45 CFR Part 46

Question 1

What does 45 CFR Part 46 cover?

Answer 1

Protection of Human Subjects

Question 2

What does 45 CFR Part 46 Subpart A cover?

Answer 2

Basic HHS policy for protection of human subjects

Question 3

What does 45 CFR Part 46 Subpart B cover?

Answer 3

Additional Protections for pregnant women, human fetuses, and neonates involved in research.

Question 4

What does 45 CFR Part 46 Subpart C cover?

Answer 4

Additional Protections pertaining to biomedical behavioral research involving prisoners as subjects.

Question 5

What does 45 CFR Part 46 Subpart D cover?

Answer 5

Additional protections for children involved as subjects in research.

Question 6

What does 45 CFR Part 46 Subpart E cover?

Answer 6

Registration of Institutional Review Boards.

Question 7

dead fetus

Answer 7

a fetus that exhibits neither a heartbeat, spontaneous respiratory activity, movement of voluntary muscles, nor pulsation of the umbilical cord.

Question 8

fetus

Answer 8

the product of conception from implantation until delivery

Question 9

neonate

Answer 9

newborn

Question 10

nonviable neonate

Answer 10

neonate after delivery that, although living, is not viable.

Question 11

viable

Answer 11

as it pertains to a neonate: means being able, after delivery, to survive to the point of independently maintaining heartbeat and respiration.

Question 12

pregnancy

Answer 12

period of time from implantation until delivery

Question 13

What is DHHS

Answer 13

Department of Health and Human Services

Question 14

children

Answer 14

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.

Question 15

assent

Answer 15

a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Question 16

permission

Answer 16

the agreement of parent(s) or guardian to the participation of their child or ward in research.

Question 17

Parent

Answer 17

a child’s biological or adoptive parent.

Question 18

guardian

Answer 18

an individual who is authorized under applicable state or local law to consent on behalf of a child to genereal medical care.

Question 19

how often must an IRB renew its registrations?

Answer 19

Every 3 years.

Question 20

When must IRB informatino be updated?

Answer 20

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.