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Human Participants

UPDATES

(January 20, 2023) Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022)

The Secretariat on Responsible Conduct of Research has released the new Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022). Please note that the TCPS 2 (2022) replaces the TCPS 2 (2018).  The current Senate Policy and related procedures and guidelines are now under review and will be updated, as needed. All revised policy, procedures, and guidelines will be available on the relevant websites by June 2023.

In the interim, researchers are advised to review the new TCPS 2022 framework. Should researchers have any questions regarding the implications of the new framework on their research, please connect with the Office of Research Ethics (ore@yorku.ca).

(November 22nd, 2022) Face to Face Research with Human Participants

While there is no restriction on on-campus research activities, researchers are advised to adopt, as the President advises, “a community of care approach” when conducting their research. Researchers are thus strongly encouraged to wear masks (tight fitting and well-constructed; preferable Level 2 masks and N95 masks) and adopt recommended health and safety measures in indoor research environments, labs, and spaces, especially in situations involving young children and other potentially vulnerable human participants or in extended periods of close contact between researchers and/or participants.

However, off-campus research (local, domestic, and international) must adhere to public health requirements in effect at the venue/country where research is being conducted

Please note that, York continues to work with public health authorities and, should it become necessary, may reinstate health and safety requirements as it speaks to face-to-face research with human participants.

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How and Where to get Ethics Review & Approval

All research involving human participants requires review and approval by York’s University’s Research Ethics Board (the Human Participants Review Committee) prior to beginning the research. For research to be subject to review it must be considered “research” according to TCPS (2018) and it must involve “human participants.” To decide if your research is subject to review or not, please see Tip Sheet 3 and Ethics Roadmap Flowchart (© Cross Campus Campstone Classroom).

Whether your research undergoes delegated review, review via Faculty of Graduate Studies (FGS) or a full board review by the HPRC, is determined by both the nature of your research (e.g. is it minimal risk? More than minimal risk? ) and the status of the researcher (Faculty member or Student). For more information and guidance please see Decision Chart Full Board and Delegated Review.

Detailed information regarding processes and forms are listed below.

All research involving human participants that is conducted by and/or involves Faculty members must be reviewed by the Human Participants Review Committee (HPRC) – this includes research led by students but with whom Faculty members collaborate.

For research that is subject to review, researchers must submit their protocol and relevant attendant documents via the online ethics review system.

For those researchers who are unable to access the online system, protocol submissions via email will be accepted.  Please contact the Office of Research Ethics (ore@yorku.ca) for further information.

NOTE:  the online system is accessible to faculty researchers only.  Student researchers should contact their department/graduate studies for the appropriate forms.

Submission dates:

Protocols are accepted on a weekly or rolling basis.  Normally, protocols received no later than a Thursday are – barring any significant issues or deficiencies with the protocol – forwarded to the committee for review the following Tuesday.

How long does the review process take?

Ethics review processes vary by committee; however, in general, protocol review takes 20 working days. While ethics review is not required at the application stage (with some exceptions), as research funds will not be administered without ethics approval in place, it is advisable to submit protocols for review well in advance of award notification dates.

Special circumstances – Research conducted in schools, hospitals and/or institutions where ethics approval and/or institutional permissions are required

Certain research contexts require additional ethics review processes and approvals.  Specifically, but not limited to, research conducted in educational institutions, hospitals and/or medical clinics, research conducted in foreign countries and research conducted in, on or about First Nations, Inuit and Metis communities all require additional ethics review processes and/or approvals to be obtained.

Guidelines are in place to assist researchers in navigating the additional ethics review requirements.  Please consult the relevant Guidelines below or contact ORE for further information.

Committee Decisions and Researcher Responses

The review of protocols and decisions made by the relevant ethics committees are done by consensus. In the event that a consensus cannot be reached, the majority decision will be conveyed to the researcher with a notation of the dissenting opinion.

Decisions of the relevant committee are communicated to researchers electronically in the form of either a letter - outlining areas of concern or requiring clarification – or a certificate of ethics approval.

Should a researcher receive a letter from the committee requiring revisions to their protocol/consent documents or requesting clarification of information contained therein, researchers shall forward their responses – in writing  electronically via email or online system – to the Office of Research ethics.  All communication regarding committee decisions shall be via the Office of Research Ethics.

FORMS

Faculty members conducting research involving human participants can access all relevant forms (such as HPRC Protocol Form, Informed Consent Form Template, Renewal Application etc.) via YU Link.

Graduate students conducting research for the purposes of completing a graduate thesis or dissertation are subject to review by a delegated ethics review committee comprised of the Associate Dean(s), Research, Faculty of Graduate studies and the Chair/Vice-Chair HPRC. Where delegated reviewers decide that a protocol should not be approved, the protocol will be referred to the HPRC for full board review.

All graduate student researchers must complete the TCPS Tutorial  to establish that they have completed the necessary education component and attach their certificate of completion to their protocols. Protocols will not be accepted for review unless a valid TCPS tutorial certificate is attached.

When is Ethics Review Required?

All research involving human participants is considered research subject to review. The Principal Investigator (researcher) of any research project involving human participants:

  • MUST have a protocol that describes how the researcher(s) will interact with the human participants; and
  • MUST have that protocol reviewed and approved by the appropriate Research Ethics Committee before the  research commences; and
  • MUST obtain informed consent from ALL research participants. For minor age participants (Those under the age of 16 for minimal risk research), both parental consent and participant assent is required.

NOTE:  Failure to obtain ethics approval prior to the commencement of research activities is considered both a breach of Senate Policy as well as research misconduct.  All such instances of non-compliance will be addressed by the appropriate institutional office.

How and Where to Obtain Ethics Review and Approval: Graduate Theses and Dissertation Research Involving Human Participants:

For graduate student research involving human participants for the purposes of completing a thesis or dissertation, please go to Faculty of Graduate Studies Research Ethics for further information and/or access to forms, guidelines,  and other resources.

Graduate, Undergraduate courses; Undergraduate theses, Independent projects and Graduate MRPs

All research involving human participants for graduate and undergraduate courses; Undergraduate theses, Independent projects and Graduate Major Research Papers (MRPs) that is non-funded and minimal-risk must be reviewed by the relevant unit level Delegated Ethics Review Committee. Research subject to review includes, but is not limited to: surveys, questionnaires, interviews, participant observation and secondary data analysis.

For the purposes of research ethics review, “minimal risk” research is defined by the TCPS as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research.

NOTE: Research conducted by students that is more than minimal risk and /or involves Aboriginal/Indigenous peoples and/or involves clinical trials, must be reviewed by the Human Participants Review Committee (HPRC). For these types of research, students are required to complete the HPRC protocol form. Please contact the Office of Research Ethics (ORE) at ore@yorku.ca for further information.

For more information on ethics review requirements for Graduate and Undergraduate course-related research and MRPS, please go to, “Ethics Review Requirements" for Course-Related Research by Students.

When Is Ethics Review Required?

All research involving human participants is considered research subject to review. The Principal Investigator (researcher) of any research project involving human participants:

  • MUST have a protocol that describes how the researcher(s) will interact with the human participants; and
  • MUST have that protocol reviewed and approved by the appropriate Research Ethics Committee before the  research commences; and
  • MUST obtain informed consent from ALL research participants. For minor age participants (Those under the age of 16 for minimal risk research), both parental consent and participant assent is required.

All undergraduate and graduate student researchers must complete the TCPS tutorial to establish that they have completed the necessary education component and attach their certificate of completion to their protocols. Protocols will not be accepted for review unless a valid TCPS tutorial certificate is attached.

NOTE:  Failure to obtain ethics approval prior to the commencement of Research Activities is considered both a breach of Senate Policy as well as research misconduct.  All such instances of non-compliance will be addressed by the appropriate institutional office.

What Forms Do I Use and Where Do I Submit Them?

If you are a Graduate or Undergraduate Course Director:

If the students in your graduate or undergraduate course are conducting research involving human participants as part of a course assignment, and all students in the class are conducting the same or similar research, then proceed as follows:

  1. Complete the Generic Protocol: Course Related Research Involving Human Participants  linked in the Resources & Forms below
  2. Submit the completed Protocol Package (Protocol form, Consent document(s), copies of TCPS certificate(s) and other relevant documents linked in the Resources & Forms below) (such as survey tools, questionnaires, recruitment materials etc) to the relevant Unit level Delegated Ethics Review Committee

If you are an Undergraduate Student:

If you are conducting research involving human participants, as part of an undergraduate course assignment, or as an individual project (either for the class or for an undergraduate thesis), then proceed as follows:

  1. Complete the Individualized Protocol: Course Related Research Involving Human Participants, linked in the Resources & Forms below;
  2. Submit the completed Protocol Package (Protocol form, Consent document(s), copies of TCPS certificate(s) and other relevant documents linked in the Resources & Forms below) (such as survey tools, questionnaires, recruitment materials etc) to the relevant Unit level Delegated Ethics Review Committee  for review and approval.

If you are a Graduate Student:

  1. If you are conducting research involving human participants, as part of a graduate course assignment, then proceed as follows: 
    1. Complete the Individualized Protocol: Course Related Research Involving Human Participants linked in the Resources & Forms below;
    2. Submit the completed Protocol Package (Protocol form, Consent document(s), copies of TCPS certificate(s) and other relevant documents linked in the Resources & Forms below) (such as survey tools, questionnaires, recruitment materials etc) to the relevant  Unit level Delegated Ethics Review Committee  for review and approval.
  2. If you are conducting research involving human participants, in support of a Major Research Paper, then proceed as follows: 
    1. Complete the MRP Protocol: Research Involving Human Participants linked in the Resources & Forms below;
    2. Submit the MRP protocol package (Protocol, Consent document(s), copies of TCPS certificate(s)and other relevant documents linked in the Resources & Forms below) such as survey tools, questionnaires, recruitment materials etc) to your Supervisory/Advisory Committee for approval and signature;
    3. Submit the signed MRP Protocol package the relevant Unit level Delegated Ethics Review Committee for review and approval. .

All Faculties/Colleges/Schools are required to form Delegated Ethics Review Committees for the purposes of conducting ethics review of relevant research ethics protocols. For those Faculties/Colleges/Schools that are larger or have multiple disparate disciplines, departmental level committees may  be more efficient and effective for the review of discipline specific research ethics protocols. It is at the discretion of the Faculty/College/School to decide whether delegated ethics review can be undertaken by a single Faculty/College/School level review committee or multiple departmental level committees are most appropriate to meet their needs.  However, all programs must have a committee to which it can submit protocols for review and approval.

To support the delegated review process, the Office of Research Ethics has created the following documents that provide assistance to Delegated Ethics Review Committee members as well as administrative staff supporting them:

Delegated Ethics Review Committee – Resources 

Training for all Delegated Ethics Review Committees is provided by the Office of Research Ethics at scheduled training sessions in the fall or individually by contacting ORE at:  ore@yorku.ca and requesting a training session.

Faculty

Faculty members conducting research involving human participants can access all relevant forms (such as HPRC Protocol Form, Informed Consent Form Template, Renewal Application etc.) via YU Link.

Course Directors

Delegated Ethics Review Committee – Resources 

Graduate Students (Course-Related Research & MRPS Only)

NOTE:  For graduate students conducting research involving human participants for the purposes of a thesis or dissertation, please go to the FGS website for access to forms and documents.

Undergraduate Students

Indigenous Research

French Translated Application Forms

Please submit your complete application to ore@yorku.ca.