45 CFR 46 Flashcards
What is 45 CFR 46 based on?
The Belmont Report
What does 45 CFR 46 offer?
The regulations were written to offer basic protections to human subjects involved in both biomedical and behavioral research conducted or supported by HHS. (health and human services)
What does 45 CFR 46 subpart B cover?
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
What does 45 CFR 46 subpart C cover?
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
What does 45 CFR 46 subpart D cover?
Additional Protections for Children Involved as Subjects in Research
What does 45 CFR subpart E cover?
Registration of Institutional Review Boards
What is 45 CFR 46 Subpart A often referred to as?
The Common Rule- Basic HHS policy for protection of Human Research Subjects
What does 45 CFR 46 NOT deem to be research?
-scholarly and journalistic activities
-public health surveillance activities
-collection/analysis for criminal justice
-authorized operational activities (homeland security)
What research is exempt under 45 CFR Part 46 Subpart A?
-educational activities not likely to affect regular learning
-educational tests, survey procedures, interview procedures, or
observation of public behavior
-benign behavioral interventions
-secondary research for which consent is not required
-research for public benefit or service programs
-taste and food evaluation
-anonymous surveys
When can research be expedited?
-Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk
-Minor changes in previously approved research during the period for which approval is authorized.
What is the IRB Composition in reviewing research involving prisoners?
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.
How can risks to subjects be minimized?
-By using procedures consistent with sound research design that do not unnecessarily expose subjects to risk
-When possible, use procedures already being done on subjects for treatment/diagnostics
What is the IRB’s criteria for approval of research?
1) Risks to subjects be minimized
2) Reasonable risk to benefits
3) Equitable selection of subjects
4) Informed consent will be sought
5) Informed consent will be properly documented
6) Data should be monitored for subject safety
7) Privacy and confidentiality should be ensured
When can the IRB suspend or terminate research?
When it is not being conducted in accordance to IRB policy or if it associated with serious and unexpected harm to subjects.
Who is responsible for rights and welfare of subjects in cooperate research?
Each institution
How many IRBs for cooperative research?
One (unless some is conducted outside of US)
How long should an IRB keep documentation of its activities?
3 years
Basic elements of informed consent
-statement that study involves research
-description of risks and discomforts
-description of benefits to subject or others
-disclosure of alternative procedures or courses of treatment
-extent of confidentiality
-explanation of compensation and medical treatments in case of injury (if more than minimal risk)
-contact info
-statement that participation is voluntary
-if biospecimens will be redistributed
Elements of broad consent for the storage, maintenance,
and secondary research use of identifiable private information or
identifiable biospecimens
-description of risks and benefits
-extent of confidentiality
-statement that participation is voluntary
-if biospecimens might be used for commercial profit
-if research might include whole genome sequencing
-types of research that might be conducted with identifiable info
-what identifiable info might be used
-period of time biospecimens might be kept
-statement that they will not know what kind of studies biospecimens will be used for
-statement that results may not be disclosed
-contact info
Where does the consent form need to be posted per the HHS?
A publicly available federal website for clinical trials.
Is posting of the consent form required by FDA regulation?
No
Is posting of the consent form required by ICH E6?
No
Is posting of the consent form required by the HHS?
Yes, at a publicly available federal website for clinical trials.
