What is informed consent?

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Informed consent is the process that gives information to people who are thinking about taking part in the research. After learning about the research, you should understand:

  • The purpose of the study.
  • The procedures involved in the study.
  • The possible benefits and risks of taking part in the study.
  • The rights of people who take part in the research.
  • That taking part in research is your choice.
  • Alternative treatments are available.
  • The right to be informed of any new information that may that might change your mind on continuing to participate.

Informed consent is a process that helps you learn about the research study. After learning about the study, you will be able to ask the researcher or his/her staff questions. You should only agree to take part after you clearly understand the study and feel comfortable. You should take time to talk over your decision with your doctors, family, and friends. If you agree to take part, you will be asked to sign an “informed consent form.”

Source: Cedars-Sinai.org

What is a Protocol?

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A protocol describes the rules to follow during the research. For example, a protocol states why it is important to study the research question and how the research team will try to answer the research question. A protocol also states how the research team will protect the health and wellbeing of the research volunteers. A protocol includes information on the study procedures, medications to be used, possible risks and benefits, possible adverse events, and data analysis methods.

Source: EUPATI

What Happens After My Clinical Trial?

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The end of the clinical trial does not mark the end of all communication between you and the research team. Once treatment is completed and the study is closed, participants should feel free to ask the trial staff what treatment they were getting. The study staff shares this information as soon as it is available, and they are allowed to do so. They will also share the clinical trial results when they become available.

Source:  ClinicalTrialsAndMe

How Long Can A Clinical Trial Last?

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The length of a clinical trial varies depending on several factors, such as the type of illness and the type of medicine being researched.4 For example, if the study is researching a treatment for a chronic condition, participants’ progress on the trial may be tracked over a relatively long period of time. Studies of antibiotics on the other-hand conclude quickly as patients are typically treated on study for a few days only.

Source: Novartis

Reimbursable & Compensation Costs

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The following items can be reimbursed for participants:

  • Travel expenses
  • Accommodations
  • Loss of income
  • Meals

What kind of compensation can participants receive?

Compensation, in regards to clinical trials, can take many forms:

  • Participants may receive monetary or other benefits for their participation in the study
  • If participants may receive a payment or other services if they suffer any harm from a clinical trial.

Compensation is most common in Phase I trials with healthy volunteers. It is given to participants as recognition of their time and as an appreciation for their contribution to science.

Source: EUPATI

What Are the Costs of Participating in a Clinical Trial?

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In some cases, taking part in a trial will not cost you or your insurance company anything. In other studies, the research team may bill your insurance company for drugs, devices, and services they provide. It is possible that your insurance company will not pay for some or all of the charges and you may receive a bill for those costs. The informed consent form will describe any costs to you in detail. If the information in the consent form is not clear, you may ask a member of the research team to explain any potential costs to you before signing the consent form.

Source: Cedars-Sinai.org

How Many Visits Are Required?

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A standard trial proceeds forward in several phases:

  1. A screening visit: During this visit, an informed consent document is reviewed with you, as well as your Medical History by the Investigational Staff.
  2. A baseline visit: When you attend this visit (the first step in your trial) you’ll receive your study medication, and the dosing will be reviewed with you. (This visit may be combined with the screening visit).
  3. Routine study visits  These are periodic visits done throughout the study to track an individual’s progress during a clinical trial. The study team may:
  • Test bloodwork
  • Administer the study drug
  • Perform a checkup on your condition.

Source: Uva Health

What Information and Medical Tests Are Required?

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Depending on each clinical trial, the information and medical tests that are required will change. Each study has a different set of criteria.  Some studies may have many tests, while others may have almost none.

During the screening visit (the first meeting), participants are given an overview of the study and are asked questions to see if they meet the requirements outlined in the study Protocol (rules). Some of the most common tests performed and information asked for are:

  • Blood tests
  • A routine physical examination
  • Detailed Medical History

Source: Uva Health

Benefits & Potentials Risks of Clinical Trials

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Benefits of  Clinical Trials

  • You may get a new treatment for a disease before it is available to the public.
  • It enables you to have a more active role in your health care.
  • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
  • You have the opportunity to help others get better treatment for their health problems in the future.
  • You may be able to get information about support groups and other resources.

 

Potential Downsides of Clinical Trials

  • The new treatment could have potential side effects.
  • The treatment may not work as intended or may not be as effective as treatments that are currently available.
  • Participating in a clinical trial is a time commitment. You may be expected to stay overnight or for several days over the course of a trial.

An important note: Patients who have signed an informed consent form may leave a trial at any time.

Source: NIH.gov

Are Clinical Trials Safe?

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The FDA works to protect participants in clinical trials by ensuring that volunteers have reliable information before deciding whether or not to join a clinical trial.

The Federal government has regulations and guidelines for the management of clinical research to protect participants from unreasonable risks. They require researchers to give prospective participants complete and accurate information on the precise nature of each step of a trial.

Therefore, before joining a study, participants are given an informed consent document that outlines their rights as a participant. They are also provided with,  details on the nature of the study, including any potential risks.

What Risks Should I Consider Before Joining a Clinical Trial?

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Before joining a clinical trial, it is recommended that you do as much research on the study as possible. Discuss your questions and concerns with members of the healthcare team conducting the trial. Also, discuss the Clinical trial with your health care provider to determine whether the study is a good/possible option based on your current treatment.

For more information please visit:

Source:  FDA.gov