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Unformatted text preview: Biomedical Ethics: Biomedical Ethics: Informed Consent in Scientific Research Objectives Objectives At the end of this module you should be able to List the criteria for a sound ethical decision Define informed consent and IRB (Institutional Review Board) Describe research that must be reviewed by an IRB Describe historical events, codes and guidelines that have led to the current ethical status of informed consent Describe the basic principles of autonomy, justice, beneficence, nonmaleficence, universalizability and rationality Discuss case studies related to informed consent issues and identify key concepts What is ethics? What is ethics? Can you quantitatively assess ethical decisions? Are they based on moral values and religious beliefs? Criteria for Criteria for sound ethical decisions It must be rationally arrived at All relevant data must be fairly and objectively considered NOT based on “gut feeling” It must be “Universalizable”. NO bias It must be consistent with the moral beliefs of society You must be willing for everyone else to do likewise (on you) under similar circumstances Ref: King TW, Patrick CW Jr., Ethical Considerations of Tissue Engineering in Society. In frontiers in Tissue Engineering, Eds: Patrick, Mikos and McIntire, Elsevier Science, NY, 1998, pp 31133 Ethics in Biomedical Ethics in Biomedical Engineering Ethical responsibilities associated with research conduct, patents, and publications which apply to all types of research. Ethics in Engineering Ethics in biomedicine and biomedical engineering? Unique ethical issues associated with human subjects and patients. Five Basic Principles Five Basic Principles Beneficence and Nonmaleficience Autonomy The duty or obligation to benefit and to NOT cause any harm (non maleficience) The duty or obligation to promote selfdetermination of others The duty or obligation to allocate social burden and benefits fairly among all persons The duty or obligation to perform only those acts that you would be willing for anyone else to perform on you under similar circumstances The duty or obligation to do only those acts which can be reasoned and justified Justice Universality Rationality Autonomy Autonomy To provide the respect, time, and opportunity necessary to make one’s own decisions. To provide “adequate” information to decide whether to enter a study or not to participate. There should not be any pressure or coercion to participate. Protection must be given to potentially vulnerable populations such as children, the elderly, the mentally ill, or prisoners. Need to assess the decision making capacity of such “vulnerable” individuals, how and when a guardian should be involved in the process? Ref: University of Minnesota, Informed consent overview http://www.research.umn.edu/consent What constitutes “adequate” What constitutes “adequate” information? A patient is adequately informed if the physician/researcher disseminates all information that a reasonable and prudent “peer” (physician/researcher) practicing in the same field would have disseminated (English rule) This is what is typically observed But do you think this is adequate? What constitutes “adequate” What constitutes “adequate” information? Informational disclosure is adequately satisfied by what information a reasonable, prudent patient would need to make an informed consent (American rule) Subjective rule: Same as American rule except the information disclosed must acknowledge any material risk for the particular patient The burden is now on the physician/researcher to ensure that the patient is satisfied (NOT based on what others would do) – This is generally a tougher a burden Beneficence Beneficence It is the researchers responsibility to ensure the well being of participants. It is YOUR responsibility to protect subjects from any harm, and ensure that they receive the possible benefits. Risk vs. benefits: The Belmont Report (1979) on the protection of human subjects indicates "maximize possible benefits and minimize possible harms." Benefits to society versus the possible risks of research? Ref: University of Minnesota, Informed consent overview http://www.research.umn.edu/consent Justice Justice Who gets to participate and who gets excluded “Are some classes or persons being selected simply because of their availability, their compromised position, or their manipulability while others are not?” Minorities and poor Participants should not be selected due to class, socioeconomic status, or race unless justified by study objectives. Underrepresentation of women and minorities Doctorpatient relationship Teacherstudent relationship The Burden The Burden The burden of adequately informed consent is greater in research (therapeutic and nontherapeutic) than in therapeutic studies The burden is greatest for non therapeutic research Benefit to researcher No benefit to patient Informed Consent: Key Events Informed Consent: Key Events Nazi experiments on prisoners The Nurenberg Code, 19461949 Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical research Involving Human Subjects, Helsinki, 1964 The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 1979 International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS, Switzerland, 1993 The Nuremberg Code (1947) The Nuremberg Code (1947)
1. The voluntary consent of the human subject is absolutely essential. 2. The experiment should be such as to yield fruitful results. 3. The experiment should be so designed and based on the results of animal experimentation and knowledge of the natural history of the disease. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided. 8. The experiment should be conducted only by scientifically qualified persons. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage. Federal regulations: Resources Federal regulations: Resources DHHS regulations: Protection of human subjects. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46 NIH Office of protection from Research Risks: Protecting Human Research Subjects: IRB Guidebook. http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm FDA 21 CFR 50 and 56. http://www.fda.gov/oc/ohrt/irbs/ National bioethics advisory commission (NBAC). https://bioethics.gov Informed consent Informed consent Must be obtained BEFORE any research involving human subjects As a researcher, it is YOUR responsibility to “adequately educate” the subject about the risks, benefits, conflicts etc. about the research involving them, obtain their voluntary consent and keep them informed Informed consent Informed consent The purpose of informed consent is not just to obtain a signature in a form. It is YOUR ethical obligation to make sure that the subject has understood and is willing to voluntarily participate in your study It is YOUR duty to ensure that participants are thoroughly informed about the purpose of the study, the procedures to be performed, potential risks and benefits to them, any conflicts of interest that the researchers might have and what are their alternatives to participating in your study. They must have the opportunity and time to consult with other researchers, physicians, advisors, friends and family before making any decision They should know that their decision is completely voluntary and they can withdraw at any time Difficulty: What constitutes disclosure of information sufficient to ensure informed consent?
Ref: University of Minnesota, Informed consent overview http://www.research.umn.edu/consent/mod1med/mod1sec2.html A Historical Case of Failure to A Historical Case of Failure to Obtain Informed Consent: The Tuskegee Syphilis Study History: From 1932 to 1972, 399 poor black sharecroppers in Macon County, Alabama were denied treatment for syphilis and deceived by physicians of the Unites States Public Health Service. As part of the Tuskegee Syphilis Study, designed to document the natural history of the disease, these men were told that they were being treated for "bad blood." However, they deliberately denied treatment to the men with syphilis and they went to extreme lengths to ensure that they would not receive therapy from any other sources. In exchange for their participation, the men received free meals, free medical examinations, and burial insurance. The IRB The IRB (Institutional Review Board) A review committee set up by each institute (university, hospitals, companies whoever ones to use human subjects) consisting of experts in various fields (related or unrelated to a particular application) along with “lay” people and members from the community Composition of the UT Austin IRB Composition of the UT Austin IRB Faculty/staff committee appointed annually by the VP for Research, Must be sufficiently qualified through the maturity, experience, and expertise of their members and diversity of membership to insure respect for their advice and counsel specific to safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific activities, the committee must be able to ascertain the acceptability of proposals in terms of organizational commitments, regulations, applicable law, standards of professional conduct and practice, and community attitudes. The Current IRB has 1 student member and 2 members from the community (including one prisoner representative) http://www.utexas.edu/research/rsc/humanresearch/aboutIRB/index.php Key IRB Rules: Key IRB Rules: UG students as Study Subjects Subject pool: Undergraduate students enrolled in particular departmental courses requiring participation in one or more research projects. All student participation in subject pool research must be completely voluntary. Departments provide students with incentives (usually extra credit) to participate in the subject pool. Reimbursement for participation must not jeopardize subject confidentiality or anonymity. Any subject pools offering extra credit to participating students must provide alternative opportunities to earn extra credit to students declining to participate in research. It is up to the student to decide whether to participate in any study; instructors cannot mandate or require student participation. In accordance with our recruitment policy, instructors are strongly discouraged from recruiting subjects they directly supervise or selecting subjects on such basis. http://www.utexas.edu/research/rsc/humanresearch/aboutIRB/index.php What do you need in an informed consent? What do you need in an informed consent? 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 A description of any reasonably foreseeable risks or discomforts to the subject; A description of any benefits to the subject or to others which may reasonably be expected from the research; A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; 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; 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 researchrelated injury to the subject; and A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. http://www.utexas.edu/research/rsc/humanresearch/manual/section4.php What do you need in an informed consent? Whenever appropriate, one or more of the following elements of information shall also be provided to each subject: 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; Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent/authorization; Any additional costs to the subject that may result from participation in the research; The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; 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; and The approximate number of subjects involved in the study. http://www.utexas.edu/research/rsc/humanresearch/manual/section4.php Before performing research with Before performing research with human subjects here at UT Go to: http://www.utexas.edu/research/rsc/humanresearch/i http://www.utexas.edu/research/rsc/humanresearch/ If you are not sure whether you need informed consent or not, check with the IRB first EVEN if you are sure you do not need informed consent check with the IRB Case Studies Case Studies Case 1: Perry, C. Informed Consent in Research. Phi Kappa Phi Journal National Forum, Vol 79, No. 3, pp. 2225. Past research has shown that healthy individuals reject foreign cancer cells faster than cancer patients. Did the foreign cancer cells survive for a longer period in cancer patients (compared to in noncancer patients) because the cancer patients had cancer or because the cancer patients were sick. Researchers proposed to test this hypothesis by studying the length of foreign cell survival in healthy patients, cancer patients, and sick patients. It was already known by the researchers that no harm would befall any of the subjects, since it was already scientifically established that humans, irrespective of their condition, would reject transplanted foreign cells. The researchers informed the patients of the proposed cell injection study, omitting any specific reference to "foreign cancer cells", because they felt this information was not essential for the decision. Were the research subjects not informed? Do the subjects have any rights to file claims of negligence? For the following “case” present arguments both for and against, based on the principles of ethics The creation of genetically engineered animals such as pigs for organ transplantation (these organs won’t be rejected by humans). Case Study: Imaging of the Brain ? Case Study: Neuroimaging, especially functional imaging of brain is becoming a reality fMRI, PET This can quantitatively tell what parts of brain “lights up” for a certain thought or certain task Some ethicists fear that functional brain imaging could eventually be used to study possible behavior, thought processes etc. not only for criminals but for other purposes: e.g. to screen job candidates, to determine intelligence. Should functional neuroimaging be regulated and restricted? Case Study: Embryonic Stem Cell Research Case Study: Embryonic Stem Cell Research
A couple went through an in vitro fertilization (IVF) process in a clinic in their local hospital. They gave birth to twins and the requested that the surplus embryos be frozen for possible further implantation at a later stage. No further possibilities for use of the embryos were suggested at this time by the hospital staff. Tragically the died in an accident oneyear later. Several years later this the clinic tried to contact the couple to determine their wishes concerning the disposition of the frozen embryos, and learned of their deaths. In the hospital there was a research group actively researching therapies for Parkinson's disease. They had already presented a proposal to the hospital Ethics Committee to be allowed to use stem cells derived from frozen embryos for research in Parkinson's disease therapy and the project had been approved. The Director of the research team approached the IVF clinic to see whether they had surplus frozen embryos that they might use. The head of this clinic offered the surplus embryos of the couple to the Director ofthe research team. In the country where this happened, there is no clear legislation concerning embryo stem cell research. Are their ethical concerns? What about informed consent? What other options are there for the use of these embryos? History of Research on Humans History of Research on Humans Atrocities and ethical disasters give rise to ethical codes and laws Nazi atrocities Nuremberg code Thalidomide disaster Kefauver Amendments Tuskegee Syphilis Study Belmont Report Source: “History of Research Ethics.” Office for the Protection of Research Subjects. Nuremberg Code Nuremberg Code The trials were conducted in 19467 by an American military tribunal Criminal proceedings against 23 German doctors who conducted horrible experiments on concentration camp prisoners Nuremberg Code established in 1948: “The voluntary consent of the human subject is absolutely essential.” Thalidomide caused 12,000 babies Thalidomide caused 12,000 babies to be born severely deformed Prescription drug prescribed in late 1950s Not approved by FDA, but FDA approval not yet required. U.S. Senate hearings followed 1962 Kefauver Amendments to FDA required drug manufacturers to prove safety Tuskegee Syphilis Study, Tuskegee Syphilis Study, 19321972 U.S. Public Health Service’s study 600 lowincome AfricanAmerican men, of whom 400 had syphilis Subjects not told about the disease Penicillin became available in 1950s, but participants denied treatment Researchers intervened to prevent treatment when subjects were diagnosed by doctors outside the study Belmont Report (1979) was in response Declaration of Helsinki, 1964 Declaration of Helsinki, 1964 World Health Organization established recommendations guiding medical doctors conducting biomedical research involving human subjects Some issued it addressed: Research with humans should be based on animal experimentation Independent committee must review research protocols Informed consent must be obtained Only qualified individuals should conduct research Risks should not exceed benefits National Research Act, 1974 led to National Research Act, 1974 led to Belmont Report The Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research That Commission identified the basic ethical principles that should underlie human subjects research The result of the Commission’s work was the Belmont Report of 1979 The Belmont Report: Principles and The Belmont Report: Principles and Applications Principle: Respect for Persons Principle: Beneficence Application: Informed Consent Application: Assessment of risks and benefits Selection of Subjects Principle: Justice Current Regulations and the Current Regulations and the “Common Rule” Based on the Belmont Report, the Department of Health and Human Services and the Food and Drug Administration issued regulations in 1981 In 1991, more than a dozen other government departments and agencies adopted the core DHHS regulations These regulations are known as the Common Rule ...
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This note was uploaded on 02/01/2011 for the course BME 314 taught by Professor Frey during the Spring '08 term at University of Texas.
- Spring '08