Vulnerable Populations

Question 1

45 CFR 46 Subpart D
21 CFR 50 Subpart D Pediatric Research

Answer 1

More than minimal risk research in children must offer direct benefits to subjects

Question 2

Different levels of Assent (ex AFCH)

Answer 2

0-6 parental permission only
7-12 child assent, no signature
13-14 assent, youth info sheet with a signature
15-17 often sign the ICF like an adult, depending on the study
A PI can check a box saying the patient assented & note it

Question 3

Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects

Answer 3

• March 1998, children must be included in all research unless there is a scientific or ethical reason to not include
• Exclude if:
• irrelevant to children
• Knowledge already avaialbe or another ongoing study
• Separate age specific study is warranted & prefereable
• Insufficient data in adults to determine risks

Question 4

HHS Vulernable vs. FDA

Answer 4

No handicapped or mentally disabled but does have individuals with impaired decision making

Question 5

ICH Requirements for Non-therapeutic trials

Answer 5

-no direct benefit, should only enroll those capable of consent
-if low risk & cannot be carried out without those groups not capable, pay attention for distress
-LAR can sign if the objectives are for this group, it is low risk, negative impact is low, trial is allowed by law and approved by the IRB for this group

Question 6

National Commission Report & Children

Answer 6

Sliding scale according to risk & direct benefits to the child
-As risk/benefit ration becuase less favorable to the child, additional protections are required
-Parents & child cannot give true consent, so give assent & permission instead
-Can have nontherapeutic trials if they are minimal risk

Question 7

Other Vulnerable Groups not Specifically in the Regulations

Answer 7

Racial/ethnic minorities
Individuals with physical disabilities
Socially Disadvantaged
Economically Disadvantaged
Individuals with mental disabilities or congitive impairments
Terminally ill or very sick

Question 8

Pregnant Women-Subpart B & All Women

Answer 8

1977-Originally excluded from Research
In 1988 FDA called for them to be included
1993-eliminated restrictions for Women
1994-NIH inclusion of Women
2001-protections for pregnant, fetus, neonates
June 2019-No fetal tissue research-abortions
-Minimal risk, benefit to mom or baby research is allowed
-No benefit only if important knowledge will be gained
-Greater than minimal risk, only if risk to baby is the least possible & benefit to mom & baby
-Can’t be included if no benefit

Question 9

Prisoners & Minimal Risk Research

Answer 9

Probability and magnitude of harm (physical or psychologically) normal to daily lives or medical, dental, or psychocolgical exam of healthy people, so not allowed

Question 10

Prisoners Subpart C

Answer 10

• Only can be included if material to lifves of prisoners
• A prisoner is anyone involuntarily confied/detained in a penal institution, hospitals, rehab, mental under court order, work release, or house arrest, but not parole

Question 11

Research for Pregnant Women & Fetuses

Neonates

Answer 11

-direct benefit to mom & minimal risk to baby, only requires the mom’s consent
-if direct benefit only to the baby, it requires both parents consent (unless not available due to unkwnown, capacity, deceased, rape, or incest)
-intervention trials-the mother’s refusal is binding

-unceratin viability or non-viable still subject & only if no added risk or to enhance survival