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MDC 1060
(813) 974-9908
(813) 974-4317
mbarber@health.usf.edu
MDC 040, 12901 Bruce B. Downs Blvd., Tampa,
FL 33612
Course Format: This course is delivered entirely on-line using Blackboard accessed
through the secure USF portal (my.usf.edu).
Course Objectives:
ealth Sciences Ethics (GMS 6871) is designed to examine selected ethical considerations
that have become significant components of the practice of the biomedical sciences and
which often represent important considerations that must be addressed in both the
basic and clinical sciences. This course emphasizes a variety of ethical issues and includes
such topics as the oversight and design of
biosciences projects, informed consent,
subject selection for clinical studies,
conflicts of interest, the social effects of
bioscience
research,
studies
using
embryos, fetuses and children, genetic
research, the use of animals in research
and questions on authorship, publication
and scientific misconduct. The course
attempts to develop a broad introduction to
many of the ethical issues that often
confront basic scientists and clinicians
during the conduct of various types of
research projects and clinical care.
While some ethical issues in medicine, such as the use of animals in basic research, euthanasia
and abortion have been under discussion for extensive periods of time, other aspects of
biomedical research, including the use of human subjects, human tissue acquisition, the
collection and use of genetic information and decisions of authorship criteria and scientific fraud,
are of comparatively recent vintage. Modern efforts to implement guidelines and standards for
the conduct of biomedical research have been developed to provide formal protections for
various classes of research participants. Health sciences ethics addresses many of the topics that
are of concern to professionals engaged in the health sciences. The course assignments focus on
a selected array of topics that are designed to introduce specific topics of ethical concern.
The course includes the review of selected case studies to provide an appropriate mechanism to
analyze and think-through difficult medical and moral situations.
All material is presented in the context of modern healthcare such that at the completion of
the course, students will be able to:
1. Describe the several points of analysis that should be addressed when evaluating the
various types of biomedical studies and will be able to address the potential social impact
of research.
2. Identify the dominant motives for most types of research study and discuss the value and
justification for the proposed activities.
3. Describe the major facets of the research process, such as the potential risks, access to the
resulting information and whether the research is justified in terms of the involvement of
animals, children and adults or other selected groups of individuals.
4. Explain the social impact of research in terms of reinforcing inequity, prejudice or
discrimination, the potential influence on the legal system and how will the benefits of
the research be distributed?
Course Meetings:
None
Location:
Web-based course located on Canvas at - http://my.usf.edu/
Course Prerequisites:
There are no course prerequisites, although some familiarity with modern biomedical issues
would be advantageous. This course is a component of the M.S. in Medical Sciences Program.
Course Evaluations:
There will be an online evaluation from the University distributed towards the end of the
course, which can be accessed from OASIS.
In addition, we may be asking for your feedback on the course, materials, delivery
methods, technology and research skills and technology-related issues you encounter
during the course.
An announcement will be made on the course website when these evaluations are available.
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Type https://my.usf.edu/
Type your NetID (and press the Tab key)
Type your password
Press ENTER or- click the Login button
Click on the COURSES tab
Technology Requirements:
General Technology Requirements:
All registered students must meet the minimum technical requirements. For details visit:
http://hsccm.hsc.usf.edu/medicine/graduatestudies/Technology+Requirements.htm
Specific Course Technology Requirements:
This course may require the student to view/listen to narrated presentations, videos, and
participate in audio-conferencing. Therefore, in addition to the general technology requirements,
this course will require the following:
Adobe Acrobat:
http://www.adobe.com/products/acrobat/readstep2.html
QuickTime player:
http://www.apple.com/quicktime/download/index.html
Flash player:
http://www.macromedia.com/software/flashplayer/
Microsoft PowerPoint
Microsoft Word
It is the students responsibility to meet the above mentioned technical requirements before
the start of the semester he/she is registered for.
Course Format:
This course is primarily a web-based course. Course materials and assignments will be posted on
the course website (Canvas). The course is divided into Units, each consisting of a number of
components:
Reading Assignments:
Specific chapters in the required textbook have been assigned for each unit. The reading
assignments are the primary means by which each student will acquire the core content of
the course. It is essential that students complete the reading assignments for
comprehension early in each unit. For some units, additional web-based research may be
required.
Responsible Conduct of Research:
The first unit in the course requires course participants to complete a brief training course
in the responsible conduct of biomedical research developed by the Collaborative
Institutional Training Initiative, or CITI, that features a number of modules on
biomedical RCR together with a number of associated brief MCQ quizzes. The modules
can be found at the website:
https://www.citiprogram.org/
Unit Quizzes:
Each of the ten (10) course units features a short quiz as an assessment and grading
exercise. For each unit, a number of questions are included that reference the material
included in the reading assignments from either the CITI exercise or the required
textbook. Each student is required to access each quiz INDIVIDUALLY at either the
CITI website or on Canvas and prior to the deadline indicated on the course calendar to
complete the quizzes. Responses to the quiz questions should NOT be shared with other
course participants. Grades received for the unit quizzes will be included in the final
course grade calculation. For the textbook-related quizzes, each quiz will be accessible
for a limited period of time and the quizzes will include a time limitation and include a
single attempt. For the CITI quizzes, only the first attempt will count towards the course
grade.
Unit Quiz Policies:
All unit 2 through 10 quizzes must be completed by way of the Quizzes folder on the
course Canvas site. In case of internet-related problems you should send the results
to the instructor as an attachment to a message within Canvas the exact same day.
Deadline Extensions for Submission of Quiz Responses:
Late submissions of quizzes or incomplete quiz completions will NOT be accepted.
Extensions are only given due to extreme circumstances, or emergencies. Students are
required to provide appropriate documentation, which will be determined acceptable by
the instructor BEFORE being granted an extension.
Examples of events qualifying for consideration include:
a. Illness of the student or immediate family (parent, spouse, child, sibling, or
grandparents) of such severity or duration to preclude completion of the
assignment(s) or exam(s) as confirmed in writing by a physician (M.D.).
b. Death of the student or death in the immediate family (parent, spouse, child, sibling,
or grandparents) as confirmed by documentation (death certificate, obituary)
indicating the students relationship to the deceased.
c. Involuntary call to active military duty as confirmed by military orders.
d. A situation in which the University is in error as confirmed by an appropriate
University official.
e. Other documented exceptional circumstances beyond the control of the student which
precluded completion of the assignment(s) or exam(s) accompanied by explanatory
letter and supporting documentation.
Unit Discussions:
Beginning in the second week of the course, are the weekly discussion cases that are also
part of the course assessment activities. Each week, a brief case study or scenario is
added to the discussion board (Discussion folder) for review and course participant
comment to aid the development of critical thinking skills as applied to ethical case
analysis. Each of the discussion topics will be open for comment for 1 week (Monday
morning, 9am EST to Sunday evening, 11pm EST).
Each course participant is required to submit a minimum of two (2) posts for each
discussion. The first should be a substantive response to the question or questions included
in the case study that provides an analysis of their interpretation of the scenario and which
can be based upon external informational resources that can be accessed and that are
relevant to the case. The second and any subsequent posts should be appropriate responses
to positions adopted by other students posts. Short posts such as I agree or I disagree
or similar simple statements would not meet this submission requirements. Posts should
include comments supported by facts derived from additional readings or experience. The
focus of the discussion posts is to generate a forum where students can discuss their
approaches to the case. Thus, course participants should endeavor to spread their discussion
posts throughout the appropriate week to encourage discussion by all participants. Please
do not wait until the last day of the week, Sunday, to post your discussion comments since
this leaves little time for other students to comment on your post(s).
Course Overview:
This graduate-level course is directed towards students who have an interest in the biomedical
sciences or who are focused on future medically-related or allied health careers. Students
interested in pursuing a medical or health-related career require familiarity with the diverse
aspects of biomedical ethics. Understanding the ethical principles that should govern biomedical
research and healthcare are a critical component of a health sciences-related education.
This course is part of the Medical Sciences Masters program, is used by the majority of the
concentrations and provides a valuable opportunity for degree seeking students to gain a deeper
understanding of the principles of modern biomedical ethics.
The course content follows a traditional curriculum in biomedical ethics for healthcare
professionals includes topics that vary from confidentiality and the design and oversight of basic
and clinical research studies to the various forms of informed consent instruments that apply to
clinical issues, such as the terminally ill or those undergoing emergency treatment. The course
also examines examples of conflicts of interest and the function of IRBs, the social effects of
research, including disclosure of study results, the ethical issues associated with genetic research
and the current issues associated with the use of medical records.
The course material is presented in a modular format which presents the essential information
in an integrated approach. The various modules are supplemented with readings and case
studies that reinforce the medically-related aspects of the material.
The course requires extensive on-line participation plus additional hours of reading and
research. Course participants will be introduced to the modern principles of healthcare and
biomedical research ethics.
Attendance Policy:
Students are expected to be active members of the course. At a
minimum each student should log into the course at least twice a
week to check for any course announcements and to complete
the various assignments.
Course Materials:
Access to course materials is limited to individuals registered for
the course. Students are not permitted to copy any of the course
materials for sale or distribution to other individuals.
Course Text:
The following textbook is required for this course. In order to
appropriately address the teaching objectives of the course, students will be responsible for
subject material from the assigned readings. Moreover, maximum benefit will be obtained by
reading the appropriate textbook material (Assigned Reading) before attempting to complete
each of the unit assignments.
Ethics for Health Professionals (Stanford, C.C. & Connor V.J.) Jones & Bartlett Learning,
2012.
ISBN-13: 978-1-4496-8960-5
Jones & Bartlett $54.95
Amazon $41.64
As described by the publisher, Ethics for Health Professionals provides a foundational
understanding of ethics for healthcare students and clinicians. Written with a conversational tone
and features within each chapter that add to its appeal including quotes, interesting facts, case
studies, and more, this indispensable text offers an enjoyable, eased reading style while
supplying information that can be practically and easily put into practice once the student enters
the field. Many ideals can also be carried over to ones personal life in terms of ethical principles
and decision making. Pedagogical features include chapter objectives, boxed articles, quotes,
case studies, key terms, chapter summary, assessment review questions. Website links are also
included for additional reference. Students will learn basic information while develop a
meaningful understanding of ethics, its importance and application in the world of health
sciences. The texts contents include:
Overview of the history of ethics Blanchard and Peales 3-step model Ecological Model
Approaches to ethics Applying ethics to the health care professional Patient Care Partnership
Vulnerable Populations Confidentiality The Medical Record Patients rights under HIPAA
and privacy standards Ethics and the Workplace Liability and Health Care Matters of Life
and Death. The text also covers additional contemporary topics in health care including:
Integrity in Research (Including conflict of interest and Institutional Review Boards) Central
Electronic Medical Record Registry Stem Cell Research Euthanasia, Abortion, Assisted
Suicide.
The modules in each course cover the standard RCR core topics: mentoring, authorship, peer
review, collaborative research, conflicts of interest, data management, research misconduct and
research with human and animal subjects.
Disability accommodation:
Information regarding qualifications for student disabilities through the Disabled Student
Academic Services Office (DSA) at the University of South Florida can be found online at:
http://download.grad.usf.edu/PDF/section14.pdf. Students can also directly contact the DSA for
arrangement of academic accommodations and assistance at (813) 974-4309, SVC 2043,
Coordinator of Disabled Student Academic Services. Students who anticipate that they will
require an academic accommodation or assistance must provide written notice to the instructor
by the beginning of the SECOND week of the course.
TurnItIn:
The University of South Florida has an account with an automated plagiarism detection service
which allows instructors to submit student assignments to be checked for plagiarism. The
instructor reserves the right to 1) request that assignments be submitted as electronic files and 2)
electronically submit assignments to TunrItIn.com. Assignments are compared automatically
with a huge database of journal articles, web articles, and previously submitted papers. The
instructor receives a report showing exactly how a students paper was plagiarized.
UNIT 5: Confidentiality
Required reading assignment: Stanford, Ch. 4.
Appendix A
University of South Florida Student Conduct Policies: http://www.sa.usf.edu/
Online Conduct/Academic Dishonesty:
All members of this course shall foster an environment that encourages adherence to the
principles of honesty and integrity. All parties shall protect the integrity of academic
materials including test materials, copyrighted documents, and all related course work.
Students are expected to represent themselves honestly in all work submitted. The presence
of a students name on any material submitted in completion of an assignment is considered
to be an assurance that both the work and ideas are the result of the students own intellectual
effort, and produced independently. Collaboration is not allowed unless specifically
permitted by the instructors.
All course participants are expected to respect others personal feelings; have the right of
freedom to hear and participate in dialogue and to examine diverse ideas; and have the right
to a learning environment free from harassment and discrimination; and the responsibility
that free discussion represents the scholarly nature of the learning community.
Cheating (the unauthorized giving, receiving, or use of material or information in quizzes,
assignments or other course work or the attempt to do so) or plagiarism (the use of ideas,
data or specific passages of another persons published or unpublished work that is either
unacknowledged or falsely acknowledged) is not acceptable in this course.
The use of Internet resources when writing your paper should be kept to a minimum. It is not
acceptable to use on-line abstracts or resources of questionable authority in your paper. The
web is acceptable for certain data sources e.g. CDC or census data. It is acceptable to use full
text journal articles that are on-line.
Academic Dishonesty & Disruption for Academic Process Policy
See http://www.sa.usf.edu/handbook/03/academics/ImportantAcademicPolicies.htm
Plagiarism & Punishment Guidelines for Plagiarism:
See http://www.sa.usf.edu/handbook/03/academics/ImportantAcademicPolicies.htm
Plagiarism is defined as literary theft and consists of the unattributed quotation of the exact
words of a published text, or the unattributed borrowing of original ideas by paraphrase from a
published text. On written papers for which the student employs information gathered from
books, articles, or oral sources, each direct quotation, as well as ideas and facts that are not
generally known to the public at large, or the form, structure, style of a secondary source must be
attributed to its author by means of the appropriate citation procedure. Only widely known facts
and thoughts and observations original to the student do not require citations. Citations may be
made in footnotes or within the body of the text. Plagiarism, also, consists of passing off as ones
own, segments or the total of another persons work.
Cheating is defined as follows:
(a) the unauthorized granting or receiving of aid during the prescribed period of a
course-graded exercise: students may not consult written materials such as notes or
books, may not look at the paper of another student, nor consult orally with any other
student taking the same test;
Appendix B Glossary
Advance directive: oral or written statements regarding the kind of medical care one wants in the future should one be unable to
communicate.
Arm of study: a course of involvement in a study; studies may have one or more arms; each arm may receive different kinds of
treatment in order to make comparisons possible.
Autonomy: the ability of human beings to make choices; the moral basis for informed consent in research.
Beneficence: action taken in the interest of the subject; the moral basis for protecting subjects from undue risk.
Blinding: in clinical trials, concealment of the nature of the intervention received by the subject; this may be single-blinding (the
subject does not know) or double-blinding (neither the subject nor the researcher knows).
Blinding: in publication, concealment of authorship when dealing with scientific reports and reviews.
Case analysis: a method evaluating particular circumstances in light of generally accepted moral principles.
Casuistry: a method of ethical analysis that involves applying general principles to individual cases, using clear-cut cases as
points of comparison.
Captive population: a group of people who are not entirely free to avoid unwanted attention or treatment.
Cell lines: cells of a particular kind grown in the laboratory; these lines can replicate themselves indefinitely.
Centers for Disease Control and Prevention: an agency of the U.S. government that studies the incidence, frequency, and
prevalence of disease and methods to control morbidity and mortality.
Certificate of confidentiality: a protection given to some researchers that exempts them from certain obligations under civil and
criminal law; for example, the duty to report observed crime.
Code of Federal Regulations: compilation of United States statutes.
Compliance and noncompliance: conformity of subjects to the terms of a study, or failure to do so.
Consent: expressed willingness, usually paired with informed to indicate a decision made in full knowledge of the nature and
scope of available choices.
Confidentiality: restriction of access to and use of information gathered in the course of research.
Conflict of interest: the prospect of financial or other gain that could undermine fiduciary or professional judgment exercised to
benefit others, not ones own self.
Consequentialism: a method of ethical analysis that relies heavily on consequences (as against motives or the nature of actions)
in order to evaluate the value of actions.
Deception: actions taken in order to mislead; it may include outright lies or withholding of information.
Deferred consent: consent sought after a course of action has been imposed on a person; usually applied to circumstances in
which people are not capable of giving consent in advance because of an incapacity.
Deontological ethics: a method of ethical analysis that relies heavily on the nature of duty (as against motives or consequences)
in order to evaluate the value of actions.
Embargo: in publication, withholding known information until a specified time.
Ethics committee: a general term used to refer to committees having oversight of either clinical or research activities; see
institutional review board.
Equipoise: a state of indeterminacy about whether one drug or device is better than another; the moral basis for asking subjects
to enroll in research.
Exclusion criteria: factors that make people ineligible to join or to continue in studies.
Exposure studies: studies that expose animals or humans to pathogens, injuries, or situations under controlled circumstances in
order to study the effect of that exposure and/or a treatment.
Framing effect: in psychology, the way in which presentation of information influences the way in which it is perceived and
evaluated.
Genetic therapy: therapy that involves alteration of the genetic make-up of an organism.
Genome: a combination of the words gene and chromosome; refers to the entire genetic make-up of an organism.
Germ-line intervention: a genetic intervention that affects not only the individual but can be passed along to offspring.
Inclusion criteria: factors that make people eligible to join a study.
Informed consent: a moral precept that requires disclosure of the nature and scope of a study to possible subjects; the process of
making that disclosure.
Institutional animal care and use committee: a committee that is charged to review and approve studies involving animals.
Institutional review board (IRB): a committee that is charged to review and approve studies involving human subjects; its
primary charge is to protect the rights and welfare of subjects.
Phase 1 studies: in government regulations, a study to evaluate the safety of a drug or device in humans; part of the process
required to make a drug or device available to the public.
Phase 2 studies: in government regulations, a study to evaluate the effect of a drug or device in humans; part of the process
required to make a drug or device available to the public.
Phase 3 studies: in government regulations, a study to evaluate the benefit of a drug or device in humans; part of the process
required to make a drug or device available to the public.
Phase 4 studies: in government regulations, a study to evaluate the effects of widespread use of a drug or device in humans after
it is made available to the public.
Randomization: the distribution by chance of subjects to the various arms of a study; intended to minimize possible bias.
Recombinant DNA: a term used to refer to intentionally modified genetic sequences either in vitro or in vivo.
Risk (minimal): in government regulations, a term that refers to the probability that anticipated research risks are not greater
than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Somatic cell nuclear transfer (SCNT): transplanting the nucleus of a somatic cell (not a gamete) into another cell which has
had its nucleus removed, usually an ovum; this transfer is part of a process of inducing the new cell to behave as an embryo.
Somatic treatment: treatments that affect the body but do not alter the underlying genetic make-up of an organism.
Subclinical markers: laboratory evaluations to study the effect of medical interventions before the emergence of symptoms.
Therapeutic research: research believed to have some possible benefit for the subjects; the opposite of non-therapeutic research
in which no benefit to the individual is foreseen.
Vector: in genetics, a mechanism by which a gene is delivered into an organism.
Graduate Programs in
Integrated Biomedical Sciences
Graduate & Postdoctoral Affairs
School of Biomedical Sciences
Morsani College of Medicine
USF Health
12901 Bruce B Downs Blvd., MDC 40
Tampa, Fl 33612-4742