This form is ONLY to be used for research projects which are course based.
NOTE – IF YOU ARE ENGAGING IN COURSE BASED RESEARCH OUTSIDE OF CANADA, YOU MUST FILL IN THE REGULAR REB-APP
Section A
“To be eligible to receive and administer research funds from the Agencies, institutions must agree to comply with a number of Agency policies set out as schedules to a Memorandum of Understanding (MOU) between the Agencies and institutions.2 This Policy is referenced in Schedule 2 to that MOU. Institutions must therefore ensure that research conducted under their auspices adhere to this Policy.” [TCPS2, p.5]
Section A, Question 3
Include everyone who will have access to identified data or direct contact with the participant.
The Instructor is defined as the individual who has ultimate responsibility for the conduct of the study.
The Instructor will receive all communications from the Ethics Office, and can opt to
If you need more than 8 rows, press TAB in last box, a new row will be generated.
Section A, Question 4
The REB will attempt to respond to urgent timelines, but cannot promise that a response can be provided in less than the normal two week period.
Section A, Question 5
In order to determine the level of risk to the participants, the REB needs to determine the experience that the principal investigator, and the rest of the research team, have with the procedures being proposed – whether they are typical of the social sciences and humanities, or of the natural and physical sciences.
Section A, Question 5.1
Examples of the type of response being sought here include
Ø Experience with overseas research
Ø Experience with focus groups
Ø Experience with in-depth interviews
Ø Experience working with vulnerable groups
Ø Experience collecting personal health information
Ø Experience with venipuncture
Ø Experience administering galvanic vestibular stimulation
Ø Experience with chiropractic techniques
Ø Experience facilitating workshops.
Ø Experience as a personal trainer.
Section A, Question 5.2
The REB needs to know what each member is doing. Is the student taking blood or is the phlebotomist? Is the faculty member leading the focus group, or someone hired to do so from outside the research team? Attach any pertinent formal qualification. Examples of the kinds of qualifications/certificates being referred to here are Good Clinical Practices training, Medical Laboratory Technologist Certificate, training in Clinical Psychology, etc.
Indicate ‘yes’ under “Contact with Identified Data” if the individual will be involved in the collection, entry, and/or analysis of the data, or have access to the data.
Indicate ‘yes’ under “Direct Participant Contact” if the individual will be in direct contact with the research participant at any point during the research process. This contact does not need to be face-to-face, but includes electronic or other communication.
Indicate ‘yes’ under “CORE Tutorial Completed” if the individual has taken the CORE tutorial on the TCPS2. This tutorial provides an applied approach to the guidance provided in TCPS 2. This self-paced course is a media-rich learning experience that features interactive exercises and multi-disciplinary examples. CORE consists of eight modules ranging from Core Principles to REB Review. It is designed primarily for the use of researchers and REB members – though anyone may take this course and print their own certificate of completion.
IT IS STRONGLY ADVISED THAT COURSE INSTRUCTOR AND ALL OF THE STUDENTS COMPLETE THE CORE TUTORIAL
Section A, Question 5.3
The Course Instructor is ultimately responsible for the actions of research team members. This question probes how the course instructor will ensure that all students are adequately prepared. Not all suggestions in the list will be pertinent to all projects. Please discuss your class, and your students in the space provided.
[TCPS2, p.22-24]
Section A Question 6
The REB requires the submission of a status report annually, and may require more frequent reporting based on the level of risk involved in the project.
[TCPS2, Article 2.8, p. 21 and Article 6.14, p. 79]
Section A, Question 7
Incidental findings are defined as “Unanticipated discoveries made in the course of research that are outside the scope of the research” [TCPS2, p. 193]
Adverse events are occurrences with an undesirable outcome for the participant.
Both types of events may be serious or minor in nature, and may have immediate or long term effects.
The purpose of this reporting is to:
Ø Ensure that the student proceeds appropriately with any external reporting which may be necessary (e.g. to Health Canada in the case of a clinical trial, or to Child and Family Services in the case of alleged child abuse).
Ø Provide advice and guidance to the student as requested
Ø Ensure that any changes are made to the class project protocol to reduce the likelihood of future adverse events within that project
Ø Act as an educational tool for the REB to ensure more complete reviews (possibly limiting or helping the researcher prepare for adverse events and incidental findings).
“Researchers shall report to the REB any unanticipated issue or event that may increase the level of risk to participants, or has other ethical implications that may affect participants’ welfare.” [TCPS2, Article 6.15, p. 81]
“Depending on the nature of the issue, and in consultation with researchers, REBs may require that researchers adjust their procedures to prevent its recurrence during the research project.” [p. 81]
Section B, Question 1
This information is collected because the location of the research has implications for the degree of risk, the vulnerability of the population, and the need for permission from authorities, for example.
Section C
Answer this question for each procedure/method you are planning on doing. If you are doing more than one procedure/method within a project, provide a short title in Section B for each method, and then, using the same titles, respond to each question in C using the text boxes.
Section C, Question 1
The amount of time spent with the participant, and the number of interactions with the participant, can inform the level of risk for that participant. For example:
· an 8 hour project with a subsistence farmer may negatively impact his/her ability to provide for the family.
A 10 minute survey about sensitive topics may not allow the researcher time to determine the impact of the project on the well-being of the participant, and provide assistance.
Concepts of Risks and Potential Benefits [TCPS2, p. 22]
Section C, Question 2
The research project should be carried out in the language in which the participant feels most comfortable.
[TCPS2, Article 3.2, p. 30]
and
When language barriers necessitate the assistance of an intermediary for communication between the research team and participants, the researcher should select an intermediary who has the necessary language skills to ensure effective communication (see Article 4.1). The involvement of such intermediaries may raise confidentiality issues (see Article 5.2).” [TCPS2, p. 32]
Section C, Question 3
This can be an approximate number, but the information is important in determining risk – particularly risk of privacy. If you are collecting data from 3 people in a company, it would be fairly easy to link a particular data point to one of those three. If you are collecting data from 300, it would be very difficult to do so.
Concepts of Risks and Potential Benefits [TCPS2, p. 22]
Section C, Question 3.3
Provide justification if you are selecting one gender or another exclusively.
“Taking into account the scope and objectives of their research, researchers should be inclusive in selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity, linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.” [TCPS2, Article 4.1, p. 48] and “Women shall not be inappropriately excluded from research solely on the basis of gender or sex.” [TCPS2, Article 4.2, p. 49] and “Women shall not be inappropriately excluded from research solely on the basis of gender or sex.” [TCPS2, Article 4.3, p. 49]
Section C, Question 3.6
Inclusion and exclusion criteria are particular characteristics of the participant group, as specified by the researcher.
Inclusion criteria can include:
Ø A particular age
Ø Membership in a group
Ø An occupation
Ø A medical diagnosis
Ø General health
Ø Students of PSYC*100
Exclusion criteria can include:
Ø A particular age
Ø A medical diagnosis
Ø Wearing glasses
Ø Residing in assisted living
This information is helpful for the REB to make suggestions regarding the management of risk. For example:
Ø if the recruitment methods are correct
Ø if the individual screening participants is adequately trained
Ø if appropriate permissions have been sought
Ø if participants posing high risks, and who are not essential to the project, are not included.
Concepts of Risks and Potential Benefits [TCPS2, p. 22]
Section C, Question 4.1
The REB reviews the recruitment process to ensure that the project is appropriately represented and that participants are not subject to undue influence.
Typical requirements for recruitment are:
Ø statement of U of G affiliation
Ø statement that it is a research project
Ø brief summary of what will be required
Ø estimate of time requirements
Ø contact information for one or more of the research team
Ø incentives or reimbursements available
Ø geographic location of the research site (if applicable)
The REB tries to be sympathetic to the need to tailor the contents of the recruitment document to the available space, so rather than having strict requirements across all research types, projects will have individual requirements based on level of risk, vulnerability of the participants, and the nature of the recruitment document.
NOTE: SIGN UP SHEETS LISTING MULTIPLE NAMES WILL NOT BE APPROVED FOR REASONS OF PRIVACY
“The approach to recruitment is an important element in assuring voluntariness. In particular, how, when and where participants are approached, and who recruits them are important elements in assuring (or undermining) voluntariness.” [TCPS2, Article 3.1, Application (a), p. 28]
Section C, Question 4.2
The physical location of the participant when they are recruited may be important. For example, if you are recruiting individuals from an organization for an interview about a sensitive topic, targeted recruitment in that organization may breach the individual’s privacy.
Section C, Question 5
This information will enable the REB to determine if the incentives and reimbursements are appropriate or if they may undermine the voluntariness of consent.
[TCPS2, Article 3.1, Application (a), p. 28 and TCPS2, Article 3.2 Application (j), p. 33]
Section C, Question 5.1
This information is required to determine the appropriateness of the incentive, and should be provided to the participant during the consent process. Note that the plan detailing how the draw should be managed should include:
Ø how identifiable information for the draw will be managed and safeguarded
Ø who will hold the identifiable information
Ø how many draws will be done, and when
Ø who will draw the names
Ø how winners will be notified
Ø how long researchers will wait for a response before contacting another winner
Ø that you have informed participants that their SIN number will be needed to claim prizes over $500.
Section C, Question 5.2
If you wish to use a lottery or draw as an incentive, you must communicate to the participant what they may win, and the likelihood that they will win this prize. You can state the chances of winning (e.g. 1/100, 1/50), or you can state how many people are eligible. (e.g. We estimate that there will be 500 people taking part, and there will be two prize draws of $250). Please establish who will draw the prize, how the winner will be notified, the number of times contact will be attempted, what will happen if the winner cannot be reached, how personal information will be managed (how long kept and where stored), and whether or not a SIN number will be required (only if over $500).
Section C, Question 5.3
Financial Services require for the purposes of audit, that you record dispersal of dollars for reimbursement or incentives. You can:
Ø have participants initial beside their name when you pay them
Ø note the gift card numbers next to the participant’s name
Please confirm with Financial Services that the method you plan to use is acceptable to them. The REB’s concern is that participants are made aware that their personal information will be provided to Financial Services, and that, if the payment is greater than $500 in one calendar year, they will have to supply their SIN number.
Section C, Question 5.4
Participants should receive any incentives or reimbursements if they chose to withdraw. These payments can be prorated based on level of participation.
“The participant should not suffer any disadvantage or reprisal for withdrawing nor should any payment due prior to the point of withdrawal be withheld. If the research project used a lump-sum incentive for participation, the participant is entitled to the entire amount. If a payment schedule is used, participants shall be paid in proportion to their participation. “[TCPS2, Article 3.1, Application (b), p. 29]
Section C, Question 5.5
Any additional expenses should be declared here and during the consent process.
Section D
In this section, describe how you will obtain consent for each procedure you are undertaking.
You may be obtaining consent for all procedures at once (this is common in health based research).
You may be interacting with different groups of participants at different times, and asking them to participate in different types of research – each requiring its own consent process.
You may be obtaining written consent OR oral consent for the same interview set, depending on the geographic location or availability of the participants. In this case, fill out both the written consent section AND the oral consent section.
[TCPS2, Chapter 3, The Consent Process, p. 27]
Section D, Question 1
Note that it is seldom the case that a waiver of informed consent is granted. If you feel that you can justify each of (a) to (e), please describe in the space provided.
If applying for a waiver of prior consent, describe in detail how each of the following conditions are met:
(a) The research involves no more than minimal risk to the participants;
(b) The alteration to consent requirements is unlikely to adversely affect the welfare of participants;
(c) It is impossible or impracticable (see Glossary) to carry out the research and to address the research question properly, given the research design, if the prior consent of participants is required;
(d) In the case of a proposed alteration, the precise nature and extent of any proposed alteration is defined; and
(e) The plan to provide a debriefing (if any) that may also offer participants the possibility of refusing consent and/or withdrawing data and/or human biological materials, shall be in accordance with Article 3.7B.
From alteration of informed consent TCPS2 Article 3.7, p. 37
Section D, Question 2
Written consent (i.e. the participant signs the bottom of the consent form indicating that they agree to participate) is the most common form of documentation of consent. If you do not think it is appropriate to require written consent, provide a justification for another method of documenting consent
[TCPS2, Article 3.12, p. 44]
Section D, Question 2.1
Informs the REB about what documents will be used to obtain written consent.
Section D, Questions 2.2 and 2.3
Deals with the logistics of obtaining consent, and can have an impact on undue influence and privacy.
Section D, Questions 2.4 and 2.5
Has the individual obtaining consent obtained the appropriate training? The level of training will be proportionate and based on the degree of risk of the project.
Section D, Question 2.6
This is a checklist, meant to alert to researcher to the documents to be attached with the application form. Documents which will be provided to participants will be printed on U of G letterhead or show a U of G logo.
Section D, Question 2.7
Participants should have sufficient time to read the consent form (or have it read to them), to engage in a discussion about the consent process and the research project, and have any questions answered. Again, the amount of time required will be dependent on the complexity of the project, the level of risk, and the capabilities of the participants.
Section D, Question 3
Oral Consent must be obtained using a script (to be submitted) . Written documentation must be provided to the participant.
Section D, Question 3.1
Informs the REB about what documents will be used to obtain oral consent.
Section D, Questions 3.2 and 3.3
Deals with the logistics of obtaining consent, and can have an impact on undue influence and privacy.
Section D, Questions 3.4 and 3.5
Has the individual obtaining consent obtained the appropriate training? The level of training will be proportionate and based on the degree of risk of the project.
Section D, Question 3.6
This is a checklist, meant to alert to researcher to the documents to be attached with the application form. Documents which will be provided to participants will be printed on U of G letterhead or show a U of G logo.
Section D, Question 3.7
Participants should have sufficient time to read the consent form (or have it read to them), to engage in a discussion about the consent process and the research project, and have any questions answered. Again, the amount of time required will be dependent on the complexity of the project, the level of risk, and the capabilities of the participants.
Section D, Question 4
Consent is assumed or implied solely by the actions of the participant (e.g. through the return of a completed questionnaire).
[TCPS2, Article 3.12, p. 45]
Section D, Question 4.1
Informs the REB about what documents will be used to obtain oral consent.
Section D, Questions 4.2 and 4.3
Deals with the logistics of obtaining consent, and can have an impact on undue influence and privacy.
Section D, Questions 4.4 and 4.5
Has the individual obtaining consent obtained the appropriate training? The level of training will be proportionate and based on the degree of risk of the project.
Section D, Question 4.6
This is a checklist, meant to alert to researcher to the documents to be attached with the application form. Documents which will be provided to participants will be printed on U of G letterhead or show a U of G logo.
Section D, Question 4.7
Participants should have sufficient time to read the consent form and have any questions answered. Again, the necessity to provide time to have questions answered will depend on the complexity of the project, the level of risk, and the capabilities of the participants.
Section D, Question 5
Researchers are responsible for ascertaining and complying with the laws, regulations, or customs of the jurisdiction where the research will take place. In some cultures, community consent is required prior to obtaining individual consent. This question gives the researcher the opportunity to discuss unique requirements for their project, and how these requirements will be addressed.
[TCPS2, Chapter 1, p. 12, and Article 8.3 (b), p. 102 and Article 9.11, p. 122]
Section D, Question 6
[TCPS2, Article 3.1, Application (a), p. 28]
Section D, Question 7
Consent shall be maintained throughout the research project. Researchers have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research.
[TCPS2, Article 3.3, p. 33]
Section D, Question 8
Examples include:
Ø “participants shall be free to withdraw their consent to participate in the research at any time, and need not offer any reason for doing so”
Ø “participants should not suffer any disadvantage or reprisal for withdrawing”
Ø “nor should any payment due prior to the point of withdrawal be withheld”
Ø Note that there are cases when withdrawal is not possible or very difficult:
o Anonymous research
o Focus groups or other types of group research where one voice/contribution would be difficult to separate from another
o When data has been anonymized and added to a data pool
[TCPS2, Article 3.1, Application (b), p. 29]
Also: “consent form should set out any circumstances that do not allow withdrawal” [p. 30]
Section E, Question 1
Please review the discussion of risk and the definition of risk and harm starting on page 22 of the TCPS2.
“Harm is anything that has a negative effect on the welfare of participants, and the nature of the harm may be social, behavioural, psychological, physical or economic”
A thorough estimate of potential risk should be made for each type if intervention proposed.
[TCPS2, Chapter 1, p. 9 and Chapter 2, p. 22]
Section E, Question 1.1
Use sub-headings to itemize risks and to discuss how they will be mitigated, or avoided.
Section E, Question 2
The REB will examine your estimation of the risk of harm, and balance this with the benefits as outlined in this section. In order for the project to go ahead, the benefits must outweigh the risks of harm to the participants. Your project may not present risks of harm to the participants.
Once the REB has established the level of risk, through information provided by the research team, a proportionate approach to review will be adopted. Higher risk projects will receive more scrutiny (i.e. full board review) than lower risk projects (i.e. delegated review).
[TCPS2, Chapter 2, p. 24 and Article 2.9]
Section E, Question 2.1
“researchers should ensure that participating individuals, groups and communities are informed of how to access the results of the research. Results of the research should be made available to them in a culturally appropriate and meaningful format”
This normally refers to aggregate results. It may not be appropriate or possible to provide individual results if the work is experimental and the individual results will not have meaning, for example.
Section F, Question 1
Indicate all that apply and then break down the response for each method or procedure you will be using in the text box below.
Note that if you are collecting identified information, and have permission to publish the identity of the participant, many of the data security questions will not apply. It may still be important to safeguard the data against loss or corruption.
[TCPS2, Chapter 5, Section A, Page 56]
Section F, Questions 2
Indirect identifiers are context dependent. They will alone, or in combination identify an individual in a particular context. Researchers should familiarize themselves with the participants’ community and environment in order to understand what will or will not identify. This can be particularly challenging in different cultural contexts.
Guideline 1-G-002 contains a list of identifiers according to the US HIPAA document
Section F, Question 3
Most research data must be stored for a period of time, even after dissemination. The REB is not concerned with the duration of this storage period – this is usually established by a particular discipline or journal requirements – but must ensure that the period of storage is communicated to the participant. In addition, the REB must ensure that the proposed storage method is appropriately secure.
[TCPS2, Article 5.3, p. 60 and Article 5.4, p. 61]
Section F, Question 4
The answer to this question will inform the level of risk to the participant, and the level of security need for the data, and calls for speculative judgement on the part of the researcher and the REB.
[TCPS2, Article 5.3, Application (d), p. 60]
University of Guelph Encryption Policy
Section F, Question 7
Please add any other information you think is pertinent, but was not requested anywhere else in the ethics application form.
Section G
The last page must be submitted in hard copy or a scanned electronic signature added.