The informed consent form is the document that participants must sign before participating in a clinical research study and before any screening procedures are undertaken. The informed consent document should provide general information, study-specific information and in addition any specific national/regional regulatory requirement:

• The name of the clinical research study and its purpose
• A statement that the study involves research
• How long the study will last, how many participants will be enrolled
• Procedures that will be performed, and whether any of the procedures are investigational and or invasive
• Information about study visits, and follow-up if applicable
• Possible risks or discomforts associated with the study
• Any benefits to the participant or to others
• A description of possible alternatives that exists, if any, to participation in the study
• A description of the level of confidentiality that will be applied to the private health information and who may have access to the records
• Reimbursements and compensations
• Contact information for questions concerning the study or a research-related injury (usually the clinical investigator), and questions concerning research participant rights (usually the Institutional Review Board [IRB]/Independent ethics committee [IEC])
• A statement that participation in the study is voluntary and that a choice not to participate, or to discontinue participation, will not result in any loss of benefits or penalty
• Other information may be included in a study’s informed consent form if the sponsor, and/or the IRB/IEC believe that the information is needed to better inform and assist in the decision-making process

General best practices to consider while drafting informed consent forms

• Have a general model document template and then customize it for each country, and if required for sites too
• Have a consistent and standard file naming convention that helps to track consent forms/assent forms/amendments at general level, country level, and site level
• Use simple language and not technical language or jargons, including in description of medicinal product and in risk language
• Draw measurements should be provided in tablespoons/teaspoons instead of millilitres
• Tailor the document to the subject population. If the population is vulnerable for example children, particular care and customization is required while drafting
• Use the second (you) or third person (he/she) to present the study details. Avoid use of the first person (I)
• The consent document must be consistent with what is mentioned in the final or latest protocol/amendment
• Use fonts that are easily readable and appropriate font size
• Be consistent with the use of drug names. Brand names must be capitalized and include either the trademark or registered symbol the first time when mentioned. Generic names should be in lowercase
• Spell out acronyms when first used
• Describe study design procedures such as “double blind,” “randomized,” and “placebo/controlled” when the concept(s) is/are first introduced. Example: A placebo is an inactive substance that looks like the study drug, but contains no medication
• For double-blind studies, include a statement that the blind can be broken in case of an emergency. Example: In the case of an emergency, the study doctor can quickly find out to what study group you are assigned
• To describe an investigational drug, device or procedure, do not use the words “treatment” or “therapy”. Use the term “study drug” not “study medication” when the drug is investigational. The word “medication” or “medicine” should only be used if the drug is commercially available
• If one of the study arms will be a placebo, do not use the term “treatment” or “therapy. Instead, use words like: “study product”, “study drug or placebo”, “study regimen” or “study procedure
• Do not describe investigational drugs, devices or procedures as “new.” For investigational drugs or devices, state they are investigational or “experimental” and describe that term (e.g., the word “investigational” means the study drug is not approved by the regulatory authority and is still being tested in research studies.) Be consistent in using “investigational” throughout the consent form
• Use “study doctor” instead of “principal investigator”
• Use “research study,” instead of “trial”
• Use the word “participant” in the consent form instead of “patient” since this is research.
• When describing randomization for 2 groups use, “like the flip of a coin,” for more than 2 groups, use “like drawing numbers from a hat”
• For optional portions of the study (e.g., for permission to store samples for future research), insert checkboxes to allow the participant to indicate his/her choice.
• Present all risks in bulleted form rather than paragraph form
• Do not use unnecessary and redundant information, that adds length to consent forms
• No coercive (intimidating) aspects which might impede voluntary participation
• Avoid any deception or incomplete disclosure
• Consent should be written at a level appropriate to the subject population, generally at an 8th grade reading level