2010 Guidelines for Preparation of Submissions for Ethics Approval
All students and faculty from the psychology department, or researchers collaborating with faculty and students from psychology, who plan to use human participants in psychological investigations must have their projects approved by the Carleton University Psychology Research Ethics Board. The following information is provided to assist researchers in preparing submissions for ethics approval. Following these guidelines will expedite ethics approval.
Purpose of the Psychology Research Ethics Board (Psychology-REB). The primary purpose of the Psychology-REB is to determine whether the procedures that are to be used in a research project satisfy the requirements for ethical treatment of participants. The Psychology-REB uses the Canadian and American Psychological Associations' published guidelines as well as the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans on ethical matters including informed consent and freedom to withdraw, debriefing, deception, confidentiality and anonymity, and potential harm to the participants. It is important to note that ultimately it is the responsibility of the researcher, and in particular, the faculty member associated with a project, to ensure that human participants are treated in accord with the ethical standards outlined by the Canadian and American Psychological Associations and the Tri-Council Policy Statement. A second function of the Psychology-REB is to provide a forum for the discussion of ethical issues. Students should feel free to contact the Chair of the Psychology Research Ethics Board (presently Monique Sénéchal, Ext. 1155, ) if they have any questions or concerns about the ethical treatment of human participants.
For additional information regarding ethical treatment of participants, see the following:
Canadian Psychological Association
American Psychological Association
Tri-Council Policy Statement
What must be passed through ethics? All research involving the use of human participants that is associated with a faculty member (including Adjunct Faculty) or student in the Department of Psychology at Carleton must be approved for ethics. This includes research conducted at Carleton, research conducted off campus (e.g., businesses, hospitals, prisons, schools), and archival research. Note that research conducted with anyone, not just students in the psychology participant pool, requires ethics permission. Note also that, for research conducted off campus, approval from both the Psychology REB at Carleton and the outside organization are needed. In some organizations such as the school boards, ethics approval from Carleton is mandatory before approval from the research department of the school board can be given. Students should consult with their advisors and the research/ethics department of the specific organization in order to determine the most appropriate course of action. If application for approval of the project from the outside organization takes place after approval from Carleton, then ethics approval from Carleton will be given conditional upon the subsequent approval of the outside organization. In that case, a copy of that outside approval, once obtained, should be provided to the Psychology-REB to obtain final approval. PLEASE NOTE THAT FINAL ETHICS APPROVAL MUST BE OBTAINED BEFORE ANY DATA ARE COLLECTED. If you are considering collecting data for teaching or research purposes from your class, read the policy on Collecting Data in the Classroom.
General submissions and timing of applications. Follow the guidelines in this memo to prepare your application. Using the Ethics Online System, you will complete a cover form and attach the ethics application you have prepared. Note that although the Psychology-REB can provide guidance, feedback, and answer questions, it is the researcher's responsibility to prepare the application and make any necessary revisions. In the case of graduate theses, it is necessary to have the prospectus completed and approved before the ethics application is submitted, in order to avoid premature and repeated evaluation of the project by the Psychology-REB. In the case of a pilot study: if you run only a few participants (2-3) just to assess your experiment setup, then there is no need for ethics approval. However, if you run more participants, and you actually collect data, then you will require ethics approval for such a pilot study.
The review process. Each application is normally reviewed by at least one member of the Psychology-REB and the chair. The entire Psychology-REB may also meet to discuss issues that are particularly sensitive. The researcher may be asked to provide additional information or clarification. Note that initial feedback from the Psychology-REB typically takes about two working weeks, except during busy periods (e.g., October-November). Once your proposal has been reviewed, you will be notified by e-mail and the feedback will be available in your online account. Your application will be assigned one of the following recommendations: accept as is, minor revisions, or major revisions. If you are told that your ethics application needs minor or major revisions, you will also receive feedback from the reviewers as to what needs to be revised in your application. Once you have made the revisions, you will have to re-submit your ethics application. Once re-submitted, do allow a minimum of one working week for feedback on the revisions.
Reference number. Approved projects receive a reference number that is used on informed consents and recruitment notices, as well as any communication with the Psychology-REB.
Addendums. If researchers would like to make changes to an approved project (e.g., recruit participants from an additional source, such as the Internet), it is necessary to submit an addendum online outlining the proposed changes. Once the addendum has been reviewed, the researchers will be notified by e-mail as to whether it is accepted or requires revisions.
Annual progress reports. Every research project that is approved by the Psychology-REB receives an ethics clearance certificate that includes a set time period during which the study may be conducted. Typically, the expiry date is August 31 following clearance. Before the expiry date, researchers must submit a progress report to either renew their project or close it.
- Renewing a study. If you plan to continue running the study, you must renew your ethics approval using the progress report form. Please note that projects must be identical in all aspects in order to qualify for automatic renewal. In particular, note that research that draws from a different population (e.g., clinical patients, the elderly, young children) than the original population of participants (e.g., introductory psychology students) may be considered as a new and separate project, rather than a renewal, in order to deal with any special ethical issues that arise from the use of the new population.
- Closing a study. Once you have completed your research project (i.e., after all the data are collected), you must close your research project using the online progress report form.
Program of research. Researchers who have a large number of projects that are very similar except for minor details that do not involve ethical issues may wish to submit an application for approval for a program of research or a Standard Operating Procedure (SOP). All parts of a regular application are required; however, it is understood that some aspects are included as examples only and may change with different projects (e.g., different stimulus presentation times for a reaction time experiment). The entire program of research will be issued a reference number. Please note that, as in the case of renewals, projects that involve different populations of participants must be submitted as separate applications in order to deal with any special ethical issues.
Submissions for archival research. The Tri-Council policy on the use of secondary data states that if data are stored anonymously (i.e., without identifying information such as names, initials, birth dates), then approval need not be sought from the Psychology-REB. If archival data are not stored anonymously, then approval must be sought from the Psychology-REB and it will be given if: (1) identifying information is necessary to the study; (2) privacy and confidentiality are ensured, and harm to participants is minimized; and (3) participants gave consent originally to the secondary use of data. If participants did not originally give their consent to the secondary use of data, then consent must be sought before ethics approval can be given. It is strongly recommended to include the term archival in the title of the application.
Submissions by Honours students. For educational purposes, all honours students must submit an ethics application for their thesis, including for anonymous archival research. In addition, honours students must include a copy of their ethics clearance certificate,which includes the study reference number, when they submit their thesis. Honours students whose theses are part of an approved program of research for the current academic year only need to submit a copy of the ethics approval certificate with their thesis and need not apply for separate ethics approval for their thesis.
Participants from the Psychology pool. Students recruited from PSYC 1001, 1002, 2001, or 2002 can apply a maximum of 4% towards their final mark in each of these courses.
Running studies as a part of course requirements. Students running studies with human participants as part of course requirements are required to have ethics approval for such studies. In order to reduce the workload for the Psychology-REB and expedite the review process, it is recommended that because there are likely many commonalities between the projects, the course instructor should present the common elements first (e.g., samples will be from classmates, friends and family; or experiment durations and locations; similar general purposes perhaps; maybe an informed consent template that all teams will use with only the relevant details changed to fit the different projects; etc.) and, in addition to the usual appendices (the recruitments, informed consent, debriefings, which in this case would be a template), add small appendices, preferably each less than one page describing the unique aspects of each project.
Parts of Ethics Applications
Cover form. Please provide all of the information requested on the cover page in the Ethics Online System. At the bottom of the cover page, you will be asked to indicate whether the research project has Tri-Council Funding. Note that this statement refers to whether either the professor or the student working on the research project has received funding from any of the Tri-Council bodies: CIHR, NSERC, or SSHRC. You will be asked to indicate not only that ethical guidelines have been followed, but also that copyright laws (e.g., not using published, copyrighted questionnaires) have been respected.
1. Body of the Application (attached to the cover form)
1.1 Description of purpose. A concise (150-200 word) description of the purpose of the study must be submitted. It is important to emphasize the benefits of the study. Lengthy documents such as a prospectus or a thesis are not acceptable, although they may be submitted as supporting material when relevant. It is the researcher's responsibility to bring to the attention of the Psychology-REB any potentially sensitive aspects of the research project (e.g., criminal behavior, sexual abuse, depression, studies involving deception).
1.2 Description of methods.Describe the full procedure of the research including how participants will be recruited/contacted, how consent will be obtained, what will be expected of participants during the research, and how they will be debriefed. Importantly, address issues of potential risk and how participants will be protected. Describe whether participants’ anonymity will be ensured and, if so, how. In addition, outline how you will protect participants’ confidentiality.
Stimulus materials should be described concisely. Copies of stimulus materials (e.g., questionnaires, scripts of videos, scripts of interview protocols, etc.) should be included. If these are too many, then provide sufficient examples for the Psychology-REB to be able to assess if there might be any ethics issues.
1.2.1 It may also be necessary to include the following:
- Anxiety, pain, embarrassment.If, in the online cover form, you indicate that your study may cause anxiety, pain, and/or embarrassment to participants, then in your ethics application you should include a description of the nature of the anxiety, etc. A detailed description of the precautions that will be taken to safeguard the participants also should be included (e.g., informing subjects, providing contact information). If the study involves sensitive material, then there is potential anxiety, pain, and/or embarrassment. Special procedures, which may include providing resources and/or reporting to authorities, must be followed in the case of potential harm to self, harm to others, or child abuse. Please contact the Chair of the Psychology Ethics Board (presently Monique Sénéchal, , ext. 1155) for further information about these special procedures.
In addition, studies that involve purposefully or potentially anxiety-inducing procedures should have a mood neutralization procedure as the final step of their study (e.g., viewing pleasant pictures).
- Deception.If the true purpose of the experiment, or other similar information is altered, then deception is used. If, in the online cover form, you indicate that your study involves deception, then your ethics application should include a description of the nature of the deception, why it must be used, and the procedures that will be used to protect the participants (e.g., explanation in the debriefing of the nature of the deception and why it was necessary, such as getting participants' natural responses). In addition, APA guidelines require that when deception is used, researchers must explicitly offer participants the opportunity to withdraw their data from the study (see Appendix D). Spontaneous withdrawals of data must be respected in all cases; however, the offer to withdraw is only required in cases where deception is used.
1.2.2 References should be provided for any sources given in the description of the study purpose or methods sections.
The following should be included as appendices:
1.3 Informed consent forms (see example in Appendix A). The purpose of a consent form is to INFORM the participant as to what they will be required to do so that they have adequate information to decide whether or not they wish to participate. The informed consent should include the following:
1. An explanation of what a consent form is and why it is required.
2. Title of research project
3. The following contact information:
Research Personnel: names, affiliations, and contact information for Principal Investigator(s) and Faculty Sponsor(s)
Ethical concerns: name and contact information for Chair of Carleton University Psychology Ethics Board for Psychological Research
Any other concerns:name and contact information for Chair of Carleton University’s Department of Psychology (if you are from another school or department, such as Cognitive Science or Child Studies, provide the contact information for the chair of that school or department).
4. Purpose of the study, described in English, not psychology jargon. Should be brief.
5. Description (in plain English, not psychology jargon) of what participation will involve, including information about questions to be answered or tasks to be performed. The participants must be informed as to what they will be required to do. This is especially important if tasks might make participants anxious or uncomfortable in any way. Even studies that use deception or do not describe the purpose of the study in detail must warn participants of any possible discomfort.
6. Duration/frequency of participant's involvement and location.
7. Are participants receiving remuneration (e.g., credit or money) for participating in the study? If yes, provide information about the compensation.
8. Clearly spell out any possible risk and/or discomfort, and if none are present, state that there are no known risks. If your study involves sensitive information, then there may be potential risk and/or discomfort.
9. Will participants’ anonymity be ensured (e.g., data coded with a number and names not used)? If yes, describe how. Describe how participants’ confidentiality will be ensured (e.g., data only shared with research personnel). Special procedures, which may include breaching confidentiality and informing participants of that potential breach, must be followed in the case of potential harm to self, harm to others, or child abuse. Please contact the Chair of the Psychology Ethics Board for further information about these special procedures.
For studies in which there is assessment of abilities (e.g., language in children; personality in adults or children) or studies in which diagnostic tools are used, participants should be informed up-front that there will be no feedback given regarding individual results. This includes parents, if the participants are children.
10. Right to withdraw at any time, and omit specific questions, without penalty. Note that if students withdraw during an hour of participation, they still receive credit for that hour. However, if a study involves multiple sessions over different days, students only receive credit for the time completed. Researchers are encouraged to gain verbal consent for additional hours after completing initial hours of credit.
In general, if participants are receiving remuneration (e.g., paid) for participating in a study, it is recommended that withdrawn participants still receive remuneration. However, if there are circumstances where the researcher can state in advance the conditions for getting or not getting the remuneration and if this information is disclosed to participants in advance on the informed consent, it may not be necessary to provide remuneration to participants who withdraw.
11. Provide space for the names and signatures of the participant and the witness, and the date. The researcher/experimenter can be used as a witness. In online surveys, participants can select “next” or “I agree/disagree” at the end of the informed consent to indicate that they have consented to participate in the study.