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Step 1
Right of the bat, state that this study is research based. Typically, informed consent is not required for standard treatment modalities. Nevertheless, it is important to acknowledge this distinction immediately. Also explain why this is a research study, in other words, why is this study being conducted. Along the same lines, explain how the research will be performed. Think of questions that the potential participant may ask related to this topic, i.e. what do you want to learn and how will you learn it? If the study involves experimental procedures or drugs, this must be explicitly conveyed and proper explanation given as to why these non-standard options are being tested. Finally, define the actual amount of time that the study will take for the person if he or she decides to participate.
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Step 2
Delving a little deeper into the “how” of the study, describe any possible risks and/or pain that may be caused by participating in this study. This includes everything from mild discomfort all the way to death. Many times a defined list of potential side effects for a treatment is available and must be presented in the informed consent, commonly categorized as “Likely”, “Less Likely”, and “Rare but Serious”. While there is no sugarcoating this part, there are ways to alleviate any apprehension the potential subject may have by exhorting the fact that all patients on the study will be watched closely for any problems that will be addressed immediately by the healthcare team.
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Step 3
Addressing the “why” portion of the consent, describe any benefits to the potential subject or to humanity as whole. In some studies, patients may have something to gain such as treating a disease that is otherwise untreatable. In other studies, there may be no personal benefit due to the inherit situation. Explain why there may be little or no benefit to the subject, but since this is being conducted for research purposes, what is learned during the study may benefit others in the future. Sometimes the altruistic nature is the most driving force behind a subject consenting to be in a study.
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Step 4
Along the same lines, other options besides this particular study must be disclosed to the potential enrollee. This generally includes standard treatments, taking part in another clinical trial, or even no treatment at all. Encourage the potential subject to discuss these options with the study doctor, family and friends.
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Step 5
As HIPAA is now omnipresent, the privacy of the subject’s records must be addressed in no uncertain terms. A clear cut statement that the investigators will do their best to keep everyone’s information in this study confidential. However, he or she needs to be informed that, by law, personal information may need to be given out in instances of public record such as an FDA request.
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Step 6
If the study involves more than a minimal risk as defined by the FDA then there must be a section that confirms medical treatment will be given if injury occurs and how that treatment will be paid for. Also let it be known that, when signing this form, the potential subject does not give up the right to seek monetary compensation if injured while being treated.
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Step 7
For any questions that weren’t answered by the informed consent, contact information must be provided to include the actual study director or his or her qualified designee. This information is also provided in case the enrollee is injured so that they may notify the study doctor immediately. There must also be contact information for the Institutional Review Board (IRB) who reviewed this study for patient safety and rights.
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Step 8
Finally, and possibly the most important decleration, it must be made crystal clear that taking part in this clinical trial is completely and absolutely voluntary, that there will be no penalty or loss of benefits for the person for saying simply: no. As an extension, if the subject does enroll, a statement to the effect that they may withdraw from the study at any and all times without any pressure or consequences must be included.
