In this section, we will discuss the process of consent or discussions that occur during the consent process. We all know that this discussion and the consent itself must precede any study related activities, including screening for eligibility as well as randomization. Study team members should always be cognizant of anything that might interfere with the participant's ability to make an informed decision. In fact, as we discussed earlier in this lecture, there may be times when it's necessary for the protocol to specify the conditions under which someone will assess whether or not it is appropriate for someone to provide informed consent or whether or not a legally authorized representative should be included in the discussions. You should always supplement with written or other visual materials about the design and the purpose of the trial. This can often help during the discussion, things such as videos or flip charts or other recruitment materials and these can help as visual reminders of some of the design aspects of the trial that should be communicated to the participant. The language of the discussion itself must be understandable, not just the consent document, but the discussion during the consent process must be understandable. In that specific situation, we have to consider the language that's used during discussion, as well as the native language of the person that you're discussing this with. It's possible that translators may be included in this discussion process and they may be helpful in making sure that the language of the discussion is understandable to all. Also consider how well the consent language explains the procedures. While we hope that explains it quite well and it probably will, you also need to consider whether or not in different situations you might need to supplement with additional descriptions or well, or use visual materials during this process. Most importantly, the discussion should be free of any coercion and should not impose any undue influence over the participants decision to participate. In other words, there should not be a situation in which a participant is approached to regarding consent for a specific trial, and that it appears that in any way that there are no other options other than to participate in this specific study. It's always important to allow sufficient time for the participant to understand the information that's provided during the consent discussion. In some instances, it may be appropriate to include an assessment of comprehension, especially if you consider the trial designed to be complex or any of the interventions or the study arms to require additional information. Now there may be tools or other things that can be used during the assessment of comprehension, you may decide to include a test at the end of the discussion, you may decide to ask questions after each section of your discussion, discussing separate parts of the trial. Those are things that are often used in trials if there is a need to assess comprehension before the signing of any consent form. Allow the participant the opportunity to ask questions, to consult with their physician or other family members. This process may be over several days, so you may anticipate that there may be several days before the participant makes their final decision. Consider documenting and monitoring the consent process. By documenting the process, that means that you may include a checklist of a number of items that you know should be covered during the discussion and that information is checked off and included in the participant study file. Monitoring the consent process is important. Documenting the consent process may include incorporating a checklist or some other tool that includes all of the important pieces of information that should be covered during a consent discussion. This can be included in the participant study file and documents that all of the specific important aspects of the trial had been covered. It may also be important and it will be important to monitor the consent process. That can be done through periodic review of all of the consent documents that have been signed, to be sure that all of the specific elements had been covered and that all the appropriate signatures have been obtained for those who agree to participate. We know that participants retain the right to withdraw from the trial at any time, but during the consent discussion, it's very important that you communicate this during this time. As well, you should communicate whether or not there is additional follow-up or the procedures that would be required at the time of withdrawal so that the participant understands at that specific time of consent before enrolling, what are the conditions under which they may always withdraw at any time, but whether or not there are any other additional follow-up or procedures that are required. Another specific situation to consider is whether or not there might be new information that could affect the participant's willingness to continue participation. Now this information should always be communicated, but investigators must provide an opportunity for participants to hear about the information or certificate modifications to the study protocol and the research ethics board as well as the investigator, will make the decision whether or not a re consenting is required. There may be instances in which there may be new risks identified, changes in the study arms, or new alternative treatments that may be available over the course of the trial and this information needs to be communicated to study participants who are enrolled, and then a decision is made whether or not they should be re-consented. Now usually, all participants are re-consented unless we determined that these modifications will only affect those who are newly enrolled or future participants and will not impact in any way those who are currently enrolled. There are a number of different ways in which you communicate this information to participants and that can depend on the type of the change, the time sensitivity of notification of participants, and the status of the trial at the time. There may be different communication methods or the urgency to communicate depending upon whether or not recruitment is still open or whether it has been completed. If it's a significant modification, the investigators and the research ethics board may require that participants are re-consented with the revised consent form or an addendum to the original consent form. Now if the re-consenting is required for participants, then consider adding a cover page to the consent form that outlines all of the changes that are made to the consent so that the participant understands all of their conditions under which they are consenting to continue participation. An information sheet to inform the changes might be important inclusion as well. This can be communicated via mail or email or other means so that all participants are aware of the changes, whether or not they are significant or not significant changes. Finally, depending also upon the time sensitivity, verbal communication might be appropriate. That can be done at any follow-up visit, and this can be documented in the study file. There are a number of different considerations to ensure a successful informed consent process. Voluntary informed consent is an essential prerequisite to participation in a clinical trial. Those obtaining consent, should be trained and knowledgeable and discussion should aim to be understandable to all potential participants and most importantly, free of coercion. We know that there are additional protections for potential participants who lack the capacity to provide informed consent, or who are maybe considered vulnerable due to illiteracy, pregnancy, or incarceration. Consent forms must include specific language and lay descriptions of procedures and medical conditions and re-consent is advised when there are significant modifications to the protocol that may affect the participant's willingness to continue trial participation. Thank you for listening to this lecture.
