Informed Consent

What are the Elements of the Informed Consent document

Do all Research Studies Require Documentation of Informed Consent?

What is Informed Consent?

Contemporary ethics regarding human subject research as stated in the Belmont Report underline the moral principle of “respect for persons”. This ethical principle requires individuals in research to have the opportunity to make a conscious decision regarding what shall or shall not happen to them (autonomous agents). The application of this principle is the informed consent document by serving as an “autonomous consent” to participate in research. Information, comprehension and willingness to participate (voluntariness) are fundamental elements of the informed consent document. The consent should adequately convey all the information needed for the subject to understand the study, in addition, to being in a language understandable to the subject. A subject’s consent to participate must be free from coercion. Above all, the subject should be able to understand the information presented in order to make an informed decision.

However, true informed consent goes beyond a document. Informed consent is really a process that begins with the recruitment phase and ends in the completion of the study. An investigator and research staff should have an informative interaction with the subject throughout each phase of the research.

What are the Elements of the Informed Consent document?

As described above, the Informed Consent process is a critical safeguard for the protection of human subjects. Given this, there are specific elements or information that need to be included in the informed consent process so that subjects may make an informed decision regarding their participation (or non-participation) in the study.

The Basic elements of informed consent are provided below [45 CFR 46.116 (b)].

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) A description of any reasonably foreseeable risks or discomforts to the subject;

(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) For research involving more than 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 where further information may be obtained;

(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and

(8) 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.

(9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

(i) 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; or

(ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

The Additional elements of informed consent are provided below. When appropriate, one or more of these elements of information shall also be provided to each subject or the legally authorized representative [45 CFR 46.116 (c)]:

(1) 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) which are currently unforeseeable;

(2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;

(3) Any additional costs to the subject that may result from participation in the research;

(4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5) A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject; and

(6) The approximate number of subjects involved in the study.

(7) 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;

(8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and

(9) 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).

The elements of Broad Consent are provided below [45 CFR 46.116 (d)(1)-(7)]. PLEASE NOTE: THE NTR IRB DOES NOT IMPLEMENT BROAD CONSENT AT THIS TIME.

Elements of broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the informed consent requirements in paragraphs (b) and (c) of this section. If the subject or the legally authorized representative is asked to provide broad consent, the following shall be provided to each subject or the subject’s legally authorized representative:

(1) The information required in paragraphs (b)(2), (b)(3), (b)(5), and (b)(8) and, when appropriate, (c)(7) and (9) of this section;

(2) A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;

(3) 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;

(4) A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite);

(5) Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject’s 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;

(6) 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; and

(7) 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.

How should an Informed Consent document be written?

The regulations state that the consent shall be in language understandable to the subject or the legally authorized representative. This goes beyond having the consent document just in the language understandable to subject (English, Spanish, etc.). To enhance understandability and readability, the consent form should be written in simple language (i.e., in lay person’s terms). The consent form must also be written at a reading level that is appropriate for the subject population, which is typically at or below an 8^th-grade reading level. However, the investigator should consider the subject population (target audience) when writing the consent form. For example, an investigator interviewing doctors might include technical (medical) terminology in the consent form, instead of using the equivalent, simplified terminology.

Nonetheless, it is important for the consent document to be clear and have a concise explanation of the various elements of the research study. In addition, the language should not contain any element of coercion nor appear to waive a subject’s legal rights, or release the investigator, sponsor or institution from liability for negligence (no exculpatory language).

Do all Research Studies Require Informed Consent?

In some instances, under certain requirements, federal regulations permit the IRB to grant a waiver of informed consent or allow an adaptation to the required elements of an informed consent. The following criteria must be met to qualify for this waiver or alteration of consent [45 CFR 46.116 (f) (3)]:

(1) The research presents no more than to subjects

(2) The research could not practicably be carried out without the requested waiver or alteration;

(3) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;

(4) The waiver will not adversely affect the rights and welfare of the subjects; and

(5) Whenever appropriate, the subjects will be provided with additional pertinent information after they have participated in the study.

It is important to note that numbers (1), (2), (3), (4) and (5) must all apply and must be cited as justification for waiver of informed consent. Number (5) is particularly important in Social Behavioral research, for example, in the following types of situations:

- - There may be new information as a result of a survey or focus group that would be relevant to the subjects.
  - The purpose of the research requires elements of deception in order to obtain a natural response that the subject would not display if the elements of deception were disclosed prior to the exercise. However, after the completion of the study, pertinent information must be disclosed to the subject.
  - Subjects may be undergoing manipulation to elicit emotional responses.

Investigators should waiver of informed consent (or an alteration of consent). The NTR IRB has created a form, the Waiver of Informed Consent form, for investigators to use for requesting such waivers. Please visit the NTR IRB Forms page to access the Waiver of Informed Consent form.

Do all Research Studies Require Documentation of Informed Consent?

The North Texas Regional Institutional Review Board under federal regulations can waive the requirement to obtain documented informed consent (i.e. initials, signature). Research studies that fall under the following criteria may qualify for a waiver of documentation of consent [45 CFR 46.117 (c) (1)]:

(i) 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 (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern;

For example, a study recruiting individuals involved in criminal activities may qualify for this waiver as their signature alone (personal identifier), if exposed, could lead to criminal liability.

(ii) That the research presents no more than of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or

For example, a study evaluating the effectiveness of a smoking cessation program among its participants. The anonymous questionnaire containing no personal identifiers will be administered after the completion of the program. The research is deemed by IRB chair to be no more than minimal risk and study procedures (evaluation survey) would normally be carried out regardless of research intention. This study may qualify for a waiver of documentation of consent.

(iii) If the subjects or legally authorized representatives 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 provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

It is important to note that only one of these regulations needs to apply in order to qualify for this waiver. All (or more than one) do not need to apply to justify for this waiver.

The NTR IRB has created a form, the Waiver of Documentation of Informed Consent form, for investigators to use when requesting a waiver of documentation of informed consent. Please visit the NTR IRB Forms page to access the Waiver of Documentation of Informed Consent form.

An investigator who qualifies for a waiver of documentation of consent must still disclose pertinent study-related information the subject. Such information can be provided to the subject in the form of a consent statement/cover letter. The NTR IRB has created a template for investigators to use when developing a consent statement/cover letter for their study. The Consent Statement/Cover letter template is available on the NTR IRB Forms page.

Informed Consent Templates

Please visit the NTR IRB Forms page to access consent form templates (e.g., general consent form template, consent statement/cover letter template, etc.). Please note that each template includes general guidance as well as instructions to investigators on how to draft an appropriate consent document. Investigators should carefully read through the information provided in each template, and ensure that all information included in the final draft submitted to the NTR IRB is appropriate to the conduct of their specific research study.

This page was last modified on May 25, 2023