01/10 - Ethics and Professionalism Flashcards
What are Duke’s core supporting values?
Excellence Safety Integrity Diversity Teamwork
Should you give out diagnostic information to a surgeon who brings you a frozen section and asks you to gross it?
NO! Never give out diagnostic information
What is the definition of medical ethics?
The study of moral values and judgments as they apply to medicine
What are the six core values of medical ethics?
Autonomy Beneficence Non-maleficence Justice Dignity Truthfulness and honesty
What are some common issues that come up with respect to clinical ethical issues?
Informed consent Truth telling Confidentiality End-of-life care Pain relief Patient's rights
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
What is addressed in Title I of HIPAA?
Protecting health insurance coverage for workers and families when they change or lose their jobs
What is addressed in Title II of HIPAA?
Requires the establishment of standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers
What is the purpose of the Administrative Simplification rules?
To increase the efficiency of the health care system, and to create standard for use and dissemination of health care information
What issues are addressed by the Privacy Rule?
Regulations for use and disclosure of Protected Health Information (PHI)
Gives individuals the right to request correction of inaccurate PHI
Requires “covered entities” to notify individuals of use of their PHI
What is the Security Rule?
A part of HIPAA that deals specifically with Electronic Protected Health Information (EPHI), and addresses security safeguards
What are the three types of security safeguards covered by the Security Rule?
Administrative
Physical
Technial
What are some administrative safeguards?
Written privacy procedures and policies
Ongoing training programs
Contingency plans
Internal audits
What are some physical safeguards?
Controlling physical access to PHI
Control of access to and introduction/removal of hardware and software
Proper workstation and computer use
What are some technical safeguards?
Control of access to computer systems
Protection of communications transmitted over open networks
Encryption, corroboration, and authentication of data
Documentation
What are some of the negative effects that HIPAA has had on clinical research?
Difficulty performing retrospective chart-based research
Decrease in patient accrual and follow-up studies
Increase in recruitment time and cost
Increase in complexity and length of informed consent forms
What are the main ethical principles outlined in the Belmont Report?
Respect for persons - autonomy and informed consent
Beneficence - assessment of risks and benefits
Justice - selection of research subjects
What populations of research subjects qualify as ‘vulnerable?’
Pregnant women, fetuses, IVF
Prisoners
Children
What is an IRB, and what is its purpose?
Institutional Review Board - a committee designated to approve, monitor, and review any research involving humans with the aim to protect the rights and welfare of the research subjects
What types of research are exempt from IRB inspection?
Any research involving collection of existing data, documents, records, or specimens whose sources are publicly available, or if the information is recorded in such a way that subjects cannot be identified
What are the requirements for the composition of an IRB?
Must have at least five members, both men and women, who have the experience, expertise, and diversity of make decisions
Must include an advocate for vulnerable populations
Must not be all of the same profession
Must have at least one scientist and one non-scientist
A patient consents to participate in a biomedical study, even though the PI didn’t go over the potential risks involved - is this informed consent?
NO! Informed consent must include providing ALL relevant information, including possible risks
A patient hears about a medical study and decides to participate because subjects are being offered $25 for an hour of tests - is this informed consent?
YES! Subjects are allowed reasonable compensation for participation in a study
What are some possible cases in which patient-physician confidentiality might be legally broken?
Child abuse Gunshot wounds Suspected driving under the influence Domestic violence Termination of pregnancy for a minor
What are some common conflicts of interest that arise amongst medical professionals?
Referrals for personal gain
Vendor relationships
Treatment of family members
Sexual relationships
