Now we will discuss in this section the actual consent document. The basic elements of the consent document, as well as specific inclusions for a clinical trial, informed consent documents. The guidance for the basic elements of a consent document, are based on US Federal Regulations for informed consent, but align with good clinical practice guidance as well as guidelines set forth in other countries. Consent forms must include specific regulatory elements, institutional language where it's applicable, as well as lay descriptions of study design features that are unique to clinical trials. So on this slide, we do outline a number of different elements that should be included in your consent document. The purpose of the research, any foreseeable risks or benefits, any alternative courses of treatment. Issues related to confidentiality of records as well as data. Compensation for injury, and that may differ depending upon country regulations. Contact information if participants have questions about any aspect of the trial. Most importantly, that their participation is voluntary, as well as any terms under which the participant may withdraw. So they may withdraw at any time, but there may be additional requirements at the time of withdrawal, and those should be included in the consent document, as well as discussed with the participant. This last bullet here, use of bio-specimens and identifiable data. This is actually a new inclusion in the basic elements of a consent document with US Federal regulations. This is a statement basically that identifiers might be removed from the identifiable private information, or bio-specimens, and that after such removal, the information or the bio-specimens could be used for future research studies. Or even distributed to another investigator for future research studies without additional informed consent. Or potentially that these participant's information, or bio-specimen that's collected as a part of the research, even if the identifiers are removed, will not be used or distributed for future research studies. There are other specific pieces of information that should be included in your clinical trial informed consent document. It's very important to be able to describe very complex design features in lay terms. So a description of the specific study arms, or the interventions, including the use of any placebos in sham procedures, should be included in your informed consent document. Lay descriptions of randomization as well as the allocation ratio should be described. Any persons who were amassed, or blinded during the course of the trial, whether they be the investigators implementing the intervention, or the participants, as well as any outcome assessors. All the persons who are amassed should be included and described in the conformed consent document. How the interventions will be administered should be described. If there are injections, if there are surgical procedures, if devices will be implanted, all of those specific details must be outlined in lay terms for a participant to review. All follow up periods, including the time points, as well as the method of contact. Whether or not they must appear at the clinic for specific examinations, or they will be telephone contacts and the times at which those contexts will occur. In the informed consent document, indications for discontinuing interventions during the trial should be included. If there are any instances in which there may be safety issues that would require the investigators to discontinue the intervention, these would be described in the informed consent document. Descriptions of the examinations, the surveys, as well as any telephone contacts, would be also included and described in lay terms. The availability of the interventions for all participants at the end of the trial would be included as well, because participants may wonder if they are assigned to the placebo, whether or not they will have the opportunity to receive any active interventions at the conclusion of the trial. If the intervention will be available in a terms under which will be available should be described in the informed consent document. What are the goals for an informed consent document? The main objective is to provide the information, so that a potential participant may provide an informed decision on participation in a trial. It's important to use simple words and short sentences. If the participant cannot understand the information in the informed consent document, then they are not considered to be truly informed. It's important to assess the readability, the health literacy, and the usability of the consent document. There are a number of different tools that can be used to assist this process. There are tools to determine whether or not the document is written at a reading level that would be appropriate. Different institutions have different requirements on what that level should be. In the United States, it's often at the eighth grade reading level. Health literacy, as well as usability. Usability of the consent document may be examined by distributing the consent document to a number of different potential participants before the start of the trial, and feedback is provided on whether or not the terms are presented in an understandable format. Translations of the informed consent document should be provided when you believe that the target population is anticipated to include non native speakers. There are regulations that are instituted within the institution that will require either certified translators, or some other processes to make sure that the document is easily read by those who are non-native speakers. Finally, avoid creating an oversimplified form because the concern is that you may not be able to convey the information that the participant needs to know. Oversimplifying medical terminology may end in not including the important pieces of information that the participant needs to know about a specific medical procedure. Think about what you, or one of your family members would like to know if they consider joining a trial. That can always help when you're developing your informed consent document and having others, as I mentioned in terms of usability, read the informed consent document before it's submitted to your research ethics board would be important so that you can determine whether or not it's actually a usable document. Consider drafting individual consent forms, or assent forms for minors. If you have multiple types of participants in your trial. If your trial includes investigational medications or devices, also consider including separate document that describes them. You may have another pamphlet or another document that you use during the consent discussion that would help inform participants about the different investigational medications or devices that are included in the trial as study arms.
