Like any adverse events reporting in clinical trials, the informed consent process is a crucial aspect, and though it may seem something simple, it must be carefully done. Informed consent is not just a simple document that patients must sign and then they can participate in clinical investigations; it is a process that goes on before the study starts, during the study, and at the end of the study, if necessary.

Informed consent is essentially giving the patient as much information as possible about the clinical study, giving them a good understanding of the study, before they can actually decide to participate. It is not a simple task to decide what is enough information for a patient to make an informed decision. Investigators or whomever will be conducting the informed consent process must make a reasonable effort to make sure patients understand what they will be getting into prior to signing the form, including using a combination of the standard consent process with video aids or other media. To fully assess the level of understanding of the patient, it is recommended that open-ended questions be asked, as opposed to closed-ended ones, allowing the patient to repeat what was said by the individual conducting the process. Another factor that may complicate this process are situations where vulnerable subjects, emergency situations may arise. No matter the study, for the most part the basic elements to be included in the consent are listed on the next page:  

 Clinical Trial Description

• Statement that the study involves research
• Study purpose (s)
• Study treatment and the possibility for random assignment to each treatment condition
• Study procedures including all invasive procedures
• Subjects responsibilities
• Aspects of the study that are experimental
• Expected duration of subjects participation
• Approximate number of subjects in study

Risks and Benefits

Reasonably foreseeable risks or inconveniences to the subject and or fetus or embryo or nursing infant

• Reasonably expected benefits (and when there’s no intended clinical benefit to the subject, s/he must be made aware of that)
• Alternative courses of treatment or procedures that may be available to subject, including their potential risks and benefits
• The name of the person to contact for further information regarding the study and the rights of study subjects, and person of contact for trial-related injuries 

Confidentiality of Subject

Explanation that the subjects medical records may be inspected by representatives of the sponsor, IRB/IEC, or a regulatory authority, and that signing the for is acknowledging consent. It is equaly important that the patient be told s/he can opt out at any time!

• Explanation of confidentiality or subjects records
• Assurance of confidential identity in the event of published results

Participation

Statement of voluntary participation and a right for participation refusal and withdrawal without penalty or loss of entitled benefits.

• Statement that subject will be informed in a timely manner if new information becomes available that could assist in decision of willingness to continue to participate
• Foreseeable circumstances and/or reasons under which the subjects participation in the study may be terminated
• Explanation of anticipated expenses, if any to the subject, for study participation
• Explanation of compensation and treatment to subject in the event of trial-related injury
• Explanation of anticipated pro-rated payment, if any, for participation in study