Part B: RISe Application Guidance Notes

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.

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 Research Ethics Board Administration (REBA). 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.

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.

 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 two 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.

The title given in the application form must correspond to the title on all study documents, including the consent form.

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.

Box 2.1A (Required Field)

In multi-phase projects, include the period that involves research with human participants.

Box 2.1B (Required Field)

In multi-phase projects, include the period that involves research with human participants.

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.

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.

Please see https://www.hhs.gov/about/agencies/hhs-agencies-and-offices/index.html for list of HHS agencies and offices

If you answer YES to this question (2.6), you will be asked to provide more detail on page 3 of the application.

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".

Please refer to TCPS2, Article 7.4 for more information on Researchers & Conflicts of Interest.

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.

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.

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.

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 affliated sites (VCH, PHC, BC Cancer, CW). For REBC sites (https://researchethicsbc.ca/) , 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.

 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 (https://researchethicsbc.ca/) 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).

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.

 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.

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.

 If the study is a clinical trial, Health Canada must be notified of the rejection/disapproval of the study.

 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.

Click here for information on minimal risk.

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.

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 researcher is creating a repository (bank) of data or tissue that is specifically intended to be accessed by the researcher and/or other researchers for future use over an extended period of time, and where the researcher intends to be the steward or guardian of the information. 

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.

Biorepositories (also known as biobanks) are types of repositories that collect and store human biospecimens specifically for use in subsequent research.  Biospecimens are defined as human biological materials obtained from a participant and may include solid tissues, blood samples and fluids.  The information associated with the biospecimen may or may not include personally identifying information.

Registries and biorepositories can be of any size.

Retrospective data: Data collected from charts 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).

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.

If the study involves any other component such as tissue collection, or prospective data/specimen collection, or direct contact with participants, mark “No” to this question.

Important Note: Studies that are exclusively retrospective chart reviews, where no consent is being sought and no contact with participants is being proposed may be directed to View A, a branch off from the main application form which asks specific questions about the retrospective chart review and after completion of View A of the application form may truncate directly to View 9 (documents).
 

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).

Box 4.9A Examples of studies that can use this truncated form:

• Research using pre-existing biospecimens  (for e.g., samples in a 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

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

Box 4.9B
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.

If Box 4.9B is marked "Yes", the application will skip to View M

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.

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.

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.

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.

Click here for information on recruitment.

Please ensure the same sites are listed on page 4 of the application.
 

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.

See TCPS 2  Article 2.11 Research Involving Communities.

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.
 

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.

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).

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".

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.

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.

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.

Click here for further information on reimbursements and incentives.

Refer to TCPS 2 Article 3.2 for more information about the consent process.

Click here for information on the consent process.

​​​​​​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: 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.

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."

Refer to TCPS2 Chapter 3, Section C for more information on decision-making capacity.

Click here for information on capacity.

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.

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.

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.

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

Best practice and templates developed by Clinical Trials BC for sharing results with participants can be found here.  

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.

Controls are people acting in a control capacity (comparison group), including normal participants.

See TCPS 2  Article 11.3 Justification for Control Groups
 

Click here for information on obtaining regulatory approval for use of drugs outside approved indication.

Enter all Natural and Non-Prescription Health Products used. Click here for information on Natural and Non-Prescription Health Products..

Click here for information on obtaining regulatory approval for experimental devices.

Click here for information on positron-emitting radiopharmaceuticals (PERs).

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.

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.

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.

7.12.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.

7.12.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.

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.

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).

See TCPS 2  Chapter 11 A. Key concepts "stopping rules"

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.

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.

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.

Please complete Box 8.6B if your study involves the handling of biospecimens (e.g. blood samples)

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.

 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.

Attach all consent forms for the research, including the following:

• Participant consent form
• Normal/Control participant consent form
• Tissue blood banking 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

Attach all assent forms for the research, including the following:

• Participant assent form
• Normal/Control participant assent form
• Tissue blood banking assent form
• Substitute decision maker assent form
• Other assent forms

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.

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.

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 . 

Examples of other types of documents:

• Peer review report
• Clinical Trial Agreement
• Other institutional ethics approvals and associated documents not attached above
• CIHR Stem Cell oversight approval letter
• Transcript of Audio Visual item
• Data transfer agreement
• Website content
• Data collection form see sample here

If applicable, please attach a transcript (the document must include a version date) of any video or audio file.

For UBC Clinical REBs only: If this is an application using the streamlined process as indicated in Box 4.6, please append ALL relevant documentation from the other approving REB, including the application form, all correspondence from and to the approving REB (including changes requested), the protocol approved, the certificate of approval, the other REB approved informed consents, etc.

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

*Documents attached in this box will NOT be listed in the BC Certificate of ethics approval.