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Which of the following are considered BASIC elements of informed consent under section 21CFR50.25 Subpart B?



A. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
B. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
C. Anticipated circumstances under which the subject s participation may be terminated by the investigator without regard to the subject s consent.
D. Any additional costs to the subject that may result from participation in the research.
E. A description of any reasonably foreseeable risks or discomforts to the subject.
F. The consequences of a subject s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
G. A description of any benefits to the subject or to others which may reasonably be expected from the research.
H. A statement that significant new findings develped during the course of the research which may relate to the subject s willingness to continue participation will be provided to the subject.
9. A disclosure of appropriate alternative procedures or courses of treatment , if any, that might be advantageous to the subject.
10. Disclosing that a description of the clinical trial will be available on www.clinicaltrials.gov.
11. A statement describing the extent, if any, to whicch confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA may inspect the records.
12. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs, and if so, what they consist of, or where further information may be obtained.
13. An explanation of whom to contact for answers to pertinent questions about the research and research subjects rights, and whom to contact in the event of a research-related injury to the subject.
14. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is othewise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

This question is part of SOCRA Practice Exam
Asked by Catherine halcombe, Last updated: Mar 13, 2020

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4 Answers

jglangston

Jglangston

Answered Aug 02, 2017

I agree the answers shown are for

50.25 Subpart a: elements of informed consent

50.25 Sbupart b: is aditional elements of informed consent.

 

John Adney

John Adney

Answered Jun 07, 2017

A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
B. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
 

iris

Iris

Answered Dec 04, 2016

Those answers are 5025. Subpart A.

The answer is incorrect.
 

John Smith

John Smith

Answered Oct 25, 2016

A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any reasonably foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject or to others which may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures or courses of treatment , if any, that might be advantageous to the subject.
5. A statement describing the extent, if any, to whicch confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA may inspect the records.
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs, and if so, what they consist of, or where further information may be obtained.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects rights, and whom to contact in the event of a research-related injury to the subject.
8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is othewise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
 

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