SAMPLE CONSENT FORM FOR PARTICIPANT

Use Appropriate Letterhead

PARTICIPANT INFORMATION SHEET

Title of Database:

Local Investigator, Department/Hospital/Institution:

Sponsor if any: e.g. pharmaceutical company, granting agency, university or hospital.

You are being invited to participate in a research database which Dr … is creating.

INSERT ONLY IF NECESSARY: ……. [insert name of Hospital or Institution]and the investigator Dr. …[insert Locally Responsible Investigator’s name]are under contract with the Sponsor of this study and are receiving compensation to cover the costs of conducting the study.

This database is being created to …Explain in layman’s terms what the database will be used for and what it will not be used for.

If you volunteer to have your personal health information added to this database, we will ask you to do the following things:

Describe the procedures chronologically using simple language, short sentences and short paragraphs. Medical and scientific terms should be defined and explained.

eg. Agree to the collection of your personal health information from your medical chart; agree to your personal health information being kept in the database for xx years; agree to being contacted by the researcher about participation in future studies; etc

There are no medical benefits to you from your taking part in this database. However, by participating, you may assist us in finding out more about insert what is appropriate e.g.disease x

Choosing not to participate in this database will in no way affect your care or treatment.

Your data will not be shared with anyone without your consent or as required by law. By having your personal health information added to a research database there is the potential for a breach of confidentiality. Every effort will be taken to ensure that your information is kept private. The only people who will have access to the information in the database are Insert the names of all people who will have access to the data. These people understand the laws regarding privacy and have signed a confidentiality agreement. The data will be securely stored Insert location e.g. a computer with limited access which is located in Dr. …’s office.

All research studies that will be conducted, using the database information, will be approved by the Hamilton Integrated Research Ethics Board.

For the purposes of ensuring the proper monitoring of the research database, it is possible that a member of theHamilton IntegratedResearch Ethics Boardmay consult your research data and medical records. By signing this consent form, you or your legally acceptable representative authorize such access.

If you volunteer to be part of this database, you may withdraw at any time and this will in no way affect the quality of care you receive at this institution. Indicate whether the participant has the option of removing data already collected. For example,You have the option of removing your data from the database.

If you have any questions about the research database now or later, please contact…insert name of investigator

If you have any questions regarding your rights as a research participant, you may contactthe Office of the Chair of the Hamilton Integrated Research Ethics Boardat 905-521-2100, ext. 42013.

CONSENT STATEMENT

I have read the preceding information thoroughly. I have had the opportunity to ask questions, and all of my questions have been answered to my satisfaction. I agree to have my personal health information included in this database. I understand that I will receive a signed copy of this form.

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Name of Participant

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Name of Legally Authorized Representative (if applicable)

______

Signature of Participant or Legally Authorized RepresentativeDate

Consent form administered and explained in person by:

______

Name and title

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SignatureDate

December 2012

Consent Form Date: insert date______Page 1 of 2