Is participating safe?

Safety protections are in place to make sure studies are safe. However, even with these protections, not every study is safe for every person. You can talk with a staff member about the study’s risks and benefits and then make a decision about participating.

Many studies will not ask you to change your current treatment plan. But, if you’re thinking about being in a study that includes any possible changes to your treatment plan, talk with your health care provider(s) before making a decision to participate.

Would you like to learn more about specific safety features in mental health research? Visit the following pages:

 


Participating is Up to You.

Taking part in research is voluntary, which means that participants choose whether or not to be in a study. It also means that at any time during a study – even if you’ve already signed up or done some activities – you can change your mind and stop participating.

Watch this video from a participant about how research participation is up to you.

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Oversight

Researchers at universities must have their projects approved by an Institutional Review Board, or IRB. This group of scientists and community members watches over all parts of studies, including:

  • What participants will do in the study
  • Who is working on the study and what their training is
  • How the study will recruit participants
  • How the staff will protect privacy
  • How information from the study (data) is stored and used

Researchers also must follow policies and safety regulations from:

  • the federal government
  • their university or health center
  • professional ethics codes

Watch this video of a member of the UM IRB about what they do.

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Inclusion and Exclusion Criteria

Each study has a set of rules for who can participate. These are called inclusion criteria and exclusion criteria. They make sure that only people who are most likely to be safe during a study’s activities participate in the project. They also make the science more accurate by making sure that findings are truly related to what the researchers are studying (like genes or a treatment), and not just differences between study participants.

This might mean that only people that are a certain age or have certain symptoms can enroll in a study. Some people are disappointed to find out that a study isn’t a good fit, but it doesn’t mean the study team didn’t want their help. If one study isn’t a good fit for you, there could be many others that are.

Watch this video about inclusion and exclusion criteria.

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Informed Consent

Before signing up for a study, all participants get information about the study’s goal, activities, risks, and benefits. This information is part of a process called informed consent.

Informed consent means researchers must share information you would need to make an informed choice about being in a study. It also means that during the study, the staff must tell you if they learn something that could affect your decision to stay in the study.

A member of the research staff will discuss important information about the study with you. Most studies provide a copy of this information in writing. If you understand the information, have asked any questions you have, and want to enroll in the study, you will then give your consent to be in the study by signing an informed consent form.

For some studies, like online or telephone surveys, you might give consent in another way – like clicking on a website button or verbally agreeing to participate.

Even if you’ve signed an informed consent form, or given consent another way, you can change your mind at any time and stop participating in the study if you wish.

Watch this video about the informed consent process.

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Protecting your Privacy

Researchers take privacy very seriously. All research centers take steps to protect confidentiality, or privacy about participants’ personal information.

For example, if a study collects information on paper, the papers will be kept in a locked laboratory and locked file cabinets. Electronic records are protected with passwords and other measures to follow federal laws about privacy. Information collected during a study is often de-identified, which means the participant’s name and other identifying information are separated from the data. That way, scientists can use the information to answer research questions, but they and anyone they work with would not know whose study information they were using.

Watch this video about how privacy is protected during research.

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