Ethics
In this section you find answers to ethical issues surrounding clinical trials.
Questions about your privacy, consent, property rights, confidentiality, remuneration and compensations are answered here. The answers are a result of a collaboration between the European Genetic Alliances Network (EGAN) and Roche.
1. Who is allowed to set up a clinical trial?
2. Who regulates clinical trials?
3. When and how is a trial approved?
4. What is an “informed consent”?
5. What will I find in an informed consent document?
6. Who decides whether elderly, incapacitated or children participate in a clinical trial?
7. Can I withdraw from a trial?
8. Will taking part in a clinical trial affect the care I receive from my doctor?
9. Will I find out the results?
10. What will happen to my samples or information about me during and after the trial? Will others be able to look at it or use it for further research?
11. Will I be compensated or paid for participating in a clinical trial?
1. Who is allowed to set up a clinical trial?
Clinical trials are designed by groups of medical and other specialists. The trial design is usually based on a thorough analysis of existing research, and a realisation that certain questions about treatment or symptom control need to be answered. It is discussed with medical staff, nurses, patients, statistical experts and support staff, as well as representatives from drug companies, to draw up the best possible trial design. The design for the study is known as the “protocol”.
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2. Who regulates clinical trials?
In order to obtain an approval for a clinical trial, a company has to submit to national Health Authorities a so-called “study protocol” in which all the details of the study are described. This protocol is reviewed by the Health Authorities and also by an Ethics Committee, whose role it is to carry out research in the respect of dignity, rights, safety and well-being of the people who take part in medical research. If the Health Authorities and the Ethics Committee have not approved a protocol, then the study cannot go ahead. Any change to the protocol must also be approved by the Ethics Committee.
An Ethics Committee must have at least 5 members and is composed of health care professionals and investigators as well as members of the public. The World Medical Association has also developed the so-called “Declaration of Helsinki”. This sets the ethical standards for research involving human beings, human material or identifiable data. Most investigators will state that their clinical trial protocol has been developed in line with these ethical principles.
In addition to this, The Food and Drug Administration (FDA) in the USA, the European Agency for the Evaluation of Medicinal Products (EMEA) as well as multiple legislative texts at European Union level have very specific rules laid out to protect patients involved in clinical trials.
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3. When and how is a trial approved?
Investigators are closely supervised by appropriate regulatory authorities. When beginning any study the doctor, or investigator, must ask approval from an Ethics Committee. The Ethics Committee is a committee of doctors and other medical personnel as well as lay people that have no ties to the study. Their role is to make sure that the study is as safe as possible and that the “informed consent” explains all of the important information to the patient.
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4. What is an “informed consent”?
Except in exceptional circumstances you cannot be entered into a trial without signing a form saying that you have given your informed consent. If you sign this form, you confirm that you believe you have been given all the important facts about a trial, you understand them and that you have decided to take part in the trial of your own free will. An informed consent is not a contract and you may withdraw from the study at any time.
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5. What will I find in an informed consent document?
While informed consent documents do vary from place to place, they should communicate all of the information described below in an intelligible language. The information covered should include:
a. The purpose of the clinical trial
In this section, investigators explain why they are conducting the trial. The reasons will depend on the type of disease and the trial type.
b. Description of procedures
This section describes the ongoing procedures, how frequently they will be applied, and where they will take place (at home, in the hospital or clinical centre, or an outpatient centre).
For interventional trials (see Question 1 in ethics section for an explanation on this type of trial) this section should also include procedures that are part of regular disease care and may be done even if the patient does not join the trial; standard procedures being done because the patient is in the trial; and procedures that are being tested or evaluated by the trial.
If it is a “randomised” trial (please see Question 12 in basics section for an explanation of what randomised trial means) the document should make clear what procedures each group will undergo. It should also indicate the chances of being placed in any one group.
c. Duration of the trial
This section indicates how long the trial will last and whether it involves follow-up, and if so, for how long. It also includes information about any circumstances under which the researcher might remove the patient from the trial (e.g. if his condition worsens or new information indicates he shouldn’t continue). The document should make clear that the patient has the right to stop participating at any time, and it should describe any possible medical consequences of sudden withdrawal.
d. Potential risks of the trial
This section includes the foreseeable physical and non-physical risks of participating in the trial. A non-physical risk might be time away from work, while physical risks might include side effects such as nausea, vomiting, pain or susceptibility to infection, among others.
The document should indicate the likelihood of these risks occurring, how serious they may be, and whether they are more likely to be short-term (last only during the trial or shortly afterward) or long-term (last weeks, months, or even years after the trial is over). The document should make clear which risks are related to the investigational aspects of the trial. It also should include specific information about reproductive risks (infertility risk, etc.).
e. Benefits
The document describes any benefits to the patients or to others which may reasonably be expected. A trial may or may not involve direct medical benefits to the participant, but it might lead to new knowledge that can help others in the future.
f. Alternatives to participation
For investigational trials, this section describes what care options the patient has besides participating in the trial, such as other commonly-used therapies or no treatment at all.
g. Confidentiality
This statement informs about the extent to which the participant’s information will be kept confidential. It should also inform about any groups or organizations that may have access to the patient’s records for quality assurance and data analysis (e.g. the trial sponsor).
h. Costs / Additional expenses
This section indicates whether participating in the trial will result in added costs to the participant or his insurance company. It also covers other cost issues, such as who will pay for emergency medical treatment in case of injury or illness, whether the patient will have to pay for drugs that become commercially available during the trial (if this is a drug trial), and whether or not he will receive payment for participating.
i. Participant’s rights
The document should specify that the participation is voluntary, the patient can choose not to take part or leave at any time without penalty or loss of benefits, and any new information that might affect his participation will be shared with him.
j. Contact information about whom to call in case of questions or problems
A contact name and phone number (usually of a member of the research team) for getting answers to questions about the study or a research-related injury should be indicated. It also should be given a phone number for the Ethics Committee or a patient representative, in case the patient has questions about his / her rights as a research participant.
k. Supplemental information
This section lists additional resources that may prove useful, such as informational booklets, community organizations, and Web resources.
l. The signature
The participant’s dated signature represents his legal consent to participate in the trial. In case of illiteracy of the participant, investigators need to pay special attention that the trial information they give is understood by the participant and a literate and disinterested person must witness the oral consent of the participant and sign the document on behalf of the participant. If any of these sections appears to be incomplete or missing from the informed consent document, the participant should not hesitate to ask for the information.
If English is not your native language, you should be able to obtain the consent documents in languages other than English. Because joining a clinical trial is an important decision, you should ask the investigator any questions you may have about the study before you make a decision.
It is also a good idea to take the consent documents home and discuss them with family members or friends. Talking about your options can help you to feel comfortable with your decision. If you decide to join the clinical trial, be sure to ask for a copy of the informed consent documents so you can review them at any time.
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6. Who decides whether elderly, incapacitated or children participate in a clinical trial?
The key concern is to ensure that elderly, incapacitated patients as well as children are protected. These patients can only be enrolled in a trial if an informed consent of the legal representative has been obtained. If no legal representative is available, then the patient cannot take part in the trial.
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7. Can I withdraw from a trial?
You can change your mind and leave a clinical trial at any time—before the study starts, during the study, or during the follow-up period. Participating in research is always voluntary. Even if you decide to participate, you can always withdraw from the study without affecting your relationship with your doctor.
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8. Will taking part in a clinical trial affect the care I receive from my doctor?
Absolutely not, in fact you will find that it is exactly the opposite that will happen. As described above, you may have to go and see your doctor more often than before, which will therefore give you more opportunities to ask him or her about the state of your condition, the treatment(s) you are given and your general well-being.
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9. Will I find out the results?
It may be some time before the results of a trial become available. Some large trials involve thousands of people and can run for five years or even longer before every participant has been assessed. There may be years between when you take part and when the trial finishes.
At the end of the trial, the study sponsor (e.g. the company) should make the results available to everyone who took part. If not, you can always ask the investigator or your doctor to tell you about the conclusions. The results should provide more information about the possible risks and benefits of the different treatments that have been tested. They may help you and others like you to make more informed decisions about your healthcare.
Some investigators will also work with patient groups to ensure that the results of trials reach other patients. Investigators have a responsibility to publicise the results of their trial even if the results show that a new treatment doesn’t work. They might do this at a conference, in a medical journal or in the press.
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10. What will happen to my samples or information about me during and after the trial? Will others be able to look at it or use it for further research?
If you agree to join a trial, some people will need to be told that you are taking part. These people are:
- Your GP, who is responsible for your healthcare on a day-to-day basis
- The doctor and research team looking after you in the trial
The fact that you are taking part in a trial will be written in your medical notes. Investigators cannot tell anyone else that you are taking part in a trial unless you give your permission. During the trial, all of the information collected about you will be kept confidential, as with any other medical records. When investigators publish the results of a trial, they are not allowed to include any information that would identify people - your name will not be used in any reports or publications.
The clinical trial protocol will define what is to be done with your samples and information. Specific sections within this document will detail for how long samples and information must be kept before they are destroyed. If samples and/or information are to be used further, then this will be either:
- included in the original trial protocol
- be part of the informed consent you will sign
- be written up in a specific informed consent which you will also be asked to sign.
11. Will I be compensated or paid for participating in a clinical trial?
For fundamental ethical reasons, the participation in clinical trials testing participants with illnesses is usually not paid/compensated. But on the other hand the sponsoring companies normally commit to provide the investigational medicinal product free for the duration of the study and the participants typically will get excellent care from the physicians during the course of the study and this care will also be free.
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