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The most important safeguard in protecting the rights of participants in clinical trials is the informed consent process. All participants in clinical trials in the United States (and in most areas of the world) are required to sign an informed consent document. In the event that the participant is not competent to sign, this responsibility is assigned to the spouse, parent, an adult child, or a brother or sister (in that order). The informed consent document must also be signed by a witness and by the investigator.      Information in the consent form usually includes the following:     Purpose of the trial. The informed consent document must include an explanation of the scientific question the trial is to answer. It must also include an explanation of why the participant qualifies for the trial.     Procedures. Informed consent must include an explanation of the trial’s design, that is, exactly how the trial will proceed. The explanation will include: the nature of the treatment arms; the method by which participants are assigned to a specific arm; the requirements for participation, including the number of clinic visits or the duration of hospitalization; the frequency and types of tests that will be done; the amount of blood that will be required; the duration of the trial; and the end point of the trial.     Risks. Informed consent must include an explanation of the drug’s side effects, including their anticipated frequency and severity. It is unrealistic to list every possible side effect, or even all of the side effects that have occurred in previous trials. But certainly the most severe and the most frequent side effects should be noted.     Benefits. Informed consent must include a statement of whether the participant has any realistic likelihood of benefiting from participation. Expenses for the drugs or for monitoring, and any payment to the participant, should also be explained.     Alternatives to participation. Informed consent must include the various options people have if they choose not to participate. This generally includes the statement that a decision not to participate will not affect your care. In other words, no one at the center offering the trial will bear a grudge if you choose not to participate.     Confidentiality of records. People with HIV infection are often concerned about the confidentiality of their trial records. Some trials are done without identifiers, that is without the names, addresses, hospital numbers, or social security numbers that would connect the data to a specific person. Trials done without identifiers essentially guarantee anonymity for the participant.     Unfortunately, it is often impractical and undesirable for clinical trials that collect clinically useful data over a prolonged period to be done without identifiers. The next best option to guarantee confidentiality is to keep the records in a locked file with limited access. The FDA and the drug company that sponsors the trial can require access to these locked files, but we are not aware that this access has ever resulted in a participant’s name being revealed to inappropriate persons.     In many instances, data obtained in the trial are also recorded in the participant’s medical record: such data can be relevant to medical treatment. Occasionally, participants object to what they view as an unnecessary dispersal of sensitive information. The best advice is to read the consent form carefully for an explanation of how data from the trial are handled and who has access to the record. If such an explanation is not included in the consent form, ask for further information.     Further information. No consent form can provide all the information desired by all the participants. And consent forms often include technical information and medical terms that may be difficult to understand. It is expected that most participants will need to discuss any questions not answered or points not clarified with a member of the investigating team. If, either before or after signing the consent form, you have questions about toxicity, alternatives to drugs, possible participation in other studies, or compensation for injury as a result of participation, you should be answered to your satisfaction. You should not sign the consent form until you are satisfied and have no further questions. One option is to take the consent form home and list the questions you have after you have reviewed the form and discussed it with others. In addition, most consent forms include the name and phone number of an appropriate person to contact if the participant has any further questions after participation begins.     Withdrawal of consent. Informed consent continues throughout the course of the trial, but withdrawal of consent at any time is the participant’s right. Withdrawal must not have any repercussions for the participant. Withdrawal may not interfere with the availability of care.     Participation. To find the nearest clinical trial, call the hotline at the National Institute of Allergy and Infectious Diseases: 1-800-TRIALS-A.*189\191\2*

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