Human Participants

The Senate of York University affirms that researchers must respect the safety, welfare, and dignity of human participants in their research and treat them equally and fairly. The University values the academic freedom of its researchers, and the ethics review process should not be used unfairly to censor researchers who support unorthodox views. However, academic freedom is complemented by the requirement to respect the rights of human participants.

York University acknowledges the need for continuing interpretation and refinement of applicable policies to account for changes in research methods, contexts, and cultures.   It is imperative for researchers to strive for ethical conduct, and the ethical guidelines need to be refined and revised as necessary. Thus, continued awareness and debate of the topic in the research community is essential. The University's principal reference is the Tri-Council ( SSHRC, NSERC, CIHR) Policy Statement (TCPS): Ethical Conduct For Research Involving Humans, 2nd edition.

York University has formulated policy for conduct of research involving human participants. Ths policy is intended to serve as joint protection for the researcher, the study participant and the University in order to ensure attention to various rights and responsibilities of the respective parties to the research endeavour. The Human Participants Review Committee (HPRC) is responsible for ensuring that research involving human participants is consistent with the guidelines set by the University and the relevant regulatory authorities.

"It is the policy of the University that researchers intending to use human subjects for research purposes must obtain approval of their research protocol by the HPRC (or delegated ethics review committees for student research) before a grant application may be endorsed by the University and/or any research activities involving human participants may be undertaken."

For more information on obtaining ethics approval at York University, please email Wendy Jokhoo or phone 416-736-2100 x55201.

How and where to get Ethics Review and Approval

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 Graduate Student).

To better understand which ethics review process, form and committee is appropriate for your research, please consult the:

Decision Chart- Full Board and Delegated Ethics Review Processes.

 

Faculty
Graduate Theses, Dissertations and Pilot Projects
Course related research (Graduate, Undergraduate courses; Undergraduate theses, Independent projects and Graduate MRPs)

 

Faculty

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 Tuedsay.

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 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 Theses, Dissertations and Pilot Projects

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.

 

Course related research (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 HPRC 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.

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 Instructor:

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
  2. Submit the completed Protocol Package (Protocol form, Consent document(s) and other relevant documents (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;
  2. Submit the completed Protocol Package (Protocol form, Consent document(s) and other relevant documents (such as survey tools, questionnaires, recruitment materials etc) to the relevant Delegated Ethics Review Committee for review and approval. Please click HERE for the list of contacts for Delegated Ethics Review Committees.

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;
  2. Submit the completed Protocol Package (Protocol form, Consent document(s) and other relevant documents (such as survey tools, questionnaires, recruitment materials etc) to the relevant Unit level Delegated Ethics Review Committee.

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;
  2. Submit the MRP protocol package (protocol, consent document(s), and other relevant documents such as survey tools, questionaires, recruitment materials etc) to your Supervisory/Advisory Committee for approval and signature;
  3. Submit the signed MRP Protocol package the relevant Delegated Ethics Review Committee for review and approval. Please click HERE for the list of contacts for Delegated Ethics Review Committees.

 

FORMS

Generic Protocol – Course-related Research Involving Human Participants : (note: this form should be used by Course instructors only)

Individualized Protocol – Course Related Research Involving Human Participants

MRP Protocol

Renewal Application

Amendment Application

End of Project

Informed Consent Form

Other Documents and Forms

Information Resources

Course Instructor Responsibilities:

Student Researcher Responsibilities:

Guidelines