Appendix Bsample Written Informed Consent Form

Project title of the study:xxxxxx. Protocol number in bold

Project no: **-HCLM-**-***Page 1 of 9

INFORMED CONSENT FORM

PROJECT NO:**-HCLM-**-***

PROJECT TITLE

OF THE STUDY:

PROTOCOL:

SPONSOR:

PRINCIPAL INVESTIGATOR:

PRINCIPAL INVESTIGATOR’S

DEPARTMENT:

ADDRESS:CSSS Champlain—Charles-Le Moyne

3120, boul. Taschereau

Greenfield Park (Québec) J4V 2H1

TELEPHONE:450466-5000, extension XXXX

514 406-XXXX pager

OBLIGATORY text for inapt subjects:

(Note: This form is addressing the subject. However, it is possible in case of sudden incapability to give consent that the form be given to his/her representative through whom this form will be addressing the subject, even if he is unconscious or unable to communicate.)

INTRODUCTION

Suggested text:

You are being asked to take part in a research study.Before you decide it is important for you to understand why the research is being done, how your information will be used, what the study will involve and the possible benefits, risks and discomforts.Please take time to read the following information carefully and once you have been fully informed about the study and had any questions answered, you will be asked to sign this form if you wish to participate.

PURPOSE OF THE STUDY

PROCEDURES

RISKS, SIDE EFFECTS AND DISADVANTAGES

WOMAN IN AGE TO PROCREATE( use this title if study applies only to women) OR

PERSON IN AGE TO PROCREATE ( use this title if study applies to both men and women)

Suggested text:

You should not become pregnant or breastfeed during your participation in the study.

The study drug taken during pregnancy may expose the fetus (unborn child) to unknown risks, including the possibility of birth defects. To participate in this study, women of childbearing age (who may become pregnant) will have a blood draw in order to have a pregnancy test before starting the study (as applicable). To begin the study, you should not be pregnant. If you are a woman of childbearing age, you must consent to avoid becoming pregnant during the study and use an acceptable method of contraception, as determined with the doctor during your participation in the study, and until at least (as applicable) three months after the last dose of the study drug. You should ask the doctor if the method you use is considered acceptable for the study.

If you become pregnant during the study, you must immediately stop taking the study drug and inform your doctor. Your pregnancy will be followed to determine its outcome.

If you are a man and are sexually active, you must agree to use an acceptable method of contraception, as determined with the doctor to participate in this study (as applicable). You should tell your partner the risk of harm to an unborn child. She should know that in case of pregnancy, she must promptly notify her doctor.

BENEFITS AND ADVANTAGES

OTHER POSSIBLE TREATMENTS

COSTS/REIMBURSEMENT

Suggested text:

You will not receive any payment for your participation in this study. There will be no costs to you for participating in this study. The drugs will be provided to you free of charge as long as you will receive treatment within the framework of this study. We will refund you reasonable expenses caused by the follow-up visits for this study (parking, travel expenses, meals).

COMPENSATION IN THE EVENT OF DAMAGE

OBLIGATORY text:

If you suffer any prejudice as a result of administering a drug or other procedures related to the study, you will receive all the care and services required by your state of health, without cost to you.

By agreeing to participate in this study, you will not waive any of your rights nor release the researchers (if any: organizations, businesses) or institutions of their legal and professional responsibilities.

CONFIDENTIALITY

Suggested text:

You also allow us to collect, gather and transmit - to...(name of company and its affiliated) like to the organizations of regulation of Canada and other countries - data collected within the framework of this study, including personal information: date of birth, sex and initial, for purposes of the study and the analyses which are associated with it.

Your identity and your personal information will be kept confidential to the extent possible. However, given the need to send your personal information to such persons, complete confidentiality cannot be guaranteed. Regulatory bodies, the Sponsor and its designees shall have the right to see your study file in its entirety and your name.

OBLIGATORY text for a secondary ICF concerning pharmacogenetic or with a genetic impact:

Participation in “genetic testing” (research for inherited genes that may cause cancer or other diseases) may involve risks to participants and their family members. If it is determined that you belong to a group at high risk of developing a particular disease, it could have an impact on your employment, your health, your life insurance or change your decision on procreation.

That is why the results of “genetic tests” are not provided to you, placed in your medical records and that every effort is made to protect the privacy and confidentiality of these. The risk that the genetic test results are disclosed in a way that connects them to you is very low, but you must be aware of the risks. If you do not want your samples used for the “genetic tests” you may indicate this at the end of this consent form.

OBLIGATORY text:

You permit to collect and maintain data from this study, including personal information such as your name, date of birth, your gender, your initials and your contact information. This information will be kept confidential to the extent possible, however given the obligation to allow access to representatives of regulatory agencies in Canada and other countries, as well as representatives of the Sponsor and its partners, total confidentiality cannot be guaranteed. All the information and data collected as part of the study will be kept by the researcher or the institution in accordance with the standards and the periods required by the Ministry of Health and Social Services of Quebec and Health Canada.

VOLUNTARY PARTICIPATION/WITHDRAWAL

Suggested text:

Your participation in this study is voluntary. You may thus refuse to participate. You may also withdraw from the study at any time, without giving a reason, simply by notifying the investigators or a member of the study team. All new knowledge acquired during the course of the study, which could affect your decision to continue to take part in it, will be communicated to you without delay.

Your decision not to participate or your withdrawal from the study will have no consequences on your future medical care or to your relationship with your doctor or other professionals.

Your doctor or investigator may withdraw you from the study at any time if he or she feels it is in your best interest, without first obtaining your consent.

Should you decide to withdraw from the study at any time, information collected on you up until that point will still be provided to _____.

CONTACT NAME

OBLIGATORY text:

Should you have any questions concerning the study, you may contact Dr______, Principal Investigator, or Study Coordinator at 4504665000, extensionXXXX or pager no______.

Cas d’exception: Le paragraphe ci-dessous "In case of an emergengy…" est généralement obligatoire, mais dans les cas exceptionnels où le chercheur peut démontrer que ce n’est pas viable, les sujets peuvent être invités à se présenter à l’urgence la plus proche. Ce paragraphe doit donc être remplacé par: In case of an emergency, go to the nearest hospital.

In case of an emergency, you can reach the ______on duty, 24hours a day by calling 4504665000extension0. The receptionist will transfer your call to the ______on duty.

If you wish to obtain additional information regarding your rights as participant in a research project or regarding any damage attributable to the research, harmful side effects to your health, you may contact the secretary of the comité d’éthique de la recherche du CSSS Champlain—Charles-Le Moyne by calling 4504665000 extension2564.

In addition, if you have any complaints as a research participant and wish to communicate with a third impartial party, you may call the Service Quality and Complaints Commissioner of CSSS Champlain—Charles-Le Moyne at 4504665434.

Consent form: Version XX – Write the dateSubject’s initials: ______

Centre de recherche – Hôpital Charles-Le Moyne

Project title of the study:xxxxxx. Protocol number in bold

Project no: **-HCLM-**-***Page 1 of 9

STUDY FLOW CHART

Consent form: Version XX – Write the dateSubject’s initials: ______

Centre de recherche – Hôpital Charles-Le Moyne

Project title of the study:xxxxxx. Protocol number in bold

Project no: **-HCLM-**-***Page 1 of 9