Initial Research Ethics Review

Initial Research Ethics Review

The initial research ethics review stage refers to new applications submitted for research ethics review and clearance that have not yet been cleared by the REB Chair.  Per TCPS 2, once a research study has received clearance from the REB Chair and its Certificate of Research Ethics Clearance, requests are then referred to as "Continuing Research Ethics Review" requests during the remaining lifecycle of the research.  If you already hold a clearance, please visit the continuing research ethics review section of this FAQ.

Initial Review FAQ Categories:

  • A. Application Preparation
  • B. Application Submission
  • C. Form 1 and Form 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 clearance?
  3. What type of research does not require REB review?
  4. Who determines what research should be cleared?
  5. Do institutional surveys require REB clearance?
  6. What is the process for having my research cleared?
  7. What are the requirements to obtain research ethics clearance?
  8. What is the process if my research has already been cleared 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 cleared elsewhere reviewed at the SMU REB as well?
  11. I am conducting research in another country.  Is my SMU REB clearance all I need?
  12. How do I prepare an international research application?
  13. What is the proportionate review approach?
  14. When can I submit a new application or request to the REB?

Answers:

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

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 and 2010. The newest version is the TCPS 2, December 2014 and all are asked to refer to the online version of the TCPS as its official version, that is time to time further updated in the online format.  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

Contents of the TCPS 2:

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

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 you may contact the Chair of the REB at reb.chair@smu.ca 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. Please seek guidance from the REB Officer (ethics@smu.ca) or REB Chair (reb.chair@smu.ca) whenever necessary.

3. What research does not require REB review?

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 Exempt Review form 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.)

4. Who determines what research should be cleared?

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. 

5. Do institutional surveys require REB clearance?

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 from the REB Chair at reb.chair@smu.ca.

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

  1. Applications for initial research ethics 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 administrative review.
  2. An email receipt including the SMU REB File number is sent to all investigators.  Applicants are asked by the REB to refer to this SMU REB File number in all subsequent communication.
  3. The application is reviewed at the Office of Research Ethics.
  4. Two committee members of the REB review the application and send their recommendations to the Office of Research Ethics.
  5. The REB Chair reviews the application 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 working on 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 application 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.

Applicants are advised to review the REB's standard operational procedures document Completing Requests for Research Ethics Review Involving Humans.

"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 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 an application requires a full board review wherein the full committee membership will review the proposal.  Normally, a full review occurs in instances wherein the research poses more than minimal risk to its participants.  Applicants will be notified if this is the case.  Applications requiring a full 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 REB 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.

7. What are the requirements to obtain research ethics clearance?

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.

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

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 complete a Form 1C- Application for Ethics Review of Research Involving Humans Currently Cleared at Another Canadian REB, and ensure that a copy of the other institution’s ethics clearance (letter or certificate) attesting the clearance is included, as well as all correspondence (between the Principal Investigator and the other Canadian REB Chair) regarding the original submission.  In this case, the research will only be reviewed by the Research Ethics Officer and the REB Chair.  Ensure that you attach all required documents to avoid any delays and follow the instructions listed on top of the application form.  It can be a common mistake that applicants 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 communicaiton or "review" that the other REB conducted, that the SMU REB is being asked to accept.  Not including all required documentation would result in delay in processing the application.

9. 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 End of Study Report review request, Form 5) please consult with the Office of Research Ethics. Please make reference to the previously cleared research by referencing your previous SMU REB file number.

10. I am a new student/faculty/staff member at Saint Mary's University.  Do I need to have my research already approved at another institution be reviewed at SMU?

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

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

No. You may need to obtain additional approval(s) local approvals, to include a research ethics review body, in country that you are conducting the research.  Please make sure that any relevant certifications are obtained and are demonstrated to the SMU REB within the body of the application form at the section it is requested. If you would like any additional information or consultation with respect to this requirment, 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

The REB application directly covers Article 8.4's requirements. To understand the application of the entailed research ethics principles and how to best demonstrate to the REB how participants will be protected in the research and provided with full information of the research proposal using a comprehensible and meaningful consent process, please review Article 8.4.

12. How do I prepare a multi-jurisdictional or international research application?

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 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, 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 10 am to noon. Feel free to book a slot to discuss your questions and draft work.

13. What is the proportionate review approach?

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 will be scrutinized. 


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.

14. When can I submit a new application or request to the REB?

The REB accepts requests at any time during regular university business hours.  If you have any questions, please contact the office for guidance at ethics@smu.ca or (902) 420-5728.


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 research ethics proposals?
  4. Do all surveys, questionnaires and interview questions need to be submitted to the REB for review?
  5. How do I submit my application?
  6. How can I learn more about the research ethics review process?
  7. When can I submit a new application or request to the REB?

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 for guidance. Office hours are Tuesday and Thursdays 10 am to 12 pm.  General tips involve following all the instructions on top of each request form.

 

  • 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 are listed
  • Faculty members must read the applications prepared by students carefully
  • Make sure the forms are signed by all researchers named in the application that are affiliated to SMU
  • Make sure all appendices that have been checked off that you are asking to be reviewed are included in all the packages. Not including research documents will cause delays
  • 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 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. 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 demonstrate the sequence and phases of events as proposed to occur in the research.  Remember the REB also becomes one of the designated contacts to research participants throughout the lifecycle of 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 as easily as in the initial 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, Chapter 3. 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 cleared quickly.  Sometimes the Board asks for clarifications but applicants take weeks to respond.  Alternately, in some cases, resubmission may be necessary if the research has not been demonstrated sufficiently.

2. What are the submission requirements?

Applicants are asked to submit the following set of documents:

  • Either: A Form 1 or a Form 1C application form
  • An informed consent form or script
  • All relating supporting documents that the research team is asking to be reviewed as it relates to their research.  These documents may include items 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 REB clearance.  
  • Research applications must be submitted to the REB by faculty (i.e., full-time, part-time, and adjunct), librarians, and post-doctoral fellows, unless the aforementioned are also students.  All students must submit their applications to the REB via a faculty supervisor.  Staff members must submit applications with a faculty supervisor or demonstrate to the REB that they have sufficient expertise to conduct a particular type of research independently.

3. Are there deadlines for submitting research ethics proposals?

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 research/recruit participants. Please take the length of the ethics approval process in consideration.)

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

  • the completed research ethics proposals 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 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 applications and requests at any time during regular university business hours.  If you have any questions, please contact the office for guidance at ethics@smu.ca or (902) 420-5728.

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

Yes. The REB must review all documents relevant and administered in the research in the manner that the participants would see them.

5. How do I submit my application?

Applications are sent to ethics@smu.ca.

6. How can I learn more about the research ethics review process?

  • Interpret the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) and complete the free online tutorial
  • Review the SMU REB website
  • Call or visit the Office of Research Ethics located in the Atrium Building, Room 202 (ethics@smu.ca)
  • 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

7.  When can I submit a new application or request to the REB?

The REB accepts applications and requests at any time during regular university business hours.  If you have any questions, please contact the office at ethics@smu.ca or (902) 420-5728.


C. Form 1 and Form 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 to or 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?
  14. Are there any recommendations about how to communicate that data might be shared with others?

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.  Research ethics reviews are contextual to the particular proposal at hand.  Feel free to include details of your research using additional sections of the forms that are provided or additional documents as you need.  Feel free to bring your circumstances to our attention and contact the Research Ethics Officer for guidance while you are working on your draft application.   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 appendices. Answer "n/a" or "no", 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' 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

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.  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

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 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

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 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.

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 SAS lab provides 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.

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.

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 to or 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?

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.

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 the Assistant Director of Student Services (420-5601, Student Centre, Room 429). 

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

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

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.

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 become a factor.

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

14. Are there any recommendations about how to communicate that data might be shared with others?

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.


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 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 may or may not fully match the REB's sample.  It is important that the components of an informed consent form are in place, not the exact format. The REB's sample consent for is a sample aimed to guide and teach you, not to direct of prescribe.  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 your research. What may work for your research may or may not work for someone else's, vice versa and this is commonly the case.  Researchers are best situated to design a suiting consent form to their potential participants and the REB can contribute to this preparation.  The TCPS clearly lays out what items are required in a consent form in Canada at this time 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 is okay and is easily achieved by submitting a change to cleared research request, when the time arises.  As you learn about what benefits your research offers further and what risks may be involved, etc., you will need to adjust the consent form and communicate it to current and potential participants of your research in a clear and meaningful way.

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

As per 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 participant'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.

Feel free to study the sample document for an Informed Consent Form found under the "Forms" Section of the REB website or reach out for guidance and discussion.

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 any paper copy.  Please refer to the answer to the Question #2 above.  Sometimes an online consent form is said to collect implied consent in that if a research participant completes an online survey, for example, it is understood that the participant agreed to the terms of the consent form by, for example, clicking "okay", or alike statement.

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 coercion.

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

6. Who are considered vulnerable persons?

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

Relevant Reading: TCPS 2, Chapter 3. Article 3.9-3.10 Decision Making 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 participant pool justify your reasons for your eligibility and your 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, Chapter 1. B. Core Principles

9. Can I obtain verbal versus signed consent?

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


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.  It is helpful to adopt a participant-centred perspective where the participant's experience with the material is considered. 

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 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.

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 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.

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