45 CFR Part 46 Flashcards
What does 45 CFR Part 46 cover?
Protection of Human Subjects
dead fetus
a fetus that exhibits neither a heartbeat, spontaneous respiratory activity, movement of voluntary muscles, nor pulsation of the umbilical cord.
fetus
the product of conception from implantation until delivery
neonate
newborn
nonviable neonate
neonate after delivery that, although living, is not viable.
viable
as it pertains to a neonate: means being able, after delivery, to survive to the point of independently maintaining heartbeat and respiration.
pregnancy
period of time from implantation until delivery
What is DHHS
Department of Health and Human Services
children
persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
assent
a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
permission
the agreement of parent(s) or guardian to the participation of their child or ward in research.
Parent
a child’s biological or adoptive parent.
guardian
an individual who is authorized under applicable state or local law to consent on behalf of a child to genereal medical care.
how often must an IRB renew its registrations?
Every 3 years.
When must IRB informatino be updated?
1) Registration info for an IRB must be updated w/in 90 days after changes occur regarding the contact person who provided the RIB registration information or the IRB chairperson. 2) Any renewal or update that is submitted to, and accepted by, OHRP begins a new 3 year effective period. 3) an institution’s decision to disband a registered IRB which it is operating also must be reported to OHRP in writing w/in 30 days after permanent cessation of the IRB’s review of HHS conducted or supported research.
