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THE INFORMED CONSENT ZONE
Patricia S. Kerby, MPAOffice of Research ComplianceSeptember 10, 2008
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PRINCIPLES OF INFORMED CONSENT Researchers must make sure patients understand the
difference between clinical research and standard therapy.
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PRINCIPLES CONT. All participants in patient oriented clinical research must
participate in an informed consent process. This process must include:
A statement that they are participating in a research study.
Purpose- disclosure of aims, procedures, risks and benefits.
It should explain randomization and placebo.
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PRINCIPLES CONT. Study participation is voluntary. Potential subjects must
be informed that there are alternatives to participation.
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To increase patient comprehension, clinical researchers and their staff should use lay language at about the 8th grade reading level.
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The investigator must present the cost-benefit ratio for the patient and for society. This includes:
Benefits Risks Costs Compensation The patient must be able to explain the difference
between the clinical study and standard therapy.
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Disclose the consequences of early termination by the patient, investigator, or sponsor.
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Clinical investigators and their staff protect the confidentiality of the study participants.
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Test the comprehension for the patient thru verbal and written questions.
Repeating information helps patients understand
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Follow institutional requirements- Patient must receive a signed and dated copy of the consent form.
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Give the patient time to talk with significant others about being in the study.
Give the patient time to read and reflect upon the consent form
Introduce a waiting period between reading and signing the consent form
Encourage questions Indicate that the study is only one of several treatment
alternatives
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Clinical investigators assume responsibility for the human subject’s welfare during and after informed consent.
The informed consent process is only one part of the investigator /research staff and patient relationship.