What questions might an IRB ask?

What questions might an IRB ask?

Why has the person been asked to participate in the study? How many people do you anticipate will be study subjects? How are you selecting them? How will you recruit them?

What are IRB concerns?

Such issues include informed consent for research with vulnerable populations, including those who may lack decision-making capacity; potential risks of studies that involve medication withdrawal; the use of placebo-controlled trials; and the privacy and confidentiality of sensitive research data.

What do research proposals tell IRBs?

The IRB reviews the proposals before a project is submitted to a funding agency to determine if the research project follows the ethical principles and federal regulations for the protection of human subjects. The IRB has the authority to approve, disapprove or require modifications of these projects.

Can you publish without IRB approval?

Please note, IRB approval cannot be granted retroactively, so research conducted for a classroom assignment without IRB approval can never be used as the basis for a publication. If there is a possibility that it might be used for a future publication, it is advisable to seek IRB approval.

How does IRB handle ethical cases?

When reviewing research IRBs are guided by three ethical principles that are fundamental to human subject protection – respect for persons, beneficence, and justice. The population of research subjects should be similar to those who may benefit from the outcome of the research.

How does IRB handle ethical issues?

The purpose of the IRB is to ensure that the investigator complies with the protocol and to demonstrate that the trial is necessary and that the risk-benefit ratio is acceptable by reviewing key trial documents to ensure that the subjects’ rights and well-being are protected.

What brought increased attention to IRB?

Which of the following brought increased public attention to the problems with the IRB system? Death of Jesse Gelsinger (Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.)

Can a clinical investigator be a member of the IRB?

May a clinical investigator be an IRB member? Yes, however, the IRB regulations [21 CFR 56.107(e)] prohibit any member from participating in the IRB’s initial or continuing review of any study in which the member has a conflicting interest, except to provide information requested by the IRB.