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  1. What questions should I ask the clinical investigator or the study staff member before deciding to participate?

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    You should ask any question you believe will help you in the decision making process. Before meeting with the clinical investigator or study staff member, write your questions down, and feel free to take notes of the responses you are provided during the discussion. Some questions that you may want to ask include:

    • What is the purpose of the study?
    • What side effects may occur if I participate in the study?
    • Has anyone been injured during participation in this study?
    • Why does the clinical investigator or study staff member believe the study product may be effective or beneficial?
    • Will I get the product being studied, and if not, why?
    • How many people has the clinical investigator enrolled in this study?
    • How many people are enrolled in this study in the U.S.? In the world?
    • What tests, procedures, and medications are involved in this study?
    • What are the alternatives to participation in this study?
    • What are the possible downsides of participating in this study?
    • What costs will I be responsible for in connection with this study?
    • Will my insurance cover any costs associated with this study?
    • Will I be paid for participation in the study?
    • How long will I be in this study?
    • Whom should I contact if I experience a side effect or complication?
    • Whom should I contact if I have a question about the study?
    • Whom should I speak with if I decide to end my participation in the study?

    You should feel free to take the time you feel is necessary to decide whether to participate in a clinical research study. This may mean several discussions with the clinical investigator or study staff member. That is okay, because in the end, it is your decision whether or not to participate, and you need to feel comfortable with that decision.

  2. Will I have a chance to talk with the clinical investigator about the study before I sign the informed consent form?

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    Signing the informed consent document should not be the first or the only step in the informed consent process. The signing of the consent form should only occur when you believe you have the information you need to make an informed decision. Prior to providing your signature, the clinical investigator or study staff member should sit down with you to discuss the study in detail and give you an opportunity to ask any questions you may have. That discussion should include a review of the information contained in the informed consent form itself. You may be asked to take the informed consent form home with you so that you have an opportunity to think about participation in the research study or to talk the matter over with your loved ones or friends. You should consider including a relative or friend in your discussions with the clinical investigator or study staff member if you believe their inclusion will help you with the decision making process.

    The informed consent process extends throughout the study, well after the signing of the document. This means that you will be told about new information learned during the course of the study if it is decided that the information could have an impact on your decision to participate in the study. It also means that you can ask questions of the clinical investigator and study staff at any time during the study or after it is completed.

  3. What is an informed consent form?

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    The informed consent form is the document that participants must sign before participating in a clinical research study. The informed consent document should give specific information about the study that you are considering and should contain the following information:

    • The name of the clinical research study and its purpose
    • A statement that the study involves research
    • An idea of how long the study will last
    • A description of procedures that will be performed, and whether any of the procedures are investigational
    • A description of possible risks or discomforts associated with the study
    • A description of any benefits to you or to others, if any, that are reasonably expected
    • A description of possible alternatives, if any, to participation in the study that you should consider
    • A description of the level of confidentiality that will be applied to your private health information and who may have access to your records
    • A description of responsibility for costs or expenses associated with participation in the study, including study-related injuries
    • Contact information for questions concerning the study or a research-related injury (usually the clinical investigator), and questions concerning research participant rights (usually the IRB/REB)
    • A statement that participation in the study is voluntary and that a choice not to participate, or to discontinue participation, will not result in any loss of benefits or penalty to you

    Other information may be included in a study’s informed consent form if the clinical investigator, the sponsor, and/or the IRB/REB believes that the information is needed to better inform you and assist you in the decision-making process.

    The informed consent form will also have a signature line. When you or your legally authorized representative sign the informed consent form you have legally consented to participate in the study. You will be provided with a copy of the signed informed consent form for your personal records and as a reference tool throughout the study.

  4. What is a research ethics board (REB)?

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    A “research ethics board” (REB) performs the same function in Canada as an IRB does in the U.S. (see above). An REB is a group of individuals responsible for reviewing a study to make sure that the research participant’s rights and welfare are protected. Most clinical research studies cannot begin in Canada without REB approval. REB members generally include health care personnel such as doctors, nurses, and pharmacists. The REB also includes other members of the scientific community, non-scientists such as clergy or social workers, and community members. The REB carries out its responsibility to protect the rights and welfare of research subjects by reviewing the protocol to make sure that risks to participants are minimized, that risks are acceptable in light of the possible benefits, that the informed consent document is accurate and complete in describing the study and its risks and benefits, and that the clinical research study is conducted in an ethical manner. If the REB believes that these conditions have been met, it may approve the study and allow it to begin. Once the clinical research study begins, the REB is responsible for periodically reviewing the approved study to assure that the rights and welfare of research participants continue to be appropriately protected. Usually, the informed consent document will provide the research participant with a phone number to contact the clinical investigator or the REB if the participant has a question or concern about how the study is being conducted.

  5. What is an institutional review board (IRB)?

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    In the U.S., an institutional review board (“IRB”) is a group of individuals responsible for reviewing a study to make sure that the research participant’s rights and welfare are protected. Most clinical research studies cannot begin without IRB approval. The IRB members generally include health care personnel such as doctors, nurses, and pharmacists. The IRB also includes other members of the scientific community, non-scientists such as clergy or social workers, and community members.

    The IRB carries out its responsibility to protect the rights and welfare of research subjects by reviewing the protocol to make sure that risks to participants are minimized, that risks are acceptable in light of the possible benefits, that the informed consent document is accurate and complete in describing the study and its risks and benefits, and that the clinical research study is conducted in an ethical manner. If the IRB believes that these conditions have been met, it may approve the study and allow it to begin.

    Once the clinical research study begins, the IRB is responsible for periodically reviewing the approved study to assure that the rights and welfare of research participants continue to be appropriately protected. Usually, the informed consent document will provide the research participant with a phone number to contact the clinical investigator or the IRB if the participant has a question or concern about how the study is being conducted.

  6. Under what regulatory authorities does Quorum operate?

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    Quorum provides review services in accordance with the ICH Guidelines for Good Clinical Practice. For research to be conducted in the U.S., Quorum applies the requirements for institutional review boards found in the U.S. Food and Drug Administration regulations (21 CFR Part 56) and the U.S. Department of Health and Human Services regulations (21 CFR Parts 50 & 56). For research to be conducted within Canada, Quorum Review applies the requirements for research ethics boards found in the Canadian Food and Drug regulations (Part C, Division 5). Quorum conducts its review in accordance with the ethical principles outlined in the Belmont Report.

  7. Is it safe to participate in a clinical research study?

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    A clinical research study involving an investigational product is an experiment to test the safety and effectiveness of the product. As a result, there may be risks to your health if you decide to participate. The risks to your health will depend on the type of study and how much is already known about the product. The risks may be no more than an unpleasant side effect that goes away quickly, or they may lead to a life-threatening condition. The risk may be that the product is ineffective and does not help your condition. The clinical investigator or study staff member should talk to you about all the reasonably foreseeable risks of participating in the clinical research study.

    While it may not be possible to eliminate all risks associated with participation in a clinical research study, steps should be taken in all such studies to reduce possible risks. These steps should include the development of a study protocol that explains exactly how the clinical investigator is to conduct the clinical research study, and review and approval of the study by an institutional review board.

  8. Why should I participate in a clinical research study?

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    The reasons for deciding to participate in a clinical research study are very personal, but we can describe some of the reasons that have been identified by research participants. Some people participate in clinical research studies in order to add to the understanding of the product, which may help others in the future. Others want the opportunity to possibly receive investigational products that are only available in a clinical research study. Still others, in exploring all their medical options, view the opportunity to participate in a clinical research study as a way to play an active role in their health care.

  9. Who is involved in a research study?

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    People who volunteer to participate in a study may be called human subjects, research participants, or another term that identifies their role as volunteers in a clinical research study.

    The doctor or healthcare professional who conducts the clinical research study may be called a clinical investigator, principal investigator, or study doctor. It is important to remember that the role of a clinical investigator is very different from the role of the health care provider. While your health care provider is responsible for making health care decisions for you based upon your medical condition, a clinical investigator is conducting a research study and is responsible for carrying out the study as described in the study protocol or study plan. This means that while the clinical investigator is responsible for carrying out the study in a way that minimizes research participant risks and maximizes the study benefits, the clinical investigator is limited by the requirements of the study with regard to the treatment options that can be provided to you, the research participant. Therefore, if you volunteer to participate in a research study, it is important that you maintain contact with your primary health care provider (your regular doctor) and other specialists before, during, and after your participation in the study to make sure that you have the best information about your health care decisions and to make sure that other treatments or medications you are taking do not interfere with your ability to participate in the study.

    The people who assist the clinical investigator are part of the research team or study staff and generally include other doctors, nurses, study coordinators, and other healthcare professionals.

    Studies involving a product are generally paid for and supported by the company that developed the product. This company is called a sponsor. Some government agencies, such as the National Institutes of Health, also act as sponsors in funding clinical research.

    Finally, studies that involve human subjects generally must be conducted under the oversight of an institutional review board (IRB) or research ethics board (REB) to confirm that the health, safety and welfare of the participants are adequately protected. See below for more information about IRBs and REBs.

  10. What is a clinical research study?

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    A clinical research study is a study involving people that seeks to answer a specific scientific or health question. The study may involve the testing of an unproven drug, an investigational medical device, a diagnostic tool, a food or drink, or an existing therapy used in a new but untested way to see if the product is helpful in preventing, diagnosing, or treating a disease or condition. The study may involve an existing product used in a way that was previously found to be safe and effective in order to learn more about the product’s safety. Or the study may involve only the collection of health information in order to study a health issue in the general population.

  11. What if my health gets worse while I am participating in the study?

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    Please contact your study doctor at the phone number listed on the first page of your consent form. If this is an emergency situation, contact 911 and follow up with your study doctor as soon as possible. If you need to seek emergency treatment, take your informed consent document or other information about the study to the hospital, if it is practical.

  12. What if I change my mind about participating?

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    As a participant you have a right to decide not to participate or to withdraw at any time without penalty or loss of benefits to which you are entitled.

  13. How do I know if this research study is right for me?

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    Participating in research is a personal decision. You should read the consent form thoroughly and weigh the personal risks and benefits for participating in a research study. If you feel that you need assistance in making a decision, Quorum encourages potential study participants to talk to study staff, their personal doctor, family, friends and /or search the internet for information that might help you make a decision that is right for you.

  14. What are my rights as a research participant?

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    • To receive full information about the study as set forth in the signed informed consent form
    • To decide not to participate or to withdraw at any time without penalty or loss of benefits to which the research participant is entitled
    • To refuse or question study tests or procedures which are not mentioned in the consent form you signed
    • To withdraw from the study if new information becomes available about the study medication which makes you uncomfortable about participating
    • To receive payment for participation as indicated in the consent form you signed. If you believe the information is unclear, you may ask the study site for further information or decide not to participate
    • To receive reimbursement for or to receive at no cost study procedures/tests as indicated in the consent form you signed; if you believe the information is unclear, you may ask the study site for further information or decide not to participate
    • To receive treatment/reimbursement for treatment for adverse events as indicated in the consent form you signed; if you believe the information is unclear, you may ask the study site for further information or decide not to participate
    • To seek alternative treatment for your condition rather than participate in the study
    • To continue with your current treatment plan rather than participate in the study
    • To ask the study staff questions about the study, the results of your lab tests or other diagnostic procedures
    • To have your personal information kept as confidential as possible as detailed in the consent form you signed; if the information is unclear, you may ask the study site for further information or decide not to participate
    • To receive a copy of your signed consent form to take home with you
  15. How can I contact Quorum?

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    Quorum’s phone number appears in all clinical research study informed consent forms that it approves. If you have specific questions about the research study you are in, you may find an answer by reading the consent form for the study or by asking your clinical investigator or a study staff member. Quorum may be able to answer general questions about the study or your rights as a research participant.

    To contact Quorum, call 888-776-9115 (toll free) Monday through Friday, 8:00am-5:00pm Pacific Time and request to speak with a Research Participant Liaison. Please have your most recent consent form on hand when you call.