Introduction:

“Research ethics” is a category that encompasses a very broad array of ethical, social and legal issues.  Examples of the types of issues that fall under the general category of research ethics and scientific integrity include the following: 1) use of humans in biomedical experimentation; 2) authorship and peer review; 3) mentoring; 4) ownership of data and intellectual property; 5) scientific record keeping; 6) genetic technology and scientific integrity; 7) collaborative research; 8) use of animals in biomedical research; and 9) conflicts of interest in biomedical research. This final issue in scientific integrity-- conflicts of interest-- is the one on which we will focus during this session of MCS2.

With increasing interdependence in the US between biotechnology companies and researchers at universities and other institutions, concerns about preserving scientific integrity in the research process are growing. One manifestation of this phenomenon is increased attention to managing conflicts of interest by universities, independent research centers, and government.  Students will learn to identify and analyze possible conflicts and how such conflicts may be managed by the institutions in which they work.  The lecture will also present results of a study of current practices by research institutions on the topics of disclosing and managing conflicts of interest, including analysis of compliance with current regulatory standards.

Some issues related to conflicts of interest include: 1) How is conflict of interest defined? 2) What are the federal regulations about handling conflicts of interest and how well do research institutions comply with them?  3) What are conflict of commitment (also known as conflict of effort) and conflict of conscience, and how does they differ from conflict of interest? 4) How are existing conflicts of interest managed by research institutions?  5) How do the views of researchers, administrators, bioethicists, and research subjects differ in their approach to conflicts of interest?

Objectives:
Upon completion, students should:

1. Be able to identify, and analyze the ethical implications of, possible conflicts of interest (and other related conflicts) in biomedical research.
2. Be aware of ways that institutions may seek to manage existing conflicts of interest.
3. Develop an ongoing awareness of the possibility of conflicts in their future research efforts and clinical practice.

Preparation:

1. Required reading
2. Suggestions for written work:
• Choose one of the cases and offer an analysis.
• Write a letter to the editor / editorial on one of the cases.
• Review one of the journal articles or one of your own choosing.
3. Be prepared to discuss the following: Practicing physicians, especially those who treat patients with rare conditions, are sometimes solicited by researchers to recruit patients for studies. Sometimes physicians are offered substantial “finders fees” ($500 to $5,000 per patient) when they refer a patient to a clinical trial (includes Phase I, II, and III trials) and the patient actually enrolls. Discuss whether physicians should accept finders fees when their patients enroll in clinical trials and what the implications are for the physician-patient relationship. Does it matter whether the trial is Phase I, II, or III? What if it is unclear whether the potential subject meets the physiological inclusion criteria for the study (or worse, clear that the subject does not meet the criteria)?  Should physicians disclose to a patient who has enrolled in a trial that the doctor has accepted a fee for referring them?  Why or why not?

Study Question:

1. Define the following concepts: conflict of effort; conflict of interest; and conflict of conscience. Discuss similarities and differences between them.

Lecture Description:

With increasing interdependence in the US between biotechnology companies and researchers at universities and other institutions, concerns about preserving scientific integrity in the research process are growing. One manifestation of this phenomenon is increased attention to managing conflicts of interest by universities, independent research centers, and government.  Students will learn to identify and analyze possible conflicts and how such conflicts may be managed by the institutions in which they work.  The lecture will also present results of a multi-phase study of current practices by research institutions on the topics of disclosing and managing conflicts of interest, including analysis of compliance with current regulatory standards.