B6.046 Research Ethics: MS

Question 1

phase 0

Answer 1

exploring if the drug may work

• exploratory studies
• few small doses in a few patients

Question 2

phase 1

Answer 2

is it safe?

• usually first that involve people
• small #s 20-80 people

Question 3

phase 2

Answer 3

does the treatment work?

• 50-100s of patients
• gets better idea of efficacy and effects in the short term

Question 4

phase 3

Answer 4

is it better than what’s available?

• compare against current standard
• large group of patients who are ill to look for statistical significance

Question 5

phase 4

Answer 5

post marketing surveillance

-reports back about positive and negative effects

Question 6

function of IRB

Answer 6

ensure research studies involving human subjects are scientifically justified
assess safety and risk/benefit ratio
protects subjects rights to:
-privacy
-right to voluntary informed consent before participation
-right to withdraw at any time

Question 7

how to determine scientific merit?

Answer 7

appropriate scientific basis in lab and animal studies
plausible scientific justification for use in humans
background about risks - lit review, tox studies

Question 8

equipoise

Answer 8

reasonable clinician would say that the current investigational approach may or may not be better than the comparison

Question 9

steps in the research process

Answer 9

recruitment of subjects?
how will consent be obtained?
protection of privacy?
how will subjects be protected from other risks of the research intervention?
will individual test results be returned to subjects during the study?
will findings be shared with participants?

Question 10

preconditions of informed consent

Answer 10

decision making capacity

voluntariness

Question 11

information that must be conveyed in informed consent

Answer 11

nature of proposed intervention
risks of the intervention, risks of the disease without intervention, and known, serious possible complications
expected benefits of the intervention
alternatives, including of doing nothing

Question 12

standard for disclosure in informed consent

Answer 12

what would a reasonable patient want to know?

in some states can use what a reasonable provider would disclose

Question 13

patient decision in informed consent

Answer 13

communication

documentation

Question 14

what is a COI

Answer 14

professional judgement or actions could be influenced by a private or personal interest, resulting in personal, financial, or professional gain
participant safety may be influenced by a tendency on the part of the investigator to want a favorable outcome

Question 15

types of COI

Answer 15

financial
non financiak:
personal
professional
institutional
perceived

Question 16

how to deal with COIs

Answer 16

adopt COI policies and procedures
obtaining disclosure forms and updating periodically
requiring any staff member with potential conflict to disclose it to their institution before study begins