Human Participant Research

All University-based research involving human participants, whether funded or non-funded, faculty or student, scholarly, commercial, or consultative, is subject to review by the University’s Research Ethics Board.

This includes all research involving:

• Living human participants;
• Human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals;
• Research involving the secondary use of personal information, whether collected for research purposes from a previous study, or through other activities (clinical, administrative), regardless of whether the data will be identifiable or de-identified; and
• Research involving the secondary use of human biological materials whether collected for research purposes from a previous study, or through other activities (clinical), regardless of whether the specimens will be identifiable or de-identified.

Research involving human participants is reviewed by Trent University's Research Ethics Board and is guided by the Trent University Senate Policy for Research Involving Human Participants and Ethics Procedures for Reviewing Research Involving Human Participants.

The Research Ethics Board (REB) is here to help you comply with research ethics. REB does not reject proposals; REB will work with you until your proposal is compliant. Please complete the TCPS2 CORE-2022 certificate before beginning your ethics application. 

All the required and applicable questions on the application should be answered. Because REB is an interdisciplinary group, you should assume that the reviewers do not know the jargon terms associated with your research discipline. Please write in plain language and define terms clearly and plainly. Please respect the word limits attached to certain questions. Do not paste your grant proposal into your REB application. 

The primary concern of REB members is determining who will participate in your study, how you will obtain their informed consent, what they will experience as they complete your study, and how you plan to address risks and compensate for costs. Your proposal should be focused on providing the reviewers with these practical details. Participants need to be as fully informed as possible about their potential participation so that they can make an informed choice to participate or not. The answers you give on your ethics application and the materials you provide will help REB determine whether participants will be able to give informed consent. 

The human ethics certification files should include: 
•    TCPS2 CORE-2022 certificate for the Principal Investigator and all team members who interact with participants.
•    All recruitment materials, including emails, posters, and social media advertisements
•    Information and consent form(s) 
•    All questionnaires, interview questions, visual displays or scenarios that may be presented to participants
•    Confidentiality agreements signed by translators/transcribers, student researchers, research assistants
•    REB approvals from other institutions
•    Letters of agreement with community research partners.

If you are unclear as to whether your research requires review, or you have any questions about the complete application package, please feel free to contact the Coordinator, Research Conduct and Reporting or the REB Chair.
 

The 2024-25 REB Membership:

• Blair Niblett (Chair)
• Alba Agostino
• Ingrid Brenner
• Chris Furgal
• Dan Longboat
• Douglas McDermid
• Janet Miron
• Aaron Slepkov
• Laura Summerfeldt
• Prachi Thakur (Master's Student Member)
• Jazmine Raine (PhD Student Member)

Trent University Recruitment of External Research Ethics Board Member

The 2024-25 Meeting Schedule:

The above timeline applies to the university-wide REB, which reviews graduate student and faculty research protocols. The departmental ethics committees review minimal-risk undergraduate student projects and teaching protocols on an ongoing basis.

What are the conditions for the use of secondary data in research?

• REB review is not required for research that relies exclusively on secondary use of anonymous information, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information (Article 2.4); 
• Researchers shall seek REB review, but are not required to seek participant consent, for research that relies exclusively on the secondary use of non-identifiable information (Article 5.5B);
• Researchers who have not obtained consent from participants for secondary use of identifiable information shall only use such information if they have satisfied all conditions listed in Article 5.5A;
• When secondary use of identifiable information without the requirement to seek consent has been approved under Article 5.5A, researchers who propose to contact individuals for additional information or for reasons related to the welfare of the participant shall, prior to contact, seek REB approval of the plan for making contact (Article 5.6);
• Researchers are encouraged to review the TCPS2 discussion of secondary use of identifiable information (Chapter 5, Section D) or of human biological materials (Chapter 12, Section C) prior to submitting an application for ethics review of research involving secondary use of data. 

When is research involving cell lines exempt from REB review?

REB review is not required for research that relies exclusively on the re-use of de-identified human somatic cell lines where:
     a.    the researcher will comply with known consent terms;
     b.    the researcher does not know or have access to the identity of the participant;
     c.    the researcher will not take any steps to identify the participant; and
     d.    the research is unlikely to reveal the identity of the participant.
REB review is not required for research that relies exclusively on the re-use of identified human somatic cell lines where:
     a.    the cell line is already available and identified in the public domain;
     b.    it is impossible or impracticable to seek consent;
     c.    the researcher will comply with known consent terms; and
     d.    the research is unlikely to harm the participant.

Is there an example of an Information Letter and Consent Form?

Access the Consent Form template here.

How long does a review take?

Human ethics protocols are reviewed on the basis of risk. A minimal risk study, which means the risk of harm by participation is no greater than a person would experience in their daily life, may be delegated for review between REB meetings. Examples of minimal-risk studies are survey/questionnaire studies of a non-sensitive nature, routine physical or psychological examinations or tests, non-interventional studies (e.g., observational studies of behavior or nutrition). Studies that pose a higher risk will be reviewed by the REB at the meeting after the proposal was submitted.

How can I add other researchers to my ethics application?

The collaborators/student researchers should register their investigator profile in ROMEO. Once registered, you will be able to add them in the Project Team Info tab of the application. TCPS2: CORE certificates for student supervisors and all team members who will work directly with human participants or their data must be attached to your ROMEO application.

How can I make a change to a project that’s been approved?

An amendment to your project can be made by selecting the appropriate form in the Events tab of your project.

Is undergraduate research subject to REB approval?

Yes, the REB will review all research involving humans at Trent. For minimal risk projects, the review may be delegated to a departmental Ethics Review Committee. Processing of the applications submitted to the delegated ethics review committees is independent from the REB meeting schedule.

How do I apply to have a coursed-based research project reviewed?

Course instructors can apply for approval of course-based research projects in ROMEO. Please include the course number, a description of the project, the responsibilities of the student(s) for the project, as well as any research instrument(s).

As a Trent staff member or student, do I require a research ethics review at Trent if my research is taking place outside of Trent?

Yes, even if another REB approved the project. Trent is responsible for all research involving humans, their data, or artifacts, which is associated with the University through the activities of any member of the University community, regardless of the actual location of the research.

Members of my research team work or study at other universities. Where do we get ethics clearance first? Is a REB review at Trent needed if another institution has approved it?

Applications for research that involve collaboration or multiple sites will require the review and approval of a REB at each location where research with human participants is taking place. If an ethics review process is not available for a prospective location, the approval of a REB may be accepted with the agreement of those responsible for that location.

Researchers may apply to multiple institutions at one time. For research that employs phases or a sequence of locations, it is recommended that researchers apply in the scheduled order. Researchers will be expected to update each REB with other institutional approvals as they are granted.

A member of the Trent community would be exempt from REB review if the data collection phase of the project they are involved in has concluded, or if their role in the research team does not involve any interaction with the study’s human participants (i.e. data analysis, knowledge mobilization).

I am a researcher at another institution who wants to conduct part of my study at Trent University. What type of approval do I need?

For the approval of a multijurisdictional study hosted at another institution, please include in your ROMEO submission the approved ethics application from your home institution, the official approval letter, and all other previously approved study materials, to be reviewed by Trent REB. The REB will be especially interested in how you plan to recruit Trent faculty, staff, or students, so please provide a clear description of your recruitment plan, including any recruitment help you plan to seek from student groups, administration, etc.

What approvals are needed for research in other jurisdictions (i.e. research conducted in other provinces or internationally)?

All research conducted on behalf of Trent University requires approval by the REB. In addition, the approval of a REB, where such exists, with the legal responsibility and equivalent ethical and procedural safeguards in the country or jurisdiction where the research is to be done, is required.

I need to access a portion of my funding prior to making my ethics application. Can funds be released prior to a REB approval?

Researchers who need to receive some start-up funds can apply for a Request for Release of Funds Pending Certification. This application can be found in the Apply New section of your ROMEO profile.

Can someone come and speak to my class about research ethics?

Please contact the Coordinator, Research Conduct and Reporting, for information.

“Quality assurance and quality improvement (QA/QI) studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research... and do not fall within the scope of REB review.” (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS2 Article 2.5)

These activities may involve collecting identifiable and personal information and may require permissions from offices at Trent University or external organizations. It is the responsibility of the team conducting the activity to obtain all necessary permissions before project commencement.

Some projects that fall within the category of QA/QI or program evaluation may involve an element of research, necessitating REB review. To assist in the determination of whether a QA/QI project requires REB review, fill out the Quality Improvement and Research Checklist. The checklist can be requested from and returned to the Coordinator, Research Conduct and Reporting.

A limited list of research activities may be exempt from REB review. These can be difficult to determine and consultation with the Coordinator, Research Conduct and Reporting, should be considered.

• Research that relies exclusively on information that is either of the following:
  • Publicly available through a mechanism set out by legislation or regulation and that is protected by law;
  • In the public domain and the individuals to whom the information refers have no reasonable expectation of privacy (non-intrusive, does not involve direct interaction between the researcher and individuals through the Internet).
• Research involving observation of people in public places where any of the following are true:
  • It does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
  • Individuals or groups targeted for observation have no reasonable expectation of privacy;
  • Any dissemination of research results does not allow identification of specific individuals.
• Research that relies exclusively on secondary use of anonymous information or ‘anonymous’ human biological materials, so long as the process of data linkage or recording or disseminating of results does not generate identifiable information. In this circumstance, ‘anonymous’ means that direct identifiers were never collected
  • Information is considered anonymous if it "never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low." Anonymized, coded, or de-identified information is not anonymous. (TCPS2, Chapter 5).
• Reflective Practice/Professional Development activities that involve others (e.g. colleagues, students and supervisors) to solicit information that can be used for self-evaluation and growth, provided no information about these other individuals is made public or identifiable.

FORMS:

• Graduate or Undergraduate: Application for Approval of Human Participant Research
• Consent Form Template
• Simplified Consent Form Template for Teaching Protocols/Class Activities
• Research Ethics - Confidentiality Agreement

GUIDELINES AND POLICIES:

• Informed Consent Form Requirements
• Consent Form Guidance
• Guidelines for Research Involving Student Participants
• Handling Sensitive Information Policy 

• Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans
• TCPS2 Interpretations
• First Nations principles of ownership, control, access, and possession

• Canadian Association of University Research Ethics Boards

COURSE ON RESEARCH ETHICS:

• TCPS2: CORE-2022