Frequently Asked Questions - Informed Consent
In general, yes, but there are some limited exceptions. The IRB has the authority to waive some or all of the federal requirements for informed consent in certain extenuating circumstances.
The principal investigator is responsible for retaining the signed informed consent documents obtained from the participants in a secure location for a minimum of three years after the study is concluded. The IRB or its designee (personnel in ORR) has the authority to conduct an audit of human research studies under its jurisdiction at any time, including a review of all signed informed consent documents.
The IRB requires disclosure of the process of obtaining informed consent during the application process. This disclosure includes specifying the names of the research personnel designated by the principal investigator to discuss the study with the potential subjects and obtained informed consent. Designated personnel must receive the Texas Tech Health El Paso-required training on the protection of human subjects in research prior to conducting any research-related activity, including obtaining informed consent. After IRB approval is granted, only authorized personnel may discuss the study and obtain informed consent from subjects.
If the subject or their legally authorized representative is unable to read, an impartial witness must also be present during the entire informed consent discussion. The witness should sign and date the informed consent document only after the subject or their legally authorized representative has consented to participate.
If the subject or their legally authorized representative is unable to read, an impartial witness must be present during the entire informed consent discussion. The witness should sign and date the informed consent document only after the subject or their legally authorized representative has consented to participate.
The informed consent document approved by the IRB be signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form. The person obtaining consent, either the principal investigator or their authorized designee, will also sign and date the form, attesting to the informed consent conversation. The principal investigator should sign the form only if he or she was present for the consent discussion.
If you have further questions, contact your local IRB office.
If the investigator or IRB determines that the research project is likely to involve the participation of subjects whose primary language is not English, a translated consent document is required. The foreign language version of a consent document should be a certified translation of the IRB approved English version. It is, therefore, submitted after the IRB has approved the English version along with a certificate verifying the translation was provided by a certified translation service. Certified translations may be acknowledged and stamped with approval by IRB administrative staff.
Note that appropriate interpreter services should be made available throughout the course of the research in order to provide effective communication throughout the research process, not only in
obtaining informed consent.
The research personnel will need to:
- Submit the English Informed Consent to the IRB for approval
- Upon receiving IRB approval, submit the English Informed Consent to:
- the sponsor’s translating service
- to the sponsor so that they can submit it to the translating service
- Or, have a qualified faculty or staff member translate the document (investigator-initiated studies). Written confirmation of inclusion of the same information obtained from a back translation (e.g. one individual creates a written document in the new language, and another person reviews the English and new language version and confirms they include the same information; include any credentials, certifications, education, native language fluency, etc. of the individual confirming the two documents include the same information).
- Submit the translated document to the IRB within 30 days of initial approval. This
submission should include:
- The certificate of translation or a statement listing the qualifications of the faculty or staff member who translated the document
- Submit any other subject questionnaires, diaries, surveys that also required translation
The cost of translating written consents is the investigator's responsibility. These costs may be quite high, particularly for large studies where multiple translations are needed and/or studies with relatively complex consent information that may require additional time by a skilled professional. Investigators should include the costs of written translations as well as medical interpreter services on grants and contracts. Industry sponsors usually pay the costs of translating consent forms.
A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document, when consistent with applicable state law.
A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means. If (1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, they may be entered into the study. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consent interview is recommended.
Note: The witness language has been removed from the Texas Tech Health El Paso informed consent templates, however, if it is felt that a situation might arise where a witness is needed, the witness language may be included on the template during the initial submission process to the IRB.
If a potential subject is blind, illiterate or mute this should not disqualify them from participating on a clinical research study. According to the FDA website “…can be entered into a study if they are competent and able to indicate approval or disapproval by other means. If (1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, they may be entered into the study. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consent interview is recommended.
The research personnel will need to:
- Read or ask the legally authorized representative to read the entire informed consent form to the subject.
- Remember that an impartial witness should be used and should be present during the entire process, and that the subject’s family or legally authorized representative cannot serve as a witness.
- You may consider video taping the process and providing the subject with a copy of the tape.
- When having the subject sign the consent, they can be guided to the location on the page where they can “make their mark” (FDA Website)
- The coordinator or person conducting the consent process should not write in the potential subject’s printed name, date and time on the subject’s designated lines. Instead a note should be made by the person obtaining consent at the bottom of the page. The note can include the subject’s name, but should be signed and dated by the person obtaining consent.
Note: The witness language has been removed from the Texas Tech Health El Paso informed consent templates, however, if it is felt that a situation might arise where a witness is needed, the witness language may be included on the template during the initial submission process to the IRB.
If a subject is not legally capable of giving informed consent or if the subject is cognitively impaired, the IRB must find that adequate provisions are made for soliciting the assent of the subject, when in the judgment of the IRB the subject is capable of providing assent. Failure to object to participate in a research study is not assent. In determining whether subjects are capable of providing assent, the IRB shall take into account the age, maturity, cognitive, and psychological state of the subjects involved. This judgment may be required for each subject individually or for all subjects in a particular research study, as the IRB deems appropriate.
If the IRB determines that the capability of some or all of the subjects is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the subject and is available only in the context of the research, the assent of the subject is not a necessary condition for proceeding with the research.
The research personnel will need to:
- Obtain informed consent from the legally authorized representative.
- Create and submit an unanticipated events form to the IRB in order to notify them of this occurrence. The outcome letter for this should be stored in the regulatory binder/file for reference.
Remote consent (sometimes referred to as “teleconsent”) is a method of obtaining informed consent using a paper or electronic consent form where the study team and participant are not in the same physical location during the consent process.
Remote consent using a paper consent form (or remote paper consent) is a specific type of remote consent where a copy of the written informed consent form is provided to the participant via email, fax, mail or during a prior in-person visit. The informed consent process may be conducted over the phone or via video conference (e.g. Zoom). The participant signs and dates a hard copy of the consent form and returns it to the study team via email, fax, mail, or at their first in-person visit.
Electronic consent (e-consent) is a method of obtaining informed consent through the use of an electronic system instead of a paper consent form. Please note: This method is currently not available at our institution. Not all e-consent systems contain the ability to document legally effective signatures.
When an e-consent system is used, the consent process can occur in-person or remotely. An example of an in-person consent process that uses an e-consent system would be giving a potential participant an iPad that displays the consent form in an e-system, discussing the consent form in person, and then the participant agreeing to participate by tapping the appropriate button in the e-system. For a remote e-consent process, the study team may give the potential participant a link to the e-consent system and go over the consent information over the phone or via Zoom. The participant would provide their consent via the electronic platform.
Please note: If you wish to use remote consent, you must submit the consent plan to the IRB via your IRB study application. IRB approval must be obtained for any consent process or change to the consent process.
Yes. When informed consent is required, the entire process can take place remotely, where the investigator and participant are not physically in the same location, however the investigator/authorized research personnel must ensure several things:
- Consent is still conducted remotely as a process/conversation (when appropriate), and the participant experiences a consent process as close to what it would be like in-person, as possible.
- The participant should have ample time and opportunity to review the consent form in advance, and then discuss it and ask any questions together with the investigator/authorized research personnel.
- The IRB-approved consent form is used and the IRB-approved Research Protocol/Study Application include an accurate description of the entire consent process.
- The physical location of the investigator/authorized research personnel and participant can be any place convenient to them (e.g. at home), but must provide adequate space for privacy and confidentiality.
- The remote environment can be virtual/online or on the phone. Video conferencing (e.g. Zoom) is allowable. Regardless of the environment, the participant must be informed in advance if the consent process will be audio and/or video recorded (i.e. at the time of recruitment or screening).
FDA requirements for electronic records and electronic signatures are set forth in 21 CFR Part 11 of the FDA regulations. When referencing a “Part 11 compliant” electronic consent system, this is referring to use of a system that complies with FDA regulatory requirements for electronic records and electronic signatures. Compliance with these regulatory requirements is required for all FDA-regulated research that is greater than minimal risk and minimal risk research where the requirement for documentation of consent has not been waived. Please visit the FDA’s guidance on electronic consent for additional information about the requirements set forth in 21 CFR Part 11 of the FDA regulations. Currently, TTUHSC El Paso does not have a Part 11 compliant system approved for use.
Currently, there is no e-consent system approved for use at TTUHSC El Paso. For research that requires documentation of legally effective consent, an e-consent system that is able to document legally effective signatures must be used. If the research is FDA regulated (includes drugs or devices), the FDA requires that the e-consent system be Part 11 compliant (21 CFR Part 11). Discussions are underway to assist with this process.
Outside e-consent systems may or may not be Part 11 compliant. If there may be the possibility of using e-consent systems from another institution or sponsor, you will need to ensure that the system meets the requirements for e-consent depending on the study type.
Remote consent must include a method to ensure that the person signing the informed consent is the subject who will be participating in the research study or is the subject’s LAR (see 21 CFR 11.100(b)). Examples of various methods that could be used include using information from some form of official identification, such as a birth certificate, government-issued passport, or a driver’s license. In addition, use of security questions to confirm an individual’s identity can also be considered.
For Research Under the Sole Authority of 45 CFR Part 46 OHRP recognizes that it may not be possible or necessary for all types of research covered by 45 CFR part 46 to verify that the person signing the informed consent is the subject or the subject’s LAR who will be participating in the research study. OHRP encourages investigators to apply a risk-based approach to the consideration of subject identity. For example, social behavioral minimal risk research will not typically warrant such verification. In addition, informed consent may be waived for minimal risk research meeting the requirements at 45 CFR 46.116(d).
The following standard language should be incorporated into the IRB study application informed consent section on documented consent if you wish to incorporate a remote consent option into the consent process for your study. You will not need to make any changes to your consent document(s).
NOTE: No study related procedures may occur until a signed copy of the consent is in the possession of the study team (this can be a faxed, emailed or mailed copy) unless the IRB has approved a waiver of documentation of consent to allow select activities to occur before written consent is finalized.
“Revisions to the informed consent process are being permanently adopted for this research. Remote consent will be used as opposed to in person consenting where possible to reduce unnecessary in person encounters specifically for a consent procedure. In the event remote consent is utilized, participants will be provided with a copy of the Informed Consent prior to the remote consent meeting either via email, fax, mail or previously provided during an in person visit.
The identity of the participant signing the informed consent, whether the subject in the research study or the subject’s legally authorized representative, will be verified through some form of official identification or other method [describe].
Participants will be given adequate time to consider the research study and ask questions prior to signing the consent form. The consent authorized representative must verify the participant physically signed the consent document either by viewing via video conference, obtaining a photo of the signed consent document, or obtaining verbal confirmation from the participant that he/she signed the consent form or agreed to participate electronically. The participant or LAR will sign and date/time the informed consent document. The document is then mailed, emailed or faxed to the consent authorized representative. The participant will be asked to return the original signed document on their first in person visit. If the Informed Consent form is mailed to the consent authorized representative by the participant the IRB-approved consent authorized representative will sign the copy, which they possess after the participant has acknowledged signature on their copy. Once the original is received by the consent authorized representative the copies will be attached to make a single document. In all other instances, once received, the IRB-approved consent authorized representative signs, dates/times the informed consent document. The Informed Consent Cover Sheet is then completed, signed, dated/timed and all components of the consent are combined into one document. After the Informed Consent process is completed, the IRB authorized research personnel will file the consent document in the research record.
Research personnel will provide the person signing the consent form with a copy of the final consent document, unless this requirement has been waived by the IRB. The copy can be provided in person or sent via secure email or regular mail.
At the time of the first clinical encounter post remote consent, authorized research personnel will review any additional questions with the study participant, prior to research procedures beginning.”
If you seek to use an external e-consent system for FDA-regulated research, the IRB requires verification that the system is Part 11 compliant to ensure the conduct of research at our site complies with FDA requirements for electronic records and electronic signatures. The following will be accepted as verification of Part 11 compliance:
- A letter/email from the system “owner” verifying that the system is Part 11 compliant
- An official product descriptor of the e-consent system (i.e. from the e-consent system’s official website) verifying it is Part 11 compliant
- An email from an IT professional at the host institution verifying the system is Part 11 compliant
- Documentation from the sponsor that the system is Part 11 compliant.
This information is attached to the initial review form upon submission and referenced in the informed consent section of the study application.