Informed Consent Process


Federal regulations require investigators to obtain informed consent of the subject prior to research interventions. The informed consent form (ICF) must have written IRB approval before implementing with subjects.

Informed Consent Form

The Emory Institutional Review Board (IRB) provides many ICF templates on their website that are specific to study sites (e.g., CHOA, Grady, and VA) and the type of research study. The IRB template provides the IRB stamping template at the header. 

Remember to use 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 the eIRB, Documents tab. 

Go to IRB Consent Toolkit

Informed Consent Discussion

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

The investigator, or his/her designee as documented on the delegation of authority log, must fully inform the subject of all pertinent aspects of the trial including all of the information in the ICF. The investigator should also discuss relevant aspects of the trial that may not be described in detail in the ICF, for example:

  • the schedule of events/procedures for the study
  • transportation to the study site
  • additional costs
  • pill diaries
  • surveys
  • follow-up procedures
It is critical that the subject understand that participation in the research study is voluntary as well as all of the alternative therapy options. All questions must be answered to the subject’s satisfaction.

The subject should be given the option to take the ICF home to read and discuss with friends and family members. The investigator should encourage the subject to call him/her if he/she has further questions.

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

View IRB Policies and Procedures

Signing the Informed Consent Form

When the subject returns to the study site, the investigator will need to assess the subject’s understanding of the study and ask if he/she has questions. If the subject is ready to sign the ICF, he/she must personally sign and date the form. The investigator, or his/her designee, must also personally sign and date the form as the person obtaining informed consent.

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. 

When the subject returns to the study site, if he/she has already signed the ICF previously provided by the study team (to take home and read), the investigator will need to provide the subject with a new ICF to personally sign and date with the investigator. Don’t use the ICF that the subject signed from home.

If there are optional further portions of the ICF, the subject 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.

The investigator is required to provide a copy of the signed and dated informed consent to the subject to keep. The original ICF must remain with the research records at the trial 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 subject was given time to read through the ICF and ask questions, who reviewed the ICF with the subject, the date and time the consent was signed, and that a copy was given to the subject to take home.

An informed consent procedure note template may be useful to remind you of all the items to cover in the informed consent process and to document them.

View IC Process Note Template

Informed Consent Form Revisions and Reconsent

Whenever there are substantive changes to the protocol or when important new information becomes available you will need to revise the ICF. Often times the sponsor will send ICF changes to the study team with a protocol change or new safety information. 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.

The IRB-approved and stamped version of the ICF must not be altered by the subject or research team.

When there is new information pertaining to safety, reconsent of subjects is almost always appropriate. The investigator should consider obtaining reconsent from subjects actively participating in the study and/or notification to past subjects who need to know about the new information (e.g., a newly identified risk of long-term osteoporosis in subjects who stopped taking the study drug years earlier).  Reconsent must occur at the next meeting between the subject and a study team member. 

The IRB and/or sponsor may require reconsent of subjects. If the Emory IRB requires reconsent of subjects, they will include the requirement in the approval letter of the consent amendment.  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, it is acceptable for the investigator to notify/obtain reconsent of subjects if he/she deems it necessary.  Revised consent forms and any other written information that will be distributed to subjects 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