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Navigating Research Ethics: RISe to the occasion. Heather Lovelace November 1, 2012. Topics. Online Resources The research process and the ethics process Why study approval? What study approval procedure involves Health authority UBC – the RISe online system - PowerPoint PPT Presentation
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Navigating Research Ethics: RISe to the occasion
Heather Lovelace
November 1, 2012
TopicsOnline ResourcesThe research process and the ethics processWhy study approval?What study approval procedure involves
Health authorityUBC – the RISe online system
Behavioural vs Clinical Ethics committeesExpedited vs full reviewsKey deadlines
Online Resources
Research Modulehttp://dieteticsinternship.landfood.ubc.ca/dieteti
cs_internship_docsKey items for review (links available in research
module):Research project planning checklist (page 9-13)RISE guidance notesSample intern research guidance notesLocal/Health Authority Specific Research Ethics
Board Information (see project requirement/resources list)
Project Planning Checklist
Your best friend in research…keeping you organized!
The Research Process
Critical parts of the process
Research questionStudy DesignResearch ProposalEthics Review
Processes are simultaneous, require constant communication and include a feedback loop
You have a research questions and a study
design…
Now what?
Study Approval
Two levels of research ethics boards exits University (UBC…among others) Health Authority (7 in BC)
Applications are simultaneous processesWhy do separate ethics boards exist? Why do we require two separate ethics
proposals?
Health Authority vs UBC Approval
UBC/Shared GoalsTri-Council PolicyProtect subjects
PrivacyConfidentialityConsent
Avoid conflict of interest
Promote inclusiveness in research
Health AuthorityProtect subjects
As earlier, considers FIPPA (Free of Information in Protection of Privacy Act)
May be collaborative with or independent from UBC
Organizational ImpactUse of resources (human,
capital, IMIT, other)Liability
Management approvalSimultaneous Processes
Health Authority Approach Varies (see online resources for links)FHA*, IH*, NH*, VIHA*, VCH
UBC approval + Health Authority Specific Health Research Ethics Board (REB); *REB includes organizational requirements
NHA – may complete UBC or UNBC REB VCH – must complete VCHRI Approval to Conduct Research; this
addresses resource use and management approvals not captured elsewhere
Note: due to a multi-site project between PHSA-BCCA, NH and VIHA interns
PHSA, NH and VIHA interns will be using the PHSA-BCCA RISe process (so do not have to apply to local Health Authority Research Boards).
•Note: Information is specific to internship and UBC Ethics may/may not be included for post-graduate research.
Health Authority Approach Varies (see online resources for links)Providence Health and Provincial Health
Services Authority (BCCA/BCCW/CYMH)UBC ethics required + site specific ethics required
(Providence ethics/BCCA/BCCW/CYMH Ethics) UBC + site specific ethics all submitted via RISe
Organizational requirements: A Certificate of Ethical Approval issued by one
of the UBC Research Ethics Boards A site specific Health Care Institutional
Certificate of Final Approval - signed by the VP of Research & Academic Affairs.
•Note: Information is specific to internship and UBC Ethics may/may not be included for post-graduate research.
RISe – Research Information Serviceswww.rise.ubc.ca
RISe access
Researcher numbers Required for system access/first time you log onto RISeAssigned in the May professional practice course
• Check your email (inbox and TRASH)• No number? Contact DEC (Tamar)
Access using CWL“Sandbox” (mock site) is available
http://rise.ubc.ca/sandbox.aspResources to allow user to experience different RISe
Modules without affecting live data on the system. E.g., researchers including graduate and undergraduate
students are able to work on different research compliance protocols without affecting their live data.
Creating a New Ethics Application
Selecting a Research Ethics Board
Two Research Ethics Boards (REB) at UBC
Behavioural Involving interaction with
subjects (but no invasive procedures, e.g., taking blood)
Examples:SurveysFocus groupsCombination chart
review and patient interviews
Clinical Involving invasive
procedures Examples:
Drug trialsSurgical/medical
intervention trial
OR Anonymous retrospective
chart review
“BREB”
“CREB”
Separate processes; different ethics applications
Two Review Categories
ExpeditedBehavioural: Surveys,
questionnaires with competent individuals
Clinical: Anonymous chart reviews, reviews of databases
No specific deadline, can be submitted anytime
Full board ReviewAll othersSpecific deadlines to
coincide with monthly meetings
For each submission, researcher is asked whether project would qualify for expedited review, but research board decides
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We’ve selected a REB… Now what?
Completing the Ethics Proposal
Who does what and when?
Principal investigator (PI) Role of PI
Reviews proposal and presses “submit” for proposal and provisos For approval purposes, must be a UBC Faculty Member or
Staff memberTamar, most core-site coordinators, some research preceptorsNote: if Tamar is not the PI, must be listed as co-investigator in
order to access/review your RISe submission
Role of Research PreceptorsResponsibility is to be the PI or co-investigator and review all
documents before they are submitted
Who does what and when?
“Department Head” LFS Associate Dean Research Must approve all projects
Other investigators (aka YOU) Prepare submission (answer the questions) and prepare
attachments
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Ethics proposal: Answering the QuestionsConsider the type of question being askedQuestions are free standing risk
assessmentsassessment of the risk to participants and
researchersdetermine how you intend to deal with those
risks and if appropriate safeguards are in place
Ethics proposal: Answering the QuestionsExpect standards questions to focus on:
Researchers, relationships, funding sourcesResearch methods, including consent
processes, in/exclusion criteria, peer review, data management, disclosure, risk/benefit
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Key Areas Consent
free, ongoing, before study begins; undue inducement, coercion, incentives
Conflict of interest interpersonal, economic or financial relationships must
not jeopardize research integrityFairness
particular individuals or groups must not bear unfair burden of participating in or not benefiting from research Vulnerable groups: women, children, people who lack
capacity to consent
Research Method Is your proposed methodology adequate to identify an
answer?
HINT
Remember to review the guidance notes when answering
questions…
Submitting your Research Proposal as part of your Ethics Proposal
Read and refer to guidance notes frequentlyKnow the specific requirements for how to label
documents, including version numbers, use of headers/footers, page numberingUse their language whenever possible
• No detail is small enough to avoid escape!• E.g., provisos have been generated to deal with
attachments that did not have page numbers or appropriate version statements
Research proposals must be included in your submission
Sample Submissions
Sample Submission included in Research Module Planning ChecklistSample Survey SubmissionSample Chart Review Submission
We’re ready to submit…
What happens next?
Approvals vs. Provisos
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Provisos – concerns identified by reviewers
Issues of concern identified by Board reviewers…Ethical concerns
Research design puts participants at risk Consent is not free of undue inducement Incongruent dates (research that is set to begin before ethics
approval could be reasonably expected)Procedures not followed
Missing logos/letterhead or missing information from consent letter
Study proposal not attached Researchers did not indicate completion of TCPS
Must provide response and updated forms Be careful not to change ANYTHING other than what you have
been asked to address
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Important!
The first response to a proviso may not be accepted
Study cannot commence until approval certificates have been received from both UBC and health authority!
Ethics Submission Deadlines
See algorithmFirst Friday in December: RISe submission
completed and ready for Tamar to review no later than 9 AM. Tamar only has one afternoon to review and submit
for approval
RISe to the occasion: lessons learned
The early bird catches the wormIt’s never too early to start, but “too late”
happens quicklyKnow your deadlines and plan to beat them
Miss a deadline? Potentially delay your project by a month or more!
RISe to the occasion: lessons learned
Be systematicAs soon as you start developing your research proposal
Start your RISe submission Review appropriate RISe guidance notes Use their language, it can make the difference between an
approval and a proviso!
Review and understand your HA requirementsCheck your assumptions
Sometimes additional forms are required – e.g., approval to conduct research, financial sign-offs, manager signatures
May have to investigate to determine who should sign Don’t assume a manager is readily available to sign your forms
Health Authority Requirements
Common Question – who is the PI on Health Authority (HA) Forms?Refer to Research Module Appendix 2Site specificGenerally, PI must be an employee of the HAConsult REB instructions at your HAWork with research preceptor and Tamar if
there is confusion
Practical Advice for completing internship research on time
Meeting Your Target
Know your deadlinesWhen is your final presentation/paper due?What are the program expectations?What are your preceptors expectations?
Set timelinesUse the Internship Research Process Algorithm
Find “due dates” for health authority specific requirements
Communication
Ensure that preceptors know your timelinesSee handout on suggested timelines
Set regular meetingsMeet at regular intervalsAgree on schedule in advanceFace to face
Be clear Identify the issues/problems you need assistance withSeek outside advice
Know Your Resources
Internship Research Process AlgorithmWho can help you find where to start?
Clinical experts (RD’s with experience in your area of research)
Expert knowledgeHelps define the limits of your literature searchPerspective on the “issue” or questionMay be able to provide key references as a starting
point
Know Your Resources…
Research Module (multifunctional resource)resources and remindersLinks and guidance for ethics, research
process, including internship specific examples
Library Search Engines/Online journalsAccess to MedLine/PubMed via acute care
hospital; UBC online journals available from home
SummaryFormulate research Q
Prepare LOI and proposal (for approval by Research Advisory Committee)
Logon to RISE (UBC):
1. Set up project title
2. Provide required information
3. Attach files (consent letters, proposal, forms, etc.)
Response from research board
PI presses “submit”
Research preceptor and PI review proposal
Complete and submit health authority approval docs
LFS Associate Dean Research reviews and approves proposal
Waiting (check meeting dates for ethics board if full review)
Address any provisos (PI must press “submit”) Obtain approval
certificate(s)
Begin study!
And finally…
This is an occasion to RISe to…