Table 1.

Adapted QuIC Items Corresponding to the Eight Basic Elements of Informed Consent

8 Basic Elements of Informed Consent	10 Perceived Understanding Items	21 Actual Understanding Items
(1) Explanation of the purposes, description of the research, along with subjects’ expected participation	1.The fact that your treatment involves research 2.Amount of time you will be in the clinical trial	1.When I signed the consent form for my current HIV/AIDS treatment, I knew that I was agreeing to participate in a clinical trial. 2.I have been informed how long my participation in this clinical trial will last. 3.In my clinical trial, one of the researchers’ major purposes is to compare the effects (good and bad) of two or more different ways of treating patients with HIV/AIDS, in order to see which one is better. 4.In my clinical trial, one of the researchers’ purposes is to test the safety of a new drug or new combination of drugs. 5.In my clinical trial, one of the researchers’ purposes is to find out what effects (good or bad) a new treatment has on me. 6.The treatment being researched in my clinical trial has been proven to be the best treatment. 7.After I agreed to participate in my clinical trial, my treatment was chosen randomly (by chance) from two or more possibilities. 8.In my clinical trial, I have a chance of getting a placebo in combination with treatment. A placebo is a pill that does not contain any medicine or drug. 9.In my clinical trial, both my provider and I know which treatment I am receiving. 10.The consent form I signed tells me what will happen when I participate in my clinical trial.
(2) description of any reasonably foreseeable risks or discomforts to subjects	3.The possible risks and discomforts of participating in the clinical trial	11.If the treatment to which I have been assigned in my clinical trial gives me side effects, the provider can change it to another treatment. 12.Compared with standard treatments, my clinical trial does not carry any additional risks or discomforts. 13.I was given a list of possible side effects relating to the drugs studied in my clinical trial.
(3) description of any benefits to subjects	4.Any direct benefits to you of participating in the clinical trial 5.Whether your participation in this clinical trial may benefit future patients	14.The main reason AIDS Clinical Trials are done is to improve the treatment of future HIV-positive or AIDS patients. 15.By participating in this clinical trial, I am helping the researchers learn information that may benefit future HIV/AIDS patients.
(4) disclosure of appropriate alternative procedures or courses of treatment	6.The alternatives to participation in the clinical trial	16.My providers did not offer me any alternatives besides treatment in this clinical trial.
(5) information related to the confidentiality of data	7.That your data from the clinical trial is kept confidential	17.Because I am participating in a clinical trial, it is possible that the study sponsor, government agencies, or others who are not directly involved in my care could review my medical records.
(6) for research involving more than minimal risk, an explanation of any compensation with respect to injury	8.Who will pay for treatment if you are injured or become ill because of participation in this clinical trial	18.If I am injured or become ill as a result of participation in this clinical trial, costs of any medical care related to the injury will be billed to me and/or my insurance company.
(7) explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights	9.Whom you should contact if you have questions or concerns about the clinical trial	19.The consent form I signed lists the name of the person (or persons) whom I should contact if I have any questions or concerns about the clinical trial.
(8) a statement that participation is voluntary	10.The fact that participation in the clinical trial is voluntary	20.I will have to remain in the clinical trial even if I decide someday that I want to withdraw. 21.If I had not wanted to participate in this clinical trial, I could have declined to sign the consent form.

Note: Perceived understanding items are prefaced with an introductory statement asking, How well did you understand the following aspects of your clinical trial? (Response range: 1–5); actual understanding items’ response options are, “Agree,” “Unsure,” or “Disagree.”