Research Ethics Board

Pre-Approval FAQ

Pre-approval refers to new applications for review and approval that have not yet been submitted to the REB. Once a research study has received approval from the REB and its Certificate of Ethical Acceptability for Research Involving Humans, requests are refered to as "Continuing Review" as per the TCPS 2. If you already hold an original REB approval date and accompanying certificate, please visit the Post-Approval section of this website.

Pre-approval FAQ Categories:

  • A. Application Preparation
  • B. Application Submission
  • C. Protocol/ Form 1, 1 C
  • D. Informed Consent
  • E. Supporting Documents

A. Application Preparation Questions

  1. What is the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)?
  2. What type of research requires REB review and approval?
  3. What type of research does not require REB review at all?
  4. Who determines what research should be reviewed?
  5. What is the non-compliance policy? Which policies do I need to abide by relating to conducting research involving humans at SMU?
  6. What is the process for having my research reviewed?
  7. What are the requirements to obtain ethics approval?
  8. What is the process if my research has already been approved by another institution?
  9. What is the procedure if I would like to do further work on a research that I have conducted in the past and it has been formally closed by the REB?
  10. I am a new student/faculty/staff member at SMU. Do I need to have my research already approved elsewhere reviewed at the SMU REB as well?
  11. I am conducting research in another country.  Is my SMU REB approval all I need?
  12. How do I prepare and international research application?
  13. What is the proportionate review approach?

Answers:

1. What is the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)?

When research involves human participants, the Governmanet of Canada's Interagency Advisory Panel on Research Ethics (PRE) (TCPS 2) is the adopted policy used by all Canadian universities, the National Research Council, Canadian Space Agency, Health Canada and National Defense and applicable federal research agencies. The TCPS 2 applies to all institutions that are eligible to receive government funding. Members of the Saint Mary's University are prohibited from conducting research involving human participants without SMU REB approval whether the researcher is funded or unfunded.

PRE is a body of external experts established in November 2001 by three Canadian research agencies: the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council (NSERC) and the Social Sciences and Humanities Research Council (SSHRC).  PRE advises the agencies on the evolution, interpretation, implementation and the educational needs of the TCPS 2 intended to promote high standards of ethical conduct, advance the protection of human research participants and enhance accountability in research ethics.  The TCPS 2 replaced its first version on November 29, 2010. The newest version is the TCPS 2, December 2014.

The guidelines in this Policy are based on the following three core principles:

  • Respect for Persons
  • Concern for Welfare
  • Justice

Contents of the TCPS 2:

2. What type of research requires REB review and approval?

According to the Tri-Council Policy Statement (TCPS 2), research is an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. Research involving human participants is work done by an individual that entails data collection involving humans for the purpose of obtaining either primary or secondary data on research participants whose data or responses to interventions, stimuli, or questions by the researcher are relevant to answering the research question. Any funded or unfunded research that involves human participants proposed by SMU faculty, adjunct professors, students, administrators, employees and other persons holding appointments by the Board of Governors requires REB review.  If you are not sure, please review the TCPS 2, Article 2.1 Scope of Ethics Review or you may submit a preliminary summary to the Office of Research Ethics for assessment.

3. What research does not require REB review at all?

The Office of Research Ethics and the Chair of the REB consult with all members of the research community relating to the review and approval requirement. The Chair will provide the formal decision and relating excemption letter, where required.  The research community is both advised and warned to ensure that they double-check with the REB how their undertaking is classified under the TCPS 2 and ensure that if it is a "research" activity, they obtain the formal approval from the REB, prior to the recruitment of any participants, understanding that there exists no options for retrospective review and approval.

Formal ethics approval from the REB will normally not be required when the research meets some of the criteria outlined below, however a formal review of whether the research is classified as an "activity" or "research" as defined by the TCPS 2, is necessary and provided by the Chair of the REB:

  • A limited type of research most often found within the humanities, fine arts and in some historical research that typically includes: (a) a public database where aggregated data that cannot be associated with any individual are obtained and/or (b) information already in the public domain (Example: autobiographies, biographies or public archives.)  Nevertheless, it is the responsibility of the researcher to ascertain that any information used from these sources is presented in an accurate fashion.
  • Archival analysis of records by college departments normally engaged in the collection, maintenance and analysis of such records does not require REB review.  Nevertheless, it is the incumbent on such units to ensure that the anonymity of individuals and confidentiality of their records are maintained.
  • Naturalistic observation of participants in, for example, political rallies, demonstrations or public meetings, where it can be expected that participants are seeking public visibility (… alternately. have no expectation of privacy.)
  • Class research projects, which involve human subjects and are conducted by students on other members of the class as exercises to learn how to conduct research.
  • Evaluations of courses or training programs that are designed to provide feedback.
  • Preliminary, informal interview or casual conversations that are carried out to help clarify the design of a research project.
  • Research about a living individual in the public arena or an artist based exclusively on publically available information.
  • Performance reviews or testing within normal educational requirements.
  • Most research involving public policy issues, the writing of modern history or literary or artistic criticism, even though they may involve human subjects.
  • Research involving a person no longer living (unless you question other people about the deceased individual.)

4. Who determines what research should be reviewed?

It is the obligation of individual researchers to determine whether a proposed project may fall under the TCPS 2 and to submit the project to the SMU REB.  In the case of student research, it is the joint responsibility of the student and of the professor giving the course and/or supervising the research.  Applications for SMU internal research grants (CIHR, NSERC, SSHRC) may be made in advance of approval by the REB but the Councils will not release funds to successful applicants until an ethics review and approval has been completed and the project has been approved. Please review the Saint Mary’s University Policies and Procedures home page, and the Saint Mary’s University Faculty of Graduate Studies and Research, Research Policy and Procedures.

The Office of Research Ethics and the Chair of the REB consult with all members of the research community relating to the review and approval requirement. The Chair will provide the formal decision and relating excemption letter, where required.  The research community is both advised and warned to ensure that they double-check with the REB how their undertaking is classified under the TCPS 2 and ensure that if it is a "research" activity, they obtain the formal approval from the REB, prior to the recruitment of any participants, understanding that there exists no options for retrospective review and approval.

5. What is the non-compliance policy? Which policies do I need to abide by relating to conducting research involving humans at SMU?

The SMU REB is obligated to report any cases in which a research does not hold a valid Certificate of Ethical Acceptability or a valid Certificate of Continuation to the Dean of Graduate Studies and Research, Associate Vice President of Research, under the provision of the Saint Mary's University Policy on Integrity Research and Scholarship and Procedures for Reporting and Investigating Scholarly Misconduct and the Memorandum of Understanding on Roles and Responsibilities in the Management of Federal Grants and Awards with the Government of Canada whether the research is funded or unfunded.

Without valid ethics approval, no research activity involving humans is permitted and data gathered without valaid ethics approval cannot be used and must be destroyed.

The REB is empowered to approve, reject, propose modifications to, suspend or terminate research activity that involve human participants and that fall under the jurisdiction of Saint Mary's University.

Furthermore, failure to obtain/hold a valid SMU REB Certificate of Ethical Acceptability or a Certificate of Continuation may result in the delay, suspension or loss of funding as required by the federal granting Councils and the full invalidation of Faculty, Student or Staff work.

6. Do institutional surveys require REB review?

If the survey is used to collect only factual information that is publicly available, then ethics review may not be necessary.  If the survey includes any questions asking for the opinions of interpretation by the participant, then ethical review may be required.  Please seek clarification from the Office of Research Ethics or submit a preliminary summary for assessment. In addition, please review answer #5, relating to non-compliance.

7. What is the process for having my research reviewed?

  1. 1 original, plus 3 copies of the application package arrives at the Office of Research Ethics. (Form 1C, requires one original copy only.)
  2. The proposal is assigned a SMU REB File number and is entered into the REB tracking system. If information or documents are missing the researcher is asked to provide the information before it can be registered, receive administrative review and be sent to the REB membership.
  3. An email receipt including the SMU REB File number is sent to all investigators.
  4. The proposal is reviewed at the Office of Research Ethics. 
  5. Two members of the REB review the proposal and send their recommendations to the Office of Research Ethics.
  6. The REB Chair reviews the proposal and the recommendations of all reviewers.
  7. The REB Chair sends an answer including the recommendations of the reviewers to the investigator(s).
  8. If clarifications are requested, the investigator(s) respond to the REB Chair. It is expected that investigators demonstrate the details of their undertaking to the REB as the subject matter experts in the area.
  9. Changes are checked by the Office of Research Ethics and the REB Chair.  The proposal is accepted or further clarifications are requested.
  10. The REB Chair sends an electronic email approval to the investigator(s). (At this time the investigator(s) may begin recruiting participants.)
  11. The REB Chair signs the Certificate of Ethical Acceptability for Research Involving Humans.
  12. The Certificate of Ethical Acceptability is sent to all investigators via email.  A copy must be retained in the investigator's records and students must retain a copy for their thesis binding. A copy of the certificate is maintained in the REB master file.

"'Delegated” versus “Full Board” review:

Most applications are assessed using a delegated review process which involves having the application reviewed by the REB Chair and 2 members of the REB.  Delegated reviews are conducted with a view to reaching consensus; however, it will be the decision of the REB Chair to determine when consensus has been reached.  Note that the REB may determine that an application requires a full review wherein the full membership will review the proposal.  Normally, full review occurs in instances wherein the research poses more than minimal risk to its participants (i.e.: exceeds minimal risk).  Applicants will be notified if this is the case.  Applications requiring a full review are assessed during a meeting of the REB.  Approval of a full review proposal requires a majority vote in favor of the application.  In keeping with Senate policy and the TCPS 2, the REB will ensure that its procedures and decisions are fair, impartial and equitable.  Minutes are kept of all meetings and decisions.  Researchers may request that decisions be reconsidered and they may appeal decisions.  When considering a negative decision, the REB shall provide the researcher with all reasons for its decision and give the researcher an opportunity to reply prior to a final ruling.  Researchers have the right, have the option and are invited to appear at the REB's full Board meeting in person, although they may not be present at the time when the REB is deliberating.

Full Board meetings essentionally are not time-consuming in this setting.  If a regular REB meeting does not fit time frames, an REB meeting is called.  Decisions of the REB, via the REB Chair, are conveyed in writting in a timely fashion once all areas of the protocol have been discussed verbally.

8. What are the requirements to obtain ethics approval?

Whether a research is funded or unfunded, in order to obtain a Certificate of Ethical Acceptability from the Saint Mary’s University REB; the research must comply with the policies and guidelines of the:

9. What is the process if my research has already been approved by another Canadian REB?

Some multi-site research projects involving multiple institutions may already have approval from another institution, meaning another Canadian REB. In this event, complete the  form 1C- Application for Ethics Review of Research Involving Humans Approved at Another Canadian Institution and ensure that you include a copy of the other institution’s ethics clearance (letter or certificate) attesting the approval, as well as all correspondence regarding the original submission. Submitting only one original copy of the form 1C and of all the correspondent materials will suffice. In this case, the research will only be reviewed by the Research Ethics Officer and the REB Chair from whom you will hear shortly. Ensure that you attach all required documents to avoid any delays.

10. What is the procedure if I would like to do further work on a research project that I have conducted in the past and it has been formally closed by the REB?

In the event that your research has been closed by the REB via the Completion of Research form (Form 5) please consult the Office of Research Ethics. Please make reference to the previously approved research by referencing your SMU REB file number.

11. I am a new student/faculty/staff member at SMU. Do I need to have my research already approved elsewhere be reviewed?

Yes. As a person becoming affiliated with SMU, any ongoing or new research projects will need to be reviewed and approved by the SMU RE

12. I am conducting research in another country.  Is my SMU REB approval all I need?

No. You may need to obtain approval from an institution or government in the country you are conducting research.  Please make sure that any relevant certifications are obtained in that jurisdiction and the laws of the country, as it pertains to research, are demonstrated to the SMU REB within the body of the application form where they are requested.

Please ensure that you are familiar and compliant with the the Chapter on Multi-Jurisdictional Research in the TCPS 2 while preparing your application:

Relating Reading: TCPS 2, Article 8.1- 8.4, Multi-Jurisdictional Research

Researchers who conduct research outside of the SMU REB jurisdiction receive education tailored to this specific circumstance via bi-annual community education sessions, attending tailored multi-jurisdictional and pre-arranged and per-request international research focused sessions or via individual or group consultation by the Research Ethics Officer. Stayed tuned to information on upcoming sessions that are held throughout the academic terms and/or contact the Office of Research Ethics to request a session or to book an individual/group consultation.

13. How do I prepare an international research application?

When it it is proposed that the research would be conducted outside of SMU jurisdiction or at a site abroad, the applicant must, per TCPS 2, Article 8.1-8.4 demonstrate to the REB, as covered by the application form (Form 1):

  • Relevant information on the rules governing human research and the ethics review requirements at the host site, where such exist;
  • The names and contact information for the relevant REBs or comparable ethics bodies, if known, that will review the proposal at the host site;
  • Relevant information about the target populations and circumstances that might have a bearing on the ethical review by the researchers’ home REB.

Please ensure that you are familiar and compliant with the Chapter on Multi-Jurisdictional Research in the TCPS 2 while preparing your application:

Relating Reading: TCPS 2, Article 8.1- 8.4, Multi-Jurisdictional Research

14. What is the proportionate review approach?

The ethics review process involves a proportionate review approach. The SMU REB is committed to employing a stict adherence to the proportionate approach. The greater the risk for participants, the more the proposed research will be scrutinized.  Most of the research conducted by members of the SMU community involves minimal risk.

The TCPS defines minimal risk as follows: “If potential subjects can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research, then the research can be regarded as within the range of minimal risk.  Above the threshold of minimal risk, the research warrants a higher degree of scrutiny and greater provision for the protection of the interests of prospective participants.” Relating Reading: TCPS 2, Article 2. 8-2.9, Approach to REB Review

The REB will pay particular attention to studies in which: 

  • Research procedures induce embarrassment, humiliation, lowered self esteem, discouragement or other emotional reactions
  • Participants are subject to physical discomfort, threat of physical discomfort or strenuous physical activity.
  • The investigation uses procedures designed to induce participants to act contrary to their wishes or if the research requires deception of the participants.
  • The populations studies consist of potentially at risk individuals (e.g., minors, pregnant women, prisoners the mentally handicapped or other individuals of diminished capacity to provide consent for themselves)
  • Personal information is collected, taken off campus or outside of Canada.

B. Application Submission Questions

  1. Do you have tips that help the application process go smoothly?
  2. What are the submission requirements?
  3. Are there deadlines for submitting ethics proposals?
  4. Do all surveys, questionnaires and interview questions have to be submitted to the REB?
  5. How do I submit my application package?
  6. How many copies do I need to submit for review?
  7. Can I submit my application package electronically?
  8. How can I learn more about the ethics approval process?

Answers:

1. Do you have tips that help the application process go smoothly?

A consultation with the Office of Research Ethics prior to submission may save you time and extra work.  You are encouraged to visit the Office of Research Ethics to seek direction if you have questions about your submission and to attend research ethics relating educational sessions held throughout the academic terms.

Ensure that the application is complete and completed on the most up-to-date form downloaded directly from the SMU REB website:

  • Ensure that the application is complete, completed using the most up-to-date version downloaded directly from the SMU REB website and that a contact information for all investigators is listed
  • Faculty members must read the applications prepared by students carefully
  • Make sure you submit 1 original, plus 3 copies for Form 1 (SMU Faculty/Student/Staff) applications and one original copy for 1C (Faculty/Student/Staff) applications that have already received approval from another Canadian REB. Make sure the forms are signed by all researchers named in the application. Make sure all appendices are included. Please make sure that the applications are well written and fully answer the questions. Ensure that your submission is free of typographical, spelling and grammatical errors.  SMU expects the researcher to function in a professional manner on and off-campus and such errors do not reflect professionalism. Ensure that there is sufficient detail presented on the research’s purpose for REB members to evaluate the ethical implications of the research.  Do not assume that reviewers are familiar with the methodology and demonstrate details as the subject matter expert. Applications that are well-written and detailed have a better chance of addressing the  requirements of the TCPS 2 and are most likely to be processed quickly because reviewers are less likely to have general or specific questions and/or concerns. It is helpful to the REB to demonstrate the sequence and phases of events involving the proposed research, for which approval must be provided, including all materials/documents that will be used in the research.
  • Applicants would be wise to anticipate potential ethical dilemmas that may arise in the course of their research and address them and how they plan to handle them were an adverse event to occur, in the application
  • Please study the Sample Informed Consent found under the “Forms” section of the REB website while preparing your draft informed consent form. Alternately, a signed consent form may not always be appropriate. Relating Reading: TCPS 2, Article 3. 2, Consent Shall Be Informed. If the Board asks for clarifications, then applicants might wish to respond promptly so that the review process can continue and the application can be approved quickly.  Sometimes the Board asks for clarifications but applicants take weeks to respond.  Alternately, in some cases, resubmission may be necessary.

2. What are the submission requirements?

Applicants are asked to submit the following documents (1 original copy with all signatures plus 3 copies (only for Form 1C, one original copy suffices):

  • Either the Form 1 or a Form 1C (Research Approved at Another Canadian Institution) obtained from the following location.
  • Informed Consent Form/Script
  • All relating supporting documents such as surveys, questionnaires, scales, scripts, draft or final interview questions, invitation letters, letters of support, feedback forms, debriefing forms, advertisements, other research tools such as new, adapted or standardized instruments, etc.) If any materials are used in the research, the material must hold current approval for safe use for humans in Canada and attached to the application that will be vetted for the REB by the SMU Biosafety Officer in the course of the REB's review process.

3. Are there deadlines for submitting ethics proposals?

There are no deadlines for submission to the REB.  Ethics proposals are reviewed shortly after they are submitted. (Your own deadline depends on the day you would like to start your research/recruit participants. Please take the length of the ethics approval process in consideration and contact the Office of Research Ethics for guidance.) While the REB understands in instances it is not possible, it is encouraged that:

  • the submissions are sent to the Office of Research Ethics as soon as possible
  • the researcher contacts the Office of Research Ethics for direction or seeks consultation with a draft application

4. Do all surveys, questionnaires and interview questions have to be submitted to the REB?

Yes. The REB must see all supporting documents relevant and administered in the research in the manner that the participants would see them in order to approve the materials.

5. How do I submit my application package?

You may submit your application package in person or by mail to either:

  1. Office of Research Ethics (Atrium Building, Room 211)
  2. Faculty of Graduate Studies and Research (Atrium Building, Room 210)
  3. Psychology Department Office (McNally South 323)

6. How many copies do I need to submit for review?

For Form 1, 1 original plus 3 copies are required. For 1C (Research Already Approved at Another Canadian Institution) one original copy is required.

7. Can I submit my application package electronically?

All post review revisions of documents may be submitted electronically but the initial application package cannot be submitted electronically.

8. How can I learn more about the ethics approval process?

  • Interpret the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)
  • Review the SMU REB website
  • Call or visit the Office of Research Ethics located in the Atrium Building, Room 211
  • Attend the Research Ethics Education Sessions. Two educations sessions are held for the University Community each academic term.  Please see the "Research Ethics Education" page of our website
  • Request an Education Session for your group/class.
  • Speak with your supervisor
  • Attend the Graduate Student Orientation session at the beginning of the academic year
  • Attend the New Faculty Orientation session at the beginning of the academic year
  • Attend the Faculty of Graduate Studies and Research Faculty Council meetings for SMU REB information and updates
  • Review the Graduate Student Handbook
  • Review the New Faculty Handbook

C. Protocol/ Form 1 and 1C Questions

  1. The application form doesn't seem to be oriented toward the type of research I am proposing. What should I do?
  2. There is no room on the form to insert my answer. What should I do?
  3. What is privacy?
  4. What is the difference between anonymous and confidential data?
  5. What is primary and secondary use of data?
  6. Can I use deception in my research?
  7. Do you have tips on the use of online survey software?
  8. What ethical issues come up in focus group research?
  9. Am I allowed/do I have to pay (compensate) participants in my research?
  10. What are the 5 types of identifying information?
  11. How do I prepare for possible adverse events in my research?
  12. How long am I expected to keep my research data?
  13. Are there any recommendations as to how my data should be stored?

Answers:

1. The application form doesn't seem to be oriented toward the type of research I am proposing. What should I do?

The REB recognizes this challenge that members of various disciplines face. All research and ethics reviews are contextual to the particular proposal at hand.  Some areas of the application form may be more or less relevant to your particular undertaking.  Answer the questions to the best of your ability and contact the Office of Research Ethics for guidance.  If you feel that you would like to insert additional information but are uncertain as to where the information fits correctly in the body of the application, feel free to attach appendices. Answer "n/a" if the question does not relate to your research.

2. There is no room on the form to insert my answer. What should I do?

Feel free to attach appendices if you find that you need more space to provide your answer(s), however there is a full additional page assigned to entering additional information.

3. What is privacy?

As per Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans TCPS 2, Article 5.1-5.7, Privacy and Confidentiality

An individual's right to be free from intrusion or interference by others.

"Privacy refers to an individuals's right to freedom from intrusion or interference by others.  It is a fundamental right in a free and democratic society.  Individuals have privacy interests in relation to their bodies, personal information, expressed thoughts and opinions, personal communications with others and the spaces they occupy.  Research affects these various domains of privacy in different ways, depending on its objectives and methods.  An important aspect of privacy is the right to control of information about oneself.  The concept of consent is related to the right to privacy. Privacy is respected if an individual has an oppotunity to exercise control over personal information by consenting to, or withholding consent for, the collection, use and/or disclosure of information."  

As per Nova Scotia Freedom of Information and Protection of Privacy Act 1993, c. 5, s. 1, 3:

  • “Personal information” means recorded information about an identifiable individual, including:
  • the individual’s name, address or telephone number,
  • the individual’s race, national or ethnic orgin, colour, or religious or political beliefs or associations,
  • the individual’s age, sex, sexual orientation, marital status or family status,
  • an identifying number, symbol or other particular assigned to the individual,
  • the individual’s fingerprints, blood type or inheritable characteristics,
  • information about the individual’s health-care history, including a physical or mental disability
  • information about the individual’s education, financial, criminal or employment history,
  • anyone else’s opinions about the individual, and
  • the individual’s personal views, opinions, except if they are about someone else

4.What is the difference between anonymous and confidential data?

Many researchers use the terms “anonymous” and “confidential” either interchangeably or incorrectly. While anonymity or confidentiality, in other more general contexts, are well understood concepts, in research, they can cause confusion and misunderstanding. Data can be anonymous even if participants are not, i.e. to the researcher.

First, it is important to note that, in any research study; there is no ‘requirement’ for confidentiality or anonymity. What you must do, as a researcher, is keep your promise to the participants regarding how their identity and data are being maintained and disseminated explicitly. The ethical obligation is to follow through and do what you have promised and if there is an alteration in your strategies then to present changes to your participants as new information. 

In the case of “anonymity” even the researcher does not have knowledge of the identity of the participant.  There is no evidence that specific persons participated in the project nor can a connection be made between the identity of the persons and their data. (In these cases the researcher specifically instructs participants not to identify themselves during the course of the involvement in order to preserve anonymity.) 

If the researcher at any point has knowledge of the identity of the participants then the term “confidential” is used. The researcher is promising to keep the identity of the participants confidential and cannot use the term anonymous when making references to the research or in documentation that is provided to participants. 

Consider promises carefully regarding confidentiality of the data and anonymity or respondents. Moreover, in some cases, applicants should consider limitations to confidentiality. Sometimes researchers make promises in the informed consent form but their research methodology makes these promises impossible to fulfill.  For instance, if you plan to interview 3 people, it may be difficult for you to fulfill your promise to participants that their responses will be anonymous (i.e., nobody will ever know what they said). It may be more appropriate for you to promise that the final report of your research will exclude any identifying information, be presented in aggregate format, etc.

Relating Reading: TCPS 2, Article 5.1-5.7, Privacy and Confidentiality

5. What is secondary use of data?

Primary data collection involves direct contact with or observation of one or more people for the purpose of collecting data about them. The REB will examine proposed methods for data collection, travel, storage, dissemination and destruction.

Secondary use of data involves the use in research information or human biological materials originally collected for a purpose other than the current research purpose. Secondary data which contain personal identifiers is subject to ethics review.  The REB will examine whether participants of research have consented to their use of data in the proposed manner and/or the plan in which the researcher is proposing to recontact participants of research.

Secondary use avoids duplication in primary collection and therefore reduces burdens and costs for participants and researchers.  Privacy concerns and questions about the need to seek consent arise, however, when information provided for secondary use in research can be linked to individuals and when the possibility exists that individuals can be identified in published reports or though data linkage.  Privacy legislation recognizes these concerns and permits secondary use of identifiable information in certain circumstances.  Please contact the Office of Research Ethics for guidance if you have questions about secondary use of data.

Relating Reading: TCPS 2. Article 5.4- 5.5.6, Consent and Secondary Use of Identifiable Information for Research Purposes

6. Can I use deception in my research?

Yes, if your research justifies it.  At times the REB receives applications that involve incomplete disclosure or deception along with the submission of a debriefing script. The Board recommends that debriefing takes place as soon as possible once the participant has completed their participation in the study.  The Board will require that all necessary information pertaining deception is clearly demonstrated in the application, a sequential flow of events is provided including the manner in which deception will be unveiled, withdrawal and withdrawal of data options are presented in the consent form and support to participants is in place and available were an adverse event to occur. If the just noted requirements are not included in the application, the Board will seek clarification.

7. Do you have tips on the use of online survey software?

Saint Mary’s University encourages the use of Lime Survey an in-house service that has been launched and is now readily available to the SMU community.  The ITSS department can help with setting up access to the system and the Centre for Academic and Instructional Development has agreed to provide assistance to users with the use of Lime Survey.

The use of American-based Survey Monkey is highly discouraged in Canada for use in research where confidentiality to participants is promised. Protocols indicating the use of “Survey Monkey” must include the following statement in their Informed Consent Form(s):

“Please note that the online survey is hosted by “Survey Monkey” which is a web survey company located in the USA. All responses to the survey will be stored and accesses in the USA. This company is subject to U.S. Laws, in particular, to the US Patriot Act/Domestic Security Enhancement Act that allows authorities access to the records that your responses to the questions will be stored and accessed in the USA. The security and private policy for Survey Monkey can be viewed at http://www.surveymonkey.com/.”

Ensure that you have reviewed the Terms of Use and Terms of Service of the application that you intend to use, demonstrate its details to the SMU REB in your application and inform your participants of such details in your Informed Consent Form/Script.

8. What ethical issues come up in focus group research?

In focus group research, you (the researcher) cannot guarantee that someone in the group will not disclose the contents of the discussion or personally identifying information to others outside the group. You can invite the focus group participants to respect each others' privacy and refrain from discussing any sensitive information outside the group, but you cannot guarantee to participants that someone won't disclose information to members outside of the group. Sometimes participants disclose very sensitive information that they don’t wish others to disclose outside the group. Researchers should advise prospective participants to consider these issues carefully and avoid disclosing sensitive or embarrassing information in this context. Researchers should also avoid making absolute promises about anonymity of the data and confidentiality of the data; these promises need the appropriate qualifiers (e.g., “I assure you that I will not tell anyone that you took part in this study and I will not tell anyone what you, personally, said. However, I cannot promise you that others will not disclose this. I ask everyone to respect each others’ privacy and I ask everyone to promise that what we say in this room stays in this room.” (Note that this is just sample wording. You are free to use whatever wording you see fit.)

9. Am I allowed/do I have to pay (compensate) participants in my research?

You may cover out-of-pocket expenses participants may incur as a result of their participation in your study.  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 them.  The REB considers requests to provide compensation on a case-by-case basis.

10. What are the 5 types of identifying information?

Identifiable information that may reasonably be expected to identify an individual, alone or in combanation with other available information, is considered identifiable information. Also referred to as "personal information".

The following catergories provide guidance for assessing the extend to which information could be used to identify an individual:

  • Directly identifying information - The information identifies a specific individual through direct identifiers (e.g. name, social insurance number, personal health number.)
  • Indirectly identifying information - The information can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g. date of birth, place of residence, or unique personal characteristics.)
  • Coded information - Direct identifiers are removed from the information and replaced with a code.  Depending on access to the code, it may be possible to re-identify specific participants (example:. the principal investigator retains a list that links the participants' code names with their actual name so data can be re-linked if necessary.
  • Anonymized information - The information is irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low.
  • Anonymous information - The information never had identifiers associated with it (e.g. anonymous surveys) and risk of identification of individuals is low or very low.

11. How do I prepare for possible adverse events in my research?

Definition of an Adverse Event:

An adverse event includes, but is not limited to, a complaint or unexpected event that alters the level of risk for the researcher or participants, or a situation that requires a substantial change in approach to a participant(s) based on the TCPS guidelines. It includes any undesirable experience or response reported by a research participant that is/may be related to his/her experience in the study. The adverse event may be emotional, psychological or physiological in nature.

The following are examples of adverse events that must be reported to the REB:

  • Participants showing signs of emotional upset in conjunction with or following interviews or other tasks associated with participation in behavioural or social science studies.
  • Any release, even inadvertent, of research participants' identities or personal information.
  • Unexpected accidents that occur during the course of a research project, e.g. a participant in an exercise study falling off an exercise bike or treadmill.

Researchers must take reasonable steps to monitor adverse events so that they can take action (if appropriate) to minimize the likelihood that other participants in the study will experience the same outcome.

Include information on how you plan to monitor and report adverse events as required by the TCPS 2. Researchers must take reasonable steps to monitor adverse events so that they can take action (if appropriate) to minimize the likelihood or recurrence. You should include language in the informed consent form/feedback/Thank you letter to participants that invites them to contact the researcher if participants experience adverse effects stemming from their participation in your study.

If you conduct research involving SMU students, you may also wish to invite student participants who experience adverse effects resulting from the participation in your study to contact Ms. Sarah Morris, Assistant Director of Student Services (sarah.morris@smu.ca, 420-5601, Student Centre, Room 429). 

Finally, if appropriate for your study, please consider providing participants with information on community resources that might help participants or provide additional information.

Remember, all adverse events of all magnitude must be reported to the REB as soon as possible but no later than one business day following the event.

Relating Reading: SMU REB Policy

12. How long am I expected to keep my research data?

How long researchers wish to keep their data will vary.

Consult your department to learn about the policy on research data retention. For example, the American Psychological Association dictates that data must be retained for 5 years after publication of the study results. For instance, normally the History or Anthropology departments will have different norms. Please consult with your supervisor, department and the Office of Research Ethics for guidance.

13. Are there any recommendations as to how my data should be stored?

Data must be stored securely, whenever possible on campus. Please take steps to ensure that your data is safe, particularly if you/your students are traveling. Stolen data or informed consent forms may compromise participants’ privacy and, in some cases, safety. Please ensure you answer data safety relating questions fully on the application form. (Please make reference to the specific location, including site, building name, room number of where the data will be stored during and post project completion as well as who will have access to the data.)

Tips:

  • Whether the data contains identifiable information or not will also be a factor. 
  • Please not that the REB asks questions relating to destruction not deletion of data.

Relating Reading: SMU REB’s Guidelines on Data Storage

Please feel free to contact IT Security Specialist, Steve Prosser, 491-6400 or steve.prosser@smu.ca for information and guidance on data security.


D. Informed Consent Questions

  1. What is an important tip involving the Informed Consent Form?
  2. What are the mandatory requirements for an Informed Consent Form?
  3. What are the mandatory requirements for an online Informed Consent Form?
  4. Who is considered to be a minor and thus need parental consent?
  5. What is voluntariness?
  6. Who are considered vulnerable persons?
  7. Why is inclusiveness important?
  8. How does one balance harms and benefits?
  9. Can I obtain verbal versus signed consent?

Answers:

1. What is an important tip involving the Informed Consent Form?

Considerably, the ethics review involves ensuring that the application form, the informed consent form and all supporting documents are harmonized.  Please ensure that information from your application form (Form 1) is fully reflected in the informed consent form. When there are discrepancies the REB will require clarification/revision.

2. What are the mandatory requirements of an Informed Consent Form?

Please study the Sample Document for an Informed Consent form found under the "Forms" Section of the REB website.

As per SMU REB guidleliens and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans , TCPS 2, Article 3.2 Consent Shall Be Informed:

Tip: You should be using this section as a checklist.

  • The identity of the researcher (full names of all researchers, designation, email, phone number);
  • The name and address of the institution;
  • The title of the study;
  • SMU REB File number
  • Information that the individual is being invited to participate in the research project;
  • A comprehensible statement of the research purpose;
  • The expected nature of participation;
  • Description of research procedures;
  • An explanation of the responsibilities of the participant;
  • A comprehensible description of reasonably foreseen harms and benefits that may arise from participation;
  • A statement explaining what the researcher will do were an adverse event to occur;
  • The expected duration of participation;
  • An assurance that prospective participants are free not to participate;
  • A statement that participants have the right to withdraw without prejudice to pre-existing entitlements and will be given continuing and meaningful opportunities for deciding whether or not to continue to participate;
  • A statement that new information will be provided in a timely manner whenever such information is relevant to a particpant's decision to continue or withdraw from participation;
  • The possibility of commercialization of research findings;
  • An indication of who will have access to information collected on the identity of participants;
  • Descriptions of how confidentiality will be protected;
  • Anticipated uses of data;
  • The presence of apparent or actual or potential conflict of interest on part of the researchers, their institutions or sponsors;
  • The identity of the qualified designated representative who can explain scientific or scholarly aspects of the research;
  • Standard wording that pertains to SMU REB certification and includes the SMU REB Chair’s  contact for questions pertaining to ethical matters;
  • Information on the appropriate resources outside the research team to contact regarding possible ethical issues in the research;
  • Information on the circumstances under which the researcher may terminate the participant's participation in the research;
  • Information on any costs, payments reimbursement for expenses or compensation for injury;
  • The ways in which the research results will be published;
  • How the participants will be informed of the results of the research;
  • In cases of randomized trials, the probability of assignment to each option;
  • For research on biomedical procedures, including health care interventions: information about (a) foregoing alternative procedures that might be advantageous to the subject, (b) which aspects of the research involve the use of procedures that are not generally recognized or accepted; and, (c) particularly in trials of therapeutic interventions, the care provided if the potential subject decides not to consent to participation in the study.

3. What are the mandatory requirements for an online Informed Consent Form?

The requirements for an online Informed Consent Form are the same as for a paper copy.  Please refer to the anwser to the Question #2 above.

4. Who is considered to be a minor and thus needs parental consent?

All University students are considered to be sufficiently mature to make their own decision about research therefore no parental consent is required.  Please refer to the SMU REB's Age Consent Guidelines. Refer to policies and guidelines that the prospective participants may fall under and demonstrate the requirements to the REB in your application.

5. What is voluntariness?

Voluntariness involves self governed, self determined action. Free and informed consent must be voluntarily given, without manipulation, undue influence or coersion.

Relevant Reading: TCPS 2, Article 3.1 Consent Shall Be Given Voluntarily

6. Who are considered vulnerable persons?

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

Relevant Reading: TCPS 2, Article 3.9-3.10, Capacity

7. Why is inclusiveness important?

No segment of the population should be unfairly burdened by the risks or only certain population pools receive the benefits of research.  Inclusiveness also ensures that individuals or groups who may benefit from advances in research are not discriminated against or neglected. Part of the REB’s mandate is to ensure appropriate inclusion and ensure research does not inappropriate exclude individuals. When selecting your subject pool justify your reasons for your eligibility/exclusion criteria in your application.

8. How does one balance harms and benefits?

The foreseeable 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 risk of even greater harm.  Participants must not be subjected to unnecessary risks. Should adverse events result from research, the research has an obligation to assist the participant in reducing or minimizing those effects. 

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

Relevant Reading: TCPS 2, Article 1.1, Core Principles

9. Can I obtain verbal versus signed consent?

A signed consent form may not always be appropriate.  Please demonstate to the REB the reasons for wanting to obtain verbal versus signed consent.

Relevant Reading: TCPS, Article 3.12, Consent Shall Be Documented


E. Supporting Documents

  1. What is an important tip involving supporting documents?
  2. What should I include in an information letter/email to potential participants?
  3. What should I include in a participant feedback letter?
  4. What should I include in a debriefing letter?
  5. What is the difference between a feedback and a debriefing letter? Which one should I use?
  6. What should be included in an advertisement for participants?

Answers:

1. What is an important tip involving supporting documents?

Considerably, the ethics review involves ensuring that the application form, the informed consent form/script and all supporting documents are harmonized.  Please ensure that information your application is fully and correctly reflected in your consent form and your supporting documents.  When there are discrepancies, the SMU REB will require clarification/revision.

2. What should I include in an information letter/email to potential participants?

The purpose of an information letter is to introduce yourself to prospective participants, explain your research and ask individuals to contact you if they are interested in taking part in your study.

At the minimum, an information letter should contain:

  • The researchers’ full names,designations and contacts;
  • The title of the research;
  • The institutions name and address;
  • The purpose of the research;
  • Statement of invitation;
  • Eligibility criteria;
  • The explicit details about what participants are being asked to do;
  • Description on the risk and benefits of the research;
  • The anticipanted duration of involvement in the research;
  • Statement that the participation is voluntary;
  • Information on anonymity and confidentiality;
  • Information on compensation;
  • Information on the right to withdraw without prejudice or penalty;
  • Indication on who they can contact if they have questions about the study/to express interest;
  • SMU REB File number.

3. What should I include in a participant feedback letter?

The purpose of a participant feedback letter is to recap the details of the research, to thank participants for their participation and to leave participants with a contact should they have any questions and/or comments about the study, would possibly like to withdraw their data and leave them with contact information were they to experience an adverse event.  Please see the Sample Participant Feedback Letter on the “Forms” section of the REB website.

4. What should I include in a debriefing letter?

The purpose of a debriefing letter is to explain to participants that the research included the use of deception.  Please explain the true nature and purpose of the research, provide your contact, your supervisor’s contact (if applies) and contacts of your professional resources you have designated to further manage possible adverse events. Components of a debriefing form also include the components of a feedback letter (please refer to the previous Question #3, “What should I include in a participant feedback letter?”) unless you choose to have separate debriefing and feedback documents.

5. What is the difference between a feedback and a debriefing letter? Which one should I use?

A debriefing letter is used when deception was used in a research.  The purpose of the debriefing letter is to explain to participants that the research included the use of deception.  Normally this is done verbally n person immediately following the research activity.  In addition, a debriefing letter is provided to the participant.  When there is no deception in the research a debriefing letter has no puropse.  Whether there was deception in the research or not, either way a feedback letter is provided to participants as its purpose is to thank participants for their participation and the leave participants with a contact should they have any questions and/or comments about the study, would possibly like to withdraw their data and leave them with a contact information were they to experience an adverse event.

6. What should be included in an advertisement for participants?

The information in advertisements should be limited to information that the prospective participant needs to determine their eligibility and interest.

Generally, the requirements for inclusion in advertisements are as follows:

  • Study title
  • Name and address of the investigator and research facility
  • How to contact the researcher to express interest (email address and/or phone number)
  • Study site location(s)
  • Purpose of the study
  • Basic eligibility criteria
  • Time commitment
  • Compensation (optional)
  • SMU REB File number