Vulnerable Populations Flashcards
(15 cards)
45 CFR 46 Subpart D
21 CFR 50 Subpart D Pediatric Research
More than minimal risk research in children must offer direct benefits to subjects
Different levels of Assent (ex AFCH)
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
Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects
- 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 available or another ongoing study
- Separate age specific study is warranted & preferable
- Insufficient data in adults to determine risks
HHS Vulnerable vs. FDA
No handicapped or mentally disabled but does have individuals with impaired decision making
ICH Requirements for Non-therapeutic trials
-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
National Commission Report & Children
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
Other Vulnerable Groups not Specifically in the Regulations
Racial/ethnic minorities
Individuals with physical disabilities
Socially Disadvantaged
Economically Disadvantaged
Individuals with mental disabilities or congitive impairments
Terminally ill or very sick
Pregnant Women-Subpart B & All Women
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
Prisoners & Minimal Risk Research
Probability and magnitude of harm (physical or psychologically) normal to daily lives or medical, dental, or psychocolgical exam of healthy people, so not allowed
Prisoners Subpart C
- 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
Research for Pregnant Women & Fetuses
Neonates
-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
What do you call persons who have not attained legal age for consent to treatment or procedures involved in clinical investigations?
Children
What is a child’s affirmative agreement to participate in a clinical investigation?
Assent
When can wards participate in a study?
- Research is related to ward status
- Conducted in an environment wher majority of children are not wards
- Advocate has best interest of child during research
- Advocate must not be associated with guardian organization, clinical investigation, or the investigator
When is a short form ICF needed?
For subjects whose first language is not English/they can’t understand written or spoken English to a degree that they could make an informed consent OR the subject or subject’s LAR cannot read (ICH E6 guidelines don’t allow for this, but FDA 21 CFR 50 does)
