Remote Consent Guidance referenced in the IRB memo sent late January 2022.
Remote Informed Consent Guidance for FDA-Regulated Research
In the current public health emergency, many study teams and investigators have had to modify the informed consent process. As a means of offering flexibility and minimizing non-essential contact, methods other than an “in person” consent discussion may be acceptable if those methods provide a potential subject or the legally authorized representative (LAR) with adequate information about the research to allow for an informed decision about their voluntary participation in the research.
Additionally, the process must facilitate the subject’s comprehension of the information and allow them adequate opportunity to ask questions and consider whether or not to participate.
When feasible, we strongly recommend a traditional method of obtaining and documenting informed consent, however remote consent will be allowed as necessary. The purpose of remote consent is to allow the investigator/designee and potential participant to engage in the informed consent process in a way that is similar to what would be conducted in-person under normal circumstances.
It is important to note that the plan to utilize a remote consent process must be prospectively reviewed and approved by the IRB at the time of initial review or via an Amendment for studies already approved by the IRB. The submission must clearly describe the method (e.g., teleconference, videoconference, etc.) that will be used to conduct the remote consent process and request an alteration of consent to conduct the consent process in this manner.
Remote consenting, if not previously approved in the protocol, is a deviation from the approved protocol. However, if it is implemented urgently to eliminate risk to an individual, it is allowed without prospective IRB approval (only if a LAR is not required) but must be followed, within 5 days, with a formal Amendment and a Reportable New Information submission.
Below are two scenarios that may allow for remote consenting. The methods that need to be followed in each are provided below and come directly from the FDA’s most recent Guidance. Importantly, both methods require sending the person providing consent the consent first, before having the consent conversation and both methods require receipt of a signature from the person providing consent.
How do I obtain informed consent from a patient unable to travel to a clinical trial site where electronic informed consent is not an option?
When investigators do not have electronic informed consent (eIC) capabilities, methods of obtaining informed consent other than a face-to-face consent interview may still be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a participant in the clinical investigation or is the LAR of the trial participant. For example, the consent form may be sent to the trial participant or their LAR by fax or email, and the consent interview may then be conducted by telephone when the trial participant or their LAR can read the consent form during the discussion. After the consent discussion, the trial participant or their LAR can sign and date the consent form.
Options for returning the document to the clinical investigator may include fax, a photographic image sent through electronic means, scanning the consent form and returning it through a secure email account, or posting it to a secure Internet address, especially if there are concerns about having the participant mail a potentially contaminated consent document. Alternatively, the trial participant may bring the signed and dated consent form to his/her next visit to the clinical site, if restrictions on traveling to the clinical trial site are alleviated or mail it to the clinical investigator. The case history (i.e., study binder) for each trial participant must document that informed consent was obtained prior to participation in the trial. In addition, the person signing the consent form must receive a copy of the consent form.
The trial participant or their LAR must sign and date the informed consent form before the investigator may conduct any study-related procedures involving the participant. Where it is not feasible for investigators to receive the signed consent form prior to beginning study-related procedures, the investigators should have the prospective trial participant or LAR confirm verbally during the consent interview that the participant or LAR has signed and dated the form. In addition, the overseeing IRB must review and approve the planned informed consent process.
How can informed consent be obtained and documented from a prospective trial participant (or LAR) when they cannot print and sign a paper copy of the consent form provided electronically by the investigator/designee, they cannot electronically sign the informed consent form, and providing a paper copy of the consent form via mail/courier is not feasible within the time frame for enrollment into the clinical trial?
The investigator may consider using the following alternative process to satisfy FDA requirements for obtaining and documenting informed consent:
1. The investigator/designee provides the prospective participant (or LAR) with an electronic version of the informed consent document.
2. The investigator/designee arranges a phone call or video call with the prospective participant (or LAR), the investigator/designee, a witness who is not otherwise connected with the clinical investigation and, if desired and feasible, additional participants requested by the prospective participant (e.g., next of kin). Alternatively, in lieu of using a witness, a recording of the conversation can be made.
3. To ensure that the prospective participant (or LAR) is approached in a consistent fashion, a standard process should be used that will accomplish the following:
a. Identification of who is on the call.
b. Review of the informed consent document with the prospective participant (or LAR) by the investigator/designee and response to any questions the prospective participant (or LAR) may have.
c. Verbal confirmation by the prospective participant (or LAR) that their questions have been answered and that they would like to participate in the trial.
4. Verbal confirmation by the participant (or LAR) that they signed and dated a blank piece of paper with a written statement that they voluntarily agree to participate in the protocol, noting both the Protocol ‘NUMBER’ and brief protocol title.
5. After signing and dating the newly created document, the trial participant (or LAR) sends a photograph of the signed and dated statement by facsimile, text message, or email to the investigator/designee; OR returns the document to the investigator by mail at a later date, or at a future study visit that might occur in person.
6. When using a witness, documentation in the trial records includes a signed and dated attestation by the witness who participated on the call that the patient confirmed their agreement to participate in the trial and signed the document referenced above.
7. When using a recording in lieu of using a witness, documentation in the trial records includes the recording of the conference call.
8. After the signed and dated document is received by trial staff, it should be appended to a copy of the consent document that was reviewed with the trial participant (or their LAR) and retained in the trial records as would normally be done for a signed informed consent document. Additionally, a note in the trial records should be made explaining the circumstances of why informed consent was obtained through an alternative method. The case history for each trial participant must document that informed consent was obtained prior to participation in the trial.
This alternative approach must be reviewed and approved by the IRB overseeing the trial as required under FDA regulations
Additional notes
Be sure to include the HIPAA Authorization in the documentation sent to and signed by the person providing consent.
- The consent conversation may not occur if the potential subject has not received the consent document, as they will need to refer to the document during the discussion.
- For data security, it is recommended that researchers use Microsoft Teams, Zoom, Vidyo, Skype, or telemedicine portal for video conferencing. Facetime is not recommended for research studies. If you plan on recording the sessions on one of the above platforms, please make sure it is in a storage location that is HIPAA-compliant (i.e., managed and has access controls in place), and documentation in the trial records includes the recording of the conference call.
- As with standard consenting requirements, the investigator / designee must document the conversation, including (at a minimum): the date and time the conversation occurred, how it occurred (e.g., telephone, video conference), the name of the witness and any other participants, confirmation that the subject/LAR received the informed consent document, and confirmation of verbal informed consent to conduct the screening. This documentation should occur in the study binder or equivalent.
- As with standard consenting requirements, the final signed and dated informed consent document must be filed in the designated investigator/research file location and a copy should be provided to the subject/LAR.
- The use of Remote Consent for FDA regulated therapeutic trials is restricted to the COVID-19 public health emergency and must be prospectively reviewed and approved by the IRB.
The following changes to Exempt research review by the IRB:
- The IRB has created additional consent templates for some types of Exempt research. They can be found on the Investigator Quick Links page.
- The IRB will no longer stamp consents for studies that are approved as Exempt. Already approved and stamped Exempt consent forms may still be used, however, stamped consent forms cannot be modified. If an Investigator wishes to make a small change to an Exempt study that would affect an approved consent form, the change must be done to an unstamped consent. This change is only permitted for research approved as Exempt.
- In line with this change, the IRB will be ending the requirement for small changes to Exempt research to be submitted as Amendments. The following are examples of changes that would and would not require review.
- Examples of changes to Exempt research that do require an Amendment to be submitted before implementing:
- Changes to data collection associated with chart reviews including: increase in N;
- adding variable to be collected;
- expanding the date range of data collection, prospectively or retrospectively
- including new, sensitive questions to a survey or interview;
- changing data collection such that de-identified data will now be identifiable;
- including an intervention in the methods;
- changing variables to be collected from medical charts;
- decreasing confidentiality measures;
- including minors or adults lacking capacity to consent as subjects when previously only adults capable of consenting were to be enrolled;
- no longer collecting signed HIPAA Authorization;
- changing data collection method from in person to phone or video call—or vice versa—if the interview contains sensitive questions;
- large changes in compensation to subjects
Examples of changes to Exempt research that do not require an Amendment to be submitted before implementing:
- adding an additional interview or survey—so long as the questions are not sensitive;
- adding additional, non-sensitive, questions to a survey or interview;
- changing data collection method from in person to phone or video call—or vice versa—if the interview does not contain sensitive questions;
- increasing the number of participants to be enrolled;
- changing contact information;
- changing recruitment material;
The standard letters sent by the IRB have had several important changes. These changes include, but are not limited to: referencing the submission number on applicable letters, creating an Exempt Approval letter, clarifying requirements associated with a Not Human Subjects Research determination, including the determined Risk of an approved study, including a link to a Satisfaction Survey.
- CITI is best accessed through our Single Sign On portal. Instructions for how to affiliate with previous institutions can be found here (this should download the Word doc immediately or request a file pathway for the download.
- Both the FDA and NIH require researchers on clinical trials—as per each agency’s definitions—require to show proof of Good Clinical Practice (GCP) training.
The NIH definition of a clinical trial is, “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
The FDA definition of a clinical trial is, “Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.”
