One of the standard documentations required for an investigator initiated trial is the informed consent form. It is a letter to the participant that describes what the study is about, any potential risks and benefits, and the rights of the research participants. The main purpose of this form is to protect the participant from any harm. Since it is also a legal document, you can imagine that an informed consent form is very lengthy and in-depth. Fortunately, there are several templates available online that you can use as a guide. In this article, we’ll go over some of the sections that you’ll need to include.
Start with a Template
Your research institution will likely have an informed consent template that they would prefer you to use, so we suggest to first check with your university or college. If your institution does not have one, then the World Health Organization has put together several comprehensive templates that you can use to create your own informed consent forms. You can also find instructions to a standard informed consent here and an example informed consent form. One of the key things to keep in mind is that as you must write it at a level that can be understood by a grade 5-6 student.
One of the key things to keep in mind is that the language for an informed consent form must be non-technical and easily understood by a grade 5-6 student. Furthermore, it must be written in such a way that it does not cause the subject or the subject’s legal representative to waive any legal rights or release the investigator, institution, or sponsor from liability for any negligence. According to the ICH’s Good Clinical Practice Guide (Link in reference) Section 4.8, the informed consent form and all related documentation must contain the following:
- A statement indicating that the trial involves research
- The study’s purpose
- Description of the trial treatment groups and the probability of being randomly assigned to each group
- Description of the trial procedures, including any invasive procedures
- Explanation of the subject’s responsibilities
- Aspects of the trial which are experimental
- Foreseeable risks and inconveniences, as well as benefits or no benefits
- Alternative procedures that may be available to the subject, including risks and benefits
- Compensation and /or treatment available in the event of a trial-related injury
- The anticipated prorated payment, if any, for participating in the trial
- Any expenses related to participating in the trial
- A statement indicating that the subject’s participation is voluntary and that the subject may refuse and withdraw from the trial at any time without any penalty or loss to benefits to which the subject is otherwise entitled
- An explanation that the study’s monitor(s), auditors(s), the IRB/IEC and regulatory authorities will be granted access to the subject’s original medical records for verification of the clinical trial procedures and/or data without violating the confidentiality of the subject. By signing the written informed consent, the subject authorizes this access
- The subject’s identity will be confidential and will never be made publicly available
- The subject (or the subject’s legal representative) will be informed in a timely manner with updated information that may be relevant to the subject’s participation in the trial
- The person to contact for further information regarding the trial and the rights of the trial subjects, and whom to contact in the event of a trial-related injury
- Circumstances or reasons in which the subject’s participation in the trial may be terminated
- Duration of the trial
- Maximum number of subjects in the trial
Most informed consent forms will attempt to capture the above requirements in either two or three sections as described below.
Part 1: Basic Information
In Part I of the form, you’ll want to introduce yourself (including affiliations) and explain that you are inviting your participants to partake in the study. They should be informed that they are free to discuss the research, ask questions, and take the time to reflect before agreeing to participate. You will also need to provide, in laymen’s terms, the title, objective, and rationale of the study, as well as the risks and benefits of the study.
Part 2: Description of the Process
Part II of the informed consent needs to describe in detail how the study will be conducted. This includes a description of the responsibilities and the rights of the participant. The procedure should clearly indicate what type of intervention will occur and what the participant will be asked to do. Details such as the location and time of visits should also be noted. Lastly, this section should also clearly detail how the participant was selected and that their participation in the study is entirely voluntary.
Part 3: Confidentiality and Reimbursements
Part III of the informed consent should explain how the participant’s identity and the data will be kept confidential. Furthermore, it should describe how the data will be protected, the types of security measures in place, and how the data will be shared (if applicable). You also need to provide the contact information to a person that can answer any questions or concerns that participants may have about the study. Lastly, and likely most important to the participant, is to state the type of remuneration for completing the study. Include a space at the end of the form for the participant’s and the researcher’s/witness’ signature and date. You will always need at least two copies of the consent form, one for the participant and one for the researcher.
Preparing an informed consent form is straightforward once you have found a suitable template. Remember, be concise and keep the language simple. If possible, always get another person to review it for accuracy and spelling errors. If you need more help with developing your own informed consent form, please contact Sengi.