How are participants protected in research?

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June 25, 2020

Research to find ways to prevent and treat COVID-19 (the new coronavirus) can’t be done without the people who volunteer to participate. Making sure research is safe for the people who take part is a top priority for researchers.

All research with humans must be approved before it starts. The group that reviews human research is called the Institutional Review Board (IRB).

What does an IRB do?

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 organization that asked people to be in research must work with an IRB. Each IRB 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 make-up 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.

Research studies must include diverse groups of people. The IRB checks to make sure there is a plan to include women, children, and racially and ethnically diverse minority groups in the research.

The IRB itself must be sensitive to the interests and needs of diverse communities. It’s important that IRB members are diverse in terms of race, ethnicity, gender, and cultural backgrounds.

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 discuss the study plan to decide if 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.

What else does the IRB look for?

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.

Signing a consent form is only one step in the process of giving informed consent. Being in a research study is your choice. It must be something you want to do without pressure from other people.

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. Even in the face of the fast pace of research to beat COVID-19, IRBs will still make sure people are safe and all the rules of research are followed.

The official name of the virus that started a worldwide outbreak in late 2019 is “Severe Acute Respiratory Syndrome Coronavirus 2.”  The abbreviation is SARS-CoV-2.  When the virus infects someone, the diagnosis is called  “Coronavirus Disease 2019.”  The abbreviation is COVID-19.  In COVID-19, ‘CO’ stands for ‘corona,’ ‘VI’ for ‘virus,’ and ‘D’ for disease.

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