Table 2.

Adherence to requirements derived from federal guidance on electronic informed consent

Requirement Number	Question and Requirement Description	Adherence (yes/no)
Q1: How should information in the eConsent be presented to the subject?
1	eConsent must contain everything required by 45 CFR 46.116 (General requirements for informed consent) and 21 CFR 50.25 (Elements of informed consent)	yes
2	eConsent must be easy to navigate, allowing user to go forward and back and to stop and continue at a later time	yes
3	Subjects should have the option to use paper-based or electronic IC methods completely or partially throughout the process	yes
Q2: How and where may the eConsent process be conducted?
4	Process must be conducted at study site or remotely. If remote, must include mechanism to ensure person electronically signing is the person participating or their LAR.	yes
5	eConsent must be legally binding, regardless of onsite or off-site	yes
6	eConsent must include mechanism to ensure person electronically signing is the participant or their LAR	yes
Q3: How and when should questions from subjects be answered?
7	Questions should be answered via in person discussions or combination of electronic messaging, telephone calls, video conferencing, or live chat with remotely located investigator or study personnel.	yes
8	eConsent should have methods in place to ensure the process allows subjects the opportunity to consider whether or not to participate and to ask questions	yes
9	When live chat or video is used, there should be reminders to conduct the discussion in a private location	no
10	Subjects should be given a description of how and when they will receive answers to their questions, and how they can communicate back in the event that they sustain a research-related injury	yes
Q4: What steps may be taken to facilitate the subject’s understanding of the information being presented?
11	eConsent content should be appropriate for intended audience based on age, language, and comprehension level	yes
Q5: What steps may be taken to convey additional information, including significant new findings, to the subject during the course of the research?
12	eConsent must contain a statement that significant new findings or updates/amendements that may affect the subject’s willingness to continue will be communicated to the subject or their LAR and that they’ll have the opportunity to ask questions and sign an updated eConsent	yes
Q6: How can electronic signatures be used to document eConsent?
13	eConsent must comply with all 21 CFR 11 (Electronic Records; Electronic Signatures) requirements	yes
Q7: What methods may be used to verify the identity of the subject who will be electronically signing an eConsent for FDA-regulated clinical investigations?
14	eConsent must comply with 21 CFR 11 (Electronic Records; Electronic Signatures)	yes
Q8: What special considerations should be given to the use of eConsent for pediatric studies?
15	eConsent must comply with 45 CFR 46 (General requirements for informed consent) and 21 CFR 50 (Elements of informed consent)	no
16	IRB must determine that there are sufficient provisions for soliciting the assent of children	no
Q9: Should subjects receive a copy of their eConsent and have easy access to the materials and information presented to them in their eConsent?
17	Subjects must be given a copy of of the signed informed consent form unless requirement for documentation has been waived.	yes
18	If the eConsent uses multimedia to convey information related to research, hyperlinks should be provided on printed paper copies and accessible until study completion	no
Q10: What steps can be taken to ensure privacy, security, and confidentiality of the eConsent information?
19	eConsent must be secure with restricted access as per 21 CFR 11 and should include methods to ensure confidentiality regarding identity, subject participation, and personal information after IC has been obtained	yes
20	If the entity holding PII is a covered entity or BAA of one, eConsent must adhere to HIPAA rules regarding privacy, security, and breach notifications	yes
Q11: Can HIPAA authorizations for research, which are frequently combined with informed consent documents, be obtained electronically?
21	When covered entities seek authorization forms, they must provide the participant with a copy of the signed authorization form	yes
Q12: What eConsent materials should the investigator submit to the IRB?
22	All forms, electronic and paper, must be submitted to the IRB, along with any modifications	yes
23	Investigators should discuss plans for using eConsent with IRB before finalizing development	yes
Q13: What are the IRB’s responsibilities in the eConsent process?
24	IRB must review and have authority to approve, require modifications to, or disapprove all research activities. IRB must approve and review eConsent and any amendments	yes
25	IRB must approve and review eConsent and any amendments, as well as maintain/retain copies of any materials	yes
26	IRB should review any optional questions or methods used to gauge subject comprehension and ensure that eConsent materials are usable, as well as maintain copies of any study-related information	yes
Q14: What eConsent documentation does FDA require for submission with applications?
27	eConsent documentation must be available for federal review for INDs. IDEs must include eConsent documentation. Documentation must be the same materials that will be presented to subjects.	yes
Q15: What steps can be taken to ensure the system archives the eConsent materials appropriately for FDA-regulated clinical investigations?
28	eConsent should incorporate procedures to ensure documents can be archived appropriate and retrieved easily in compliance with applicable FDA regulations.	yes
Q16: What materials or documents will FDA require during an inspection?
29	When sites are inspected by FDA, FDA must be granted access to site-specific versions of the EIC along with all amendments and subject-signed forms.	yes