45 CFR Part 46 Flashcards
Which part of 45 CRF Part 46 is called “The Common Rule”?
Subpart A
What is Subpart A of 45 CFR Part 46 called?
The Common Rule
What is Subpart B of 45 CFR Part 46 about?
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
What is Subpart C of 45 CFR Part 46 about?
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
What is Subpart D of 45 CFR Part 46 about?
Additional Protections for Children Involved as Subjects in Research
What is Subpart E of 45 CFR Part 46 about?
Registration of Institutional Review Boards
What portion of 45 CFR 46 deals with protection of pregnant women, fetuses, and neonates?
Subpart B
What portion of 45 CFR 46 deals with protection of prisoners?
Subpart C
What portion of 45 CFR 46 deals with protection of children?
Subpart D
What portion of 45 CFR 46 deals with registration of IRBs?
Subpart E
Which part of 45 CFR 46 matches another CFR? And which CFR does it match?
45 CFR 46.111 matches 21 CFR 56.111
What are the 8 categories of research eligible for IRB exempt status?
- Research in educational settings w/normal educational practices that won’t adversely affect the students’ learning opportunity or assessment of the educators.
- Research w/educational tests, surveys, interviews, or observation of public behavior if 1 of 3 is met: information recorded is not easily identifiable, disclosure wouldn’t put subject at increased risk of liability or personal damage, or info is recorded in a way so that the human subject’s identity can be ascertained and the IRB can conduct a limited review. (This only applies to children if the investigator does not participate in the observed activities).
- Benign behavioral interventions in adults (verbal, written or audiovisual) and subject prospectively agrees. (And at least 1 of the 3 criteria listed in #2 above). Deceit is not allowed unless the subject agrees to ahead of time to being mislead about the nature or purpose of the research.
- Secondary research for which consent is not required. Uses identifiable private info or biospecimens if the info or biospecimens are publicly available or the information is recorded so the subject cannot be readily identified, the investigator doesn’t contact them, and they do not re-identify them.
- Research & projects conducted or supported by federal departments/ agencies for public benefit or service projects.
- Taste & food quality evaluation and consumer acceptance studies (wholesome food w/out additives or ingredients /contaminants at or below safe levels per FDA / EPA / Food Safety & Inspection Service.
- Storage or maintenance for secondary research or which broad consent is required.
- Secondary Research for which broad consent is required. (Broad consent was obtained, documentation of consent or waiver of documentation obtained, IRB conducts limited review and determined research meets scope of the broad consent, investigator does not return results to subjects).
What is the “point” of 45 CFR 46?
Protection of human subjects
What are 45 CFR 46.111 and 21 CFR 56.111 about?
Criteria for IRB approval of research
What are the three types of IRB review?
Exempt, Expedited, and Convened (Full Committee). “Limited review” is a subset of Exempt review.
Which types of Exempt research sometimes or always need Limited Review?
SOMETIMES need Limited Review:
Category 2 (Educational tests/surveys/interviews/observing public behavior)
Category 3 (Benign behavioral interventions in adults, collecting verbal/written/audiovisual responses)
ONLY IF the recorded information could readily be used to identify the subjects. Limited review must determine whether requirements of 46.111.7 (adequate privacy/confidentiality provisions) are met.
ALWAYS need Limited Review:
Category 7 (Storage of identifiable private info/biospecimens for secondary research for which broad consent IS required). Limited review must determine that broad consent is obtained/documented, and that any change in storage/maintenance protects privacy/confidentiality.
Category 8 (Secondary research with identifiable private info/biospecimens for which broad consent IS required). Limited review must determine whether requirements of 46.111.7 (adequate privacy/confidentiality provisions) are met.
Which types of Exempt research do NOT need Limited Review?
Category 1: Research in educational setting with normal educational practices that aren’t likely to adversely impact students’ ability to learn or assessment of educators
Category 4: Secondary research for which consent isn’t required.
Category 5: Research by a Federal department to examine public services.
Category 6: Taste/food quality evaluation and consumer acceptance studies
What are the types of secondary research for which consent isn’t required?
Category 4:
1) identifiable info is publicly available
2) info isn’t readily identifiable and won’t be re-identified
3) info for health care operations/public health activities/purposes
4) research done by/for a Federal department using government created/collected info that was obtained for non-research purposes.
What are the potential outcomes of an IRB vote?
1) Approve
2) Require modifications (modifications may require review by one IRB member for approval or require another review by the convened IRB)
3) Disapproved
4) Table or Defer - Used for example if they run out of time or lose a quorum. This is not a required option per the CFR but included by many IRBs
Groups susceptible to coercion or undue influence
Children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantages persons
Nine elements of informed consent (per 45 CFR 46)
1) Statement that the study involves research
2) Description of foreseeable risks or discomforts
3) Description of expected benefits
4) Disclosure of appropriate alternatives that may be advantageous
5) Description of the extent confidentiality will be maintained
6) If more than minimal risk - Explanation of any compensation and access to medical treatments for injuries
7) Whom to contact with questions about the research, subject rights, and in the event of injury
8) Statement that research is voluntary, no loss of benefits for not participating, & can end at any time
9) Statement about how biospecimens will be identified and if they will be distributed or used for future research
Additional elements of consent to include if relevant
1) Statement that there may be unforeseeable risks
2) Circumstances under which participation may be terminated
3) Approximate # of subjects in the study
4) Statement that biospecimens may be used for commercial profit and the subject will or will not share in the profit
5) Consequences for withdrawal
6) Any additional costs for participating
7) Statement that significant new findings that may relate to willingness to participate will be provided
8) Statement regarding whether clinically relevant research results will be disclosed to the subject (and when)
9) If there are biospecimens, whether the research will or might include whole genome sequencing
When can broad consent be used?
For the storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens
Elements of broad consent
- Risks
- Benefits
- Confidentiality
- Voluntary participation
- Commercial profit
- Whole genome sequencing
- Broad description of the types of research that may be conducted
- Description of information or biospecimens to be used
- Length of maintenance/storage/use
- Details provided re: subsequent research?
- Clinically relevant results disclosed?
- Contact information
