MRHP Protocol Form Information
Before You Begin
Researchers should familiarize themselves with research ethics requirements before filling out their human ethics application. Recommended options include:
- watching “Tips for writing a human ethics application”: https://youtu.be/rNAyIWWoSJc
- completing the Course on Research Ethics (CORE) tutorial: https://tcps2core.ca/welcome
- reading the Tri-Council Policy Statement: Ethical conduct for research involving humans (TCPS2): http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf
- reviewing relevant U of policies and guidelines: http://www.research.utoronto.ca/policies-and-procedures/
- watching “Data Protection” https://youtu.be/5r-EUoSMASE and “Passwords and Encryption” https://youtu.be/qWTwv75yUUI videos
- attending a Research Ethics 101 lecture
We also provide individualized consults to discuss specific research studies or ethical dilemmas. Please contact firstname.lastname@example.org to book a consult.
Investigator submission – general ethics protocol submission for individual research projects including theses.
Course template – ethics protocol submission that is specific to an undergraduate or graduate course and will cover all research projects conducted by students in that course. It is normally written and submitted by the course instructor.
Please note: Course-based research that is minimal risk should be reviewed by the respective Delegated Ethics Review Committee (DERC), if there is one. This is a process outside of MRHP. If there is no DERC, then the protocol should be submitted through the MRHP system for delegated REB review.
TAHSN-approved research study for Administrative Review – submission to ROCO-HREP for administrative review of research taking place at one of the University of Toronto- affiliated teaching hospitals and where the University plays a role (e.g. administration of funding, graduate student, data or tissue analysis and/or storage). REB approval from the respective hospital(s) is required before submission to the University.
- Title of Research Application: Generally speaking, titles should reflect the subject of the research. Where more than one ethics application is required to cover the research of a specific project, please use the title plus subtitle or other form of identification. When submitting multiple protocols for review, ensure that the titles are different.
- Applicant Information: Researchers must have a UTOR ID account in order to create and submit an ethics application. The applicant is the principal investigator (PI) for the project. For faculty research, the PI is the person who assumes responsibility for the conduct of the research. This may not be the same researcher who serves as PI on the grant, nor the PI on the overarching project, if it is multi-centred. For graduate student research, if the project will serve as the thesis or degree-fulfilling requirement, the graduate student will normally be the applicant and create the ethics application. However, the faculty supervisor is responsible for submitting the application. Post-doctoral fellows and Visiting Professors may apply for REB review, if they have been provided a UTOR ID. A faculty member must take on the role of “Faculty Sponsor” for these protocols and must submit the application on the researcher’s behalf. The Faculty Sponsor, like the Faculty Supervisor, takes responsibility for ensuring that the investigator conducts the research project ethically, in accordance with the REB-approved protocol.
- Alternate Contact: This may be a research assistant/associate or other that maintains communication with the PI to assist in keeping ethics review processes up to date.
- Collaborator/Co-investigator: These are other researchers involved with the research project that should be made aware of ethics review process updates and communications.
- Projected project dates: The start date should refer to the beginning of a formal recruitment process, or, in the case where there is no formal process, the commencement of the informed consent process and data collection. For research involving secondary use of data, this would approximate when data will be received. The completion date should refer to the point at which data analysis has been completed in order to answer the original research question(s). Researchers are not to engage in data collection or recruitment until they have REB approval, regardless of anticipated start date.
1-History – Progress
- History: If this application is a continuation of a previously approved study that was closed with a Protocol Completion Report within the past two years, or is to replace a protocol that has been renewed six (6) times, please provide the relevant protocol reference number(s).
- Location where the research will be conducted: Specify all the locations where the research (i.e., recruitment and/or data collection) will be conducted and where the data will be stored.
- Administrative Approval/Consent: Research in external institutions or with community groups may require administrative approval or consent. The researcher should approach the respective heads for approval or consent prior to submitting their ethics application. If appropriate, a letter authorizing the research should be obtained.
- Other REB Approval(s): Research conducted in other institutions may require ethics review by another board or committee. It is the responsibility of the researcher to make sure that all necessary processes required are followed, and that all approvals are obtained prior to the commencement of the research activity.
3-Agreements and Reviews
- Funding: For funded research, investigators should indicate the corresponding source of funding. When one protocol covers several grants, make sure to include all known funding information. Scholarships and fellowships are not relevant to this section unless there is a research allowance component that involves human participants. If the research is not funded but it entails costs (e.g., participant reimbursement, purchasing equipment, etc.), provide an explanation for how costs will be covered.
- Agreements: Include funding and non-funding agreements with external organizations.
- Reviews: Scholarly review is required for all supervised/sponsored research as well as all research that is greater than minimal risk. Student research should be reviewed by the thesis committee or supervisor and at least one other expert in the research area if no thesis committee exists. In some situations, departments or faculties may have their own internal scholarly review committees. The REB maintains the authority to review the science or scholarship for any of the protocols it is assigned. Please upload a copy of the scientific review if available. Dentistry studies submitted to the Health Sciences REB must include a letter from the department attesting to the scientific merit of the proposal. Please note that community investigators must obtain scientific review prior to submission of their ethics application to the HIV REB. Sometimes funders approve large projects which include multiple research protocols. Please indicate whether the scholarly review was done for this specific protocol or whether the review was part of a larger project.
- Conflicts of Interest: Any interest that is unrelated to the PI’s role as researcher has the potential to be in conflict with their research interests. Conflicts do not necessarily imply wrongdoing. It is important that they are identified and managed. Interests may provide benefit to the researcher or close relation at the time of the research or have the potential to do so in the future.
- Restrictions on Information: Please consult with the University’s Publications Policy.
- Researcher Relationships: Does anyone within the research team have a prior relationship with the participant pool or prospective participants? If so, please describe the relationship and any implications it may have on recruitment, voluntariness of consent, etc.
- Collaborative Decision Making: Community engaged research involves a non-academic partner that is actively involved in the design, execution, analysis and dissemination of the research. Decision-making may be done through a steering committee, or in accordance with terms of reference, a memorandum of understanding or less formal process.
- Rationale: This section should be clear, concise, and provide just enough information to give the reviewers an understanding of why the research is being proposed, and what research has already been done in this area. It should be assumed that the REB is not familiar with the discipline, but is knowledgeable in research. In general, lengthy literature and thesis proposals are not appropriate. Researchers should describe the purpose and scholarly rationale for the study and provide some references.
- Methods: This section should include a description of all formal and informal procedures to be used in the study with respect to human participants, data, and/or biological materials. When presenting a complex proposal, tables, figures and timelines may be useful. It is not necessary to describe standard analytical techniques in detail (e.g. DNA analysis, fMRI). The researcher is responsible for obtaining any necessary permission to use standard instruments (e.g., Beck’s Depression Inventory) in their research. As per Article 2.7 of TCPS2, “as part of research ethics review, the REB shall review the ethical implications of methods and design of the research.” Please upload all tests, questionnaires, and tools (including standard instruments), interview guides and focus group questions. For semi-structured and unstructured interviews, please provide a general sense of the types of questions you plan to ask. It is understandable that some interview questions may change once the research begins. For naturalistic or participant observation, describe the setting, type of information and interactive or observational procedures that will be used.
- Clinical Trial: A clinical trial is defined as a research study that prospectively assigns human participants to one or more health-related interventions – drugs, devices or natural health products – to evaluate the effects on health outcomes.
6-Participants and Data
- Participants and/or Data: This section should include all the relevant details about the study participants. List the inclusion and exclusion criteria. If appropriate, state sample size and how this was determined. When using existing data, explain how the data will be collected/extracted, what it will include, and how the researcher will gain access to the data. If available, provide details on how the data were originally collected, including how/if consent was obtained. If prospective participants maybe in vulnerable circumstances that could potentially compromise their capacity or voluntariness to consent, this should be described, along with how this will be mitigated.
- Recruitment of Participants: Describe in detail how participants will be recruited, whether in person, indirectly (e.g. flyers, word of mouth) or online (email, social media, website). Any pre-recruitment activities, such as consultation with community leaders or living among the population should be included. Recruitment materials should be uploaded to the application. If translation is required, please describe how this will be done with respect to materials and/or in communication with prospective participants.
- Participant Compensation: Before completing this section, you should be familiar with U of T’s Compensation and Reimbursement Guidelines. If applicable, justify the amount of compensation to be offered to participants. If you will not be providing compensation or reimbursement, and participants will incur cost (e.g., child care, travel), provide a rationale. Where compensation is offered in foreign currency, a Canadian equivalent should be provided. Whenever possible, participants who withdraw should receive prorated compensation.
- Experience of Investigator with this Type of Research: This section should outline the training and experience of the individuals involved in the research relevant to their roles and responsibilities in this study. If the research is to involve methods that pose greater than minimal risk, collection of sensitive data and/or a vulnerable population, provide a brief description of the research team’s experiences and/or ability to conduct the research. If the research is supervised or sponsored, the degree of supervision by the faculty supervisor and/or sponsor should be included. If the project involves community members or research associates, their training should be outlined with special attention to privacy and confidentiality in research.
8-Possible Risks and Benefits
- Possible Risks: All research carries some risk. Evaluate risk based on the probability that it will occur and seriousness of the harm. If the research involves greater than minimal risk, it is important for the researcher to contemplate the best way to manage or minimize it.
- Potential Benefits: It is important that possible benefits listed are realistic. If there is no benefit to the participant, this should be expressed. Discuss the potential benefits to the community/society if applicable. Also discuss any benefits to the scientific or scholarly community.
- Consent Process: Informed consent is an ongoing process that starts with the researcher’s first contact with the individual and continues through study completion/participant withdrawal, and beyond. Any verbal exchange about the study, the written informed consent form and any other written documentation given to participants should provide adequate information for the participant to make an informed decision about his/her participation. While the default, according to the TCPS2, is written consent, the REBs understand that many disciplines and cultures do not accept written consent as appropriate. It is the quality of the consent process, not the format that is most important. This section should include a full description of how you will obtain free and informed consent from participants, in addition to appending all relevant consent materials. REBs are interested in reviewing the consent documents but also wish to know how the consent process will take place (e.g., who will approach whom, where will it take place, how it will be documented). Please consult our Informed Consent guideline. If your data has been/will be used for secondary purposes, describe how consent was or will be obtained for this new purpose. Upload all consent documents and materials including informed consent forms, scripts, website text etc.
- Community and/or Organizational Consent, or Consent by an Authorized Party: If applicable, community consent should be sought prior to any data collection. Certain communities may have their own review boards and they should be consulted as well. In Canada, there is no definitive age below which parental/guardian consent is required in order to participate in research. Whenever children (under 18 years of age) are to be included as participants, the researcher must consider the risk of the research, the maturity level of the children and any potential risks versus benefits associated with parental knowledge of the research. Adolescents that do not live with their parents can consent for themselves. Similarly, university students are considered to be adults, whether or not they live at home. If an adult participant is not competent to formally consent, a surrogate decision maker can do so. However, the research should be explained to the participant, and given the opportunity to provide assent or dissent. Assent from children should also be obtained, as even very young children can be made to understand simple explanations of what the research involves and determine whether they want to participate or not. Community engagement is a key component of research taking place in traditional communities. Researchers should outline their process of engagement and provide all letters of support. Similarly, letters of administrative support should be provided if the research is taking place with organizations or companies. If consent will not be sought, please provide justification and describe alternative consultation that may take place.
10-Debrief, Dissemination and Withdrawal
- Deception and Debrief: Researchers engaging in deception should be familiar with U of T’s guidelines for Deception and Debriefing in Research. Deception may pose additional risks, and may require consideration as to what the debriefing process should include. Deception should, whenever possible, be through omission (leaving details out), not commission (providing false descriptions). Deception is considered a risk, as it can have a negative impact on a participant’s feelings of trust in the study, in the researcher, and in research. Therefore, whenever deception is to be used, it is important that debriefing be done so as to provide the participant with an opportunity for real informed consent. The participant should also be re-consented, or asked whether they wish to have data withdrawn, after debriefing. It is important that participants have access to study findings. For some populations, it may not be appropriate for dissemination of results to only be accessible in a scholarly journal format. Please describe the format by which participants can access findings (e.g., newsletter, summary of thesis material, town hall meetings, etc.), and how they will be notified of this.
- Participant Withdrawal: Describe how participants can withdraw from the study. Specify whether or not participants can withdraw their data after their participation. If participants cannot withdraw their data after a certain point for any reason (e.g., de-linking of data), this should be explained.
11-Confidentiality and Privacy
- Confidentiality: The procedures and measures used to protect participants’ confidentiality should be outlined in detail. There are some cases where participants would not wish to keep their data confidential. In these situations, the researcher needs to make an argument why this is the case. Describe any limits to confidentiality (e.g. focus groups, duty to report).
- Data Protection: Researchers should outline how data will be stored securely and in what format. In some cases data may be stored for an indefinite period of time. Any data sharing with other researchers or users should be described, making mention to the consent process. The REB does not mandate how long data should be retained; however data security standards do exist and should be understood. Some of the factors that should be considered are sensitivity of data, identifiability, disciplinary or departmental practices and how long the data will be needed. Health Canada requires that data for clinical trials are retained for at least 25 years. Data that is truly anonymous can be retained indefinitely.
12-Level of Risk and REB
- Indicate the Risk Level for the Project: To determine the risk level for the project, please indicate the Group Vulnerability (low, medium, high) and Research Risk (low, medium, high). Group vulnerability is usually defined as the presence or absence of circumstances that may negatively affect the ability to give free and informed consent; research risk is usually defined as the invasiveness of the procedures. If there are multiple groups with various vulnerabilities and research risks, the REB sets the risk by considering the most vulnerable of the groups and most invasive of the procedures.
- Explain/Justify: Explain the identification of Group Vulnerability and Research Risk by tying in answers provided for Participants and/or Data and Possible Risks sections of the application.
- REB: Social Sciences Humanities and Education (SSHE) and Health Sciences (HS) REBs are department-specific. SSHE REB: Faculty of Arts and Science, Ontario Institute for Studies in Education (OISE), Faculty of Music, Faculty of Information, Faculty of Management, Mississauga and Scarborough campuses, programs through the colleges and Toronto School of Theology (TST). HS REB: Faculty of Medicine, Faculty of Applied Science and Engineering, Faculty of Nursing, Faculty of Pharmacy, Faculty of Social Work, Faculty of Kinesiology and Physical Education, and Faculty of Dentistry. HIV REB: all research that has a significant component relevant to HIV/AIDS. In situations where it may be more appropriate for the proposed research to be reviewed by another REB, ROCO-HREP may re-assign the protocol. In cases where the student and the primary supervisor are from different departments, the protocol is reviewed by the supervisor’s respective REB.
- Upload Document: Upload any supporting documents or materials that have not been uploaded elsewhere.
- Uploaded Documents: All uploaded documents appear in the table.
- Applicant Undertaking: This statement describes the responsibilities of the applicant in conducting the research. This includes adherence to privacy legislation, Tri-Council requirements, University policies and others. If changes to the protocol must be made, it is expected that the PI makes those changes and receives REB approval prior to executing them in the research.