Ethics in Human Research

ETHICS IN HUMAN RESEARCH

What Graduate Students Need to Know

Does my project need ethics review?

·  All graduate students who will be undertaking research involving human subjects for their thesis, dissertation, or other projects must have their project reviewed and approved by the University Research Ethics Board (REB) prior to starting their research.

What does “research involving human subjects” mean?

For the REB, research means: “a systematic investigation to establish facts, principles, or generalized knowledge.” It includes both quantitative and qualitative methodologies such as:

·  Surveys or questionnaires

·  Interviews and focus groups

·  Human sample (tissues)

·  Human testing (psychological, physiological)

·  Human behavioural observation

Human subject research which requires ethics review includes research that involves:

·  Living human subjects

·  Human remains, cadavers, tissues, biological fluids, embryos, or fetuses

·  Secondary use of data that was originally collected for a purpose other than

research

·  Observation of human behaviour in a natural environment

·  Third-party interviews (interviews of an individual for information about

another individual)

Human subject research that DOES NOT require ethics review includes:

·  Research which only uses available information (published reports and

literature, Statistics Canada data)

·  Observation of subjects at public meetings or political rallies

My project needs ethics review…what do I do?

FIRST

·  You must complete the on-line introductory tutorial for the Tri-Council Policy Statement: Ethical Conduct for Research Involving Human Subjects (TCPS) at the Research Ethics Board web site www.uwindsor.ca/reb under “Useful Links” or www.pre.ethics.gc.ca/english/. This tutorial, which takes approximately two hours, will allow you to become familiar with the first few sections of the TCPS and will provide you with a background on ethics prior to filling in your application. A printed copy of the certificate received upon successful completion of this tutorial must be included with your application.

SECOND

·  Prepare your submission. All ethics forms are available on the REB web site.

An application includes:

·  A completed checklist

·  A completed, signed application

·  Copies of questionnaires, interview guides, recruitment ads, or telephone

scripts

·  Copies of consent forms, information letters, etc.

Supplementary documentation includes (as applicable):

·  Research contracts

·  Permission or support letters from agencies

·  Clearance letters from hospitals or school boards

THIRD

·  Before you submit your project for ethics review, you must ensure that your research proposal has been carefully reviewed, approved, and signed by your supervisor or course/practicum professor.

FOURTH

·  Deliver the appropriate number of copies of your ethics submission and supplementary materials to the Research Ethics Coordinator, Office of Research Services, Room 309, Chrysler Hall Tower, no later than noon on the Wednesday prior to the REB meeting day. Meeting dates are listed on the REB web page.

What happens next?

·  Your project will be read and assigned for either full or expedited review based on the degree of risks to the research participants. The level of review is determined by the REB chair.

·  Projects that receive full review will be presented and discussed at the next monthly REB meeting. An email describing any necessary revisions will be sent to you and copied to your supervisor, within a few days of the REB meeting.

·  Projects that receive expedited review will be presented and discussed at the next weekly meeting. An email describing any necessary revisions will be sent to you and copied to your supervisor, within a few days of the meeting.

·  If your project requires major revisions, you should submit to the Research Ethics Coordinator sufficient copies of your revised documents for the full REB to review. Please observer the submission deadline when sending your revisions back to the full REB as they will be dealt with at a regular monthly meeting.

·  If your project requires minor revisions, you can submit them by email to the Chair of the REB and to the Research Ethics Coordinator as soon as they are ready (see “Where do I get help? below for email addresses). They are usually reviewed at the next expedited meeting. You may submit minor revisions either electronically as attached files, or as the required number of paper copies.

·  When you have successfully completed the requested revisions, your project will be approved by the REB and you (and your supervisor) will be notified by email. You may start your research immediately as of the effective date. You will receive a formal clearance letter shortly after your email notification.

How long does all this take?

·  If only minor revisions are needed, the review process can take as little as two weeks (from submission to email approval notification). This depends, in part, on how quickly you make your revisions. NOTE: Very few projects are approved without some revision being required.

·  If significant changes are required, there may be two or three rounds of revisions and the process will take longer, though generally not more than 6 or 7 weeks.

·  If, after the full REB has reviewed your application, there are major questions concerning your research, the REB may ask that you and your supervisor come to the next meeting to discuss the project and try to resolve the outstanding issues.

Once my project has been approved…what else is expected?

·  Each ethics approval is only for twelve months from the clearance date. If you complete your project prior to the expiry of your approval, you must submit a Final Report to the Research Ethics Coordinator. Please ensure that your supervisor signs this report.

·  If, after twelve months, your project is still underway, then you must complete a Progress Report form to have your approval extended for a further twelve months. Remember, once your project is completed the Research Ethics Coordinator needs to be notified as above.

·  Also, if you want to make changes to your methodology or to any of the research instruments or documents (consent letter, recruitment ads, etc.) during your research, you will need to submit these for review by using the Request to Revise form available on the REB web site. Amendments can usually be reviewed within a few days.

Where do I get help?

·  If you have any questions or need assistance with your application, you can contact Dr. Maureen Muldoon, Chair, University Research Ethics Board, Chrysler Hall North, Room 1165, ext. 2401, or Linda Bunn, Research Ethics Coordinator, Chrysler Hall Tower, Room 309, ext. 3916, .

·  Also check our web site at www.uwindsor.ca/reb for the review process and forms.