The Carleton University Psychology Research Ethics Board: Overview and Guidelines

Transcription

1 The Carleton University Psychology Research Ethics Board: Overview and Guidelines 1 Table of Contents A. Overview and FAQs... 2 What is the purpose of the Psychology Research Ethics Board (Psych-REB)?... 2 What must be passed through ethics?... 2 Who Reviews Submissions?... 2 What is minimal risk?... 3 How can I assess the risk level of my research?... 4 My research requires the use of deception. What do I need to know?... 5 How Do I Submit a Protocol to the Psych-REB?... 5 How do I get feedback from the REB?... 5 How Much Time Does it Take the REB to Review a Submission?... 5 Where can I find out more about ethical principles?... 5 Do I need additional permissions if I m recruiting participants from organisations?... 5 Can I get Ethics approval for a program of research?... 6 Do I need Ethics clearance for archival research?... 6 Can Grad students submit a protocol for their thesis before their prospectus meeting?... 6 Do I need ethics clearance for pilot studies?... 6 Do Honours students always require ethics approval for their thesis?... 6 Can I recruit participants in the courses I teach or other courses in Psychology?... 7 Can I recruit participants from other courses in Psychology?... 7 Can students in the course I teach conduct studies as a part of course requirements?... 7 What is the ethics reference number?... 7 How can I make changes to an approved protocol?... 7 What is the duration of my Ethics approval?... 7 Do I need to do anything once a study is completed?... 7 How long to I need to keep personal information, consent forms, and raw data?... 7 What is an annual progress report?... 8 Who can recruit participants from the Psychology pool?... 8 Should incidental findings be communicated to participants?... 8 Do I need to inform the Psych-REB if some unforeseen event happens while conducting research?... 8 Anything I should know when planning to do research online?... 8 Are there special concerns when recruiting participants via ? B. Guidelines to Prepare a Submission Cover form Application Sections Appendix A: Evaluating Risk to Participants Form Appendix B: Example of Informed Consent Appendix C: Example of Debriefing Appendix D: Example of SONA Recruitment Notice Appendix E: Example of Consent to Use Data in Case of Deception Appendix F: Create a Template Using an Client Program... 21

2 2 A. Overview and FAQs What is the purpose of the Psychology Research Ethics Board (Psych-REB)? The primary purpose of the Psych-REB is to determine whether the procedures that are to be used in a study satisfy the requirements for the ethical treatment of participants. The Psych-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 (TCPS-2) 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. Canadian Psychological Association: American Psychological Association: Tri-Council Policy Statement 2: A second function of the Psych-REB is to provide a forum for the discussion of ethical issues. Students should feel free to contact the Chair of the Psych-REB (presently Shelley Brown, Ext. 1505, shelley_brown@carleton.ca) if they have any questions or concerns about the ethical treatment of human participants. What must be passed through ethics? All research involving human participants that is associated with a faculty member (including Adjunct Faculty) or students 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 may include archival research. To be clear, all research conducted with human participants, not just students in the psychology participant pool, requires ethics approval. Importantly, students from the Psychology Department who are conducting research with a faculty sponsor who does not have access to the Psych-REB must obtain clearance from the other REB on campus (web address). Who Reviews Submissions? In accordance with the Tri-Council Policy Statement, the Psych-REB uses a proportionate approach when reviewing ethics applications, whereby the level of review depends on the foreseeable level of risk to participants. Applications that have a lower risk level will receive less scrutiny than applications with a higher risk level. The two levels of review are: 1) Delegated REB review of minimal risk research If an ethics application is deemed to have minimal risks for participants, it will be reviewed by one Psych-REB member and the Chair of the Psych-REB. 2) Full REB review If an ethics application is deemed to be above minimal risk, the entire Psych-REB will meet to review the application.

3 It is the Psych-REB who decides whether an application receives delegated or full REB review. We strongly recommend that researchers provide a detailed description of any risk (real or perceived) in their research and what procedures they have taken to minimize risk. 3 For full-board meetings, quorum is established at 60%. Moreover, Psych-REB members are in a conflict of interest when their own research projects are under review by their REB, when they are a co-investigator, or when they are in a supervisory or mentoring relationship with a graduate student applicant, or a recent collaborator. Psych-REB members may also be in a conflict of interest situation when they have interpersonal or financial relationships with the researchers, or personal or financial interests in a group that may be the sponsor of the research project, or that may be substantially affected by the research. When reviewing research proposals, Psych-REB members shall disclose real, potential or perceived conflicts of interest to the Psych-REB. When necessary, the Psych-REB may decide that some of its members must withdraw from REB deliberations and decisions. The expertise and advice of a member in conflict might be sought, but the conflict should be recorded in the minutes, and the member should not be present when final decisions are made. Members in conflict would normally not be the sole reviewer on minimal risk proposals, but may be included when their expertise is required. To ensure access to competent expertise, exclusions based on past relationships (e.g., collaboration, supervision, etc.) that created conflicts of interest will normally expire after two years. Psych-REB members shall disclose circumstances that might lead to a real or perceived conflict that exceeds two years (e.g., a particularly close or wide ranging collaborative relationship). What is minimal risk? In accord with the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans (2010; abbreviated to TCPS2), the Psych-REB relies on the principle that more invasive or hazardous research requires a more careful ethical analysis afforded by a full-board review. In contrast, research proposals with no more than minimal risk to the participants (research subjects and personnel) may be expedited. Expedited review means that the research proposal is reviewed by one member or a subset of the full board. Researchers must complete a required form on risk (see Appendix A) in their proposal and when submitting the proposal may recommend an expedited review, but the decision rests with the Chair of the Psych-REB or his/her designate. The Tri-Council has recognized the difficulty in assessing risk. To help determine what constitutes minimal risk research, the Tri-Council has defined the term: For the purposes of this Policy, minimal risk research is defined as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research (p. 23 TCPS2). The Tri-Council Policy goes on to indicate that researchers and REBs must take into account (1) the type of risk; (2) the extent and likelihood of experiencing harm; and (3) known pre-existing individual or group vulnerabilities that might exacerbate or alter the likelihood or extent of harm. Each of these is described below. 1. Type of risk has been interpreted as risk that is physical (e.g., risk of harm through bodily contact or administration of a substance, or by administering a painful stimulus), psychological or emotional (e.g., feeling uncomfortable, embarrassed, anxious, or upset), and social risk (e.g.,

4 risk of loss of status, reputation, or privacy, financial loss, legal risk following disclosure of duty-to-report events). 2. The extent and likelihood of experiencing one of these harms (physical, psychological, social) must also be taken into account. The magnitude of the harm (e.g., a little emotional discomfort, loss of reputation, experience of pain) and the likelihood of harm (very unlikely to certain) are independent constructs. 3. With respect to individual and group vulnerabilities, the Tri-Council has indicated that REBs (and researchers) have special ethical obligations to individuals or groups whose situation or circumstances make them vulnerable in the context of a specific research project, and to those who live with relatively high levels of risk on a daily basis. Their inclusion in research should not exacerbate their vulnerability (see Article 4.7) (p. 23 TCPS 2). This does not imply that any research involving a vulnerable group should necessarily require full board review. To qualify for minimal risk, however, researchers must make the case that participation in the research is unlikely to exacerbate the participant s (or group s) vulnerability or increase their risk of physical, psychological, or social harm. Designating a group as vulnerable presumes that the researcher or the REB believes that there is a reasonable expectation that at least one member of the group will experience a physical, psychological, or social harm in the course of or as a result of participating in the study/experiment. This is a question of probabilities that should be substantiated with empirical evidence or advice from those with extensive and direct experience with the group (e.g., clinicians for those with a disorder, teachers for children). Such evidence or advice must take into account the nature of the study or experiment being proposed. Where there is a reasonable expectation that at least one member of the group will experience harm in the course of or as a result of participating in the study or experiment, researchers must have a plan for mitigating the harmful consequence. Deception. Experiments involving serious deception (e.g., giving false negative feedback about an important aspect of self; creating a fearful environment; convincing someone they have a serious medical condition; covert recording of individuals with the intent of obtaining consent after the fact 1 ) should be considered more than minimal risk if there is a reasonable expectation that at least one member of the sample will experience a physical, psychological (e.g., feelings of emotional upset or anxiety), or social harm. Stress induction. Experiments involving the instigation of stress or anxiety (e.g., where the Trier Stress Test is used) should be considered more than minimal risk if there is a reasonable expectation that at least one member of the sample will experience a physical, psychological (e.g., feelings of emotional upset or anxiety), or social harm. Finally, the Tri-Council Policy notes that in assessing risk, special attention needs to be given to the culture, values and beliefs of population being studied. Where expertise is lacking, REBs should consult ad hoc advisors as needed (p. 24 TCPS 2). How can I assess the risk level of my research? If the study involves sensitive material, then there is potential anxiety, pain, and/or embarrassment. When completing the Evaluation of Risk form (see Appendix A), researcher must assess whether their procedures may cause anxiety, pain, and/or embarrassment to participants. If so, the ethics application should include: (1) a description of the nature of the anxiety, etc.; and (2) a detailed description of the precautions that will be taken to safeguard the participants also should be included (e.g., informing participants, providing contact information). Special procedures, which 1 This list of examples comes from the Queen s REB policy. 4

5 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 Shelley Brown, ext. 1505) for further information about these special procedures. 5 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). My research requires the use of deception. What do I need to know? If the true purpose of the experiment, or other similar information is altered, then deception is used. If 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). Moreover, your debriefing form must explain clearly what was the nature of the deception as well as provide the reasons why it was necessary to use this method. In addition, the Psych-REB (as well as APA guidelines) requires that once the true purpose of the study is revealed at the end of the study, that the researchers must explicitly offer participants the opportunity to withdraw their data from the study (see Appendix E for the consent to use data form). How Do I Submit a Protocol to the Psych-REB? Follow the guidelines in this document to prepare your application. On the Ethics Online System, you will complete a cover form and attach the ethics application you have prepared. Note that although the Psych-REB can provide guidance, feedback, and answer questions, it is the researcher's responsibility to prepare the application and make any necessary revisions. How do I get feedback from the REB? Once your proposal has been reviewed, you will be notified by and the feedback will be available in your online ethics 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, allow a minimum of one working week for feedback on the revisions. How Much Time Does it Take the REB to Review a Submission? Initial feedback from the Psych-REB varies depending on the level of ethics review; delegated reviews take two weeks on average whereas full REB reviews take four to six weeks. During busy periods (e.g., October-November) the review time may be longer. Where can I find out more about ethical principles? Honours, graduate students, and faculty are encouraged to learn more about ethical principles by completing the self-paced web-based tutorial designed by the Tri-Council Panel on research ethics. Do I need additional permissions if I m recruiting participants from organisations? Yes. Approval from both the Psych-REB and the outside organization (e.g., businesses, hospitals; schools; prisons) are needed. In some organizations, ethics approval from Carleton is mandatory

6 6 before approval from the organisation can be given. 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. Conditional approval does not permit researchers to collect data. Final approval will be granted once a copy of that outside approval, scanned and uploaded as an addendum to a conditionally approved protocol has been processed by the Psych-REB. Final ethics clearance must be obtained before any data are collected. Can I get Ethics approval for a 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. Do I need Ethics clearance for archival research? The Tri-Council Policy states that the use of secondary data when stored anonymously (i.e., without identifying information such as names, initials, birth dates), then Ethics approval need not be sought. In the case of data that are not stored anonymously, approval must be sought from the Psych-REB. If participants originally gave their consent to the secondary use of their data, the REB will give approval if: (1) identifying information is necessary to the study; (2) privacy and confidentiality are ensured, and harm to participants is minimized. However, if participants did not originally give their consent to the secondary use of their data, then consent must be sought before ethics approval can be given unless the researcher can demonstrate that they meet the requirements outlined in Section D, Article 5.5 (pg. 62) of the Tri-Council Policy ( It is strongly recommended to include the term archival in the title of the application. Can Grad students submit a protocol for their thesis before their prospectus meeting? No. 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 Psych-REB. Do I need ethics clearance for pilot studies? 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 actually collect data, then you will require ethics approval for the pilot study. Do Honours students always require ethics approval for their thesis? Yes. 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.

7 Can I recruit participants in the courses I teach or other courses in Psychology? No. Use SONA instead. For further detail, see the document titled Collecting data in the classroom available on the department website. 7 Can I recruit participants from other courses in Psychology? No. Use SONA instead. For further detail, see the document titled Collecting data in the classroom available on the department website. Can students in the course I teach conduct studies as a part of course requirements? Instructors teaching Honours seminars or other courses may want their students to conduct small research projects for pedagogical reasons. Note that 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 Psych-REB and expedite the review process, the course instructor should submit a single protocol. The instructor should present a 1- to 2-page overview the series of studies proposed. If applicable, particular attention should be given to issues of risk to participants as well as deception. Following this overview is the brief presentation of each study including its description and appendices (i.e., recruitment notices, informed consent, debriefings). Instructors should the chair of the Psych-REB for an example of such an application. What is the ethics reference number? Approved projects receive a reference number that is used on informed consent and debriefing forms, recruitment notices, as well as any communication with the Psych-REB. How can I make changes to an approved protocol? 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. What is the duration of my Ethics approval? All approved studies expire on August 31. At that time, all researchers who have not already closed a study must submit a progress report to renew their protocol if the study is ongoing or close it if the study is completed. Do I need to do anything once a study is completed? Yes, you must submit a progress report to close your study. How long to I need to keep personal information, consent forms, and raw data? To respect the requirements of the Freedom of Information and Protection of Privacy Act (FIPPA), researchers need to indicate clearly, in the informed consent, the length of time for which any personal information collected (e.g., signatures on the consent forms, contact information, identifying information from audiotapes or in a dataset) will be kept in a secure location before being destroyed. Researchers also need to indicate that personal information will only be viewed by researchers directly involved in the study. Signed informed consent forms, raw data that contains identifying information, and any other personal data (contained in any format) should be retained for at least three years following one of two options: (a) the completion of the study; or (b) after a report of the work is published or otherwise publicly presented. Researchers might need to keep these records for longer periods depending on the requirements of individual funding agencies, psychological associations, and/or publishers.

8 8 Anonymized datasets (i.e., with all identifying information removed) or anonymous datasets (i.e., where participants never provided identifying information) can be retained indefinitely. However, if researchers wish to utilize these data in the future for purposes beyond the initial intent of the study (e.g., educational purposes, secondary data analyses), this possibility must be clearly indicated on the informed consent. What is an annual progress report? Every study that is approved by the Psych-REB receives an ethics clearance certificate that includes a set time period during which the study may be conducted. The expiry date for all studies is August 31 following approval. 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. Projects must be identical in all aspects in order to qualify for automatic renewal. In particular, 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) should 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 study (i.e., after all the data are collected), you must close your study using the online progress report form. Who can recruit participants from the Psychology pool? Researchers in the Psychology Department can recruit participants from PSYC 1001, 1002, 2001, 2002 and NEUR 2001, 2002 through the SONA system. These students can earn a maximum of 4% towards their final mark in each of these courses. Because we want the students to gain knowledge about research, it is important that researchers who recruit from the participant pool provide a debriefing that is informative and Should incidental findings be communicated to participants? According to the Tri-Council Policy: Incidental findings is a term that describes unanticipated discoveries made in the course of research but that are outside the scope of the research. Material incidental findings are findings that have been interpreted as having significant welfare implications for the participant, whether health-related, psychological or social. (pg. 34) Researchers are obligated to disclose any material incidental findings to participants. In some cases, incidental findings may be such that they prompt legal reporting obligations (e.g., law enforcement or child welfare agency). If you are unsure how to disclose incidental information to participants or whether your findings need to be reported to the relevant authorities, you should contact the Chair of the Psych-REB. Do I need to inform the Psych-REB if some unforeseen event happens while conducting research? Yes. You must submit a progress report detailing what happened and how you responded. Anything I should know when planning to do research online? When collecting data from participants with online tools, there are risks to data anonymity, confidentiality, and privacy. Researchers must consider these risks in their proposals to conduct online research. These are described below. Server location. When researchers select an online survey tool or service, it is important for them

9 9 to know and describe in their proposal the geographical location of the servers that host the survey and store participants data. The location of their server is often listed on the survey program main page. If not, researchers should contact the program administrator directly for this information. Data anonymity and confidentiality are vulnerable when stored out of Canada, particularly in the USA. Data stored on servers based in the USA are subject to the United States Patriot Act that permits US law enforcement officials, for the purpose of an anti-terrorism investigation, to seek a court order that allows access to the personal records of any person without that person's knowledge. Given this, researchers are to include a statement to that effect in the informed consent. This statement differs whether the survey is anonymous or and the survey topic sensitive or not. (1) For online surveys that are anonymous and for which the topic is not sensitive: Researchers are to include a sentence, on the informed consent, indicating where the data is being stored and that, as a result of the data being stored outside of Canada, anonymity cannot be guaranteed. In cases where it is not possible to know the server location, then the sentence to be included could be modified to: Because the server for this study may be located in a country other than Canada, we cannot absolutely guarantee the full confidentiality and anonymity of your data. With your consent to participate in this study you acknowledge this. (2) For online surveys that are not anonymous and/or for which the topic is sensitive: With respect to surveys hosted in the United States, the consent form should advise participants about the risks to confidentiality/anonymity relating to the US Patriot Act. A suggested wording for studies employing servers located in the US is: Please note that the online survey tool used in this study (add here the name of the survey) is hosted by a server located in the USA. The United States Patriot Act permits U.S. law enforcement officials, for the purpose of an anti-terrorism investigation, to seek a court order that allows access to the personal records of any person without that person's knowledge. In view of this we cannot absolutely guarantee the full confidentiality and anonymity of your data. With your consent to participate in this study you acknowledge this. Research Tools. There are a number of different tools available for students and faculty to conduct their surveys online. The Psych-REB encourages researchers to use online survey tools whose servers are located in Canada (e.g., Fluid Surveys Ask It If the sample consists of students (in either PSYC 1001, 1002, 2001, 2002 or NEUR 2001, 2002) and they will be assigned a credit or financial compensation for taking part in a study, the following tool, located in Canada, is available: SONA ( If those tools do not meet the objectives and methods of the research effectively, there are other tools located in the United States or elsewhere (e.g., Survey Monkey ( Qualtrics ( IP addresses. Researchers must indicate, in their proposal and on the informed consent, whether IP addresses are recorded by the online survey tool or service. And, if so, how confidentiality is assured. Anonymous surveys and compensation. Researchers should include, in the proposal and the informed consent, a description of how credit or other forms of compensation will be given if participation is completely anonymous. For instance, some researchers give credit to all students requesting the link to the survey.

10 10 Note that researchers conducting online research are encouraged to render their surveys anonymous. One way to do so is to create two surveys. The first survey, using an online tool located in Canada, includes the informed consent and is used to collect the identifying information necessary for compensation, as well as randomly assign an ID number. The Next button at the bottom of the informed consent is a link to the second survey. The tool to create this second survey could be located outside of Canada. Participants start the survey by typing their ID number. Hence, the second survey is completely anonymous (ensure that IP addresses are not recorded). By creating a second (separate) survey and not just a separate page, researchers are creating two separate databases for the actual study. Thus, there will be no personal information in the database that contains the actual survey data. As always, researchers are to indicate when the personal information in the first database will be destroyed. Debriefing. Researchers proposing on-line surveys must specify the mechanism by which participants may withdraw at any point and be directed to appropriate debriefing (e.g., a withdraw button), or to indicate and provide the rationale for an alternative to such a mechanism. Recruiting participants online. Researchers planning to recruit participants online, must specify: (1) what program will use to do so (e.g., Fluid Surveys); (2) where the link to the study will be placed online (e.g., forums, Facebook, My Space); (3) as well as the recruitment notice. For example, if you are planning to place the link to your study on Facebook, specify where on Facebook the link will be placed (e.g., a paid ad will be created or the link will be posted on the wall of an existing group). Remember that you must receive permission before placing your study online. Are there special concerns when recruiting participants via ? If participants are being recruited by for your online study, describe how notifications and reminders to participate will be done (i.e., specify which program will be used). Note that you should be using an client program (e.g., Microsoft Outlook or Mozilla Thunderbird) rather than a web-based program (e.g., your Carleton , Gmail, Hotmail, Yahoo), in order to have better security and more control over mail features. Avoid using mail-merge, Bcc or copy and paste to send out mass s. Rather, using an client program you will be able to generate templates that can be used for mass s (see Appendix F).

11 11 B. Guidelines to Prepare a Submission To submit applications to the REB you must have an account on the online system. For more information on this, please go to Cover form. You are to complete the cover form on the online system. 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 study has Tri-Council Funding. Note that this statement refers to whether the professor or the student working on the study 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. Application Sections The application should be submitted as a single document (either PDF or a Word document) 1. Purpose. A concise ( 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 Psych- REB any potentially sensitive aspects of the study (e.g., criminal behavior, sexual abuse, depression, studies involving deception). 2. 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. Include copies of all questionnaires, testing instruments, etc. - Stimulus materials should be described concisely. Copies of stimulus materials (e.g., questionnaires, scripts of videos, scripts of interview protocols, etc.) should be included as an appendix. If there are too many, then provide sufficient examples for the Psych-REB to be able to assess if there might be any ethics issues. 3. Confidentiality and anonymity. Outline how you will protect participants confidentiality. Describe the circumstances where you might be obligated to breach confidentiality. Describe whether participants anonymity will be ensured and, if so, how. 4. Risk to participants. Complete the form Evaluating Risk to Participants (Appendix A of these guidelines). If the study involves sensitive material or procedures (e.g., deception or stress induction), then there is potential anxiety, pain, and/or embarrassment. Anticipate and describe on the form the nature of the participants reactions to your materials/procedures. Include a detailed description of the precautions that will be taken to safeguard the participants (e.g., informing participants, providing contact information). 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. In addition, it is recommended that 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). 5. 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,

12 12 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, at the end of the study, when the true purpose of the study is revealed the researchers must explicitly offer participants the opportunity to withdraw their data from the study (see Appendix D of these guidelines). 6. References should be provided for any sources given in the description of the study purpose or methods sections. Present the remaining sections in separate appendices. 7. Materials: Copies of stimulus materials (e.g., questionnaires, scripts of videos, scripts of interview protocols, etc.). 8. Informed consent forms (see example in Appendix B). The purpose of a consent form is to INFORM participants 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: a) An explanation of what a consent form is and why it is required b) Title of study c) The following contact information: (a) Research Personnel: names, affiliations, and contact information for Principal Investigator(s) and Faculty Sponsor(s) (b) Ethical concerns: name and contact information for Chair of Carleton University Psychology Research Ethics Board (c) Any other concerns: name and contact information for Chair of Carleton University s Department of Psychology (if you are from another university or department, such as Cognitive Science or Child Studies, provide the contact information for the chair of that university or department). d) Purpose of the study, described in English, not psychology jargon. Should be brief. e) Description (in plain English) 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. f) Duration/frequency of participants involvement and location. g) Are participants receiving remuneration (e.g., credit or money) for participating in the study? If yes, provide information about the compensation. h) Clearly describe 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. i) Confidentiality and anonymity. Describe how participants confidentiality will be ensured (e.g., data only shared with research personnel). Will participants anonymity be ensured (e.g., data coded with a number and names not used)? If yes, describe how. In compliance with FIPPA describe the length of time that you ll keep the informed consents, identifying information, and raw data.

13 13 j) 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. k) Right to withdraw. Participants must be informed that they have the right to withdraw at any time or omit specific questions, without penalty. In addition, it should be stated that if participants withdraw, they have the right to request that their data or human biological materials (e.g., blood, saliva) be withdrawn. If there are any circumstances that would not allow the researcher to withdraw participants data (e.g., if participants survey data is anonymous) or human biological materials, this should be specified in the informed consent. l) Right to withdraw and remuneration. If participants are receiving remuneration (e.g., paid) for participating in a study, they should still receive remuneration even if they withdraw. For multiple session studies in which participants are being paid a lump sum, they are entitled to the full amount. However, if a payment schedule is used for multiple sessions, then it is only necessary to pay participants in proportion to their participation. The current guidelines for the Psychology Department include the paragraph below. However, the Tri-Council Policy does not include this type of provision. If there are circumstances where the researcher can state in advance the conditions for receiving or not receiving 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. m) 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. n) Include the following statement: This study has received clearance by the Carleton University Psychology Research Ethics Board (12-xxx, indicate your ethics file number once obtained). 9. Debriefing (see example in Appendix C). A debriefing is given to participants whether or not they complete the experiment. In the case of studies conducted over a lengthy period, it may be necessary to wait until the end of the study to provide the debriefing. Although debriefings will differ across projects, the goals should be to educate the participants, to undo any potential harm caused as a result of the study (e.g., by deception, embarrassment), and to provide resources for future reference. In most cases, a full written debriefing should be given to the participant. A copy of the written debriefing must be included in the ethics submission. If a written debriefing cannot be given, then note this in the application and explain why. Researchers are encouraged to use the following user-friendly headings and including the information indicated under each heading: What are we trying to learn in this research? Purpose of the research Why is this important to scientists or the general public?

14 Brief review of the research issues What are the hypotheses and predictions? Describe the hypotheses, predictions, and/or implications Where can I learn more? Provide a couple of academic or other appropriate references What if I have questions later? As participants may have questions about the research or ethical concerns, include the following 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 university or department provide the name of the chair of that university or department). University phone numbers should be included for faculty and, if available, lab phone numbers for student investigators. Carleton University s should also be included for both students and faculty. Is there anything that I can do if I found this experiment to be emotionally draining? In special cases in which studies include sensitive material (e.g., information about being abused) or procedures that might result in continuing concerns by participants (e.g., career choices), contact numbers (e.g., Carleton University Health and Counselling Services, ; Distress Centre of Ottawa and Region, ) should be provided for follow-up consultation. In addition to the above, studies that use deception should also include a debriefing of what the deception was, why it was necessary, and an explicit offer for participants to withdraw their data or give a new informed consent, now that they know the true purpose of the study. Finally, if the researchers plan on any follow up studies with the same participants and intend to contact them in the future; this information should be disclosed as part of the debriefing. A second informed consent should be obtained to get participants permission for this future contact, along with assurances that their identity will remain confidential and separate from their data. 10. Announcement for recruiting participants (see example in Appendix D). Recruitment can be done in various ways (e.g., from the psychology participant pool, notices on boards across campus, s, snowball methods, word of mouth, Facebook, etc.). For all venues of recruitment, include the particular announcement that is to be used. Note that recruitment announcements should alert potential participants to any sensitive procedures, so that they can select themselves out of the study. Recruitment announcements should also be as anonymous and private as possible. For example, recruitment posters should not include the student numbers and names of the researchers. Rather, initials, s and/or phone numbers can be used. Recruitment announcements should include the following statement: This study has received clearance by the Carleton University Psychology Research Ethics Board (12-xxx, indicate your ethics file number once obtained). 14

15 15 Appendix A: Evaluating Risk to Participants Form 1a) Is there any risk that participants will experience physical harm (e.g., pain, injury, nausea), psychological/emotional harm (e.g., distress, upset, anxiety, guilt), and/or social harm (e.g., embarrassment/shame, stigma, loss of privacy or income, legal consequences) during or subsequent to the experiment that would be attributable to their participation in the research? No Yes 1b) If Yes, please complete the table below. In the first column, identify the type of harm as physical or psychological/emotional and provide an example to illustrate. Then rate the magnitude/seriousness of each type of harm in the second column. In the third column, estimate the probability that such harm will be experienced by at least one participant (Note: where possible, justify these estimates with evidence from prior research or from experts) Potential Harm Magnitude/seriousness of harm Probability of harm 1 mild (lasts < 5 min) 2 moderate (lasts < 1 hr) 3 high (lasts > 1hr) 1 < 1 in 100 participants 2 1 < 6 in > 6 in mild (lasts < 5 min) 2 moderate (lasts < 1 hr) 3 high (lasts > 1hr) 1 < 1 in 100 participants 2 1 < 6 in > 6 in mild (lasts < 5 min) 2 moderate (lasts < 1 hr) 3 high (lasts > 1hr) 1 < 1 in 100 participants 2 1 < 6 in > 6 in 100 Justification of the estimates for each potential harm for (a) the magnitude/seriousness of harm and (b) the probability of harm: Group vulnerability: Are there any pre-existing vulnerabilities associated with the proposed group s participation in the study that may have a bearing on the likelihood that a member of this group might experience physical, psychological/emotional, or social harm as a result of their participation? Yes No 2a) If Yes, explain this vulnerability and the associated risk(s).

16 16 Appendix B: Example of Informed Consent The purpose of an informed consent is to ensure that you understand the purpose of the study and the nature of your involvement. The informed consent must provide sufficient information such that you have the opportunity to determine whether you wish to participate in the study. Present study: Self-Appraisals, Coping, and Well-Being Research personnel. The following people are involved in this study, and may be contacted at any time if you have questions or concerns: your name ( phone: , ext. xx), Dr. xx (Faculty Sponsor, phone: , ext. xx). Concerns. Should you have any ethical concerns about this research, please contact Dr. Shelley Brown (Chair, Psychology Ethics Board, , ext For other concerns, please contact Dr. Joanna Pozzulo (Chair, Department of Psychology, , ext. 1412). Purpose. The purpose of this study is to investigate the relationship between personal characteristics (e.g., demographics, depressive symptoms, mindfulness) and how individuals appraise themselves and different types of situations. We are interested in examining how these personal characteristics and appraisals influence the types of strategies people use when dealing with stressful situations, as well as how these variables predict well-being. Task requirements. We are asking you to fill out a number of online questionnaires regarding your background (e.g., demographics), personal characteristics (e.g., how you cope with things in your life), and how you feel about yourself (e.g., self-appraisals, well-being). We will also ask you to write a brief description of a stressful event you have experienced. The questionnaires will take about 60 minutes to complete. Benefits/compensation. You will receive a 1% increase in your final grade in PSYC 1001, 1002, 2001, 2002 or NEUR 2001, 2002 for participating in this study. Potential risk/discomfort. There are no physical risks to participating in this study. Some individuals might feel uncomfortable when asked to recall stressful situations or to answer personal, sensitive questions about the coping strategies they use or feelings of depression they may have experienced. If you feel any discomfort or distress, you may choose not to answer specific questions, and you will not be penalized in any way if you do this. The debriefing form at the end of the study provides contact information for local support services that you may contact if you need or want help. Anonymity/Confidentiality. The data collected in this study are strictly confidential. All data are coded such that your name is not associated with the responses you provide. Any identifying information associated with your code will be confined to a single page that will be separated from your questionnaire, and kept in a separate, secured file by the research investigators, who will keep this information confidential. The informed consent and all other identifying information will be destroyed after three years. The anonymously coded data will be kept and will be used for research and teaching purposes. Right to withdraw. Your participation in this study is entirely voluntary. At any point during the study, you have the right to not complete certain questions, or to withdraw without penalty. If you withdraw, you have the right to request that your data be deleted.