Clinical Trials

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 19 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 17 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 organisations 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 organisations, 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.