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. Here is an Informed Consent Template .
Elements of Informed Consent
Obtaining Informed Consent
Documentation of Informed Consent
Informed Consent Language
Assent of Minors and Consent of Parents(s)/Guardians(s)
Exceptions from Informed Consent Requirements
FDA (21CFR50.25(a)) and DHHS(45CFR46.116(b)) both require that the following basic information be provided to subjects asked to participate in a research project:
Additionally, one or more of the following elements of information, when appropriate, must also be provided to each subject or legally authorized representative:
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.
During the informed consent process, the subject or representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether or not to participate. The informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. The informed consent as a whole must present information in sufficient detail relating to the research and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s understanding of the reasons why one might or might not want to participate.
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.
The IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.
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.
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.
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.
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.
Broad consent pertains to storage, maintenance, and secondary research with identifiable private information or identifiable biospecimens. Investigators who anticipate that they or others may want to use information or biospecimens collected through the primary research for unspecified secondary research may consider obtaining broad consent from the subjects as part of the informed consent process.
Broad consent is required to comply with general elements of informed consent, including obtaining informed consent before involving a human subject in research activity, only seeing consent under circumstances that provide the prospective subject sufficient opportunity to discuss and consider whether or not to participate, providing information to potential subjects in a way that is understandable to the subject, providing prospective subjects with all of the information that a reasonable person would want to have in order to make an informed decision about participation, and not including exculpatory language.
In addition, the following elements of information must be provided as part of broad consent (45CFR46.116(c)):
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.
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.
Please contact the IRB with any questions or concerns