H OW TO PREPARE AN APPLICATION TO THE REB Jennie Prasad, Manager U B C C H I L D R E N ’ S A N D W O M E N ’ S R E S E A R C H E T H I C S B O A R D ( U B C C & W R E B )
OVERVIEW 1. Institutional and national policies that outline & guide the UBC ethics process 2. Do you need ethics approval? 3. RISe application 4. Subject Consent/Assent 5. Institutional Approval 6. Post-Approval Activities 2
UBC POLICIES THAT OUTLINE/GUIDE THE PROCESS • UBC Policy 85 – Scholarly Integrity • UBC Policy 89 – Research and Other Studies Involving Human Subjects • UBC Policy 97 – Conflict of Interest and Conflict of Commitment http://universitycounsel.ubc.ca/policies/scholarly-activity/ 3
TRI-COUNCIL POLICY STATEMENT (TCPS2) • Overarching Canadian policy framework for research involving human participants Effective September 1, 2016 – all study team members are required to • complete the TCPS2 tutorial • Ensure your RISe profile is updated with this information • Link to TCPS: http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf Link to tutorial: http://www.pre.ethics.gc.ca/eng/education/tutorial- • didacticiel/ 4
DO I NEED REB APPROVAL? • TCPS2 defines research as: “An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation” • involves living human participants and/or human remains, cadavers, tissues, biological fluids, embryos or fetuses derived from living and deceased individuals. • Also includes data that has been previously collected (secondary use) 5
ACTIVITIES NOT REQUIRING REVIEW • Quality assurance & improvement studies, program evaluation & performance reviews Comes down to intent – are you asking a research question? • • Checklist may be helpful http://www.aihealthsolutions.ca/arecci/screening/163134/746e90fb9a80 5aedec3064e7c1c27b9e • Note a desire to publish does not necessarily mean that ethics is required • QA/QI data that you want to later use for research is considered secondary use of data and REB review is required • Refer to TCPS2 Article 2.5: http://www.pre.ethics.gc.ca/eng/policy- politique/initiatives/tcps2-eptc2/chapter2-chapitre2/#toc02-1a 6
WHAT IF YOU WANT TO USE QA/QI DATA FOR RESEARCH PURPOSES? Data collected for QA/QI or assessment purposes but later proposed for research would be considered secondary use of data (see TCPS2, Article 2.5) Secondary use of anonymously collected data does not require REB review (Article 2.4) Secondary use of identifiable data (including de-identified and anonymized data) does require REB review 7
DEFINITIONS Anonymous : The information never had identifiers associated with it (e.g. anonymous surveys) and risk of identification of individuals is low or very low. Anonymized : The information is permanently stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re- identification of individuals from remaining indirect identifiers is low or very low. De-identified : The individual's identifying information has been removed, and there is no reasonable basis to believe that the information could be used to identify an individual. • De-identified data may be coded (e.g. via a confidential master list created by the researcher) so that the information can be linked to the individual and his/her clinical or other records. 8
UBC RESEARCH ETHICS BOARDS (REBS) Behavioural REB (BREB) Clinical REB (CREB) UBC Okanagan Providence Health Care BC Cancer Agency Children’s and Women’s 9
TO WHICH BOARD SHOULD YOU SUBMIT YOUR APPLICATION? REB should be chosen based on the following: • Principal Investigator’s primary affiliation • Primary site where study is being conducted If study is being conducted at more than one UBC-affiliated institution (i.e. C&W and VGH) use the above as a guide when choosing your REB UBC REBs have a one board of record agreement 10
TYPES OF ETHICAL REVIEW Minimal Risk (Delegated Review) • No greater risk than everyday life • Examples include: • Chart reviews • Case studies (more than 2 cases) • Questionnaires or surveys Full Board • Everything else • There are situations where Minimal Risk studies need to be reviewed at Full Board, e.g. creation of a tissue bank, altered consent process, genetic research • Any Minimal Risk study can be referred to the Full Board if the reviewer feels it should be reviewed at the Full Board 11
C&W REVIEW PROCESS All applications must be submitted online via RISe The C&W REB meets once a month to review Full Board applications Check the REB website for submission deadlines (http://bcchr.ca/research-support/reb) Minimal Risk applications are reviewed as they are submitted Do not expect to have your application approved the first time through. Provisos (changes requested by the REB) are typical, not the exception 12
TYPES OF RESEARCH The C&W REB reviews both clinical and behavioural research Clinical research involves clinical trials, review of clinical charts, collection of blood and tissues Behavioural research includes questionnaires, interviews and focus groups Once you select the board, the appropriate application will open automatically 13
RESEARCH INFORMATION SERVICES (RISE) You will need a Campus-Wide Login (CWL) Account • https://it.ubc.ca/services/accounts- passwords/campus-wide-login-cwl Step by step directions for accessing RISe: • http://www.rise.ubc.ca/content/how-register-access- rise RISe tutorials • http://www.rise.ubc.ca/content/tutorials-and-guides 14
Ensure that you have included all your appointments and affiliations in your profile. If you have not done so already, click on your name to edit your profile. Ensure that your are using the “PI & Staff” role by clicking on the link.
Page 1 of the Application Begin by selecting the Principal Investigator. If you have previously held a PI role, this field may automatically be populated with your name. Guidance Notes are located in the boxes to the right of the application form. They include detailed explanations of the questions, instructions on how to fill out the form and useful links to documents and contacts.
VARIOUS STAGES OF THE RISE APPLICATION FORM 17
COMMON CHALLENGES WITH SUBMISSIONS Administrative • Submit to the appropriate REB and for appropriate level of review Submit with enough time for your Department Head to sign off in • order to meet the Full Board deadline • Ensure all fields in the application form are filled out as appropriate, and that this information matches what is written in the study documents Ensure all documentation attached to page 9 opens properly, and that • version numbers and dates match the application form Proviso/Deferral Responses • Ensure that all amended documents have requested changes TRACKED or HIGHLIGHTED Include a letter outlining each proviso and how they have been • addressed 18
DOCUMENTATION REQUIREMENTS Full protocol with appropriate section headings and references. A grant application is not sufficient Consent and assent forms as needed Data collection form Any other documents – surveys, questionnaires, telephone scripts, advertisements – anything that a potential subject might see 19
CONSENT Consent is generally necessary in all situations where researchers prospectively gather data from individuals under a research protocol A waiver of consent can be requested and is normally approved for retrospective research USE THE TEMPLATE! Most provisos come from not reading the template and missing required wording. Ensure that any statements that don’t apply are not included; use best judgment. Please have someone proof read your consent/assents. People without a scientific background are good people to judge whether or not it is an acceptable reading level and would be objective enough to spot spelling/grammar mistakes. ***CONSENT IS A PROCESS, NOT JUST A FORM*** 20
ASSENT An assent form is a simplified consent form that allows children or those that lack capacity to participate in research by agreeing to or ‘assenting’ to their participation Assent forms are required for research involving children 7 years and older The general guideline is for a 1-2 page form for children 7-13 years of age and then depending on the complexity of the study, a more informative form for adolescents under 19. If an adolescent is capable of reading and understanding the consent form then they should sign the consent form instead A consent form is NOT a legal document and the age ranges are a guideline. It is up to the PI to determine whether a minor has the capacity to assent or consent to a study Long term studies will be asked to provide a plan for consenting subjects when they become capable of providing consent rather than assent 21
INSTITUTIONAL APPROVALS Research cannot begin until you have both an REB certificate of approval AND an institutional approval certificate Program utilization forms can be found on our website – send in as soon as possible You may need other program sign off than what we have asked for – let us know 22
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