Title 45 Part 46 Flashcards
what is title 45 part 46?
The HHS regulations for the protection of human subjects in research at 45CFR 46 include five subparts.
Subpart A
Also known as common rule: This policy applies to all research involving human subjects conducted, supported, or subject to regulation by any Federal department or agency.
Who is covered under subpart A
- All studies under DHHS
* All studies under FDA regulation
Why is it called the Common rule?
· called the common rule because many federal departments have subscribed to part of all of this part. Including: o DHHS o Department of education o Department of defense o Department of agriculture
What is subpart b?
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Regulatory requirements and ethical concepts related to protection of pregnant women
(10 conditions)
- preclinical studies have been conducted to
- risk to the fetus is caused by interventions/ procedures that offer direct benefit to the woman or the fetus
- Any risk is the least possible
- If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge
- If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions
- Everyone providing consent is fully informed
- For children who are pregnant, assent and permission are obtained
- No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
- Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and
- Individuals engaged in the research will have no part in determining the viability of a neonate.
Regulatory requirements and ethical concepts related to protection of neonates and fetuses
(6 requirements)
- preclinical and clinical studies have been conducted
- Each individual providing consent is fully informed
- Those engaged in the research will have no part in determining the viability of a neonate.
- Until it has been determined whether or not a neonate is viable, a neonate may not be involved in research covered by this subpart unless the IRB determines that the research holds out the prospect of enhancing the probability of survival of the neonate
-After delivery nonviable neonate may not be involved in research covered by this subpart unless all of the following additional conditions are met:
o Vital functions will not be artificially maintained;
o The research will not terminate the heartbeat
o There will be no added risk to the neonate resulting from the research;
o The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
o The legally effective informed consent of both parents of the neonate is obtained (d)
-Viable neonates. may be included in research only to the extent permitted by and in accord with the requirements of subparts A and D of this part
What is subpart C?
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
IRB involvement in with prisoner participants
- Most of the Board shall have no association with the prison(s) involved, apart from their membership on the Board.
- At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a research project is reviewed by more than one Board only one Board need satisfy this requirement.
Requirements to prisoner participation in research
5 conditions
- Any possible advantages to the prisoner through his or her participation in the research, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;
- The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers;
- Procedures for the selection of subjects within the prison are fair to all prisoners.
- The information is presented in language which is understandable to the subject population;
- parole boards will not consider a prisoner’s participation in the research in making decisions regarding parole
What is subpart D?
Additional Protections for Children Involved as Subjects in Research
Research not involving greater than minimal risk to children
HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is presented, if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians
Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects in children (3 conditions)
- The risk is justified by the anticipated benefit to the subjects;
- The relation of the anticipated benefit to the risk is at least as favorable
- Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians
Research involving greater than minimal risk and no prospect of direct benefit to individual subjects in children (4 conditions)
- The risk represents a minor increase over minimal risk;
- The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
- The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition; and
- Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians
Requirements for permission by parents or guardians and for assent by children.
IRB shall determine that adequate provisions are made for soliciting the assent of the children when the children are capable of providing assent.
- In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved.
- Adequate provisions are made for soliciting the permission of each child’s parents or guardian.
