45 CRF Part 46 Flashcards
At least how many members must an IRB have
5
Who is responsible for conducting continuing review of a protocol
IRB
Criteria for IRB approval or research
- Risks to subjects are minimized
- Selection of subjects is equitable
- informed consent will be obtained
- informed consent will be documented
- if needed, there is a plan to monitor the data collection to ensure safety of subjects
- if needed, there are measures to protect privacy of subjects
- if vulnerable subjects will be involved: there are additional safeguards to protect the rights and welfare of these subjects
Definition of fetus
product of conception from implantation to delivery
Definition of Neonate
newborn
Definition of Nonviable neonate
A living newborn that is not viable
Definition of Dead fetus
Fetus that exhibits neither heartbeat, spontaneous respiration, spontaneous movement of voluntary muscle, nor pulsation of the umbilical cord
Definition of Viable
Neonate can survive to independently maintain their own heartbeat and respiration
Definition of pregnancy
Period of time from implantation until delivery
Requirements for using prisoners as patient populations
Institution responsible for research has certified to secretary that the IRB has approved the research
AND
in judgement of Secretary, research only involve:
- study of causes/effects/processes of incarceration or criminal behavior. no more than minimal risk and no more than inconvenience
- study of prisons as institutional structures
- research on conditions particularly effecting prisoners
- research on practices which have the intent and reasonable probability of improving the health or wellbeing of subjects
How frequently does the IRB have to renew their registration with OHRP
every 3 years
Basic elements of consent
- statement that study involves research, purpose, duration, procedures, which procedures are experimental
- description of risks
- description of benefits
- disclosure of alternative procedures
- how records will be confidential
- greater than minimal: compensation for injury
- contact information
- participation is voluntary
Additional elements of consent
- statement that there are risks that are unforeseeable
- when subject’s participation may be terminated
- additional costs
- consequences of withdrawal
- significant new findings will be shared
- approximate number of subjects
- biospecimens may be used for commercial profit
- whether clinically-relevant research results will be disclosed
- biospecimens: whether research will involve WGS
