Hamilton Integrated Research Ethics Board
Faculty of Health Science
Course or Program Student Research Projects Ethics Clearance
GUIDELINES
(DO NOT SUBMIT THESE WITH YOUR APPLICATION)
Many undergraduate and graduate courses include class projects and activities designed to have students
engage in research. These projects may be carried out by individual students, small groups or as a single
class project.
The Faculty of Health Sciences wants to support instructors in providing research skill development
opportunities to student within the class-room context. Class exercises may not fit the standard definition
of research since the results are not intended for publication or generalization. Given that students are
typically novices in research, there are potential inadvertent risks to subjects particularly concerning free
and informed consent, privacy, data security, and psychological risk to participants.
Course or program research activities vary in scope, but may include:

having students conduct interviews, administer standard tests, or distribute questionnaires
to develop interview or questionnaire design skills;

conduct “mini” research projects where students pose research questions, gather data from
human participants, and analyse the data for presentation;

other activities that would be considered research within the disciplinary traditions in which
the course is being taught; or,

program evaluation activities that are not usually considered research but still need review
given that students are novice researchers and/or there are vulnerable populations
involved.
A.
Distinguishing Research from Case/Professional Skill Development
In some courses, the information gathering procedures and practices students are expected to use are
exclusively required for teaching or professional development purposes. These practices are not conducted
within a research framework. For example, professional faculties have students conduct interviews as
part of skill development or individual knowledge acquisition. Information gathering projects within these
situations are not subject to HiREB review requirements, however they must align with the appropriate
professional standards or codes of conduct and review processes required by the relevant Faculty.
Instructors who are uncertain as to whether a learning activity or project falls outside the scope of the
criteria outlined in this document should contact the Research Ethics Officer, Janice Sancan, at
sancan@hhsc.ca.
B.
The Application Process
1.
The Instructor(s) for the course takes the role of principal investigator(s) and submits a signed
application form with all documentation to the Student Research Committee of HiREB.
2.
The application also needs to be signed by the Instructor(s) Department Chair. This Department
Chair should be the same Chair through which the course is offered.
3.
All Instructors will be required to submit evidence of the Good Clinical Practice Guideline (GCP)
http://fhs.mcmaster.ca/healthresearch/GCP.html or Tri-Council Policy Statement (TCPS2) training
http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/ at the time of application
submission.
3.
All students in the course will be required to submit evidence of the Good Clinical Practice Guideline
(GCP) http://fhs.mcmaster.ca/healthresearch/GCP.html or Tri-Council Policy Statement (TCPS2)
training http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/ to their instructor prior to
commencing their assigned research project.
4.
If the student projects are to be carried out at other institutions or agencies (such as schools,
hospitals, government agencies etc.) students should be aware that approval granting permission
to access premises or to obtain private information from the other institution may be required, and
should be obtained, where appropriate. Typically, letters of support would be required by HiREB at
a later date.
5.
All forms related to approving the ethical acceptability of each student’s project must be retained
by the instructor for a period of two years. HiREB may request to review previous years’ projects.
6.
Course-based ethics approval is maintained for five years, provided that there are no changes to
the course assignments. One year updates will be required with examples of previous years’
projects submitted with the update. If changes are made a “Amendment Request” form must be
completed and submitted to the Research Ethics Officer, Janice Sancan, at sancan@hhsc.ca. All
sections of the course, whether on campus or not, must follow the procedures, and all Instructors
must ensure that these policies are complied with.
7.
All questions and clarifications concerning the interpretation of these guidelines should be directed
to the Research Ethics Officer, Janice Sancan, at sancan@hhsc.ca.
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Hamilton Integrated Research Ethics Board
Faculty of Health Science
Course or Program Student Research Projects Ethics Clearance
Please complete this form if you are an instructor and you wish to oversee the conduct of
course or program student research, in accordance with the Guidelines for Ethics Review of
Course-Based Research Projects Involving Human Participants.
Protocol#:
DATE:
COURSE NAME & NUMBER:
COURSE TITLE:
DEPARTMENT OR PROGRAM:
NOTE: This form is to be completed by the course coordinator if more than one instructor is teaching the
course.
Cross-listed as:
Name of instructor reviewing student research:
How many sections of this course?
How many students are enrolled (or estimated) in this course?
How many separate projects are anticipated?
COURSE
CO-ORDINATOR
CAMPUS
ADDRESS
PHONE NUMBER
(if course is team
taught)
INSTRUCTOR(S)
E-MAIL
(address you regularly
use)
CAMPUS
ADDRESS
PHONE NUMBER
E-MAIL
1.
Has an Approval for a Course-Based Research Project been obtained for this course on any prior
occasion?
YES
NO
DON’T KNOW
2.
If Yes, please provide the following:
Name of Instructor who received approval:
Department/program:
Name of course if different from the above:
Was this a 3 or 6 unit course when clearance was previously obtained? 3 units
Name of Research Ethics Board or Committee that issued the clearance:
Date of the clearance and clearance number if known:
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2/8/2016
6 units
3.
ASSIGNMENT PURPOSE AND METHODOLOGY: Describe in the space below, the projects you
will be requiring your students to complete (e.g., surveys, participant observation, interviews etc)
and the purpose of these projects. You may write a description for the Ethics Committee or attach
the written explanation that you will be providing to students and a course outline.
3b.
Describe the training will you give your students in the ethical conduct of research.
Will you require support from the Student Research Committee of HiREB? If so, please
indicate.
5.
INSTRUCTIONS PROVIDED TO YOUR STUDENTS: What written or verbal instructions will you
provide your students regarding the following?
a.
Recruitment of study participants
b.
Obtaining consent from study participants
c.
Explaining participants’ right to withdraw from the research project
d.
Confidentiality of data and data security
e.
Feedback for participants about the study (where applicable)
f.
Assessing and minimizing risk to participants
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g.
6.
Describe how you, as course instructor, will review and approve the course projects
proposed by your students, if they are not using the same standardized materials.
SUPPORTING MATERIALS: Please provide copies of the following materials:
a.
Full course outline
b.
Handouts pertaining to the assignment
c.
Sample Letters of Information/Consent Forms that students will be using
(Samples of these materials can be found on the ethics website:
http://fhs.mcmaster.ca/healthresearch/hireb/forms.html)
If applicable, please also provide copies of:
d.
Any standardized recruitment materials that you may be using (i.e., posters, email,
telephone or verbal scripts)
e.
Any standardized data collection instruments that you may be using (survey
questionnaires, test instruments interview guides.)
f.
Any standardized participant feedback/debriefing materials that you may be using
g.
Any standardized consent forms
Other comments you feel may be relevant:
8.
Instructor’s Agreement
In submitting this application, I acknowledge that:
I have reviewed the Hamilton Integrated Research Ethics Board, Faculty of Health Science, Course
or Program Student Research Projects Ethics Clearance and I agree to comply with the
requirements of those guidelines and to ensure that the design of all student projects will fit within
the criteria for course-based student projects. I understand that I will have to submit for annual
renewals and will need to reapply for a course-based ethics approval after 5 years.
I am familiar with and agree to abide by the ethical guidelines and policies of McMaster University,
including the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans and of
my profession or discipline.
I will meet with the student investigators to actively monitor the research progress, and I will make
myself available, should problems arise during the course of the research, to supervise the
students and assist in solving such problems.
If I have questions about the ethical conduct of this research I will contact the Research Ethics
Officer, Janice Sancan, at sancan@hhsc.ca.
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Course Instructor
Date
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Course Instructor
Date
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2/8/2016
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Course Instructor
Date
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Course Instructor
Date
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Name of Department
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Name of Department and/or Program Chair
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Department Chair Signature
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Date
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