HIV CLINICAL TRIALS

PHASE IV Trials - After a drug is approved, trials may study different formulations of the drug, different age groups, populations and medication interactions.

The informed consent is a written document that informs potential study participants of all details of the study medications and the study plan. Researchers are required by law to give potential study participants all the facts known about a study and study drug before the individual agrees to participate. This information must be explained so that it is understood by the participant. Before a participant enters a study, he/she will be asked to read and sign a consent form. This docum ent is signed by the participant, indicating that he/she has been "informed" about the study plan and gives their written permission to participate. Participants do not give up any rights when the consent is signed. Signing an informed consen t means that the individual agrees to participate. It is not a legal contract and the individual is not penalized for deciding to leave a study program. You can still leave the study at any time. It is okay to change your mind.

• Take their time and read the informed consent document.
• Take the document home, ponder it carefully and if possible, talk to family and friends
• Be clear about where they would go or who they would call if they feel sick while on the study
• Be reminded that they have a choice and can choose not to enroll or delay enrollment

• Be reminded that not every trial is for every one

Enrolling in a trial is ultimately a personal choice.

STUDY PARTICIPANT RIGHTS

Study participants have the right to:

• Quit a study at any time
• Ask questions and have them answered
• Refuse any test, procedure or medication
• Make their own decisions about their health care
• Have their medical records kept confidential
• Know whether or not they will be able to receive study medications after the study ends
  

STUDY PARTICIPANT RESPONSIBILITES

Study participants are expected to:

• Ask questions when there is anything unclear
• Follow instructions and take the study drugs as agreed
• Keep appointments or re-schedule them when needed
• Report any changes in health
• Report any problems in living that may inhibit participating in the study

• There are studies where there are no benefits to the participant
• Clinical trials may be the only way to get a promising new drug
• The treatment may work!
• Participants may get free medications/specialized testing/laboratory tests that he/she may not have access to outside a study
• Participants may receive extra attention by having research staff assigned to follow them while on a study
• Participants may receive transportation, child care assistance or financial incentives
• Participants help others by adding to the medical knowledge known about HIV/AIDS

• DISADVANTAGES/RISKS OF PARTICIPATING
• The study medication may not work; in fact it may be harmful or cause unpleasant side effects.
• It is inconvenient and interferes with the participants schedule if frequent medical appointments are required by a study
• While in the study, participants can use only treatments approved by the researchers
• After the trial ends, participants may not be able to continue receiving the tested drug

A placebo is a tablet or capsule that contains no drug, but looks and tastes like a tablet or capsule that does contain a drug. If placebos are being used in a research study, patients are informed in writing. In trials that use placebos, patien ts may be separated into two or more groups. Some patients will be assigned to take a drug while other patients will be assigned to take a placebo. Researchers compare the patients in both groups to see the benefits, if any, of taking the real drug vers us taking the placebo. Most clinical HIV trials do not use placebos. If you take part in a trial that does, you will be informed of your chances of getting the placebo versus the real drug.

"Guinea Pigs" are thought of as helpless, manipulated animals that are used solely for the benefit of the researcher. A "guinea pig" is unable to think, speak or choose for itself. People who are asked to participate i n a study are sometimes afraid that they will be treated like "guinea pigs" by researchers. Every effort must be made to ensure that human research participants are aware of what is going on with their health care and are fully informed of any risks. Study participants must always be encouraged to think, speak and choose for themselves.

INSTITUTIONAL REVIEW BOARDS (IRBs)-All clinical trials in the United States must be approved by an IRB before people can be enrolled. The IRB is a committee of physicians, statisticians, community advocates and others that ensure that a clinical trial is ethical and that the rights of study participants are protected.

COMMUNITY ADVISORY BOARDS (CABs)-Clinical trial programs have CABs made up of community representatives, treatment activists, people living with HIV illness themselves or their advocates. CAB members look at studies from the per spective of the patient and act as advisors to the researchers.

The confidentiality of research participants are protected by keeping research records under lock and key and by using patient identification numbers rather than names on all research records

Compiled by: Melissa Turner, LICSW

Melissa Turner has been a medical social worker in HIV/AIDS care in Washington, DC since 1989. She provides clinical social work services for research patients and their families and is responsible for maintaining the unit’s Community Advisory Board. She received her Master of Social Work degree from the State University of New York at Albany, New York.