Standard application guidelines - sections K-T
K. Recruitment
Recruitment & selection of participants
In these sections, be as brief and specific as possible about the population that will be targeted in your study. Ensure all participant groups are identified here and throughout your application.
In item K.1d:
- the anticipated number of participants will indicate the scale of the research study
- the number of participants may also be relevant to the issue of limits on confidentiality
In item K.2a:
- clearly describe all recruitment steps and attach relevant recruitment materials, such as recruitment scripts, posters and information letters
- ensure that recruitment information for each participant group is clearly explained
- missing recruitment information or inappropriate recruitment methods are common reasons why researchers are required to submit revisions to their application
When the reviewers assess your recruitment process, they will consider the following questions:
- Are all recruitment steps included and adequately described?
- Does the recruitment process protect privacy? Does it conform to privacy requirements?
- When confidentiality is to be protected, does the recruitment process pose potential risks to confidentiality?
- Where permission to recruit participants is required from another institution or organization, is there a copy of a letter addressed to the organization that outlines the research and the request for permission?
- Is there a power-over relationship? Does the recruitment process include safeguards to prevent or minimize power-over?
- Does the researcher have an influential relationship with the potential participants? This may include being a family member, friend or colleague.
- Would the relationship lead potential participants to feel pressure to participate?
- Does the recruitment process include safeguards to prevent or minimize any such pressure?
See Appendix I: Recruitment for more information.
Power relationships
For research to be conducted ethically, participation must be voluntary. If the researcher is in a power-over relationship with potential participants, they may not feel entirely free to refuse to participate.
Conversely, potential participants may also perceive positive inducements for their participation. These may include gaining advantages or earning favour with the researcher.
Even when the research is of a non-sensitive nature, the human research ethics board (HREB) requires researchers to mitigate the power-over relationship with potential participants.
The safeguard(s) that should be employed in a particular study depends on the design and nature of the researcht. Tese safeguards must be clearly explained in the application. Simple assurances such as “there will be no negative consequences” are not sufficient.
See Appendix II: Power-Over for more information.
L. Data collection methods
Data collection
Provide a clear and succinct description of your research project. It must have sufficient detail so that the human research ethics board (HREB) can assess your application appropriately. Different data collection methods will raise different ethical issues.
- item L.1a: use the checkboxes to identify all the data collection methods to be used
- if your research involves methods with technical or specialized names, briefly explain these in plain language
- item L.1b: explain how these methods will be sequenced in the research process
- see Appendix III: Self-reflective & Emergent Research for more information
US Freedom Act
Data collection and storage in the USA may occur in several ways, including:
- the use of US-based online survey instruments, such as Surveymonkey (the non-UVic hosted/owned version)
- cloud storage and other data storage
- the sharing of raw data with US-based research team members
When research includes data storage in the USA, this data is subject to the US Freedom Act. As such, there is a possibility that information collected/stored in the US may be accessed by the US government without the participant’s knowledge or consent.
For this reason, the HREB requires this information to be disclosed to research participants during the consent process. In the case of US-based online surveys, this should be stated at the beginning of the questionnaire. Alternatively, you may choose to use only Canadian-based data storage and a Canadian-based survey tool.
Ensure that the location of your survey instruments and any other sources of data storage is disclosed in items L.1a and L.1bt. This information should also be included in item P.2a and in item Q.3 as necessary.
M. Benefits, inconveniences & risks of harm
Benefits
Ethical research includes an anticipated benefit to either the participants, society or the state of knowledge. Potential benefits should outweigh potential risks. Ensure you do not overstate the potential benefits within recruitment and consent materials.
Inconveniences
As research will pose different inconveniences for different demographics, describe any possible inconveniences to participants. These may include time, absence from work or school or child care expenses.
Level of risk
The TCPS 2 holds the principle of proportionate review based on the level of risk the research poses for participants. The lower the level of risk, the lower the level of scrutiny (delegated review). The higher the level of risk, the higher the level of scrutiny (full board review).
Studies which are judged to be above minimal risk are normally reviewed by the full HREB. Minimal risk studies are usually reviewed by the chair or vice-chair, the ethics coordinator or facilitator and 2 HREB members. Some studies may only be reviewed by the chair/vice-chair and the ethics coordinator/facilitator. While minimal risk studies require less scrutiny, they must meet all the same ethical requirements as higher risk studies.
You can find the TCPS 2 definition of minimal risk in item M.3 of the application. Using this definition, explain the level of risk you judge your study to be. Refer to the characteristics of the participants (their social position, relevant life experiences) and the research activities they will be involved with.
Your assessment of the level of risk will help the HREB decide which type of review process is appropriate for your application. The final decision on the level of risk is made by the HREB.
See Chapter 2 of the TCPS 2 for more information.
Risks of harm estimate
You must assess all possible risks involved in the research. These include risks to the participants, clearly identifiable third parties and to broader cultural and ethnic interests.
Participants have the right to be fully informed of any risks that may be associated with their involvement in the study. Risks are rarely absolutely and are instead based on probabilities.
Make sure to assess risks from the point of view of participants. Think about their life circumstances and experiences. An activity that may not present a risk of harm to one individual may do so to someone with a different life history or social position.
Risk examples
- psychological/emotional: increased sadness, anxiety, fear, depression, loss of privacy and re-traumatization, embarrassment, feeling demeaned
- social: loss of status, respect, alienation, changes in relationship, social stigma attached to being involved in research on issues such as substance misuse, anorexia, etc.
- physical: falls, pain, scarring, infection, physical violence
- economic: costs of being involved in a study (child care, travel time, days off work), threats of job loss if participation becomes known
- incidental findings: unanticipated discoveries made in the course of research that are outside its scope
- you should exercise caution in disclosing incidental findings that may cause needless concern to participants
- when necessary, direct participants to a qualified professional to discuss the possible implications
- in some cases, incidental findings may trigger legal reporting obligations (e.g., evidence of child abuse)
It is unethical to conduct research with potential or known risks if measures are not taken to prevent or minimize risks and to respond appropriately should any harm occur. Risks identified as “possibly” or “likely” must be described to participants.
Risk to researchers
The HREB will assess whether you have:
- adequately anticipated possible risks to participants
- incorporated safeguards to prevent or minimize potential risks
- established adequate plans to respond to any harm should it occur
- appropriately informed participants about those potential risks
When reviewing your answers, the HREB will consider the characteristics of the participants, the nature of the research and the procedures to see if your research project could pose risks to the data collectors. If relevant, it is important to explain what you will do “in the moment” if a participant experiences harm.
See Appendix IV: Risks for more information.
Deception
Deception involves the use of limited or partial disclosure in the consent process. It is used when full disclosure would render the research impossible. Deception is most used in social or psychological research where full disclosure could likely bias the responses received.
For research to be ethically acceptable, the HREB requires that research involving deception meet 5 tests:
- The research involves no more than minimal risk to the participants.
- The deception is unlikely to adversely affect the welfare of the participants.
- The research could not practicably be carried out without deception.
- If possible and appropriate, the participants will be debriefed and provided with additional pertinent information after participation; at which point they will have the opportunity to refuse consent.
- The research involves no therapeutic intervention or other clinical or diagnostic interventions.
If your study involves deception, please refer to Article 3.7A of the TCPS 2. You must complete the Request to Use Deception in the Conduct of Human Research form.
N. Incentives, reimbursement & compensation
Incentives
Incentives differ from reimbursements and compensation. Incentives are anything offered to participants to encourage participation in a research project or to honour a participant’s contribution.
Incentives can be monetary, gifts, gift certificates, honoraria, course credits and raffle prizes. If you plan to offer incentives to research participants, the HREB requires a description of the incentives. You must include its monetary value (or estimated monetary value) and your rationale for use.
Consider if the amount of the incentive could seem like a form of inducement. The onus is on you to justify to the HREB the use of the incentives and the level of incentives.
You should take into consideration issues specific to your participants. These may include:
- economic circumstances
- age and capacity of participants
- customs and practices of the community
- magnitude and probability of harms
Potential participants should not be offered an incentive that is so great that it causes them to become involved in a study in which they would otherwise choose not to participate.
Inform participants that if they begin the research but then withdraw, they will still receive the incentive (or a portion thereof). The TCPS 2 states that a participant should not suffer any disadvantage or reprisal for withdrawing.
Any payment due before the point of withdrawal must still be provided. This means that if the research project uses a lump-sum incentive for participation, any participant that withdraws part-way through data collection is entitled to the entire amount.
If a payment schedule is used, participants must be paid in proportion to their participation. This will ensure that their ongoing consent is voluntary.
Ensure that this is made clear in the consent process and materials and your application form.
Visit the Research Accounting website for information on research participant payments and alternatives that may effect the university's and the participant's tax reporting requirements
Reimbursement & compensation
Many research projects don’t require compensation for participant time and contribution because they require minor amounts of time, do not cause significant inconvenience or are part of student learning.
Note that it can be ethical to offer reimbursement for costs associated with research participation. These may include transportation costs or child care expenses. You may also compensate research participants for wages lost or injury due to research participation.
If you plan to offer reimbursement or compensation to research participants, the HREB requires a description of the reimbursement/compensation. Include its monetary value or estimated monetary value and your rationale for its use. Consider if the amount of the reimbursement/compensation could seem like a form of inducement.
Inform participants that if they begin the research but then withdraw, they will still receive the reimbursement/compensation (or a portion thereof). Ensure that this is made clear in the consent process and materials and your application form.
O. Free & informed consent
By the TCPS 2’s standards, for consent to be informed, prospective participants must be given adequate time and opportunity to take in all the information, including time to ask questions and discuss and consider whether they will participate.
As the HREB closely reviews both the consent process and materials, you must use an appropriate process of consent and ensure that granting of consent is properly documented.
When developing the consent process, consider participants’ differences in culture, age, gender, class, experiences of marginalization, etc., which may give rise to important questions. Consent cannot be validly given until these questions are been addressed, especially for vulnerable populations.
See Chapter 3 of the TCPS 2 for more information.
Participant’s capacity to provide free & informed consent
According to the TCPS 2, “capacity refers to the ability of prospective or actual participants to understand relevant information presented about a research project.” Participants must be able to understand the potential consequences of their decision to participate.
In this section, you must check all boxes that describe the prospective participants and their capacity to provide free and informed consent. If you check off any box labelled “other,” you must provide an explanation.
Refer to Appendix V: Informed Consent for more information.
Means of obtaining & documenting consent and/or assent
Use the checkboxes to identify which consent processes and/or assent processes and documentation procedures will be used.
Written consent
Written consent is the usual process for gaining and documenting informed consent.
The consent process and materials are your explanation to participants of what the research entails. You are bound by all the commitments you make in the consent process.
In creating your consent materials, the HREB recommends that you:
- ensure that your consent materials are consistent with the content of this application
- ensure the language and concepts are consistent with the potential participants (e.g., if you are recruiting lay participants, avoid academic language and concepts)
- consult the consent form template
- proofread your consent materials prior to submitting
Written consent is not always appropriate for your research. If written consent is not used, you must explain why and detail how informed consent will be documented.
Verbal consent
Some researchers will audiotape participants’ verbal consent. Others may note the circumstances and date of the consent in a research journal or log. In some situations, “witnessing” verbal informed consent may be employed.
If verbal consent is used, the TCPS 2 states that “whether or not a consent form is signed, it may be advisable to leave a written statement of the information conveyed in the consent process with the participant”.
See Appendix VI: Alternative Methods of Gaining Consent for more information.
Informed consent process
In this section, ensure you provide:
- a description of how you will obtain consent
- a rationale if you are not using written consent
- a description of how you will document consent
If you are not seeking informed consent from all or some of your participants, you must provide an explanation.
If you are using distinct consent methods for different groups or data collection methods, ensure you provide full details on all your informed consent processes.
You must indicate when potential participants will first be provided with the informed consent materials. Consider whether you can provide potential participants with informed consent documents in advance of the first data collection session. This gives them time to consider the nature of their participation and to come up with any questions.
The time needed for participants to consider their participation will depend on the magnitude of risks and the vulnerability of the participants.
Child & youth consent/assent
If any of your participants are children or youth, you must obtain informed consent or assent from them as well as their parents/guardians.
Ensure that both processes are fully explained in your application. Clarify how and when children or youth – as well as parents/guardians – will provide consent/assent.
Describe the process for providing parents/guardians with information about the research study. If you won’t be asking parents/guardians for consent or providing them with any information about the research study, clarify why.
Ongoing consent
Research may be conducted over more than one session or over a period ranging from hours to years. In such cases, provisions must be made for assuring that participants continue to consent to participate.
If your research occurs over more than 1 session (including transcript review), provide an explanation of how you will obtain ongoing consent. For example, some researchers:
- use periodic reminders
- have participants initial the signed consent form on a subsequent research activity (e.g., a second interview)
- develop multiple consent forms or verbally confirm consent at each interaction
Participant’s right to withdraw
You must make it clear to participants that they are under no obligation to participate or continue to participate in a study. Refusal or withdrawal will have no negative consequences.
Disclose what will happen to participants’ data if they withdraw from the study. If implied consent will be used, inform participants that it is logistically impossible to withdraw the participants’ data once the questionnaire is returned. This is because the data was submitted anonymously. If a tracking system, such as number codes on questionnaires, is used with the implied consent method, this would not be the case.
In focus groups, it may be difficult or impossible to remove the data of a person who withdraws. If the group is not too large, you may be able to do so if you can identify which statements were made by this person.
If a participant withdraws and you want to use the data collected to that point, you as the researcher must obtain consent. Make it clear that this data will not be used if the participant does not provide this consent.
It is not appropriate to ask participants at the time of initial consent to provide this permission for use of their data in the case of withdrawal.
The reasons and rationale for withdrawal may impact a participant’s consent. You can only ask permission to use the previously collected data at the time of withdrawal.
The information in this section must be consistent with the information provided to participants in the consent materials.
P. Anonymity & confidentiality
Protecting participants' identities and confidentiality is an important part of how you conduct your research.
Exceptions to protecting identity: In certain circumstances, (e.g., oral history), it may be appropriate to use participants’ names in reports or publications. In such instances, a participant’s permission for the use of his or her name must be documented in the consent.
Read Chapter 5 of the TCPS 2 for more information.
Anonymity
Anonymity means that there is no way the researcher can ever link the data to the participant. For example, anonymity is possible in circumstances such as mail-in questionnaires that have no identifying information on them.
Confidentiality
Confidentiality means the preservation of participants’ anonymity. This includes respect for their privacy and confidentiality.
The obligation to maintain confidentiality extends to the entire research team. If you tell participants that their confidentiality will be protected, you must tell them specifically how. Confidentiality issues need to be considered at each phase of the research, such as:
- recruitment
- consent process
- security
- analysis
- final disposition of the data
- publication or dissemination of the data and results
Although personal information and data disclosed to a researcher must be held in confidence, the participant can waive this right.
If they do so, they must be fully informed of the potential harms this might bring about. Protection of a participant’s identity may need to extend beyond personal identification and to organizations, institutions, etc.
When confidentiality is to be protected, research data must be stored in a secure manner. This may include removing specific identifiers, e.g. contact information, a combination of social factors which would make it easy to identify the participants and using codes or pseudonyms.
You should also take care to prevent data from being released in a form that would permit participants' identification.
See Appendix VII: Anonymity and Confidentiality for more information.
Q. Data management
The HREB is responsible for ensuring that research studies:
- have appropriate provisions for storage and disposal of data
- inform participants of the use(s) that will be made of their information
- ensure that participants’ information is not used for purposes for which they have not consented
Participants have the right to full disclosure of how their data will be kept secure and protected. This includes:
- where and under what conditions it will be stored
- who will have access to the data
- whether those with access to the data have signed a confidentiality agreement with the researcher (e.g., transcribers)
Read Chapter 5 of the TCPS 2 for more information.
Use(s) of data
When responding to this question, ensure that you refer to all data forms, such as:
- transcripts
- audio/video-recordings
- quantitative data sets
- field notes
Describe all the uses that the researchers and research team will have for the data.
Researchers may find part-way through a study that the data is useful for their other research interests or for research interests of colleagues.
As it is not ethical to use the information of participants for these purposes without their consent, you must anticipate all possible uses before data collection so that you can request appropriate consent. Note that you may not be able to obtain consent after data collection.
If the data will be kept for possible future uses, consider whether this will be in anonymous or identifiable form.
If you want to share identifiable research data with other researchers in future, asking participants for consent at this time may not be appropriate, especially if the other researchers and other study objectives are unknown.
Instead, consider asking participants’ permission to contact them again in the future, when full information can be provided about the subsequent study. They will then be in a position to provide fully informed consent for the use of their identifiable data.
Note that consideration of future uses of personal information doesn't just refer to research, but also to other purposes such as research materials for educational purposes.
Read Chapter 5 of the TCPS 2 for more information.
Commercial purpose
Research leading to commercial products, services or other forms of commercial intellectual property, must be disclosed to participants.
The rights of participants to benefit from commercialization must be described. You are also required to disclose any conflict of interest on the part of the researchers, their institutions or sponsors that may result from the commercialization of the intellectual property.
Read Chapter 7 of the TCPS 2 for more information.
Maintenance & disposal of data
Researchers’ plans for preserving or destroying participants’ data must be appropriate to the field of research and honour the wishes of participants.
For example, in oral history, the best practice may be to archive the collected information (with the participants’ consent) for future generations. Where the release of information could harm participants, it may be best to destroy the collected data as soon as possible.
In this section, explain your plans for preserving and protecting participants’ data or for destroying data. Include information about the best practices in your field of research and participants’ wishes.
Some funding agencies, professional organizations and publishers have established minimum requirements for data retention. You must disclose their plans for data destruction that includes a time frame and the methods to destroy the data (e.g., shredding, electronic file deletion).
See Chapter 5 of the TCPS 2 for more information.
Dissemination
You must disclose all the various ways you anticipate the results of the research may be disseminated. This includes publications, presentations, film and the internet. Read Chapter 5 of the TCPS 2 for more information.
Note that most UVic theses are posted on UVicSpace on the internet. This should be checked and conveyed to participants in the consent form when appropriate.
If you are providing participants or groups involved with the results of the research, indicate how you will do this, ensuring the information is consistent with the consent form. For example, if participants need to provide you with an email address to receive the results, make sure you ask for this in the consent form.
In the “other” category, explain other ways you plan to disseminate the results of the study.
R. Conflict of interest
You must disclose any conflicts of interest to participants and to the HREB.
These are any personal, professional or economic interests you or your team members have that may conflict with the rights and interests of participants. This includes perceived and potential conflicts as well as actual conflicts. Explain any such conflicts and how you will manage them.
Read Chapter 7 of the TCPS 2 for more information.
S. Attachments
Attach the following documents to your application and check off the ones you've attached.
- recruitment materials (e.g., scripts, letters)
- consent form(s)
- copies of all other research instruments, including standardized instruments, questionnaires or interview guides (if large, attach sample questions)
- approval from external organizations (or proof of having made a request for permission)
- permission to gain access to confidential documents or materials
- request to Use Deception in the Conduct of Human Research form
- biosafety approval, or your correspondence with the Biosafety Committee
- any other necessary documents
Note: not all documents will be applicable to your application.
T. Agreement & sign-off
The sign-off/approval by the chair, director, dean or designate indicates that adequate resources are in place within the department or faculty to conduct this research. Please ensure you identify the right people to sign off on your application to avoid any delays.
Submission of the application by the PI to the chair/director/dean or their designate indicates PI’s agreement to abide by all UVic regulations, policies and procedures that govern the ethical conduct of human research.
The sign-off must be completed by:
- the PI
- the department chair, director, dean or their designates
Note: the same person may not sign in more than one of the above categories/positions. If the PI is also the chair, director or dean, sign-off must go one level up to the person you report to.
Need help?
Call the Human Research Office at 250-472-4545 or email us if you have any questions or concerns while completing your application.