Understanding Clinical Trials
What should you ask before agreeing to participate in a research study?
The decision to participate in a research study should be made after careful consideration of the risks, benefits, and alternatives, and should involve input from a variety of sources including friends, family members, and health care providers. The following questions are meant to serve as a guide to help with this decision-making process. Note that most of these questions are relevant to clinical trials of medications as opposed to survey or services research. Many of the questions also do not apply to studies that involve routine testing procedures that are conducted for the purpose of evaluating the causes and consequences of mental illness.
What is the purpose of the study?
- You should have a clear understanding of what questions are being addressed and how the information will be used to better understand or treat the illness or symptoms under investigation.
What are the risks?
- Are painful or uncomfortable procedures included in the research study?
- What are the known risks involved using treatments or procedures in this protocol?
- What are possible risks based upon what is known in the scientific and medical literature?
- Are there any known long-term or irreversible risks?
- If new information becomes available during the course of the study concerning additional risks, how will I be informed of this information?
- Who will be responsible for my care if I suffer an adverse consequence as a result of participation in this study?
- If I suffer adverse consequences from the study participation, what are my legal rights?
Will I have to stop my current treatment (particularly medications)?
- If so, for how long?
- Will the medication be tapered or abruptly discontinued?
- How will I be cared for if my symptoms worsen?
- Who will make the decision and on what criteria will a decision be made to stop the medication-free period (or experimental treatment or placebo) and provide rescue medications or treatment? (i.e., under what circumstances will my clinical condition take priority over the experimental protocol?)
- What efforts will be made to ensure that I do not feel worse at the time my study participation is terminated?
- What is the likelihood that I will respond equivalently to a medication after being off of it for some period of time?
Is there a possibility that I will be given a placebo?
- If yes, what is the likelihood that I will receive a placebo (100%; 50%; 25%)?
- Will I have an opportunity to receive active treatment after the completion of the study if such treatment appears promising?
- If I suffer a relapse during this period, will the placebo period be terminated?
- (As above, who will make that decision and on what criteria?)
Is the study being conducted as a single- or double-blind procedure?
- Will I know what treatment I am receiving during the study?
- Will the researchers or staff know what treatment I am receiving?
- If not, who will have this information in case my symptoms worsen and I require assistance?
- When will I be informed about my treatment?
What follow-up care can I expect when my participation in the study terminates (even if this occurs before the trial is completed)?
- Will medication or treatment be reinstated prior to my being discharged from the protocol?
- Will the investigators help coordinate my follow-up care?
- Will I be able to receive the study treatment if it appears to be beneficial to my condition?
How will this affect my daily life?
- How will the research protocol differ from my current treatment?
- What is the time commitment required for my participation in this study?
- Will I be compensated for my time?
- Will I be provided transportation to and from the study site?
- Is daycare available?
- What criteria will be used to exclude or terminate me from the study?
Will I have to be hospitalized as part of the study?
- If so, for how long?
- Will there be recreational, educational and/or vocational opportunities available during this period?
- Will there be any restrictions on visitors?
- Will it be possible to obtain a pass to leave the hospital grounds?
What are the benefits I can expect to receive from participation in this study?
- Are there any direct benefits to me?
- If not, how will this research contribute to a better understanding or treatment of my disorder?
- Will I be informed about the results of this study? If so, when?
How will informed consent be assured?
- What safeguards are taken to ensure that I comprehend the important aspects of the study (e.g., readability of consent documents, videotapes, tests of comprehension, someone not associated with the study to answer my questions)?
- What is the time frame that I have to decide?
- Will someone not associated with the research be available to assist in my decision-making?
- If my condition worsens during the course of the study and my decision-making capacity becomes impaired, how will my informed consent to continue be assured?
What information will I be given about the research personnel?
- Who will be a contact person for me or my family should any problems arise (24 hours/7 days a week)?
- What are the researchers’ credentials and/or experience in conducting clinical trials?
Are there any conflicts of interest for the personnel associated with this research?
- Who is funding this research project?
- Are there financial or any other conflicts of interest for the researchers with regard to this study?
- Is the researcher paid only when a participant completes a clinical trial?
- Does the researcher or the institution have a significant financial involvement with the trial sponsor?
Will my medical information be kept confidential?
- Who will have access to my medical records?
- How will confidentiality be assured?
Will a sample of my DNA be collected?
- What are the planned and potential uses of my DNA sample?
- How will you ensure confidentiality of the information obtained?
- Will I be informed of the results?
- If there are unexpected findings that may affect my health status will I be informed of these results?
- Will my relatives also be contacted to provide DNA samples? If so, how will my health status be kept confidential?
- If unexpected personal information is obtained as a result of a DNA analysis, will this information be revealed to me or the other parties involved?
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