The Application Guidance Notes (AGNS) provide question by question guidance for filling out the UBC Clinical research ethics application. These can be seen once you click the blue question mark 
within the form.
It is recommended that researchers click on the guidance note while filling out the application. To see a list of all application guidance notes, please see Application template.
The AGNs are connected with the main UBC Clinical Guidance notes (GNs). The main GNs are UBC's overarching clinical guidance notes and are a less administrative discussion of UBC's ethical framework. There are links between the two sets of guidance notes, where applicable, to avoid redundancies.
Guidance Notes by Section
Part A1: The Roles and Responsibilities of the Researcher and the Research Ethics Board
Part A2: The Principles of Review
Part B: RISe Application Guidance Notes (AGNs)
Post-Approval Guidance Notes
Appendix: Acronyms and Glossary
RISe Application Guidance Notes
The Application Guidance Notes following this Introduction correspond to the questions in the UBC online Clinical Application for Ethical Review. The online application form is divided into pages or views with required fields in each view which will prevent you from proceeding to the next page unless you have completed all of the required fields. Required fields are marked by a red asterisk in RIse. While only some fields are "required", it is recommended that all fields are completed in the application form, marking "N/A" for questions which do not apply to your study.
If you wish to search for a specific term in the page, please first expand all of the content.
Page 1: Study Team, TCPS 2, and Study Title
1.1 PRINCIPAL INVESTIGATOR
box1pt1 Please select the Principal Investigator (PI) for the study. Once you hit "Select", you can enter the PI's name, or enter the first few letters of his or her name and hit "Go". You can sort the returned list alphabetically by First name, Last name, or Organization by clicking the appropriate heading.
The PI bears the overall responsibility for the conduct of the study and is required to act within the guidelines of the TCPS2.
UBC affiliated PIs must have a faculty appointment (Clinical Assistant Professor, Clinical Associate Professor, Clinical Professor, Assistant Professor, Associate Professor, Professor or BCCA Investigator) OR is deemed a PI by an affiliated institution or by a Dean. Non-UBC affiliated PIs will be present here, if allowed by your institution, e.g. harmonized applications being processed through Research Ethics BC (REBC).
If you cannot find the PI's name in the list, have it added into the RISe system by emailing the following information to RISe Support: Full Name (Including Middle Initial), Department (or affiliation with the University), UBC Rank, Email Address, Phone Number and UBC employee number (if applicable). Once an account is created, new users will receive their researcher number via email.
1.2 PRIMARY CONTACT
box1pt2 Provide the name of ONE primary contact person in addition to the PI who will receive ALL correspondence, certificates of approval and notifications from the REB for this study. This primary contact will have online access to read, amend, and track the application.
Selecting a primary contact is optional. If a primary contact is not selected, the PI will be the only person to receive all correspondence from the RISe system. Graduate students preparing ethics applications for their dissertation projects should list themselves as the primary contact. The Primary Contact may also be listed in one of the application boxes below. Note that the PI may change the Primary Contact anytime without an amendment.
1.3, 1.4, and 1.5 CO-INVESTIGATORS AND ADDITIONAL TEAM MEMBERS (with and without online access)
box1pt345 Box 1.3
List all the Co-Investigators of the study. These members WILL have online access which will allow them to read, amend and track the application. These members will be listed on the certificate of approval (except BC Cancer Research Ethics Board certificates).
If this research application is for a graduate degree, enter the graduate student's name in this section.
Please make sure you have added yourself as either the Principal Investigator, primary contact, co-investigator, or a study team member with online access in order to continue with the application.
If you cannot find your name or any of your study team members' names in the list, have them added or inform them to add themselves by emailing the following information to RISe Support(risesupport@ors.ubc.ca): Full Name (Including Middle Initial), Department (or affiliation with the University), UBC Rank, Email Address, Phone Number and UBC employee number (if applicable). Once an account is created, new users will receive their researcher numbers via email.
If you are applying to the BC Cancer, co-investigators will not be listed on the certificates of approval; however, all participating BC Cancer centre PIs will be listed. You will be asked to enter the BC Cancer centre PI's names in View 11. For further information click here for the BC Cancer Research Ethics Board policy.
Box 1.4
List the additional study team members who WILL have online access to read, amend, and track the application but WILL NOT be listed on the certificate of approval.
Examples of additional study team members who you may wish to have online access to the application include Clinical Trial Coordinators and Research Assistants.
Box 1.5
The study team members listed in this section do not have online access to RISe. Please print off the application and ensure that each member listed in this section has read and understood the objectives and procedures of this study.
1.6. TRI-COUNCIL POLICY STATEMENT TUTORIAL
box1pt6 All research personnel who are associated with a research project are required to complete the TCPS2 online tutorial (CORE) and enter their date of completion in their RISe profile before the application is submitted to the REB. This includes (but is not limited to) undergraduate and graduate students, medical residents, research assistants, research coordinators and faculty, whether they are the Principal Investigator or not.
The TCPS CORE Tutorial is free and can be completed in about four hours. CORE Certificates do not need to be attached. Copies should be retained and available on request.
Click here for the TCPS 2 Document.
Click here for the TCPS 2 'CORE' Tutorial.
This tutorial provides an essential orientation to Canadian human research ethics guidelines.
CORE-2022 is now available, please contact the REB for your institution to inquire about CORE-2022, as completion requirements may differ.
1.7 PROJECT TITLE
box1pt7 The title given in the application form must correspond to the title on all study documents, including the consent form.
1.8 PROJECT NICKNAME
box1pt8 The nickname will not be printed on the certificate. It will be used throughout the online application and review process to serve as a quick reference to identify the project.
Page 2: Study dates & Funding Information
2.1 PROJECT PERIOD
box2pt1ptA Box 2.1A
In multi-phase projects, include the period that involves research with human participants.
Box 2.1B
Note that the study closure date does not activate an ethics application closure. All ethics applications need to be closed by the PI at the appropriate time by submitting a Post Approval Activity (PAA) for a Completion. At the time of closure, the data retention and destruction plans may need to be updated if available data storage methods or locations have become outdated.
In multi-phase projects, include the period that involves research with human participants.
You will need to close your application in RISe once all research activity has concluded by submitting a PAA Request for Completion of Research. Note that the closure steps require you to include details about storage of data as laid out in Box 8.5.
2.2 SOURCE OF FUNDING
box2pt2ptA Box 2.2A
"Source of Funds" refers to the funder, sponsor, grantor, or agency (government, industry, and non-profit) that is providing the funds needed to undertake the project. Note that you should not indicate that your study is "For Profit" if a sponsor is only collaborating and not funding the study, e.g., they are providing the study drug or laboratory space only.
2.3 RESEARCH FUNDING APPLICATION/AWARD ASSOCIATED WITH THE STUDY THAT WAS SUBMITTED TO THE UBC OFFICE OF RESEARCH SERVICES
box2pt34 Question 2.3 lists the research funding applications/awards that have been submitted to the UBC Office of Research Services and entered into our database. Identifying the associated research funding application/award will ensure that awarded research funds will be made available to you once this ethics application receives approval.
Please ensure you select the correct application. Note that the first two digits of the application number indicate the year the application was submitted (e.g., Application #F08-00001 was submitted in 2008).
Selecting "Add" will list the sources of all research funding applications that have been submitted by the PI (and the person completing this application if different from the PI). If the research funding application/award associated with this study is not listed below, please enter those details in question 2.4.
2.6 CONFLICT OF INTEREST
box2pt6 If you answer YES to this question (2.6), you will be asked to provide more detail on page 3 of the application.
Page 3: Conflict of Interest
Box 3.1
box3pt1 All investigators: Click here for TCPS 2, Chapter 7 - Conflicts of Interest
UBC Investigators & Faculty: Click here for information on Policy SC3 (formerly Policy 97) Conflict of Interest and Conflict of Commitment.
Reminder: receiving a recruitment or finder’s fee for each participant enrolled is not permitted, and for physicians, is considered unethical practice by the Canadian Medical Association. Please click here or search for CMA Policy | "Guidelines for Physicians in Interactions with Industry".
Box 3.2
box3pt2 Please refer to TCPS2, Article 7.4 for more information on Researchers & Conflicts of Interest.
Box 3.3
box3pt3 The REB needs to be satisfied that conflicts of interest are appropriately managed. This can include disclosing the conflict of interest in the consent process. It also requires that any conflicts of interest be minimized to the extent possible. Some conflicts of interest will need to be managed further than disclosure, e.g. having someone arms length review the data to ensure objectivity, and/ or additional measures.
Box 3.4
box3pt4 It is the individual investigators' responsibility to ensure they comply with all relevant and applicable COI policies.
Researchers who are also UBC Faculty must renew their Conflict of Interest (COI) declaration annually and update it if things change. Information provided in this view will not be reflected in UBC COI declarations.
Click here for information on UBC's Conflict of Interest policy.
Page 4: Research Ethics Board, Location, Risk Level
4.1 UBC RESEARCH ETHICS BOARDS
box4pt1 The difference between Clinical or Behavioural studies is not always clear. The final decision is at the discretion of the Boards. Please reach out to your REB if you have any questions around which study type should be selected for box 4.1.
Behavioural and social sciences projects intend to study the relationship between people and their surroundings, including how people interact with each other, their communities, and institutional systems. They include psychological phenomena such as emotions, biases, and motivations etc. Psychological therapy and counselling studies fall under behavioural research. Emergent design and community-based studies are considered social science and behavioural research unless a clinical intervention is involved. Common methods include, but are not limited to, interviews, focus groups, surveys, questionnaires, behavioural therapy workshops, experimental coaching, observations, and secondary use of data.
Behavioural and social sciences studies can be about health and include health care providers and patients, where the goal is not to modify direct patient clinical care (e.g. diagnosis, medication, or treatment). When clinical charts are being accessed for a behavioural study full patient consent is required. Retrospective medical chart review projects should be submitted using the Clinical application form.
Clinical research intends to evaluate the effects of one or more health-related interventions on health outcomes. Investigations include, but are not restricted to, drug administration, surgical procedures, radiologic procedures, devices, genetic therapies, cells and other biological products, radiopharmaceuticals, natural health products (NHPs), process-of-care changes, preventive care, manual therapies, and psychotherapies.
Health Canada and US FDA regulated research, research evaluating human anatomy, physiological outcomes and processes, medical chart reviews, secondary analysis of clinical data, biobanks and clinical data registries should be submitted as a Clinical application.
A clinical research project that also includes questionnaires or interviews as part of its methodology should be submitted to a Clinical Research Ethics Board.
4.2A UBC/UBC AFFILIATED INSTITUTIONS AND SITES
box4pt2ptA Pre-populated content is generated from PI and Co-I's profiles. This content is only pre-populated once and can be edited.
This Box only has UBC and UBC affiliated sites (VCH, PHC, BC Cancer, CW). For REBC sites , please add in box 4.2B.
Enter the locations for the institutions and sites where the research will be carried out under this Research Ethics Board approval (including specimens processed by pathology, special radiological procedures, specimens obtained in the operating room, or tissue requested from pathology).
Include the PI’s and Co-I’s home institution as a site, even if data collection/recruitment is not happening there.
Please click "Add" and enter the appropriate letter to see the locations for the institutions and sites where the research will be carried out under this Research Ethics Board approval:
B for BC Cancer
B for BC Centre for Disease Control
C for Children's and Women's Health Centre of BC
P for Providence Health Care
V for Vancouver Coastal Health (VCHRI/VCHA)
U for University of British Columbia
4.2 B. All other locations: Please describe other locations where research participants will be recruited and / or where data collection will occur.
4.2B Non-UBC INSTITUTIONS AND SITES
box4pt2ptB Pre-populated content is generated from PI and Co-I's profiles. This content is only pre-populated once and can be edited.
Only BC sites that are a part of the REBC are listed in this box. For UBC/UBC affiliated sites, please add in Box 4.2A.
Enter the locations for the institutions and sites where the research will be carried out under this Research Ethics Board approval (including specimens processed by pathology, special radiological procedures, specimens obtained in the operating room, or tissue requested from pathology).
*If study site(s) cannot be found, please select “Other” which is available for each Health Authority (eg, Interior Health – Other) then add site name & address to box 4.2C. If you are adding more than 5 sites in a particular Health Authority, please contact that ethics board before proceeding.
Ensure that the primary affiliations of all study team members are represented here.
Please click "Add" and enter the appropriate letter to see the locations for the institutions and sites where the research will be carried out :
F for Fraser Health
I for Interior Health and Island Health
N for Northern Health
S for Simon Fraser University
U for University of Northern British Columbia and University of Victoria
Institutional Approvals: Research at hospitals and in Health Authorities cannot commence until you receive local site / resource approval from the hospital(s) selected. Issuing of the certificate of ethical approval may be delayed until site approval from the hospital(s) has been obtained.
4.2D ROLES OF STUDY SITES
box4pt2ptD Sites Listed are populated based on Boxes 4.2.A & 4.2B. In order to remove/add site(s) please update boxes 4.2A & 4.2B on the previous page.
4.3B RELATIONSHIP WITH OTHER PROPOSALS
box4pt3ptB Indicate whether the study is an extension or a sub-study of a primary study or if the study is utilizing samples or data collected under a previous study.
A sub-study is a concurrent study on a sub-sample/population of the original study sample/population.
The REB reserves the right to require that a sub-study or extension study be submitted as a new application.
4.3C REJECTION OF STUDY
box4pt3ptC If the study is a clinical trial, Health Canada must be notified of the rejection/disapproval of the study.
4.3D COLLECTION OR ANALYSIS OF BIOSPECIMEN
box4pt3 Definition of Biological Material: Genetically modified organisms that may be hazardous to humans or the environment, biological products, microorganisms, human/animal tissues, cells, blood and bodily fluids. The term 'infectious' includes biological toxins, viruses, bacteria, fungi, parasites and other organisms/genetic systems that, by virtue of their replicative properties, are potentially harmful to humans, animals and the environment.
To verify if a biosafety permit is required or for more information, please contact the Research Safety Manager of your institution’s Risk Management Services.
4.5A PEER REVIEW
box4pt5ptA Article 2.7 of the TCPS 2 stipulates that the REB must review the ethical implications of the methods and design of a research project. Peer review is required by all Research Ethics BC-affiliated REBs for research projects that pose more than minimal risk to participants.
Enter peer review information in this box and attach any relevant documentation to box 9.8 of the RISe application. If your study is not minimal risk, DO NOT leave this box blank or state "not applicable." Your application will be sent back to you if appropriate information is not provided. If a peer review has not been conducted, the Scientific / Peer Review document can be used as a template.
If your protocol has not received External or Internal peer review, please provide a scientific review [i.e. from a recognized independent authority in your field OR from your trainee’s supervisory committee] using the Peer - Scientific Review Template here.
4.7A CREATION OF A REGISTRY (DATA OR TISSUE BANK)
box4pt7ptA This does NOT apply to:
i) a database that will be created for the sole purpose of routine data analysis of a project.
ii) instances where the industry sponsor will be the steward or guardian of data or tissue for future research.
iii) secondary use of existing data which has already been collected clinically or under a previous research project that you plan to re-analyze for a different purpose.
This applies to situations where the registry/biobank team is creating a registry of data or biobank that is specifically intended to be accessed by the researcher and/or other researchers for future use over an extended period of time.
Definitions:
Registries are repositories that collect and store information about humans specifically for use in subsequent research. The information may or may not include personally identifying information, clinical files, clinical test results, x-rays, MRIs, information about race, age, or place of origin, etc., that is collected retrospectively or prospectively.
Biobanks (also known as biorepositories) An organized collection of searchable human biological materials stored for one or more specific or future unspecified research purposes. It may also include associated information about individuals from whom biological materials were collected.
Registries and biobanks can be of any size.
Please note that once your application has been approved, then this box cannot be revised via an amendment.
4.8A CLINICAL CHART REVIEW
box4pt8ptA Please note that once your application has been approved, then this box cannot be revised via an amendment.
4.8B Date Range
box4pt8ptB Applications that are retrospective chart or database records reviews are applications that are seeking to access data that is currently/already in existence. In order to qualify as a retrospective chart review, no information or records that are dated subsequent to the date of the initial ethics approval can be requested. If you are conducting a prospective chart review, you must answer “no” to this question and complete the full application.
4.8C Exclusively retrospective
box4pt8ptC Retrospective data: Data collected from charts/records dated on or before the date of initial ethics approval.
Prospective data: Data collected on an ongoing basis (i.e. chart information is taken from patients who are seen after the date of ethics approval).
If the study involves any other component such as biospecimen collection, or prospective data/biospecimen collection, or direct contact with participants, mark “No” to this question.
Please note that once your application has been approved, then this box cannot be revised via an amendment.
4.8D Access to personally identifiable information
box4pt8ptD Mark "Yes" if researchers will have access to personal identifiers. If researchers will be the ones that pull records/charts, or review records in the Electronic Medical Records (EMR) system then please mark "Yes".
Mark "No" if researchers will be provided with de-identified data Only (i.e personal identifiers are remove from the dataset provided by another party such as Popdata)
Personally identifiable information is information that could reasonably be expected to identify an individual, alone or in combination with other available information. Directly identifying information is information that identifies a specific individual through direct identifiers (e.g. name, social insurance number, personal health number) Indirectly identifying information is information that can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal characteristic).
4.8E Is this a retrospective chart review study for which participant consent will be obtained?
box4pt8ptE If a retrospective chart review is retaining personal identifiers, participant consent may be required. Similarly, if a retrospective chart review is being conducted on a small set of charts, looking at a rare disease, consent may be required as there is potential for participants to be identified.
Please note that once your application has been approved, then this box cannot be revised via an amendment.
4.9A/4.9B Biospecimen Analysis
box4pt9A Biospecimens- human biological materials which include tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva and other body fluids. The term also includes materials related to human reproduction, including embryos, fetuses, fetal tissues and human reproductive materials.
Examples of studies that can use this truncated form:
- Research using pre-existing biospecimens (for e.g., samples from the hospital Pathology Dept)
- Research using biospecimens obtained from a dedicated biobank.
- Research conducting new analyses on biospecimens collected in a different research study.
- Cadaveric studies
- Stem cell research
“Previously collected biospecimen” is in regards to retrospective biospecimen: Biospecimen collected before the date of initial ethics approval.
Please note that once your application has been approved, then this box cannot be revised via an amendment.
If Box 4.9A is marked "Yes", the application will skip to View M
4.9B Biospecimen Analysis
box4pt9B Prospective study wherein BC researchers are only involved in sample analysis.
For e.g., A study is enrolling in Montreal and Paris only. Biospecimens are transferred to BC researchers for analysis. No enrollment in BC. This study would answer “Yes” to this question.
Please note that once your application has been approved, then this box cannot be revised via an amendment.
Prospective: Biospecimen and data collected on an ongoing basis (i.e.collected after the date of ethics approval).
If Box 4.9B is marked "Yes", the application will skip to View M
4.11 Artificial Intelligence/Machine Learning (AI/ML)
Page 5: Summary of Study and Recruitment
5.1 B. SUMMARY OF RESEARCH
box5pt1ptb 5.1.B: Summarize the research proposal using the following headings:
Purpose:
Include the following where applicable:
- Name of the investigational drug(s) used in this study
- Name of any marketed drug(s) used outside of its approved indication
- Name and description of any positron-emitting radiopharmaceuticals to be used
- Name and description of any new investigational device(s) to be used
- Name and description of any marketed device to be used in an experimental mode.
Justification:
Include the rationale for the study and the following when applicable:
- A description of the standard treatment
- A description of alternative treatments (other than standard treatments)
- Justification of the use of placebo, if applicable.
Research Design:
Enter a brief description (e.g. “This is a cross-over design involving 3 study visits”). Detailed study procedures should be listed in Box 5.7.
Statistical analysis:
- A summary of the primary and secondary end-points
- Statistical analysis planned
- Planned sample size
If this study involves more than one participant group please clearly state how many participants will be in each group (for e.g., 30 patients and 15 physicians).
A copy of the research protocol/proposal must be attached to Box 9.1.A. Please ensure to include the reference list in the Protocol document.
5.2 INCLUSION CRITERIA
box5pt2 Please enter the inclusion criteria as an itemized list and justify, if applicable. For research involving human pluripotent stem cells, provide a detailed description of the stem cells being used in the research.
Refer to TCPS 2 Article 4.1 for information on appropriate inclusion.
Refer to TCPS 2 (2018) Chapter 12, Section F for information on research involving human pluripotent stem cells.
5.3 EXCLUSION CRITERIA
box5pt2 Describe which potential participants will be excluded from participation, list the criteria for their exclusion, and justify the grounds for their exclusion.
As TCPS 2, Chapter 4 cautions against research that excludes particular populations, it is important to ensure that a justification is provided if participants are excluded on the basis of such attributes as culture, language, religion, race, mental or physical disability, sexual orientation, ethnicity, gender, age, or being HIV positive.
Please enter the exclusion criteria as an itemized list.
5.4A RECRUITMENT
box5pt4ptA Privacy legislation in BC states that organizations cannot provide contact information for clients without their consent, unless permission is obtained from the Provincial Privacy Commissioner or through other approved Health Authority channels.
Click here for information on recruitment.
Please ensure the same sites are listed on page 4 of the application.
If you intend to use REACH BC as a recruitment tool, please attach recruitment posting and scripts to box 9.5. Templates available from REACH BC.
5.4B RECRUITMENT OF NORMAL/CONTROL PARTICIPANTS
box5pt4ptB Control participants are defined by the U.S. Office of Human Research Protections as "Subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled."
Attach copies of initial letters of contact and any other recruitment documents to view 9. If this proposal does not involve a control group, enter "N/A".
See TCPS 2 Article 11.3 Justification for Control Groups.
Normal participant refers to a randomly chosen member of the general population. Any individuals chosen for enrollment in a study based on specific baseline characteristics are, by definition, not "normal" individuals for this purpose.
5.5 FOCUS ON INDIGENOUS PEOPLE
box5pt5 Click here for TCPS 2 Chapter 9 on Research Involving the First Nations, Inuit and Metis Peoples of Canada.
While Chapter 9 is designed for Indigenous research, the guiding principles can also be applied for distinct communities as well such as for eg, the Deaf community.
See TCPS 2 Article 2.11 Research Involving Communities.
5.6 USE OF RECORDS
box5pt6 Where the investigator is in a dual relationship - that is the researcher maintains the records (e.g. as a clinician, educator, etc.) and is proposing to undertake research on them, steps need to be taken to ensure participants' rights are not violated.
Please ensure that the access and use of the charts or data from an existing registry or database is permitted under privacy law and that the organization or department with custody and control of the information is aware of this use and access and has either approved it or explain the status of that approval.
5.7 SUMMARY OF PROCEDURES
box5pt7 Research procedures may include:
- interview or questionnaires;
- tests and assessments;
- type, quantity, and route of administration of drugs and radiation, operations;
- use of medical devices that are prototypes or altered from those in clinical use;
- specify what procedures in this project involve an experimental approach, in that there may be diagnostic procedures or treatment dictated by the protocol differing from those required for standard patient care.
Page 6: Participant Time, Risk and Benefits, and the Consent Process
6.1 TIME TO PARTICIPATE
box6pt1 How much time will a participant be asked to dedicate to the project beyond that needed for normal care?
Include how many minutes/hours over how many weeks/months the participant will be asked to dedicate to the project.
Ensure that you indicate the number of visits that will be required and the amount of time necessary for each visit. Ensure that you also include this information in the consent form. The amount of time stated in the application must be consistent with ALL other study documents (e.g. recruitment letters or posters, protocol, and consent forms).
6.2 TIME TO PARTICIPATE - NORMAL/CONTROL PARTICIPANTS
box6pt2 Include how many minutes/hours over how many weeks/months the participant will be asked to dedicate to the project. Ensure that you indicate the number of visits that will be required and the amount of time necessary for each visit.
This must be consistent with the information noted in the consent form document.
Please refer to Box 5.4B for a definition of a control group. If the proposal does not involve a control group, enter "N/A".
6.3 RISKS/HARMS
box6pt3 Include any information about discomfort or incapacity that the participants are likely to endure as a result of the study participation, along with the details of any known side effects which may result from the experimental treatment if applicable. Clinical risks should be listed as bullet points. Risks should be quantified using percentages where possible.
Ensure this information matches what is listed in the protocol and consent form documents.
Refer to TCPS 2, Chapter 2, Section B for more information about risks.
6.4 BENEFITS
box6pt4 Specify the benefits to the participant. If there are no benefits, state this explicitly. If any specific therapeutic benefits cannot be assured, but may be hoped for by the participant, state explicitly that the participant may or may not benefit from participation in the study.
Ensure this information matches what is listed in the consent form.
6.5B REMUNERATION
box6pt5ptB As per TCPS 2 Article 3.1, incentives offered to participants should not be so large or attractive as to encourage reckless disregard of risks.
Additional Info not in RISe:
If remuneration per research participant is $500 or more per year, as per UBC Finance Department Research Subject Payments Guideline Research Subject payments:
“If the research subject is a Canadian resident, their social insurance number will be required and a T4A will be issued in order to meet Canada Revenue Agency reporting requirements.” Please verify with your institution’s finance department.
-Please include that this personal information will be collected in the consent form.
6.6 OBTAINING CONSENT
box6pt6 Refer to TCPS 2 Article 3.2 for more information about the consent process.
Click here for information on the consent process.
6.7.A WAIVER / ALTERATION OF CONSENT
box6pt6pta Please see below for the different types of waivers. Along with links to the appropriate TCPS 2 articles.
For Retrospective (pre-existing) data collection refer to Article 5.5A; click here Address criteria (a) to (f) individually.
For Retrospective (pre-existing) biospecimens refer to Article 12.3A click here. Address criteria (a) to (f) individually.
For Prospective data collection, please refer to Article 3.7A please click here.
Address criteria (a) to (e) individually.
If a researcher satisfies all of the applicable conditions the REB may approve the research without requiring consent from the individuals to whom the information relates.
6.7.B WAIVER OF CONSENT IN INDIVIDUAL MEDICAL EMERGENCIES
box6pt7ptb 6.7.B: Refer to TCPS2 Article 3.8 for further information on the following criteria.
a. A serious threat to the prospective participant requires immediate intervention
b. Either no standard efficacious care exists or the research offers a realistic possibility of direct benefit to the participant in comparison with standard of care
c. Either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the prospect for direct benefits to the participant
d.The prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the research project
e. Third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so, and
f. No relevant prior directive by the participant is known to exist.
6.8 TIME TO CONSENT
box6pt8 TCPS 2 Article 3.2 states "For consent to be informed, prospective participants should have adequate time and opportunity to assimilate the information provided, pose any questions they may have and discuss and consider whether they will participate. The time required for this initial phase of the consent process will depend on such factors as the magnitude and probability of harms, the complexity of the information conveyed and the setting where the information is given."
6.9 CAPACITY TO CONSENT
box6pt9 Refer to TCPS2 Chapter 3, Section C for more information on decision-making capacity.
Click here for information on capacity.
6.9.1 ASSESSING CAPACITY TO CONSENT
If capacity to consent is determined by the clinical care team please indicate as such. If capacity to consent is determined by research staff indicate experience/training of the individuals.
6.10 RENEWAL OF CONSENT
box6pt10 TCPS 2 Article 3.3 states that consent encompasses a process that begins with the initial contact (e.g., recruitment) and carries through to the end of participants' involvement in the project. Throughout the process, researchers have an ongoing duty to provide participants and REBs with all information relevant to the participants' ongoing consent to participate in the research.
6.11 PROVISIONS FOR CONSENT
box6pt11 What provisions are planned for participants, or those consenting on a participant's behalf, to have special assistance, if needed, during the consent process (e.g. consent forms in Braille, or in languages other than English)?
Attach copies of contact letters or consent forms that have been translated into other languages to page 9.
For all documents which have been translated into other languages, a document verifying the translation must also be submitted.
6.12 RESTRICTIONS ON DISCLOSURE
box6pt12 For more information on the expectation of researchers to provide study results to participants, refer to TCPS 2 Article 4.7 "Equitable Distribution of Research Benefits". You will need to scroll down to Article 4.7 once in the link.
6.13 COMMUNICATION OF RESULTS
Any prohibition or undue limitation on the publication or dissemination of findings from research is ethically unacceptable. Informing participants of the research results is as important as disseminating results to the research community. See TCPS 2 Article 4.8
Include the following information as applicable:
a) Have relevant knowledge users (e.g., participants, patient or community groups, researchers, people embedded within healthcare or other systems that could affect change, etc.) been consulted regarding sharing results in a culturally appropriate, accessible, and meaningful way? See TCPS 2 Chapter 1, Ethics Framework
b) Have you committed to developing a plan that includes sharing results in plain language?
c) How will participants be informed about the study results, and how will they access them?
See TCPS 2 Article 4.8. – for items a, b, c
d) Will there be consultation with community representatives/patient partners/peer researchers before finalizing publications? See TCPS 2 Article 9.17
e) Are there any existing conflicts, barriers, limitations, or competing priorities that could impede the timely sharing of results. If so, how will these be mitigated? See TCPS 2 Article 6.24 and TCPS 2 Chapter 7, Conflicts of Interest
Page 7: Regulatory Approvals
7.1A MULTI-CENTRE STUDIES
box7pt1ptA These questions will assist the REB to consider coordination of their review with the other study sites. If your study has multiple sites within BC and those sites are listed on page 4 of this application, they do not need to be repeated here.
For example, if your study is being conducted at McGill University as well as UBC, McGill University should be listed here.
7.2C NUMBER OF CONTROLS
box7pt2ptC Controls are people acting in a control capacity (comparison group), including normal participants.
See TCPS 2 Article 11.3 Justification for Control Groups
7.3 DRUG APPROVALS
7.5 NATURAL HEALTH PRODUCTS
7.6 EXPERIMENTAL DRUGS AND DEVICES
7.7 POSITRON-EMITTING RADIOPHARMACEUTICALS (PERS)
7.8A HEALTH CANADA REGULATORY APPROVALS
box7pt8ptA The sponsor is an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. For unfunded/investigator-initiated studies, the sponsor could be the principal/qualified investigator. The sponsor is usually responsible for applying for regulatory approval with the Health Protection and Food Branch of Health Canada. Refer to Section 5 of the GCP Guidelines by clicking here for a full description of the duties and responsibilities of the sponsor.
Click here for information on regulatory approvals and registration.
7.9A DETAILS OF HEALTH CANADA REGULATORY APPROVALS
box7pt9ptA If regulatory approval from a Health Canada directorate is required for this study, your certificate of ethical approval will not be released until the regulatory approval certificate, approval date and control number are received by REB administration.
Click "Add" to enter the name of the regulatory agency, the date of the application (if pending) or the date of the approval, and the control number and the date of approval, for either the initial application or subsequent amendments.
Applications to the Research Ethics Board (REB) and Health Canada may be concurrent, however, NO REBC Affiliated REB will issue a "Certificate of Approval" until the Health Canada Regulatory Approval is received.
7.10 Stem Cell Research
7.11 REGISTRATION FOR PUBLICATION OF CLINICAL TRIALS
box7pt11 Refer to TCPS 2 Chapter 11, D. Registration of Clinical Trials
If there is any possibility of the intent to publish results of the study it must be registered BEFORE the study is started (but not necessarily before ethical approval is granted).
The International Committee of Medical Journal Editors (ICMJE) requires registration for all clinical trials. The ICMJE accepts registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) or in ClinicalTrials.gov, which is a data provider to the WHO ICTRP.
The ICMJE defines a clinical trial as “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome.
Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioural treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes.
Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.
There is a requirement for researchers to submit study results for registered Clinical Trials. Please ensure you submit your study results to the Authorized Registry upon study completion.
Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) do not require registration.
For more information concerning registration requirements, click here.
7.12A US REGULATORY REQUIREMENTS
box7pt12ptA 7.12.A: Mark "yes" if this study is:
a) conducted or funded by the US Department of Health and Human Services (DHHS) (see link below), or
b) is required to comply with either the U.S. FDA or any other U.S. regulations. The PI is responsible for ensuring that the study complies with the applicable U.S. regulations.
Click here for a listing of the DHHS operating and staff divisions.
7.12B US REGULATORY REQUIREMENTS
box7pt12ptB 7.12.B: The Office of Research Ethics is responsible for reporting Unanticipated Problems to the DHHS Office For Human Research Protections (OHRP) or the U.S. FDA. In the latter case, the IND or IDE number must be referenced in the report(s). If a U.S. FDA IND or IDE number is applicable, the Ethical Certificate of Approval will not be released until a valid number is entered in Box 7.12B and if available, appropriate documentation is attached to Box 9.1.C.
Page 8: Data Monitoring, Data Security, Confidentiality, and Data Retention
8.1 UNBLINDING IN AN EMERGENCY
Additional Info not in RISe:
There are a number of circumstances where research participants or caregivers may need to be able to access information about a clinical trial on an "emergency" basis. At present, CREB requires that an emergency number be available for studies involving clinical interventions 24 hours a day, 7 days a week.
While a true 24-hour, 7-day a week access telephone number is optimal, it may not be possible, practical or even realistic for every study. For this reason, access to information/research personnel should be, to some degree, individualized based on the risk associated with the study.
In clinical trials where patients are treated with a drug or device (or other form of treatment), there are a few types of "emergency" information that could be required at some time:
unblinding to reveal treatment assignment
information about the nature and risks of the particular treatment the participant is or has received
access to the Principal Investigator for advice about the nature and risks associated with a particular treatment
The CREB recommends that all participants enrolled in a clinical trial involving drug administration in which they are not continually in a controlled environment (hospital, research clinic, etc.) should be provided with a wallet card describing the basic information about the trial.
An example of such a card could be as follows:
Name of Participant
Name of Study
Participant Study Number (if applicable)
Name of Principal Investigator
Treatment they are receiving (or which they could be receiving if they are in a blinded study)
Contact information of investigator/research staff (not necessarily 24/7)
OPTIONAL INFORMATION AS DICTATED BY THE NEED OF THE PARTICIPANT
Phone number for immediate unblinding
Website for more detailed information about the study
Contact information of investigator/research staff (24/7)
"Key information for clinicians". There may be some particularly important issues that need to be highlighted. For example, there could be important information that would be required for life-threatening situations - information that treating physicians might not have time to obtain by contacting the investigators.
8.2 DATA MONITORING PROCEDURES
box8pt2 For clinical trials, the researcher is responsible for providing the REB with an acceptable plan for monitoring the safety of participants, including a plan for the tabulation, analysis and reporting of safety data, and the sharing of other new information in a form that permits REBs to interpret and respond appropriately (TCPS 2 , Chapter 11 C. Safety Monitoring and Reporting New information).
8.3 STUDY STOPPAGE
8.4A PERSONAL IDENTIFIERS
box8pt4ptA REBs require the use of a unique study code.
Information is considered de-identified if the following conditions are met:
- the unique study code is not derived from or related to the information about the individual (i.e., name, SIN, PHN, hospital number, DOB, address, or unique characteristic);
- the unique study code could not be translated to identify the individual, and;
- the investigator or their institution could not use OR disclose the unique study code for other purposes OR disclose the mechanism for re-identification.
Refer to TCPS 2 , Article 5.3 for more information on safeguarding participant information.
Please note specific institutional privacy considerations will be addressed on page 11.
While it may be necessary to collect participant personal identifiers (e.g., names, MRN) for linkage to administrative databases, it is highly unusual to have both participant names and study ID on forms. Personal identifiers with the corresponding study ID numbers should be stored on a separate linking document
8.4B.2 JUSTIFICATION FOR PERSONAL IDENTIFIERS
box8pt4Bpt2 Personally identifying information is any information that may reasonably be expected to identify an individual, alone or in combination with other available information, e.g. name, SIN, PHN, date of birth, address, or unique personal characteristic etc.
IF personal identifiers will be retained as a part of the dataset, please provide justification in Box 8.4.B.2
8.5A DATA ACCESS AND STORAGE
box8pt5ptA Study documents must be kept in a secure locked location/filing cabinet.
Computer files should be password protected and encrypted, and data should not be stored or downloaded onto an unsecured computer or a portable laptop.
8.5B.1 MASTERLIST
Masterlist - key that links the study ID to the identifiers.
8.6A DISPOSITION OF STUDY DATA
box8pt6ptA Please include the following information:
Final disposition/storage of all research-related study documents. According to UBC Policy SC6 (formerly Policy 85), study data should be kept for a minimum of 5 years after publication. Effective February 11, 2022 Clinical trials data must abide by Health Canada's regulations regarding data retention and generally must be kept for 15 years.
Final disposition of any electronic data. The procedure that will be followed in response to additional requests for access to the study data (after the study has been completed and analyzed).
Note: The REB requires at a minimum an annual report for multi-year projects, and an end-of-study report for all studies at study completion. A completion of study notice must be submitted via RISe.
8.6B DISPOSITION OF BIOSPECIMEN
box8pt6ptB Please complete Box 8.6B if your study involves the handling of biospecimens (e.g. blood samples)
8.7 DATA TRANSFER TO OTHER INSTITUTIONS
box8pt7 If information will be sent outside of the local site, please indicate the type of information to be transferred and in what form it will be in when transferred.
TCPS 2, Chapter 5, identifies 5 different categories of data collected from research participants, each with different implications for the privacy of participants. When sending data off site, the data should be coded. Justification for sending directly identifying information or indirectly identifying information off site must be provided and approved by the REB before data is transferred.
- Directly identifying information - the information identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number).
- Indirectly identifying information - the information can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal characteristic).
- Coded information - direct identifiers are removed from the information and replaced with a code. Depending on access to the code, it may be possible to re-identify specific participants (e.g., the Principal Investigator retains a list that links the participants' code names with their actual name so data can be re-linked if necessary).
- Anonymized information - the information is irrevocably 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.
- Anonymous information - the information never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low.
Page 9: Documentation
9.1 PROTOCOL OR PROPOSALS
box9pt1 Clinical Applications:
- Clinical trial protocol
- Clinical research proposal
- Amendments to full protocols
- History or Summary of Changes to Amendments
Please ensure to include the reference list.
9.2 CONSENT FORMS
box9pt2 Attach all consent forms for the research, including the following:
- Participant consent form
- Normal/Control participant consent form
- Biobanking consent form
- Substitute decision maker consent form
- Other consent forms
Click here for the BC Common Clinical Informed Consent Form Template.
Refer to the appropriate REBs' website for other consent form templates, e.g. optional, tissue banking etc. (Click on name for link: BC Cancer Research Ethics Board, Children's and Women's Research Ethics Board, and Providence Health Care Research Ethics Board.)
For BC Cancer Studies, please see website for template here
9.3 ASSENT FORMS
box9pt3 Attach all assent forms for the research, including the following:
- Young child assent form
- Adolescent assent form
- Adult assent form
- Biobanking assent form
- Other assent forms.
9.5 RECRUITMENT MATERIALS
box9pt4 This includes any type of communication (e.g. flyer, email recruitment message, Internet posting, radio/television script, poster, newspaper ad) that is directed to potential participants for the purpose of recruitment. The purpose of this documentation is to ensure that the recruitment measures are appropriate and do not cause undue influence on potential participants.
Click here for UBC C&W Research Ethics Board policies regarding participant handouts and advertisements.
9.6 QUESTIONNAIRES
box9pt6 All questionnaires, surveys, tests, interview scripts etc. must be attached as a separate document to this box even if they are included in the protocol or research proposal.
9.7 LETTER OF INTIAL CONTACT
box9pt7 The letter of initial contact should contain a brief overview of the study and include the following:
- Why the participant is being contacted and invited to participate
- How the participant’s contact information was obtained
- If a follow-up phone call will happen, when it will happen, by who, and how the participant can opt-out of being contacted
The PI’s name and study title should be referenced on the letter.
If you are doing research in Vancouver Costal Health, ensure to use the following template for initial contact see here .
9.8A OTHER DOCUMENTS
box9pt8ptA Examples of other types of documents:
- Data collection form
- Clinical Trial Agreement
- Other associated documents not attached above
- CIHR Stem Cell oversight approval letter
- Transcript of Audio Visual item
- Website content
- Peer review report
If applicable, please attach a transcript (the document must include a version date) of any video or audio file.
9.9 REFERENCE DOCUMENTS
box9pt9 REBs at times, request reference documents during the review process to inform their decisions. These documents however, are not being approved by the BC REB. Such as:
- Consent forms from non-BC sites
- Certificate of Ethics approval-from non BC sites
- Material transfer agreement.
- Purchase agreement
For REBX, Alberta documents do not need to be uploaded here as this will be downloaded by RISe.
*Documents attached in this box will NOT be listed in the BC Certificate of ethics approval.
Page 10-Fee for Service CREB
10.1 Fee Payment
For a video tutorial on the invoice feature in RISe please see here.
10.3 Sponsor Name
Sponsor name must be entered, this will be included on the invoice issued by the REB
Page 11. Vancouver Coastal Health
11.1 If you have not yet received hospital approval to conduct this study an email will be sent to the PI listed in Box 1.1 and the primary contact listed in Box 1.2 on submission to the ethical review board listing the steps required to receive approval by the appropriate VCHA Health Service Delivery Area(s).
11.2A In order for a research project to be undertaken at VCHA, either a VCHA employee or a member of the VCHA medical staff needs to be designated as the "Site Investigator at VCHA". This individual must have actual responsibility with respect to the project.
If you have a faculty appointment at a post-secondary institution that has a research agreement with VCHA, but do not have an appointment at VCHA, you must either:
- Obtain a VCHRI Affiliated Investigator Appointment. This person will assume the role of “Site Investigator at VCHA”. To apply for VCHRI Affiliated Investigator Appointment, please contact the Associate Director, VCHRI at 604-875-4111 Ext 66687.
- Designate a VCHA person as the “Site Investigator at VCHA”. If a co-investigator on the study is a VCHA employee or is a member of VCHA medical staff, this person may assume the role of "Site Investigator at VCHA". If you choose this option, please ensure that the "Site Investigator at VCHA" is listed as a co-investigator on the UBC ethics certificate (you would still remain the Principal Investigator on the UBC Research Ethics Certificate of Approval).
Page 11. Providence Health Care
11.1 Once each hospital service or area has granted approval for use of services or facilities, please forward a copy to the Office of Research Ethics c/o Alex Trethewey (Ethics Review Coordinator). Note that each letter or email must include the title of the research, the name of the principal investigator, and the UBC PHC REB ethics file number.
11.2A
Please note that the Providence Health Care Certificate of Final Approval to commence the research will not be released until the Office of Research Services receives all relevant hospital services/areas approval letters, the contract (if applicable) has been finalized, and the ethics review fee (if applicable) has been paid.
11.3 Send the completed PHC declaration form to:
Alex Trethewey
Pre&Post Review Manager
Office of Research Ethics
Providence Health Care Research Institute
mailto:alex.trethewey@ubc.ca
(604) 682-2344 x68366
Ensure that the form includes the REB File number for the research
Page 11. BC Cancer Agency
11.1 Additional participating centre PIs listed in this section WILL be listed on the certificate of approval and WILL have online access to read, edit, and track this application. (Only the PI named in View 1 can submit an application or amendment etc. to the REB).
Click here for the BC Cancer policy on listing Principal Investigators and Co-investigators (see "BCC & non-BCC Researchers").
If a centre PI is on a leave of absence longer than 6 months they should be replaced with a new centre PI. If the PI on a leave wishes to have access while they are away so they can continue to monitor the study, they should be added to Box 1.3 as a co-investigator.
11.2 The Certificate of Approval will not be released until BC Cancer has received a copy of the signed contract, which should be attached in Box 9.8.
All industry-related and "for-profit" sponsored studies require a Clinical Trials Agreement between the sponsor, BC Cancer and the Investigator.
Page 11. UBC Children's and Women's
11.1 If you cannot find the PI's name in the list, have it added by clicking here. Include the name, department, rank (or affiliation with the University), email, UBC employee number (if applicable), and phone number of the PI.
Once added to RISe, new user will receive their researcher number by email.
11.2 Completion of this form is not required by those affiliated with a UBC academic department. This form is intended for those in professional departments (e.g. Occupational Therapy, Social Work, Nursing).
11.3 Send the applicable forms listed in Box 11.3 to the Research Ethics Board Office at the Children's and Women's Health Centre. If you have any questions, please email the Children’s and Women’s Research Ethics Board office at cwreb@bcchr.ubc.ca.
View A - Retrospective Clinical Chart/Records Review
A.1 Retrospective data: Data collected from charts/ records dated on or before the date of initial ethics approval.
Prospective data: Data collected on an ongoing basis (i.e. chart information is taken from patients who are seen after the date of ethics approval).
A.1.B. Click here for TCPS 2 Chapter 9 on Research Involving the First Nations, Inuit and Metis Peoples of Canada.
While Chapter 9 is designed for Indigenous research, the guiding principles can also be applied for distinct communities as well such as for eg, the Deaf community.
A.2 Please ensure that the access and use of the charts/records or data from an existing registry or database is permitted under privacy law and that the organization or department with custody and control of the information is aware of this use and access and has either approved it or explain the status of that approval.
Note that data, such as medical records, under the custody of health authorities require Institutional/Operational approval.
Example:
a) STEMI database at DHCC, St. Paul’s and Privately owned Clinic ABC.
b) Custodians: VCH, PHC and Clinic ABC director"
A.3 Please attach a data collection/ data extraction form to Question 9.8A of the application for review.
A.4 Specify the minimum number of charts / records required to conduct the study.
A.5.1 Personally identifiable information is information that could reasonably be expected to identify an individual, alone or in combination with other available information. Directly identifying information is information that identifies a specific individual through direct identifiers (e.g. name, social insurance number, personal health number) Indirectly identifying information is information that can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal characteristic).
A.6.1 The TCPS2 Article 5.5 A mandates that the criteria in A.6.1. through to A.6.6. be satisfied in order for the REB to consider approval of the research without requiring the consent of the individuals to whom the information relates.
The TCPS2 defines impracticable in this context as being put into practice due to a degree of "hardship or onerousness that jeopardizes the conduct of the research; it does not mean mere inconvenience."
A.6.5 The TCPS2 defines impracticable in this context as being put into practice due to a degree of "hardship or onerousness that jeopardizes the conduct of the research; it does not mean mere inconvenience."
A.8 Unique Participant Study Code: UBC REBs require the use of a unique study code not derived from or related to the information about the individual, i.e., name, initials, SIN, PHN, hospital number, DOB, or unique characteristic. See Guidance Note 8.4 for further directions on coding that is consistent with de-identification of data.
A.10 For example, study documents must be kept in a secure locked location/filing cabinet, computer files should be password protected and encrypted and data should not be stored or downloaded onto an unsecured computer or a portable laptop.
For further information on encryption requirements and useful tools and resources on how to do this, please see here.
Please note that personal devices should not be used to store research data.
A.10.1 Masterlist - key that links the study ID to the identifiers.
A.11 Reference procedural measures, technical measures, and physical measures planned for the protection of data. If a coding procedure is being used, describe the procedure in detail in this box
A.12 Please include the following information:
Final disposition/storage of all research-related study documents. According to UBC Policy SC6 (formerly Policy 85), study data should be kept for a minimum of 5 years after publication.
Final disposition of any electronic data.
The procedure that will be followed in response to additional requests for access to the study data (after the study has been completed and analyzed).
Note: The REB requires at a minimum an annual report for multi-year projects and an end-of-study report for all studies at study completion. A completion of study notice must be submitted via RISe.
A.13 Data Transfer Note that if this changes in the future an amendment must be submitted before data is transferred.
Data transfer agreements may be required by the institution receiving or sending data. Please verify with the institutions. Completed agreements can be attached to Box 9.9 after initial approval via an amendment.
A.14.B Note that if this changes in the future an amendment must be submitted before data is linked.
A.15. Data collection/extraction form is almost always required. See example here
View C - Creation of a Research Database, Registry or Biobank
C.0 Select “Biobank” if you will be collecting and storing biospecimens and data.
Select “Data registry” if you will be collecting and storing data only, this may include imaging (MRI, X-Ray) and medical chart/record data.
Some institutions may request that a Privacy Impact Assessment (PIA) be completed when creating a research database or registry. Consult your hospital or institutional privacy office for more information.
C.1 Scope and purpose– what kind of research will be supported, types of biospecimen/data that will be collected, services offered, design of the biobank/registry, target enrollment.
C.3 Include a clear date range of the collection period. If collection will be indefinite, clearly indicate that data and/ or biospecimen will be collected indefinitely or until the participant withdraws, if applicable.
C.3.B. Click here for TCPS 2 Chapter 9 on Research Involving the First Nations, Inuit and Metis Peoples of Canada.
While Chapter 9 is designed for Indigenous research, the guiding principles can also be applied for distinct communities as well such as for eg, the Deaf community.
Please see Article 9.19 to 9.22 regarding Collection of Human biological materials involving First Nations, Inuit and/or Métis People
C.4.C. Biospecimens - human biological materials which include tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva and other body fluids. The term also includes materials related to human reproduction, including embryos, fetuses, fetal tissues and human reproductive materials.
C.5. A. Personally identifying information is any information that may reasonably be expected to identify an individual, alone or in combination with other available information, e.g. name, SIN, PHN, date of birth, address, or unique personal characteristic etc.
C.5.B For databases or registries, a data collection form should be attached to Box 9.8.A.
C.5.C Anonymized data are irrevocably 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 to very low.
C.5.D. Include the name, degree, affiliation, role on the project, and email address of ALL individuals who have access to personally identifying information.
C.6.A. Consent Attach a copy of the consent form to Box 9.2.
C.6.B. If participant will not have capacity to consent, please include the following information:
A. Provide details of the nature of the incapacity (for instance, young age, mental or physical condition).
B. How capacity to consent will be evaluated. Please see here
C. Who will consent on their behalf?
D. Will they be able to give assent to participate?
E. If yes, explain how assent will be sought.
C.7 Please see below for the different types of waivers. Along with links to the appropriate TCPS 2 articles. Include the corresponding letter (A, B, C, D, E, etc.) before each answer.
- For Retrospective (pre-existing) data collection refer to Article 5.5A; click here Address criteria (a) to (f) individually.
- For Retrospective (pre-existing) biospecimens refer to Article 12.3A click here. Address criteria (a) to (f) individually.
- For Prospective data collection, please refer to Article 3.7A please click here.
Address criteria (a) to (e) individually.
If a researcher satisfies all of the applicable conditions the REB may approve the research without requiring consent from the individuals to whom the information relates.
C.8 TCPS Article 3.1: If a participant withdraws consent, the participant can also request the withdrawal of their data or biospecimens
*TCPS Article 12.2: The process for requesting withdrawal of Biospecimens shall be clearly explained, along with an explanation of the conditions under with researchers would NOT be able to remove a participant’s data from the project (information already derived from the biospecimens and aggregated cannot be withdrawn, or anonymized data)
C.9 A data/biobank custodian is an entity or person who is responsible for overseeing the management and use of the data/biobank, including the main rules governing use of the database/ biobank, the process by which access requests will be reviewed, and the organization to whom the researcher is accountable for the proper management of the data/biospecimens.
C.10. Biospecimens/data will be stored in facilities overseen by the institution under the supervision of the <PI, department x and name of institution>.
C.11. Reference procedural measures, technical measures, and physical measures planned for the protection of data. If a coding procedure is being used, describe the procedure in detail in this box.
C.13.A. Data/Biospecimen Transfer Note that if this changes in the future an amendment must be submitted before data is transferred.
C.13.C. Material/data transfer agreements may be required by the institution receiving or sending biospecimen/data. Please verify with the institutions. Completed agreements can be attached to Box 9.9 after initial approval via an amendment
C.14.A. Data Linking Note that if this changes in the future an amendment must be submitted before data is linked.
C.16.B. Reference who will have access to the database in the future and under what circumstances, what will happen if an individual data custodian leaves the institution, where the ongoing database will be stored or maintained, and what security measures will be in place.
UBC's REBs encourage researchers who are creating biobank to consider certification of their biobank with the 1. Canadian Tumour Repository Network (CTRNet) Biobank Certification Program 2. or accreditation with the College of American Pathologists (CAP) biobank Accreditation Program or 3. The international biobanking standard - ISO 20387:2018 - https://www.iso.org/standard/67888.html
C.18.Researchers have an ongoing duty to provide participants and REBs with all information relevant to the participants’ ongoing consent to participate in the research.
The biobank/registry may choose to provide participants with access to information within a reasonable timeframe via a website or newsletter.
View M - Biospecimen Analysis
For a tutorial on how to complete this form please see this video here
M.1 Please summarize study details, this would be similar to a Journal Abstract. The Protocol attached to 9.1A would contain more details regarding the study.
M.2 Biospecimens under the custody of health authorities require Institutional/Operational approval. Contact the health authority for more details.
Please ensure that the access and use of biospecimens is permitted under privacy law and that the organization or department with custody and control of the information is aware of this use and access and has either approved it or explain the status of that approval.
M.3.A Biospecimens can include: Tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva, fecal matter and other body fluids. The term also includes materials related to human reproduction, including embryos, fetuses, fetal tissues and human reproductive materials.
M.3.B Leftover biospecimens should only be used for research if they are in excess of that required for any clinical diagnosis.
M.5.A Include participant, clinical and biospecimen data that will be provided along with the samples, for e.g., age, sex, disease type, date of specimen collection.
Note that data, such as medical records, under the custody of health authorities require Institutional/Operational approval. Contact the health authority for more details.
M.6.A If applicable, please ensure to include the study application number of the associated study or biobank in Boxes 4.3A and 4.3B
Attach previously used consent form template to Box 9.9.
M.6.1 As per UBC policy LR9 “Genetic material shall not be considered anonymous unless a BC REB determines otherwise”. As such, if consent was not obtained for the proposed research, waiver criteria must be meet. Note that this will be determined by the REB.
Researcher must address all the waiver conditions listed in Boxes 6.1-6.6, for the REB to consider approving the research without requiring consent from the individuals from whom the biological materials were collected.
Please see TCPS2 Article 12.3A
M.6.5 Impracticable – Incapable of being put into practice due to a degree of hardship or onerousness that jeopardizes the conduct of the research; it does not mean mere inconvenience.
Please provide a justification as to why it is impracticable or impossible to consent.
M.6.6 Biospecimens under the custody of health authorities require Institutional/Operational approval. Contact the health authority for more details.
M.7 Mark "Yes" if listed researchers will be the ones that pull records/charts/ or review records to retrieve the biospecimens.
Mark "No" if researchers will be provided with de-identified data Only (i.e. personal identifiers are removed from the dataset provided by another party)
Personally identifying information is any information that may reasonably be expected to identify an individual, alone or in combination with other available information, e.g. name, SIN, PHN, date of birth, address, pathology accession number, or unique personal characteristic etc.
M.7.1 Consent was not obtained for the use of identifiable information. Researchers must address all the waiver conditions listed in Boxes 7.1-7.6, for the REB to consider approving the research without requiring consent from the individuals from whom the information relates.
Please see TCPS2 Article 5.5A
M.7.5 Impracticable – Incapable of being put into practice due to a degree of hardship or onerousness that jeopardizes the conduct of the research; it does not mean mere inconvenience.
Please provide a justification as to why it is impracticable or impossible to consent.
M.8 Click here for TCPS 2 Chapter 9 on Research Involving the First Nations, Inuit and Metis Peoples of Canada.
While Chapter 9 is designed for Indigenous research, the guiding principles can also be applied for distinct communities as well such as for eg, the Deaf community.
Secondary use of human biological materials identifiable as originating from a specific First Nations, Inuit or Métis community, or a segment of the Indigenous community at large, is addressed in TCPS2 Articles 9.20 to 9.22.
M.9 REBs require the use of a unique study code.
Information is considered de-identified if the following conditions are met:
- the unique study code is not derived from or related to the information about the individual (i.e., name, SIN, PHN, hospital number, DOB, address, or unique characteristic);
- the unique study code could not be translated to identify the individual, and;
- the investigator or their institution do not currently or in the future use OR disclose the unique study code for other purposes OR disclose the mechanism for re-identification.
Refer to TCPS2, Article 5.3 for more information on safeguarding participant information.
M.12 Please note that future use of biospecimens may require a separate ethics application. Please consult your REB regarding future use.
M.13 Study documents must be kept in a secure locked location/filing cabinet.
Computer files should be password protected and encrypted, and data should not be stored or downloaded onto an unsecured computer or a portable device.
M.14A Please include the following information:
Final disposition/storage of all research-related study documents. According to UBC Policy SC6, study data should be kept for a minimum of 5 years after publication
Final disposition of any electronic data. The procedure that will be followed in response to additional requests for access to the study data (after the study has been completed and analyzed).
M.14.B Material incidental findings: Researchers should refer to the guidance in TCPS2 here, which addresses material incidental findings.
M.15 Please note that future use of data may require a separate ethics application. Please consult your REB regarding future use.
M.16 Please indicate the type of biospecimens/data to be transferred and in what form it will be in when transferred.
Material Data transfer agreements may be required by the institution receiving or sending biospecimen/data. Please verify with the institutions. Completed agreements can be attached to 9.9 after initial approval via an amendment.
Note that if this changes in the future an amendment must be submitted before biospecimen/data are transferred.
M.16.B Please indicate the type of biospecimens/data to be transferred and in what form it will be in when transferred. Material Data transfer agreements may be required by the institution receiving or sending biospecimen/data. Please verify with the institutions. Completed agreements can be attached after initial approval via an amendment. Note that if this changes in the future an amendment must be submitted before biospecimen/data are transferred.
M.17 Click here for information on human pluripotent stem cell research.
Certain types of research involving the use of human pluripotent stem cells conducted under the auspices of institutions receiving Tri-Council funding are required to apply to the CIHR SCOC for approval.
M.18 Please attach these documentations for the previously collected biospecimen/data. Note that in some instances when biospecimens/data were collected over a period of time, there may be more than one applicable document in each category.
Consent form, if applicable, should be from when the biospecimens/data were originally collected. Do not create an example or potential new consent form.
Data collection forms includes variables that are provided along the biospecimen, such as: sex, date of collection and disease type. A data collection form should also be attached if data will be extracted from medical records.
Material/data transfer agreements may be required by the institution receiving or sending biospecimen/data. Please verify with the institutions. Completed agreements can be attached after initial approval via an amendment.
Appendix Appendix: Acronyms and Glossary
Acronyms
AGN: Application Guidance Note
C&W: Children's & Women's
CREB: Clinical Research Ethics Board
GN: Guidance Note
PHC: Providence Health Care
PI: Principal Investigator
QA/QI: Quality Assurance/Quality Improvement
REB: Research Ethics Board
TCPS2: Tri-Council Policy Statement (2nd version)
U.S. DHHS: United States Department of Health and Human Services
VCHRI: Vancouver Coastal Health Research Institute
Glossary
For a complete guide to ethics definitions please refer to the Glossary of the TCPS2. The most common definitions have been added below.
authorizedthirdparty Authorized third party: Any person with the necessary legal authority to make decisions on behalf of a prospective participant who lacks the capacity to consent to participate, or to continue to participate, in a particular research project. In other policies/guidance they are also known as "authorized third party decision makers."
autonomy Autonomy: The capacity to understand information and to be able to act on it voluntarily; the ability of individuals to use their own judgment to make decisions about their own actions, such as the decision to consent to participate in research.
clinicalequipoise Clinical Equipoise: The existence of a genuine uncertainty on the part of the relevant expert community about what therapy or therapies are most effective for a given condition.
dutyofcare Duty of Care: The obligation of clinicians to act in the best interest of patients. In the context of clinical trials, researchers are concerned with the welfare of individual participants, but are also focused on the generation of new knowledge that may or may not confer direct benefits on participants. Nevertheless, researchers do have a duty of care to ensure that the participant is an integral part of the research design and conduct. Refer to Chapter 11 of the TCPS2 for more information.
deidentifieddata De-identified Data: information where an individual's identifying information has been removed, and where there is no reasonable basis to believe that the information could be used to identify an individual. De-identified data may nevertheless 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. See AGN 8.4 for further directions on coding that is consistent with de-identification of data.
humanparticipants Human Participants: An individual whose data, or responses to interventions, stimuli, or questions by a researcher are relevant to answering a research question; also referred to as "participant," and in other policies/guidance as "subject" or "research subject."
humanbiologicalmaterials Human biological materials: Tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva, and other body fluids. The term also includes materials related to human reproduction, including embryos, fetuses, fetal tissues and human reproductive materials.
identifiabledata Identifiable information - Information that may reasonably be expected to identify an individual, alone or in combination with other available information. Also referred to as "personal information."
Directly identifying information- The information identifies a specific individual through direct identifiers (e.g. name, social insurance number, personal health number).
Indirectly identifying information- The information can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g. date of birth, place of residence, or unique personal characteristic).
Coded information- Direct identifiers are removed from the information and replaced with a code. Depending on access to the code, it may be possible to re-identify specific participants (e.g. the principal investigator retains a list that links the participants' code names with their actual name so data can be re-linked if necessary).
Anonymized information- The information is irrevocably 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.
Anonymous information- The information never had identifiers associated with it (e.g. anonymous surveys) and risk of identification of individuals is low or very low.
impracticable Impracticable: Incapable of being put into practice due to a degree of hardship or onerousness that jeopardizes the conduct of the research; it does not mean mere inconvenience.
multijurisdictionalstudy Multi-jurisdictional Study: A multi-jurisdictional study is a research study that requires review and approval by more than one Canadian research ethics board (i.e. by more than one Canadian REB that is not a UBC affiliated REB) as a result of the requirements of the TCPS2 and/or UBC's and/or another institution's human ethics policies.
retrospectivedata Retrospective Data: Data collected from charts dated on or before the date of ethics approval
prospectivedata Prospective Data: Data collected on an ongoing basis (i.e. chart information is taken from patients who are seen after the date of ethics approval)
secondaryuseofdata Secondary use of data: The use in research of information or human biological materials originally collected for a purpose other than the current research purpose.
therapeuticmisconception Therapeutic Misconception: A misunderstanding, on the part of participants, of the purpose, benefits, and/or risks of clinical trials. Often participants do not understand that research is aimed primarily at producing knowledge and may not provide any therapeutic benefit to them.
vulnerability Vulnerability: A diminished ability to fully safeguard one's own interests in the context of a specific research project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on their circumstances. See also "Autonomy." Refer to Chapter 4 of the TCPS 2 for more information.