Informed Consent

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What is Informed Consent

What are the Elements of the Informed Consent document

How should it be written

Do all Research Studies Require it

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.

Often research studies involve the collection and use of health information (medical records, patient prescription, health status, disease progression, etc.) in order to successfully carry out the protocol. Whenever research involves health information, a new batter is brought to the informed consent plate…HIPAA. For more guidance regarding HIPAA authorization for research purposes click here or call ORC – North Texas Regional IRB at 817-735-0409. back to top

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 Revised Common Rule has made updates to these elements required in the informed consent process. The intent of these revisions is to help “modernize, strengthen, and make more effective the federal policy for the protection of human subjects” (HHS 2017).  

These updates include the following:

Highlights of New Elements of Informed Consent

Key Information

Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative 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.

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 or legally authorized representative’s understanding of the reasons why one might or might not want to participate.

[45 CRF 46.116 (a) (5) (i) & (ii)]

Identifiable Information/Biospecimens

One of the following statements about any research that involves the collection of 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; or

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

[45 CFR 46.116 (b) (9) (i) & (ii)]

Clinically Relevant Research Results

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

[45 CFR 46.116 (c) (8)]

Biospecimens Research

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;

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).

[45 CFR 46.116 (c) (7), (9)]

Broad Consent

PLEASE NOTE OUR INSTITUTION WILL NOT BE IMPLEMENTING BROAD CONSENT AT THIS TIME [45 CFR 46.116 (d) (1) – (7).

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:

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

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;

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 (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);

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;

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

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.

[45 CFR 46.116 (d) (1) – (7)

The following are basic elements of informed consent [45 CFR 46.116 (a)]:

(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 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 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 following are additional elements of informed consent. When appropriate, one or more of these elements of information shall also be provided to each subject [45 CFR 46.116 (b)]:

(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 following are elements of broad consent [45 CFR 46.116 (d)]:

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.

PLEASE NOTE OUR INSTITUTION WILL NOT BE IMPLEMENTING BROAD CONSENT AT THIS TIME [45 CFR 46.116 (d) (1) – (7).

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How should an Informed Consent document be written?

The regulations state that the consent shall be in languageunderstandable to the subject. This goes beyond having the consent document just in the languageunderstandable to subject (English, Spanish, etc.). To enhance understandability and readability, the consent should be written in active voice, and avoid grammatical and typographical errors. It is primarily recommended, in order to maintain consent language simple (layman terms), the consent should not be written beyond a 9th grade reading level (Flesch-Kincaid Grade level). However, the investigator should consider the subject population (target audience) when writing the consent. For example, an investigator interviewing doctors might include in the consent technical (medical) terminology instead of using the equivalent simplified version.

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 subject’s legal rights, or release the investigator, sponsor or institution from liability for negligence (no exculpatory language).

The structure of the consent document entails the following:

(1) Heading and Title of the Study: The IRB recommends the heading of the document to be “INFORMED CONSENT TO PARTICIPATE IN A RESEARCH PROJECT”

(2) Identification of Investigators: Starting with the PI, the names and titles of all the investigators should be included. In addition, name the institution affiliated with each investigator(s).

(3) The Key Information section must be located at the beginning of the consent form and must include the following elements:

(a) The fact that consent is being sought for research and that participation in voluntary

(b) The purpose of the research, expected duration of the prospective subject’s participation, and procedures to be followed in the research

           (c) The reasonably foreseeable risks or discomforts to the prospective subject

(d) The benefits to the prospective subject or others that may reasonably be expected from the research; and

(e) Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject.

GUIDANCE NOTE: The Key Information section does NOT replace the other basic and additional elements of informed consent. This is also required for all DHHS studies and each section will need to be modified as needed. For an example of how to draft a Key Information section for your consent document, click here.

(4) Introduction: Give a brief description why the subject is being asked to participate in this research study.

(5) Study Purpose: State in layman terms the overall purpose, objective or goal of the study. The subject must understand how this procedure, intervention or observation differs from medical/health care, and research.

(6) Study Procedures: Give a step-by-step description of the procedures to occur in the study place. The subject should be able to understand what is expected of them, when and how often the visits will take place, and the duration of each visit and study. Be thorough- describe what will occur when and for how long with each visit, etc. If appropriate, include the approximate number of subjects to be enrolled in the study.

If your project involves the use of biospecimens for research purposes, the following statements should be included:

– 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.

– 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).

(7) Risks and Discomforts of the Study: There are two types of risks associated with research studies i) informational and ii) physical risk. Informational risk involves the possibility of a breach of confidentiality. This is not limited to only personal identifiers but also responses to sensitive questions. Physical risk also called “procedural risk” is more common in biomedical research studies or clinical trials.

(8) Contacts: Indicate the contact information of the principal investigator (research coordinator, if applicable) and the Chairperson of the North Texas Regional Institutional Review Board (at 817-735-0409).

(9) Benefits: Explain whether the study will have a direct or indirect benefit to the subject. If no direct benefit to a subject say so but also mention the value of doing this research. NOTE: Receiving compensation is NOT considered a benefit for the subject.

(10) Alternative Treatment (if any): If applicable, explain if there is any alternative to a subject’s research procedure or intervention.

(11) Confidentiality: Provide a description of the measures that will be taken to secure the privacy of subject data and identifiers. Since there is always a potential risk of loss of confidentiality, refrain from any language guaranteeing/assuring complete privacy.

Additional elements to include this section:

a. Please see the below for suggested language that may be included in addition to the researchers’ description of security measures and explanation regarding subject confidentiality:

“Your participation in this study, and all your research information will be kept as confidential as possible under current local, state and federal laws. However, the Office of Human Research Protections, possibly other federal regulatory agencies, and the North Texas Regional Institutional Review Board may review your research information/data in order to assure that the study was properly conducted. If the final results are published, your name or personal identifiers will not appear in any published material.”

b. If identifiable private information or identifiable biospecimens will be collected as part of the research, one of the following statements will need to be included:

(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.

(12) Compensation for Injury (if applicable): Explain the availability of compensation and/or medical treatment in case of a research-related injury.

(13) Costs and Compensation of the Study: If applicable, detail any costs subject may accrue during this study or any payment the subject may receive for time and effort.

(14) Withdrawing from the Study: This statement must clearly indicate that participation is voluntary and the subject may withdraw/leave at any moment without penalty or loss of benefits that the subject was otherwise entitled. If investigators will be recruiting from UNTHSC, the following statement must be included.

“If you are a [List affiliation, e.g., student/employee/resident] of the [Include institution, e.g. UNTHSC, JPS], your participation (or non-participation) will in no way affect your [insert as applicable, e.g. academic standing or employment status].”

a. In addition, please include the following information:

    • Anticipated circumstances under which the subject’s participation may be terminated by the investigator without the subject’s consent.
    • The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.

(15) Study Findings: Include a statement for each of the following:

a. Clinically Relevant Research Results: Whether clinically relevant research results, including individual results, will be disclosed to subjects, and if so, under what conditions;

b. Significant New Findings: 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.

(16) Consent Statement: This statement should indicate that the subject will receive a copy of the signed informed consent and the subject voluntarily agrees to participate in the study. This is the only statement that should be written in first person (e.g. “I” instead of “you”).

(17) Signatures: Have signature lines for the subject or legal representative and the investigator/research staff who administered consent. Label signature lines as well as indicate the date of signing.

For more guidance on writing an informed consent document, please contact the North Texas Regional Institutional Review Board (at 817-735-0409).

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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 (d)]:

(1) The research presents no more than minimal risk to subjects

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

(3) The research could not practicably be carried out without the waiver; and

(4) 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) and (4) must all apply and must be cited as justification for waiver of informed consent. Number (4) 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.

An investigator who qualifies for an alteration of federal required elements of consent must still disclose to subject pertinent study information. This consent can be in form of a recruitment/cover letter, which includes a brief study explanation and procedures. The letter should also include a brief statement about:

  • Risks associated with the study
  • Option to withdraw
  • Voluntary participation
  • Confidentiality and
  • Appropriate contact information (principal investigator and IRB Chairman)

If a research study qualifies for a waiver informed consent, the North Texas Regional IRB may require an investigator to have an oral or written script containing core information about the research study. Follow this link for a sample template of a cover/recruitment letter (used in lieu of informed consent).

Investigators must formally request a waiver of informed consent in the Waiver of Informed Consent or protocol synopsis. This request must also include a justification apart from citing the federal requirements. back to top

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:

(1) The only record linking the subject and the research would be the consent document; and the principal risk would be potential harm resulting from a breach of confidentiality.

45 CFR 46.117 (c) (1)

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.

OR

(2) The research presents no more than minimal risk of harm to subjects; and involves no procedures for which written consent is normally required outside the research context.

45 CFR 46. 117 (c) (2)

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. 

It is important to note that either regulation needs to apply in order to qualify for this waiver. Both do not need to apply to justify for this waiver. An explanation for waiver of documentation of consent must be included in the application or protocol synopsis.

An investigator who qualifies for a waiver of documentation of consent must still disclose to subject pertinent study information. This consent can be in the form of a recruitment cover letter, which includes a brief study explanation and procedures. The letter should also include a brief statement about:

  • Risks associated with the study
  • Option to withdraw
  • Voluntary participation
  • Confidentiality and
  • Appropriate contact information (principal investigator and IRB Chairperson)

If a research study qualifies for a waiver of documentation informed consent, the North Texas Regional IRB may require an investigator to have an oral or written script containing core information about the research study. Follow this link for a sample template of a cover letter/consent statement (used in lieu of informed consent). back to top

This page was last modified on April 18, 2019