Elements of Informed Consent Flashcards
An essential element of informed consent affirmed in most ethical frameworks is:
a) That the research should bear fruitful results
b) That the risk of the research should always be minimal
c) That participation is voluntary, without penalty or loss of benefits
d) That compensation for research is fair
c) That participation is voluntary, without penalty or loss of benefits
An essential element of consent that is affirmed in most ethical frameworks is that:
a) There should be compensation for medical injury
b) There should be no deception used in the study
c) The subject may discontinue participation at any time without penalty
d) Drugs which might diminish the quality of life not be used
c) The subject may discontinue participation at any time without penalty
The essential basic elements of consent include:
a) A statement that the study involves research and its purpose
b) A description and identification of experimental procedures
c) The duration of the study
d) All of the above
d) All of the above
a) A statement that the study involves research and its purpose
b) A description and identification of experimental procedures
c) The duration of the study
The essential basic elements of consent include:
a) Statements about the risk, benefits and alternate procedures
b) Any compensation for injury
c) Confidentiality of records and contact information regarding subject’s rights
d) All of the above
d) All of the above
a) Statements about the risk, benefits and alternate procedures
b) Any compensation for injury
c) Confidentiality of records and contact information regarding subject’s rights
The statement that significant new findings, which may affect participation will be provided to subjects:
a) Is required in all consent forms
b) Is an essential element of consent
c) Is only required for risks and not benefits
d) Is an added element included on the consent form only if the IRB deems it appropriate to do so
d) Is an added element included on the consent form only if the IRB deems it appropriate to do so
Regarding the risks of pregnancy and harm to the fetus during the research study, the consent form requires that it:
a) Mention the procedure may involve such risks that are unforeseeable
b) Include the need for contraception
c) Provide specific instructions regarding the efficacy of specific contraceptive methods
d) Advise subjects that only women need to be aware of such risks.
b) Include the need for contraception
Regarding the termination or withdrawal of a subject from a research study the consent form should:
a) Advise that termination may occur without the subject’s consent
b) Advise regarding the consequences of the subject’s decision to withdraw
c) Describe the circumstances in which such termination might occur
d) Provide procedures for orderly termination
e) All of the above
e) All of the above
a) Advise that termination may occur without the subject’s consent
b) Advise regarding the consequences of the subject’s decision to withdraw
c) Describe the circumstances in which such termination might occur
d) Provide procedures for orderly termination
Regarding costs of the research to the subject the consent form should:
a) Assume the subject knows that the institution will pay for all research costs
b) Disclose any additional costs as this is an additional element of consent
c) Provide detailed analysis of the study’s cost structure
d) Transfer as much of the costs to the subject as possible.
b) Disclose any additional costs as this is an additional element of consent
An additional element of consent to be disclosed to subjects in the consent form if appropriate, is the number of subjects involved in the study. The likely reason behind this requirement is:
a) Satisfy the subject’s curiosity
b) The sponsor’s desire to impress the subject with the enrollment numbers
c) Provide the subject with an idea of how risks and burdens are being shared
d) Assure subjects that they are not alone in their decision to enroll
c) Provide the subject with an idea of how risks and burdens are being shared
In ICH, a clinical trial with randomization should:
a) Explain the reasons for the use of control groups
b) Provide a justification for why an active control group is or is not being used
c) Should describe the need for placebo controlled design
d) Explain the probability for random assignment to each treatment group
d) Explain the probability for random assignment to each treatment group
In ICH the consent form should explain the responsibilities of:
a) The sponsor
b) The investigator
c) The subject
d) The IRB and other regulatory agencies.
c) The subject
In describing the risks of a clinical trial the informed consent should detail the risks to:
a) The subject
b) Embryo or fetus
c) Nursing infant
d) All of the above.
d) All of the above.
a) The subject
b) Embryo or fetus
c) Nursing infant
In a clinical trial regarding the statement of benefits:
a) Reasonably foreseeable benefits should be stated
b) Explicitly indicate that there are no benefits if none are expected
c) a only
d) a and b
d) a and b
Regarding compensation for trial-related injury the informed consent should:
a) Provide no fault insurance
b) Always state that no compensation will be provided
c) State that medical care but no compensation is available.
d) Merely state if compensation is available.
d) Merely state if compensation is available.
Regarding payments in the informed consent ICH implies that:
a) A statement that fair payment is being made should be included
b) The payment will be based on the risk and discomfort of the clinical trial
c) The payment will be based on time and inconvenience
d) The anticipated prorated payment will be stated.
d) The anticipated prorated payment will be stated.
Regarding the subjects’s expenses the informed consent should state:
a) That every effort to cover all expenses will be made
b) Detail the expenses which will or will not be covered
c) Make no commitment regarding expenses
d) State the anticipated expenses, if any
d) State the anticipated expenses, if any
Regarding access to the subject’s medical records the informed consent should state:
a) That the original medical record will be abstracted but not directly accessed for cellular trial data
b) The monitor will always have access to the medical record
c) That signing of the informed consent automatically authorizes public release of the medical record
d) The access to the medical record should be limited to protect the confidentiality of the subject and permitted by applicable laws and regulations
d) The access to the medical record should be limited to protect the confidentiality of the subject and permitted by applicable laws and regulations
The informed consent defines significant new information that should be updated in the informed consent as including:
a) Other new clinical trials on the same drug
b) Other new drugs that have come on the market
c) New side effects of the most commonly used alternative medication
d) Information relevant to the continued participation of the subject in the clinical trial
d) Information relevant to the continued participation of the subject in the clinical trial
Regarding contact information about the rights of a trial subject the informed consent should mention:
a) The institution
b) The investigator
c) The IRB
d) The person or persons to contact
d) The person or persons to contact
The most likely person to contact for a trial related injury would be:
a) The IRB
b) The investigator or other designated person for medical safety
c) The sponsor
d) The institution
b) The investigator or other designated person for medical safety
For a patient with dementia the informed consent process should ensure that:
a) Consent of the legally acceptable representative should be obtained
b) The subject should be informed about the trial to the extent compatible with understanding
c) If capable the subject should sign and personally date the written informed consent
d) All of the above
d) All of the above
a) Consent of the legally acceptable representative should be obtained
b) The subject should be informed about the trial to the extent compatible with understanding
c) If capable the subject should sign and personally date the written informed consent
The informed consent should be signed by:
a) The subject
b) The legally acceptable representative if applicable
c) The person conducting the consent discussion
d) All of the above
d) All of the above
a) The subject
b) The legally acceptable representative if applicable
c) The person conducting the consent discussion
The language of the informed consent should be all of the following except:
a) Non technical
b) Practical
c) Understandable to legally acceptable representative
d) At the high school level
d) At the high school level
The informed consent should adhere to:
a) GCP
b) Declaration of Helsinki
c) a only
d) a and b
d) a and b
