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Research Involving Human Participants

The Research Ethics Board (REB) strongly recommends that all applicants consult the Terms of Reference regulating the mandate and procedures of the REB and familiarize themselves with the processes followed for review, decisions, and appeals. Any questions about the ethical review process can be directed to ethics@nipissingu.ca. 

 

Purpose

The Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (TCPS2 2022) document describes standards and procedures for governing research involving human participants. The Councils (CIHR, NSERC, and SSHRC) have adopted this policy and required, as a minimum, that researchers and institutions apply the ethical principles and the articles of this policy. The Councils aim to protect human research participants, ensuring the respect of the principles of free and informed consent, privacy, confidentiality, and minimum risk.

 

Mandate

The mandate of the Research Ethics Board is “to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human participants which is conducted within, or by members of, the institution, using considerations set forth in this Policy as a minimum standard.” (TCPS, Article 1.2, Authority of the REB)

 

Accountability

Each institution through its REB is directly accountable to the Tri-Councils. External audits or research ethics monitoring are regularly carried out. The Councils will consider funding (or continued funding) only to individuals and institutions which certify compliance with the TCPS regarding research involving human participants.

 

Protocol

Each protocol submitted will be thoroughly reviewed and processed in a timely manner. Please await a response as one will be shared as soon as the review has been completed. The REB appreciates your patience.

It is the responsibility of any researcher (Principal Investigator or Co-Investigator) to become familiar with the Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (2018) and complete the TCPS-2: CORE 2022 training course.

Members of the Research Ethics Board

Voting Members

  • Dr. Rosemary Nagy, Chair - Department of Gender Equality and Social Justice
  • Dr. Geoff Hartley, Vice-Chair - School of Physical and Health Education
  • Dr. Kristina Karvinen, Vice-Chair - School of Physical and Health Education
  • Dr. Anahita Baregheh - School of Business
  • Dr. Nancy Black - Executive Director, Library Services
  • Dr. Christine Lalonde - Department of Psychology, Sociology, Child and Family Studies and Social Welfare
  • Dr. Louela Manankil-Rankin - School of Nursing
  • Dr. Tara McGoey - Canadore College Representative
  • Dr. Anna-Liisa Mottonen - Canadore College Representative
  • Dr. Derek Neal - Department of History, Anthropology and Ancient Studies
  • Dr. Laurie Peachey - School of Nursing
  • Jessica Stickle - Community Member At-Large

Non-voting Members

  • Research Coordinator (non-voting)

For composition requirements please refer to ourTerms of Reference.

Meeting Dates

The NUREB meets monthly throughout the entire year to discuss ethics protocols and ethics education. Applications are reviewed on a rolling fashion and may be submitted at any time. 

Research with Indigenous Participants/Communities

In accordance with a commitment made by Nipissing University in 2010 all faculty, student and staff research and academic engagements related to Indigenous peoples and/or communities will involve the participation of the Office of Indigenous Initiatives - Research (OII) prior to submission of an REB Protocol. The OII will assist in facilitating and coordinating with appropriate First Nation, Inuit and/or Métis resource people and communities. Researchers intending to conduct research related to Indigenous peoples, communities and institutions as participants are expected to:

  1. become familiar with “Research Involving First Nations, Inuit and Métis Peoples of Canada,” Chapter 9 in the Tri-Council Policy Statement - Ethical Conduct for Research Involving Humans
  2. initiate and engage in dialogue with the OII about the proposed research, including steps already taken by the researcher to build and maintain a trusting, collaborative research relationship, and plans for engagement with the Indigenous community or communities.

Protocol Submission

Applications for research with human participants

All REB forms are accessible through the Romeo Researcher Portal. 

Requirements for submission of a complete protocol

  • Tri-Council Policy Statement (TCPS 2) CORE-2022 Certificate of Completion - for all project team members (create an account with your Nipissing email address and complete training here). Note that as of July 2022, we will only accept the newest version of the CORE module (CORE-2022).
  • Participant Information Letter/Consent - if required
  • Confidentiality Forms - if required
  • Recruitment Posters/Adverts - if required
  • Additional Certifications/Approvals - if required
  • Community Engagement Plans - if appropriate (through Office of Indigenous Initiatives)

See the Protocol Forms page for guides to creating Participant Information Letters and recruitment materials. If you would like further assistance or samples, contact ethics@nipissingu.ca. 

REB will not review incomplete protocols. If your protocol has any missing or incomplete information, it will be returned to you for completion before NUREB review. In all cases the Principal Investigator (PI) is required to make the official submission of a protocol. The PI must confirm that all information within the application is accurate and they believe the application is ready for review. In the cases of student research, the faculty supervisor shall be designated the PI.

Multi-Stage protocols

The NUREB requires that programs of research involving successive studies or multiple stages be broken into separate protocols, that is, one study per protocol. If there are any questions, please contact the Chair or Vice-Chair of NUREB.

Types of reviews

Minimal risk studies will be eligible for Delegate Review (2 reviewers, 1 chair). Allow up to 5-6 weeks after submission for the Research Ethics Board to respond with a decision.

Above minimal risk studies may require Full Board Review (reviewed by all REB members, 1 chair). Allow a minimum of 6 to 8 weeks after submission for the REB to respond with a decision.

Events for research with human participants:

  • Renewals
  • Modifications
  • Report on Adverse Events
  • Final Reports

If minor in nature, events are reviewed by the REB Chair or Vice-Chair. Allow up to1 week after submissionfor a response with decision on any event. 

Protocol Forms and Guidance Documents

Ethics Forms

All ethics forms are available through the ROMEO system; click here to sign into the ROMEO system.

Guidance Documents not in the Romeo system

TCPS2 Certificate of Completion

Each member of the research team must complete the TCPS2 online tutorial (CORE-2022). Note that as of July 2022, we will only accept the newest version of the CORE module (CORE-2022). Submission of the Certificate of Completion is required. Tutorial is found at the following link: http://tcps2core.ca/login. 

For Nipissing students, faculty and staff, please ensure that you use your Nipissing University e-mail address to register in Romeo.

Researchers External to Nipissing University

If you are external to Nipissing University/Canadore College and wish to conduct research with Nipissing or Canadore faculty, staff or students, you must first obtain (1) institutional authorization (Institutional Support for Research Request) from the Associate Vice-President, Research, Innovation & Graduate Studies and then (2) ethical approval from the Nipissing University Research Ethics Board.

Once you have obtained a signed institutional authorization form, you can request ethical approval by completing an Institution Approval Request using the Romeo system. You will need to attach your home institution’s approved protocol, ethical clearance letter/certificate, and all corresponding appendices.

Research with Canadore College

Please note that NUREB approval does not signify authorization from Canadore College to participate. Nipissing University acts as their REB and reviews files for ethical compliance only. Prior to submitting your application to the NUREB, you should contact Canadore College directly regarding their willingness to participate. Proof of institutional authorization should be included in the application as a condition of final approval. 

Please contact the Research Office for institutional authorization: research.centre@canadorecollege.ca.

Appeals

Researchers have the right to request, and the NUREB has an obligation to provide, reconsideration of decisions affecting a research project, through deliberation, consultation or advice. The researcher and the NUREB must have fully exhausted the reconsideration process, and the NUREB must have issued a final decision before the researcher initiates an appeal.  

Nipissing University has signed a formal Memorandum of Understanding – Ethics Appeal Agreement with a cooperating university.

 The application for appeal should include:

  •  A letter from the Researcher justifying their reasons for requesting the appeal;
  • The original ethics application submitted; and
  • Documentation outlining the NUREB’s decision (minutes, REB reviews, etc.).

The Research Coordinator will be responsible for forwarding the documentation to the Appeal Committee.

Appeals may be granted only on procedural grounds or when there is a significant disagreement over an interpretation of the Tri-Council Policy Statement 2 (TCPS2) at www.pre.ethics.gc.ca. The decision of the Appeal Committee shall be binding. The Appeal Committee shall forward a report summarizing their findings and recommendations within 30 days of their decisions to the Ethics Chair of the other institution's REB.

Resources and Useful Links

TCPS Core 2 Certification

The Federal Granting Agency's tri-council Panel on Research Ethics (PRE) is offering an on-line seminar on the operation of the ethics rules for researchers doing research that in any way involves humans. All researchers who will be directly contacting participants or their identifiable data are required to provide the NUREB with evidence of their certification within their applications.

Please use the link below to acquire a TCPS Core certificate:

http://tcps2core.ca/login 

Useful Links:

  • ROMEO login/Registration ROMEO
  • Interagency Advisory Panel on Research Ethics  (PRE) 
  • Canadian Association of Research Ethics Boards (CAREB) 
  • Tri-Council Policy Secretariat 2nd Edition of Policy for Research Involving Humans Document - TCPS2
  • Assembly of First Nations Research Ethics (AFN)
  • Guidelines for Ethical Aboriginal Research (GEAR)
  • First Nations Principles of Ownership, Control, Access, and Possession (OCAP)

International Research

When doing research in another country, please check the following link to ensure you have obtained the required approvals. Ensure you have obtained institutional authorization from the host institution to conduct your research. Researchers are still expected to follow all the TCPS guidelines regardless of where the research is taking place. https://www.hhs.gov/ohrp/international

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