12) If an undergraduate student is conducting an experiment that uses the fMRI scanner, is this considered minimal risk (and therefore covered under the generic ethics protocol form), and/or do they need to apply for ethics approval through HRPC?
1) FACULTY RESEARCH:
All faculty research involving human participants (even if it is minimal risk) must obtain approval from York's Human Participants Review Committee (HRPC). Additional information can be obtained from the Office of Research Ethics.
All research undertaken by undergraduate students under the auspices of the Department of Psychology must be supervised by a full-time faculty member from the Department or by a qualified supervisor approved by the Undergraduate Program Director.
All undergraduate students conducting research (whether using human participants or not) must complete the Tri-Council Policy Statement (TCPS2) tutorial. Once completed students should submit one copy of the certificate of completion to their supervisor and one copy to the undergraduate research coordinator. Note: TCPS2 certificates expire after 2 years and must be renewed. The certificate must not expire before the completion of the proposed research (thus, often new TCPS2 certificates must be submitted with ethics protocols). After completing this tutorial there are 3 pathways for obtaining ethics review and approval for research involving human participants. See point 6 below regarding research with animals. Appropriate ethics approval must be obtained before any research begins.
1) If the supervisor intends to be involved in the dissemination of the results, use the findings as a pilot study (or is for any other reason considered a collaborator), then the supervisor is responsible for obtaining ethics approval from York’s Human Participants Review Committee (HPRC). In order to develop the ethical competence of undergraduate researchers Form 2 must also be completed by the student with the guidance and instruction of the supervisor. Documentation of ethics approval from HPRC (i.e., letter from ORE) and page 1 of Form 2 must be submitted to the course director. This submission ensures a) the department has a record of all undergraduate research and b) that the undergraduate student has been oriented to research ethics through the completion of Form 2. Undergraduate student researchers seeking access to the Undergraduate Research Participant Pool must present a copy of the approval letter and certificate number from York’s HPRC.
2) If the supervisor is serving a purely supervisory and non collaborative role (typically a course director), and the proposed research does not involve animals, and is minimal risk, then the supervisor may choose to submit the proposed research to either York’s HPRC or the Department of Psychology Research Ethics Board (Psychology REB). If the proposed research is submitted to the Psychology REB it must be accompanied by a cover letter from the supervisor indicating they are serving a purely supervisory role for the project. The cover letter and Form 2 should be submitted to the Psychology Ethics Board through the Undergraduate Office (firstname.lastname@example.org), BSB 291. The student, with the guidance and instruction of the supervisor, should complete Form 2. This submission to the Psychology REB ensures a) the proposed research has been reviewed and approved by an ethics review board and b) that the department has a record of all undergraduate research. Undergraduate student researchers seeking access to the Undergraduate Research Participant Pool must present a copy of the approval letter from the Psychology REB. Upon completion of research approved via Form 2 the supervisor and student must complete and submit Form 3 (Confirmation and Reporting) to the Psychology Ethics Board through the Undergraduate Office (email@example.com), BSB 291.
3) If the research is happening in the context of a course (such as 4170 or 4175) where the course director is simultaneously supervising multiple students or research projects, and the proposed research does not involve animals, and is minimal risk, then the course director/supervisor may choose to submit Form 1 (generic Protocol for Course-related Research Involving Human Participants) to Psychology Ethics Board through the Undergraduate Office (firstname.lastname@example.org), BSB 291. In such circumstances the course director/supervisor provides oversight, ensuring that each undergraduate researcher is conducting their research ethically in accordance with regulations and standards stipulated in Form 1 . This submission of Form 1 to the Psychology REB ensures the proposed research has been reviewed and approved by an ethics review board. In order to develop the ethical competence of undergraduate researchers Form 2 must also be completed by the student with the guidance and instruction of the supervisor/course director. Page 1 of Form 2 (signed by the course instructor) must be submitted to the course director . This submission of Page 1 of Form 2 to the course director ensures a) the department has a record of all undergraduate research and b) that the undergraduate student has been oriented to research ethics through the completion of Form 2. Upon completion of the course the course instructor and student must complete and submit Form 3 (Confirmation and Reporting) to the Psychology Ethics Board through the Undergraduate Office (email@example.com), BSB 291. Undergraduate students conducting research that has been approved via Form 1 (i.e. within a course such as 4170) are not normally allowed access to the Undergraduate Research Participant Pool.
3) RESEARCH BY GRADUATE STUDENTS:
All Graduate student research involving human participants (i.e., research undertaken in connection with graduate courses, Major Research Papers, Theses, Dissertations, and independent research) is subject to Ethics Review.
As of 2005 all graduate students proposing research that involves human participants are required to complete the Tri-Council Policy Statement (TCPS2) tutorial, available online. The tutorial is available in English (TCPS Tutorial) and French (Didacticiel sur l’EPTC). Once they have completed the tutorial (a time commitment of about 2 hours) students are to submit the tutorial completion certificate, available online, to their programme office. The certificate will then be placed in the student’s file. The graduate program director or assistant will be asked to confirm its presence when they forward the TD1 form to FGS. Students who conduct research involving human participants within course assignments or Major Research Papers (MRPs) will have to meet the same requirement; the TD2 form. These aforementioned forms can be found on the FGS webpage under Forms and Documents, click on the document next to FGS Human Participants Research Protocol Form (TD2).
If the research is done in collaboration with the graduate student's supervisor, or is a part of the supervisor's program of research, then the research must be reviewed by the HPRC as Faculty research.
Graduate students should consult with the Graduate Psychology Office for all other research. They will fill out a checklist that directs them to either FGS (for submission to FGS, see instructions on the FGS website or to the Psychology Department Ethics REB (through the Graduate Office). It is the graduate student's responsibility to ensure that ethics approval is obtained prior to undertaking research.
4) RESEARCH CONDUCTED BY STUDENTS IN COURSES ( undergraduate and graduate ):
For course-related research in courses OTHER THAN the undergraduate thesis course, wherein students are engaged in the same (or similar) data collection activities to fulfill a course assignment, the course director must submit Form 1 and Form 2 , the generic research protocol to the Psychology REB to get ethics approval for the data collection, and Form 3 must be filled out and submitted (to the Psychology Ethics Board through the Undergraduate Office (firstname.lastname@example.org), BSB 291; or in the case of graduate research through the Graduate Office) upon completion of the data collection.
5) RESEARCH WITH MINORS ( applicable to everyone ):
It is your responsibility to complete any appropriate forms and be aware of each organizations unique guidelines and procedures.
York's HPRC has established the following guidelines for research involving minor age participants:
1. For participants under the age of 16, parental consent is required.
2. For minimal risk research involving participants 16 years of age and older, parental consent is not required.
3. For more than minimal risk research involving participants 16 – 17 years of age, parental consent may be required.
As there may be contexts in which the guidelines may not be appropriate, it is advised that when utilizing participants under the age of 18, you should consult with the organization that you are working with and the Office of Research Ethics (ORE) for advice and direction where needed as to the applicable consent processes.
6) RESEARCH WITH ANIMALS:
All research involving animals is governed by the Ontario Animals for Research Act, 1968-69 (the Act), implemented by the Ontario Ministry of Agriculture and Food, Animal Industry Branch (the Ministry), and by the Canadian Council on Animal Care (CCAC). York has an Animal Care Committee (subcommittee of the Senate Committee on Research) which has developed Animal Care Protocol Instructions as well as other documents available on the York Research Webpage on Animal Research (York Passport userid and password required).
No students should be conducting independent research with animals--their projects should all come under the 'umbrella' of their supervisor's work, which will have received approval from York's Animal Care Committee (ACC). So the student should talk to the supervisor to find out how ethics approval is obtained. Each approved animal protocol is given an approval number and there is an official letter from the ACC.
8) CHOOSING BETWEEN SUBMITTING TO REB OR HPRC.
Whether you submit to the departmental REB or HPRC is dependent on whether you are a faculty member (see point 1 above), undergraduate student (see point 2), or graduate student (see point 3), or conducting fMRI research (see point 12). Please refer to the appropriate section for the details.
9) CORRECT CONTACT INFORMATION ON CONSENT FORM FOR ETHICS/RESEARCH CONCERNS.
The department research ethics board (REB) is acting for the university HPRC, therefore Ms. Alison Collins-Mrakas is still the correct person for ethics concerns, and for questions about the research, the student's supervisor is the correct person. The following can be included on consent forms : “ This research has been reviewed and approved by the Department of Psychology’s Research Ethics Review Committee within the context of York’s Senate policy on Research Ethics. If you have any concerns about any of the ethical aspects of the study you can contact the university’s Research Ethics senior manager and policy advisor of the university Human Participants Review committee, Ms. Alison Collins-Mrakas at 416-736-5914. If you have questions about the research in general or about your role in the study, please feel free to contact the faculty supervisor of this research, Dr. xxxx either by telephone (416-736-2100 xxxx) or by e-mail (email@example.com) "
10) IMPLEMENTATION OF POLICY AND GUIDELINES RELATED TO RESEARCH AND ETHICS.
Responsibility for implementation of policy and guidelines resides in the Office of Research Ethics (ORE)
11) Researchers conducting surveys on-line must obtain consent from the participants. Recognizing that obtaining a signature is not feasible; researchers are advised that consent must be obtained in an alternate manner. Implied consent, meaning that participants do not explicitly consent to participate by signature or by virtue of completing the survey is NOT permitted as per TCPS guidelines. See the Office of Research Ethics (ORE) website on research ethics for further details.
12) Experiment that uses the fMRI scanner, is this considered minimal risk? No. All research studies that use fMRI are by definition NOT minimal risk. Ethics for such studies must first be approved by HRPC before the study can be implemented.