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Specific Questions about Participating in Research

The best time to ask questions is before you decide to participate in research. However, you can ask any questions at any time.
Here are some possible questions:

  1. What kind of information do I need to decide if I want to participate?
  2. What is the purpose of the research study?
  3. Who is doing the research study?
  4. Who is paying for the research study?
  5. Who can answer questions about the research study?
  6. Why am I being invited to join the research study?
  7. If invited, do I have to join the research study?
  8. What am I being asked to do?
  9. What are the risks of participating in the research study?
  10. Are there any benefits to taking part in the research study?
  11. Will I be paid for participating in the research study?
  12. Will I have any expenses if I participate in the research study?
  13. What will happen to the information I provide during the research study?
  14. If I decide to participate, can I change my mind?
  15. Will I be told the results of the research study?

1. What kind of information do I need to decide if I want to participate?

It is important to get information about a research study before deciding whether to participate. The following questions may help you better understand important facts about the research study. They may help you decide if the research is of interest to you. Answers to the questions may help you understand the impact the research may have on you. It may help you decide if you feel comfortable taking part in the research.

TCPS 2 requires researchers to give you enough information to help you decide whether or not you want to take part in a research study. Researchers have a duty to answer your questions. Researchers should answer your questions in a way that you can understand.

You may have questions in addition to those listed below that are important to you personally. Any question you have is important. Ask it!

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TCPS 2 requires researchers to provide the information that individuals need to make an informed decision about taking part in research. Researchers must provide the information, and respond to the individuals’ questions before and during the research.

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2. What is the purpose of the research study?

Each research study is designed to answer a research question. You may be interested to know:

  • Why the researchers are doing the research study.
  • What the researchers are trying to learn from the research study.
  • If the specific research study or part of it is of interest to you.

3. Who is doing the research study?

You might want to ask:

  • Who is leading the research study?
  • What are the researchers’ professional qualifications, and if these qualifications are relevant to the research being studied?
  • Do the researchers and their team have experience with this type of research?
  • Who in the research team will be your contact if you have any questions?

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TCPS 2 requires Research Ethics Boards to pay close attention to situations of possible conflicts of interest. Conflicts of interest can occur when the authority and relationship of researchers to individuals can make them feel intimidated or pressured to take part in research. Examples include an employer and employees, a teacher and students, a correctional officer and prisoners. It can include researchers who are also health care providers and their patients.

Researchers must manage any conflicts of interest.

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4. Who is paying for the research study?

Knowing the source of funding for the research might interest you. Some research studies are funded publicly, for example by a government or a not-for-profit organization. Others are funded by private companies. Not all research is funded by an outside source.

  • Ask who pays for the research.
  • Once you know the source of funding, do you still feel comfortable participating in the research study?

5. Who can answer questions about the research study?

Find out who is responsible for answering your questions. Researchers and their teams can provide details about the research study. If you have questions, complaints or concerns about a study, you can contact the Research Ethics Board (REB) that approved the study.

Ask for the name and contact information of:

  • the lead researcher,
  • others on the research team who can be available to answer your questions
  • the organization (university, college, hospital, or another group) responsible for the research
  • the REB or others who approved the research.

6. Why am I being invited to join the research study?

Find out why the researcher invited you to join the research study. This will help you decide whether you want to participate. You may also want to ask the researcher why the study focuses on certain types of people and not others.

7. If invited, do I have to join the research study?

Only you can decide to join a research study. No one should pressure you to participate in a research study. For example, a doctor must not pressure a patient to join a research study. A teacher must not require a student to participate in research. Organizations must not require you to take part in research as a condition of accessing their services.

  • Consider how you feel about joining the research study.
    • If you feel pressured or uncomfortable, you may ask for more information or choose not to participate in the research study.
    • If you feel excited or curious about it, you may seek more information or ask other questions.
  • Consider whether you want to join the research study.

If you are already in a research study, remember that you can ask these and other questions at any time. You may also choose to leave the study at any time.

8. What am I being asked to do?

Ask what the researchers expect you to do if you decide to take part in research. For example, researchers may ask you to answer questions or give blood samples. They may ask you to do special tasks, or to participate through other activities.

Researchers rely on participants to be open, honest, and provide accurate information. Researchers expect that participants follow through with what they are being asked to do. This could be as simple as, for example, being at the research site on time. Participants should understand what is expected of them.

It may be useful to ask:

  • How long will I be in the research study?
  • How much time will I have to spend at each session of the study?
  • Where will the research take place?
  • Do I have to travel to go to the research site?

Consider:

  • Will I be able to participate in the research study for the expected length of time?
  • What impact will my participation have on me?
  • Will I be giving up other options that I value?

9. What are the risks of participating in the research study?

All research involves some level of risk. Not all risks are known. Some studies pose little risk to participants. If you respond to a survey about your colour preference, for example, the study is minimal risk. When research presents the same types of risk you face in your everyday life, it is considered to be minimal risk.

Some research studies may pose more than minimal risk. For example, being asked about sensitive topics, such as sexual history, can trigger bad memories or cause distress. Research studies that seek to determine the safe dose for a new drug might put you at a higher risk – if, for example, the new drug results has unexpected side effects for you.

TCPS 2 requires researchers to inform you of any expected risks of participating in the research study. Researchers should also explain if and how risks can be reduced or managed.

Consider:

  • Do I fully understand the risks of the research study?
  • Do I accept the risks as explained to me?
  • What does the researcher offer to protect me from risks?
  • Will there be any help if I am harmed?

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In TCPS 2, the core principle of Concern for Welfare makes researchers and Research Ethics Boards responsible for avoiding unnecessary risks. They must balance research risks with its potential benefits.

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10. Are there any benefits to taking part in the research study?

Benefits of research are possible, but not certain. As a participant, you can sometimes benefit directly or indirectly from taking part in research. A direct benefit can be, for example, an extra medical checkup. You may have an opportunity to use new computers or technology. You may have a chance to say what you think about policies.

In other research studies, there are no direct benefits to participants. However, the study could address matters you care about. For example, the study may shed new light on an important question. It may lead to a small improvement for a group of people that you want to help. These types of benefits are called “indirect benefits.”

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Did you know?

The core principle of Respect for Persons in TCPS 2 requires researchers to share important information about the research with individuals that they invite to take part in their research. To help the individuals decide whether they wish to participate in a particular research study, researchers must describe all known risks and potential benefits of the research.

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11. Will I be paid for participating in the research study?

Researchers try to encourage people to participate in research. They may offer you an incentive, such as money or a gift of some kind, to encourage you to participate. All incentives must be reasonable. Incentives should not be so large that they convince you to agree to take a risk you would usually refuse.

12. Will I have any expenses if I participate in the research study?

Sometimes there are costs involved in research participation. Common ones include the cost of your transportation to the research site (such as bus fare, gas, and parking). In some research, researchers may cover “out-of-pocket” expenses for participating in a research study. This includes, for example travel, lost income, child care or other expenses resulting from your participation in research.

13. What will happen to the information I provide during the research study?

You have a right to privacy regarding your personal information. This includes, for example, your medical records, application for services, or admission to universities. Similarly, information you provide when taking part in research must be kept private. Only individuals who carry out the research have the right to access this information.

Before you agree to participate in research, researchers must inform you what information they will keep private. Sometimes, research participants wish to be identified in the research. If there are exceptions to keeping your information private, researchers should inform you what information will be kept private and what will be made public.

There are limits to the extent to which researchers can keep your information private. Sometimes, by law, researchers must share certain types of information with appropriate government authorities if they discover it during their research. Examples include child abuse or a reportable infectious disease.

Ask:

  • Who can access the information that I provide to the research study?
  • Will the researcher report on my personal information? Will the researcher keep it on a public computer?
  • How will the researcher protect my personal information?
  • Will the researcher destroy information that could identify me at the end of the research study? If not, why not?

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Concern for participants’ welfare in TCPS 2 requires researchers to protect the privacy and confidentiality of participants.

Researchers have a duty to keep the personal information they collect from participants confidential.

Researchers have a general obligation to protect the personal information they collect from participants. Researchers must protect stored information. They must also protect the information when disposing of records and machines that keep participants' information.

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14. If I decide to participate, can I change my mind?

If you agree to participate, you can still leave the research study at any time. You can also ask that your data or human biological materials not be used in the research study. However, in some cases, the practical aspects of the research study may prevent you from removing your data. There may be other reasons that you decide to stay in the study. For example if some harm has occurred, remaining with the research study might facilitate treatment.

Ask:

  • How can I end my participation if I change my mind?
  • Can I withdraw my data or human biological materials from the research if I wish to do so?
  • Up to what point can the researcher remove my data or human biological materials from the research study?

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Did you know?

“Respect for Persons” in TCPS 2 means respect for a person’s right to make their own judgment about participating in research. This applies when they decide to take part in research. It also means that participants can change their mind about continuing to participate in research. Participants can do that by withdrawing their consent. Participants can also request to withdraw their data or human biological materials from the research if they decide to stop participating in a research study.

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15. Will I be told the results of the research study?

Normally, researchers present or publish the general results of their research study shortly after the study is completed. In some cases, researchers also provide participants with the results of the research that apply to them personally.

Before you agree to take part in a research study, the researchers should tell you how to access the general results of the research study. They should also tell you if you will be provided with information that applies to you personally. If you want to know the results, the researchers should make the results available to you in a way that you can understand. For example, they may provide the research results in a plain language report or summary.

Ask:

  • Will the researcher tell me the results of the research study?
  • If so what information will the researcher provide me?
  • In what form will the researcher share the results with me?
  • When will the researcher share the results with me?

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