EMB Cis lecture

Question 1

declaration of Helsinki

Answer 1

ethical principles for medical research involving human subjects

Question 2

the belmont report

Answer 2

respect for persons: voluntary participation AND protection of vulnerable

beneficence: doing good, risk::benefit ratio
justice: each person treated FAIRLY, EQUITABLE, and given what is due. EQUAL distribution of benefits as well as BURDENS!

Question 3

how can researchers entice participation of subjects without being deceptive?

Answer 3

TRANSPARENCY

Question 4

Why is transparency important?

Answer 4

less likely to DEVIATE from protocol, less likely to drop out!

Question 5

Common rule

Answer 5

federal policy on human subjects PROTECTION; DHHS via the Office for Human research protections (OHRP)

Question 6

what is NOT regulated by OHRP?

Answer 6

FDA

veterans have additional protections

Question 7

IRB assures that

Answer 7

risks to subjects MINIMIZED
risks to subjects are REASONABLE
the selection of subjects is equitable
the informed consent process and documentation are adequate AND appropriate
–also, safety, privacy, confidentiality, not INFLUENCED

Question 8

vulnerable populations

Answer 8

pregnant women, fetus, prisoners, autistic

Question 9

three categories of IRB review

Answer 9

1. exempt–trust you are going to do what you say, NOT determined by investigators!!
2. expedited– full review but LESS MEMBERS;; minimum risk AND informed concent
3. full

Question 10

Informed consent

Answer 10

basic elements; 8th grade reading level or LOWER

Question 11

Non-compliance will to ____

Answer 11

SUSPENSION!

Question 12

pros and cons of community research site

Answer 12

•	advantages:
o	patients tend to be older, sicker and less affluent they may be more representative of the overall population
•	problems: 
o	fly under the federal government radar
o	poor record keeping
o	slack on proper ethics

Question 13

are foreign sites tightly regulated?

Answer 13

NO :(