Expedited IRB Review:
- Minimal or no risk
- Involve data, documents, specimens etc that have been collected for non-research purposes.
- Research in established or commonly accepted educational settings
- Use of educational tests where subjects cannot be IDed
- The use of texts and surveys if the subject is a public official under FOIA.
- Collecting or studying existing data that is redacted or available under FOIA.
- Federal research for public benefit or social programs
- Taste and food quality
- Each IRB needs 5 members.
- They must have at least 1 science and 1 non-science member
- Consideration is made race, gender, cultural background and sensitivity to the subject matter.
- Try to get an equal number of males and females, but it’s not a requirement.
- At least one IRB member must be non-affiliated with the intuition
- No IRB member may have a conflict of interest.
Common Rule – informed consent
- Additional protections for pregnant women, human fetuses, and neonates; additional protections for prisoners; and additional protections for children
- Children under 18 need to have their parents’ permission in order to participate in research. In addition, they must themselves be asked to agree (“assent”) to participate.
- Situations may arise where a grandparent or other relative is raising the child and has physical custody but, may not be the child’s court-established legal guardian. Therefore, a copy of the court order naming her or him as the child’s legal guardian with the ability to consent for the child’s medical care must be provided to the study team and filed with the consent form.
- In determining whether children are capable of assenting, the IRB must take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Usually, the age of assent is 7, but some institutions may have higher or lower age limits.
- Permitted research on prisoners:
- A study on criminal behavior that has minimal risk and inconvenience
- A study of prisons as an institution or prisoners as incarcerated people that have minimal risk and inconvenience
- Research on topics that particularly affect prisoners as a class
- Research on practices, innovative and accepted, that have the intent and reasonable probability of improving the health or well-being of the subject.
- Pregnant Women:
- For research that holds out the prospect of direct benefit to the pregnant woman, the prospect of direct benefit both to the pregnant woman and fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is to provide important biomedical knowledge that cannot be obtained by other means, consent of the pregnant woman must be obtained
- If research has the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and father is obtained. The father’s consent need not be obtained if he is unavailable, incompetent, or the pregnancy resulted from rape or incest.