7.0 Informed Consent
7.1 General Requirements
7.1.1 Obtaining Informed Consent
7.1.2 Informed Consent Language
7.2 Exceptions from Informed Consent Requirements
7.2.1 Emergency Use of a Test Article
7.2.2 Emergency Research Consent Waiver (FDA Studies Only)
7.3 Elements of Informed Consent
7.4 Documentation of Informed Consent
7.5 Assent of Minors and Consent of Parent(s)/Guardian(s)
7.5.1 Minors Assent
7.5.2 Consent of Parent(s)/Guardian(s)
7.6 Retention of Signed Consent Documents
7.7 Iowa Law
Research investigators shall ensure that no human subject will be involved in their research activity approved in the IRB protocol prior to obtaining informed consent from the subject or his/her legally authorized representative.
7.1.1 Obtaining Informed Consent
Research investigators shall obtain informed consent from the subject or the subject's parent, guardian or other legally authorized representative (hereafter referred to as the legally authorized representative) in accordance with 45CFR46.116, 21CFR50.20 and these policies. This responsibility cannot be delegated to personnel who are not listed as investigators on the research protocol approved by the IRB. Research investigators shall ensure that no human subject will be involved in any research project prior to obtaining informed consent from the subject or his/her legally authorized representative. Informed consent must be obtained prior to any stage or procedure performed solely for the purpose of determining eligibility for the research project.
Informed consent must be obtained under circumstances that offer the subject or his/her legally authorized representative sufficient opportunity to consider whether the subject should or should not participate. The informed consent must not include exculpatory language through which the subject or the subject's legally authorized representative is made to waive or appear to waive any of the subject's legal rights or releases, or that appears to release the research investigator, the sponsor, the institution or its agents from liability for negligence.
- In Person Consent: The research investigator is responsible for providing informed consent in the presence of the human subject, his/her legally authorized representative if applicable, and an adult witness if the subject is a minor. The witness must be an adult person not involved in the research study and may be an adult relative of the human subject. The written informed consent document must be signed by the human subject, his/her legally authorized representative if applicable, and the adult witness before the human subject can participate in the research. Each person that signs the written consent document shall be given a copy of the signed document.
- Telephone Consent: The research investigator may obtain consent by telephone, as approved by the IRB. In such instances, the research investigator is responsible for providing informed consent to the human subject and his/her legally authorized representative, if applicable, over the telephone. If the subject is a minor, an adult witness must be present during the informed consent process. The research investigator shall document in the research record the informed consent process. The written informed consent document shall be sent by mail or facsimile to the human subject and his/her legally authorized representative if applicable and the witness (if witnessed by an adult present with the human subject)for signature and returned before the human subject can participate in the research. If a witness is present with the research investigator, then he/she shall sign the informed consent document once the signed document has been received from the human subject. A facsimile of the signed informed consent document is as valid as the original. Each person that signs the written consent document shall be given a copy of the signed document.
- Electronic Consent: The research investigator may obtain consent electronically. The informed consent must be presented prior to participation in the study. Consent can be considered received if after the page with the informed consent is presented the particiant clicks to continue on the electronic study, or by answering a question saying consent is given. A copy of the informed consent should be available to the participant upon request and all electronic informed consents must have writen in them 'Print for your records.'
7.1.2 Informed Consent Language
Informed consent must be obtained in language understandable to the subject and/or the subject's legally authorized representative.The research investigator should use language that the average person of the age of the proposed research subject is likely to understand. Technical and scientific terms should be adequately explained or common terms substituted. Research investigators are urged to write the consent using the second person writing style (i.e., "you,", "I/we") as it helps communicate that there is a choice to be made by the prospective subject. In all cases, the writing style should be consistent throughout the written consent document. In cases where the study population includes non-English speaking people, the IRB will require that the informed consent document be written in each subject population's language and that an independently qualified translator be available during the consent process for those subject populations that do not understand English. If any member of the research population is illiterate, then the research investigator is responsible for having the informed consent document explained in the research subject's native language by an individual fluent in that research subject's native language.
7.2 EXCEPTIONS FROM INFORMED CONSENT REQUIREMENTS
7.2.1 Emergency Use of a Test Article
A test article is defined as a drug, biological product, medical device, food additive, color additive, electronic product or any other article subject to regulation by FDA 21CFR56.101(1) or under sections 351 or 354-360F of the Public Health Service Act. Single emergency use of a test article is exempted from prospective IRB review (21CFR50.23) and informed consent requirements provided that written certification of such use, as outlined in all of the criteria below, is reported to the IRB within five working days after use.
- The subject is confronted by a life-threatening situation
- Informed consent cannot be obtained from the subject due to an "inability to communicate" subject's inability to speak a particular language would not be considered an "inability to communicate"
- Time is insufficient to obtain consent from the subject's legally authorized representative
- No alternative method is available that provides an equal or greater likelihood of saving the subject's life
7.2.2 Emergency Research Consent Waiver (FDA Studies Only)
In very limited emergency research situations, the IRB may approve FDA-regulated research without requiring prior informed consent from the research subject. A protocol that clearly is identified as one that may include subjects who are unable to consent because of their life-threatening medical condition and who do not have a legally authorized representative.
In both situations listed above the Principal Investigator is responsible to ensuring that procedures are in place to inform, at the earliest feasible opportunity, each subject or his/her legally authorized and the IRB. If the IRB determines that it cannot approve the research because the research fails to meet the criteria for waiver of informed consent or because of other ethical concerns, the IRB must document its findings and provide them in writing to the Principal Investigator and any sponsor.
7.3 ELEMENTS OF INFORMED CONSENT
FDA (21CFR50.25(a)) and DHHS(45CFR46.116(a)) both require that the following basic information be provided to subjects asked to participate in a research project:
- A statement that the study involves research, an explanation of the purposes and duration of the subject's participation, description of the procedures to be followed and identification of any procedures that are experimental
- A description of any anticipated risks or discomforts to the subject
- A description of the expected benefits to the subject or others
- Alternative treatments available (if applicable)
- Plans for maintaining confidentiality of subject information
- A statement regarding any compensation that will be provided to study participants
- A contact person for the research
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
- A statement that a copy of the consent form will be given to the subject
- The date that the consent form was approved by the IRB (21CFR50.27(a))
- A statement explaining procedure for study participants to be provided results of research study, if appropriate
7.4 DOCUMENTATION OF INFORMED CONSENT
The informed consent document must be prepared in at least a 12-point easily-readable font with adequate margins on the sides, top and bottom.
Research investigators are responsible for insuring that informed consent is documented by the use of a written consent document most recently approved by the IRB. Research investigators shall also be responsible for ensuring that the most recently IRB-approved consent document is used to enroll each research subject and is signed by the subject or the subject's legally authorized representative, unless this requirement is specifically waived by the IRB.
7.5 ASSENT OF MINORS AND CONSENT OF PARENT(S)/ GUARDIAN(S)
7.5.1 Minor's Assent
Assent is defined as a child's affirmative agreement to participate in a research project. Assent is NOT granted by a child's passive resignation to an intervention procedure. When a research study involves minors as research subjects, both FDA and DHHS require that the research investigator obtain and document the minors' assent (where the minors are capable of providing assent) prior to initiating the research project. For research studies involving minors aged 7-17, the research investigator shall prepare and submit an informed assent document for IRB approval, which outlines the study in simplified language. A separate assent document outlining the key aspects of the research in very simple terms should be prepared for minors aged 7-12. The assent document for minors aged 13-17 may be more comprehensive, but must still use simplified, age-appropriate language.
Research investigators are responsible for obtaining each minor's assent and for insuring that assent is documented by use of a written document recently approved by the IRB, as indicated by the dated bottom page of the assent document. The research investigator is responsible for insuring that the minor signs the most age-appropriate assent document and that a copy of the assent is given to the minor and his/her parent(s)/guardian(s). Once a minor subject turns 18 years of age, the research investigator must re-consent the subject with a more recently approved adult consent document.
7.5.2 Consent of Parent(s)/Guardian(s)
Research investigators are responsible for obtaining parental consent from the parents or guardians of each minor subject enrolled in a research project. Parental consent should be obtained using the parental consent document most recently approved by the IRB, as indicated by the date entered at the bottom of the consent document. If the parents of a potential subject are minors themselves, they are not allowed to consent to their child's participation as a research subject unless the IRB has granted a waiver to this requirement. The IRB may grant waivers for projects that include no invasive procedures and present no more than minimal risk to the minor subjects. In rare instances, waivers may also be granted in situations where parent/guardian consent does not provide reasonable protection to thte subjects (e.g., neglected or abused children). However, an adequate mechanism to protect the children as research subjects must be in place and accurately documented.
7.6 RETENTION OF SIGNED CONSENT DOCUMENTS
Research Investigators are responsible for retaining all consent and assent documents signed by human subjects or the subjects' legally authorized representatives. These documents shall be maintained by the research investigator for a minimum of three (3) years after completion of the research project.
7.7 IOWA LAW
The informed consent requirements in this policy are not intended to preempt any applicable Federal, State or local laws which require additional information to be disclosed in order for informed consent to be legally effective.
