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Frequently Asked Questions


What is a clinical trial?


Who are investigators?


Who sponsors clinical trials?


How do I decide whether to participate in a clinical trial?


How are my rights and safety protected?


What are the investigators responsibilities during the conduct of an approved research study?


Do investigators have to obtain Institutional Review Board (IRB) approval before involving human subjects in research?


Where should I go for more frequently asked questions?


What is a clinical trial?

Clinical trials are research studies involving human volunteers that test how well new medical approaches work in people. Each study answers specific scientific questions. Carefully conducted clinical trials are the safest and fastest way to find better ways to prevent, screen for, diagnose, or treat a disease.


Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol. (Definitions of Common Research Language)


Clinical trails have several purposes:

  • Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
  • Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
  • Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
  • Screening trials test the best way to detect certain diseases or health conditions.
  • Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

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Who are investigators?

Persons who are involved in conducting human subject research studies.  Physicians, nurses, scientists, administrative staff, teachers, and students.  Specifically: any person involved in:

  • Studying, interpreting, or analyzing identifiable private information for research purposes
  • Obtaining voluntary informed consent
  • Obtaining identifiable private information

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Who sponsors clinical trials?

Clinical trials are sponsored by a number of different organizations or individuals, such as physicians, medical institutions, foundations, voluntary groups, pharmaceutical companies, and federal, state or local government agencies.


Sponsors typically fund only some of the costs of a clinical trial. Remaining costs may not be covered by a participant's health insurance or managed care provider. What costs are covered varies by health plan and study. Health plans may not cover trials that they consider "experimental" or "investigational." They may also require that the treatment focus on types conditions for which no standard treatments are available, be judged "medically necessary" by the health plan, or not significantly more expensive than treatments the health plan considers standard.

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How do I decide whether to participate in a clinical trial?

Choosing to participate in a clinical trial is an important decision. Before participating, you should find out as much as possible about the clinical trial-, and make sure you understand what happens during the trial, the type of health care you will receive, and any costs to you. Feel free to talk to the research team about any questions or concerns you may have. Talking to your doctor, family members, or friends can also help you decide whether to join a trial. (Download "Questions To Ask Your Doctor" pdf


Each clinical trial is unique. Before you decide to take part in a clinical trial, consider the following questions:

About the Study

  • What is the purpose of the study?
  • Who is sponsoring the study?
  • How long will the study last?

Possible Risks and Benefits

  • What are the possible short-term and long-term benefits?
  • What are the short-term and long-term risks?
  • What are my other options? What are their advantages and disadvantages?

Participation and Care

  • What kinds of treatment, medical tests, or procedures will I have during the study and how often will I receive them? Are there any side effects?
  • Who will be in charge of my care? Will I still see my own doctor?
  • Will I be able to take my regular medications while in the clinical trial?
  • How long will I need to stay in the study? Will there be follow-up visits after the study?
  • How could being in the study affect my daily life?
  • If the treatment is working for me, can I choose to continue getting it even after the study ends?
  • Will I be able to find out about the results of the study?
  • If I am harmed as a result of the research, what treatment will I be entitled to?

Cost Issues

  • Will I have any costs for any treatment, tests, or other charges? If so, what will the approximate charges be?
  • Will any of the treatment be free?
  • Will my insurance cover any of the costs?

If You Want to Leave the Study Early

Your participation is always voluntary. You have the right to leave the study at any time, for any reason. Regardless of when or why you leave the study, you may be asked if the researchers can follow up with you from time to time to see how you are doing. This may provide them with important information and can also help ensure your safety, even after you leave the study.

 

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How are my rights and safety protected?

Clinical trails must follow the same ethical and legal codes that all healthcare providers follow. Several levels of safeguards help protect participants of clinical trials.

Institutional Review Board

Researchers wanting to start a study must first submit the study protocol (the plan describing the study in detail) to an Institutional Review Board (IRB) made up of physicians, statisticians, community advocates, and others. The IRB must make sure that the study is ethical, that the patient's rights are protected, and that the risks of the study are as low as possible. Most clinical trials are also federally regulated. The IRB also decides how often to review the trial once it has begun. Based on this information, the IRB decides whether the clinical trial should continue as initially planned and, if not, what changes should be made. An IRB can stop a clinical trial if the researcher is not following the protocol or if the trial appears to be causing unexpected harm to the participants. An IRB can also stop a clinical trial if there is clear evidence that the new intervention is effective, in order to make it widely available.

Informed Consent

The rights of participants are also ensured by requiring that they are fully informed about the study before consenting to participate. Researchers are required to give prospective participants complete and accurate information about what will happen during the trial. Informed consent is not a contract, and the participant may withdraw from the trial at any time.


While consent forms are not all the same, they should include the following:

  • the reason for the study (what the researchers hope to find out)
  • who is eligible to take part in the study
  • what is known about the treatment being tested
  • the possible risks and benefits of the new treatment (based on what is known so far)
  • alternative treatments that may be an option for you
  • the design of the study (whether it is randomized, double blinded, etc.)
  • how many and what types of tests and doctor's visits are involved
  • who is responsible for the costs of the clinical trial (tests, doctor's visits, etc.) and for the costs if you need additional care as a result of the clinical trial
  • explanation of how your identity will be protected
  • emphasis of the voluntary nature of the study and your right to leave the study at any time without fear of compromised care
  • contact information if you have further questions.

Confidentiality

To the extent possible, all of your personal and medical information is kept confidential. Your health care team needs to have access to this information to provide the best possible care, just if you were not in a clinical trial. Medical information that is important for the study, such as test results, is assigned a specific number or code - your name does not appear on the forms and is not used in any publications of study results.

 

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What are the investigators responsibilities during the conduct of an approved research study?

  • Obtain IRB approval prior to implementing the protocol, and whenever modifications occur. 
  • Obtain informed consent of subjects prior to the subjects’ participation.

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Do investigators have to obtain Institutional Review Board (IRB) approval before involving human subjects in research?

Yes.  Investigators must submit to the IRB all materials  (protocol, consent form, grant applications, advertisements, diaries) related to the implementation of the research.

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Where should I go for more frequently asked questions?

There is a lot of good information on the Office for Human Research Protections (OHRP) website.

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