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General Questions about Participating in Research

  1. Why do people participate in research?
  2. What does participation in research mean?
  3. How do researchers identify who they need to participate in their research?
  4. Who can take part in a research study?
  5. How do researchers ask people to join a research study?
  6. What does consent mean?
  7. Who decides if a person should agree to participate in a research study?
  8. What is a Research Ethics Board?

1. Why do people participate in research?

There may be more than one reason why people decide to volunteer to participate in research. Some people decide to participate in research because they want to help others. Some may want to learn more about the topic of a research study. Others believe they may get some personal benefit from the research study. There may be other reasons.

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  • People want to help others
    Some research can lead for example to better health care or better laws. Other research can help to explain how human bodies and minds work. Some research studies may lead to important discoveries. Some studies result in new knowledge even if they do not have the expected result.
  • People may take part in research to learn more about the topic of the research study
    Some research may be about topics that are important to them. It may be important for their families or their communities. Being in a research study might help them better understand these topics.
  • People who take part in research believe they may get some personal benefits from the research study
    In some research studies, participants might benefit directly. They might get an extra medical checkup. They might have an opportunity to use new computers. They might have a chance to say what they think about policies. In other studies, the participants might not benefit directly, but other people they care about may benefit.

2. What does participation in research mean?

Participation in research means agreeing to share information with researchers. This information may help researchers answer their research questions or meet their research goals.

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The answers to research questions can only come from information provided by research participants. The way participants provide that information will depend on the type of research study and the specific research questions. For example, researchers might ask participants to answer questions in writing or in an interview. Researchers might wish to measure the effect of a physical activity on participants’ condition. They may ask participants to donate a blood sample or some tissue for analysis. There are many ways to participate in research.

Participating in research is a choice. People who agree to participate in research can still change their minds.

Did you know?

Participants in research are sometimes referred to as “subjects.” TCPS 2 prefers “participants” because of the active role that participants play in research.

Find it in TCPS 2

3. How do researchers identify who they need to participate in their research?

In planning their research study, researchers decide which people or groups of people they will need. Information from these groups of people should help researchers answer their research questions or meet their research goals. Researchers also decide how many people they need. Researchers often need a certain number of people to take part in their research in order to be sure of its results.

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Depending on their research question, researchers will invite certain types of people to participate. For example, the focus of the research study may be on people with a specific kind of arthritis. It may focus on people who belong to a certain cultural group or occupation. It may focus on children of a certain age, for example children who are three to eight years old with a certain condition.

To make sure they can trust the results of their research, researchers will continue to invite people until they have enough individuals who can answer their research questions or meet their research goals.

Did you know?

Based on the principle of “Justice” in TCPS 2, researchers must not exclude individuals from their research because of their culture, age, gender or other reasons unrelated to the research question or goals. If the researcher plans to exclude some people and include others in a research study, the researcher must explain to the Research Ethics Board (REB) why that is necessary. For example, if a researcher only wanted to conduct research on men, the researcher would have to justify why excluding women from the study is necessary. The REB must be satisfied with the explanation.

Find it in TCPS

4. Who can take part in a research study?

Anyone can accept an invitation to participate in research. Researchers invite people who have information needed to answer their research questions or meet their research goals.

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Human research may focus on anyone, at any age, in any circumstance. It may focus on men or women, children or adults. It may involve people who are healthy or those with an illness or a particular condition. It may look at people from different cultures, or people who are poor or wealthy. People become participants when researchers use their information, stories, or human biological materials to answer a research question or meet a research goal. Individuals whose circumstances might make them vulnerable can participate in research.

Did you know?

TCPS 2 has requirements for what to do when research includes individuals who are not fully capable of making their own decisions on whether to participate in a research study. Some people might not understand the research, its risks and benefits or consequences of their participation. Those individuals can participate only if:

  • they agree to participate in research (also called assent), and
  • someone authorized to make their decisions agrees to their participation (also called consent). Usually an authorized person is a family member, caregiver or legal guardian.

Find it in TCPS

5. How do researchers ask people to join a research study?

Researchers can use one or many ways to ask people to take part in their research study. Researchers may advertise their study. They may invite people directly. Researchers may ask other people to help them find possible participants.

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Researchers may advertise their study in posters, newspapers, and websites or in other ways. These advertisements may be on social media, in doctors' waiting rooms, hospitals, community centres, universities, or other places. Participating in research is an individual’s choice no matter what other people think or say.

6. What does consent mean?

To consent means to agree. Ethical research requires that consent be informed, voluntary and ongoing. Informed means that people can only consent (agree) to take part in a study if they understand the research study and what researchers are asking them to do. It also means that people understand the risks and potential benefits of participating in research.

Voluntary consent means that people agree to participate without any type of pressure. Consent must also be ongoing as the research continues. People can consent to participate in research at the beginning, but they can change their mind. If they change their mind and no longer wish to participate in the research, they may stop. They don’t have to give any reason as to why they changed their mind.

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Informed consent is the ethical foundation for research. The informed consent process involves the researcher providing people with information about the research study. It is important that people have all the information needed to decide whether they wish to take part in research, so researchers should respond to people’s questions.

People who choose to participate may indicate their decision by signing a written consent form. For some types of research and for some groups, verbal consent or a handshake may be more appropriate.

Researchers must provide people information about the study before the study begins. They must provide participants information as the study continues. This includes giving participants new and relevant information. For example, if the researchers become aware of new risks to participants, they must tell the participants about those risks.

Consent also means that a person’s decision to participate is voluntary. People may agree or refuse to participate. If they agree, they may change their mind later, for any reason. They should not agree to participate because they feel pressured by the researcher. So, for example, they should not feel they have to say yes just because their teacher or their doctor asks them to participate in a study. Researchers may offer individuals something (like money for example) to encourage them to take part in research. Such offers should not be the reason that they choose to participate in research.

Did you know?

The TCPS 2 core principle of Respect for Persons requires researchers to follow a consent process that is informed, voluntary, and ongoing:

  • Informed consent means giving individuals who are considering whether to participate in a research study all known information they need to make this decision.
  • Voluntary (free) consent means that individuals are free to choose to take part in a research study. They should make this choice without coercion or undue inducement. They are also free to refuse to participate.
  • Ongoing consent means that the participant consent process must be followed throughout the life of the research study.

Find it in TCPS

7. Who decides if a person should agree to participate in a research study?

Only the people invited to take part in a research study can decide if the study is right for them. Individuals considering participating in research might find it useful to get advice from people they trust (such as, family members, friends, experts or professionals).

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If researchers want to include certain individuals in a research study, they will invite those individuals. If those individuals are satisfied that all questions that matter to them have been answered, they can agree to take part in the study. Only the individuals themselves can make the final decision to join or continue to participate in research.

Researchers may involve individuals who are not fully capable of making their own decisions but agree to take part in research. To do so, researchers must involve an authorized person to make the decision on the individuals' behalf.

8. What is a Research Ethics Board?

A Research Ethics Board (REB) is a group of people responsible for deciding if research involving humans is ethical. An REB makes independent decisions. It ensures that the research study respects and protects the welfare of research participants.

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A Research Ethics Board (REB) should include researchers, community members and people with knowledge of ethics and law. The role of the REB is to review proposals for research involving humans. An REB considers every ethical issue that the research raises. If the REB is satisfied that all ethical issues are appropriately dealt with, it approves the research. The REB may also request that the researchers change the research study design in some way to minimize risks to the participants.

In Canada, most REBs follow the ethics policy document of the three federal research agencies. It is called the second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans or "TCPS 2."

Did you know?

According to TCPS 2, the Research Ethics Board (REB) must approve the research before the researchers start collecting data from participants. The REBs and the researchers remain responsible for the ethics of the research study until the study is complete. The REBs and researchers must also follow additional requirements their institutions may have.

Find it in TCPS 2

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