Bioethics and the Application of Regulations to Research
These resources, while developed with the postdoctoral trainee in mind, are useful to a broader group of individuals, including medical residents, study coordinators, and nursing or allied health students.
| On-campus Instructional Opportunities | Campus Resources | Online Resources |
On-campus Instructional Opportunities:
| Credit | Non-Credit |
MED HIST 545: Ethical and Regulatory Issues in Clinical Investigation
1 credit; fall
Exploration and examination of the ethical issues central to clinical research, regulations governing clinical investigation, and the role of good clinical practice for clinical trials. Ethical and regulatory issues in the design, conduct and reporting of research will be examined. Topics include history, consent, randomized clinical trials, special subjects, medical records and database research, cultural issues, research in developing countries, animal studies and institutional review boards and responsible conduct of research.
MED HIST 559: Topics in Ethics and History of Medicine
3 credits; fall and spring
A survey of ethical and social issues in medical ethics and history of medicine. Cooperating faculty may be drawn from philosophy, law, medical ethics, history, political science, public health, economics, education, and communication, as well as medicine and the biological sciences.
P: Cons inst; enrollment may be limited depending on topic and approach.
MED HIST 565: The Ethics of Modern Biotechnology (Crosslisted with Agronomy, Philos, Rur Soc)
3 credits; spring
Study of ethical issues arising from the application of modern biotechnology to microorganisms, crops, and non-human animals. Readings cover moral theory, technology studies, political philosophy, the science used in biotechnology, and current regulations governing its use.
P: Jr st & cons inst.
MED HIST 905: Bioethics and the Law
2-4 credits; semester unknown
Introduction to the legal, ethical and public policy dimensions of modern medicine and biomedical research. Informed consent, human experimentation, death and dying, organ transplantation, allocation of scarce resources. May cover reproductive and genetic issues in some years.
P: Cons inst.
MED HIST 906: Law, Science and Biotechnology Seminar
2-3 credits; semester unknown
Legal, ethical, social and public policy questions raised by modern scientific and technological developments, with a particular focus on biotechnology.
P: Cons inst.
NURSING 802: Ethics and the Responsible Conduct of Research
1 credit; spring
Ethical issues in the design, conduct and reporting of research are examined in the context of the nature of the scientific endeavor, the structure of the research community, and professional and federal guidelines for supporting scientific integrity and controlling misconduct.
P: Grad st.
SURG SCI 812: Research Ethics and Career Development
2 credits; fall
The purpose of this seminar series is to provide trainees with information that will be useful in their development as scientists and will provide a frame of reference as they struggle with issues of authorship, plagiarism, scientific misconduct or fraud, mentoring, starting their career, developing a research program, and writing.
Graduate School Seminar Series
(via the Office of Human Resource Development)
http://www.ohrd.wisc.edu/home/
Human Research Protections:
https://www.ohrd.wisc.edu/OHRDCatalogPortal/Default.aspx?tabid=29&SeriesKey=347
Responsible Conduct of Research:
https://www.ohrd.wisc.edu/OHRDCatalogPortal/Default.aspx?tabid=29&SeriesKey=349
The Graduate School offers many free seminars and workshops related to policies, procedures and regulations for research and graduate education through the year. The sessions are open to all members of the campus community. Presenters include representatives of the Graduate School Office of Admissions and Academic Services, Office of Research and Sponsored Programs, Office of Research Policy, Office of the Administrative Legal Services, Wisconsin Alumni Research Foundation and other faculty and staff.
The 2008-2009 schedule is posted at www.ohrd.wisc.edu under Graduate School Seminar Series. Please bookmark this site to check the schedule, presentation description, registration information and any additional seminars. A reminder will be sent at the beginning of the month with the listing of the seminars being offered that month.
For a complete list to use as a reference, see http://www.grad.wisc.edu/admin/outreach/GSSSsched08-09.pdf
Campus Resources:
Wisconsin Alumni Research Foundation
http://www.warf.org/inventors/index.jsp?cid=14
For UW-Inventors, the Wisconsin Alumni Research Foundation (WARF) is the designated patent management organization for UW-Madison. It provides, free of charge, patenting and licensing services for inventions, copyrights and other intellectual property that has the potential to be commercially developed. Particularly helpful for graduate students and other new investigators are the sections on the process for disclosure at UW-Madison and suggested practices for protecting your ideas.
Online Resources:
Proposal Submission Review at UW-Madison
http://www.rsp.wisc.edu/routing/proposalsub.html
Before you may submit a proposal, you must demonstrate that the proposal is in compliance with Federal, State, and UW-Madison regulations.
Collaborative Institutional Training Initiative
https://www.citiprogram.org
Also accessed locally via UW site at:
https://my.gradsch.wisc.edu/citi/index.php
Features on online Responsible Conduct of Research course, available for free access (with a free CITI account).The Collaborative Institutional Training Initiative (CITI) was founded in March 2000 as a collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop a web based training program in human research subjects protections. In response to the June 2000 education policy announcement, the collaboration was expanded to include content experts from 10 institutions who provided the content for the first 12 biomedical modules. In addition to the "Basic" content, the CITI model provides the opportunity for institutions to post additional instructional materials specific to their institution.
NIH Clinical Center: Introduction to the Principles and Practice of Clinical Research
Video archives of 2007-2008 course presentations are available for viewing at:
http://www.nihtraining.com/cc/ippcr/archive07f/menu.html
Site for information about the current NIH IPPCR course:
http://www.cc.nih.gov/training/training/ippcr/info.html
The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a study curriculum on how to effectively conduct clinical research. The program trains researchers in how to design a successful clinical trial by focusing on epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. Other areas covered include data management and ethical issues, including protection of human subjects. Videos include captions. Links to presentation materials are also provided.
NIH Clinical Center: Ethical and regulatory aspects of clinical research
http://www.bioethics.nih.gov/hsrc
Video archives of presentations from the previous years of this course are available for viewing at:
http://videocast.nih.gov/PastEvents.asp?c=22
By the end of this course, participants will be able to:
- Utilize a systematic framework for evaluating the ethics of a clinical research protocol.
- Apply appropriate codes, regulations, and other documents governing the ethical conduct of human subject research to their own research.
- Discuss controversial issues relating to human subject research, including Phase 1 research, randomization, children in research, international research, etc.
- Identify the critical elements of informed consent and strategies for implementing informed consent for clinical research.
- Describe the purpose, function, and challenges of IRBs
- Appreciate the experience of human subjects who have participated in research protocols.
Background Requirements: There are no background requirements in terms of education, knowledge, or experience; just an interest in clinical research with human subjects. This course is readily accessible to the non-medically trained as well as to those in the field of scientific research. As a rule, background education includes a mix of MD, PhD, RN, MPH, SW, MPH, and BA/BS.
NIH Clinical Center: Clinical Research Training On-line course
Course overview and information: http://www.cc.nih.gov/training/training/crt.html
Course login URL: http://www.nihtraining.com/crtpub_508/index.html
The web-based Clinical Research Training On-Line Course for Principal Investigators addresses one of the essential standards (training and education) approved by the National Institutes of Health (NIH) for performing clinical research in the Intramural Research Program. All NIH intramural clinical principal investigators are required to take the course and successfully complete a final exam.
Former participants of the "Introduction to the Principles and Practice of Clinical Research" and "Ethical and Regulatory Aspects of Human Subjects Research" who have passed both courses, as exhibited by successful completion of a final exam, are not required to take the course to fulfill the training and education standard for principal investigators.
Objectives of the course are:
- To be aware of the ethical issues involved in human subjects research
- To become familiar with the roles and responsibilities of the principal investigator and the institution when conducting clinical research in the NIH intramural research program
- To have an understanding of Food and Drug Administration (FDA) oversight of clinical research
- To become familiar with how developments in science and health are reported by the media and how to work effectively with reporters.
Topics covered in the course are:
- Ethical Issues in Human Subjects Research
- Roles and Responsibilities of the Investigator
- Roles and Responsibilities of the Institution
- Regulatory Issues
- Clinical Investigators and the Mass Media.
