Process of Value Analysis

Assessing value in health care is based on outcome. The policy that is implemented to analyze value must be one that is specific to the healthcare organization, and must address the value issues (i.e., past, current, and forecasted). It is important to note that ethics and values are both inclusive and exclusive of each other in terms of policy; from both the stance of “professional decision-making” and “policy analysis.” In a minimum of 250 words, discuss the following:

• Review the “General Requirements for Informed Consent” in Chapter 12 of your text.
• Create an Informed Consent (for a hypothetical human subject research) using items 1 – 8 under Section A. (SEE BELOW)

• §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 regulationsunless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorizedrepresentative. An investigator shall seek such consent only under circumstances that provide the prospective subject or therepresentative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undueinfluence. The information that is given to the subject or the representative shall be in language understandable to the subject or therepresentative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or therepresentative 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 thesubject’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 toothers 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 notesthe 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 whetherany 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 whomto 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 subjectis otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which thesubject is otherwise entitled.

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