Informed Consent Process

Federal regulations require investigators to obtain informed consent of the participant prior to research interventions. The informed consent form (ICF) must have IRB approval before implementing with participants. The best resource with updated informed consent templates and guidance is the Emory IRB Consent Toolkit and Emory IRB Consent Instructions and Guidance for alternative consent methods.

Informed Consent Form

The Emory IRB provides many ICF templates on their websites that are specific to study sites (e.g., CHOA, Grady, and VA) and the type of research study. The IRB template has been written at an 8^th grade reading level and provides the IRB stamping template at the header. Periodically review Emory IRB’s informed consent form templates to stay up-to-date on the available templates.

Utilize the most current IRB-approved ICF within the approval and expiration dates on the IRB stamp. The best way to ensure that you have the most updated version is to print the ICF from eIRB, Documents tab.  Resist the urge to print 20 copies for future use or saving to your computer desktop because doing so will increase the chance that you will use an outdated form.

The IRB-approved and stamped version of the ICF must not be altered by the participant or research team. Study teams may provide a copy of the ICF to the participant to make notes during the informed consent discussion.

Informed Consent Discussion

The researcher must conduct the informed consent discussion in a language that is understood by the participant. Additionally, the informed consent form must be in a language that the participant can read. 

The investigator, or his/her designee as documented on the delegation of authority log, must fully inform the participant of all pertinent aspects of the study including all of the information in the ICF. The investigator should also discuss relevant aspects of the study that may not be described in detail in the ICF (e.g., the schedule of events/procedures for the study, transportation to the study site, additional costs, pill diaries, surveys, and follow-up procedures). Participation in the research study is voluntary and participants must be made aware of alternative therapy options. All questions must be answered to the participant’s satisfaction.

The participant should be given the option to take the ICF home to read and discuss with friends and family members. The investigator should encourage the participant to call with further questions.

When a researcher specifically targets individuals that are non-English speaking, the researcher must obtain IRB approval for a fully translated ICF for the participant to sign. When there is not enough time to obtain a fully translated ICF or the researcher expects low accrual of participants of the particular language, the researcher must seek IRB approval of a short-form that is in the participant’s language.  For further information on short-form consent or obtaining consent in other special circumstances (e.g., children, cognitively impaired, or participants who are blind or illiterate), visit the IRB website

Signing the Informed Consent Form

When the participant returns to the study site, the investigator will need to again assess the participant’s understanding of the study and ask if he/she has questions. If the participant is ready to sign the ICF, he/she must personally sign and date the form. If he/she has already signed the ICF from home, the investigator will need to provide the participant with a new ICF to personally sign and date with the investigator. Do not use the ICF that the participant signed from home. The investigator, or his/her designee, must also personally sign and date the form as the person obtaining informed consent.

If there are optional portions of the ICF, the participant and investigator must also personally sign and date the signature lines. If there are initial lines on each page of the ICF, those should also be completed on all pages.

If a legally authorized representative (LAR) signs the ICF, the person obtaining informed consent should make reasonable attempts to obtain documentation of the authentication of the LAR. 

The investigator is required to provide a written copy of the ICF to the participant to keep.  The original ICF must remain with the research records at the study site.

Documentation of the Informed Consent Process

The informed consent process must also be documented in the research or medical record.  A brief note should describe the date and time the informed consent discussion began, whether the participant was given time to read through the ICF and ask questions, who reviewed the ICF with the participant, the date and time the consent was signed, and that a copy was given to the participant to take home.

An informed consent process note template is useful as a reminder of all the items to cover in the informed consent process and how to document.

Informed Consent Form Revisions and Reconsent

Whenever there are substantive changes to the protocol or when important new information becomes available, the ICF will be modified. The sponsor will inform the study team of a protocol change or new safety information and updated language for the ICF. If the changes are being initiated by the investigator rather than sponsor, the PI must first seek the sponsor’s approval for the ICF changes prior to submitting them to the IRB as an amendment.

When there is new information pertaining to safety, reconsent of participants is almost always appropriate. The investigator should consider obtaining reconsent from active participants and/or notification to past participants who need to know about the new information (e.g., a newly identified risk of long-term osteoporosis in participants who stopped taking the study drug years earlier).  Reconsent must occur at the next meeting between the participant and study team member. The reconsent process must also be documented as for initial consent, with the focus of the reconsent documentation being the reason for reconsent and changes to the ICF.

The IRB and/or sponsor may require reconsent of participants. If the Emory IRB requires reconsent of participants, they will include the requirement in the approval letter of the consent modification. The sponsor may notify study teams of a reconsent requirement via letters, email, or phone. Even if the IRB and/or sponsor do not require reconsent, the investigator should seek reconsent of notification to previous participants when  necessary. Revised consent forms and any other written information that will be distributed to participants must receive approval from the IRB in advance of use. 

References

21 CFR 50, 21 CFR 56, 45 CFR 46, Emory IRB Policies and Procedures, and International Conference of Harmonization, Efficacy Guidelines, Good Clinical Practice