HIPAA and Research Flashcards
1
Q
What is the HIPAA law?
A
- regulates privacy and security of health information
- standardizes electronic health care transactions
- allows employees to change jobs w/o a gap in health insurance coverage
2
Q
What are the laws that regulate the conduct of research?
A
- DHHS Common Rule
- FDA Part 21
3
Q
What violates LUMC policy with regard to sending emails?
A
sending unencrypted email containing PHI over the internet
4
Q
HIPAA trumps State law unless the State law…
A
- provides greater privacy protections to a patient’s PHI
- affords greater access to information rights to a patient
5
Q
What is the #1 priority of the IRB?
A
to protect human subjects from physical or psychological harm
6
Q
Does Common Rule address PI responsibilities?
A
no, not directly
7
Q
What is the Common Rule (1981)?
A
- federal law governing human subject research
- baseline standard of ethics by which any govt.-funded research is held
- regulates IRB
- applies to federally-funded research activities
- contains additional protections for vulnerable populations
8
Q
What is FDA Part 21?
A
- contains many of the FDA regulations pertaining to human subject research
- mostly regulates food, drug, cosmetic, and device research
- many regulations parallel Common Rule
- additional reporting responsibilities
