Part B: RISe Application Guidance Notes

The Application Guidance Notes (AGNS) provide question by question guidance for filling out the UBC Clinical research ethics application.

It is recommended that researchers have the AGNs close at hand while filling out the application for quick reference. Along with the AGNs, the right hand side of the application is also a useful resource, so it is recommended that researchers read the application thoroughly as they are filling it out.

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 A: (A1: The Roles and Responsibilities of the Researcher and the Research Ethics Board and A2: The Principles of Review)
Part B: RISe Application Guidance Notes (AGNs)
Appendix: Acronyms and Glossary


RISe Application Guidance Notes

The Application Guidance Notes following this Introduction correspond to the questions in the UBC online 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. 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.     Open All  

Page 1: Study Team, TCPS 2, and Study Title
1.1 PRINCIPAL INVESTIGATOR (required field)

The Principal Investigator (PI) bears the overall responsibility for the conduct of the study, including the activities of co-investigators, who are assumed to be acting under the delegated authority of the PI, and is required to adhere with the requirements of TCPS2 and other relevant guidelines. The PI accepts this responsibility by submitting the completed CREB application by clicking "OK" in the Submit Activity view on the application homepage. Based on security in the RISe system, only the PI listed in Question 1.1 on the application has access to this Submit Activity button for initial submission on the application homepage. The PI's signature attests to the following:

By signing below, I certify that I have read this application together with its attachments and that all information provided herein is accurate and complete. If circumstances should arise that materially affect the accuracy and completeness of the information provided, I will immediately report the new information in writing. I will abide by all applicable laws, regulations and international guidelines, and the policies of the UBC CREB regarding the conduct of research in humans [UBC Policy, #87 and #89], including UBC's conflict of interest policy [Policy # 97] and the Tri-Council Policy Statement for Ethical Conduct for Research Involving Human Subjects.

Department Head Signature

The PI's Department Head must also approve the application by clicking "OK" in the Approval Activity view on the application homepage to indicate that the PI has the qualifications, experience, and facilities to carry out their research. If the PI is a Department Head, the Dean of the Faculty or the Head of Division must sign the form.

Division Heads for the Department of Medicine, Faculty of Medicine are permitted to sign the application forms on behalf of the Head of the Department of Medicine. A Division Head who is also the PI must have the Head of the Department of Medicine sign the application form.

Once a PI hits Submit on an application form, it does not appear in the Research Ethics Board's (REBs) in-box until the Department Head has signed off on it. If an application is submitted close to a deadline, it is a good idea to follow-up with the Department Head so that the application does not miss a CREB deadline. The CREB is very strict about its deadlines. See the CREB deadlines . Note only full board applications have deadlines.

Who can be a Principal Investigator?

a) UBC Faculty

The Principal Investigator must have a Faculty Appointment (for example, Assistant Professor, Associate Professor, Professor, or Emeritus Professor). This includes Clinical Faculty appointments in the Faculty of Medicine.

b) Hospital Employees

The UBC Research Ethics Boards also review research carried out at affiliated teaching hospitals by employees who do not have Faculty appointments and who are not UBC students. In this case, the employee should be listed as the Principal Investigator and the employee's Hospital Department Head should sign the application.

Non-UBC Researchers

Faculty and students from other educational institutions wanting to conduct clinical research on UBC premises, including the UBC-affiliated hospitals, must have a UBC-affiliated Principal Investigator who is willing to take on the above mentioned responsibility. It is the responsibility of the non-UBC researcher to find an appropriate UBC PI.

1.2 PRIMARY CONTACT

The primary contact is the only other person listed on page 1 of the RISe application who will receive all correspondence from the RISe system about the application. The primary contact may also be listed as a co-investigator. For graduate research, it is recommended that the student who is completing the thesis list themselves as both the primary contact and a co-investigator.

Note that the PI may change the primary contact on an application without submitting an amendment. This can be done from the study homepage by clicking on the "Change Primary Contact" button under Activities on the left hand side of the screen.

1.3, 1.4, and 1.5 CO-INVESTIGATORS AND ADDITIONAL TEAM MEMBERS (with and without online access)

All co-investigators, including students, medical residents, and other study team members should also be listed in box 1.3, 1.4, or 1.5 of the application form. Note that anyone who interacts with study participants or their data should be listed on page 1 of your RISe application. Researchers may interact with individuals who are not directly involved in their research but who also have access to participant data, e.g. people managing charts, databanks or research registries. These people do not need to be listed on page 1 as access and proper management of this data is part of their terms of employment.

OTHER INFORMATION ABOUT STUDY TEAM

Designating Signing Authority

Once an ethics application has been approved, the Principal Investigator can designate one or two co-investigators to act as "co-investigators with full signing authority" to submit post-approval activities to the Research Ethics Board.

It is important to emphasize that the PI will continue to be entirely responsible for the research study. The PI must ensure that designated "co-investigators with full signing authority" are completely conversant with all aspects of the study. This option may be particularly helpful in situation where the PI is absent for a short time; however, if the PI will be away for longer periods the REB expects to be formally notified of a change of PI (see below).

In order to designate signing authority, the PI should go to the study homepage. Under the Activities menu on the right, click on "Designate Signing Authority" then select "Add" to display the list of co-investigators on the study. You may then designate up to two co-investigators with full signing authority. Click "Ok" to complete the activity. Click here for visual directions.

Examples of additional study team members who you may wish to have online access to the application include Clinical Trial Coordinators and Research Assistants who play an intricate part in managing the research in question.

Change in Principal Investigator

When the PI terminates his or her employment/association with UBC or his or her role on a study, the PI must inform the CREB by submitting an amendment that a new PI (meeting the above criteria in 1.1) will assume this role for the study for the CREB approval to be considered valid. If you need to change the PI permanently or temporarily, submit an Amendment to the REB using the RISe system. This involves completing the Change of PI form located in the Amendment PAA Coversheet in RISe. The form requires the signature of the following and then to be reattached in the PAA Coversheet as a .pdf file;
-the current PI
-the new PI
-the new PI's Department Head.

-What if the PI is not available to sign the form?

Provide a thorough explanation on the form as to why they are not available to sign it.

-What if the PI is not available to submit the amendment?

A co-investigator with signing authority listed in RISe can submit the amendment. The PI can access RISe from any location where they can access the internet. 

1.6. TRI-COUNCIL POLICY STATEMENT TUTORIAL (Required field)

All non-Faculty personnel who are associated with a research project and who will have contact with the research participants are expected to have completed the TCPS online tutorial 'CORE' (Course in Research Ethics) before the application is submitted to the CREB. This includes (but is not limited to) undergraduate and graduate students, medical residents, research assistants, research coordinators, etc. The CREB requires that all Principal Investigators be familiar with the TCPS2 and recommends that Principal Investigators also complete the TCPS tutorial, especially when the Principal Investigator supervises or teaches classes for graduate students or medical residents. TCPS Certificates do not need to be attached to applications; however, you may enter details in the comment box in this section, e.g. date of completion. Copies should be retained by the Principal Investigator and be available on request.

The tutorial is free. It takes around two hours to complete and can be found at the following:

http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/ (English) TCPS 2: CORE

http://www.ger.ethique.gc.ca/fra/education/tutorial-didacticiel/ (French) EPTC2: FER

The following tutorials are acceptable substitutes for CORE: past completion of the previously offered TCPS tutorial or the CHRPP (Course in Human Research Participant Protection) tutorial.

1.7 PROJECT TITLE (Required field)

The title given in the application form must correspond to the title on the consent form and other study documents. If the study is supported by research grant or contract funding that is being administered by the University or one of the teaching hospitals, the title should also correspond to the title on the grant or contract. If the research project is supported by multiple grants with different titles, ensure that all of the grants are clearly listed on page 2 of the application and the title is thematically similar to the grants listed.

1.8 PROJECT NICKNAME (Required field)

The project nickname or short title will appear in your inbox for applications and post approval activities (amendments, renewals, etc.). The nickname will not be printed on the Certificate of Approval. It will be used to serve as a quick reference to identify the project.

Page 2: Study dates, Funding Sources and Conflicts of Interest
2.1 PROJECT PERIOD (Required field)

The start date should correspond to the beginning of the period during which you anticipate collecting data and should not pre-date this application. In multi-phase projects include the period that involves research with human participants (i.e. the beginning of the project for the purposes of this application should not pre-date the application).

The end date can be an estimate of when you expect to have completed data collection and can be extended by an application for renewal or amendment.

For chart reviews, the dates entered here should be the dates the study will be conducted. The date range of charts to be reviewed should be indicated on page 5 of the RISe application form.

2.2 SOURCE OF FUNDING

Select the type of funding the research has received to conduct the study. If "Other" is selected, please provide details. For-profit studies will be charged a fee of $3000. If the sponsor is only collaborating on a project and not fully funding it, e.g. they are providing the study drug or laboratory space only, select "Other" and provide details on the sponsor's role in the study.

Researchers must inform the CREB office of any changes or additions to the funding source(s) using the Post Approval Activity "Amendments to Study". See the Post Approval Activity Guidance Notes for Amendments . The UBC Office of Research Services can only release the funds for awards/grants when the CREB Certificate of Approval has been updated to reflect the addition or change of a funding agency, should this occur.

2.2.B. For Industry sponsored studies please provide a sponsor contact (i.e. study monitor or CRO contact).

2.3 RESEARCH FUNDING APPLICATION/AWARD ASSOCIATED WITH THE STUDY THAT WAS SUBMITTED TO THE UBC OFFICE OF RESEARCH SERVICES

Research grants or contracts administered by the University or affiliated institutions will not be released until the project has been reviewed and approved by the appropriate Research Ethics Board. The information entered into these boxes will be used to cross-reference the Application for Ethical Review with a research grant or contract that may be flagged as pending ethical review in the Research Services database. Your Certificate of Approval will list the title that was entered in box 1.7 of the RISe application, as well as titles of all grants or other funds listed in boxes 2.3 and 2.4

2.4 RESEARCH FUNDING APPLICATION/AWARD ASSOCIATED WITH THE STUDY NOT LISTED IN QUESTION 2.3

2.5. U.S. FUNDING (Required field)

US Department of Health and Human Services (DHHS) Funded Research

If the study is funded by the DHHS, attach the actual grant application to box 9.8 of the ethics application. The DHHS requires that the UBC REB review the actual grant application to compare it to the protocol being approved to ensure that they are the same.

2.6 CONFLICT OF INTEREST (Required field)

As defined in UBC Policy #97: Conflict of Interest and Conflict of Commitment, Article 12.4, "in the research context, Conflict of Interest includes a situation where financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research. Conflicts of interest may be potential, actual or apparent".

Even though Investigators may supply the information requested in the application to their departments or hospitals, the REB must consider whether this information has any bearing on the ethics of the research study. Furthermore, as stated in Procedure 2 of UBC Policy #97, assessors of annual conflict of interest disclosures by UBC members (with members being defined as faculty, clinical faculty and staff) will disclose the existence of the conflict of interest to the relevant REB where the conflict of interest relates to a particular research project. Note that "immediate family members" includes partners and children (whether living in the household or not). The REB does not require that the researcher declare holdings in managed mutual funds in the conflict of interest statements.

Participants must be informed of significant individual financial conflicts of interest in the consent form. At a minimum, potential conflicts must be disclosed to the Board and to potential participants. The Board may require further action of the researcher to minimize or abandon a conflict, require formal oversight procedures for the research (including audits, independent data safety monitoring processes, regular reports to the CREB), or may disallow the research altogether. The Board may also inform the investigators' Department Head or Dean of Faculty about the conflict of interest.

Investigators are also advised of the following relevant national policies and guidelines:

If "yes" is answered to question 2.6., an extra page (page 3) will open and further detail will be requested.

Page 3: Conflict of Interest
Box 3.1

This box should describe all potential benefits

Answer questions A through E, giving as much detail as possible.

Recruitment Fees

The Canadian Medical Association Policy Guidelines for Physicians in Interactions with Industry 2007 states:

12. Because of the potential to influence judgment, remuneration to physicians for participating in research studies should not constitute enticement. It may cover reasonable time and expenses and should be approved by the relevant research ethics board. Research subjects must be informed if their physician will receive a fee for their participation and by whom the fee will be paid.

13. Finder's fees, whereby the sole activity performed by the physician is to submit the names of potential research subjects, should not be paid. Submission of patient information without their consent would be a breach of confidentiality. Physicians who meet with patients, discuss the study, and obtain informed consent for submission of patient information may be remunerated for this activity.

Box 3.2

Clarify how much money the investigator has received from the funder, as well as why the money has been received.

Preceptor Agreements

Disclosure to potential subjects is required where Preceptor agreements exist between a PI and a sponsor whereby the PI is consulted by the PIs at community sites for the same study; and where Preceptor agreements exist between a PI and a sponsor whereby the PI is consulted by the PIs at community sites for the same study.

Box 3.3

Disclose whether any of the investigators and/or their partners/family members are directly involved with the sponsor financially.

Box 3.4

Disclose whether any of the investigators and/or their partners/family members hold patent or intellectual property rights

Box 3.5

Clarify whether all UBC COI declarations for the Principal Investigator and Co-Investigators (if UBC Faculty) are up to date

Faculty members must disclose the extent, nature, and timing of their Extra-University Activities, their use of University resources for any Extra-University Activities, and any Financial Interests they or their Related Parties have in entities related to the Members employment at the University. This disclosure must be current and renewed at least annually.

Page 4: Research Ethics Board, Location, Risk Level, and Pandemic Research
4.1 UBC RESEARCH ETHICS BOARDS (Required field)

UBC's REBs have signed a one board of record agreement. Studies taking place at multiple UBC sites require review and approval by only one UBC-affiliated REB. The choice of Board should be determined by the PI's primary appointment and/or the main location of the research. See the following link to the UBC Clinical Guidance Note #2 on the jurisdiction of the UBC-affiliated REBs

Ensure to appropriately select whether the application is clinical or behavioural for each of the applicable boards as the application changes according to your selection. See the right side of the application for further discussion of the differences between clinical and behavioural research. BC Cancer Agency, Providence Health, and Children's and Women's REBs all review both behavioural and clinical research.

4.2 INSTITUTIONS AND SITES FOR STUDY (Required field)

You may add more than one site under this question. The letterhead of all recruitment and consenting documents are required to correspond to the selected institution(s).

VCHA - Vancouver Coastal Health Authority: All research conducted at any of the institutions within the authority of Vancouver Coastal Health (VGH, etc.) must be approved for resource utilization by the Vancouver Coastal Health Research Institute (VCHRI) in addition to the UBC Behavioural or Clinical REB.

C&W - Children's and Women's Health Centre of BC: Any research conducted at Children's Hospital, Sunny Hill Hospital, and Women's Hospital, collectively known as C&W, must be reviewed by the C&W REB. Please check the CFRI web page for the Children's & Women's REB deadlines.

PHC - Providence Health Care: Any research involving human participants conducted at a Providence Health Care (PHC) site must be reviewed and approved by the UBC-PHC Research Ethics Board. The UBC-PHC REB also needs to review any research protocols in which patients who are receiving care at a PHC site are enrolled.

BCCA - BC Cancer Agency: Researchers at the BC Cancer Agency should submit their new applications for ethical review to the UBC-BCCA REB for all clinical projects and in the case of behavioural projects to either the UBC-BCCA REB or the UBC Behavioural REB. However, anyone conducting research, behavioural or otherwise, at the BC Cancer Agency, must make sure they obtain approval from any BCCA Department whose resources are affected by the conduct of the study. The Principal Investigator is responsible for identifying and meeting those requirements.

4.2 B. All other locations: Please describe other locations where research participants will be recruited and / or where data collection will occur.

4.3 RELATIONSHIP WITH OTHER PROPOSALS

If this proposal is closely linked to any other proposal previously or simultaneously submitted to the CREB, please indicate this here and describe the relationship of this proposal to the others. Ensure to clearly indicate the related RISe file number, e.g. H11-00000.

Extension or Sub-studies

Indicate whether the study is an extension or a sub-study of a primary study. For example, in an extension study, the study period could be extended in order to give participants the opportunity to undergo an extra regimen of treatment with the experimental drug. A sub-study is a concurrent study on a sub-sample/population of the original study sample/population. The CREB reserve the right to require that a sub study or extension study be submitted as a new application.

4.4 LEVEL OF RISK (Required field)

UBC's REBs use a proportionate approach to review research involving human participants. They review applications in accordance with the level of risk that the proposed study poses to the research participants: the lower the level of risk, the lower the level of scrutiny; the higher the level of risk, the higher the level of scrutiny. In accordance with the TCPS2, full review by a fully convened REB is the default requirement unless the REB has determined that the research is of minimal risk and that delegated review by one or more experienced reviewers appointed by the REB is appropriate.

Minimal Risk is defined in the TCPS2 as follows: "research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research". See Guidance Note #5, Article 2 for a more thorough discussion of minimal risk research and specific examples.

Differences in Review Processes for Minimal Risk versus Full Board

-Full Board: The CREB reviews all greater than minimal risk applications at the full board. Full board meetings take place on the 2nd and 4th Tuesday of each month, with the exception of December, when only one meeting takes place. The CREB full board meeting deadlines are strictly followed and are at noon on the Friday which is 11 days before the meeting. See CREB deadlines for a list of upcoming deadlines and meetings. Studies that are reviewed at a full board meeting on a Tuesday can expect to hear back about the review before Friday of the same week.

-Minimal Risk: There are no deadlines for applications that meet the minimal risk criteria. The application will be assigned for review to designated members of the CREB. The turnaround time depends on the volume of applications received and the availability of reviewers; generally, it is approximately two weeks.

4.5 PEER REVIEW (Required field)

All studies submitted to the CREB which are more than minimal risk require a peer review or scholarly review, or an accepted argument about why one has not been obtained. The application will be sent back before it is reviewed if appropriate peer review information is not included. See Guidance Note #8, Article 2 on Required Information for a thorough discussion of peer review requirements.

4.6 HARMONIZED REVIEW OF MULTI-JURISDICTIONAL STUDIES (Required field)

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 as well as 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.

UBC has entered into partial reciprocity and collaborative review arrangements with certain other institutions and entities in situations where a study requires review and approval by more than one Canadian Research Ethics Board. For detailed guidance on harmonization processes and requirements click here.

List of institutions with which UBC has a reciprocity or collaborative review agreement:

  • Simon Fraser University
  • University of Alberta
  • University of Northern British Columbia
  • University of Saskatchewan University of Victoria

If Box 4.6 is marked "Yes", the application will skip to View E

4.7 CREATION OF A RESEARCH DATABASE, REGISTRY OR TISSUE BANK

Research databases or 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. Research databases, registries, and biorepositories can be of any size.

If Box 4.7.A is marked "Yes", the application will skip to View C

4.8 CLINICAL CHART REVIEW

Important Note: Studies that are exclusively retrospective chart reviews where no consent is being sought and no contact with participants is being proposed will be re-directed to a shortened application form for retrospective chart reviews only.

A retrospective chart review for the purpose of this application includes charts that were collected before the date of ethics approval (dates in the past), e.g. Sept. 2005-Sept. 2011.

If Box 4.8.D is marked "Yes", the application will skip to View A

If Box 4.8.D is marked "No", but Box 4.8.E is marked "Yes", the application will skip to View A

Page 5: Summary of Study and Recruitment

Note on Terminology

Although the TCPS2 guidelines specify a preference for the term 'participant', applicants may use the term of their choice (e.g. 'participant' or 'subject') as long as they are consistent throughout their application rather than switching back and forth. It is also important to be clear in your terminology. For example, if your study involves collaborators and participants, and these are distinct groups, do not use the term 'participants' interchangeably to refer to both.

5.1 A. SHORT SUMMARY (Required field)

Provide a short summary in lay language in 100 words or less.

5.1 B. SUMMARY OF RESEARCH (Required field)

The research proposal should be separated into 6 different headings: Purpose, Hypothesis, Justification, Objectives, Research Method, and Statistical Analysis. Read the right hand side of the application carefully for the required elements, when relevant, under each of the different headings. See the below for a discussion of each heading:

1. Purpose: This is the main reason that the study is being conducted (e.g. to determine efficacy, equivalence, safety, dosage levels, effectiveness) and should include the direct implications/applications of the research. Specify whether or not optional studies that may be part of a protocol are being conducted at the local site.

2. Hypothesis or Aim: This specifies the precise research questions being evaluated in the study.

3. Justification for the study: This includes background evidence that explains the need for the study. In particular, this section should explain what is unique about the study and what new research questions can be answered in order to support the ethical tenet that the proposed research has value.

For clinical trials, this information should provide evidence of clinical equipoise, which is defined as "...a genuine uncertainty on the part of the expert medical community about the comparative therapeutic merits of each arm of a clinical trial." The justification must include the differences between what is considered the current standard of care and the experimental intervention.

Some studies are conducted in order to satisfy requirements for Health Canada or FDA approval. This is not a sufficient ethical justification for the study. Ensure that a more precise justification is provided which explains why additional studies are needed and warranted.

4. Objectives: This includes the specific outcomes/endpoints of the research.

5. Research Method: This should include a description of the target population and/or sample, sample size, sampling method (e.g. randomization), type of research design (e.g. experimental parallel group or cross-over design) and the statistical analysis plan. It should also include a justification for the use of deception or placebo or for the need to carry out research in emergency health situations, if applicable.

5.2 INCLUSION CRITERIA

The selection of participants must take TCPS2 Article 4.1 into consideration, which states that: "Taking into account the scope and objectives of their research, researchers should be inclusive in selecting participants". The TCPS2 cautions against recruiting participants into research studies solely because they are easy to access or manipulate and highlights researchers' special obligations toward individuals or groups whose circumstances may lead to or increase their vulnerability in the context of a specific research project or study. For a thorough discussion of inclusion criteria, see Guidance Note #9, Article 1

When filling out the application form, ensure that all inclusion criteria as listed in the protocol are stated. Otherwise, indicate how these criteria differ from that in the protocol.

5.3 EXCLUSION CRITERIA

The selection of participants must take TCPS2 Article 4.1 into consideration, which states that: "Taking into account the scope and objectives of their research, researchers should be inclusive in selecting participants". The TCPS2 cautions against recruiting participants into research studies solely because they are easy to access or manipulate and highlights researchers' special obligations toward individuals or groups whose circumstances may lead to or increase their vulnerability in the context of a specific research project or study. For a thorough discussion of inclusion criteria, see Guidance Note #9, Article 1

When filling out the application form, ensure that all inclusion criteria as listed in the protocol are stated. Otherwise, indicate how these criteria differ from that in the protocol.

5.4 RECRUITMENT

\The described recruitment method should be free from undue influence, as per Guidance Note #10, Article 1.2, and include the following elements:

  1. The source (i.e. its original purpose, if relevant) of the contact information, and how the researcher gained access to it;
  2. Who will collect the contact information;
  3. Who will make the initial contact with the prospective participant(s);
  4. How the prospective participant will be initially contacted;
  5. When the prospective participant will be initially contacted;
  6. The relationship, if any, of the study team members to the participants (e.g. treating physician, teacher); and
  7. All recruitment materials such as letters, advertisements, flyers, television or radio scripts, internet/e-mail messages

Ensure this section contains sufficient detail. If appropriate information is not included, the board will request clarification. For a more thorough discussion on recruitment, including examples of appropriate recruitment methods, see Guidance Note #10 .If contact information is being obtained from Medical Records, Databases, or Registries, see Guidance Note #11for guidance on using this information appropriately and ensure that this is disclosed in the application form. In box 5.6 (further described below) indicate why the Principal Investigator and/or other study team members have access to this information.

5.5 RECRUITMENT OF NORMAL/CONTROL PARTICIPANTS

If the study is recruiting control participants and the recruitment method differs from that described in box 5.4., clearly describe the recruitment strategy based on the criteria outlined in box 5.4. If the study is using controls and the recruitment method is the same, state this. If the study is not using controls, then N/A may be used in this box.

5.6 USE OF RECORDS

If the study is using existing records, e.g. health records, clinical lists, or other records/databases, for recruitment purposes, clearly disclose why the Principal Investigator or another study team member has access to this information. An example of this may be that the Principal Investigator is a doctor in a specialized clinic and, therefore, has access to patient records within the clinic. In these cases, special care needs to be taken to ensure that the patients' rights are not violated. See Guidance Note #11, Article 5 for further information for appropriate use of these lists The method of contacting people on these lists should be clearly disclosed in box 5.4.

5.7 SUMMARY OF PROCEDURES (Required field)

Describe in a step-by-step manner the research procedures and how they differ from normal, non-research activities (ensure to clearly describe what is normally done, i.e. standard of care, and what is being done for research purposes). Describe the period during which the procedures will be carried out, how long each procedure will last, and the frequency of the procedures.

The description should include the sampling method (e.g., random sampling), group assignment (e.g., randomization), and type of research design (e.g., double blind).

The application and the consent form should include a description of the method of being assigned to one group or another in a study comparing two or more different experimental conditions. The researcher should provide a separate consent form for each group describing the experimental procedures that will affect the participant directly.

Back to Table of Contents

Page 6: Participant Time, Risk and Benefits, and the Consent Process
6.1 TIME TO PARTICIPATE

Indicate the amount of time a participant will be asked to dedicate to the project. The time should be above that which the participant would do regardless of participating in the research as part of standard of care. Include both the minutes/hours of the actual experimental procedure and the length of time the participant will be asked to do this, e.g. "the participants will attend the clinic once a week for a 1 hour appointment for 7 weeks. The total amount of time participants are being asked to dedicate to the project is 7 hours over 7 weeks."

Your times may be estimates where the exact time is unknown, e.g. 15-30 min; however, there must be consistency throughout the application and on all study documents.

6.2 TIME TO PARTICIPATE - NORMAL/CONTROL PARTICIPANTS

Using the criteria outlined in 6.1 indicate the amount of time that controls will be asked to dedicate to the project. If the research does not involve a control group, this box may be marked N/A.

6.3 RISKS/HARMS

Describe the potential risks or inconveniences to the participant associated with each procedure, test, or other aspect of the study. Please also address, where applicable, the broader impacts of the study on individual participants and the groups to which they belong. Such impacts may include: social stigmatization, threats to reputation, the creation of unfair stereotypes, and/or psychological harms such as anxiety, regret, or guilty feelings. Describe strategies to be used to minimize or manage the study impacts for participants and other affected individuals.

Clinical risks should be listed as bullet points and quantified using percentages, where possible. Ensure that there is consistency between this box and study documents, especially the consent form. See Guidance Note #12 for a detailed discussion of required information around risks.

6.4 BENEFITS

Specify the potential benefits to the participants. If there are no direct benefits, state this explicitly, and ensure this is disclosed in the consent form. If any specific 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. If benefits at a community or broader societal level are expected, these should be mentioned. See Guidance Note #12, Article 7 for Benefits.

6.5 REIMBURSEMENT

Voluntary consent must be free of undue influence in the form of inappropriate inducements. The amount or kind of payment should not be such that the participant will base his/her decision to participate on the potential material rewards.

TCPS2 page 29 states, "In considering the possibility of undue influence in research involving financial or other incentives, researchers and REBs should be sensitive to issues such as the economic circumstances of those in the pool of prospective participants, the age and capacity of participants, the customs and practices of the community and the magnitude and probability of harms".

The CREB will weigh the amount of remuneration offered against the amount of time and inconvenience to the participant on a case-by-case basis. It is considered unacceptable to have payment depend on completion of the project. However, reimbursement may be pro-rated based on the time a participant was enrolled in the study.

Ensure that a clear discussion of reimbursement and payments is in the consent form, including a schedule for pro-rating the reimbursement, if applicable. However, do NOT include reimbursements or payments on recruitment materials, see Guidance Note #10, Article 1.3, Exclusion of Remuneration from Recruitment Materials.

No Remuneration or reimbursement:

If the participant will not be remunerated for participation or reimbursed for expenses, this should be clearly stated in the consent form.

Lotteries and Draws:

As an incentive to participate in studies, researchers frequently offer participants a chance at a prize in a draw. If such a draw does not include those who decline to participate, technically it becomes a lottery and is illegal in British Columbia (without a license). You must have a license from the province of British Columbia to run any kind of lottery scheme. This includes draws where the subject pays or "barters" for a chance at a prize by completing some aspect of the research project. Consequently, researchers must ensure that participation in the draw is not contingent on participation in the research, and any subjects who withdraw must also have the opportunity to have their names included in such draws.

The CREB considers the use of draws as an acceptable incentive if the names of those who withdraw from the study are also included in the draw.

Reimbursement of Expenses:

Include specific details of the reimbursement of expenses related to transportation and parking and when these will be paid. The timing of the reimbursement should be appropriate to the length of time the study is to continue i.e. if a study is 2 years long, consider reimbursement of expenses every 6 months and not at the end of the study.

6.6 OBTAINING CONSENT

This box should clearly indicate who will explain the consent form to potential participants and obtain consent. The person obtaining consent must be sufficiently familiar with the study, the disease being treated (if applicable), and the process of informed consent. Ensure to disclose the relationship between the person obtaining the consent to the potential participant, e.g. doctor - patient. For a detailed discussion on the general principles of informed consent and on obtaining consent, see Guidance Note #13. If the study involves a departure of the normal principles of consent or involves assent, see as well Guidance Note #14 and #15

Refer to the BC Common Clinical Informed Consent Form Template for guidance on developing an appropriate consent form.

6.7.A WAIVER / ALTERATION OF CONSENT

In the TCPS2, Article 3.7 and Article 5.5 outline specific criteria for requesting a waiver or alteration of the consent in certain circumstances. The REB will consider an alteration or waiver of consent when outlined criteria are met. See the right hand side of the application for a list of the criteria. Ensure that your response to each of the criteria is labelled with the article indicating that criteria, i.e. The proposed research is not more than minimal risk, ii. Participants' rights will unlikely be adversely affected as [insert description of confidentiality method and research sensitivity], iii…, iv….etc. See Guidance Note #14 for further information on alteration or waiver of consent.

Note that retrospective chart review (access to past chart information only), generally fulfills the criteria for waiver of consent. However, prospective chart review (ongoing review of charts) does not meet the requirements for waiver of consent.

6.7.B WAIVER OF CONSENT IN INDIVIDUAL MEDICAL EMERGENCIES

Refer to TCPS2 Article 3.8 for further information on the following criteria.

  1. A serious threat to the prospective participant requires immediate intervention
  2. 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
  3. 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
  4. The prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the research project
  5. Third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so, and
  6. No relevant prior directive by the participant is known to exist
6.8 TIME TO CONSENT

Prospective participants should have adequate time to make a fully informed decision about participating in a study. For studies involving more than minimal risk, twenty-four hours is often considered an appropriate amount of time to give participants to think about participating in a study. However, the time given to consent should be based on the nature of the study in question. The TCPS 2 states that the time required for initial consent should "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". See Guidance Note #10, Article 1.4 for further information.

6.9 CAPACITY TO CONSENT

Indicate whether or not the research will include participants who lack the capacity to consent on their own behalf.

The Principal Investigator must judge the potential participant's capacity to consent on his or her own behalf, in all participants, in all research projects, regardless of age. The TCPS2 cautions around treating a group as inherently vulnerable. For example, within a group of 15 year olds, some may have the capacity to consent while others will not. It is the responsibility of the PI to determine this. Ensure that the research proposal indicates a method for determining capacity. For research involving individuals who lack the capacity to consent, either permanently or temporarily, these individuals should be given information and involved in decision making to the extent possible. See the related discussions in TCPS2 (Article 3.9, Articles 4.4, 4.5, 4.6). Also, see Guidance Note #15 for further discussion of capacity and obtaining consent in those who lack the capacity to consent.

6.10 RENEWAL OF CONSENT

TCPS2 Article 3.3 states that "consent will be maintained throughout the research project. Researchers have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research". Renewal of consent might be particularly appropriate in the context of clinical trials research where risks become known as the trial progresses. In these cases, a clear description of how the participants will be told of new risks should be outlined in your application. Note that depending on the nature and urgency of the risks, the participant may be told verbally of new risks or presented with an updated consent form. If the participant is told verbally, this should be clearly disclosed in the investigator's study notes. When the nature of the risks has the potential to affect a participants' decision to continue to participate, written re-consent is generally required.

Once the risks are known, an amendment must be submitted to the CREB in order to update the application form and submit any new materials that may be given to participants. For most cases (non-emergency), the amendment should be granted REB approval before the participants are contacted. In emergency situations, please contact the CREB as soon as possible to discuss the situation.

6.11 PROVISIONS FOR CONSENT

Describe any provisions 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 of the application.

6.12 RESTRICTIONS ON DISCLOSURE

Describe any restrictions regarding the disclosure of information to research participants (during or at the end of the study) that the sponsor has placed on investigators, including those related to the publication of results.

Page 7: Regulatory Approvals
7.1 MULTI-CENTRE STUDIES

Mark "yes" when the study is occurring in one or more site that is outside of UBC's one board of record agreement e.g. sites not including PHC, C&W, VCHRI, and UBC.

TCPS2 Article 8.3(b) states, "Research conducted under the auspices of a Canadian research institution and conducted outside its jurisdiction, whether elsewhere in Canada, or outside Canada, shall undergo prior ethics review by both: (i) the REB at the Canadian institution under the auspices of which the research is being conducted; and (ii) the REB or other responsible review body or bodies, if any, at the host research site". Please indicate the agency having jurisdiction over the site of the research and whether approval has been applied for or received. If approval has been received, append this to box 9.8 of the RISe application.

7.2 NUMBER OF PARTICIPANTS

This section must be completed. It is acceptable to provide an estimate for the number of participants if the exact number is not known in advance. However, the number provided should be consistent throughout the application.

7.3 DRUG APPROVALS

Enter the generic name for all experimental drugs or marketed drugs used in the study outside of their approved indication. See 7.8 below for further information on regulatory approvals for the use of these drugs in research.

7.4 MARKETED DRUGS

Enter the generic name of all marketed drugs used within their approved indication.

7.5 NATURAL HEALTH PRODUCTS

Enter the name of any Natural Health Product used in the study. Natural Health Products include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotic, and other products like amino acids and essential fatty acids. All Natural Health Products must be safe as over-the counter products. If they need a prescription to be sold, they are regulated under the food and drug regulations. See the following Health Canada link for further information: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php .

7.6 EXPERIMENTAL DRUGS AND DEVICES

Enter the name of all investigational devices or marketed devices used outside of their approved indication. See 7.8 below for further information on regulatory approvals for the use of these devices in research.

7.7 STUDIES INVOLVING POSITRON-EMITTING RADIOPHARMACEUTICALS (PERS)

Enter the name of any positron-emitting radiopharmaceuticals used in the study. For further information, please consult with the Health Canada 2006 interim compliance policy and guidance documents found at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/pol_0053_tc-tm-eng.php

7.8 HEALTH CANADA REGULATORY APPROVALS

Investigators conducting clinical trials involving either investigational drug(s), device(s), or natural health products formulated for therapeutic purposes OR involving a drug/device/natural health product used for an indication outside those specified in the Health Canada Drug Identification Number, Notice of Compliance or Medical Device License, must submit the appropriate application for regulatory approval to Health Canada before research can begin. Note that the CREB will not release a Certificate of Approval until the Health Canada No Objection Letter (NOL) has been received. In these situations, once a study has been approved in principle, the CREB administration will issue an additional proviso requesting that the study team attach the NOL once received. When the study team receives the NOL, attach it to Box 9.1.B. of the application and re-submit for REB approval.

The Clinical Trial Application (CTA) for drugs/natural health products or the Investigational Testing Authorization (ITA) for devices must be filed with the appropriate directorate within the Health Protection and Food Branch of Health Canada:

1. Clinical trials for drug and devices: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/tpd-dpt/index-eng.php

2. Clinical trials involving natural health products formulated for therapeutic purposes: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index-eng.php

Compliance with the Food and Drug Act

All investigators conducting clinical trials must be familiar with the details of the Food and Drugs Act and Regulations: http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/act-loi_reg-eng.php

C.05.001 of the Regulations empowers the Research Ethics Boards to review, approve and conduct periodic reviews of biomedical research involving human participants to ensure the protection of their rights, safety and well-being.

Several of the important new regulations are summarized below:

  • These regulations apply to clinical trials for both new investigational drugs and some marketed drugs. The use of a marketed drug outside of its approved indication now requires Health Canada approval for use in a clinical trial (whether investigator or industry initiated).
  • A 'Sponsor' is defined in the Regulations as an individual, corporate body, institution or organization that conducts a clinical trial.
  • All clinical trials, including Phase IV trials, must be conducted in accordance with good clinical practices as specified by ICH GCP. However, Phase IV clinical trials are not subject to the Clinical Trial Application filing requirements with Health Canada.
  • Each clinical trial must have a 'Qualified Investigator' who is responsible to the sponsor for the conduct of the trial and who has appropriate medical qualifications (see the definition under C.05.001).
  • All information collected in a clinical trial must be stored in accordance with C.05.012, which includes the requirement for the sponsor to store records for 25 years.
7.9 DETAILS OF HEALTH CANADA REGULATORY APPROVALS

If as per the above questions, if the study needs a Health Canada NOL, ITA, NOA, it must be listed here. Note that is also must be attached to the application in Box 9.1.B or C (if US).

7.10 STEM CELL RESEARCH

As of 30 June, 2010, the updated CIHR Guidelines for Human Pluripotent Stem Cell Research apply to all new or ongoing human stem cell research that is:

  1. funded by the CIHR agencies;
  2. conducted under the auspices of an institution that receives any agency funding, whether on site or off site or;
  3. conducted elsewhere with any source of funding by faculty, staff or students from an institution that receives Agency funding.

See the above guidelines and the GN on Stem Cell Research for a more thorough discussion of the types of research the SCOC must approve and the types of research that does not need to conform to these guidelines.

CIHR requires that stem cell investigators seek REB approval for their non-clinical research, in addition to approval from the UBC Animal Care Committee (when appropriate) and the UBC Biosafety Committee.

7.11 REGISTRATION FOR PUBLICATION OF CLINICAL TRIALS

The TCPS 2, Article 11.3, states that all clinical trials should be "registered before recruitment of the first trial participant in a recognized and easily web-accessible public registry." Note that the CREB requires that all clinical trials must be registered with a registry that meets the requirements of the International Committee of Medical Journal Editors (ICMJE), e.g. ClinicalTrials.gov and Controlled-trials.com.

The PI of a clinical trial being done at UBC/affiliated sites is responsible for ensuring that the trial is registered with an acceptable international registry. Ordinarily, multi-centre studies will have been registered by the sponsor so the PI at UBC/affiliated sites need only verify that the trial has been registered by the sponsor and note the registry on the application form.

The CREB expects that the PI will ensure that the trial is registered and appropriately updated when the trial is complete or results are published. Note you may register your trial in ClinicalTrials.gov prior to getting approval from the CREB, provided the trial is not yet recruiting. Before the first participant is recruited, REB approval must be obtained and the protocol record updated on the site according to that approved by the REB. Please refer to http://prsinfo.clinicaltrials.gov/faq.html for more information.

7.12 US REGULATORY REQUIREMENTS

If the study is conducted or funded by the US Department of Health and Human Services (DHHS) or is required to comply with either the US FDA or any other US regulations, this must be indicated on the application See the right hand side of the application and the list below for further information.

Office of Human Research Protections (US Department of Health & Human Services)
Food and Drug Administration (FDA)
US National Cancer Institute (NCI)
National Institutes of Health (NIH)

Page 8: Data Monitoring, Data Security, Confidentiality, and Data Retention
8.1 UNBLINDING IN AN EMERGENCY

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:

  1. unblinding to reveal treatment assignment
  2. information about the nature and risks of the particular treatment the participant is or has received
  3. 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:

  1. Name of Participant
  2. Name of Study
  3. Participant Study Number (if applicable)
  4. Name of Principal Investigator
  5. Treatment they are receiving (or which they could be receiving if they are in a blinded study)
  6. Contact information of investigator/research staff (not necessarily 24/7)

OPTIONAL INFORMATION AS DICTATED BY THE NEED OF THE PARTICIPANT

  1. Phone number for immediate unblinding
  2. Website for more detailed information about the study
  3. Contact information of investigator/research staff (24/7)
  4. "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

The TCPS2 Article 11.7 states: "Researchers shall provide 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." Provide this information in detail, if applicable to your study.

8.3 STUDY STOPPAGE

The TCPS2 Article 11.8 states that "When new information is relevant to participants' welfare, researchers shall promptly inform all participants to whom the information applies (including former participants). Researchers shall work with their REB to determine which participants must be informed, and how the information should be conveyed." Outline any set stopping rules for the study and the way in which participants will be informed in the event that the clinical trial is stopped, if applicable to your study.

8.4 PERSONAL IDENTIFIERS

The TCPS2 Article 5.3 states: "Researchers shall provide details to the REB regarding their proposed measures for safeguarding information, for the full life cycle of the information: Its collection, use, dissemination, retention and/or disposal."

The CREB expects that research-related documents (except the master randomization schedule, consent forms, or screening logs) do not include information that would allow the participant to be identified. To this end, spaces/fields for participant's name, the first or last three letters of a participant's name, actual initials, reversed initials, birth date, hospital medical record number, provincial personal health number, social insurance number, address or phone number are not permitted on study-related documents.

Information is considered de-identified if the following conditions are met:

  1. the unique study code is not derived from or related to the information about the individual;
  2. the unique study code could not be translated to identify the individual, and;
  3. the investigator or their institution could not use OR disclose the unique study code for other purposes OR disclose the mechanism for re-identification.

It is not necessary to use a personal identifier (for example, birthdate) as a secondary identifier in order to confirm the identity of the participant. This can be accomplished by using any two unique identifiers.

Participant Enrolment Logs, documents or databases, which correlate participant names with study code numbers, must be kept on the locked premises of the PI or in an appropriately secured electronic form.

As per the above discussion, Box 8.4 of the application should specifically state that a unique study code, not derived from or related to the information about the individual, i.e. name, SIN, PHN, hospital number, DOB, address, or unique characteristic, will be used. A proviso will be sent back if this is not directly specified.

8.4A USE OF PERSONAL HEALTH INFORMATION OR IDENTIFIERS

If you will be collecting personal identifiers, this must be indicated and justified. If the full date of birth will be collected, justify why this is necessary as opposed to only collecting the month and year of birth.

8.5 DATA ACCESS AND STORAGE

Give the names (if known) of those who will have access to the raw data, which may include information that would identify the participants. The research participants must also be told in the consent form who will have access to his/her data and what use will be made of it, either now or in the future. Temporary student assistants and clerks may be referred to by their role instead of name.

8.6 DISPOSITION OF STUDY DATA

UBC Policy #85 states, "A factor in many cases of alleged scholarly/scientific misconduct has been the absence of a complete set of verifiable data. The retention by the University of accurately recorded and retrievable results is of utmost importance. Wherever possible, all primary data should be recorded in clear, adequate, original and chronological form. In scientific departments, a record of the primary data must be maintained in the laboratory and cannot be removed. Original data for a given study should be retained in the unit of origin for at least five years after the work is published or otherwise presented (if the form of the data permits this, and if assurances have not been given that data would be destroyed to assure anonymity)".

This means data should be stored for at least 5 years after publication within a UBC facility, but may be retained for a longer period provided that they are stored securely. UBC has no explicit requirement for the shredding of data at the end of this period; however, destruction of the data is the best way of ensuring that confidentiality will not be breached. Please note that the responsibility for the security of the data rests with the Principal Investigator.

Please note that if it is not stated specifically in the response to this box that a study's data will be maintained for at least five years after publication, a specific statement explaining why not must be provided. If not, a proviso will be issued to ensure that data will be maintained the appropriate amount of time.

If your study is regulated by Health Canada, the data retention period is 25 years.

Describe any future use of the data beyond the conclusion of this research project (e.g., justification for future studies, publication, etc.) and indicate whether subject consent will be obtained now in the current consent procedure or the subject will be contacted later to obtain consent. Either possibility must be described in the consent form. If consent is to be obtained now, the future use of the data must be described in full in the consent form included with the current application. If consent for future use of the data is to be obtained later, full details, including the consent form, must be submitted to the CREB for review and approval before the research begins.

8.7 DATA TRANSFER TO OTHER INSTITUTIONS

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.

The TCPS2 identifies 5 different categories of data collected from research participants, each with different implications for the privacy of participants (see TCPS2, Chapter 5, P. 56 - also below). 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 CREB 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.
8.8 DATA TRANSFER TO INSTITUTION

Give details about any data being received from other sites, if applicable.

8.9 DATA LINKAGE

If data is to be linked to any other data source (including a biorepository) the data set, how the linkage will occur and how confidentiality regarding shared information will be reserved needs to be identified and elaborated upon.

Page 9: Documentation

Assign a version date to all attached documents created by the researcher. This version date must be included as a footnote on each page of the study documents. Pagination of attached documents should be in the form 'page X of XX'. Please ensure the date listed on the RISe application form matches what is on the actual document. The Certificate of Approval generates the date listed on the RISe application form; if this does not match what is in the document, your Certificate of Approval will be incorrect.

Identifiers on Research Documents

As per box 8.4., all study documents including participant information should be marked with a unique study number only. See discussion in Box 8.4.

9.1 PROTOCOL OR PROPOSALS

All applications for CREB review require a research protocol to be attached to this box. See Guidance Note #8, Article 1 for further discussion of what should be included in a research protocol. Note that research proposals submitted to granting agencies may be used to meet this requirement.

9.1B and 9.1C REGULATORY APPROVALS

Enter regulatory information when applicable. See Application, page 7, for further information about regulatory approvals.

9.2 CONSENT FORMS

Participant Consent Form - Informed consent is often documented by means of a written, signed, and dated informed consent form, following a process by which a participant voluntarily confirms his or her willingness to participate in a particular study, after having been informed of all aspects of the study that are relevant to the participant's decision to participate. Refer to the BC Common Clinical Informed Consent Form Template. The document can be downloaded in Word, saved to your desktop, and edited to meet the needs of a particular study. Note sections that are not relevant to your study do not need to be included.

If you are obtaining oral rather than written consent, you must describe the procedures you will use to obtain consent, including a script of how consent will be broached and obtained. Please note that even if you obtain oral consent, it may be advisable to leave a written statement of the information conveyed in the consent process with the participant. However, researchers should not leave any documentation with a participant if it may compromise their safety or confidentiality or if it is culturally inappropriate to do so. See TCPS2 Article 3.12 and Article 10.2 for further discussion.

See Guidance Notes #13, #14 and #15 for thorough discussions of consent and consent processes.

9.3 ASSENT FORMS

9.3 ASSENT FORMS

Assent Form - TCPS2 Article 3.10 stipulates that the assent of a participant is required in situations where free and informed consent has been obtained from an authorized third party, and where the individual substantially understands the nature and consequences of the research. Also, see Guidance Note #15 for UBC specific assent procedures. Finally, refer to the CREB Assent Form Template.

9.4 INVESTIGATOR BROCHURES/PRODUCT MONOGRAPHS

The most recent Investigator Brochure (IB) for all investigational drugs must be attached to the CREB application. The IB should be updated via amendment as updates become available. For products that have Health Canada approval, the most recent product monograph should be attached to the application.

9.5 ADVERTISEMENTS

Advertisement to Recruit Participants - This includes any type of communication (e.g., flyer, radio/television script, poster, newspaper ad, Internet message) that is directed to potential participants for the purpose of recruitment.

All recruitment material used must be approved by the REB in the form it will be used in before recruitment begins, e.g. a newspaper ad and a poster should be submitted separately even if the text is only slightly different. Recruitment materials should give potential participants a basic understanding of the research, what would be expected of them (including time commitment), and their potential eligibility for the study. Include directions for the potential participant to contact the research team, if they are interested in the study. All recruitment material should be labelled with a version date. Do not include any payment or remuneration value for participation on the recruitment material; however, you may mention an honorarium, gift, or small token of appreciation will be given. Refer to Guidance Note #10, Article 1.3

9.6 QUESTIONNAIRES

Ensure that all questionnaires, surveys, tests, interview scripts etc. are attached as separate documents to this box. They should be in their final form. If they are included as an appendix in the protocol or study proposal, they still must be attached to this box as separate documents.

9.7 LETTER OF INTIAL CONTACT

Attach any letters of initial contact that are being used for the study. Ensure that they include the required elements listed in Guidance Note #10, Article 1.1

9.8 OTHER DOCUMENTS

Attach all other documents relevant to the study and REB approval in this box. This could include but is not limited to the following: peer review reports, clinical trial agreement, other REB approvals, transcript of audio visual item, data transfer agreement, website content, DHHS Grants. See the right hand side of the application for further information.

Page 10: Fees

A fee for ethical review applies only to sponsored research studies (i.e., those funded by industry or for-profit sponsors). Please note that if the study team is collaborating with a sponsor, e.g. a sponsor is supplying the study drug or laboratory space but no other funding, the study does not need to pay for REB review.

Sponsored Research Fees

An initial application fee of $3,000 CAD per application covers the cost of the submission and initial review of the application. As of April 1, 2012, an annual renewal fee of $500 CAD will be levied (at the time of the annual renewal) to cover the cost of the annual renewal and other on-going oversight, including amendments and unanticipated events (Refer to the Annual Renewal Update posted below). The Principal Investigator must ensure the sponsor is aware of these fees.

Payment of the fee, or a letter stating the date payment is expected to be made, must accompany the Application for Clinical Ethical Review on RISe (See Page 10 of the Application Form). Review the Wire Payment Instructions document for advice on paying the review fee via wire transfer.

The Certificate of Approval will not be released until the review fee has been received. If you have outstanding fees, no new CREB reviews will be undertaken until your account is brought into good standing. For a current statement of your fee account or other specific queries relating to CREB fee payment, please contact (604-875-4111 x68917).

Fee for Renewal of Sponsored Research

Effective April 1st, 2012, all applications for annual renewal of ethics approval for current (active and approved prior to April 1, 2011) privately sponsored (industry funded) research studies will be subject to an annual renewal fee of $250 upon submission of the renewal. All new studies submitted for initial ethics approval subsequent to April 1st, 2011 will be subject to an annual renewal fee of $500 upon submission of the renewal.

For further information about the renewal fee and CREB procedures in this regard, see the notice of Fee for Annual Renewal 

View A - Retrospective Chart Review

A.1 (Required field)

Summarize the research proposal using the following headings:

  1. Purpose
  2. Hypothesis
  3. Justification
  4. Objectives
  5. Analysis of Data

A.2 (Required field)

Describe how permission to access the medical records and to collect and use these records will be obtained.

A.3

Briefly describe the type of data that you intend to collect (e.g., disease, diagnosis, outcome, demographic, aggregate, personal-level).

Important Note: If you intend to collect personally identifiable information, a data collection / data extraction form must be appended to Box 9.8.A. of the application form.

A.4

Specify the minimum number of charts / records required to conduct the study.

A.5 Personal Information (Required field)

A.5 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.

A.5.1 Types of personally identifiable information include but are not limited to the examples above. For example gender, e-mail address, telephone number, healthcare provider, discharge dates, photographs, postal codes etc. can all constitute personally identifiable information.

A.7. (Required field)

Describe the risks associated with the possible disclosure of the data. Include any foreseeable circumstances where disclosure of identifying data may be required by law.

A.8 (Required field)

Describe how the identity of the participants will be protected both during and after the research study, including how the participants will be identified on data collection forms.

Unique 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, SIN, PHN, hospital number, DOB, or unique characteristic.

A.9 (Required field)

Explain who will have access to the data at each stage of collection, processing and analysis, and indicate whether a current list of the names of study personnel (including co-investigators) and their delegated tasks will be maintained in the study file. If a list will not be maintained, please explain.

A.10 (Required field)

Describe how the data will be stored (e.g. computerized files, hard copy, video-recording, audio-recording, personal digital device, other).

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.

A.11 (Required field)

Describe the safeguards in place to protect the confidentiality and security of the data. 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.

A.12 (Required field)

Describe what will happen to the data at the end of the study, including how the data will be destroyed, and what plans there are for future use of the data, including who will have access to the data in the future and for what purpose.

Please clarify that data will be stored according to UBC's Policy #85 http://www.universitycounsel.ubc.ca/policies/policy85.pdf

Original data for any given study must be retained in the unit of origin for at least five years after the work is published or otherwise presented (if the form of the data permits this, and if assurances have not been given that data would be destroyed to assure anonymity).

A.13 Data Transfer (Required field)

Will data be transferred outside of UBC or its affiliated hospitals?

If yes, please describe the type of data to be transferred, who the data will be transferred to, where the data will transferred, and how the data will be sent.

Note that if this changes in the future an amendment must be submitted before data is transferred.

A.14.A Data Linking (Required field)

Do you plan to link the data to any other data? Note that if this changes in the future an amendment must be submitted before data is linked.

A.14.B

Identify the data set, how the linkage will occur, and provide a list of data items in the other database. Also, identify what personal information will be used to link the databases and how confidentiality regarding this shared information will be preserved.

View C - Creation of a Research Database, Registry or Biorepository

 

C.1 (Required field)

What is the scope and purpose of the database, registry or biorepository?

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.

In addition to other attributes, biorepositories may be considered as: a) mono-user biobanks (i.e., a collection aimed at supporting a specific, single research project; b) an oligo-user biobank (i.e., a collection aimed at supporting several research projects, a research group or a research consortium); or c) a poly-user biobank (i.e., a collection aimed at supporting undetermined, multiple users with REB-approved research projects, through a defined access/application mechanism).

C.2 (Required field)

What are the anticipated public and scientific benefits of the database, registry or biorepository?

C.3

Over what period of time will data be collected? Include a clear date range of the information that will be included in the registry or biorepository. If data will be collected indefinitely, clearly indicate that data will be collected indefinitely or until the participant withdraws, if applicable.

C.4.A What information source(s) are you accessing?

Elaborate on the recruitment method. Answer C.4.A. and B if your project involves creation of a database or registry. Answer C.4.C. if your project involves creation of a biorepository. Tissue biospecimens are any human biospecimens or biological material comprised of whole solid tissues, cells isolated from solid tissues and fluids other than blood.

C.4.B. Provide specific details about the source(s), i.e. including name of the database or type of health records, location etc.

C.4.C. What are the sources of your biospecimens, check all that apply.

Direct from live subject (procedure conducted for research purposes)

Indirect from live subject (procedure conducted for clinical purposes and excess tissue leftover after clinical diagnosis obtained for research)

Post mortem tissue collection

C.5. A. Confidentiality (Required field)

Are you collecting personally identifying information/will the biospecimens be linked to personally identifiable information? [If not, skip to C.9] (if no, form should truncate to C.9) 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

Indicate the type of personally identifying information you will be collecting/that will be linked to the specimens. Include a justification for its inclusion in the registry or database and/or retention of the link. Important Note: For databases or registries, a data collection form should be attached to question 9.8. of the application.

C.5.C

How long will data remain identifiable/ specimens be linked (i.e. when, if ever, will it be irreversibly anonymized). Justify why data/specimens need to remain identifiable, if this is the case.

Irreversibly 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. Refer to the appendix of definitions at the end of this document.

C.5.D.

List the individuals (who are not already listed on page 1 of the application) who will have access to personally identifying information at any stage in the data collection or review/abstraction of the data,/analysis of the specimens including those who will have access to master lists of keys linking identifiable participants to research data/specimens.

C.6.A. Consent (Required field)

Will participants consent to be included in the database or registry? Have their specimens included in the biorepository? [If no, skip to C.7.]

Important Note: Attach a copy of the consent form to Box 9.2 of the application.

Click here for the required elements of the Consent related to banking:

UBC Guidance Note #16

CREB Guidance Notes Related to Tissue Collection and Banking

Pre-procedure consent is consent obtained prior to the individual undergoing a medical procedure (e.g. surgery or biopsy to remove a tumour). Post-procedure consent is consent obtained after the individual has undergone a medical procedure. For additional information click here.

C.6.B.

Specify who will explain the consent form and invite participants to contribute. Include details of where consent will be obtained and under what circumstances. For biorepositories, please explain whether the consent process is pre-procedure or post-procedure.

C.7

If you do not plan to obtain individual participant informed consent please provide justification for not doing so following the criteria outlined on the right. Please address each criterion individually.

Refer to TCPS2 Articles 3.7 and 5.5 for further information on the following criteria.

  1. Explain why inclusion in the registry or database/biorepository involves no more than minimal risk to the participants;
  2. Confirm that the lack of participants' consent is unlikely to adversely affect the welfare of the participants;
  3. Demonstrate that the purpose or aim of the registry/database/biorepository would be impossible or impracticable to carry out, if the prior consent of the participant is required;
  4. Explain why the public interest in conducting this research using this registry or database exceeds the public interest in protecting the privacy of individuals;
  5. Demonstrate that whenever possible and appropriate participants will be provided with information regarding their participation in the database, registry, or biorepository;
  6. Demonstrate compliance with any known preferences previously expressed by individuals about any use of the information/ their specimens; and
  7. Confirm that any other necessary permission for secondary use of information for research purposes are in place.

C.8.A. Participant access to data and withdrawal (Required field)

Will individual participants have the right to access their data, or right to amend or withdraw their information?

C.8.B.

Provide details of the process for accessing and/or withdrawing data, including what data can be withdrawn.

C.9. (Required field)

What is the entity or who is the person that will have custodianship of the database or registry/bio-repository?

A data/biorepository custodian is an entity or person who is responsible for overseeing the management and use of the data/biorepository, including the main rules governing use of the database/biorepository, 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. (Required field)

What will be the address of the database, registry or the location of the biorepository? This should be a mailing address; however, if there is a URL, please also provide it.

C.11. (Required field)

What steps will be taken to ensure the security of the data/biospecimens? 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.12 (Required field)

For databases and registries, describe the risks associated with the possible disclosure of the data/. Include any foreseeable circumstances where disclosure of identifying data may be required by law.

C.13.A. (Required field) Data/Biospecimen Transfer

Will data/biospecimens be sent outside of the institution? [If no, skip to C.14]

C.13.B.

Explain why it is necessary to send the data/biospecimens outside of the institution, and indicate what data/biospecimens will be sent, where it/they will be sent, who it/they will be sent to, how it/they will be transferred (faxed, emailed, couriered, encrypted electronic transfer etc.) and where it/they will be stored.

C.13.C.

Will there be a data transfer/material transfer agreement? If so attach a copy of the data transfer agreement to box 9.8. of the application.

C.14.A. (Required field) Data Linking

Do you plan to link all or some of the data or the biospecimens to another data source (e.g. database, biorepository)? Note that if this changes in the future an amendment must be submitted before data is linked.

C.14.B.

Identify the data set, how the linkage will occur, and provide a list of data items in the other database. Also, identify what personal information will be used to link the databases and how confidentiality regarding this shared information will be preserved.

C.15.A. (Required field) Data Retention

How long are you planning to keep the data/biospecimens?

C.15.B.

If the data/biospecimens will be destroyed, indicate the planned method for erasure/destruction of the data/biospecimens.

Please clarify that data will be stored according to UBC's Policy #85 http://www.universitycounsel.ubc.ca/policies/policy85.pdf

Original data for any given study must be retained in the unit of origin for at least five years after the work is published or otherwise presented (if the form of the data permits this, and if assurances have not been given that data would be destroyed to assure anonymity).

C.16.A. Future Use (Required field)

Will the information in the database/biorepository be retained as an ongoing database/biorepository (or as part of an ongoing database/biorepository) for future research? [If no, skip to C.17]

C.16.B.

Provide a full description of the data/biospecimen stewardship process, including whether the dababase / biorepository will have formalized SOPs. 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 biorepositories to consider certification of their biorepository with the Canadian Tumour Repository Network (CTRNet) Biobank Certification Program or accreditation with the College of American Pathologists (CAP) Biorepository Accreditation Program.

C.17.A. (Required field)

Describe any commercial uses for which the data/biospecimens may be used, including any disclaimers concerning participant remuneration for such use.

database. Also, identify what personal information will be used to link the databases and how confidentiality regarding this shared information will be preserved.

 

View E - Harmonized Review of Multi-Jurisdictional Studies

THIS VIEW IS ONLY AVAILABLE TO APPLICANTS SUBMITTING TO THE HOSPITAL RESEARCH ETHICS BOARDS)

 

E.1 (Required field)

Is this the first/initial application for review of the multi-jurisdictional study at any of the sites where the research is going to be conducted? The first/initial application for review is the first application for ethical review of the research submitted to any of the Institutions with which UBC has a signed reciprocity agreement.

UBC has entered into partial reciprocity and collaborative review arrangements with certain other institutions and entities in situations where a study requires review and approval by more than one Canadian Research Ethics Board. For more information on the BC Harmonization Initiative click here. For a list of institutions with which UBC has a reciprocity or collaborative review agreement click here

E.2. (Required field)

Are you the Lead Investigator for this multi-jurisdictional study? The Lead Investigator is the only Investigator conducting the multi-jurisdictional study at various sites external to UBC or the Investigator chosen from amongst numerous Investigators from various sites external to UBC to lead the multi-jurisdictional study. The Lead Investigator is the Investigator who submits the first/initial application for ethical review of the multi-jurisdictional study at any of the sites where the research is going to be conducted. The Lead Investigator is required to submit the initial application for review of the research to his or her home institution's REB regardless of where the research is taking place.

If this is an initial application for review of the study and you are NOT the lead investigator, you cannot continue with this submission.

If you are a UBC faculty member, you cannot answer 'no' to question E.1 and 'yes' to question E.2 because UBC must perform the review of initial/first application since UBC is your home institution.

E.3. Please indicate which external institution with UBC has a signed reciprocity agreement is your home institution.

  • University of Saskatchewan
  • University of Alberta
  • University of Victoria
  • Simon Fraser University
  • University of Northern British Columbia

If your institution appears on this list the application will truncate to section 9, where you will need to append all UBC site specific documents as applicable. Please append to section 9 all available documentation and information from the Lead PI and his/her REB, including the Lead PI's REB Application, Certificate of Approval, Informed Consent and recruitment documents and all available correspondence between the Lead PI's REB and the Lead PI, including, if available, the minutes from the Lead PI REB's review of the study.

If your institution does not appear on this list, you will be directed to 4.8 and will need to fill out the full CREB application.


Appendix: Acronyms and Glossary 

Acronyms

AGN: Application Guidance Note

BCCA: British Columbia Cancer Agency

C&W: Children & 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.

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: 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.

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.

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.

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.

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."

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.

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: 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.

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.

Retrospective Data: Data collected from charts dated on or before the date of 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)

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.

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: 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.