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Requirements for informed consent for patients and human subjects in research represent a constraint on provider autonomy. They add to the staff burden, but are a regulatory requirement. Table 12-1 illustrates part of the federal regulations governing informed consent by research subjects in federally funded research. You might ask yourself this: What values are represented here, and why were they made an added requirement of all research in the first place? Table 12-1 Code of Federal Regulations Section 50, Subpart B, Informed Consent of Human Subjects
§50.20: General requirements for informed consent
Except as provided in 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
Section 50.24 Basic elements of informed consent.
(a) In seeking informed consent, the following information shall be provided to each subject:
(1) 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 which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration 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 otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject
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is otherwise entitled.
(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(1) 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.
(2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.
(3) Any additional costs to the subject that may result from participation in the research.
(4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
(5) A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.
(6) The approximate number of subjects involved in the study.
(c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1) (A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
(d) The informed consent requirements in these regulations are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed for informed consent to be legally effective.
(e) Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care to the extent the physician is permitted to do so under applicable Federal, State, or local law.
Source: Reproduced from: Code of Federal Regulations (2013, April 1). Protection of human subjects. Washington, D.C: Government Printing Office. Title 21, Volume 1, Part 50. Retrieved on December 17, 2013, at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm? CFRPart=50&showFR=1&subpartNode=21:1.0.1.1.20.2.
PERSONAL RESPONSIBILITY A significant portion of the cost of health care can be attributed to lifestyle choices, such as smoking, lack of exercise, overeating or poor nutrition, not wearing seat belts or cycling helmets, and use of drugs and alcohol. Many policy proposals seek to change the behavioral risk factors or shift those costs to the individuals at risk. Smokers pay higher insurance premiums for long-term care, for example. Some analysts have suggested that those involved in risky behaviors, such as not wearing motorcycle
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