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 TTUHSC 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 TTUHSC 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 TTUHSC 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.