Informed Consent

What is Informed Consent?
Informed consent is a process, not a form
More than a signature
Basic Principles
Autonomy
Beneficence
Justice
Your responsibility: protect and inform
What information is required on the consent form
Special requirements for special situations
Consent Checklist
Links to forms

What is Informed Consent?

Informed consent means the knowing consent of an individual without undue inducement or any element of force, fraud, duress or any other form of constraint or coercion. Sufficient information must be presented (in understandable language) so that the potential subject can make an informed judgment about participation. This information can take on a variety of shapes. It can be provided to the potential participant as: a document which may or may not require a signature; a script which is read to the participant prior to proceeding with a telephone survey; a paragraph to be read prior to completing an online survey.

Research involving human subjects can pose complex ethical issues which require careful thought and consideration on the part of both researchers and research participants. Prospective participants should always be given adequate information on both the possible risks and the potential benefits of their involvement to allow them to make informed decisions about whether or not to participate in the research.

Informed consent is a process, not a form

As a researcher, it is your responsibility to educate the participants about risks and benefits, obtain their consent before involving them in your research, and keep them informed. This is the "informed consent process".

It is essential that consent forms be written in plain language that research subjects can understand. The consent document should always be revised if there are changes in the study that might affect the participant or when additional information will improve the consent process.

In addition, the consent form should not contain any exculpatory language. That is, subjects should not be asked to waive (or appear to waive) any of their legal rights, nor should they be asked to release the investigator, sponsor, or institution (or its agents) from liability for negligence.

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More than a signature

Obtaining a signature on a consent document is important, but it is just one step in the continuous process of informed consent.

Informed consent is about people's understanding and willingness to participate in your study and not about signing a form. Prospective participants in your research study must understand the purpose, the procedures, the potential risks and benefits of their involvement, and their alternatives to participation. While a consent document that gives this information, and more, is a vital part of the process, the opportunity to discuss any questions or concerns with a knowledgeable research team member is also necessary.

Making an informed decision about participating in research includes having an understanding of the possible risks and benefits to their involvement, and knowing absolutely that they do not have to volunteer and can withdraw at any time.

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Basic Principles

To discern the key components of informed consent, you need to understand the ethical issues of research involving human subjects. The principles of autonomy, beneficence, and justice are basic to these ethical issues and merit your consideration.

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Autonomy

Autonomy means that each person should be given the respect, time, and opportunity necessary to make his or her own decisions. Prospective participants must be given the information they will need to decide to enter a study or not to participate. There should not be pressure to participate. Likewise, there should also be no unrealistic inducements to participate in a study.

The principle of autonomy requires that protection be given to potentially vulnerable populations such as children, the elderly, the mentally ill, or prisoners. Individuals in these groups may be incapable of understanding information that would enable them to make an informed decision about study participation. They are considered potentially "vulnerable." Consequently, careful consideration of their situation and needs is required and extra care must be taken to protect them. For example, how will you assess the diminished capacity of an elderly individual, who will be the guardian, and how and when will you involve another individual as guardian in the process?

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Beneficence

Beneficence obligates you, as the researcher, to secure the well-being of all study participants. It is your responsibility to protect participants from harm, as well as ensure that they have an equal opportunity to experience the possible benefits of involvement.

Balancing risks and benefits is an important consideration. The key, according to the 1979 Belmont Report on the protection of human subjects, is to "maximize possible benefits and minimize possible harms."

When do the benefits to society outweigh the possible risks of research? This is an ethical question that researchers face. The peer review process and the principle of beneficence help you answer this question and protect your research participant's rights.

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Justice

The ethical considerations of risks versus benefits raise the question of justice. Who should bear the risk of a study? Who is equal and who is not? Who should receive the benefits of the study?

The concept of justice may be questioned when we attempt to decide who will be given an opportunity to participate and who (and for what reason) will be excluded. Are some classes or persons being selected simply because of their availability, their compromised position, or their manipulability while others are not?

Keep the following tips in mind when selecting prospective participants:

  • Participants should not be selected due to class, socioeconomic status, or race unless justified by study objectives.
  • Provide justification or sound arguments for the exclusion criteria.
  • Avoid the potential for “power-based” coercion. An existing relationship might require special consideration when expanding that relationship to include investigator-subject role. Provision, or adjustments, might need to be made to attempt to equalize the roles.

For example:

  • Professors may not administer surveys in their own classrooms but need to find an unbiased person to perform that duty.
  • Teacher-student relationships always carry a perception of inequality in roles. The informed consent process should reflect the precautions taken to balance the relationship and guard against even the perception of coercion.

Justice is a difficult and complex ethical issue. However, attempt at all times in your study to distribute the risks and benefits fairly and without bias.

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Your responsibility: protect and inform

Keep the principles of autonomy, beneficence, and justice in mind when you are selecting participants, obtaining consent, and conducting your study. The responsibility to protect and inform research participants is ultimately yours and cannot be ignored or delegated. Although you may delegate various tasks to certain team members, you cannot delegate the responsibility of protecting and informing participants of their rights.

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What information is required on the consent form?

NOTE: All informed consent documents must be submitted on appropriate letterhead stationery.

  • The following is a list of the minimum information which should be provided for all types of research including anonymous surveys or questionnaires as required by the Code of Federal Regulations:
  • A statement that the study involves research
  • Explanation of the purposes of the research
  • Name(s) of the principal researchers and sponsor(s) where appropriate
  • Expected duration of the subject's participation
  • Description of the procedures to be followed
  • Identification of any procedures which are experimental
  • Description of any reasonably foreseeable risks or discomforts to the subject
  • Description of any benefits to the subject or to others which may reasonably be expected from the research
  • For research involving more than minimal risk, an explanation as to whether there are any treatments or compensation if injury occurs and, if so, what they consist of, or where further information may be obtained
  • NOTE: A risk is considered "minimal" when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests)
  • Explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights
  • Statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  • Statement that participation is voluntary, their right to decline to participate and to withdraw from the research once participation has begun and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

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Special requirements for special situations

Course requirements: When research participation is a course requirement or an opportunity for extra credit, the prospective participant is given the choice of equitable alternative activities.

Participants incapable of giving informed consent: For persons who are legally incapable of giving informed consent, you must, nevertheless (1) provide an appropriate explanation, (2) seek the individual's assent, (3) consider such persons' preferences and best interests, and (4) obtain appropriate permission from a legally authorized person, if such substitute consent is permitted or required by law.

Web-based studies and obtaining consent: In the case of web-based studies, informed consent can be "documented" by requiring participants to click on a link or image that

  • (1) indicates acceptance of the consent form (i.e. a button that says "I accept" or "I agree", and
  • (2) advances participants to an online study web page that is otherwise inaccessible.
  • The consent form for web-based studies must:
    • contain all the elements ordinarily required in a consent form clearly identifying the institutional review board that approved the study (e.g., the UNC Charlotte Institutional Review Board),
    • state the name and email address of the principal investigator (or faculty supervisor if the study is a student project), and
    • provide information for participants who:
      • wish to discuss their rights as participants in the study (e.g., the name and telephone number of the Compliance Office).
      • would like more information about the study itself (e.g. the name and telephone number of the investigator).
    • inform participants that responses transmitted over the World Wide Web may not be secure (unless the study is using a secure server with "https" rather than "http")

Assent from minors: Assent is defined as "a child’s affirmative agreement to participate in research." By the same token, a child’s passive resignation to submit to an intervention or procedure should not be considered assent.

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research recommends that the assent of children should be required when they are seven years of age or old (i.e. ages 7-17).

UNC Charlotte’s IRB believes that children should be given the opportunity to express or discuss their willingness to participate in a given research project or not and recommends that the assent process should be developmentally appropriate to the age of the children. For the intelligent older child, the assent process may be almost indistinguishable from the consent process one would use with a competent adult. For a younger child, it may be a much simpler process.

The researcher should take into account the child's experience and level of understanding and compose a document that is at the same time respectful of the child and conveys the essential information the child needs to make a decision.

In language the child can understand, the form should:

  • include a brief statement of purpose;
  • describe procedures (including time commitment);
  • affirm the voluntary nature of the assent process;
  • describe, if applicable, any pain or discomfort that may be experienced;
  • include a brief explanation of alternatives, if applicable;
  • describe benefit or compensation, if any; and
  • offer to answer questions.

While the design of an assent form is a critical component of the assent process, no form will ever replace the thoughtful discussion of assent with a child.

Other thoughts on the assent form: Limit the document to one page if possible. Include or attach pictures or any graphics that might be helpful to convey information to the child. Use of larger type might also be helpful to young children. Studies involving older children or adolescents should include more information and may use more complex language than studies involving younger children.

Waiver or Alteration of Informed Consent Procedure: Investigators may request a waiver of informed consent or an alteration of the consent procedure if certain criteria are met. In these cases, the IRB may approve a consent procedure that does not include or that alters some or all of the elements of informed consent. The following criteria must be met:

  • The research involves no more than minimal risk to the subjects;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The research could not practicably be carried out without the waiver or alteration and, where appropriate,
  • The subjects will be provided with additional pertinent information after participation.

It is the responsibility of the investigator to provide sufficient reason(s) why the waiver is necessary and explain whether the entire informed consent is being waived. 

Waiver of Documentation of Informed Consent: The regulations require written, signed documentation of consent, unless waived by the IRB. The use of digital signatures is not yet a common practice and, in most cases, there is no way to obtain this kind of consent documentation over the Internet.

An IRB may waive the requirement for actual signatures if it finds either:

  • That the only record linking the subject and the research would be the consent document and the principal risk would be the potential harm resulting from a breach of confidentiality, or
  • That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent in normally required outside of the research context.

Consent document revisions in on-going studies: Study participants need to be informed of any new and important information that might affect their willingness to participate. If new information, knowledge, or an adverse event has been discovered, it should be communicated to the subjects. This may require a revised consent document.

New information will require the investigator evaluate the facts to decide on a revised consent document for future participants as well as what information should be given to former or current subjects. If existing subjects are being re-consented, then the changes should be highlighted for them instead of just giving them a new form to sign with the changes imbedded in it.

Unexpected complications, adverse events, or breaches in confidentiality all signify developments that may require a revised consent form. Consult the IRB to establish if a revised document is required.

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Consent checklist

Print the Consent Checklist to use as a handy guide during the development of your consent form. The items reflected in the Checklist are based on requirements from the U.S. Office for Human Research Protections (OHRP) Code of Federal Regulations (CFR).

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Links to:

Consent Checklist 
Consent Template
Consent Sample#1 - Age 18+
Consent Sample#2 - Age 18+
Parental Consent Sample#1
Parental Consent Sample#2
Parental Consent Sample#3
Assent for Minors(7-14)
Assent Minors(15-17)
Online Consent Sample#1
Online Consent Sample#2
 

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