Getting to know your… R E B ESEARCH THICS OARD

What is the REB? Who are the members of the REB? When do I need to submit to the REB? How do I submit to the REB? What should I be aware of when submitting to the REB?

What is the REB? The REB is a resource for you to: protect you and your participants save you time encourage you and can provide guidance help enhance the rigour of your project facilitate your process of learning research help you do the best research you can

Purpose of the Sault College REB To review, deliberate, and approve or disapprove applications for participation in proposed research activity in the best interest of participants (students, faculty, staff, and public) and researchers.

Core Principles Underlying Research on Human Subjects Respect for persons Individual autonomy Informed consent Voluntary participation Privacy and confidentiality Beneficence Assessment and balance of real/potential risks/harms/ benefits Non-maleficence Minimize harm and maximize benefit Justice Selection of study participants Inclusiveness

Respect for Persons Individual Autonomy Informed Consent: - full information - voluntary (without coercion) - protect the vulnerable who cannot protect themselves

Respect for Persons (cont) Voluntary Participation: Statement that the study involves research Description of potential/actual risks & benefits Statement that participation is voluntary Statement how all records will be kept Statement describing the degree of record confidentially Disclosure of appropriate alternatives

Respect for Persons (cont) Confidentiality and Privacy: How public/private is the research setting? Confidentiality & Privacy: Remove or change personally identifiable information Storage requirements for all research data Sensitivity of the topic/data: Can responses/results affect the subject’s life if known by others? When appropriate, access to supportive resources will be provided

Beneficence: Doing Good Putting the study participants first Assessment of real and potential risks, harms, and benefits to study participants The benefits need to outweigh the risks

Non-Maleficence: Doing No Harm There is no pre-specified level for the unethical threshold of harm The risk/benefit ratio: making sure the benefits from the study outweigh the risks to individual participants

Justice “Treating individuals equally and fairly” Participant selection: Equitable distribution of research risks and benefits Equitable selection of participants within the population

Composition of the REB Council Full and alternate members 2 members with expertise in research 1 member knowledgeable in ethics 1 member knowledgeable in law (not associated with the College) 1 community member not affiliated with the College Additional members with diverse expertise will serve as alternates/ad hoc members Must include both men and women Institutional senior administrators may not sit on the REB College staff supporting the REB or attending an REB will do so in a non-voting capacity

When do I need to submit to the REB? All research involving human participants conducted: By Sault College students, faculty and staff On Sault College premises Using Sault College resources/facilities Elsewhere under the auspices of Sault College

Types of Application Reviews Exempt: “no risk” i.e. program evaluation Delegated: “minimal risk”. Typically reviewed by 2-3 REB members and chair Full Review: i.e. conflict of interest or potential risk to participants. Here the entire REB committee meets

When is REB submission required? REB’s review study proposals at inception (privacy of participant information, risk/benefit ratio, informed consent) REB’s monitor studies as they progress (continuing annual reviews, reporting of adverse events, unanticipated situations)

When is REB submission required? (cont) 3. REB’ s file final reports once the study is done (final reports kept on file at Sault College and posted on the website)

When is submission to the REB not required? Course evaluation only Research not involving human participants Research using public documents Student learning activities for the purpose of learning about research Quality assurance for College purposes

How do I submit to the REB? Go to the Applied Research Centre webpage: http://www.saultcollege.ca/services/AppliedRes earch/index.asp Contact Manager of Applied Research to request: Multisite Application Form Talk about what kind of information an applicant would have to outline on the Multisite form.

What should I be aware of when submitting to the REB? REB committee knowledge is only based upon the CLARITY of your study proposal and the COMPLETENESS of your REB application. Committee members are often outside of the applicant’s discipline so the applicant must write the application so it can be clearly understood. Key element: how HUMAN SUBJECTS are treated which should be the FOCUS of your proposal.

Some Common Concerns Conflict of interest statement Use of “informed” consent documents Vulnerable group protections Coercion: i.e. use of college students/class

Faculty Role In Student Projects Faculty is sponsor/supervisor of student work Faculty signature on the student research application to the REB means shared accountability from start to finish of the project. Identify each research team member’s role

Suggestions for Successful Applications Clear description of how participants will be recruited Copy of data collection tools Copy of research protocol Clear description: what participants will actually do Risk/benefit ratio assessment How you have minimized risks Privacy concerns identified How privacy concerns will be addressed Provide all components of informed consent Formal letter of agreement (when appropriate)

Websites Panel on Research Ethics: http://www.pre.ethics.gc.ca/eng/index/ TCPS Core 2: Tutorial: https://tcps2core.ca/welcome National Institutes of Health: http://www.nih.gov/

Case Scenarios

Scenario 1 Professor Jones asks her students to complete a survey at the end of the year to evaluate her course content and teaching style. She uses the results of the survey to improve her class for the following year. Who is the researcher? Who are the participants? Does this require REB approval? Why? Researcher: Professor Jones Participants: students Ethics: No Why/why not: For course improvement and not for research purposes

Scenario 2 Professor Smith asks all his students to complete a ‘getting to know you’ questionnaire on the first day of class so he knows which type of students are in his class and their reasons for enrolling in his course. Over the summer, he reviewed the responses from the last 5 classes and drew some conclusions regarding what type of student did well in his program. He wrote a paper summarizing these conclusions and is hoping to get it published. Who is the researcher? Who are the participants? Does this require REB approval? Why? Researcher: Professor Smith Participants: students Ethics: Yes Why/why not: Using the findings of the questionnaires to develop research conclusions and aimed at publishing the findings. Therefore, need to ensure that human participants were treated in a fair manner according to the ethical principles set out by the TCPS.

Scenario 3 A local family health team has developed a proposal for Sault College to track usage of their walk in clinic with the purpose of making recommended scheduled changes meet volume. Who is the researcher? Who are the participants? Does this require REB approval? Why? Researcher: family health team, Sault College partners Participants: none Ethics: No Why/why not: Because there are no participants; therefore, there are no concerns as to how human participants are treated in the research

Questions/Comments