Regulation of Biomedical Research on Humans - April 22 & 24 Flashcards
(12 cards)
What is the Common Rule? (Q)
The Federal Policy for the Protection of Human Subjects.
What does the Common Rule govern? (Q)
The Common Rule governs research that meets two requirements. Specifically, the Common Rule governs any research that (1) involves human subjects and (2) receives funding from a federal agency that has adopted the Common Rule.
When does research involve a human subject? (Q)
In this context, research involves a human subject if the researcher obtains, uses, or studies information or an identifiable biospecimen from a living person, regardless of whether the researcher gets that information or specimen directly from the person or through a secondary source. See 45 C.F.R. § 46.102.
Has the FDA adopted the Common Rule? (Q)
The Food and Drug Administration, or FDA, hasn’t adopted the Common Rule and uses its own research standards instead. If research is jointly funded by the FDA and another federal agency, the research must comply with whichever agency’s standards are stricter.
What are the Common Rules requirements? (Q)
For starters, all proposed research that’s subject to the Common Rule must be evaluated by an institutional review board, or IRB.
What is an institutional review board (IRB)? (Q)
This board approves the proposed research only if it meets the specific requirements.
What are some examples of the specific requirements IRBs go over? (Q)
Examples of these requirements include:
Minimizing risks to the human subjects,
Having a plan to monitor research data to ensure the human subjects’ ongoing safety, and
Getting the subjects’ informed consent.
See 45 C.F.R. § 46.111.
For the purposes of using human test subjects during research, what is informed consent? (Q)
For consent to be informed, the researchers must explain certain information to the subject in an understandable manner. This required information includes items like:
The research’s purpose, which parts of the research are experimental, whether a subject’s biospecimens will be used for commercial profit, and the reasonably foreseeable risks to the subject.
What happens if biospecimens might be used for the commercial profit? (Q)
If biospecimens might be used for commercial profit, the subjects are also entitled to know whether they will share in that profit.
What happens if foreseeable risks change during the study? (Q)
If the foreseeable risks change during the study, the subjects must be notified of the change for their consent to remain adequately informed.
Can human subjects take actions for research violations? (Q)
Most courts have held that human subjects can’t sue directly for violations of the Common Rule. However, in some cases, the informed-consent agreement may create a special relationship that can give rise to negligence liability.
If the same person is acting as both a healthcare provider and a scientific researcher, how can the two roles’ conflicting obligations can lead to breaches of either role’s duties? (Q)
If a breach happens, a patient-subject might have state-law claims, such as negligence, lack of informed consent, or breach of contract.
