs with standard approaches to determine which is more effective
- Results or findings are written in a format that would be acceptable for a research journal or academic conference presentation.
- Professional Skill Development:
- Information gathering procedures and practices students are expected to use are exclusively required for pedagogical purposes.
- Intent is to use the information to provide advice, identification of appropriate analysis or general advice
- The development of skills which are considered standard practice within a profession (e.g. observation, assessment, evaluation, analysis)
- They are not conducted within the context of, or embedded within, a research framework
- The information gathering processes are part of the normal relationship between the student and the participants (e.g. classroom teacher and students)
- The data collected, or conclusions drawn are to be disseminated in a private forum, such as in the course for which the information was gathered.
- Researchers or their qualified designates shall provide prospective participants a minimum of the following:
- The individual is being invited to participate in a research project
- A clear statement of the research purpose, the identity of the researcher, the expected duration and nature of participation, and a description of research procedures
- A clear description of foreseeable harms and benefits that may arise from research participation
- An assurance that prospective subjects are free not to participate, have the right to withdraw at any time without prejudice to pre-existing entitlements, and shall be given continuing and meaningful opportunities for deciding whether or not to continue to participate
- The possibility of publication of research findings and the presence of any apparent, actual or potential conflict of interest on the part of researchers, their institutions or sponsors
- The name and contact information for a person who may be contacted in the case of concerns, complaints or consequences
- Tri-Council Policy Links & Resources:
Interagency Panel on Research Ethics (PRE)
CIHR Ethics Statement:
NSERC Statement on Ethics Review for certain types of research:
SSHRC Statement on Research Integrity:
- Research Ethics Associations & Resources:
National Council on Ethics in Human Research (NCEHR)
The Canadian Association of Research Ethics Boards (CAREB)
The Association of Internet Researchers (AOIR):
Canadian Standards Association (CSA): (copy of Canada's privacy legislation)
Aboriginal Rights & Ethical Research:
Royal Commission on Aboriginal Peoples Ethical Guidelines for Research (1993)
Association of Canadian Universities for Northern Studies
Northwest Territories: Scientist Act,RSNWT, c.S-4
Correctional Services Canada (CSC) :
Commissioner's Research Directives: DCOO9 (1987)
Application may be picked up from:
National Defence (ND): Research Involving Human Subjects: DAOD 5061-0,5061-1 (1998)
Ottawa-Carleton District School Board:
Personal Information & Privacy:
Personal Information Protection & Electronic Documents Act (PIPEDA) (2000),especially arts.5,7
Privacy Commissioner of Canada, Privacy Act
- Quebec - Policies and Law regarding research ethics:
Quebec, Civil Code of Quebec, arts.20-24
Quebec, Fonds de Recherche sur la Société et la Culture, Ethique de la Recherche Sociale, November 2002 (draft)
Quebec, Minister of Health and Social Services, -Ministerial Action PlanEthics of Research and Scientific Integrity(1998)
[Clear explanation of study, time commitment, where it will take place and any risks to their involvement]
Your rights as a participant in this research project are described below. By signing this contract, you are indicating that you have been made aware of these rights, that you understand the nature of this study, the purpose to which the data collected will be put, and that you voluntarily consent to participate in this project.
As a participant in this project,
(1) I understand the intent and purpose of this research project;
(2) I have been assured that all that language information I provide will remain anonymous, although my participation will be acknowledged;
(3) I understand that others may be reading the language information I provide and that the results of this research may eventually be published in an academic journal, in a grammar or dictionary of this language, or in classroom materials developed to teach this language;
(4) I have the right to withdraw from this or any subsequent session at any time;
(5) I have the right to change or retract any language data which I may give;
(6) I may express any concerns that I have about the data, the data-gathering process, or the purpose to which these data will be used at any time;
(7) I have been given the opportunity to assess the individual and social risks and benefits of this project;
(8) I can have access to the data collected from any session in which I am or was a participant;
(9) I will be provided with a contact name at the University of Alberta should I want to express concerns about the project.
I, ____________________________________________ , willingly agree to participate in the research project as explained to me. I have been informed of my rights as a participant and have been guaranteed that all personal and language information obtained from this study will not be used for purposes other than this research project, except with my prior consent.
Participant’s Signature ____________________________________
Contact information of Researcher and Research Ethics Board
Also from this web page:
PERL site menu
Ethics Review/Approval for studies with human participants
- Non-Canonical Predication Workshop 2009
- Journées PFC 2007 au Canada
- Des corpus oraux aux théories phonologiques : le cas du français.
- Linguistics Talks @ Western