[Template Updated: 16 June 2010]

It is important to download a new template for each study to ensure you are using an updated version. To use the template you may copy this and use it as a guideline.

For assistance with lay language, refer to the Canadian Cancer Glossary of Terms: http://info.cancer.ca/e/glossary/glossary.html

The Guidelines at the end of this document can be used as a checklist and should be deleted after completing the consent.

Required wording is highlighted in yellow. New information added on or since the last update noted above are highlighted in blue Notes from the REB are contained in square brackets in blue writing […] these should be

deleted from the final version. If you have questions, these may already be answered under the BCCA REB FAQ web

page or BCCA REB Policies web page. This template is to be used in conjunction with the applicable UBC consent guidelines:

UBC CREB: Guide32 or UBC BREB: BREB Guidelines] A consent document may be returned to the applicant for correction before the Full

Board can review the document if one or more of the requirements are not met.

*Subject Information and Consent Form[*The individual participating in a study should be referred to as the “subject” or “participant”. The chosen term must be used consistently throughout the document including the Title of the Study]

[Title of Study]

BCCA Principal Investigator: [Name, center, and contact telephone number.Format Example:]

BCCA Principal Investigator: Dr. John DoeVancouver Centre: Telephone: (604) 877-6000 L. XXXX

Principal Investigator at additional participating BCCA Centres:[If Applicable: List the name, centre, and contact telephone number of the Principal Investigator for each additional participating centre. Do not include “co-investigators” or “sub-investigators”. Format example:]

Principal Investigator at additional participating BCCA Centres:Dr. Peter Doe Fraser Valley Centre

Telephone: (604) XXX-XXXX

Dr. Helen Doe Vancouver Island CentreTelephone: (250) XXX-XXXX

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 1 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

Dr. Mary Doe Centre for the Southern InteriorTelephone: (250) XXX-XXXX

Sponsor(s): [List all sponsoring agencies and coordinating groups]

Emergency Contact Number (24 hours / 7 days a week): [All centres are to be listed under Emergency Contact regardless of whether centre is participating in the study so that a study subject can call the nearest center in an emergency. Exception: Emergency contact numbers are unnecessary for minimal risk research projects that are suitable for expedited review.]For emergencies only: Call the centre nearest you and ask for your usual oncologist or, if he or she is not available, the oncologist on-call.

Vancouver Centre (604) 877-6000Vancouver Island Centre (250) 370-8000Fraser Valley Centre (604) 581-2211Abbotsford Centre (604) 851-4700Centre for the Southern Interior (250) 862-4000

Non-Emergency contact numbers are noted at the end of this document under the section heading “Contact”.

[Once all the REB notes have been removed all of the above information should fit on Page 1 then proceed to Page 2]

Background[Explain why the subject is being invited to participate in the study. For example “You are being invited to participate in this study because you have [a disease] that [the new treatment] has been developed to treat”].

[Clearly State the standard/usual treatment at BCCA for subjects with the type and stage of cancer who are eligible for this trial. Indicate the likelihood of that standard treatment causing a response in the cancer and the likely duration of such a response. Point out in lay terms how the experimental treatment differs from this standard treatment.]

[If applicable, modify the following Health Canada information as needed for drug or device studies:]

Health Canada has not approved the sale or use of [insert study drug] to treat this kind [or stage] of cancer, although they have allowed its use in this clinical study.OrHealth Canada has approved the sale or use of [insert study drug] to treat [type of disease or cancer], although they have not approved its use for [this stage of cancer, or at this dose, etc], they have allowed its use in this clinical study.

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 2 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

[Explain who is sponsoring the study.]

[State that participation is voluntary and that the participant may decide not to participate or to withdraw at any time and that the participant’s doctors will continue to provide the best available treatment. Avoid statements such as “may withdraw without penalty” or “if you fail to continue to participate” which are unnecessarily negative.]

Purpose

[Begin this section with a clear statement identifying the type of study: feasibility study or pilot study, phase I, phase II, phase III, Expanded Access Study, or otherwise, then explain the nature of that type of study. Continue with specific information relevant to this individual study.

In the following examples the yellow highlighted language is required. If not used, its omission or alteration should be justified in the application for ethical review.]

[For Feasibility Study or Pilot Study]

Before proceeding to a full-scale study, a ”pilot study” or “feasibility study” is often carried out first to test the design of a study, the likelihood of successful accrual or the acceptability of the intervention to potential subjects. The basic idea is to find out if it will be useful to commit the resources to proceed to a potentially definitive study. The “design” of a study is how the study will be done, how the data are collected, whether that data can provide useful information and whether it will be practical to proceed to a larger study that will include more subjects. This type of study involves only a small number of subjects and therefore the results can only used as a guide for further larger studies. Only descriptive statistics are appropriate. Neither the project description nor the consent document should imply that a definitive answer will result. There is no guarantee that a larger study will be done and subjects should not be led to expect that they will benefit from taking part in the feasibility or pilot study, although the knowledge gained may help to develop future studies that may benefit others.[Please also follow the guidelines in the document "Elements required for a Pilot or Feasibility study" posted on the BCCA REB webpage for New Applications.]

[For Phase I Studies:]

This is a phase I clinical trial. Phase I clinical trials are the first studies of a potential new treatment in humans. In these studies, researchers evaluate how a new drug should be given (for example by mouth, injected into the blood or otherwise), how often, and what dose is safe. Because less is known about the possible risks and benefits in Phase I, these studies usually include only a limited number of subjects who have not been helped by other known treatments.

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 3 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

The purpose of this phase I study is to determine how much __________ can be safely given to subjects with __________. Subjects are given ___________and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more subjects are asked to join the study and are given a higher dose of _________. Subjects joining the study later on will get higher doses of _________ than subjects who join earlier. This may continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. Your study doctor will discuss with you what dose you will receive and what has been learned about ___________ from this study. Your safety is our primary concern and your study treatment with _________will be discontinued if you experience severe side effects. [It should be clear that this is NOT a study in which efficacy will be determined – Phase I studies are neither expected nor intended to provide personal benefit. The language used throughout the consent form should make this clear.]

In addition to carefully noting any side effects you experience, you will have a number of blood tests to find out how the drug moves through and leaves your body. Scans and other tests will also be done to look at whether or not your cancer responds to treatment with _____________.

[Describe additional relevant details of this particular study.]

[For phase II studies]

This is a phase II clinical trial. The purpose of a phase II clinical trial is to determine whether a new treatment has any effectiveness for a particular type of cancer [or other condition, if applicable][add in brackets a simple appropriate question. For example (Does it shrink the cancer? Or Does it reduce the severity of a side effect? Or Does it reduce pain?)]. In addition to that main purpose this study will also test the safety of____________ by looking at what side effects it causes.

This phase II study will evaluate the effect of ______ on _______[name of cancer or condition]. Researchers will also evaluate the tolerability (how it makes you feel) and safety of ________ by watching for harmful side-effects.

[For phase III studies]

This is a phase III clinical trial. The purpose of a phase III clinical trial is to compare the safety and effectiveness of a new treatment with a standard treatment (e.g. which treatment is more effective? Has fewer side effects?)

This phase III study will compare ________ with ________. [If there is no effective treatment for this subject’s cancer or other condition and, therefore, a placebo or best supportive care arm is part of this trial, explain this here.]

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 4 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

[Explain in simple lay terms the specific details of this trial, for example to compare the safety and effectiveness of the new treatment with the old treatment or the new treatment with no treatment.]

[Symptoms, clinical findings, and laboratory results will be evaluated. Specify.]

[For Expanded Access Protocols (EAP) -See BCCA REB guidelines posted on the web page for New Applications http://www.bccancer.bc.ca/RES/REB/NewAppl.htm#eap]

Who Can Participate In This Study?

You may participate in this study if: You fully understand the study and give your informed consent to participate as

demonstrated by signing this consent form. [List, in point form, the major characteristics indicating eligibility to participate in

this study. This list should be limited to inclusions that the potential subject is likely to be aware of.]

Who Should Not Participate In This Study?

You cannot participate in this if: [List, in point form, the major characteristics indicating ineligibility to participate in

this study. This list should be limited to exclusions that the potential subject is likely to be aware of.]

The "exclusion criteria" should not be the opposite of inclusion criteria. The exclusion criteria addresses the question: of those who meet ALL of the inclusion criteria, what characteristics, criteria features are there ANY ONE of which would make an otherwise eligible subject ineligible.

[If specific medications must be avoided by subjects participating in this trial, indicate that here and list them.]

[If excluding subjects who are HIV positive etc. the reason must be provided] [If subjects must live within a certain distance of the center indicate this restriction

and that it is necessary because subjects receiving experimental drugs must be able to come back to the cancer center quickly if any severe or unexpected problem develops]

[If applicable:Where the potential effects to an unborn child of a course of treatment are unknown,women of child bearing potential must either be excluded or, after a pregnancy test to ensure that they are not pregnant, must agree to use a reliable method of birth control and indicate for how long (i.e. only while on the study drug or while on the study drug and for an extended period of time after to ensure that the drug is no longer in their body.]Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 5 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

Study Procedures

[Explain in simple lay terms exactly what will happen to a subject who participates in the study.]

[If applicable, divide this section into one that describes the screening procedures that will be used to determine eligibility for enrollment and a separate one that describes the conduct of the study.

[If mandatory tissue/blood collection is applicable (mandatory tissue collection must be related to the study objectives otherwise it is considered optional); Boundaries must be defined and assurance given that biobanking for unspecified, unrelated or hereditary genetic research will not occur. The scope of the research must be explained in lay language. Explain how the samples will be identified, where they will be stored and for how long. Explain that once these tests have been completed, any leftover samples will be returned to the facility from which they were obtained if needed, or destroyed (or if applicable; that they will be given an option to donate these for other future research purposes, in which case they will be given a separate optional consent form to sign.) If the tissue sample will be obtained from previously collected tissue explain that no additional biopsy will be required. Explain that the samples will only be used for the purposes described in this document and will not be sold. Explain who will/will not receive reports about any research tests done on these samples and whether the reports will or will not be put in their medical records.]

[If optional specimens are to be obtained (tissue, blood, other material) for research a separate “BCCA REB Optional Consent Template for tissue and/or blood collection or other additional optional testing” should be used to obtain this consent. Only tests which are required for participation in the main study should be described in the main consent. A statement may be made to indicate that an optional component is available and that a separate consent document will be provided and reassure the subject that they may choose not to participate in the optional part of the study and still participate in this main study].

[If applicable include the following:- randomization - how it will be done - i.e. flip of a coin {probability of being

assigned to different treatment options}- double-blind - explain that in order to avoid bias that neither the subject nor

investigators will know what treatment they are receiving and in case of an emergency the code can be broken

- placebo controlled - explain that a placebo is an inactive substance- dosage - of drugs or radiation, frequency, tests- number of office visits, amount of time required for each visit, amount of time

required for interviews, questionnaires, etc.- a statement of the total amount of time for participating in the research required

of a subject, beyond that normally needed for standard careDescription: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 6 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

- amount of blood withdrawn – e.g. 1 tsp. (lay language)]

[An offer to answer any inquiries concerning the procedures, to ensure that they are fully understood by the subject.]

[Stopping rules.]

Risks

Therapeutic trials must include an applicable warning that unexpected severe, disabling or irreversible side effects may occur including death. This should be stated clearly at either the beginning or the end of the Risks section. The REB suggests wording such as; The treatments being tested in this study may cause unexpected, severe, disabling or irreversible side effects, or may even cause death.

Risks and side effects of standard treatment are not required to be listed. The REB assumes that side effects and other issues related to standard interventions will be explained as per usual clinical practice. However, a statement should be included in the consent to explain this e.g.; "The risks and side-effects of the standard or usual treatment of [indicate] will be explained to you as part of your standard care.

[If applicable:]The study drug [name of drug] is in an early phase of development and so the side-effects in humans are unknown at this time. Animal studies to date show [list as per Investigator Brochure using lay language]. There may be additional risks and side-effects that are currently unforeseen and therefore not listed in this study information and consent form.

[Describe all known side effects of the experimental intervention(s) (physical, emotional, psychological) and include a numerical estimate (if severe) or descriptive estimate (if insignificant) of the probability of each side effect occurring, i.e. numerical: 'occurs in 1/1000 cases' or descriptive: 'rarely occurs' or use percentage examples below.[Explain that “unless noted the side effect is reversible” and indicate the ones that are irreversible.] Use lay language. Do not use symbols such as > (state 'more than' or 'less than')

[Arrange the list of side effects by groups of likelihood. This is an example. Individual categories or % brackets may differ.]

Very common (approx. 50% or greater)1.2.etc.

Common (approx. 20%-50%)1.

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 7 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

2.etc.

Less common (approx. 5%-20%)1.2.etc.

Uncommon (approx. 2%-5%)1.2.etc.

Rare (less than approx. 1% -2%)]1.2.etc.

[Indicate that unanticipated side effects, including severe or irreversible ones, could occur if a novel combination of drugs is being tested, even if the individual drugs themselves are not expected to do so.]

[If applicable: If the study drug will be used in combination with standard treatment, the consent should include language indicating that the combination or addition of the experimental intervention could potentially introduce new side effects or increase the side effects of the standard treatment/therapy.]

[If applicable: When limited numbers of individuals have been exposed to the drug (less than 100), and the risks cannot accurately be quantified, the following language should be included:As of [date], only [n] people have been given this drug and the side effects that have been reported are: [specify - examples]: n experienced headaches n experienced diarrhea It is not yet known if these side effects are caused by [XXXXXXX] or how likely these side effects will be. There also may be other side effects not yet known.

[If applicable explain:Where the interaction with other drugs is unknown, other drugs, including over the counter medication should be taken only with the knowledge and approval of the Principal Investigator.]

List in bold text any medications, supplements, or foods that should not be taken while on the study.

[Side effects should be reported to the Investigator. Severe side effects immediately, less severe at the time of the next doctor’s appointment.]

If applicable:Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 8 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

Reproductive Risks[Avoid using terms such as “nursing”, “fetus”, or “contraception”]

Because the effects the [insert study drug] may have on an unborn child are unknown, you should not become pregnant or father a baby while on this study. An effective method of birth control should be used while you are on study treatment. [or explain if this extends for a period of time after treatment has stopped and specify how long it should continue]. Ask the study doctor about counseling and more information about preventing pregnancy. You should not breastfeed your baby while on this study because it is possible the drugs used in this study may be present in your breast milk. [Include a statement about possible sterility when appropriate (i.e. "Some of the drugs used in the study may make you unable to have children in the future. Your study doctor will discuss this with you."]. If you [or your partner] become pregnant while you are on this study, you should notify your study doctor.

[If a pregnant partner form is to be used, this should also be submitted to the REB. If this is not available at the time of the initial REB submission, it may be submitted as an amendment after the study is approved, however, it may NOT be used until approved by the REB.]

[If applicable]Data Safety Monitoring BoardA Data Safety Monitoring Board, an independent group of experts, will be reviewing the data from this research throughout the study.

BenefitsIf you agree to take part in this study, there may or may not be direct benefit to you. We hope the information learned from this study will help other patients in the future. [For phase II or III trials describe the potential benefits to the subject if the treatment is effective, however, remember to indicate that if the subject is assigned to a placebo or best supportive care arm there is no expected benefit.]

[For phase I trials this section must be carefully worded NOT to imply expected effectiveness for the treatment being tested. Use this wording or justify changes.]You are being offered this experimental drug because it has shown anticancer activity in preliminary experiments. However, since there is very little information about the drug's effect on cancer in humans, we do not expect that you will benefit from taking part in this study, although the knowledge gained may benefit others. The drug you receive may even be harmful.

Alternative Treatments

If you decide not to participate or to withdraw at some later date [describe what, if anything, is available i.e. standard treatment, best supportive care, alternative treatments, as well as harms/benefits.]

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 9 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

[Future use of research data, anticipated or not.]

Confidentiality[If alternate wording is used than noted below, ensure that this section clearly defines the type of information being referred to, such as medical records or records with identifying information versus de-identified study-related data and then use consistent terms throughout. Note: Sponsors may only receive de-identified study-related data].Your confidentiality will be respected [note: NCIC CTG requires that the additional specific phrase “to the extent permitted by applicable laws and regulations and your medical and study records will not be publicly available” be added here]. No information that discloses your identity will be released or published without your specific consent. Your identity will not be used in any reports about the study. In records that leave this centre you will be identified by a study code only [for NCIC CTG studies the following phrase MUST be added here “which includes your initials”; for trials sponsored by other organizations that same phrase should be used if initials are required or omitted if they are not required]. Your birth date will also be provided if requested by the sponsor or responsible regulatory agency.

[If applicable; collection of data on demographic features such as race/ethnicity, birthplace, gender, and sexual orientation must be justified in the ethics application and the reason for the collection explained to subjects and that providing this information is voluntary. Reference: UBC BREB guideline: 6.3.1 Stereotypinghttp://www.ors.ubc.ca/ethics/behavioural/forms/BREB_GN_20081029.doc#Risks ]

Studies involving humans now routinely collect information on race and ethnic origin as well as other characteristics of individuals because these characteristics may influence how people respond to different medications. Providing information on your race or ethnic origin is voluntary.

All information associated with this study will be kept behind locked doors or in secure computer files.

Research records and medical records identifying you may be inspected by representatives of [DRUG COMPANY SPONSOR’S NAME], Health Canada, the U.S. Food and Drug Administration [delete reference to US FDA if it does not apply, this should be consistent with Section 7.12 of the study application in RISe] and the UBC BCCA Research Ethics Board for the purpose of monitoring the research. However, no records that identify you will be allowed to leave the centre. These organizations have policies of strict confidentiality and the individuals inspecting your records must sign a BC Cancer Agency confidentiality form (the form is not applicable to Health Canada or U.S. Food and Drug Administration [delete reference to US FDA if it does not apply] officials, who have the legal right to inspect health records and are bound to confidentiality by specific laws.)

Reports concerning your progress and photocopies of certain portions of your medical record, identified by a study code only, may also be sent to:Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 10 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

[the sponsor(s) of the study] [any cooperative group(s) conducting the study, e.g. NCIC CTG] UBC BCCA Research Ethics Board, the research ethics committee that oversees

the ethical conduct of this study in your centre Health Canada The U.S. Food and Drug Administration[delete reference to US FDA if it does not

apply]

Information in these reports may include: Tests results Reports of operations X-rays, other body scans Results of your treatment Laboratory tests Imaging tests/reports

Even after your treatment is complete, information will still be sent on your progress to see how well the treatment worked. If you stop taking part in the study, information will also still be sent because it is important to follow the progress of all people who started out on the study, unless you choose to withdraw your consent for the release of information as well.

Your family physician will be notified of your participation in the trial so that your study doctor and your family doctor can provide proper medical care.

[If data and/or samples will be sent outside of Canada (clarify if it data and/or samples and include the following;]Any study related data [and samples], sent outside of Canadian borders may increase the risk of disclosure of information because the laws in those countries dealing with protection of information may not be as strict as in Canada.  However, all study data [and samples], that might transferred outside of Canada will be coded (this means it will not contain your name or personal identifying information).  Any information will be transferred in compliance with all relevant Canadian privacy laws. By signing this consent form, you are consenting to the transfer of your information [and samples], to organizations located outside of Canada. 

Your rights to privacy are legally protected by federal and provincial laws that require safeguards to insure that your privacy is respected and also give you the right of access to the information about you that has been provided to the sponsor and, if need be, an opportunity to correct any errors in this information. Further details about these laws are available on request to your study doctor or the UBC BCCA Research Ethics Board. [Note: The words "and guaranteed" have been removed from the first sentence in the above paragraph as this cannot be guaranteed.]

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 11 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

Compensation:

You will not be paid for participating in this study.

[Subjects should be reimbursed for extra costs incurred due to participation in the study such as meals, travel, parking or other incidental costs for expenses over and above those needed for standard care and they should be re-imbursed for supportive care medications that the subject would not otherwise have been required to purchase. Such reimbursement should be described with the following statement. Either quote a specific dollar amount or use the term “reasonable”.]

You will be provided reasonable reimbursement for your extra costs such as parking or extra medications that you need due to participation in this trial. Your study doctor or research assistant will discuss how this will be done.

[Studies that are funded by not-for-profit entities such as investigator driven studies and cooperative group studies such as NCIC CTG may be exempt from this requirement for re-imbursement; however, if this is intended the following should be stated]:

Because the funding for this study is provided by ___________________ (enter name of sponsor), which is an organization based on donated support or governmental funding, no funding has been provided to BCCA for re-imbursement of extra costs such as parking or extra medications that you need due to participation in this trial. You will need to pay these extra costs yourself.

[Note: Any statement that could be interpreted by the subject as waiving compensation for injuries resulting from the research is not permitted.]

If you are injured as a result of participating in this study, your medical condition will be evaluated and all necessary medical treatment will be made available to you at no cost.

No funds have been set aside to compensate you for such things as lost wages, disability or discomfort in the event of injury or illness related to the study treatment or procedures.

You do not waive any of your legal rights for compensation by signing this form.

Remuneration:

The sponsors of this study may reimburse the BC Cancer Agency for all or part of the costs of conducting this study or they may provide the BC Cancer Agency some or all of the standard or experimental medications being used in this study. However, the investigators conducting this study will not receive any personal payments for

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 12 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

conducting this study. In addition, neither the BC Cancer Agency nor any of the investigators or staff conducting this study will receive any direct financial benefit from conducting this study.

After the study is finished [This section should be included, however, the wording may be altered according to the type of study or drug or omitted in the case of adjuvant trials.]You may not be able to receive the study treatment after your participation in the study is completed. There are several possible reasons for this, some of which include: the treatment may not turn out to be effective or safe; the treatment may not be approved for use in Canada; your oncologist may not feel it is the best option for you; coverage may not be available for this treatment in British Columbia and you may decide it is too expensive to purchase on your own.

Contact

You understand that if you have any questions or desire further information with respect to this study, or if you experience any adverse effects, you can ask your doctor, who is:

Dr. ________________________________ Telephone:___________________

In the event of a research related injury, please speak to your doctor (indicated above) or (after hours) call the centre nearest you and ask for your doctor or, if he or she is not available, the oncologist on call.

Or, you can speak to the doctor who is the principal investigator, [Name of PI] at (xxx) xxx-xxxx ext. xxxx.

Or, you can speak to the Head of [indicate the correct program, e.g. Systemic Therapy or Radiation Therapy or other] Program of the BC Cancer Agency. That person can be reached at [insert only the telephone number of the applicable main switchboard, do not include this person’s name or telephone extension]

If you have any concerns about your treatment or rights as a research subject you may contact the Research Subject Information Line at the UBC Office of Research Services at the University of British Columbia at (604)-822-8598 or toll free at 1-877-822-8598, or by email to: RSIL@ORS.ubc.ca.

New Findings

If you choose to enter this study and at a later date a more effective treatment becomes available, it will be discussed with you. You will also be advised of any new information that becomes available that may affect your willingness to remain in this study.Subject Consent

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 13 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

I understand that participation in this study is entirely voluntary. I authorize access to my medical record [if applicable include 'and samples'] as described in this consent form. I may choose not to participate or I may withdraw from the study at any time and I will continue to be offered the best available medical care. I understand that I may ask questions about this study in the future.

I will receive a signed copy of this consent form for my own records.

I consent to participate in this study.

____ Subject’s Signature Printed name Date

____ ____ Signature of Printed name Study Role DatePerson Obtaining Consent

If this consent process has been done in a language other than that on this written form, with the assistance of an interpreter/translator, indicate:

Language:_____________________

Was the subject assisted during the consent process in one of ways listed below?

Yes   No [Note: For typical situations where the person conducting the consent discussion simply reads the consent with the subject to ensure that informed consent is properly obtained, check "no".

If yes, please check the relevant box and complete the signature space below:

The consent form was read to the subject, and the person signing below attests that the study was accurately explained to, and apparently understood by, the subject (please check if subject is unable to read ).

The person signing below acted as an interpreter/translator for the subject, during the consent process (please check if an interpreter/translator assisted during the consent process).

____________________________ _______________ _____________Signature of Person Assisting Printed Name Datein the Consent Discussion

A witness signature is allowed but no longer required except in certain circumstances:http://rise.ubc.ca/helpCenter/GN/CREB_Guidance_Notes.html#Guide39.8These circumstances are covered by including the section regarding assistance.

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 14 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

[A line for "investigator signature" (example below) is optional – this may be 'added' if needed or required by the sponsor but this may not replace the line for the "person obtaining consent"] ____________________ ______________ _____________Investigator Signature Printed name DateMy signature above signifies that the study has been reviewed with the study participant by me and/or by my delegated staff. My signature may have been added at a later date, as I may not have been present at the time the participant’s signature was obtained.

[The "person obtaining consent" must be sufficiently familiar with the study, the disease being treated and the process of informed consent to be able to obtain properly informed consent and, thus, will usually be the investigator or a designated research assistant.]

[The investigator should independently document the obtaining of informed consent in the medical record, noting the date, the subject's full understanding of the risks and benefits of enrollment and the voluntary nature of participation.]

[Translated Consent Documents: A translated consent document cannot not replace the English language version but it can serve as an additional aid in the consent process. A translated consent document also does not replace the requirement for a translator/interpreter to be present during the consent process and throughout study. The investigator should ask for the translated version to be independently reviewed for accuracy. A copy of the translated consent document must be submitted to the REB for approval along with a statement signed by the interpreter confirming that the translation is accurate, stating the name and version date of the document they translated and their qualifications. This may be submitted as an amendment after the REB has approved the English version.

[A translator/interpreter should be a PHSA/BCCA or other such certified or qualified translator/interpreter. They should be impartial i.e., not a relative or study team member or a person who might have influence over the subject. Reference: PHSA Provincial Language Services:http://www.phsa.ca/AgenciesAndServices/Services/Provincial-Language-Service/default.htm].

[See the following additional Guidelines for Consent Documents]

Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 15 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

GUIDELINES FOR CONSENT DOCUMENTS

[A Consent Document may be returned for correction before being reviewed by the Full REB if revisions of one or more of the following are required.]

1. Type size – no smaller than the type on this page (11 point).

2. Use headings, small paragraphs and spaces between the paragraphs.

3. The BCCA Principal investigator must be identified and one Principal Investigator for each additional participating center.

4. Use ‘subject’ or ‘participant’ throughout the consent form rather than ‘patient’.

5. Use second person pronouns for the subject information part of the consent form (you/your). Use first person pronoun (“I”) only for the final “consent statement” portion of the form.

6. Consent forms should be written at a Grade 7 level of understanding. Use simple lay language – explain medical terms and jargon (see examples below).

7. Use GENERIC not TRADE NAMES for all medications in Consent documents: If it is felt desirable to indicate the trade name of medications it should follow the

generic name in parentheses, e.g. generic name (Trade name); cotrimoxazole (Septra). Note that generic names are not capitalized but Trade names are.

Exception: Where a drug product contains multiple ingredients that make use of their generic names impractical, the trade name for the combination product may be used.

8. Acronyms should be avoided. If they must be used they should be written out the first time they appear, e.g. Peculiar Acronym for General Use (PAGU).

9. Spelling and grammar must be corrected before submission for review.

10. All information required by the subject must be included in the informed consent form with the exception of ancillary drug information sheets, if applicable.

11. Standard treatment information should be included.

12. Statements about confidentiality, remuneration for injury and protection from waiver of subject’s rights should be included using the required wording from the consent template.

13. Signature lines should be formatted and labeled as shown in the template.

14. “Subject Consent” section should be on one page.

15. Number the pages using: “1 of 3”, “2 of 3”, “3 of 3” etc.

16. Footer: Include a footer ON EACH PAGE which should include:Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 16 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]

the version date a brief (two or three word description of the consent (eg: Protocol

number) NCIC CTG studies may add “NCIC CTG Subject Serial Number ______”.

Remember to update the version date with each revision in the footer on all pages.

[Note: Enter date manually…do not use Word auto insert date as this will change to the current date each time the consent is opened]

17. The consent form submitted for review should be in its final form (as it will be seen by the subject), including letterhead.

18. References to “doctor” should be clarified to identify who is being referred to ie: the family doctor, study doctor or oncologist)

19. This list is a partial guide meant only to provide examples of wording that should be avoided:

jargon preferable

active drug effective drug

experimental agent experimental drug or experimental treatment

mucositis mouth sores

dyspnea shortness of breath

angina pain in the chest near the heart

MUGA scan to determine heart function

liver function tests blood tests of how your liver is working

insomnia inability to sleep or trouble sleeping

may be life-threatening may cause death

eligible “it is safe for you to participate” or“you may participate if”

refuse choose not to

“the subject failed to “the subject’s cancer failed to respond” or betterrespond” “the subject’s cancer did not respond”

without penalty you will continue to be offered the best available medical care

elderly indicate the age e.g. “over age 65”

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Description: [enter brief 2 to 3 word description of the study]Version: [Enter Date Updated.] Page 17 of 17[Note: Enter date manually do not use Word auto insert date as this will change to the current date each time the consent is opened][If this is an NCIC CTG study add, in the footer: NCIC CTG Subject Serial Number ____]