PARTICIPANT INFORMED CONSENT FOR OPTIONAL PHARMACOGENETIC TESTING - TEMPLATE
Protocol No:______
Protocol Title:______
Participant No: ______
Name of Investigator:______
Dear Participant
You have already agreed to take part in the main research study [Insert title or descriptive phrases of the study] which we will call the ‘main study’ in this document. You are also being invited to participate in a separate pharmacogenetic study we will call the ‘sub-study’. Even if you decide not to participate in the sub-study, you can still continue with participation in the main study. You should not sign the form until you understand all of the information presented in the following pages and until all of your questions about the research have been answered to your satisfaction.
As noted in the main study Informed Consent Document, the study doctor will be paid by (specify Sponsor) for conducting this sub-study.
1. About This Sub-Study
This optional sub-study is strictly voluntary. This consent form explains why we are performing this sub-study and what your role will be if you choose to participate. This form also describes the possible risks associated with being in this sub-study. After reviewing this information from the person responsible for your enrolment, you should know enough to be able to make an informed decision on whether you want to participate in this sub-study or not.
You will be asked to allow the sponsor or its designee to perform genetic (pharmacogenetic) tests on the normal cells of your body. During genetic testing we will be looking at parts of your DNA. Deoxyribonucleic acid (DNA) is inherited from your parents and may determine things like the colour of your hair or eyes. People may react in different ways to medicines in their bodies because of their genes.
The purpose of this sub-study is to find out more about what causes (specify disease or condition under investigation in the protocol) and the differences in the way peoples respond to (specify medication).
2. Study Procedures
If you agree to be in this optional sub-study, a portion of the blood sample (specify amount in millilitre and teaspoon measures) already collected in the main study will be used / additional blood samples (specify amount in millilitre and teaspoon measures) will be taken during visit _ ____.
Your blood samples will be sent to an international central laboratory called (specify name and physical address of central laboratory)
The optional pharmacogenetic analyses will use various scientific methods to evaluate
variations in deoxyribonucleic acid (DNA) that influence your response to (specify study medication).
3. Potential Benefits
Results of this sub-study are for research purposes only and are not expected to benefit you directly or to alter your treatment course. Future participants may benefit from information learned from this sub-study. This information will help doctors learn more about the use of the investigational product (specify) to treat and/or to help investigate (specify disease).
The sponsor does not intend to provide you with ownership or financial benefits that may result from this sub-study.
4. Potential Risks
Taking blood from your arm may cause swelling, pain, redness, bruising, infection, dizziness or fainting.
There is a risk that if people other than the researchers get your medical and genetic information they could misuse it. The Sponsor has strict privacy and confidentiality protection procedures to prevent this from occurring so the chance of this happening is extremely small. To help prevent others from finding out anything about you, your name and other information that directly identifies you will not be included with your sample or your medical genetic information.
5. Costs
There will be no costs to you, your medical scheme of you healthcare provider for participating in this sub-study.
6. How will information that identifies me be protected?
Information about you will be collected and shared as described in the main study consent form.
All of your exploratory samples will be disguised using labels with a unique code number. Only the study doctor and designated study staff will have the ability to link that code to you. All pharmacogenetic samples will be double-coded and stored independent of your identification number for the study. Similarly, all pharmacogenetic analysis results will be double-coded and stored in an independent, secure database to ensure your confidentiality. All genetic research information obtained from your samples will be kept strictly confidential as specified below.
Samples used for this research may be stored for up to 15 years and will be stored at a central laboratory (specify name and address). During and after the sub-study, you will retain the right to have the sample material destroyed at any time by contacting your study doctor. If you decide to have your sample destroyed, any data or analysis that were done before the request will not be removed; however, all of your remaining samples will be destroyed, and no additional analysis will be done with your samples. The Sponsor is responsible for the destruction of the samples at your request or otherwise, at the end of the storage period.
7. Who will have access to my medical information if I sign this informed consent form?
Since this optional pharmacogenetic sample evaluation is not expected to benefit you directly or to alter your treatment course, these results will not be placed in your medical record and will not be made available to you, members of your family, your personal physician, or other third parties, except as specified below.
Unless required by law or regulatory authorities for the purpose of verifying information obtained from this sub-study, only (specify Sponsor) and its authorised personnel and agents will have access to your confidential data. The Sponsor will not collect or maintain data that identify you by name. The study doctor and designated study staff will collect and maintain that information. The results and other information from this sub-study may be submitted to regulatory agencies in countries where the licensing application may be submitted. You will not be identified in any reports or publications resulting from this sub-study. However, because of the need for these parties to have access to your medical information, absolute confidentiality cannot be guaranteed.
8. What happens if I get hurt?
It is unlikely that you will get hurt during this part of the study. However, if you are injured in any way while participating specifically in the pharmacogenetic sub-study, compensation will be the same as for the main study. Please refer to the Patient Information and Consent Form for the main study for more information.
9. Questions
If you have questions about this trial you should first discuss them with your doctor or the Pharma-Ethics Research Ethics Committee at:
PO Box 786
Irene
0062
Tel: (012) 664 8690
Fax: (012) 664 7860
Email:
After you have consulted your doctor or the ethics committee and if they have not provided you with answers to your satisfaction, you should write to the National Health Research Ethics Council (NHREC) or the South African Medicines Control Council (MCC) at:
The Chair The Registrar
National Health Research Ethics Council Medicines Control Council
Tel: (012) 395 8113 Department of Health
Fax: (012) 3958467 Private Bag X828
E-mail: Pretoria, 0001
Fax: (012) 3959201
Email: or
10. Consent statement
By signing below, I agree that: Initial Blocks
· I have read or had read to me the information sheet and consent form, version [insert version details] for this study.· I understand that this sub-study is investigational and what is means.
· The purpose, treatment and procedures of this sub-study have been explained to me and I understand them.
· I understand my responsibilities as a participant.
· I understand that participation in the sub-study is voluntary and that I can refuse to participate or withdraw at any time, without it affecting my ongoing care.
· I have been informed of the possible risks, harm and inconvenience of participating.
· I have been informed of the expected benefits of the trial.
· I have been informed of the compensation and treatment that would be available to me in the event of a trial-related injury.
· I have been informed of any payment or reimbursement I may receive, as well as any anticipated expenses that I may incur while participating in the trial.
· I have had sufficient time to ask questions and they were answered to my satisfaction.
· I have been given time to discuss the trial with others and to decide whether or not to take part.
· I am aware that the results of the trial, including personal details about me and my health information may be reasonably disclosed to the sponsor, regulatory authorities and research ethics committees, if required by law.
· I agree for my blood/tissue samples to be transferred to a secure central laboratory outside South Africa.
· I will receive a signed and dated copy of this informed consent form.
· I agree to participate in this trial.
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Printed name of participant
______
Participant Signature Date (personally completed by participant)
______
Printed name of person conducting consent (if other than the investigator)
______
Date
______
Signature of person conducting consent (if other than the investigator)
______
Printed name of investigator
______
Date
______
Signature of investigator
I hereby verify that verbal consent was obtained from the above participant. The participant has been informed about the risks and the benefits of the research, understands such risks and benefits and is able to give consent to participate, without coercion, undue influence or inappropriate incentive.
______
Printed name of witness (Witness signature is required in instances where the participant is illiterate. Verbal consent must be obtained from the participant, in the presence of an independent witness who is present during the entire informed consent discussion. The witness’s name, signature and date must be completed by the witness at the same time when consent is obtained by the participant and the document is signed and dated by the study doctor/delegate. A competent witness for research purposes is a person who is 18 years or older, and of sound mind and who is not involved with the trial in any way)
______
Date
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Signature of witness
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