How to Obtain Informed Consent for a Clinical Trial

Three Parts:Explaining the TrialAssessing the Participant's ComprehensionGetting Required Signatures

Before a drug can be approved by the FDA, it must undergo extensive testing through clinical trials – medical studies that treat volunteer human participants with a new or experimental drug to evaluate its effects. These studies typically are conducted by hospitals or universities, but may also take place in private doctor's offices or in community clinics.[1] Before people can become test subjects, they must give informed consent to participate in the trial. FDA regulations set forth the basic requirements for documents that must be presented to and signed by participants – however, informed consent is an ongoing process, not just a set of forms.[2][3]

Part 1
Explaining the Trial

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    Provide an overview of the procedure and purpose of the trial. Participants must have a big-picture understanding of the research being conducted and what it involves.[4]
    • If you are a researcher, you must include information such as the purpose of the research, how long the trial is expected to last, and a description of the procedures that will be involved.[5]
    • Generally, the participant should have a good understanding of the schedule of treatment, including when he or she will have doctor's appointments, what will happen during those appointments, and how long they will last. You should include the locations where procedures or treatment would occur.[6]
    • When you describe the procedures, take care to identify which are routine and which are experimental.[7]
    • Generally, any scientific or technical terms should be explained, or replaced with common words. Use language that the average participant would understand. If your participants are children, the study and its risks and benefits should be explained in a way that children can understand.[8][9]
    • Participants should understand that their participation is voluntary, and that they can leave the study at any time without any consequences or penalties as a result.[10]
    • Explain the reason the participants are being chosen to participate in simple, straightforward terms that can be easily understood.[11]
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    Describe the probable benefits of participation. For this portion of the informed consent process, you should let the participant know why he or she would want to participate and what possible results can be achieved.
    • Benefits include not just those the participant can reasonably expect, but also the general benefits to society or to medical knowledge or understanding.[12]
    • You should be careful not to overstate or overestimate the benefits. For some studies, the individual participant may not notice any personal benefit, and if this is the case the participant should be informed of this up front.[13]
    • Explain direct, individual benefits first, and then go into general benefits, such as those to medicine or society at large as a result of the study's findings.[14]
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    Describe all possible risks associated with participation. All risks of participation should be included along with the probability those risks might occur.
    • You should point out particular risks inherent in experimental procedures or treatments that are entirely research-related, as well as other general risks related to the study as a whole.[15]
    • Particular note should be made of any tests or procedures that themselves carry a risk that the participant will die or be permanently disabled.[16]
    • Your explanation of the risks should be objective and reasonable, without minimizing or dismissing any possible problems or side effects.[17]
    • The risks of each procedure, if there is more than one, should be listed separately. Within each procedure, the risks should be organized according to their severity and how likely they are to happen. The likelihood of risks can be described using words such as "occasional" or "frequent," but these words should be defined using percentages at least once. For example, you might define "occasional" risk as one that will happen to between 1 and 10 percent of participants.[18]
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    Explain any costs and compensation associated with the trial. Participants should have an understanding of the compensation they will receive, if any, for participation, as well as what treatments are included in the study and which remain their responsibility.
    • If participants are receiving compensation for their participation, any discussion of this should be separate and apart from the discussion of any potential medical benefits.[19]
    • If the study involves more than a minimal risk of harm to the participant, you should include information on any additional treatments or compensation that may be provided if the participant is harmed as a result of the trial.[20]
    • The participant also must be informed of any possible alternative treatments that might be appropriate or advantageous for his or her condition.[21]
    • If the study includes no compensation, this should be clearly stated. Likewise, if participants won't incur any additional costs for treatment as a result of participation in the study, this should be clearly stated as well.[22]
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    Discuss privacy and confidentiality policies. To meet the standard of informed consent, each participant must know who will have access to their personal medical information and how it will be used.
    • Many clinical trials also may require participants to sign a HIPAA Authorization for Research.[23] This document, as opposed to the participant's informed consent document, indicates the participant gives the researchers permission to use his or her health information for purposes of the study.[24]
    • If identifying information about participants will be retained in the record of the clinical trial and open to inspection by the FDA, this should be disclosed to the participants as well.[25]

Part 2
Assessing the Participant's Comprehension

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    Allow ample time to review the information presented. Some participants may only need a few hours to review written materials, while others need several days.
    • Since the information may be complicated or potentially distressing to the participant, be sure each person has as much time as he or she needs to fully absorb and appreciate the materials presented.[26]
    • Additionally, potential participants may want to discuss the study and their participation with friends and family members, or get opinions from doctors or other medical professionals not involved in the study.[27]
    • After sufficient time has passed, the participant should be allowed to meet with a researcher and ask questions about the study.[28]
    • If the participant doesn't read or understand English well, he or she should be provided with an approved translation of the consent forms in his or her native language.[29][30]
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    Encourage the participant to ask questions. Asking questions allows the participant to gain a better understanding of the study from his or her own perspective.
    • Although the consent documents contain all information that must be disclosed about the study, they should not serve as a substitute for discussion.[31]
    • All the details in the informed consent documents should serve as a starting point for discussion with the participant, and you should assume that the participant will have questions about the research and about his or her participation after reviewing these materials.[32]
    • Potential participants may ask questions about how the study will be conducted, whether the researchers will know what treatment each participant is receiving, or what possible treatments they may receive during the trial. Additionally, participants may want to know if they can continue receiving the treatment after the trial ends if they benefit from it or their condition improves as a result.[33]
    • Participants also may have questions, such as whether they will have to be hospitalized, how many doctor's visits they will have and how frequent those visits will be, or whether they will be reimbursed for any other expenses such as travel or lodging that they may incur as a result of participation.[34]
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    Ask the participant open-ended questions. Open-ended questions help you gauge the participant's understanding and highlight any areas where there might be confusion.
    • Asking questions can further discussion about the study as well as elicit additional questions from the participant that he or she may not have thought of before.[35]
    • Open-ended questions encourage participants to demonstrate their knowledge of what they've been told about the trial. For example, you might ask the participant to explain in his or her own words what the researchers are asking her to do, or what the purpose of the study is.[36]
    • Avoid questions that can be answered with a "yes" or "no," as they don't serve to further discussion or give you any true understanding of how informed the participant really is.[37]
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    Provide contact information for assistants or advocates. In some cases, you may have designated nurses or patient's advocates who are there to assist participants and answer any questions they may have concerning the study.
    • Even if there isn't a specifically designated person, participants should have the name and contact information of someone they can go to with any questions or concerns about the research or their rights as a patient.[38]
    • A special advocate may be assigned to a participant if he or she is a member of an especially vulnerable population. These advocates are more than just witnesses, but are charged with actively protecting the participant's rights.[39]
    • At least one researcher in charge of the study should be included if at all possible, as well as other researchers who may be available to answer any questions the participant might have about the study as it progresses.[40]

Part 3
Getting Required Signatures

  1. Image titled Obtain Informed Consent for a Clinical Trial Step 10
    Have the participant sign the initial forms to enter the study. For most clinical trials, the FDA requires a signed consent document for every participant in the study.[41]
    • Informed consent documents must include specific information laid out in the FDA regulations to meet the FDA requirements. Some of these required statements may be copied verbatim from the regulations, while others must be adapted to fit each clinical trial.[42]
    • The form the participant signs cannot include any waiver of his or her legal rights, or release the researcher or research institution from liability for negligence.[43]
    • After the participant has signed the document, he or she should be given a copy for later reference.[44]
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    Get signatures from the appropriate researchers. Typically the researcher who went through the informed consent process with the participant should sign the informed consent form on the same day the participant does.
    • While it may be appropriate for the researcher to sign the form after the participant has, the researcher should never sign the form before the participant does.[45]
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    Get a signature from an impartial witness. In some situations or with some participants, the FDA may require a witness's signature in addition to that of the participant.
    • A witness may be required in situations where the participant doesn't speak or understand English well, or if the participant cannot read or write. A witness also is required if the participant can't talk or if he or she is blind. In these cases, the participant must be able to indicate his or her consent in another way, such as by blinking or nodding.[46]
    • If the participant is incapable of giving informed consent, you still must explain everything to them and get their assent, and then get consent from someone authorized to provide medical consent. For example, if the participant is a child, you should get the child's assent and the informed consent of his or her parent or guardian.[47]
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    Update the information as necessary and maintain continuing consent. If new risks or other information is discovered as the trial proceeds, you must get continuing consent from each participant to remain in the trial.[48]
    • Even if the participant is incapable of giving informed consent, he or she must continually be updated if any new risks or benefits are found, and his or her preferences and best interests should be considered at all times.[49]
    • Any new information that might affect the participant's willingness to participate in the ongoing study should be included in a revised consent form.[50]

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