Ethical principles in research 2 Flashcards
(14 cards)
What is research ?
- It can improve the quality of life for many and the quality of medicine.
- Research should not harm
- Ethics must be upheld
- What is RIGHT LEGAL and Fair
What is HIPAA?
Health Insurance Portability and Accountability Act.
* Sets standards and regulations for the protection and privacy of individuals health information.
What are the rules of HIPAA?
- Privacy
- Security
- Breach notification
- Enforcement
What is title I HIPAA?
- Continutation of health insureance
1. Cannot deny or charge more for past or present poor health
1. Limits the degrees pre-exciting conditions can be excluded.
What is Title II HIPAA?
To potect identifiable health information of PHI (protected health information)
Title II HIPAA includes?
- Privacy standards
- Covered entitles (TPO)- treatment, payment, operations
- Business associates - perform a function or activity on behalf of a convered entity. ( need to obtain contracts)
- Patient rights- Access to records, amendement to, accounting of disclourses, file complaint, restricitng information, protocols and time frames.
- Administrative requirements- designated privacy officer or contact person, training for employees, safeguards to protect PHI, Computer passwords and identify and track users
exceptions HIPAA violations?
- consulting with another healthcare provider for the patient, patient health activites, law enforcement and de-identified information.
What are some HIPAA compliance during community health projects?
- Perform clinical interventions with much privacy as possible
- Do NOT Share records with administrators, teacher or even school nurse (unless there is a medical need)
- Maintain screening records at your organoxation for a period of 3 years.
What are the government and private entities?
- FDA-Reviews treatment, medicines, and medical device research done in private sector
- NIH- Conducts research through PHS and military
- Local health Departements- Conducts research on local populations (themselves or in partnership)
- Private institiutions-Designs and conducts bulk of medical research in the US
Ethical practice issues may be present
What was the tuskegee study of Untreated syphilis?
- US Public Health Service
1932-1972
Purpose of the study: progression of untreated syphillis
600 volunteers- 399 with syphilis and 201 without
What medication was given has TX?
1945 penicillin
What was nuremburg code?
- trials exploited human beings
- humans were test subjects for experimental conditions
over 6 miliion in death
What was BELMONT Report?
- drafted in 1979 ethical principles and guidleines for human research
What was belmont report three core principles ?
Respect for persons
Benefocence
Justice
** Also includes informed consent, assessment of risks and beenfits, selection of subjects