Initial REB Review Guidance

In order for a request to be registered for initial REB review, the SMU REB Standard Operating Procedure (SOP) REB Review Criteria must be met.  The criteria is listed in the REB's short standard operating procedures document.  When the criteria is met, the request will receive a SMU REB file number, and the review process will begin.  A request receipt will be issued that will detail SMU REB file number and confirm that review work is under way!

When "research" as defined by the TCPS 2 involves human participants, the Government of Canada's Interagency Advisory Panel on Research Ethics (PRE)'s policy 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 Tri-agency 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. This requirement relates to all SMU affiliated persons, faculty, students and staff as well as those who hold affiliation to the University through the Board of Governors.

The Panel of Research Ethics (PRE) is a body of external experts established in November 2001 by three Canadian research agencies: (often referred to as the "Tri-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 previous versions from 1998, 2010, 2014, and 2018. The newest version is the TCPS is the 2022 version.  The online version of the TCPS 2 (2022) is the official version.  The "Glossary" section at the end of the Policy provides helpful definitions of research terminology.

The guidelines in this Policy are based on the following 3 core principles:

• Respect for Persons
• Concern for Welfare
• Justice

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". 

It is necessary to understand that any research, whether the research is funded or unfunded, 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 and clearance.  If you are uncertain about whether your activity is considered "research" and whether it requires research ethics review or not, please review the TCPS 2's relating article, TCPS 2, Chapter 2. A. Scope of Research Ethics Review or submit a Request for Exemption Review to assist with the determination.  The REB Chair will either ask you to submit an application to the REB or let you know that the proposal is exempt from REB review can even provide you with a letter of exemption for your records should you need.

Reminder:

Any research involving living human participants or human biological materials (including human embryos, fetuses, fetal tissue, reproductive materials and stem cells) must be submitted to the University’s Research Ethics Board. 

Pilot studies (i.e., endeavours intended to inform the design of another study by collecting data from humans) require REB review prior to any undertaking.  Research review is not required before making contact with any individual or community as long as the purpose is to establish a partnership and does not involve data collection for the purpose of the research.

No research with human participants shall begin before research ethics clearance is received from the University’s Research Ethics Board. Research protocols must have a valid Certificate of Research Ethics Clearance/Continuation. This includes piloting and the recruitment stages of the research project.

TCPS 2 Articles 2.2 - 2.6 provide guidance surrounding research and activities that might not require REB review.  An important item to note is that a determination that research is the intended purpose of the undertaking is key for differentiating activities that require ethics review by an REB and those that do not.  It is also important to note that choice of methodology and/or intent or ability to publish findings are not factors that determine whether or not an activity is research requiring ethics review.

The REB Chair can provide the formal decision, whenever needed.  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 with human participants per federal guidelines, that they obtain the formal review and clearance from their REB, prior to the recruitment of any participants, understanding that there exists no options for retrospective clearance. When in doubt, please submit a Request for Exemption Review to ethics@smu.ca. 

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

• 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 departments normally engaged in the collection, maintenance and analysis of such records does not require REB clearance.  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 participants and are conducted by students on other members of the class as exercises to learn how to conduct research (not intended for research rather for learning purposes);
• 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 publicly 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 participants;
• Research involving a person no longer living (unless you question other people about the deceased individual.)

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. 

If the survey is used to collect only factual information that is publicly available, then ethics clearance may not be necessary.  If the survey includes any questions asking for the opinions or interpretation by the participant, then ethical clearance may be required.  Please seek further clarification if needed via a Request for Exemption Review. 

1. Request for initial REB review are sent to ethics@smu.ca.  If information or documents are missing the applicant is asked to provide the information before it can be registered, and before it can receive a proper administrative review.
2. An email receipt including the SMU REB File number is sent to all investigators.  Investigators are asked by the REB to refer to this SMU REB File number in all subsequent communication.
3. The request is reviewed at the Office of Research Ethics.
4. Two committee members of the REB review the request and send their recommendations to the Office of Research Ethics.
5. The REB Chair reviews the request and the recommendations from the committee reviewers.
6. The REB Chair sends email communication including the recommendations from the reviewers to the investigator(s).
7. If clarifications are requested, the investigator(s) respond to the REB Chair assigned to their file.  It is expected that investigators demonstrate the details of their undertaking to the REB as the subject matter experts in the area. In the case of student research, all communication must be submitted by the faculty supervisor, requests from students only cannot be processed.
8. Any changes are checked by the REB Chair.  The request is cleared or further clarifications are requested.
9. The REB Chair sends an email communication conveying the clearance to the investigator(s). At this time the investigator(s) may begin recruiting participants.
10. The REB Chair signs the Certificate of Research Ethics Clearance.
11. The Certificate of Research Ethics Clearance 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, if applicable.  A copy of the certificate is maintained in the REB master file of the research.

Investigators are advised to review the REB's standard operational procedures document for completing requests to the REB, before submitting a request for REB review.  

"Delegated” versus “Full Board” review:

Most requests for initial REB review are assessed using a delegated review process which involves having the request reviewed by the REB Chair and two committee 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 a request requires a full board review wherein the full committee membership will review the current research plan.  Normally, a full review occurs in instances wherein the research poses more than minimal risk to its participants.  Investigators will be notified if this is the case.  Requests requiring a full Board review are assessed during a meeting of the REB.   In keeping with 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 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 making its decision. (TCPS 2, Article 6.13 is helpful guidance involving the decision making process.)  If the research team choses to be present a the full Board meeting, if the research proposal is a student research proposal, the faculty supervisor of the research must be present together with the student investigator.

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 writing in a timely fashion once all areas of the proposal have been discussed.

Whether a research is funded or unfunded, in order to obtain a Certificate of Research Ethics Clearance from the Saint Mary’s University REB; the research must comply with the TCPS 2.

Some multi-site research projects involving multiple institutions may already have current clearances from another institution, meaning another Canadian REB has granted research ethics clearance for the research and the clearance is "current", meaning it has present day clearance.  In this event, researchers submit a Demonstration of the Current Research Plan for Initial REB Review Currently Cleared by Another Canadian REB.

Researchers ensure that a copy of the other institution’s ethics clearance (letter or certificate) attesting the clearance is current, as well as all correspondence (between the Principal Investigator and the other Canadian REB Chair) regarding the original research plan submission.  In this case, the research will only be reviewed by the Research Ethics Officer and an REB Chair.  Ensure that you attach all required documents to avoid any delays and follow the instructions listed on top of the request form.  It can be a common mistake that researchers don't include all communication between the Principal Investigator and the other Canadian REB Chair and only include the certificate or letter of clearance, but not the communication or "review" that the other REB conducted and that the SMU REB is requested to accept.  Not including all required documentation would result in delay in processing the request.

In the event that your research has been closed by the REB (via the End of Study Report) please consult with the Office of Research Ethics to confirm the proper next steps. Please make reference to the previously cleared research by referencing your previous SMU REB file number.

Yes. As a person becoming affiliated with SMU for any ongoing or new research projects will need to be reviewed and cleared by the home SMU REB.

Please ensure to use the correct request form, requesting initial REB review for a research plan that is currently cleared by another Canadian REB.

Maybe and no. You may need to obtain additional local-to-the-research clearance(s) or license(s), or from a local research ethics review body, in the country where the research is conducted.   Please make sure that any relevant certifications are obtained and well demonstrated to the SMU REB on the request form.

If you would like any additional information or consultation with respect to this requirement, please reach out to the Research Ethics Officer at ethics@smu.ca for information and guidance. Helpful relating TCPS 2 reading is Chapter 8-Multi-jurisdictional Research, especially Section B. Ethics Review of Research Conducted outside the Institution.  Additional resources are provided in the reference section, at the end of Chapter 8.  

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

To make things simpler, the REB request form directly covers Article 8.4's requirements. To understand the application of the relating research ethics principles and how to best demonstrate the plan to the REB about how participants will be protected in the research and how they will be provided with full information about the full details of the research and the need for creating a type of consenting approach that is comprehensible and meaningful to the research participants, please review Article 8.4.

When 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 request form):

• 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, Chapter 8. B. Ethics Review of Research Conducted Outside the Institution

To obtain information or guidance relating to how to best prepare your application, please contact the Research Ethics Officer for guidance at ethics@smu.ca. Office hours are Tuesdays and Thursdays from 1- 3 pm. Feel free to book a slot to discuss your questions and draft work.

The ethics review process involves a proportionate review approach. The SMU REB is committed to employing a strict adherence to the proportionate approach. The greater the risk for participants, the more the proposed research is scrutinized. This means that a plan to mitigate any known risks is in place.

The REB accepts requests at any time during regular university business hours.  

A consultation with the Office of Research Ethics prior to submission of the current research plan may save you time and extra work.  Researchers are encouraged to visit the Office of Research Ethics to seek direction if there are questions about the preparations for support and guidance. Office hours are Tuesday and Thursdays 1-3 pm.  General tips involve following all the instructions on top of each request form.

 Most frequent items causing delays with processing the request:

• Ensure that the request form 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 are listed
• Faculty members must read the applications prepared by students carefully
• Make sure the forms are signed by all SMU-affiliated researchers
• Make sure all appendices submitted for initial REB review are included in the submission. 
• Please make sure that the applications are well written and fully answer the questions
• Ensure and double check that your submission is free of typographical, spelling and grammatical errors
• Ensure that there is sufficient detail presented on the research’s purpose needed for the REB committee 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. Current research plans 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 REB reviewers are less likely to have general or specific questions.  It is helpful to demonstrate the sequence and phases of events as proposed to occur in the research.  Remember the REB also becomes one of the designated contacts for the  research participants throughout the lifecycle of the research and needs to understand the research fully
• Investigators would be wise to anticipate potential ethical dilemmas that may arise in the course of their research and address how they plan to handle them were any adverse event to occur 
• Please study the sample Informed Consent Template while preparing the draft informed consent process
• If the Board asks for clarifications, researchers might wish to respond promptly so that the review process can continue and the request can be cleared quickly.  Sometimes the Board asks for clarifications but applicants take weeks, even months, to respond as they are unsure about the research plan.  Alternately, in some cases, resubmission may be necessary if the research plan the REB is requested to review and clear has not been demonstrated sufficiently

Researcher need to review the Board's standard operating procedure for completing requests to the REB.  This short documents covers the review criteria that must be met in order for a request to received review form the REB. 

There are no deadlines for submission to the REB.  Requests may be submitted during regular university business hours.  Research ethics proposals are reviewed shortly after they are submitted. (Your own deadline depends on the day you would like to start your recruitment of  research participants. Researchers are advised to give themselves a total of 6-8 weeks to go through the process, although it may be quicker.)

While the REB understands in instances it is not possible, it is encouraged that:

• the Board's short standard operational procedure for completing requests to the REB is reviewed
• the completed current research plans are sent to ethics@smu.cas as soon as possible
• the researcher contacts the Office of Research Ethics for direction or seeks consultation with a draft request prior to submission of an application
• all requests are submitted by the faculty supervisor for student research
• instructions on top of each request form are carefully followed in order to avoid delays

Please note the REB accepts requests at any time during regular university business hours.  If you have any questions, please contact ethics@smu.ca

Yes. The REB must review all documents relevant and administered in the research in the manner that the participants would see them. Research materials are part of the current research plan. 

Requests for initial REB review are sent to ethics@smu.ca.

Requests for continuing REB review are sent to ethics.continuingreview@smu.ca. 

• The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 
• Completing the free online tutorial (CORE) 
• The SMU REB website
• Call or visit the Office of Research Ethics located in the Atrium Building, Room 210, Office hours: Tuesday and Thursdays 1- 3 pm 
• 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 biannually
• Review the Graduate Student Handbook
• Review the New Faculty Handbook

The REB recognizes this challenge that members of various disciplines face.  Research ethics reviews are contextual to the particular proposal at hand.  Feel free to include details of your research plan using additional sections of the forms that are provided or additional documents as you need and answer "yes" and "no" throughout the request form.  Feel free to bring your circumstances to our attention. 

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 or current intentions as you know it.  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 unlimited appendices. The composition of a research master file and the plan is up to researchers. 

Feel free to attach appendices if you find that you need more space to provide your answer(s).  There is a full additional page assigned to entering additional information at the end of the request form. 

Please feel free to reach out to the University's Privacy Officer for further information. 

As per Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans TCPS 2, Article 5.1-5.7, Privacy and Confidentiality, privacy is an individual's right to be free from intrusion or interference by others.

"Privacy refers to an individuals' 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 opportunity 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 origin, 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

The best quick and very useful source of TCPS 2 information on the types of data researchers may be planning to collect is located in the Glossary section of the TCPS 2, "i", "Information Types".  Understanding what type of information may be collected allows for a common understanding and language between participants, researchers and REBs.  

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.  It remains of outmost importance that research participants can make sense of what the research encompasses and that the research plan follows the promises that were made to participants.

First, it is important to note that, in any research study; there is no requirement for confidentiality or anonymity.  What researchers must do, is keep their promises 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 down the line.

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 because there was a point when the identity was in fact known by the researcher.

Consider promises carefully regarding confidentiality of the data and anonymity of 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, Chapter 5. Privacy and Confidentiality

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 of research results, data file sharing and destruction or archiving if applicable.

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 re-contact 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. 

Relating Reading: TCPS 2, Chapter 5. D. Consent and Secondary Use of Identifiable Information for Research Purposes

Yes, if your research plan justifies it.  At times the REB receives requests 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 or script and support to participants is in place and available were an adverse event to occur.  If the just noted requirements are not included already in the application, the Board will seek clarification.

Saint Mary’s University encourages the use of Qualtrics, an online survey service that is available to the SMU community. Please submit a request to the Web Team if you have any questions or would like to set up a 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 review request and inform your participants of such details in your Informed Consent Form/Script.

Overall, researchers use various types of software to collect their data and communicate the relating details of these systems to their participants during the consenting process.  The larger questions revolve around understanding the system you intend to use so you can have a dialogue about the system and its details to potential or current participants of research, and thereby be able to demonstrate it to others, such as the REB committee.

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.)

You may reimburse 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.

Understanding the type of data you would be handling is essential for both during the design and active research stages. Identifiable information that may reasonably be expected to identify an individual, alone or in combination with other available information, is considered identifiable information. Also referred to as "personal information".  Researchers find reviewing the following definitions, from the TCSP Glossary section, very useful:

The following categories 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.

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 the Assistant Director of Student Services. 

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.  Reporting and discussing adverse events with the REB may or may not cause a change to the research design. 

Relating Reading: SMU REB Policy

How long researchers wish to keep their data will vary depending on their departmental regulation or practices as well as any obligatory responsibilities they may have in connection with their sponsor or funder of the research.

Applicants need to consult with their departments to learn about the policy on research data retention, etc.  For example, the American Psychological Association dictates that data must be retained for 5 years after publication of the study results for instance. History or Anthropology departments will have different norms, etc.  Please consult with your supervisor, department, etc. when considering what promises to make to research participants.

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 become a factor.

Please feel free to contact IT Security Specialist at 491-6400 for information and guidance on data security.

Researchers should keep their options open in terms of sharing data files.  Increasingly, scientists are being asked to shar their data files.  Not sharing could be a roadblock for publication, reducing the benefits of the study.   To maximize benefits, researchers should keep that door open.  To keep the door open, they need to tell participants of their research what their data sharing intentions, obligations may be or the possibilities upfront.  It may be the case that researchers may need to share their data files with other researches, journal editors, or scholars for the purposes of advancing science or the knowledge in the field and need to include a relating statement into their informed consent form or scripts.

Considerably, the ethics review involves ensuring that the request form, the informed consent form/script and all supporting documents are harmonized.  Please ensure that information from the request form, that demonstrates the current research plan, is fully reflected in the informed consent form/script so the research is fully transparent through the consenting process. 

When there are discrepancies the REB will require clarification or revision.  The final version of the consent form/script may or may not fully match the REB's sample template. Consent processes must align with what the TCPS 2 requires in Article 3.2. and what is believed to be most comprehensive and meaningful to the research participant(s). 

It is important that the components of an informed consent form/script are in place, not the exact format however it generally makes sense to include the details of the study such as the purpose, expectations, risk and benefits prior to compensation, methods for result dissemination and contacts.  The REB's sample template for is only a sample aimed to guide and teach, not to direct of prescribe a draft or a final version. 

The Research Ethics Officer is happy to help you with your questions or discuss your draft consent forms together!

There are general tips for consent forms but it will be guided by the individual research plan.  What may work for your research may or may not work for someone else's, vice versa and this is more often than not the case.  Researchers and research supervisors are best situated to design a suiting consent form to their potential participants and the REB can contribute to this preparation. In this process, it may be most important to leave room for the research participant to contribute to the design, thereby offering them to be a "participant" in the research fully.  The participant may be the best person to achieve the best design. 

The TCPS clearly lays out the Canadian minimum requirement of a consent process presently in Article 3.2.. Consent Shall Be Informed.  Remember, during the course of the research you may learn new ways to make your consent form better and wish to make changes at such time. This can be updated any time, and is easily achieved by submitting a change to cleared research request, when such time arises.  Research materials may be altered whenever needed.  As you learn about what benefits your research offers further and what risks may be involved, etc., you will like to adjust the consent form and communicate it to current and potential participants of your research in a clear and meaningful way. The REB will hold a record of all versions of the consent process within the master file of the research. 

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans , TCPS 2, Article 3.2 Consent Shall Be Informed provides a listing of the required items. 

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 request. 

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

Relevant Reading: TCPS 2, Chapter 3. A. Article 3.1 Consent Shall Be Given Voluntarily

Those who lack competence or decision-making capacity are considered vulnerable. 

Relevant Reading: TCPS 2, Chapter 3. C. Decision Making Capacity, Article 3.9-3.10 

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 participant pool justify your reasons for your eligibility and your exclusion criteria in your application.

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, Chapter 1. B. Core Principles

A signed consent form may not always be appropriate.  Please demonstrate to the REB the reasons for wanting to obtain verbal versus signed consent and provide a copy of the informed consent script.

Relevant Reading: TCPS 2, Chapter 3. D. Consent Shall Be Documented

Considerably, the ethics review involves ensuring that the current research plan, the informed consent form/script and all supporting/research documents are harmonized.  Please ensure that information in the review request is fully and correctly reflected in your consent form and your supporting/research documents.  When there are discrepancies, the SMU REB will require clarification/revision.  It is important to adopt a participant-centered perspective wherein the participant's experience with the material is considered. 

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

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. 

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. 

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 in 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 purpose.  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 or think of additional items they may wish to tell you at a later time.

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