How is My Safety and Privacy Protected?
Research participants’ privacy is protected through a combination of ethical guidelines, informed consent, and data protection measures. Researchers must follow protocols to anonymize or de-identify data, ensuring that participants’ personal information cannot be traced back to them. Institutional Review Boards (IRBs) also play a critical role in reviewing and approving studies to ensure compliance with ethical standards. Data is often stored securely, and access is restricted to authorized personnel only. For more detailed information, you can refer to resources like NIH’s guidelines on privacy and confidentiality and the Office for Human Research Protections (OHRP).
What is the consent form?
The consent form is another written document that is carefully checked by the IRB. They make sure the consent form matches the written research plan.
The consent form must tell people everything they will be asked to do in the study. The consent form must also state what the risks may be. The IRB makes sure people know their rights when taking part in a research study.
Participating in a research study is fully voluntary and should not negatively affect someone's level of care; however, participating in reasearch does provide access to products that are still being studied. Clinicians don't have permission to use unapproved products outside of a clinical trial.
Being in a research study is your choice. It must be something you want to do without pressure from other people.
Institutional Review Board (IRB)
What does an IRB do?
Research with people is guided by three golden rules. These golden rules are to treat people with dignity and respect, to do good, and to be fair.
The IRB makes sure the possible risks and benefits of a research study have been carefully considered. This group also makes sure people are told about what they will be asked to do. It’s important to fully understand what the research is about and any risks that might be involved. This is called the “informed consent process.” Every research center or institution that asked people to be in research must work with an IRB. Each study must go through an approval process. The IRB must prove that the group meets all requirements for doing this kind of work.
What is the makeup of an IRB?
Each IRB must have at least 5 members. The members can be researchers, doctors, and people outside of the medical field. Each IRB should have at least one member from the local community.
Members of the IRB must complete training that teaches them about all federal research regulations and laws related to human research.
How does the IRB evaluate the safety of a research study?
IRB members look at a detailed written plan of every research study. The research plan gives details about the research. This plan tells why the research is important. The plan also states what participants will be asked to do. This plan is called a protocol.
The IRB makes sure the research plan meets all regulations and laws. The IRB also checks to see that everyone on the research team has the required training to do research with people.
The possible risks that people may face in a study are looked at very closely. IRB members review the study plan to determine if the risks are acceptable. They make sure that researchers have taken adequate steps to protect participants. They also make sure researchers reduce any risks as much as possible. This includes protecting people’s confidentiality during and after the research study.