Informed Consent

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)
Broad Consent
Exceptions from Informed Consent Requirements

Elements of Informed Consent

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:

• 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 reasonably forseeable risks or discomforts to the subject
• A description of the expected benefits to the subject or others that may reasonably be expected from the research
• Alternative treatments available (if applicable)
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
• For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or whether further information may be obtained
• A statement regarding any compensation that will be provided to study participants
• An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contactin the event of a research-related injury to the subject
• 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
• One of the following statements about any research that involves the collection if identifiable private information or identifiable biospecimens:
  • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility
  • A statement that the subject’s information or biospecimens collected as part of the research, even if identifers are removed, will not be used or distributed for future research studies
• 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))

Additionally, one or more of the following elements of information, when appropriate, must also be provided to each subject or legally authorized representative:

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable
• Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or the legally authorized representative’s consent
• Any additional costs to the subject that may result from participation in the research
• The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject
• A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject
• The approximate number of subjects involved in the study
• A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
• A statement regarding whether clinically relevant research results, including individual research results will be disclosed to subjects, and if so, under what conditions
• For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e. sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

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.'

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.

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.

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:

• That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern.
• That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
• If the subjects are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and that there is an appropriate alternative mechanism for documenting that informed consent was obtained.

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 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.

Assent of Minors and Consent of Parents(s)/Guardians(s)

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.

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

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)):

• A description of any reasonably forseeable risks or discomforts to the subject
• A description of the expected benefits to the subject or others that may reasonably be expected from the research
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
• 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 the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit, if applicable
• For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e. sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen), if applicable
• A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens
• A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens
• A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained and a description of the period of time that they may be used for research purposes
• If applicable, a statement that subjects will not be informed about the details of any specific research studies that might be conducted using identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies
• Unless it is known that clinically relevant research results, including individual research results will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject
• An explanation of whom to contact for answers to questions about the subject’s rights and about storage and use of the subject’s identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm

Exceptions from Informed Consent Requirements

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

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 IRB staff with any questions or concerns
515-271-2850
irb@drake.edu